For an Executive Summary of this report please contact ediz.ibrahim@visiongain.com (+44 (0)20 7549 9976) or refer to our website http://www.visiongain.com/Report/1209/Generic-Drugs-World-Market-2014-2024
2. Contents
1.1. Executive Summary
Executive Summary
1.1 Overview of Findings
1.2 Structure of the Report
1.3 Research and Analysis Methods
1.4 Glossary of Terms in this Report
2.2. Introduction to Generic Drugs
Introduction to Generic Drugs
2.1 The Pharmaceutical Industry: a Very Brief Overview
2.2 What are Generic Drugs?
2.2.1 The Early History of Generic Drugs
2.2.2 The Hatch-Waxman Act and the Rise of Generics
2.3 Criteria for Demonstrating Bioequivalence
2.4 Authorised, Branded and Unbranded Generics
2.5 Classification of Generic Drugs Markets
2.6 Generic Substitution and the Decline of Big Pharma
2.6.1 The 'Evergreening' of Pharmaceuticals
2.7 Regulation of Generic Drugs
2.7.1 Regulation in the US
2.7.1.1 Obtaining FDA Approval: NDAs and ANDAs
2.7.1.2 The Hatch-Waxman Act Title I: Promotion of Generic Drugs
2.7.1.3 The Hatch-Waxman Act Title II: Incentives for the Branded Industry
2.7.1.4 The Impact of the Hatch-Waxman Act on the US Market
2.7.1.5 Me First: Timing as a Crucial Factor
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2.7.2 Regulation in Europe
2.7.2.1 EU Marketing Approval Procedures
2.7.2.2 The 8+2+1 Rule: EU Data Exclusivity
2.7.2.3 Supplementary Protection Certificates
2.7.2.4 Variation Between European Countries
2.7.2.5 Towards Harmonisation of Standards
2.7.2.6 A Unitary European Patent System
2.7.3 Regulation in Japan
2.7.4 Regulation in China
2.8 Compulsory Licensing
2.9 Scope of this Report
3.3. Generic Drugs: World Market 2014-2024
Generic Drugs: World Market 2014-2024
3.1 The World Generic Drugs Market in 2012 and 2013
3.2 World Generic Drugs Market: Sales Forecast 2014-2024
3.3 Geographical Breakdown of the World Generic Drugs Market
3.4 World Generic Drugs Market: National Markets Forecast 2014-2024
3.5 World Generic Drugs Market: Regional Markets Forecast 2014-2024
3.6 How Will National Market Shares Change to 2024?
3.7 How Will Regional Market Shares Change to 2024?
3.8 World Generic Drugs Market: Drivers and Restraints 2014-2024
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4.4. Leading Generic Drug Manufacturers 2014
Leading Generic Drug Manufacturers
4.1 World Generic Drugs Market: Top 10 Companies
4.2 Novartis
4.2.1 Novartis: Revenue Shares by Segment
4.2.2 Novartis: Generic Drugs Sales Forecast 2014-2024
4.2.3 Novartis: Recent Developments
4.2.3.1 Loss of Enoxaparin Exclusivity Hits Sandoz Profits in 2012
4.2.3.2 Emphasis on Difficult-to-Manufacture Products
4.2.3.3 FDA Quality Concerns at Sandoz Manufacturing Plants
4.2.3.4 Acquisition of Fougera Pharmaceuticals in 2012
4.2.4 Novartis: Generic Drug Market Prospects to 2024
4.3 Teva
4.3.1 Teva: Revenue Shares by Segment
4.3.2 Teva: Generic Drugs Sales Forecast 2014-2024
4.3.3 Teva: Recent Developments
4.3.3.1 Expansion Through Acquisitions
4.3.3.2 High-Value Generics to Drive Teva’s Generics Growth
4.3.3.3 Generic Viagra to Launch in 2017
4.3.3.4 Teva’s Shift Towards Innovation
4.3.3.5 Copaxone Faces Generic Competition
4.3.4 Teva: Generic Drug Market Prospects to 2024
4.4 Actavis
4.4.1 Actavis: Revenue Shares by Segment
4.4.2 Actavis: Generic Drugs Sales Forecast 2014-2024
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4.4.3 Actavis: Recent Developments
