The Biopharmaceutical market is broadly divided in three Geographical clusters. All three have different characteristics in terms of potential, regulatory pathways, growth and uptake of Biosimilars.
1. USA:
a. USA is the Potential leading market for Biosimilars.
b. Biosimilar uptake is negligible in USA
c. CAGR (2005 -10) is 9%
d. There is Less clarity on regulatory pathways
2. Advanced Economies ( Europe, UK and Canada)
a. There is established frame work of regulatory pathways
b. Slow uptake of Biosimilars in these markets
c. Uptake of Biosimilars is not homogenous in all countries
d. CAGR (2005 -10) is 13-14
3. Pharmerging Markets (Brazil, China, Korea, India and Vietnam)
a. Loose regulatory pathways
b. Fast growing Biologics market
c. Uptake of Biosimilars is better than US and Advanced economies
d. The growth is the highest
Most of the immediate value creation will be from Pharmerging markets. In long term US will be the main driving worth $11 billion to US $25 in 2020 representing 4% and 10% of the total biologic market. The overall penetration of Biosimilars within the off patent biologic market is forecast to reach up to 50% by 2020, assuming a price discount of 20-30%.
Entry Barrier / Challenges
Biosimilar market is Lucrative but there are entry barriers. Some of the entry barriers have been created by existing Bio Pharmaceutical companies.
1. Manufacturer of Biologicals have started working on 2nd generation products where patents are applicable. There is motivation for clinician to use 2nd generation products as they offer better efficacy, convenience and pricing etc.
2. The investment required in developing Biosimilar facility is significantly higher than the generic drugs. It takes longer time to get the returns in case of Biologicals
3. USA is the most potential market for Biologicals and the regulatory pathways are not very clear.
4. The uptake of Biosimilars is slow and uptake is not homogenous in Europe.
5. The manufacturer of branded products use patient assistance plan. They have differential pricing for patients as per the need and requirement. They have good infrastructure and well trained team. The clinicians using these kinds of products are generally not very low in number. This creates very competitive scenario. Moreover there are safety concerns for Biosimilars at least on short term bases.
6. The manufacturers of branded products have created differentiation by using new delivery devices. There are fewer companies manufacturing these delivery devices and many of them have exclusive arrangement.
Advantage India (Biosimilars)
Worldwide, Biosimilars have expanded the market. There is advantage in setting up manufacturing plant in India
1. Low Cost
• 40 – 50% of Development cost
• 30 – 40% of Manufacturing cost
• 10 – 20% of Salaries
……….. Compared to US / EU
2. Regulatory
• International standards in Infrastructure & Mfg.
• Understanding of Biosimil
2. Potential of Biopharmaceuticals
Biopharmaceuticals will continue to outperform
• Address the clinical need which is unmatched by conventional therapies
• At some point, patent will expire and potential of a sizeable market will attract
generic companies
• Opportunity for significant and sustained cost reduction in health care system.
– Advanced Markets
• Limited Economic Growth, Treatment cost, Cost of Biologic
Therapies, lucrative source of saving on drug expenditure after 2015
– Pharmerging Markets ( Brazil, India and China)
• There is need to broaden health care coverage to large population group
against limited budget and growing demand for innovative drugs
• Key driver for growth, attracting foreign capital by creating manufacturing
and R&D centers of excellence.
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3. Potential of Biopharmaceuticals
Biopharmaceuticals will continue to outperform
• Since the origin in 1980, biologics have prospered into a US$138
Billion Market (2010)
– Major Launches are Insulin, HGH, EPO, G CSF and MAbs
– Currently accounting for 16% of global pharmaceutical
expenditure
• Top selling products including
Herceptin, Embrel, Humalog, Mabthera, Remicade and Arnacep are
due to lose patent protection over the next five years.
