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Bio similar- An opportunities or challenge for Indian Company


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Opportunities, critical success factors for Indian biosimilar players

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Bio similar- An opportunities or challenge for Indian Company

  1. 1. Biosimilars : Strategic Outlook Debashish Kar, Ph.D. Head-Regulatory & Bioequivalence
  2. 2. Drivers of Biosimilars Biosimilars : Landscape Contents Challenges to Overcome Way Forward
  3. 3. Global Therapeutic Overview 0% 2% 4% 6% 8% 10% 12% -10% -5% 0% 5% 10% Anti-hyperlipidaemics Anti-bacterials Bronchodilators Anti-hypertensive Oncology Anti-diabetics Anti-rheumatics Anti-virals Bone-calcium regulators vaccines Key Drivers Avastin, Rituxan (Roche), Erbitux (BMS/LLY/ Merck KgaA) Glivec (NVS). Patent Expiries Taxotere (SAN), Eloxatin (SAN), Arimidex (AZN), Gemzar (LLY) Key Drivers HPV vaccines (GSK & MRK), Pneumo. (WYE,NVS & GSK) & Herpes zoster vaccine (MRK). Plus strong influenza sales. Key Patent Expiry Angiotensin II antagonists segment Diovan (NVS) in 2012, Cozaar (MRK) 2010, Avapro (BMY/ SAN) in 2012 Key Patent Expiry Lipitor (PFE) in 2011 % Sales Growth: CAGR 2008-14 WWMarketShare% Bubble = WW Sales in 2014 $70bn $29bn $23bn $26bn $15bn $15bn $28bn $37bn $34bn Analysis of Top 10 Therapy Areas in 2014, Market Share & Sales Growth (2008-14) Oncology potentially outperforming market by both volume & value growth in the space
  4. 4. 1. Global biologics market is estimated to be ~ $ 108 billion from 200 products. Annual growth of 7.8% expected to be $160 billion by 2016. (Source:- Reported by Evaluate Pharma) 2. Top 10 products contribute for 50 % of the market share. Innovative Biological
  5. 5. Shifting R&D Pipeline Major Pharma/Biotech Players The most comprehensive biosimilars pipeline- 775 candidate biosimilars development pipeline, from preclinical through marketed. The most comprehensive biosimilars pipeline-
  6. 6. Biosimilars : what’s the buzz ? High level of interest across the industry throughout the value chain
  7. 7. Global Market : Size & Potential MarketPotential In the worst-case scenario, with an estimated price erosion of biologics of up to 30% , potential market worth ~$40bn remains very appealing & attractive spread across next five years Year Estimated Revenue of Patented Drugs Only Biologics 2010 $23bn $2bn 2011 $36bn $1bn 2012 $44bn $8bn 2013 $22bn $17bn 2014 $14bn $9bn 2015 $16bn $20bn Total $155 $59bn 2010-2015 : Golden period of Biosimilars space to derive advantages from patent expiry Mc Kinsey report As per the latest report, Mc Kinsey & Co. expects the average patent expiry at $39.6bn per annum between 2010-2015 as compared to just $14.2bn in last decade and $16.5bn per annum between 2016-2020. This indicates that 2010-2015 is a golden period for Global Biosimilars space Source : US FDA website, Bloomberg, HDFC Securities Institutional Research
  8. 8. Income Growth Medical Infrastructure Insurance Penetration Increased Prevalence Others 40% 20% 14% 14% 12% Ref: IMS world review , McKinsey India pharma demand model-best case Biosimilars : Indian Positioning Global pipeline at different clinical stages Ref: From pipeline to market. R&D Directions. 2009;15(6):4-89. 20 25 25 25 32 38 38 46 82 9 6 20 13 19 31 13 32 68 Brazil India Italy Canada UK Germany China France Japan 2005 2015 Top 10 Pharma markets expt. US : 2015 Values in $billion Drivers for 5X Growth from 2010 Ref. Mckinsey India pharma outlook 2015 Goldmine to be explored Indian companies to add $20bn by 2015 Value will be driven by - Derm a. Blood Dis GI Resp. Meta. Dis. Cardio Pain,I nfla Infec. CNS Onco 66 83 97 137 166 191 204 229 329 831
  9. 9. 1. Global biosimilars market ≈ $19.4 billion by 2014, growing at an expected CAGR of 89.1% from 2009 to 2014. 2. By 2015, sales of biosimilars in US are expected US$1.9-2.6 billion, up from US$378 million in 2011. 3. The Indian biosimilars (excluding vaccine) market in 2008 was around about $ 200 million, $ 700 million in 2010 and with an expectation to reach around about $ 1 billion plus by 2012 at 30% CAGR. 4. The Indian biologics market consists primarily of vaccines, monoclonal antibodies, recombinant proteins and diagnostics. 5. The main players of biosimilars in India :  Dr. Reddy’s Ltd.  Biocon Ltd.  Cipla Ltd.  Intas Biopharmaceuticals Ltd. and  Wockhardt Ltd. . Biosimilars –Indian Positioning (Cont) (Source:-Ariyanchira, 2010). (Source:-IMS –December 2011) (Source:-Biosimilar News Oct-2011)