4.4.3.1 Actavis Rejects Valeant and Mylan Merger Offers
4.4.3.2 Actavis Acquires Warner Chilcott
4.4.3.3 Actavis’s Biosimilar Ambitions
4.4.3.4 Exiting the Chinese Generics Market
4.4.4 Actavis: Generic Drug Market Prospects to 2024
4.5 Mylan
4.5.1 Mylan: Revenue Shares by Segment
4.5.2 Mylan: Generic Drugs Sales Forecast 2014-2024
4.5.3 Mylan: Recent Developments
4.5.3.1 Mylan to Double Manufacturing Capacity by 2016
4.5.3.2 Mylan Acquires Rights to GSK’s Advair, Diskus and Seretide
4.5.3.3 Launch of Generic Copaxone in 2014
4.5.3.4 Acquisition of Agila Expands Mylan’s Injectables Business
4.5.3.5 Mylan Working with India’s Biocon on Biosimilars
4.5.4 Mylan: Generic Drug Market Prospects to 2024
4.6 Abbott
4.6.1 Abbott: Revenue Shares by Segment
4.6.2 Abbott: Generic Drugs Sales Forecast 2014-2024
4.6.3 Abbott: Recent Developments
4.6.3.1 Abbott Retains Established Products After Spinning Off AbbVie
4.6.3.2 Acquisition of Solvay Pharmaceuticals and Piramal Healthcare Solutions
4.6.4 Abbott: Generic Drug Market Prospects to 2024
4.7 Pfizer
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4.7.1 Pfizer: Revenue Shares by Segment
4.7.2 Pfizer: Generic Drugs Sales Forecast 2014-2024
4.7.3 Pfizer: Recent Developments
4.7.3.1 Pfizer Spins Off Animal Health into Zoetis
4.7.3.2 Pfizer Restructures into Three Business Units
4.7.4 Pfizer: Generic Drug Market Prospects to 2024
4.8 Fresenius Kabi
4.8.1 Fresenius Kabi: Revenue Shares by Segment
4.8.2 Fresenius Kabi: Generic Drugs Sales Forecast 2014-2024
4.8.3 Fresenius Kabi: Recent Developments
4.8.3.1 InnoPharma Licensing Deal Bolsters Portfolio Grown Via Past Acquisitions
4.8.3.2 FDA Manufacturing Quality Concerns at Fresenius Kabi Plants
4.8.3.3 Fresenius Kabi’s Joint Venture with PT Soho Global Health
4.8.4 Fresenius Kabi: Generic Drug Market Prospects to 2024
4.9 Hospira
4.9.1 Hospira: Revenue Shares by Segment
4.9.2 Hospira: Generic Drugs Sales Forecast 2014-2024
4.9.3 Hospira: Recent Developments
4.9.3.1 Mayne Pharma and Orchid: Expansion Through Acquisitions
4.9.3.2 Javelin Pharma’s Dyloject Fails to Deliver
4.9.3.3 Manufacturing Concerns and Remediation Efforts
4.9.4 Hospira: Generic Drug Market Prospects to 2024
4.10 Aspen
4.10.1 Aspen: Revenue Shares by Segment
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4.10.2 Aspen: Generic Drugs Sales Forecast 2014-2024
4.10.3 Aspen: Recent Developments
4.10.3.1 Acquisition of GSK Anti-Thrombosis Brands
4.10.3.2 Aspen Acquires Merck MSD’s Dutch API Plant
4.10.4 Aspen: Generic Drug Market Prospects to 2024
4.11 Sanofi
4.11.1 Sanofi: Revenue Shares by Segment
4.11.2 Sanofi: Generic Drugs Sales Forecast 2014-2024
4.11.3 Sanofi: Recent Developments
4.11.3.1 Acquisitions in Emerging Markets
4.11.3.2 Sanofi’s “Brazil Generics Issue”
4.11.4 Sanofi: Generic Drug Market Prospects to 2024
5.5. The US Generic Drugs Market 2014-2024
US Generics Market 2014-2024
5.1 US Generic Drugs Market: Overview
5.2 US Generic Drugs Market: Generic Penetration by Volume
5.3 The US Generic Drugs Market: Revenue Forecast 2014-2024
5.4 US Generic Drugs Market: Drivers and Restraints
5.5 US Generic Drugs Market: Leading Companies
5.6 US Generic Drugs Market: Trends and Developments
5.6.1 High Consumer Acceptance of Generic Medicines
5.6.2 Affordable Care Act: Expanding Medicare Coverage
5.6.3 A US Biosimilars Market?
5.6.4 The ANDA Backlog
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5.6.5 Generic Drug User Fee Amendments (GDUFA) 2012
