BIOTECHNOLOGY INDUSTRY ANALYSIS

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A MINI PROJECT ON
ANALYSIS OF BIOTECHNOLOGY INDUSTRY
IN INDIA
Submitted by:
P.PAVANI SRIJA,
MBA II SEM,
Reg. no.: 22HX1E0093.
Under the guidance of
Ms.PRANAVASREE,
(ASSISTANT PROFESSOR)
SANSKRITHI SCHOOL OF BUSINESS, PUTTAPARTHI
(Affiliated to JNTU, Anantapur)

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CONTENTS
CHAPTER
NUMBER
CHAPTER
NAME
PAGE
NO
1 INTRODUCTION 3-6
2 INDUSTRY
PROFILE
7-15
3 INDUSTRIAL
DESIGN
16-38
STRUCTURE 16-26
CULTURE 27-33
CLIMATE 33-38
4 SWOT ANALYSIS 39-40
5 SUMMARY OF
FINDINGS
41
6 SUGGESTIONS 42-43
7 CONCLUSION 44
- MISCELLANEOUS 45

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CHAPTER NO.1
INTRODUCTION
WHAT IS BIOTECHNOLOGY INDUSTRY?
Biotechnology is a field that uses living organisms or their parts to develop useful products and technologies.
It involves using the knowledge of biology to create new and improved ways to solve problems and make
our lives better.
In the biotechnology industry, scientists and researchers work with things like cells, genes, and proteins to
develop new medicines, treatments, and technologies. They use advanced techniques to modify or
manipulate these living things to produce desired outcomes.
For example, in medicine, biotechnology has led to the development of various drugs and therapies.
Scientists can modify genes to produce proteins that can fight diseases, create vaccines to prevent infections,
or develop treatments that target specific diseases based on a person's genetic makeup.
Biotechnology also has applications in agriculture, where scientists can genetically modify plants to make
them more resistant to pests or improve their nutritional value. It can help increase crop yields and develop
more sustainable farming practices.

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In addition, biotechnology plays a role in environmental conservation by creating solutions for waste
management, developing biofuels as alternatives to fossil fuels, and cleaning up polluted environments using
biological processes.
The biotechnology industry includes companies, research institutions, and laboratories that work on
developing and commercializing these biotech products and technologies. It is an exciting and rapidly
growing field that has the potential to address some of the most pressing challenges we face in healthcare,
agriculture, and the environment.
Highlights of Indian Biotechnology industry:
 Largest Supplier of DPT, Measles and BCG Vaccines
 Developed World’s First DNA Vaccine Against COVID-19
 World's highest number of USFDA Approved Manufacturing Plants Outside the USA.
OBJECTIVES:
 To identify key growth drivers and trends in the biotechnology industry.
 To assess the competitive landscape of the biotechnology industry.
 To analyze the regulatory environment impacting the biotechnology industry.
 To know the financial performance of biotechnology companies.
 To understand the current and emerging technologies and their potential impact on the biotechnology
industry.
 To identify potential opportunities and challenges for biotechnology companies.
 To determine the factors influencing the adoption of biotechnology solutions by various industries
and governments.
 To know ethical implications of biotechnology innovations.
SCOPE:
The biotechnology industry encompasses various sectors that use biological processes, organisms, and
systems to develop products and services. It involves the application of scientific and engineering principles
to create new knowledge and develop innovative technologies. The scope of biotechnology industry is vast
and includes the following sectors:

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1. Healthcare: Biotech companies are developing new drugs and therapies for various chronic and
acute diseases, including cancer, diabetes, autoimmune diseases, and genetic disorders.
2. Agriculture: Biotech companies are developing genetically modified (GM) crops that can withstand
diseases, pests, and adverse weather conditions, resulting in increased crop yield and reduced
pesticide use.
3. Industrial Biotechnology: Biotech companies are using biological processes to produce biofuels,
biomaterials, and other sustainable products that reduce the reliance on fossil fuels and minimize
environmental impact.
4. Environmental Biotechnology: Biotech companies are developing innovative technologies to tackle
environmental challenges such as pollution, waste management, and climate change.
5. Forensic Science: Biotechnology is increasingly being used in forensics to identify and analyze
DNA evidence, trace the origin of biological samples, and provide evidence in criminal cases.
6. Research and Development: Biotech companies are continuously investing in research and
development to discover new technologies and innovations that can improve human health and
wellbeing.
In summary, the biotechnology industry has a wide scope and is transforming various sectors by developing
innovative solutions to social, economic, and environmental challenges.
LIMITATIONS:
1. Complexity of technology: Biotechnology is a highly complex field that requires specialized skills and
knowledge. Although advances in technology have made some aspects of biotech more accessible,
complexity remains a significant barrier to entry for many potential investors and entrepreneurs.
2. Regulation and safety concerns: Biotech regulations can vary significantly from one region or country
to another, and regulatory approval can be a long and challenging process. Additionally, there are often

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public safety concerns associated with biotech products and practices, which can create obstacles to
commercialization.
3. Ethics and social acceptance: Many biotech advancements raise ethical or moral dilemmas relating to
their potential impact on society, the environment, or life itself. As such, public opinion on the biotech
industry can be divided, making it difficult to secure funding or gain approval for new projects.
4. Intellectual property challenges: The protection of intellectual property rights is a key challenge for the
biotech industry, which relies heavily on patents to safeguard products and processes. Maintaining these
patents can be very expensive and time-consuming, potentially stymieing innovation and competition.
5. Market competition: The biotech industry is highly competitive, and companies must navigate a
complex landscape of established players, emerging technologies, and shifting consumer preferences

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CHAPTER NO.2
INDUSTRY PROFILE
HISTORY AND DEVELOPMENT OF BIOTECHNOLOGY INDUSTRY:
Biotechnology is the application of scientific methods to modify living organisms to develop products or
new forms of life. India has been using biotechnology methods for centuries in the form of traditional
medicine and agriculture practices. However, modern biotechnology has been introduced in India since the
1980s.
The Department of Biotechnology (DBT) was created in 1986 to oversee and promote biotechnological
research in India. In the same year, the first National Biotechnology Conference was held in New Delhi to
discuss biotechnology development in India.

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In the 1990s, India started to focus on biotechnology for sustainable agriculture and food security. The
development of genetically engineered crops started to gain momentum, and the first genetically modified Bt
cotton was commercialized in 2002. India is now the fourth-largest producer of biotech crops in the world
after the United States, Brazil, and Argentina.
In the early 2000s, India started to focus on biotechnology for healthcare applications, such as diagnostics,
vaccines, and therapeutics. The indigenous development of hepatitis-B vaccine by Shantha Biotechnics was
an important milestone for India's biotech industry. India is now a major exporter of generic drugs and
vaccines to the world.
Recently, India has been focusing on developing biotechnology in the areas of industrial biotechnology,
bioenergy, and environmental biotechnology. The government has announced many initiatives, including the
Biotechnology Industry Partnership Program, the Biotech-Krishi Innovation Science Application Network,
and the National Biotechnology Development Strategy, to promote biotechnology innovation and
entrepreneurship.
India has emerged as a leading biotechnology destination in the world due to the combination of a talented
workforce, immense biodiversity, and a cost-effective research and development system. The biotechnology
industry in India is expected to grow rapidly in the coming years, and India could become a major player in
the global biotechnology landscape.
DETAILS OF BIOTECHNOLOGY INDUSTRY:
Biotechnology industry in India is one of the fastest-growing industries and has immense potential for
growth in the future. The sector has seen tremendous progress and investment in the last few years, making
India a hub for biotech research and development.

