Biosimilars in Europe: The Road Ahead


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An analyst briefing about the road ahead for the biosimilars market in Europe.

Published in: Business, Economy & Finance
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  • hello sir,

    i am the student of MBA from gujarat, india.
    sir i am on a project to prepare a report on business plan of biosimilar, like what could be the cost and expenses of a whole new setup in european country. sir it would be so kind of you, if provide me atleasst a round about info. not exact but atleast to understand and to prepare the report, i only need the financial side of all setup...
    thank you, regards

    my email is
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Biosimilars in Europe: The Road Ahead

  1. 1. Biosimilars in Europe: The Road Ahead K. Srinivas Sashidhar, Research Analyst Healthcare 6th March 2012© 2012 Frost & Sullivan. All rights reserved. This document contains highly confidential information and is the sole property ofFrost & Sullivan. No part of it may be circulated, quoted, copied or otherwise reproduced without the written approval of Frost & Sullivan.
  2. 2. Today’s Presenter Functional Expertise •Experience in Healthcare and Biotechnology domain - R&D Industry Expertise •Experience in Healthcare industry •Experience in the clinical diagnostics segment What I bring to the Team •Strong Technical background and expertise •Effective communication and Presentation skills Career Highlights •Currently working as Research Analyst for Life sciences Division at Frost & Sullivan (Feb 2011 – Present)K. Srinivas Sashidhar •Worked as Associate Genetic Research Analyst at Histogenetics India PrivateResearch Analyst Limited (2 Years)Lifesciences ProjectsHealthcare CompletedEurope •European Diabetes Therapeutics Market (Published September 2011) •Analysis of European Biosimilars Market (Published December 2011)Frost & Sullivan Presently WorkingChennai •Western European In Vitro Diagnostics (IVD) Market •European Diabetes Diagnostics Market 2
  3. 3. Focus Points Biosimilars Overview and Key Segments Key Drivers, Restraints and Challenges Sneak Peek – Current scenario and how far would it go?Focus Points Key market participants involved and where do they stand? Regional Focus and factors influencing the biosimilars market Key Strategies and Conclusions Source: Frost & Sullivan analysis. 3
  4. 4. Market OverviewBiosimilars: Legally approved subsequent versions of innovator biopharmaceutical productsfollowing patent and exclusivity expiry.Huge Opportunities from patent expiries. More than $100 billion worth biologics due to expire in thenext decade.Early stages—very limited experience in the biosimilar market. High initial investment is still amajor barrier for new entrants. Biosimilars Market: Market Segmentation (Europe), 2010 Existing Biosimilars Emerging Biosimilars Erythropoietin Monoclonal Antibodies Granulocyte Colony Stimulating Factors Insulins Human Growth Hormone Interferons Source: Frost & Sullivan analysis. 4
  5. 5. European Biosimilars Market—Comparative Analysis: Generics, Biosimilars and Biologics Generics Biosimilars Biologics Probability of success Moderate (50−75%) Low (~30%) High (~90%) DevelopmentProduct Time Moderate (7−8 Yrs) Short (3−4 Yrs) Long (8−12) Cost $100−200 million High Low (~$5 million) ($350−800 million) Pricing Lower pricing value Commodity pricing Premium (full pricing) Moderate Marketing investment Marketing Low High Group purchasing / Payers, prescribers Decision makers Medical professional Prescribers, patients Organisations Few, Partially differentiated Competitors High, Few, Less differentiated well differentiated Price, Product profile & technology Point of differentiation Price, Product profile, Other Dynamics breadth of portfolio marketing Barriers to entry High (capital and development) Low High (Cost efficiency) (development process) Mixed (25−30%) Product operational profit Low (~20%) High (~40%) margins Source: Hospira Education Forum and Frost & Sullivan analysis. 5
  6. 6. Key Industry Challenges Biosimilars Market: Key Industry Challenges (Europe), 2011−2017 − Complex manufacturing process is a major challenge for manufacturersInterchangeability and biosimilarsubstitution is a contentious issue Complex regulatory approval Industry process is a challenge for product Challenges entry into marketHigh manufacturing cost poses amajor barrier for market entrants Scaling up of production to meet market demands will be a challenge with increase in demand Source: Frost & Sullivan analysis 6