5.6.6 Falling Generic Drug Prices
5.6.7 Shortages of Generic Drugs Will Restrain the Market
5.6.8 An End to ‘Pay for Delay’?
5.7 US Generic Drugs Market: Conclusions
6.6. Leading European Generics Markets 2014-2024
Leading European Generics Markets 2014-2024
6.1 The European Generic Drugs Market: Overview
6.1.1 Europe’s Mature and Developing Generics Markets
6.1.2 Pricing Systems and Generic Penetration
6.1.2.1 The Effects of Tendering for Generic Medicines
6.1.2.2 Lower Patient Co-payments Drive Demand for Generics
6.1.3 Will Europe Move Towards Free-Pricing Systems?
6.1.4 Challenges in the European Regulatory Environment
6.1.5 Ending Pay For Delay in Europe
6.1.6 FDA and EMA Joint Data Sharing and Inspections
6.2 EU5 Generic Drugs Market Forecast 2014-2024
6.3 German Generic Drugs Market: Overview
6.3.1 German Generic Drugs Market: Sales Forecast 2014-2024
6.3.2 German Generic Drugs Market: Generic Penetration by Volume
6.3.3 German Generic Drugs Market: Generic Penetration by Value
6.3.4 German Generic Drugs Market: Leading Companies
6.4 French Generic Drugs Market: Overview
6.4.1 French Generic Drugs Market: Sales Forecast 2014-2024
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6.4.2 French Generic Drugs Market: Generic Penetration by Volume
6.4.3 French Generic Drugs Market: Generic Penetration by Value
6.5 UK Generic Drugs Market: Overview
6.5.1 UK Generic Drugs Market: Sales Forecast 2014-2024
6.5.2 UK Generic Drugs Market: Generic Penetration by Volume
6.5.3 UK Generic Drugs Market: Generic Penetration by Value
6.5.4 UK Generic Drugs Market: Trends and Developments
6.5.4.1 Cost Pressures and Demand-Side Policies Drive UK Generic Penetration
6.5.4.2 Reducing Generic Drug Prices: the Drug Tariff System
6.5.4.3 The Increasing Role of Pharmacists
6.6 Italian Generic Drugs Market: Overview
6.6.1 Italian Generic Drugs Market: Sales Forecast 2014-2024
6.6.2 Italian Generic Drugs Market: Generic Penetration by Volume
6.6.3 Italian Generic Drugs Market: Generic Penetration by Value
6.7 Spanish Generic Drugs Market: Overview
6.7.1 Spanish Generic Drugs Market: Sales Forecast 2014-2024
6.7.2 Spanish Generic Drugs Market: Generic Penetration by Volume
6.7.3 Spanish Generic Drugs Market: Generic Penetration by Value
7.7. Leading Asia-Pacific Generics Markets 2014-2024
Leading Asia-Pacific Generics Markets 2014-2024
7.1 Japanese Generic Drugs Market: Overview
7.1.1 Japanese Generic Drugs Market: Sales Forecast 2014-2024
7.1.2 Japanese Generic Drugs Market: Generic Penetration by Volume
7.1.3 Japanese Generic Drugs Market: Generic Penetration by Value
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7.1.4 Japanese Generic Drugs Market: Leading Companies
7.1.5 Japanese Generic Drugs Market: Trends and Developments
7.1.5.1 Government Initiatives Driving Generic Penetration
7.1.5.2 Japanese Attitudes to Generic Drugs
7.1.5.3 Generic Substitution by Pharmacists
7.2 Chinese Generic Drugs Market: Overview
7.2.1 Chinese Generic Drugs Market: Sales Forecast 2014-2024
7.2.2 Chinese Generic Drugs Market: Generic Penetration by Volume
7.2.3 Chinese Generic Drugs Market: Generic Penetration by Value
7.2.4 Chinese Generic Drugs Market: Trends and Developments
7.2.4.1 Compulsory Licensing of Generic Drugs
7.2.4.2 Expansion of Healthcare Coverage and Reimbursement
7.2.4.3 Growth Opportunities in Branded Generics
7.2.4.4 Price Controls and the Anhui Model
7.3 Indian Generic Drugs Market: Overview
7.3.1 Indian Generic Drugs Market: Sales Forecast 2014-2024
7.3.2 Indian Generic Drugs Market: Leading Companies
7.3.3 Indian Generic Drugs Market: Trends and Developments
7.3.3.1 Drug Prices Control Order 2013
7.3.3.2 Expansion of Healthcare Provision
7.3.3.3 Manufacturing Quality Failures
8.8. Emerging Generics Markets 2014-2024
Emerging Generics Markets 2014-2024