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Here are a few details about the biotechnology industry in India:
 In 2019, the biotechnology industry in India was worth about $64 billion and is projected to reach $150
billion by 2025.
 The Government of India has invested significantly in the biotech industry, and as of March 2020, the
Ministry of Science and Technology set aside INR 7,837.50 crore ($1.1 billion) for research and
development. The government has also set up various biotech parks, research centers, and incubation
centers to promote the growth of the sector.
 India has a robust R&D infrastructure with over 600 biotech companies engaged in research activities.
There are more than 50 research centers, 28 biotech parks, and 15 biotech incubation centers in India.
 The biotech industry in India produces a variety of products such as vaccines, biopharmaceuticals,
biosimilars, gene therapy products, and industrial enzymes among others.
 The biotech industry in India provides employment to around 250,000 people, and this number is
expected to grow in the future with the sector's expansion.
 The Indian biotech industry faces challenges such as high costs of research and development, lack of
skilled manpower, and regulatory challenges that affect the approval process for new products.
 India has a diverse range of biological resources, and there is an immense potential for innovation in the
sector. The government has also launched various initiatives such as Make in India, Startup India, and
Atma Nirbhar Bharat to promote and support the growth of the biotech industry.
Overall, the biotech industry in India is growing at an unprecedented pace and has the potential to contribute
significantly to the growth of the Indian economy.
TURNING POINT FOR BIOTECHNOLOGY INDUSTRY:
The biotechnology industry in India has been witnessing significant growth in recent years, thanks to a
multitude of factors such as supportive government policies, growing investor interest, and the emergence of
cutting-edge technologies. However, one particular event that is considered a turning point for the biotech
industry in India is the introduction of the National Biotechnology Development Strategy (NBDS) in
2015. The NBDS is a comprehensive roadmap that aims to make India a global hub for cutting-edge
biotechnology research and innovation. The strategy prioritizes key areas such as health, agriculture,
environment, and industrial biotechnology, and outlines specific goals and targets to be achieved over a ten-
year period.
One of the key highlights of NBDS is the establishment of an Investment Fund for New Biotechnology
Startups that provides funding and infrastructure support to young entrepreneurs and researchers in the

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biotech space. The fund has helped kickstart several promising startups that have gone on to achieve great
success in the global biotech market.
Another important aspect of the NBDS is the creation of a Biotechnology Industry Partnership Programme
that acts as a bridge between industry and academia and facilitates collaboration between the two sectors.
Through this program, several research projects have been initiated that have the potential to translate into
groundbreaking discoveries.
Overall, the introduction of the NBDS has been a game-changer for the biotech industry in India. It has
provided a clear roadmap for growth and development, encouraged innovation and entrepreneurship, and
helped establish India as a leading player in the global biotech market.
SUCCESS FACTORS FOR BIOTECHNOLOGY INDUSTRY:
Here are some success factors for the biotechnology industry in India:
1. Strong government support: The Indian government has been supportive of the biotechnology industry
and has implemented policies and initiatives that have encouraged the development of the sector.
2. Skilled workforce: India has a large pool of highly skilled and trained scientists and researchers who are
educated in biotechnology and related fields, creating a robust workforce for the industry.
3. Cost-effective research: India has a cost-effective research and development (R&D) infrastructure,
which enables companies to conduct R&D at much lower costs compared to other countries.
4. Collaborations and partnerships: The biotechnology industry in India has benefited from numerous
collaborations and partnerships with international organizations, academic institutions, and industry partners,
which has helped them to access new technologies, gain new insights, and enter new markets.

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5. Access to capital: Indian biotech companies have been receiving increasing amounts of investment from
both domestic and foreign investors, providing them with the necessary capital to develop and
commercialize their products.
6. Well-developed regulatory framework: India has a well-developed regulatory framework for the
biotechnology industry, ensuring that companies adhere to the highest safety and quality standards while
developing and producing their products.
7. Growing market opportunities: India has a large and growing market for biotech products, with rising
demand for healthcare and agriculture-related biotech solutions, creating significant opportunities for Indian
biotech companies.
COMPETITORS:
Biotechnology industry in India has competitors from other industries that indirectly compete with biotech
companies.
1. Pharmaceutical Industry: The pharmaceutical industry develops and produces traditional chemical-
based drugs and therapies, which can compete with biotech products in certain therapeutic areas. Both
industries aim to address healthcare needs but often employ different approaches.
2. Healthcare Services: The healthcare services sector includes hospitals, clinics, diagnostic centers, and
healthcare providers. While not directly involved in biotech research or manufacturing, they provide
alternative treatment options and services that may compete with biotech products or therapies.
3. Medical Device Industry: Medical devices, such as diagnostic equipment, implants, and surgical
instruments, serve as alternatives or complementary solutions to biotech therapies. Companies in the medical
device industry may offer competing products or technologies.

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4. Nutraceutical and Dietary Supplements: The nutraceutical industry focuses on products derived from
natural sources, including vitamins, minerals, herbal supplements, and functional foods. These products can
sometimes overlap with biotech products, especially in areas related to nutrition and wellness.
5. Agricultural and Agrochemical Industry: While not directly in the healthcare domain, the agricultural
and agrochemical industries are involved in the development and production of genetically modified crops,
agricultural biotechnology products, and agricultural inputs. They may share some common biotech
techniques and compete in terms of research or technological advancements.
6. Technology and Digital Health Companies: With the rise of digital health technologies, telemedicine,
health apps, and wearable devices, technology companies that offer healthcare solutions or platforms can
indirectly compete with certain aspects of the biotech industry, such as diagnostics or remote monitoring.
Market dynamics and the pace of innovation further contribute to the complexity of competition within and
outside the biotech industry in India.
DEPARTMENTS:
In the biotechnology industry, various departments play crucial roles in the research, development,
manufacturing, and commercialization of biotech products and technologies. Here are some common
departments in the biotech industry.
1. Research and Development Department: This department is
responsible for conducting research in the field of biotechnology,
developing new products, tools, and technologies, and testing and
validating existing products.
2. Manufacturing and Operations Department: This
department is responsible for the scale-up and production of
biotech products on a commercial scale. They oversee
manufacturing processes, quality control, supply chain
management, logistics, and distribution. This department ensures efficient and compliant production of
biotech products.
3. Quality Assurance Department: This department is responsible for ensuring that the products
manufactured are of high quality and meet the regulatory standards. They conduct quality checks at various
stages of development and production.

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4. Regulatory Affairs Department: This department is responsible for ensuring compliance with regulatory
requirements and obtaining approval for products from regulatory authorities.
5. Sales and Marketing Department: This department is responsible for promoting and selling products to
customers, such as hospitals, drug stores, and medical facilities.
6. Medical Affairs Department: This department is responsible for providing medical information and
support to healthcare professionals and patients.
7. Human Resources Department: This department is responsible for recruiting, training, and managing
the workforce in the biotechnology industry.
8. Finance and Accounting Department: This department is responsible for managing the financial
operations of the company, including budgeting, accounting, and financial reporting.
9. Information Technology Department: This department is responsible for managing information
technology infrastructure and systems, including computer networks, hardware, and software.
PRODUCTS AND SERVICES OF BIOTECH INDUSTRY:
The biotech industry in India has a wide range of products and services that are aimed at addressing various
health challenges and improving the quality of life. Here are some of the key products and services of the
biotech industry in India:
 Biopharmaceuticals:
 Vaccines: India is a major producer of vaccines for various diseases such as COVID-19, hepatitis B,
polio, and meningitis.