  10. 10. Indian companies & biosimilar Company Biosimilar Classification Status Turn over $ million(201 0) Overseas Revenue $ million Dr. Reddy Grafeel Filgrastim Approved in 2001 and sold in 7 countries 336.00 239.00(71% of total) Reditux Monoclonal antibodies mAB Approved in 2007 and sold in 7 countries,exploring for others Cresp Darbepoetn alfa Launched in 2010 and sold in India only Peg-grafeel Pegfilgrastim Launched in 2011 and is the only single source pegfilgrastim in world Intas (Ahmadabad) Neukine Filgrastim Neukine® (rHu GCSF) was the first drug introduced by Intas in India domestic market and few international markets. 69.00 23.50 (34% of total)Neupeg PEGylated G-CSF India and semi-regulated markets of Europe, Asia-Pacific, Middle East, Russia & CIS, South and Central America and Africa. Intalfa Interferon alpha 2b Epofit Erythroproietin Biocon Eripro Erythroproietin India and semi-regulated markets 126.00 63.00(50 % of total) Biomab Monoclonal antibodies mAB Nufil Filgrastim,G-CSF Insugen Human Insulin India and china Wockhart Wepox Erythropoietin India and semi-regulated markets 168.00 116.70(70% of total) wosulin Recombinant insulin Sheffield Bio-Science and Wockhardt Announce Worldwide Exclusive Partnership to Supply Recombinant Insulin to Cell Culture Market Cipla Avastin,Herce ptin & Enbrel Monoclonal antibodies mAB India and semi-regulated markets 291.00 159.00(55% of total) Source:- Reported by Genomic network –Oct 2011
  11. 11. Biosimilars : SWOT Analysis Based upon India Brand Equity Foundation , The Biosimilars industry is fast-growing and has a strong economic value proposition . However, there are a number of competitive threats that make a well-developed strategy critical to any company wishing to develop in this sector Weaknesses Cost of Biosimilars products to consumers in emerging markets is still relatively high unlike small molecules generics . Extensive funding is required due to emerging rigorous regulatory requirements. Lack of widespread awareness and credibility of industry. Strengths Lower price point and similar effectiveness to originator products. Shorter time to market than originator products. Higher probability of Return on Investment (ROI) than with new product R&D. Due to rapidly increasing healthcare costs, there is high consumer demand for discounted high quality treatments Opportunities Large and growing market for biosimilar products. Emerging regulatory frameworks provide structured approval guidelines. High-revenue bio-pharmaceutical projects that have less equivalent Biosimilar approved/available in their portfolio Threats Future regulations for Biosimilars is still being defined Particularly in US ,few Biosimilars have been formally approved , resulting in little precedence for future rulings. The industry will require greater focus on new investments for future growth
  12. 12. Biosimilars : Landscape Contents Way Forward Drivers of Biosimilars Challenges to Overcome
  13. 13. Biosimilars : Big Savings worldwide $49 $51 $55 $60 $65 $69 $78 $86 $101 $121 $0 $20 $40 $60 $80 $100 $120 $140 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 Savings to U.S. Health Care System by Generics  $734 bn in savings to the U.S. health care system over the past decade (1999-2008)  $121 bn of savings in 2008 alone  Biologics spending in US to exceed $100bn in 2011 • Shapiro study (Clinton under secy. of commerce) : Biogenerics of top 12 biologic categories with patent expiring would save $67-108bn over 10 years and up to $378bn over 20 years • Even an assumption of long term consolidated global savings will be enough to understand upcoming gravity shift Based upon Economic Analysis of Generic Medicines 1999-2008 ; GPhA analysis 2009 $bn
  14. 14. Biosimilars : Drivers & Inhibitors Expiring biologics Patents Fastest Growing market segment Mounting cost containment pressure Promising Biosimilars development Opposition from Innovators Unclear approval guidelines Cost & Complexity of development Lack of time on market Biosimilars Market Based upon qualitative analysis on dynamics of developed markets
  15. 15. Biosimilars –Why India or Indian Company? 1. Indian generics Companies have gross margins closer to 50%. Straightway 50–60% discount. 2. Dr. Reddy’s launched a Biogeneric of Roche’s Rituxan/Mabthera at 50% discount to Roche’s price in India. 3. The most obvious reason is cost arbitrage. Development cost for a biosimilar molecule requires 10 to $20 million, as compared to $50 to $100 million in developed countries. (Source:-Frost and Sullivan, 2011) 4. India is one of the major contributors in the world biogeneric market along with the china. 5. Out of 50 biotech drugs, 13 are available in India and 7 drugs are indigenously developed and produced by the Indian companies. 6. Market share in India for biosimilars is 75%. 40 biologicals marketed in India, of which 30 are biosimilars More Over  Highest number of US FDA approved plants outside the US.  Compliance with GCP guidelines is an rise with Indian Companies.  Highly qualified human resource availability. Low capital and operational cost.  Pharma sector highly competitive in bioprocessing skills.  Excellent genomic research opportunity.