8.1 Emerging Markets: A Key Growth Opportunity
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8.2 Russian Generic Drugs Market: Overview
8.2.1 Russian Generic Drugs Market: Sales Forecast 2014-2024
8.2.2 Russian Generic Drugs Market: Trends and Developments
8.2.2.1 Pharma2020, Healthcare and Industry Reform
8.2.2.2 Self-Medication and Russian Pharmacy
8.3 Brazilian Generic Drugs Market: Overview
8.3.1 Brazilian Generic Drugs Market: Sales Forecast 2014-2024
8.3.2 Brazilian Generic Drugs Market: Trends and Developments
8.3.2.1 Increasing Access to Medicines
8.3.2.2 Foreign Companies Entering the Brazilian Market
8.4 Mexican Generic Drugs Market: Overview
8.4.1 Mexican Generic Drugs Market: Sales Forecast 2014-2024
8.4.2 Mexican Generic Drugs Market: Trends and Developments
8.4.2.1 International Interest in Mexico
8.4.2.2 Government Initiatives Driving Generic Use
8.5 South Korean Generic Drugs Market: Overview
8.5.1 South Korean Generic Drugs Market: Sales Forecast 2014-2024
8.5.2 South Korean Generic Drugs Market: Trends and Developments
8.5.2.1 The Evolution of Pharmaceutical Price Controls
8.5.2.2 KORUS FTA: The South Korea – US Free Trade Agreement
8.5.2.3 EU-Korea Free Trade Agreement
8.6 Turkish Generic Drugs Market: Overview
8.6.1 Turkish Generic Drugs Market: Sales Forecast 2014-2024
8.6.2 Turkish Generic Drugs Market: Trends and Developments
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8.6.2.1 Regulatory Aspects of Generics in Turkey
8.6.2.2 HTP: Transforming Turkish Healthcare Provision
8.6.2.3 Price Controls in the Turkish Pharma Market
8.6.2.4 Draft Patent Law Amendments
9.9. Qualitative Analysis of the Generic Drugs Market 2014-2024
Qualitative Analysis of the Generic Drugs Market 2014-2024
9.1 SWOT Analysis of the Generic Drugs Market
9.2 Strengths
9.2.1 Strong Political Support for Domestic Generic Industries
9.2.2 Improving Regulatory Processes
9.2.3 Global Presence and Manufacturing Capacity
9.2.4 Higher Growth Rates than Innovative Pharma
9.3 Weaknesses
9.3.1 Highly Competitive Industry with Low Profit Margins
9.3.2 Patent Extension and Exclusivity Create Uncertainty in Product Launch
9.3.3 Manufacturing Safety and Quality Concerns
9.3.4 Perceptions of Generic Drugs as Unsafe or Low Quality
9.4 Opportunities
9.4.1 Patent Expiration of Innovator Drugs
9.4.2 Increasing Demand for Generics due to Demographic Trends
9.4.3 High Growth in Emerging Markets
9.4.4 Biosimilars and Complex or Branded Generics
9.5 Threats
9.5.1 Price Controls by Governments
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9.5.2 Decline in Pipeline of Drugs Nearing Patent Expiry
9.5.3 Defensive Patenting Strategies
9.5.4 Consolidation Among Pharmacies and Healthcare Payers
9.6 Porter’s Five Forces Analysis of the Generic Drugs Market
9.6.1 Rivalry Among Competitors [High]
9.6.2 Threat of New Entrants [High]
9.6.3 Power of Suppliers [Low]
9.6.4 Power of Buyers [Medium]
9.6.5 Threat of Substitutes [Low]
10. Research Interviews
10. Research Interviews
10.1 Interview with Professor Joshua P. Cohen, PhD, Research Assistant Professor, Tufts Center
for the Study of Drug Development, Boston, Massachusetts, USA
10.1.1 The US Generic Drugs Market
10.1.2 Challenges for the Generic Drugs Industry
10.1.3 The Future of the Generic Drugs Market?
10.2 Interview with David Gaugh, R.Ph., Senior Vice President of Science and Regulatory Affairs,
Generic Pharmaceutical Association, Washington DC, USA
10.2.1 The US Generic Drugs Market
10.2.2 Challenges for the Generic Drugs Industry
10.2.3 The Future of the Generic Drugs Market?
10.3 Interview with Pieter Dylst, PhD, Post-doctoral Researcher, Katholieke Universiteit Leuven,
Leuven, Belgium
10.3.1 The European Generic Drugs Market
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10.3.2 The Future of the Generics Industry