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 Biosimilars: India is a significant player in the biosimilars market, producing affordable versions of
biologic drugs for diseases like cancer, diabetes, and rheumatoid arthritis.
 Insulin: Recombinant human insulin produced by biopharmaceuticals has several advantages over
animal-derived insulin, including reduced risk of allergic reactions and better consistency in dosing.
 Regenerative medicine: Regenerative medicine is a field of biopharmaceuticals that aims to restore
or replace damaged tissues or organs by using cells, biomaterials, and growth factors. It includes a
range of technologies such as stem cell therapy, tissue engineering, and gene therapy.
 Medical devices: Biotechnology industry is involved in manufacturing and marketing medical
devices. Medical devices are products that are used to diagnose, prevent, or treat medical conditions.
In the biopharmaceutical industry, medical devices can range from simple tools such as syringes and
catheters to complex devices such as implantable pacemakers and robotic surgical systems.
 Bio Services
 Clinical research: Clinical research is a critical component of the bio services. It involves the
evaluation of new drugs, devices, and treatments in human subjects to determine their safety,
efficacy, and optimal dosage.
 Contract research and manufacturing services (CRAMS): India has become a hub for contract
research and manufacturing services for biotech companies around the world. It is outsourcing of
research activities by biopharmaceutical companies to third-party organizations
 Bio Agri services
 Biofertilizers,Biopesticides are living microorganisms that are added to soil to enhance its fertility
and promote plant growth. They are used as an alternative to chemical fertilizers and pesticides
which can have negative environmental impacts and can also lead to the development of resistance in
pests and diseases.
 Hybrid seeds are produced by cross-breeding two genetically different parent plants to create a new
plant variety with desirable traits such as improved yield, disease resistance and quality
 Bio Industrial services
 Biofuels are fuels that are produced from renewable biological resources, such as crops, algae, and
organic waste. They are an alternative to fossil fuels, which are finite and contribute to climate
change.
 Biopolymers are polymers that are produced from natural, renewable resources, such as plant-based
materials, instead of synthetic, petroleum-based materials.
 Industrial enzymes are proteins derived from living organisms, such as bacteria, fungi, and plants,
that are used in various industrial processes. These enzymes act as catalysts, accelerating chemical
reactions or facilitating specific biological processes.
 Bio-IT

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 Bioinformatics is an interdisciplinary field that combines biology, computer science, statistics, and
mathematics to analyze and interpret biological data, such as DNA and protein sequences, gene
expression patterns, and protein structures.
 Big data is an important aspect of bioinformatics, as the field deals with large amounts of biological
data that requires advanced computational tools and methods to process and analyze. The increasing
availability of large-scale biological data sets has led to the development of new computational
techniques and approaches in bioinformatics, such as machine learning, data mining, and network
analysis.
 Precision medicine is an approach to healthcare that aims to tailor medical treatments to an
individual's specific genetic, environmental, and lifestyle factors.
 Overall, the biotech industry in India is playing a significant role in developing innovative solutions to
address global health challenges and is poised for further growth and expansion in the coming years.

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CHAPTER NO.3
INDUSTRIAL DESIGN
INDUSTRIAL STRUCTURE
The Biotechnology industry is driven by scientific advancements and research in areas such as genomics,
genetic engineering, molecular biology, and cell biology. Biotech companies conduct extensive research and
development (R&D) activities to discover new drugs, therapies, and technologies. They often collaborate
with academic institutions, research organizations, and government agencies to accelerate innovation and
knowledge exchange.Here is an overview of the agencies of biotechnology industry in India:
 Government Bodies and Regulatory Agencies: The Department of Biotechnology (DBT) and the
Indian Council of Medical Research (ICMR) are two key government bodies responsible for promoting
and regulating biotechnology activities in India. They provide funding, set policies, and oversee the
development of the industry.
Here are some key government agencies:
The Central Government is responsible for major policy relating to higher education in
India. Figure shows the administrative organisational set-up of the government agencies involved in the
funding of public research. The National Biotechnology Board (NBTB) under the Ministry of Science
and Technology, as an apex coordinating body to identify priorities, oversee and plan for required
manpower, integrated industrial development and large-scale use of biotechnology products and
processes. Several government agencies like Department of Science and Technology (DST), Department
of Scientific and Industrial Research (DSIR), Council for Scientific and Industrial Research (CSIR),

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Indian Council for Agricultural Research (ICAR), Indian Council for Medical Research (ICMR),
Department of Atomic Energy (DAE) and University Grant Commission (UGC) are dedicated to
biotechnology development in India. The UGC is responsible for the coordination, determination and
maintenance of standards and for the release of grants. The Department of Biotechnology (DBT) is
promoting the development of specialised degrees, such as MSc in Biotechnology or Bio-informatics in
several institutions. The State Governments are responsible for the establishment of State Universities
and colleges, and provide plan grants for their development and non-plan grants for their maintenance.
 Research and Academic Institutions: Several renowned research institutions and universities in India
contribute to the biotechnology industry. These include the Council of Scientific and Industrial Research
(CSIR) labs, Indian Institutes of Technology (IITs), Indian Institutes of Science Education and Research
(IISERs), and universities with dedicated biotechnology departments. These institutions engage in
cutting-edge research, technology development, and human resource training.
 Biotechnology Companies: India is home to numerous biotechnology companies, including both large
corporations and startups. These companies focus on different areas of biotechnology, such as
pharmaceuticals, diagnostics, agricultural biotechnology, industrial biotechnology, and bioinformatics.
Some notable Indian biotech companies under each category are
1. Bio-Pharmaceuticals:
Bio-pharmaceuticals, also known as biologics, are pharmaceutical drugs that are produced using
living organisms or their components, such as cells, proteins, nucleic acids, or antibodies. Unlike
traditional pharmaceutical drugs that are synthesized chemically, bio-pharmaceuticals are derived
from biological sources and exhibit complex structures and mechanisms of action.
Here are some key features and examples of bio-pharmaceuticals:
 Production: Bio-pharmaceuticals are typically produced through recombinant DNA
technology, where specific genes are inserted into host organisms, such as bacteria, yeast, or
mammalian cells. These host cells then produce the desired protein or molecule, which is
subsequently purified and formulated into a drug.
 Types: Bio-pharmaceuticals include a wide range of therapeutic products, such as:
- Recombinant proteins: These are proteins produced by genetically modified
organisms, and they include insulin, growth factors, blood clotting factors, and
cytokines.

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- Monoclonal antibodies: These are antibodies that target specific proteins or cells in
the body and are used in the treatment of various diseases, including cancer,
autoimmune disorders, and inflammatory conditions.
- Vaccines: Vaccines are bio-pharmaceuticals that stimulate the immune system to
provide protection against infectious diseases. They can be made from inactivated or
attenuated pathogens, as well as from specific proteins or genetic components of the
pathogens.
- Gene therapies: Gene therapies involve the introduction of genetic material into cells
to treat or prevent diseases. This can be achieved by delivering genes that encode
therapeutic proteins or by modifying existing genes to correct genetic disorders.
- Cell therapies: Cell therapies involve the use of living cells to treat diseases.
Examples include stem cell therapies for regenerative medicine, chimeric antigen
receptor (CAR) T-cell therapies for cancer treatment, and tissue-engineered products
for organ replacement or repair.
Top Biopharmaceutical companies in India :
- Biocon Limited
- Dr. Reddy's Laboratories Limited
- Lupin Limited
- Cadila Healthcare Limited
- Aurobindo Pharma Limited
- Glenmark Pharmaceuticals Limited
- Torrent Pharmaceuticals Limited
- Alembic Pharmaceuticals Limited
- Emcure Pharmaceuticals Limited
Top companies that produce Vaccines in India:
- Serum Institute of India
- Bharat Biotech International Limited

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2. Diagnostics:
Bio-diagnostics, also known as in vitro diagnostics (IVDs), refers to medical tests or procedures that
are performed on samples taken from the human body, such as blood, urine, or tissue, to aid in the
diagnosis, monitoring, and management of diseases or conditions. These tests provide valuable
information about a patient's health status and help healthcare professionals make informed decisions
regarding patient care.
Here are some key aspects of bio-diagnostics:
 Types of Tests: Bio-diagnostics encompass a wide range of tests and procedures, including:
- Clinical Chemistry Tests: These tests measure the levels of various substances, such
as glucose, cholesterol, electrolytes, enzymes, and hormones, in bodily fluids. They
are used to assess organ function, diagnose diseases, and monitor treatment
effectiveness.
- Hematology Tests: Hematology tests analyze blood samples to evaluate the cellular
components, such as red blood cells, white blood cells, and platelets. They help
diagnose and monitor conditions like anemia, infections, and blood disorders.
- Microbiology Tests: These tests identify and characterize microorganisms, such as
bacteria, viruses, fungi, and parasites, in clinical samples. They aid in the diagnosis of
infectious diseases and guide appropriate treatment.
- COVID-19 Diagnostics: The COVID-19 pandemic has highlighted the importance of
diagnostic testing, and India has witnessed a significant surge in COVID-19
diagnostic capabilities. Indian companies have played a crucial role in developing and
manufacturing COVID-19 test kits, including RT-PCR tests, rapid antigen tests, and
antibody tests.
- Immunology Tests: Immunology tests assess the immune system's response by
measuring antibodies, antigens, or immune cells in the blood. They help diagnose
autoimmune disorders, allergies, and infectious diseases.
- Molecular Diagnostics: Molecular diagnostic tests detect and analyze genetic
material (DNA or RNA) to identify genetic variations, mutations, or infectious agents.
They are used in diagnosing genetic disorders, cancer, infectious diseases, and
personalized medicine.
- Point-of-Care (POC) Testing: POC tests are performed near the patient, often at the
bedside or in a doctor's office, providing rapid results. Examples include pregnancy
tests, glucose meters for diabetes management, and rapid infectious disease tests.