• Key therapy areas are Cancer, Diabetes and RA
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7. Challenges
• Sophisticated defensive tactics
• Second-generation products
• Capital investment
• Post-approval safety monitoring
• European guidelines
• Brand development
• Relative safety and efficacy of Biosimilars
• Improved delivery devices
• Regulatory pathway in the USA
• EU generic and biopharmaceutical markets are not yet homogenous.
• Price competition
• Originator products’ pricing strategies
• Time
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8. Time Lines – Indian Market
1
• Clone Development : 1 to 1.5 Years
2
• Process Development : 1- 2 Years
3
• Pre Clinical Study : 6 Months
4
• Short Phase 3 Study : (Indication and treatment
type) : 1 Year
5
• Approval for Marketing : 3 Month to 1 Year
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9. Time Lines – Europe
1
• Clone Development : 1 to 1.5 Years
2
• Process Development : 1- 2 Years
3
• Pre Clinical and Toxicity study : 1 year to 1.5
Years
4
• Phase 3 Study : (Indication and treatment type) :
1.5 - 2 Year
5
• Approval for Marketing : 1 – 1.5 Years
9
10. 2020 Out Look
• Number of Differential factor will impact value creation
in three Geographical Cluster
– Regulatory Pathways
– Speed of Intake
• Most of the Immediate value creation will be from
Pharmerging markets
• In long term, US will be the main driving worth US $ 11
Billion –US$ 25 in 2020 representing 4% and 10% of
the total Biologic Market
• The overall penetration of Biosimilars within the off
patent biologic market is forecast to reach up to 50%
by 2020, assuming a price discount of 20 – 30%
10Source IMS Health
12. Key Drivers
• US Uptake
– Regulators favoring innovator companies will drive down
• Pharmerging Market
– Any shortfall in quality standard can drive down
• Europe
– Late adopters major EU markets such as Spain and Italy
– Physician resistance can drive down
• Technology
– Higher complexity of future Bio Products
• Volume Effect
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15. Bio Pharma in India - Hope or Hype
• Worlds’ 2nd biggest supplier of childhood
vaccines
• Worlds’ 4th biggest supplier of Pharmaceuticals
• 3rd in Asia-Pacific (160 biotech Cos >
Japan, Taiwan or Korea)
• India is among TOP 11 World biotech powers
• Grown by 74% in the last 2 years, 39% last year
• Largest number of US-FDA-approved plants (80)
outside USA
• R&D spend increasing by 36% YTY
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16. ADVANTAGE INDIA
(for Biosimilars)
• Low Cost
– 40 – 50% of Development cost
– 30 – 40% of Manufacturing cost
– 10 – 20% of Salaries
……….. compared to US / EU
• Regulatory
– International standards in Infrastructure & Mfg.
– Understanding of Biosimilars
– Monographs in Indian Pharmacopoeia
• Clinical Trial
– Speedier recruitment
– Vast pool of treatment naïve patients
• Other
– English language
– IT support
– Freedom to operate
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19. The Way Forward – Indian Biosimilars
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Source :India Brand
Equity Foundation
www.ibef.com
20. Conclusion
• Companies likely to succeed in the Biosimilars market
need to have an appropriate marketing structure as
well as the financial resources to develop the products
and to accept higher upfront risks in
development, commercialisation and capital
investment, a major shift in skills for most generic
players.
• This skills shift means that Biosimilars players will need
to evaluate their strategic options and to adopt
different business models and skill sets to conventional
generics companies. This is new territory for most
generic players and the likely commercial rewards of
entering most Biosimilars markets, in the short-term at
least, will probably be small…..
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It is not mediatory to do the comparative study in India. Toxicity study is also not required while doing preclinical study
Stage 3, toxicity study is must. Stage 4. There has to comparative study with the brand which is available in Europe. Additionally, immunogenicity test is required in Europe. Phase 3 added by 6 monthsYou need to fix up centers in advanceReview process is one yearThere is proper scientific advisory – you need to go to Scientific advisory before conducting phase 1 and phase 3 trial