11. Conclusions
11. Conclusions
11.1 The World Generic Drugs Market in 2012 and 2013
11.2 World Generic Drugs Market Forecast 2014-2024
11.3 Generic Penetration by Volume in Leading National Markets
11.4 Leading National Markets
11.5 Leading Generic Drug Manufacturers
11.6 The Future of the Generic Drugs Market?
Appendix AA
Appendix
Supplementary Information: Patent Expiries by Year
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List of Tables
Table 1.1 Currency Exchange Rates, 2012-2013
Table 2.1 Types of Drug Names, 2014
Table 3.1 World Generic Drugs Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 20122024
Table 3.2 World Generic Drugs Market Forecast: Revenues ($bn) and Market Shares (%) by
National Market, 2012-2013
Table 3.3 World Generic Drugs Market Forecast: Revenues ($bn) and Market Shares (%) by
Region, 2012-2013
Table 3.4 World Generic Drugs Market Forecast: Revenues ($bn), AGR (%), CAGR (%) by
National Market, 2012-2024
Table 3.5 World Generic Drugs Market Forecast: Revenues ($bn), AGR (%), CAGR (%) by
Regional Market, 2012-2024
Table 3.6 Market Shares (%) of Leading National Generic Drugs Markets, 2012, 2018 and 2024
Table 3.7 Market Shares (%) of Leading Regional Generic Drugs Markets, 2012, 2018 and 2024
Table 4.1 Top 10 Generic Drug Manufacturers: Generic Drugs Revenue ($bn), Market Share (%),
2012-2013
Table 4.2 Top 10 Generic Drug Manufacturers: Generic Drugs Revenue ($bn), Market Share (%),
2018 and 2024
Table 4.3 Novartis: Overview, 2012-2013
Table 4.4 Novartis: Revenue ($bn), Revenue Shares (%) by Segment, 2012
Table 4.5 Novartis: Generic Drugs Revenue ($bn), AGR (%), CAGR (%), 2012-2024
Table 4.6 Teva: Overview, 2012-2013
Table 4.7 Teva: Revenue ($bn), Revenue Shares (%) by Segment, 2012
Table 4.8 Teva: Generic Drugs Revenue ($bn), AGR (%), CAGR (%), 2012-2024
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Figure 6.3 German Generic Drugs Market: Generic Penetration by Volume (%), 2000-2013
Figure 6.4 German Generic Drugs Market: Generic Penetration by Value (%), 2000-2013
Figure 6.5 French Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024
Figure 6.6 French Generic Drugs Market: Generic Penetration by Volume (%), 2000-2013
Figure 6.7 French Generic Drugs Market: Generic Penetration by Value (%), 2000-2013
Figure 6.8 UK Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024
Figure 6.9 UK Generic Drugs Market: Generic Penetration by Volume (%), 2000-2013
Figure 6.10 UK Generic Drugs Market: Generic Penetration by Value (%), 2000-2013
Figure 6.11 Italian Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024
Figure 6.12 Italian Generic Drugs Market: Generic Penetration by Volume (%), 2000-2013
Figure 6.13 Italian Generic Drugs Market: Generic Penetration by Value (%), 2000-2013
Figure 6.14 Spanish Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024
Figure 6.15 Spanish Generic Drugs Market: Generic Penetration by Volume (%), 2000-2013
Figure 6.16 Spanish Generic Drugs Market: Generic Penetration by Value (%), 2000-2013
Figure 7.1 Japanese Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024
Figure 7.2 Japanese Generic Drugs Market: Generic Penetration by Volume (%), 2000-2013
Figure 7.3 Japanese Generic Drugs Market: Generic Penetration by Value (%), 2000-2013
Figure 7.4 Chinese Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024
Figure 7.5 Chinese Generic Drugs Market: Generic Penetration by Volume (%), 2000-2013
Figure 7.6 Chinese Generic Drugs Market: Generic Penetration by Value (%), 2000-2013
Figure 7.7 Indian Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024
Figure 8.1 Russian Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024
Figure 8.2 Brazilian Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024
Figure 8.3 Mexican Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024
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Figure 8.4 South Korean Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024
Figure 8.5 Turkish Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024
Figure 9.1 World 65+ Population Forecast: Size (m), 2013-2024
Figure 9.2 Porter’s Five Forces Analysis of the Generic Drugs Market, 2014-2024
Figure 11.1 Generic Penetration by Volume in Leading National Markets (%), 2013
Companies Listed
Abbott Laboratories (Abbott)
AbbVie
Aché Laboratórios Farmacêuticos S.A. (Aché)
Actavis (Foshan) Pharmaceuticals Co., Ltd (subsidiary of Actavis)
Actavis plc (Actavis)
Actelion Pharmaceuticals
Advanced Medical Optics (subsidiary of Abbott)
Agila Specialties (acquired by Mylan)
Alcon (part of Novartis)
Alembic Pharmaceuticals
Allergan
Altra Investments
Amgen
Amphastar Pharmaceuticals
APP Pharmaceuticals (acquired by Fresenis Kabi)
Arrow Group (part of Actavis)
Ascent Pharmahealth (acquired by Actavis)
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Aspen Pharmacare Holdings Limited (Aspen)
Astellas Pharma
AstraZeneca
Aurobindo
Aventis (part of Sanofi)
Barr Pharmaceuticals (acquired by Teva)
Bayer AG (Bayer)
Bedford Laboratories (currently part of Boehringer Ingelheim)
Bergamo Ltda
Biocon Limited (Biocon)
Bioniche Pharma Holdings Ltd (acquired by Mylan)
BMP Sunstone (acquired by Sanofi)
Boehringer Ingelheim
Bolar Pharmaceutical (now Circa Pharmaceuticals, part of Actavis)
Cephalon (acquired by Teva)
Chattem (acquired by Sanofi)
Chiron Corporation (part of Novartis)
CIBA VISION (part of Novartis)
Cipla
Claris Lifesciences Ltd (Claris)
Compañía Internacional de Comercio, S.A.P.I. de C.V. (CISCA) (acquired by Taisho)
Corporación Infarmasa (Infarmasa) (acquired by Teva)
Cubist Pharmaceuticals
Dabur Pharma (acquired by Fresenis Kabi)
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Daiichi Sankyo Brazil (subsidiary of Daiichi Sankyo)
Daiichi Sankyo Co., Ltd.