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- Imaging Diagnostics: While not strictly bio-diagnostics, imaging techniques like X-
rays, ultrasound, computed tomography (CT), magnetic resonance imaging (MRI),
and positron emission tomography (PET) are commonly used in medical diagnosis
and complement bio-diagnostics.
Top Bio-diagnostic companies in India:
- Mylan Laboratories Limited
- Transasia Bio-Medicals Limited
- Bio-Rad Laboratories India Private Limited
- Thermo Fisher Scientific India Private Limited
3. Contract Research:
Contract research in biotechnology refers to the outsourcing of research and development (R&D)
activities to specialized research organizations or contract research organizations (CROs) by
biotechnology companies, pharmaceutical companies, and academic institutions. In the context of
India, contract research in biotechnology has seen significant growth and plays a vital role in
supporting the biotech industry. Here are some key points regarding contract research in
biotechnology in India:
 Services Offered: Contract research organizations in India offer a wide range of services to
their clients, including:
- Preclinical Research: Conducting studies on animals or in vitro systems to evaluate
the safety and efficacy of new drug candidates or other biotechnology products.
- Clinical Trials: Conducting human trials to assess the safety, efficacy, and side
effects of new drugs, therapies, or medical devices.
- Analytical Testing: Providing analytical services to evaluate the quality, purity, and
stability of biotech products, including pharmaceuticals, biopharmaceuticals, and
medical devices.
- Formulation Development: Assisting in the development and optimization of dosage
forms for drug delivery, including tablets, capsules, injectables, and topical
formulations.

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- Regulatory Support: Assisting in regulatory affairs and submissions, including
preparing documentation, conducting gap analysis, and ensuring compliance with
regulatory requirements.
- Bioinformatics and Data Management: Providing bioinformatics analysis, data
management, and statistical analysis for clinical trials and other research projects.
- Customized Research: Offering specialized research services tailored to the specific
needs of clients, such as target validation, biomarker discovery, genomics, proteomics,
and molecular biology studies.
 Expertise and Infrastructure: Contract research organizations in India have developed
expertise in various areas of biotechnology and pharmaceutical research. They often have
state-of-the-art infrastructure, including laboratories, animal facilities, clinical trial centers,
and advanced analytical equipment. These resources enable them to provide high-quality
research services to their clients.
 Cost-Effectiveness: One of the reasons India has become a preferred destination for contract
research is its cost-effectiveness. The availability of skilled researchers and competitive
pricing make India an attractive option for outsourcing research activities, offering potential
cost savings compared to conducting research in developed countries.
Top Contract research companies in India:
- Syngene International Limited
- GVK Biosciences Private Limited
- IQVIA India
4. Agricultural Biotech:
Agricultural biotechnology, or agri-biotech, in India refers to the application of biotechnology
techniques and tools in agriculture to improve crop productivity, sustainability, and food security.
Agri-biotech plays a significant role in addressing challenges such as crop diseases, pests, climate
change, and limited natural resources.
 Here are some key services of agri-biotech in India:
- Genetically Modified (GM) Crops: India has been a prominent player in the adoption and
cultivation of genetically modified crops. Bt cotton, a genetically modified cotton variety that

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produces an insecticidal protein, is the most widely grown GM crop in the country. Bt cotton
has helped in reducing the damage caused by bollworm pests and increasing cotton yields.
- Crop Improvement: Agri-biotech research in India focuses on developing crops with
improved traits, such as enhanced yield, drought tolerance, disease resistance, and nutritional
value. Techniques like genetic engineering, marker-assisted selection, and genome editing are
employed to introduce desirable traits into crops.
- Hybrid Seed Development: Agri-biotech companies in India are engaged in developing
hybrid seeds through biotechnological approaches. Hybrid seeds offer improved
characteristics, including higher yield potential, better resistance to diseases and pests, and
improved adaptability to different environmental conditions.
- Disease and Pest Control: Agri-biotech plays a vital role in developing disease and pest-
resistant crops. Biotechnology techniques enable the introduction of genes that confer
resistance to specific diseases or pests, reducing the dependence on chemical pesticides and
promoting sustainable farming practices.
- Crop Protection: Agri-biotech also involves the development of biopesticides and biocontrol
agents derived from naturally occurring organisms, such as bacteria, fungi, and viruses, to
control pests and diseases in an environmentally friendly manner.
- Seed Technology: Agri-biotech companies in India focus on seed technology innovations,
including seed treatment methods, seed quality testing, and seed storage techniques. These
advancements help ensure the availability of high-quality seeds for farmers, promoting better
crop establishment and productivity.
 Biotech Inputs: Agri-biotech in India extends beyond crops to include the development of
biotechnology-based inputs for agriculture. This includes biofertilizers, which are beneficial
microorganisms that enhance nutrient availability to plants, and biostimulants that improve
plant growth and resilience.
 Public and Private Sector Collaboration: Agri-biotech research in India involves
collaborations between public research institutions, agricultural universities, and private agri-
biotech companies. These collaborations help in knowledge sharing, technology transfer, and
capacity building for sustainable agricultural practices.
 Regulatory Framework: The use of agri-biotech products in India is regulated by the
Ministry of Environment, Forest and Climate Change (MoEFCC) and the Genetic
Engineering Appraisal Committee (GEAC). The regulatory framework ensures the safety,
efficacy, and environmental impact assessment of genetically modified crops and biotech
products.
Top Agri biotech companies in India:

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- Mahyco Monsanto Biotech (India) Limited
- Rasi Seeds Private Limited
- JK Agri Genetics Limited
5. Bioinformatics:
Bioinformatics in India refers to the interdisciplinary field that combines biology, computer science,
and statistics to analyze and interpret biological data. It involves the application of computational
methods, algorithms, and tools to organize, analyze, and extract meaningful insights from biological
information, including DNA sequences, protein structures, gene expression data, and clinical data.
Here are some key points about bioinformatics in India:
- Research and Education: India has a strong presence in bioinformatics research and
education. Several academic institutions, research organizations, and universities offer
bioinformatics programs, courses, and research opportunities. These institutions focus on
training students and researchers in bioinformatics techniques, data analysis, and
computational biology.
- Genomic Data Analysis: Bioinformatics plays a crucial role in the analysis of genomic data,
including DNA sequencing and genotyping data. It involves tasks such as sequence
alignment, genome assembly, variant calling, functional annotation, and comparative
genomics. These analyses provide insights into genetic variations, evolutionary relationships,
and disease associations.
- Protein Structure and Function Prediction: Bioinformatics tools and algorithms are used for
predicting the three-dimensional structure of proteins and their functions. This helps in
understanding protein interactions, drug design, and identifying potential targets for
therapeutic interventions.
- Next-Generation Sequencing (NGS) Data Analysis: With the advent of high-throughput
sequencing technologies, bioinformatics has become instrumental in the analysis and
interpretation of NGS data. This includes tasks such as read mapping, variant detection,
transcriptomics analysis, and metagenomics studies. NGS data analysis aids in understanding
genetic variations, gene expression patterns, and microbial communities.
- Database Development: Bioinformatics in India involves the development and maintenance
of biological databases and resources. These databases store and organize vast amounts of
biological data, including DNA sequences, protein structures, gene expression profiles, and
disease-related information. They serve as valuable repositories for researchers worldwide.