  7. 7. Key Market Drivers Biosimilars Market: Key Market Drivers (Europe), 2011−2017 − Emergence of new market participants in Europe drives market expansion Reduction in medical expenditure drives More patent expiries demand for lead to increase in biosimilar drugs market opportunity Source: Frost & Sullivan analysis. 7
  8. 8. Key Market Restraints Biosimilars Market: Key Market Restraints (Europe), 2011−2017 − Uncertainty and Lack of access to reluctance of process information physicians to adopt may effect product biosimilars may quality have a negative impact on biosimilar sales Time-consuming approval process may lead to slow market growth Source: Frost & Sullivan analysis. 8
  9. 9. Key Stake Holders Biosimilars Market: Key Stake Holders (Europe), 2010 Biosimilar Market Regulatory Demand Supply Pathway Wholesalers Hospitals/ Doctors Health Pricing Production Hospital Patients Regulators &Pharmacists Ministry Authorities Companies Pharmacies Pharmacists Source: Frost & Sullivan analysis. 9
  10. 10. Product Profiling—Biosimilars in Europe Biosimilars Market: Approved Biosimilars (Europe), 2011 ReferenceProduct Common Name (INN) Company Product Date of ApprovalOmnitrope Somatropin Sandoz Genotropin April 12, 2006Valtropin Somatropin Biopartners Humatrope April 24, 2006Binocrit Epoetin Alfa Sandoz Eprex August 28, 2007Epoetin Alfa Hexal Epoetin Alfa Hexal Eprex August 28, 2007Abseamed Epoetin Alfa Medice Eprex August 28, 2007Retacrit Epoetin Zeta Hospira Eprex December 18, 2007Silapo Epoetin Zeta STADA Eprex December 18, 2007Biograstim Filgrastim CT Arzneimittel GmbH Neupogen September 15, 2008Filgrastim Ratiopharm Filgrastim Ratiopharm GmbH Neupogen September 15, 2008Ratiograstim Filgrastim Ratiopharm GmbH Neupogen September 15, 2008Tevagrastim Filgrastim Teva Generics GmbH Neupogen September 15, 2008Zarzio Filgrastim Sandoz Neupogen February 6, 2009Filgrastim Hexal Filgrastim Hexal Neupogen February 6, 2009Nivestim Filgrastim Hospira Neupogen June 8, 2010Note: According to EMEA’s latest information, Filgrastim Ratiopharm was withdrawn on 20 April 2011. Thismedicinal product is no longer available in Europe. Source: Frost & Sullivan analysis & EMEA. 10
  11. 11. Market Share Analysis—Segment Breakdown EuropeThe European biosimilars market is valued at approximately $172.0 million in 2010. The market is expected toreach approximately $3,987.0 million in 2017, at a CAGR of 56.7 percent from 2010 to 2017. The biosimilarmarket was divided among the following segments as shown below. Biosimilars Market: Market Share percent by segment (Europe), 2010 Human Growth Hormone 20% Erythropoeitin Granulocyte Colony 60% Stimulating factor 20% Note: All figures are rounded; the base year is 2010. Source: Frost & Sullivan analysis. 11
  12. 12. Competitive Landscape Analysis (continued) Biosimilars Market: Key Market Players - Rank/Market Share (Europe), 2011 Market 1 2 3 4 5 6 Segment CT Total Market Sandoz Teva Hospira STADA Medice Arzneimittel Erythropoietin Sandoz Hospira STADA Medice Granulocyte Colony CT Stimulating Factor Teva Sandoz Arzneimittel Human Growth Sandoz Hormone Source: Frost & Sullivan analysis. 12
  13. 13. Competitive Landscape Analysis (continued) Key Takeaway: Companies with a strong integration of marketing and R&D is likely to succeed Sandoz Merck Big Generics and High Pharma Specialty Mylan Teva Pfizer PharmaSales and Marketing Hospira Eli Lilly Celltrion Stada Medice Strength Astrazeneca CT Arzneimittel Biopartners Reliance Biocon Potential Cangene Life Sciences Entrants Dr. Reddy’s Crucell Shantha Ranbaxy Biotechnics (Part of Sanofi Biotech Actavis Low Group) Zydus Cadila Low High Product Development Strength Source: Frost & Sullivan analysis. 13