Dalim BioTech
Dey Pharma (now Mylan Specialty, subsidiary of Mylan)
Dr. Reddy's Laboratories
Ebewe Pharma (acquired by Novartis)
Eden Biopharm Group (part of Actavis)
Egis Pharmaceuticals
Eisai
Elder Pharmaceuticals
Eli Lilly and Company (Lilly)
Elyson Pharmaceutical
EMS Sigma Pharma
Endo Pharmaceuticals
Eon Labs (acquired by Novartis)
Eurofarma Laboratories
F. Hoffmann-La Roche Ltd. (Roche)
Facet Biotech (acquired by Abbott)
Farmacias Similares
Fenwal (acquired by Fresenis Kabi)
Filaxis (acquired by Fresenis Kabi)
Forest Laboratories
Foshan Chanbende Development
Fougera Pharmaceuticals (acquired by Novartis)
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Fresenius Kabi (division of Fresenius SE & Co. KGaA)
Fresenius SE & Co. KGaA
Fuji Pharma Co., Ltd.
Gedeon Richter
Genzyme (acquired by Sanofi)
Gilead Sciences
GlaxoSmithKline (GSK)
Greenstone (subsidiary of Pfizer)
Grupo Imperial (acquired by Taisho)
Grupo Sanborns
Grupo Uriach
H. Lundbeck A/S (Lundbeck)
Handok Pharmaceutical (acquired by Teva)
Harris Interactive Inc.
Helvepharm (part of Sanofi)
Hexal (acquired by Novartis)
Hisun-Pfizer Pharmaceuticals (Pfizer / Zhejiang Hisun joint venture)
Hospira, Inc. (Hospira)
Ilsung Pharmaceuticals
IMS Health
InnoPharma Inc.
Itero Biopharmaceuticals
Janssen Pharmaceutica (part of Johnson & Johnson)
Javelin Pharmaceuticals (acquired by Hospira)
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Johnson & Johnson (J&J)
Kmart
KMS Pharmaceutical
Kos Pharmaceuticals (acquired by Abbott)
Kosei (acquired by Taisho)
Kowa Company
Krka Pharmaceuticals
Labesfal (acquired by Fresenis Kabi)
Laboratoires Servier (Servier)
Laboratorio Sanderson (acquired by Fresenis Kabi)
Laboratório Teuto Brasileiro (Teuto) (part-owned by Pfizer)
Laboratorios Best
Laboratorios Kendrick (acquired by Sanofi)
Lek (acquired by Novartis)
Lupin Pharmaceutical
Matrix Laboratories (part of Mylan)
Mayne Pharma (acquired by Hospira)
Medis (part of Actavis)
Medley (acquired by Sanofi)
Merck & Co. (Merck)
Merck KGaA
Microdose (acquired by Teva)
Momenta Pharmaceuticals
MSD (subsidiary of Merck)
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Mustafa Nevzat Pharmaceuticals (MN Pharma)
Mylan Inc. (Mylan)
Mylan Laboratories Limited (subsidiary of Mylan)
Mylan Seiyaku (subsidiary of Mylan)
Mylan Technologies Inc. (subsidiary of Mylan)
Natco Pharma
Nestlé
Neurosearch A/S
Nexus Pharmaceuticals
Nichi-Iko (acquired by Sanofi)
Nippon Chemiphar Co. Ltd.
Novartis International AG (Novartis)
Novast Laboratories
Novo Nordisk
Orchid Chemicals & Pharmaceuticals (now Hospira Healthcare India, part of Hospira)
Oriel Therapeutics (acquired by Novartis)
Otsuka Pharmaceutical
Parenteral Drugs India Ltd
Patriot Pharma (part of Johnson & Johnson)
Pfizer, Inc. (Pfizer)
PGT Healthcare (Procter & Gamble / Teva joint venture)
Pharmacia & Upjohn
PharmaDerm (now part of Novartis)
Pharmagenus (division of Grupo Uriach)
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Piramal Healthcare Solutions (acquired by Abbott)
PT Ethica Industry Farmasi (subsidiary of Fresenius Kabi / PT Soho Global Health
PT Soho Global Health
Purdue Pharma
Ranbaxy Farmaceutica (subsidiary of Daiichi Sankyo)
Ranbaxy Laboratories Limited (Ranbaxy) (acquired by Daiichi Sankyo)
Ratiopharm (acquired by Teva)
Ribbon (acquired by Fresenis Kabi)
S.E. Massengill Co. (now part of Prestige Brands)
Sabex Holdings (acquired by Novartis)
Salomon, Levin and Elstein (subsidiary of Teva)
Sandoz (part of Novartis)
Sanofi Mexico (subsidiary of Sanofi)
Sanofi Pasteur (acquired by Sanofi)
Sanofi S.A. (Sanofi)
Sawai Pharmaceutical Co., Ltd. (Sawai)
Schein Pharmaceutical (part of Actavis)
Shelys (part of Aspen)
Shire
Sicor (acquired by Teva)
Sigma Pharmaceuticals (acquired by Aspen)
Solvay Pharmaceuticals (acquired by Abbott)
South African Druggists (SA Druggists, part of Aspen)
Specifar Pharmaceuticals S.A. (acquired by Actavis)
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STADA Arzneimittel
STARLIMS (acquired by Abbott)
Strides Arcolab
Sun Pharmaceutical Industries (Sun Pharma)
Sunovion Pharmaceuticals, Inc. (subsidiary of Dainippon Sumitomo Pharma)
Swisse Wellness ( (acquired by Teva)
Synthélabo (part of Sanofi)
Synthon
Taisho Pharmaceutical Co., Ltd. (majority owned by Teva/Kowa joint venture)
Taiyo (acquired by Teva)
Takeda Pharmaceutical
Target Corporation (Target)
Tecnofarma (acquired by Valeant)
Teva Pharmaceutical Industries (Teva)
Teva Seiyaku (subsidiary of Teva)
The Rohatyn Group
TheraDoc (part of Hospira)
Theramex (acquired by Teva)
Torrent Pharmaceuticals
