The biologics market is projected to increase significantly to meet the changing global demographic needs: aging of the global population and the impact on the type of care that individuals will need to receive (e.g., shift from acute care to chronic care).
By 2018, seven of the top 10 large molecule biologics are projected to need cold chain (per Pharmaceutical Commerce).
What implications will this have on the customer’s supply chain?
- Access to secure and reliable network
- Access to temperature data on-line
- Ability to monitor shipments and intervene as needed
- Ability to scale operations seasonally as needed (e.g., flu season)
The world’s drug makers continue to fret over the patent cliff. Pharma manufacturers are struggling to find new blockbuster products.
The patent cliff, in which the exclusive rights to top-selling drugs expires, has been a theme troubling the industry for several years. While a handful of drug makers are inventing new products that will sustain them, others are buying their way to a more stable future.
The emergence of generics have significantly impacted revenue from branded pharma drugs.
Source for stat:
Persistence Market Research “Global Market Study on Biological Drugs: North America to Witness Highest Growth By 2020”.
Key trends affecting growth:
People aged 60+ will rise from 11% to 22% by 2050 giving rise to an increase in chronic illnesses (e.g., diabetes, cardio)
Specialty drug spending in U.S. expected to quadruple from $87B in 2012 to $401B in 2020
Emergence of Bio-Markers for targeting individualized therapies (e.g. CAR-T therapies for oncology)
Due to the pharmaceutical patent cliff and diminishing margins in the traditional pharma model, pharmaceutical manufacturers are strategically targeting new, more complex specialty drugs and new channels to diversify their portfolio.
These large-molecule drugs are complex and costly to manufacture, so the development of generic equivalents, known as biosimilars, is difficult. Specialty drugs, therefore, are a safer bet for manufacturers looking to generate long-term margins.
The population is aging worldwide and significantly increasing the demand for healthcare services. In fact, per-person spending by seniors is about three times more than the average for working adults. (Source: CMS)
Facts to mention, if needed:
1) The number of people 65 and older is projected to triple by mid-century, from 531 million in 2010 to 1.5 billion in 2050.
2) In the U.S., the population of seniors is expected to slightly more than double in that time period, from 41 to 86 million.
3) By 2050, the majority of people in Japan, South Korea and Germany are expected to be older than 50.
4) Some Latin American countries, which are now younger than the U.S., will likely be older than the U.S. by 2050.
Source: United Nations, Department of Economic and Social Affairs, World Population Prospects: 2012 revision
The interpretation of the human genome is transforming medicine. We are moving from the inefficient and experimental medicine of today towards the data-driven medicine of tomorrow. Soon, diagnosis, prognosis, treatment, and most importantly, prevention will be tailored to individuals’ genetic and phenotypic information.
As we enter the second decade of the 21st century, investments in molecular biology, bioinformatics, disease management and the unraveling of the human genome are all finally bearing fruit. Personalized medicine promises to revolutionize the practice of medicine, transform the global healthcare industry, and ultimately lead to longer and healthier lives.
Increasing numbers of older patients needing specialized therapies (i.e. oncology, rheumatology) will continue to drive the shift from acute to chronic care.
Key Cancer and Rheumatoid Arthritis stats:
Spend for cancer medications is growing 24% per year from 2014 to 2016 with an average Rx cost of $4,023. (Source: Express Scripts 2013 Drug Trends Report)
In 2010, there were 13.2M new cases of cancer with an economic cost of $290bn.
By 2030, there will be 22.2M new cases of cancer with an estimated economic cost of $458bn.
65% of disease states are non-communicable diseases including Heart Disease, Cancer, Diabetes and Lung Disease.
Cancer makes up 15% of all disease states globally.
In 2010, there were 8M deaths from cancer globally.
By 2030, there will be an estimated 13.1M deaths from cancer globally.’
Source: www.cancer.org/research/infographicgallery/rising-global-cancer-epidemic
Rheumatoid Arthritis (RA) is growing 20% per year from 2014 to 2016 with an average Rx cost of $2,551. (Source: Express Scripts 2013 Drug Trends Report)
RA is an autoimmune disease that attacks tissues near joints and other body parts causing chronic swelling and pain that is sometimes severe enough to cause permanent disability.
60% of inadequately treated RA are unable to work after 10 years.
Risk of heart attack rises 60% one year after diagnosis.
Patients who treat Rheumatoid Arthritis with a biologic specialty drug can spend between $15K and $20K per year.