  14. 14. Key Revenue Generating Avenues : Replacement Sale in Western Europe andRegional Analysis Europe New Installations in Eastern Key Takeaway: Germany is expected to be the most attractive market for biosimilars inthe long term owing pro-generic policy environment, and emphasis on cost-containment. UK - Strong generic culture and efforts to reduce healthcare expenditure Scandinavia Germany – Largest and High potential market in Europe; Contributed approx. 53% of European biosimilars market in 2010. France – Emphasis on cost-containment and efforts to encourage biosimilar prescription Benelux Italy - Branded biologics dominate the market; UK Medium growth expected Germany Spain - High use of branded biologics; More ` incentives required to encourage biosimilar subscription France Benelux - Strong generics culture and Italy demand for low-cost drugs Spain Scandinavia – Transparent system, rational ` use of medicines, and efforts to monitor prescription rates Source: Frost & Sullivan analysis. 14
  15. 15. European Biosimilars Market—Impact Assessment of Top Trends Biosimilars Market: Impact Assessment of Top Trends (Europe), 2010 Increase in number of High Growth Impact biosimilar approvals High demand of drugs due to low Medium cost Growth Impact Huge Opportunity from patent expiries ProjectedImpact on the Emergence of new protein class segments leading to market expansion European Biosimilars Market Penetration of Indian companies in Europe in the future leading to increase in competition Low Growth Impact Low Impact Low High Certainty Note: All figures are rounded; the base year is 2010. Source: Frost & Sullivan analysis. 15
  16. 16. Biosimilars Market—Key Success Factors • Clearly defined long-term vision • Stable multi-step reproducible commitment and strategic fit. manufacturing facilities • Goals for in-house development • Proper supply chain management marketing, and geographic focus. • Standard testing control facilities Scale-up Vision Production & • Technical know-how for• Competitive intelligence Capabilities Strategy clinical development on biologics and biosimilars market. • Regulatory expertise on• Competitor pipeline guidelines such as EMEA, analysis competitor’s FDA and R&D investment pharmacovigilance strategy. Clinical & Competitive Expertise• Competitive regional Success Regulatory benchmarking. Knowledge Expertise • Effective sales communication • Healthy finance infrastructure to the scientific community for high upfront investments Capital Marketing • Effective market activities for • Ability to cope with high commercialization of biosimilars manufacturing, maintenance, Investments & Sales • Continuous promotional activities and promotional costs Skills and marketing relationship with doctors, pharmacists etc. Source: Frost & Sullivan analysis. 16
  17. 17. Biosimilars Market—Manufacturing Strategies Scale-up Acquisitions Collaborations• With past experience in • Acquisition of biopharmaceutical • Collaboration with companies biotechnology, scale-up of the companies, having a biosimilar with expertise in biosimilar or R&D and manufacturing pipeline, e.g., Teva’s acquisition biotech companies and access capabilities to make a logical of Barr Pharmaceuticals. to production technologies e.g. extension to the existing • Acquisition of companies with Biocon and Pfizer. business, e.g., Sandoz large-scale production facilities • Collaborations with companies like CMOs which also have of emerging markets who are experience in biopharmaceutical already manufacturing production scaling up. biosimilars, e.g., Ranbaxy with Zenotech Laboratories. Source: Frost & Sullivan analysis. 17
  18. 18. Biosimilars Market—Commercialisation Strategies Sales & Marketing Regulatory • Access to expertise in • Access to sales and marketing regulatory approval by capabilities through collaborating with contract collaborations research organisations (CROs) • Companies need to build these • Companies will have to capabilities in-house as well educate, train employees about regulatory processes, and build these capabilities in house. Source: Frost & Sullivan analysis. 18
  19. 19. Conclusions Expected Increase in biosimilar approvals Low costs of drugs leading to higher demand Conclusions New protein class segments to emerge in Europe Uncertainties and risks for biosimilar manufacturers to continue Source: Frost & Sullivan analysis. 19
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  23. 23. For Additional InformationJanique Morvan Noel AndersonCorporate Communications European Vice PresidentHealthcare New Business Development+ 33 (0) 679 22 4142 +44 (0) 207 343 noel.anderson@frost.comRanjith Gopinathan Siddharth SahaProgram Manager Research DirectorHealthcare Healthcare((+91) 044-66814240 (+44) 23