Towa Pharmaceutical Co. Ltd. (Towa)
UDL Laboratories (part of Mylan)
Uteron Pharma S.A. (acquired by Actavis)
Valeant Pharmaceuticals
Veropharm
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30. Contents
Vitacilina Corporation of America (VitaCorp) (acquired by Taisho)
Wal-Mart Stores, Inc. (Walmart)
Warner Chilcott (acquired by Actavis)
Watson Pharmaceuticals (part of Actavis)
Winthrop Pharmaceuticals (part of Sanofi)
Wockhardt
Wyeth Pharmaceuticals (part of Pfizer)
Xenon Pharmaceuticals
Zentiva (acquired by Sanofi)
Zhejiang Chiral Medicine Chemicals Co., Ltd
Zhejiang Hisum Pharmaceutical
Zoetis
Zydus Cadila
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31. Contents
Other Organisations Mentioned This Report
Other Organisations Mentioned inin This Report
American Pharmaceutical Association (APhA)
Assogenerici (Italy)
Blue Cross Blue Shield Association (BCBSA)
British Generic Manufacturers Association (BGMA)
Centers for Medicare and Medicaid Services (US)
China Food and Drug Administration (CFDA)
Congressional Budget Office (US)
Depart of Health (UK)
Department of Pharmaceuticals (India)
European Commission
European Generic Medicines Association (EGA)
European Medicines Agency (EMA)
Farmácia Popular (Popular Drugstores) (Brazil)
Federal Commission for the Protection against Sanitary Risk (COFEPRIS) (Mexico)
Federal Health Monitoring System (Germany)
Federal Joint Committee (Germany)
General Directorate of Pharmaceuticals and Pharmacy (GDPP) (Turkey)
Generic Pharmaceutical Association (GPhA) (US)
Generics and Biosimilars Initiative (GaBi)
German Association of Pharmacists (ABDA)
International Union of Pure and Applied Chemistry
Katholieke Universiteit Leuven (KU Leuven)
Leonard Davis Institute for Health Economics (University of Pennsylvania)
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32. Contents
Mexican Institute of Social Security
Ministry of Health (Turkey)
Ministry of Health and Welfare (South Korea)
Ministry of Health, Labour and Welfare (MHLW) (Japan)
Ministry of Industry and Trade (Russia)
National Development and Reform Commission (NDRC) (China)
National Health Service (NHS) (UK)
National Pharmaceutical Pricing Authority (NPPA) (India)
Pan American Health Organization (PAHO)
Pharmaceutical and Medical Devices Agency (PMDA) (Japan)
Pharmaceutical Manufacturers Association of Turkey (IEIS) (Turkey)
Progenericos (Brazil)
Public Health Institution (Turkey)
Seguro Popular (Popular Insurance) (Mexico)
Servicio Sanitario Nazionale (SSN) (Italy)
Social Security Institution (SSI) (Turkey)
State Intellectual Property Office (China)
Statutory Health Insurance (SHI) (Germany)
Tufts Center for the Study of Drug Development
Turkish Association of Research-Based Pharmaceutical Companies (AIFD) (Turkey)
Unified Health System (SUS) (Brazil)
United Nations' Department of Economic and Social Affairs
United States Adopted Name (USAN) Council
University of Amsterdam
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33. Contents
US Census Bureau
US Federal Trade Commission
US Food and Drug Administration (FDA)
US Patent and Trademark Office
Veteran Affairs Medical Center, Philadelphia
World Health Organization (WHO)
World Trade Organization (WTO)
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34. Generic Drugs: World Market 2014-2024 &
Future Prospects for Leading Companies
Table 4.14 Mylan: Generic Drugs Revenue ($bn), AGR (%), CAGR (%), 2012-2024
Mylan ($bn)
Annual Growth Rate (%)
CAGR (%, 2012-2018
and 2018-2024)
CAGR (%, 2012-2024)
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
6.0 5.8 6.5 7.2 8.0 8.8 9.5 10.2 10.9 11.7 12.5 13.3 14.2
-3.0 12.0 11.5 11.0 9.5 8.0 7.7 7.3 7.0 6.8 6.7 6.5
8.0
7.0
7.5
Source: visiongain 2014
Figure 4.11 Mylan: Generic Drugs Revenue ($bn), AGR (%), 2012-2024
14.0
14.0
12.0
12.0
10.0
8.0
10.0
6.0
8.0
4.0
6.0
AGR (%)
Sales ($bn)
16.0
2.0
4.0
0.0
2.0
-2.0
0.0
-4.0
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
Year
Sales ($bn)
AGR (%)
Source: visiongain 2014
4.5.3 Mylan: Recent Developments
4.5.3.1 Mylan to Double Manufacturing Capacity by 2016
Mylan is expanding its manufacturing capacity across a range of types of formulation as part of its
long-term growth strategy. The company reportedly invested $305m in 2012 and around $350m in
2013 to approximately double production capacity across various formulations between 2012 and
2016. The company has expanded its US transdermal patch manufacturing facility in St. Albans,
Vermont, which doubles its capacity from 105 million units in 2012 to 206 million units in 2013.