Source: http://www.healthline.com/health/rheumatoid-arthritis/facts-statistics-infographic
Other specialty therapy areas that are growing rapidly include HIV, Multiple Sclerosis and Growth Deficiency. (Source: Express Scripts 2013 Drug Trends Report)
Patient experience is crucial - Power of the patient; patients becoming more educated and demanding an improved customer experience
Specialized therapy areas – The aging population is experiencing a shift from acute care to chronic care (e.g., Diabetes, Oncology) and involve individualized therapies to treat diseases
Visibility and intervention – Customers require 24/7 visibility of time and temperature sensitive critical shipments that often contain high dollar value product; conduct shipment intervention as needed to prevent temperature excursions
Customs holds – Globalization brings opportunities to transport shipments internationally which can result in shipment holds taking longer than expected; will the customer’s shipment maintain temperature integrity if the shipment is held up in customs?
Complex compliance – Manufacturers have international customers who are subject to complex compliance requirements (e.g., FDA, IATA, WHO)
High Value / Security – Emergence of specialty therapies are often high value prescription drugs that require cold chain shipping; a need exists for stakeholders in the supply chain to maintain product integrity and chain-of-custody
What does your supply chain look like?
How will you handle the challenges of doing business globally to meet dynamic shipment requirements (e.g., cold chain temperature requirements, visibility and intervention needs)?
Additional probing questions for UPS Temperature True Cryo:
- Are you experiencing any temperature excursion or on-time performance issues with your dry ice shipments (i.e., temperatures below -20 Degrees Celsius)?
- Would your shipments benefit from avoiding cellular degradation?
- Do your shipments incur long shipment transportation times (e.g., customs holds)?
- Are you conducting clinical trial shipments domestically or internationally and would you benefit from a cryogenic solution that can maintain temperatures of -150 Degrees Celsius for 10+ days?
- Is there complete visibility to enable shipment intervention?
- Would you like to learn more about the UPS Temperature True Cryo service offering?
A partner who understands that what’s in the package means everything to the patient. And that’s what matters most.
This is what we do. And here’s how we do it.
It’s critical that biological specimens maintain temperatures of -150 Degrees Celsius to prevent cellular degradation and apoptosis (cell death). We get it . . . UPS Temperature True Cryo maintains temperatures of -150 Degrees Celsius for 10+ days
When minimum shipment levels occur for enabling usage of UPS Proactive Response Secure, you can count on UPS to mitigate risk by being able to retrieve and reclaim spoiled shipments without disrupting operations or disappointing patients. UPS has control towers overseeing time-sensitive shipments, and in the instance that a package is not going to meet its guaranteed time-in-transit, the UPS Proactive Response team has the ability to intervene and provide assistance.
All of this means that controlling and overseeing the supply chain from end-to-end is imperative and UPS provides critical support
PLEASE NOTE: Presentations in Canada and Brazil must remove the line “It’s a patient. Not a package.”
The UPS Temperature True Cryo solution is a parcel solution that maintains temperatures of -150 Degrees Celsius for 10+ days
UPS Temperature True Cryo leverages Cryoport’s web portal to enter shipment orders with documentation (e.g., pre-printed labels, air way bill, etc.)
Upon ordering a dewar on-line, customers will receive a pre-charged dewar leased by UPS to the customer
The shipment will automatically receive UPS Proactive Response shipment tracking and intervention support in US and Europe.
Customers also have the option to choose UPS Proactive Response Secure when minimum shipment levels occur to provide shipment insurance protection and interventional capabilities on a per shipment basis.
Customers can access on-line shipment reporting and temperature data for a shipment
UPS Temperature True Cryo leverages Cryoport’s web portal to enter shipment orders with documentation (e.g., pre-printed labels, air way bill, etc.)
Upon ordering a dewar on-line, customers will receive a pre-charged dewar leased by UPS to the customer
The pre-charged dewar is then returned by the customer to the origin location
The shipment will automatically receive UPS Proactive Response shipment tracking and intervention support in US and Europe.
Customers also have the option to choose UPS Proactive Response Secure when minimum shipment levels occur to provide shipment insurance protection and interventional capabilities on a per shipment basis.
Customers can access on-line shipment reporting and temperature data for a shipment
UPS provides our customers with a pre-charged dewar that is IATA approved for international transportation under IATA Special Provision A152 which exempts the “dry vapor” shipper because the insulated packaging in the dewar does not allow the build-up of pressure within the container and would not permit the release of any refrigerated liquid nitrogen.
The UPS Temperature True Cryo solutions maintains temperatures below – 150 Degrees Celsius which is below the -136 Degrees Celsius “glass transition point” which is the temperature at which cellular activity / degradation ceases to occur
The UPS Temperature True Cryo solution provides uses a data logger to record shipment temperatures that can be accessed online after the shipment has been delivered
UPS Temperature True Cryo key differentiator is UPS Proactive Response Secure. Customers can choose UPS Proactive Response Secure when minimum shipment levels occur to provide shipment insurance protection and interventional capabilities on a per shipment basis.
UPS Temperature True Cryo shipments also automatically receive UPS Proactive Response shipment tracking and intervention support in US and Europe.