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- Drug Discovery and Development: Bioinformatics contributes to the discovery and
development of new drugs by assisting in target identification, virtual screening, lead
optimization, and pharmacogenomics studies. It helps in predicting drug-target interactions,
understanding drug resistance mechanisms, and optimizing drug efficacy.
Top Bio informatics companies in India:
- Strand Life Sciences Private Limited
- Molecular Connections Private Limited
 Incubators and Accelerators: To foster innovation and entrepreneurship, India has witnessed the
emergence of biotech-focused incubators and accelerators. These organizations provide support to early-
stage startups by offering mentorship, access to infrastructure, funding, and networking opportunities.
Here are some prominent incubators and accelerators in India's biotech sector:
- Centre for Cellular and Molecular Platforms (C-CAMP): C-CAMP is an initiative of the
Department of Biotechnology (DBT), Government of India. It offers a range of programs and
services to support biotech startups, including access to lab facilities, seed funding, mentorship, and
networking opportunities.
- BIRAC Regional Innovation Centre (BRIC): BRIC, established by the Biotechnology Industry
Research Assistance Council (BIRAC), provides support and infrastructure to biotech startups. It
offers incubation, funding, and mentoring services to promote innovation and entrepreneurship in the
biotech sector.
- IKP Knowledge Park: IKP Knowledge Park is a leading science and technology park that supports
startups and entrepreneurs in the life sciences sector. It provides incubation services, access to state-
of-the-art facilities, business development support, and access to a network of experts and investors.
- Venture Center: Venture Center, located in Pune, is a technology business incubator that supports
startups in the areas of biotechnology, healthcare, and other technology domains. It offers incubation
services, access to lab facilities, technology development support, and business mentoring.
- NCL Innovation Park: NCL Innovation Park, based in Pune, is an incubator established by the
National Chemical Laboratory (NCL). It provides incubation support to startups in sectors such as
biotechnology, nanotechnology, and material sciences. The park offers facilities, mentoring,
networking, and funding support to early-stage companies.
- IIM Ahmedabad's Centre for Innovation, Incubation, and Entrepreneurship (CIIE): CIIE
supports startups across various sectors, including biotechnology. It provides incubation, mentorship,
and funding support to early-stage companies. CIIE has specific programs like iAccelerator and
Bharat Inclusion Initiative that cater to startups in the healthcare and biotech domains.

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- BioIncubator at the Bangalore (BBC): The BioIncubator is a biotech-focused incubator located in
Bangalore. It offers incubation support, lab facilities, access to experts and mentors, and business
development assistance to biotech startups.
 Trade Associations and Industry Bodies: Several trade associations and industry bodies represent the
interests of the biotechnology sector in India. These organizations facilitate collaboration, advocacy,
knowledge sharing, and policy advocacy. Examples include the Association of Biotechnology Led
Enterprises (ABLE), the Confederation of Indian Industry (CII), and the Biotechnology Industry
Research Assistance Council (BIRAC).
 Financial Institutions and Venture Capitalists: The biotechnology industry relies on funding from
various sources, including venture capitalists, private equity firms, banks, and government schemes.
These financial institutions provide capital to support research, product development, and
commercialization activities. Here are some notable financial institutions and venture capital firms in
India's biotech industry:
- Biotechnology Industry Research Assistance Council (BIRAC): BIRAC, a government initiative
under the Department of Biotechnology, provides funding and support to biotech startups and
entrepreneurs. It offers various funding schemes, including the Biotechnology Ignition Grant (BIG),
Biotechnology Industry Partnership Program (BIPP), and Small Business Innovation Research
Initiative (SBIRI).
- National Bank for Agriculture and Rural Development (NABARD): NABARD offers financial
assistance and credit facilities to agri-biotech companies and startups involved in agricultural
biotechnology innovations. They provide loans, grants, and financial support for research and
development projects in the biotech sector.
- Small Industries Development Bank of India (SIDBI): SIDBI provides financial support and
assistance to small and medium-sized enterprises (SMEs) in various sectors, including
biotechnology. They offer funding programs, venture capital, and other financial products to support
biotech startups and SMEs.
- Indian Angel Network (IAN): IAN is one of India's largest angel investor networks and actively
invests in early-stage companies across different sectors, including biotech. They provide capital,
mentorship, and industry connections to help startups grow and succeed.
- Accel Partners: Accel Partners is a prominent venture capital firm that invests in technology and
healthcare sectors, including biotech. They have a strong presence in India and have supported
several successful biotech startups through funding and strategic guidance.

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- Sequoia Capital India: Sequoia Capital India is a leading venture capital firm that invests in a wide
range of industries, including biotech. They have a dedicated healthcare and life sciences team that
focuses on supporting innovative biotech companies through funding and expertise.
- Nexus Venture Partners: Nexus Venture Partners is an early-stage venture capital firm that invests
in technology and healthcare sectors. They have made investments in biotech companies and provide
financial backing, mentoring, and operational support.
- IDG Ventures India: IDG Ventures India is a venture capital firm that invests in sectors such as
technology, consumer goods, and healthcare. They have made investments in biotech companies and
offer funding, industry expertise, and network support.
3% 5%
12%
3%
19%
4%
1%
7%
7%
2%
12%
22%
3%
Percentage of companies in each sector
of Biotech Industry (India)
Agri bio
Bio informatics
Contract manufacturing
Cosmetics
Diagnostics
Drug deliver
Environment
Nutraceuticals
Genomics
Industrial Biotech
Suppliers
Therapeutics
Veterinary

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INDUSTRIAL CULTURE
SUPPLY CHAIN OF BIOTECH INDUSTRY INDIA
The supply chain of the biotech industry in India involves several stages and companies that contribute to the
production, distribution, and delivery of biotech products and services. Here is an overview of the supply
chain and some key companies involved in each stage:
1. Research and Development:
- Research Institutions: Government research organizations, academic institutions, and specialized research
centers conduct fundamental research in biotechnology. Examples include the Council of Scientific and
Industrial Research (CSIR), Indian Council of Agricultural Research (ICAR), and Indian Institutes of
Technology (IITs).
- Biotech Startups: Emerging biotech startups in India focus on innovation, discovery, and early-stage
research. Examples include Avesthagen, Genotypic Technology, and Aten Porus Lifesciences.
2. Manufacturing and Production:
- Biopharmaceutical Manufacturers: Companies involved in the production of biopharmaceuticals,
including vaccines, recombinant proteins, and biosimilars. Examples include Biocon, Serum Institute of
India, and Bharat Biotech.
- Contract Development and Manufacturing Organizations (CDMOs): Companies that offer contract
manufacturing and development services to biotech companies. Examples include Syngene International,
GVK Biosciences, and Veeda Clinical Research.
3. Distribution and Logistics:
- Distributors: Companies that distribute biotech products, including pharmaceuticals, vaccines, and
diagnostics, to hospitals, clinics, pharmacies, and research institutions. Examples include MedPlus, Apollo
Pharmacy, and Bio-Rad Laboratories India.
- Logistics and Warehousing: Companies that provide specialized logistics and warehousing services for
biotech products, ensuring proper storage, handling, and transportation. Examples include Gati-KWE, Blue
Dart, and DHL.

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4. Regulatory Compliance and Quality Assurance:
- Regulatory Bodies: Government regulatory agencies responsible for approving and monitoring the safety,
quality, and efficacy of biotech products. In India, the Central Drugs Standard Control Organization
(CDSCO) and the Food Safety and Standards Authority of India (FSSAI) oversee regulatory compliance.
- Quality Assurance and Testing: Independent quality assurance and testing companies ensure compliance
with regulatory standards and conduct product testing. Examples include SGS India, TUV SUD South Asia,
and Eurofins Scientific India.
5. Healthcare Providers and End Users:
- Hospitals and Clinics: Healthcare institutions that administer biotech products, such as vaccines,
biologics, and diagnostic tests, to patients. Examples include Apollo Hospitals, Fortis Healthcare, and
AIIMS (All India Institute of Medical Sciences).
- Patients and Consumers: Individuals who benefit from biotech products and services, such as
pharmaceuticals, genetic testing, and personalized medicine.
MARKET SIZE
The size of India’s bioeconomy is estimated to be at US$ 80.12 billion as of 2021, which is a 14.13% growth
over US$ 70.2 billion in 2020. India’s bioeconomy contributes 2.6% to India’s GDP, as of 2021.