Mylan has also doubled its semi-solid and aerosol capacity and further plans to expand its oral
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35. Generic Drugs: World Market 2014-2024 &
Future Prospects for Leading Companies
Figure 6.3 German Generic Drugs Market: Generic Penetration by Volume (%), 20002013
Generic penetration by volume of
prescriptions (%)
100
90
80
70
60
50
40
30
20
10
0
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
Year
Generic penetration by
volume of prescriptions (%)
Source: visiongain 2014; Gesundheitsberichterstattung des Bundes (Federal Health Monitoring System,
Germany) (2000-2012 figures). The 2013 figure is visiongain’s estimate.
6.3.3 German Generic Drugs Market: Generic Penetration by Value
Table 6.4 and Figure 6.4 illustrate the trend in generic penetration by proportion of total
pharmaceutical sales from 2000-2013 for the German market. Generic penetration by value is
relatively high in the German market.
Table 6.4 German Generic Drugs Market: Generic Penetration by Value (%), 20002013
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
Generic penetration by
proportion of total
pharmaceutical sales (%)
31.9
30.0
29.9
30.4
34.3
34.6
35.9
36.4
36.8
35.9
34.7
35.3
36.7
37.8
Source: visiongain 2014; Gesundheitsberichterstattung des Bundes (Federal Health Monitoring System,
Germany) (2000-2012 figures). The 2013 figure is visiongain’s estimate.
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36. Generic Drugs: World Market 2014-2024 &
Future Prospects for Leading Companies
introduced a law to encourage public-private partnerships, stimulate hospital construction and
improve healthcare provision. The government has expanded the Seguro Popular ('Popular
Insurance') programme, whereby government-sponsored public healthcare is available to
nationals. As of 2013 nearly every Mexican is covered by the public health system. Consequently,
public institutions such as the Mexican Institute of Social Security have embraced the move
towards generics, and public expenditure on medicines has been increasing steadily.
Counterfeiting of drugs continues to pose a significant threat to revenues from generic drugs during
the forecast period. Counterfeit drugs are estimated to cost drug companies around $1.5bn in
sales.
8.4.1 Mexican Generic Drugs Market: Sales Forecast 2014-2024
Visiongain estimates that in 2012 the Mexican generic drugs market generated revenues of
$3.4bn, representing 2.0% of the world market. Sales for 2013 increased to $3.8bn, up 14% on
2012. Table 8.3 and Figure 8.3 show visiongain’s forecast for the Mexican generic drugs market
from 2012 to 2024.
Visiongain predicts that the Mexican market will grow at a CAGR of 12.6% over 2012-2018 to
reach revenues of $6.8bn in 2018. Growth will be driven by increasing healthcare coverage and
rising demand for generic medicines to treat a growing burden of chronic disease. Improvements in
the regulatory environment in Mexico will also encourage the development of the generics market.
In the second half of the forecast period, price controls will limit growth, but growth is expected to
remain high due to unmet medical need and increasing generic penetration. We predict that
Mexican generic drug sales will grow at a CAGR of 8.5% over 2018-2024 to reach revenues of
$11.2bn in 2024, representing an overall CAGR of 10.5% over 2012-2024.
Table 8.3 Mexican Generic Drugs Market Forecast: Revenues ($bn), AGR (%),
CAGR (%), 2012-2024
Mexico ($bn)
Annual Growth Rate (%)
CAGR (%, 2012-2018
and 2018-2024)
CAGR (%, 2012-2024)
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
3.4 3.8 4.3 4.9 5.5 6.2 6.8 7.5 8.2 8.9 9.6 10.4 11.2
14.0 13.5 13.0 12.5 11.7 10.8 10.0 9.3 8.7 8.0 7.8 7.5
12.6
8.5
10.5
Source: visiongain 2014
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