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Biosimilars: Benchmarking the key players - With increasing regulatory clarity and high revenue potential, interest in biosimilars increasesPublished by: Datamonitor Published: Dec. 20, 2006 - 109 Pages Table of ContentsCHAPTER 1 EXECUTIVE SUMMARY Scope of the report Key findings Key definitions CHAPTER 2 REVIEW OF KEY BIOSIMILAR DEVELOPERS’ PORTFOLIO AND PIPELINE Introduction Future launches are expected to increase the diversity of the biosimilar market Human growth hormone dominates the therapeutic focus of currently-marketed biosimilars Pipeline biosimilars are targeting an increased number of recombinant protein classes Biosimilar developers are turning to a range of drug delivery and formulation technologies to differentiate their products from competitors Innovative injection devices dominate advanced biosimilar drug delivery Improving biosimilar pharmacodynamics using pegylation-like technologies dominates advanced biosimilar drug reformulation Biosimilar developers deprioritize emerging markets and focus pipeline launches on Western markets to maximize profit CHAPTER 3 COLLABORATION AND M&A TRENDS IN THE BIOSIMILARS MARKET There are a wide range of drivers powering licensing and M&A deals Deals are used extensively in the biosimilars market to enable biosimilars to penetrate new markets Top-12 biosimilar developers use M&A deals over licensing deals to access emerging markets Both M&A deals and licensing deals are used by biosimilar developers to access Western markets The core focus for licensing deals is to source marketed and/or pipeline products Much licensing and M&A activity focuses on improving market access or putting up barriers for competitors Biosimilar manufacturers use licensing deals rather than M&A deals to gain access to reformulation and/or drug delivery technologies Deals can also be used to provide a biosimilar with a larger specialist sales force to remove barriers to entry and improve market access CHAPTER 4 BIOSIMILAR COMPANY PROFILES Key biosimilar companies profiled Leading biosimilar developers Teva (and its subsidiary SICOR) Sandoz Barr (through acquisition of Pliva) Stada (through Bioceuticals) BioPartners BioGeneriX (ratiopharm group) New, smaller biosimilar-focused companies Cangene Hospira Phage Biotechnology Dragon Pharmaceutical Neose Technologies GeneMedix Emerging market-based biosimilar developers and very early-stage companies Indian biosimilars players Chinese biosimilars players Very early-stage biosimilars companies CHAPTER 5 BIBLIOGRAPHY CHAPTER 6 APPENDIX : SUPPORTING DATA Definitions LIST OF TABLES Table 1: Patent expiries of selected key recombinant proteins Table 2: Western M&A targets tend to be more expensive than deals focusing on acquiring emerging market targets Table 3: Teva’s biosimilar product portfolio and pipeline Table 4: Sandoz’ biosimilar product portfolio and pipeline Table 5: Pliva’s biosimilar product portfolio and pipeline Table 6: Stada acquisitions and divestments, 2005-06 Table 7: Bioceuticals’ biosimilar product portfolio and pipeline Table 8: BioPartners’ biosimilar product portfolio and pipeline Table 9: BioGeneriX’s biosimilar product portfolio and pipeline Table 10: Cangene’s biosimilar product portfolio and pipeline Table 12: Dragon Pharmaceutical’s biosimilar product portfolio and pipeline Table 13: Superbiosimilar products developed by Neose Technologies Table 14: GeneMedix’s biosimilar product portfolio and pipeline Table 15: Biosimilar products already marketed in India Table 16: Marketed products from Chinese biosimilars manufacturers LIST OF FIGURES Figure 1: Launched biosimilars belong to six classes of recombinant proteins Figure 2: At least fourteen classes of recombinant proteins are being targeted by biosimilar pipeline drugs in development by the major biosimilar developers Figure 3: Pegylation accounts for the majority of biosimilar modifications made by developers Figure 4: The majority of currently-marketed biosimilars have launched in emerging markets, although the majority of pipeline biosimilars are targeting Western markets Figure 5: Licensing and collaboration deals are used for different purposes compared to M&A deals Figure 6: The focus for licensing and collaboration deals differs from the focus for entering into M&A deals Figure 7: There are three core deal drivers powering both licensing and collaboration deals, and M&A deals Figure 8: Datamonitor expects the initial market leaders to be those with the greatest financial backing and commercial expertise Figure 9: Phage Biotechnology’s biosimilar product portfolio and pipeline AbstractIntroductionWith increasing regulatory clarity and the expiries of key patents covering innovator biologics, the development of biosimilars for a range of recombinant protein classes is becoming increasingly attractive. Although many companies are targeting the market, 12 companies dominate. These include established generics companies, leading biosimilars developers, plus emerging biosimilar developers. Scope
Well-established generics companies such as Sandoz and Teva have led the drive into the biosimilars market, by launching across a range of emerging and Western markets in a small number of well-characterized and relatively simple recombinant protein classes with significant market potential. Although established generics companies have so far dominated the biosimilars landscape, emerging biosimilar developers have the greatest number of disclosed pipeline biosimilar programs, which are set to broaden the range of biosimilars being developed in terms of protein class, drug delivery and formulation. There has been significant licensing and M&A deal activity among the top-12 biosimilar companies, enabling them to build a stronger product portfolio and gain greater access to capabilities that are key to competing in this market, such as drug delivery (primarily advanced injection technology) and drug formulation (mainly pegylation) technologies. Reasons to Purchase
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