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Nearly a fifth of India’s bioeconomy, standing at US$ 14.56 billion, was due to the Covid-19 vaccination
and testing drive. Covid-19 vaccines had a worth of US$ 8.7 billion, whereas testing cost US$ 5.9 billion.
1.45 billion Covid-19 doses were administered in 2021, and 1.3 million Covid tests were taken every day.
The largest portion of the Indian bioeconomy continues to be accounted for by biopharma. Biopharma
accounted for 49% share of the bioeconomy, and its total economic contribution was estimated at US$ 39.4
billion.
From 2015-2020, India’s biotechnology industry grew rapidly, doubling from US$ 30.2 billion to US$ 70.2
billion in five years. As of 2021, India’s biotech industry clocks in about US$ 12 billion in annual revenue.
The Indian biotechnology industry is expected to reach US$ 150 billion by 2025 and has the potential to
reach US$ 270-300 billion by the year 2030.
By 2025, the contribution of the Indian biotechnology industry to the global biotechnology market is
expected to grow to 19%. The Indian biologics market is forecasted to reach US$ 12 billion by 2025, at a
CAGR of 22%.
INVESTMENTS AND RECENT DEVELOPMENTS
India allows 100% FDI under the automatic route (a non-resident or Indian company will not require any
approval from the government) for greenfield pharmaceuticals and manufacturing medical devices. Some
recent developments/investments in the Indian pharmaceutical sector are as follows:
 On November 10, Minister of State (Independent Charge) Ministry of Science and Technology; Minister
of State (Independent Charge) Ministry of Earth Science; MoS PMO, Personnel, Public Grievances,

30
Pensions, Space and Atomic Energy, Dr. Jitendra Singh, inaugurated India’s first national repository for
life science data - ‘Indian Biological Data Center’ (IBDC) at Faridabad, Haryana.
 In February 2023, CrisprBits, a biotechnology startup and one of the first Indian companies using
CRISPR, raised US$ 250,000 in the pre-seed funding from a US-based VJ Group, for product
development, team expansion, and for research and development.
 In August 2022, Eyestem, a Bengaluru-based cell therapy company, raised US$ 6.4 million in a Series-A
funding round to create cell therapy products.
 In June 2022, Serum Institute of India partnered with US company Novavax to manufacture their Covid
vaccine (NVX-CoV2373) for the US market.
 In June 2022, Thrissur-based biotechnology startup Zaara Biotech received an undisclosed amount of
investment from US-based Transcend International to set up its Algal seaweed technology facility in the
US.
 In FY22, India’s pharmaceutical exports touched Rs. 1.8 trillion (US$ 23.04 billion). Formulations and
biologicals account for 73.31% of the country's total exports, followed by bulk drugs and drug
intermediates.
 December 2022:
 Union Health Minister Dr. Mansukh Mandaviya and , Minister of State, Ministry of Science
and Technology, Earth Science, Personnel, Public Grievances, Pensions, Space and Atomic
Energy Minister, Dr. Jitendra Singh launched the world's first COVID-19 intranasal vaccine,
iNCOVACC, which has been developed by Bharat Biotech.
 Bengaluru-headquartered Centre for Cellular and Molecular Platforms (C-CAMP), an
initiative supported by the Department of Biotechnology, announced a next-generation Indo-
Dutch bilateral collaboration to address challenges posed by Antimicrobial Resistance
(AMR).
 February 2022:
 ARISTA Biotech announced its plans to set up a cleanroom environment production facility
in Hong Kong to manufacture Covid-19 rapid antigen testing kits to serve the rapidly-
increasing local demand.

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 Gennova Biopharmaceuticals, who were conducting phase 2 and 3 trials of India’s first
indigenous mRNA vaccine on humans, have finished those trials. The data is currently being
reviewed by the Drug Controller General of India (DCGI).
 American biotech company Vaxart announced plans to start phase II clinical trials of its oral
tablet-based Covid-19 vaccine in India soon.
 In November 2021:
 Karnataka announced its aim to be a US$ 50 billion bio-economy by 2026, from the current
US$ 22.6 billion.
 Serum Institute of India restarted deliveries of Covid-19 shots to global vaccine-sharing
platform COVAX for the first time since April 2021.
 INOVIO announced that it has received authorisation from India's Central Drugs Standard
Control Organization’s (CDSCO) Drug Controller General of India (DCGI) to proceed with
the Phase 3 segment of INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy) in
India.
 The World Health Organization (WHO) issued an emergency use listing (EUL) for Bharat
Biotech’s Covid-19 vaccine COVAXIN. It was found to have 78% efficacy against Covid-19
virus of any severity.
 US-based Akston Biosciences announced that it will start clinical trials of its second-
generation Covid-19 vaccine ‘AKS-452’ in India.
GOVERNMENT INITIATIVES
The Government of India has taken multiple initiatives to make India competitive internationally in
biotechnology research, innovation, entrepreneurship, and industrial growth. Some of these are:
 February 2023: In the Union Budget 2023-24, the Department of Biotechnology (DBT) was allotted US$
162.7 million (Rs. 1,345 crore) to promote research and development, agriculture biotechnology, etc.
 On November 14, India and Finland agreed to advance bilateral collaboration and expand cooperation in
sectors like digital education, future mobile technologies, biotechnology, and the digital partnership in
ICT.
 In August 2022, Minister of State (Independent Charge) Science & Technology; Minister of State
(Independent Charge) Earth Sciences; MoS PMO, Personnel, Public Grievances, Pensions, Atomic

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Energy and Space, Dr. Jitendra Singh, announced 75 "Amrit" Grants worth Rs. 10-15 crore (US$ 1.22-
1.83 million) for biotech projects involving startups, industry, academia, and research organisations
working together.
 On June 9, Prime Minister Mr. Narendra Modi inaugurated the Biotech Startup Expo – 2022. The event
was being conducted to commemorate BIRAC's tenth anniversary since its foundation. The Expo's theme
was 'Biotech Startup Innovations: Towards AatmaNirbhar Bharat. The Expo showcased 75 successful
startups supported by BIRAC, 75 Specialized Biotech Incubation Centres supported by BIRAC, 21 IITs/
universities, 50 successful startups supported by DPIIT and various national and international programs
of BIRAC.
 February 2022: In the Union Budget 2022-23, the Department of Biotechnology was allotted Rs. 2,581
crore (US$ 343.56 million) for developing basic infrastructure, genetic engineering, technologies and
bioinformatics, agriculture biotechnology, and training skilled professionals.
 In November 2021, Dr. Jitendra Singh, Minister of Science & Technology, Earth Sciences, MoS PMO,
Personnel, Public Grievances, Pensions, Atomic Energy and Space, inaugurated a new Biotechnology
Centre for Northeast tribals in the remote area of Kimin (Arunachal Pradesh). He also launched a pan-
India Star College Mentorship Programme for young innovators supported by the Department of
Biotechnology.
Department of Biotechnology:
 Atal Jai Anusandhan Biotech Mission was implemented by Department of Biotechnology (DBT),
Ministry of Science and Technology. The purpose of this mission is to address the challenges of maternal
and child health, antimicrobial resistance, vaccines for infectious disease, food and nutrition, and clean
technologies.
 In October 2021, the Department of Biotechnology launched a ‘One Health’ consortium that will survey
important bacterial, viral and parasitic infections of zoonotic as well as transboundary pathogens in the
country. The consortium consists of 27 organisations and is led by the DBT-National Institute of Animal
Biotechnology, Hyderabad.
BIRAC
 Biotechnology Industry Research Assistance Council (BIRAC) established by the Department of
Biotechnology (DBT) is aimed at strengthening and empowering emerging biotechnology enterprises to
undertake strategic research and innovation.