  16. 16. Indian : Save Time & Cost
  17. 17. Biosimilars : Landscape Contents Way Forward Drivers of Biosimilars Challenges to Overcome
  18. 18. Biosimilars : The Competency Matrix High capital investment Specialist Marketing Pharmacovigilance studies Clinical Trials Regulatory Experience Legal/IP Expertise Low cost manufacturing Competencies of Innovators Competencies of Generics business Competencies of Biosimilars Business TraditionalGeneric Players TraditionalInnovators Low High LowHighStrength Biotechnology Expertise Based upon qualitative analysis on dynamics of developed markets
  19. 19. Challenges & Success Strategy Challenges Strategy  High development cost  Clinical complexity  Stringent guidelines  Partnership for cost effective development  Well designed trials & protocols  Strong developmental capabilities in India Development Big US/EU Pharma Indian Pharma  High promotional spend  Uptake by stakeholders  Market competition  Patent Barriers  Regulatory Barriers  Competition from Brands  Enter marketing agreements  Right product for right indication  Low cost manufacturing  Gain legal expertise  strong product positioning  Gain experience in emerging markets Profitability Marketing Strengths meter  Technical Barriers  Lack of Manufacturing facilities  Cost Barriers  Early planning & analysis  Team up with companies having expertise  Access to GMP facilities Manufacturing Based upon qualitative analysis on dynamics of developed markets
  20. 20. Biosimilars : Landscape Contents Way Forward Drivers of Biosimilars Challenges to Overcome
  21. 21. Biosimilars : Potential Uptake Favorable for Biosimilars Non-favorable for Biosimilars Biosimilars uptake seems to come from hospital settings with challenges of pricing & promotions to face from innovators Based upon qualitative analysis on dynamics of developed markets
  22. 22. Way forward to a successful Biosimilars Venture Cost effective development & manufacturing Access to GMP facilities & expertise Clinical/Regulatory expertise Effective & right size field force Relationship with stakeholders Early entrants Globally joint efforts are required to improve worldwide availability, affordability and access to the therapies needed for humankinds
  23. 23. Investing in Biosimilars Outpaces Benchmark Returns from R&D Internal Rate of Return (IRR) Biosimilar vs. industry benchmark 11.5 % Median IRR Industry benchmark (R&D ) IRR of 12 Top R&D PharmaCos) -10 -5 0 5 10 15 20 25 30 2010 (publicly available document) 10-year IRR Most likely interval for biosimilars IRR 6.4% - 15% Biosimilars IRR (Number of competitors in the market) Time-to-market (First mover vs. Follower) Value chain optimization, especially on R&D and Manufacturing Degrees of competition (Numbers of competitors into the market) Critical Source: IMS analysis. Benchmark from Deloitte & Thomson Reuters Research 2011 ALTHOUGH RISKY, THE EXPECTED PRODUCTIVITY OF INVESTING IN BIOSIMILARS MATCHES OR OUTPACES BENCHMARK RETURNS FROM R&D
  24. 24. New Global Pharma/Biotech Outsourcing Trends Outsourcing is in demands in recent years, many major Pharma/Biotech companies have remodeled their traditional drug R&D operations to de-risking their R&D efforts Latest New Technologies And Services Pharma/Biotech companies are focusing more on new services such as biosimilar characterization and antibody screening, and cell-line development primarily through collaboration with specialty biotech CROs. Focusing On Emerging Markets/CRO The new model of "more achievements for less cost" has forced many drug companies to investment into these emerging countries especially true in India and China . The global Pharma outsourcing industry will experience fast growth in the next five years, $85 B in 2011 to as much as $150B by 2015 with a CAGR of about 12% . Total CRO market value, which is about $40.5B in 2011 will grow up to $65B by 2015 with a CAGR of about 13% . The biology-related services, preclinical and clinical development will account for about 75% of total outsourcing . Financial Outlook Focusing On CRO 1.Vertical growth, partnerships (including joint ventures) or 2. Acquisitions with major Pharma/Biotech players .
  25. 25. * Information presented here is available in public domain.