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 In February 2022, BIRAC invited proposals for development, validation and pre- commercialization of
products/ technologies in the areas of healthcare, energy and environment, veterinary sciences and
aquaculture, agriculture and secondary agriculture.
 In October 2021, Jawaharlal Institute of Postgraduate Medical Education and Research in Pondicherry
established a research unit funded by BIRAC to undertake clinical trials of new Covid-19 vaccines that
are currently in their development stage.
 In October 2021, BioNEST Bioincubator, a healthcare innovation incubation centre, was inaugurated at
the Sri Ramachandra Institute of Higher Education and Research in Chennai, Tamil Nadu.
Biotech Parks:
 Biotechnology Parks and Incubators are established across the country by the Department of
Biotechnology (DBT), under the Ministry of Science and Technology, to translate research into products
and services by providing the necessary infrastructure support.
 These biotechnology parks offer facilities to scientists, and SMEs for technology incubation, technology
demonstration and pilot plant studies to accelerate the commercial development of biotechnology.
 The government supports nine biotechnology parks in various states with the bulk being in the southern
region of the country.

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INDUSTRIAL CLIMATE
GROWTH OF BIOTECHNOLOGY INDUSTRY:
The growth of the Indian biotechnology sector is fuelled by rising demand at both a domestic and
international levels. The rise in domestic demand is fuelled by intiatives such as Aatmanirbhar Bharat and
Make In India, while overseas demand for Indian vaccines and biopharmaceuticals is due to the globally
competitive efficacy of Indian products.
India exports vaccines to over 150 countries and is a leading destination for contract manufacturing and
clinical trials. In order to contain healthcare costs, companies are leveraging generics and biosimilars, and
India has poised itself as a hub to deliver affordable access to innovative and inclusive healthcare solutions.
India ranks at the 7th position worldwide as the preferred destination to conduct clinical trials.

35
India has the 5th largest area of organic agricultural land.
To promote sustainable agricultural practices and innovation in agriculture technologies, Department of
Biotechnology has funded 51 Biotech-KISAN (Biotech Krishi Innovation Science Application Network)
hubs connecting Indian farmers with best scientists and institutions, empowering farmers, especially women
farmers with information on soil health, irrigation and new agri-technologies. 44 hubs have been set up in 15
argo-climatic zones of the country and are conducting activities in 169 districts.
Under the Union Budget 2023, the government announced - "500 new ‘waste to wealth’ plants under
GOBARdhan (Galvanizing Organic Bio-Agro Resources Dhan) scheme to be established for promoting
circular economy". These will include 200 compressed biogas (CBG) plants, including 75 plants in urban
areas, and 300 community or cluster-based plants at total investment of INR 10,000 crore.
The percentage share of the biotechnology segments is:
 Biopharmaceuticals- 68%
 Diagnostics- 33%
 Therapeutics- 13%
 Vaccines- 22%
 BioAgriculture-13%
 BT-Cotton- 12%
 Biofertilizers, Biopesticides & Bio Stimulants- 1%
 Bioindustry- 12%
 Biofuels- 7%
 Enzymes- 5%
 Bio IT & BioServices- 7%
TRENDS IN BIOTECHNOLOGY INDUSTRY
The biotech industry in India is witnessing several latest trends that are shaping its development and growth.
Here are some of the prominent trends observed in the Indian biotech industry:
 COVID-19 Response and Vaccine Manufacturing: The ongoing COVID-19 pandemic has
significantly impacted the biotech industry in India. Indian biotech companies have been actively
involved in the development, manufacturing, and distribution of COVID-19 vaccines. This has
showcased the country's capabilities in vaccine research and production, highlighting the importance
of biotech in addressing public health emergencies.

36
 Gene Editing and CRISPR Technology: The field of gene editing, particularly using CRISPR-Cas9
technology, is gaining momentum in India. Researchers and biotech companies are exploring the
potential of CRISPR-based gene editing for various applications, including disease treatment,
agricultural improvement, and industrial processes. This technology holds immense promise for
precision medicine and targeted genetic interventions.
 Precision Medicine and Personalized Healthcare: The concept of precision medicine, which
involves tailoring medical treatment to individual patients based on their genetic makeup, is gaining
attention in India. Biotech companies are leveraging genomic information and advanced diagnostics
to develop personalized therapies and treatment approaches. The integration of genomics, data
analytics, and digital health technologies is driving advancements in personalized healthcare.
 Biopharmaceuticals and Biosimilars: The development and production of biopharmaceuticals and
biosimilars continue to be a significant focus in the Indian biotech industry. Biotech companies are
investing in research and development of biologic drugs, including recombinant proteins, monoclonal
antibodies, and vaccines. The focus on biosimilars is expected to enhance accessibility to affordable
treatment options and address healthcare affordability challenges.
 Agricultural Biotechnology and GM Crops: Agriculture plays a vital role in India's economy, and
biotechnology is increasingly being applied to enhance crop productivity, sustainability, and
nutritional value. Biotech solutions, including genetically modified (GM) crops, are being developed
to address challenges such as pest resistance, drought tolerance, and nutrient enrichment. Agricultural
biotechnology is expected to contribute to food security and sustainable farming practices.
 Digital Health and Telemedicine: The adoption of digital health technologies and telemedicine has
accelerated in India, especially during the COVID-19 pandemic. Biotech companies are integrating

37
digital platforms, mobile health applications, remote patient monitoring, and artificial intelligence for
improved healthcare delivery and patient outcomes. The convergence of biotech and digital health is
reshaping the healthcare landscape.
 Emerging Biotech Startups and Entrepreneurship: India is witnessing a rise in biotech startups
and entrepreneurial ventures. There is a growing ecosystem supporting biotech innovation, including
incubators, accelerators, and funding opportunities. Startups are leveraging technologies like AI,
blockchain, and bioinformatics to drive innovation and develop novel solutions across various
biotech domains.
FUTURE
The future of the biotech industry in India holds significant potential for growth and innovation. Several
factors indicate a promising outlook for the industry:
 Favorable Government Policies: The Indian government has been actively promoting the biotech
sector through supportive policies, regulatory reforms, and financial incentives. Initiatives such as the
National Biotechnology Development Strategy and the Biotechnology Industry Partnership Program
(BIPP) aim to foster research, development, and entrepreneurship in the biotech industry.
 Growing Domestic Market: India's large and diverse population presents a substantial domestic
market for biotech products and services. With increasing healthcare needs, rising disposable
incomes, and a greater focus on preventive healthcare, the demand for biotech solutions is expected
to grow significantly.
 Increasing Investment and Funding: The biotech industry in India has been attracting significant
investments from both domestic and international sources. Venture capital firms, private equity
funds, and strategic investors are showing keen interest in supporting innovative biotech startups and
companies. Additionally, the government and various funding agencies provide grants, loans, and
funding support for research and development activities in the biotech sector.
 Strong Research and Innovation Capabilities: India has a strong scientific and research talent
pool, with several renowned research institutions and universities. The country's expertise in areas
like genomics, bioinformatics, molecular biology, and clinical research positions it well for
advancements in biotech innovation. Collaborations between academia, industry, and research
institutions further facilitate knowledge sharing and technology transfer.
 Emerging Technologies: The biotech industry is witnessing rapid advancements in emerging
technologies such as gene editing, synthetic biology, personalized medicine, and regenerative
medicine. India has the potential to leverage these technologies to develop innovative products,
therapies, and solutions for various healthcare challenges.

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 Focus on Bio-agriculture: India's agricultural sector can benefit greatly from biotech advancements.
The development of genetically modified crops, biofertilizers, and biopesticides can enhance crop
yields, improve resilience against pests and diseases, and contribute to sustainable agriculture
practices.
 International Collaborations and Export Potential: Indian biotech companies are increasingly
forging collaborations and partnerships with global players, enabling technology transfer, market
access, and knowledge exchange. This opens up opportunities for Indian companies to expand their
global footprint and tap into international markets.
Overall, with the right support, investments, and strategic initiatives, the biotech industry in India is
poised for a promising future, contributing to advancements in healthcare, agriculture, and other sectors
while driving economic growth and societal benefits.

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CHAPTER NO.4
SWOT ANALYSIS
SWOT analysis of the biotechnology industry in India is as follows:
 Strengths:
 Large talent pool: India has a large pool of highly skilled and educated professionals, which is a
significant advantage for the biotech industry.
 Cost-effective operations: India offers cost-effective operations, which makes it an attractive
location for foreign investors to set up their manufacturing units or research and development
centers.
 Strong research capabilities: Indian biotech companies have strong research capabilities in areas
such as genomics, biopharmaceuticals, and clinical research.
 Large domestic market: India has a large and growing domestic market for biotech products and
services, thanks to its large population and high disease burden.
 Weaknesses:
 Complex regulatory environment: The regulatory environment in India is complex, which creates
hurdles for biotech companies trying to get their products approved.

40
 Limited funding: Biotech companies require significant investment to support research and
development, but funding in India is often limited, which hinders the growth of the industry.
 Talent retention: Indian biotech companies often struggle to retain top talent, which can lead to a
loss of expertise and knowledge.
 Lack of infrastructure: The biotech industry requires specialized infrastructure, such as high-quality
research labs and manufacturing units. However, India still lacks such infrastructure in some areas.
 Opportunities:
 Growing global demand: The global demand for biotech products and services is growing, which
presents opportunities for Indian biotech companies to expand their market reach.
 Increasing government support: The Indian government is increasingly supporting the biotech
industry through policies and funding initiatives.
 Collaborations and partnerships: Indian biotech companies can leverage collaborations and
partnerships with international companies to expand their research capabilities and market reach.
 Emerging technologies: The biotech industry is rapidly evolving, and emerging technologies such as
gene editing and cell therapy present opportunities for Indian biotech companies to develop
innovative products and services.
 Threats:
 Competition from other countries: The biotech industry is highly competitive, and India faces
competition from other countries such as China, the US, and Europe.
 Intellectual property rights issues: Intellectual property rights issues such as patent infringement can
create legal hurdles for Indian biotech companies.
 Economic downturns: Economic downturns can lead to decreased funding and investment in the
biotech industry.
 Ethical concerns: Some biotech products and technologies, such as gene editing, raise ethical
concerns that can create opposition from regulatory bodies and the public.

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CHAPTER NO.5
SUMMARY OF FINDINGS
 India is the third-largest biotechnology market in the Asia-Pacific region and one of the top 12
globally. The nation controls 3% of the worldwide biotechnology market.
 India is also the world's second-largest producer of BT cotton and the third-largest producer of the
recombinant Hepatitis B vaccine.
 The biotechnology sector is divided into five segments - biopharmaceuticals, bio-services, bio-
agriculture, bio-industrial and bio-IT.
 India also has a strong start-up ecosystem, originating from gradual improvements in the ease of
doing business, proof-of-concept funds for start-ups, and favourable government policies.
 BIRAC, a public sector undertaking of DBT, has partnered with innovative foundations and
universities to focus on ‘Make in India’ and ‘Startup India’ programmes.
 Biotechnology parks and incubators are established across the country by the Department of
Biotechnology (DBT), under the Ministry of Science and Technology, to translate research into
products and services by providing necessary infrastructure support.
 These biotechnology parks offer facilities to scientists, and small and medium sized enterprises
(SMEs) for technology incubation, technology demonstration and pilot plant studies to accelerate
commercial development of biotechnology.
 The government, at present, supports nine biotechnology parks in various states, with the bulk being
in the southern region.
 In February 2023, as part of the Union Budget 2023-24, the Department of Biotechnology was
allotted Rs.2,683.86 crores for developing basic infrastructure, genetic engineering,
technologies and bioinformatics, agriculture biotechnology, and training skilled professionals.
It is 1% more than the budget allocated in Union Budget 2022-23 which is Rs.2581 crores.

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CHAPTER NO.6
SUGGESTIONS
To improve the biotech industry in India, here are some suggestions:
 Increase Research and Development (R&D) Investment: Encourage both public and private sectors
to increase investment in biotech R&D. This will facilitate the development of innovative products,
technologies, and therapies, enhancing the competitiveness of Indian biotech companies.
 Strengthen Collaboration Between Academia and Industry: Foster closer collaboration between
academic institutions, research organizations, and biotech companies. Encourage the transfer of
knowledge, expertise, and technology from academic research to commercial applications. This can
be achieved through joint research projects, technology licensing, and industry-academia
partnerships.
 Enhance Funding Opportunities: Provide more funding opportunities, grants, and incentives for
biotech startups and small-to-medium enterprises (SMEs). This will support the growth and
development of early-stage companies, enabling them to conduct research, build infrastructure, and
commercialize their innovations.
 Simplify Regulatory Processes: Streamline regulatory processes and create a favorable environment
for biotech companies. Establish clear and transparent regulatory guidelines for product
development, clinical trials, and market approval. Simplified regulations will attract more
investments, facilitate timely product launches, and ensure patient safety.
 Promote Intellectual Property Rights (IPR) Protection: Strengthen IPR protection and enforcement
mechanisms to encourage innovation and protect the intellectual property of biotech companies.
Robust IPR policies will provide confidence to investors, incentivize research, and foster a culture of
innovation.
 Encourage Entrepreneurship and Startup Support: Foster an entrepreneurial ecosystem by
providing startup incubators, accelerators, and mentorship programs specifically tailored for biotech
startups. Facilitate access to funding, business support, and market networks to promote the growth
of biotech entrepreneurs.
 Skill Development and Talent Retention: Invest in biotech-focused skill development programs,
training initiatives, and academic courses to develop a skilled workforce. Encourage talent retention
by offering competitive salaries, career growth opportunities, and a supportive work environment.
This will help attract and retain top talent in the biotech sector.

43
 Promote International Collaboration: Foster collaborations and partnerships between Indian biotech
companies and international counterparts. This can facilitate technology transfer, access to global
markets, and knowledge exchange, strengthening India's position in the global biotech landscape.
 Support Market Access: Facilitate market access and export opportunities for Indian biotech
companies. Provide assistance in navigating international regulations and standards to enable the
export of biotech products and services.
 Public Awareness and Outreach: Increase public awareness about the benefits and potential of
biotechnology. Educate the public about biotech advancements, dispel misconceptions, and build
trust in biotech products and applications. This will create a favorable environment for the
acceptance and adoption of biotech innovations.
Implementing these suggestions will help foster the growth, competitiveness, and sustainability of the
biotech industry in India, positioning it as a global player in biotechnology research, development, and
commercialization.

44
CHAPTER NO.7
CONCLUSION
 Key growth drivers and trends in the biotechnology industry are identified.
 The competitive landscape of the biotechnology industry is accessed.
 The regulatory environment impacting the biotechnology industry is analysed.
 The financial performance of biotechnology companies is known.
 The current and emerging technologies and their potential impact on the biotechnology industry is
understood.
 Potential opportunities and challenges for biotechnology companies are identified.
 Factors influencing the adoption of biotechnology solutions by various industries and governments
are identified.
 Ethical implications of biotechnology innovations are known.

45
MISCELLANEOUS
BIBLIOGRAPHY
Department of Biotechnology, Government of India. (2018). Biotechnology Industry Research Assistance
Council (BIRAC) Annual Report 2017-18. Retrieved from
http://www.birac.nic.in/dl/birac_annual_report2017-18.pdf
PwC India. (2020). Biotech in India: Unlocking Potential, Fueling Innovation. Retrieved from
https://www.pwc.in/assets/pdfs/publications/2020/biotech-in-india-unlocking-potential-fuelling-
innovation.pdf
Indian Budget. Department of Biotechnology. https://www.indiabudget.gov.in/doc/eb/sbe90.pdf
Pande, S. (2019). Biotechnology in India: Trends and Prospects. International Journal of Science and
Research, 8(3), 2164-2168.
Pandey, A. (2019). Biotech Industries in India: A Review of Current Status, Opportunities, and Challenges.
Journal of Biotechnology and Biomedical Science, 1(1), 9-16.
Invest India (2023, May 10). Biotechnology Industry in India. Retrieved May 15, 2023, from
https://www.investindia.gov.in/sector/biotechnology
Indian Brand Equity Foundation (IBEF). (2020). Biotechnology in India. Retrieved from
https://www.ibef.org/industry/biotechnology-india.aspx
APPENDIX
GLOSSARY
▪ CAGR: Compound Annual Growth Rate
▪ FDI: Foreign Direct Investment
▪ FY: Indian Financial Year (April to March); So, FY24 implies April 2023-March 2024
▪ R&D: Research and Development
▪ US$ : US Dollar

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