Biosimilars: Benchmarking the key players - With increasing regulatory clarity and high revenue potential, interest in biosimilars increases

Table of Contents

• CHAPTER 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)
      • Overview
      • Teva' s biosimilar product portfolio and pipeline
      • Teva' s alliances
      • Teva' s strategy
      • Teva' s outlook
    • Sandoz
      • Overview
      • Sandoz' s biosimilar product portfolio/pipeline
      • Sandoz' s alliances
      • Sandoz' s strategy
      • Sandoz' s outlook
    • Barr (through acquisition of Pliva)
      • Overview
      • Barr' s biosimilar product portfolio/pipeline
      • Barr' s alliances
      • Barr' s strategy
      • Barr' s outlook
    • Stada (through Bioceuticals)
      • Overview
      • Bioceutical' s biosimilar product portfolio/pipeline
      • Stada/Bioceuticals' s alliances
      • Stada/Bioceuticals' s strategy
      • Stada/Bioceuticals' s outlook
    • BioPartners
      • Overview
      • BioPartners' s biosimilar product portfolio/pipeline
      • BioPartners' s alliances
      • BioPartners' s strategy
      • BioPartners' s outlook
    • BioGeneriX (ratiopharm group)
      • Overview
      • BioGeneriX' s biosimilar product portfolio/pipeline
      • BioGenerix' s alliances
      • BioGenerix' s strategy
      • BioGenerix' s outlook
  • New, smaller biosimilar-focused companies
    • Cangene
      • Overview
      • Cangene' s biosimilar product portfolio/pipeline
      • Cangene' s alliances
      • Cangene' s strategy
      • Cangene' s outlook
    • Hospira
      • Overview
      • Hospira' s outlook
    • Phage Biotechnology
      • Overview
      • Phage Biotechnology' s technology
      • Phage' s biosimilar product portfolio/pipeline
      • Phage Biotechnology' s alliances
      • Phage Biotechnology' s strategy
      • Phage Biotechnology' s outlook
    • Dragon Pharmaceutical
      • Overview
      • Dragon Pharmaceutical' s biosimilar product portfolio/pipeline
      • Dragon Pharmaceutical' s alliances
      • Dragon Pharmaceutical' s strategy
      • Dragon Pharmaceutical' s outlook
    • Neose Technologies
      • Overview
      • Neose Technologies' s product portfolio and pipeline
      • Neose Technologies' s alliances
      • Neose Technologies' s strategy and outlook
    • GeneMedix
      • Overview
      • GeneMedix' s biosimilar product portfolio/pipeline
      • GeneMedix' s manufacturing
      • GeneMedix' s technology
      • GeneMedix' s alliances
      • GeneMedix' s strategy
      • GeneMedix' s outlook
  • Emerging market-based biosimilar developers and very early-stage companies
    • Indian biosimilars players
      • Wockhardt
      • Biocon
      • Bharat Biotech
      • Shantha Biotech
      • Dr. Reddy' s
      • Cipla
    • Chinese biosimilars players
    • Very early-stage biosimilars companies
      • Microbix Biosystems
      • Aceto
      • CJ Corporation
• CHAPTER 5 BIBLIOGRAPHY
  • On-line articles and paper references
• 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 11: Dragon Pharmaceutical' s biosimilar product portfolio and pipeline
    • Table 12: Superbiosimilar products developed by Neose Technologies
    • Table 13: GeneMedix' s biosimilar product portfolio and pipeline
    • Table 14: Biosimilar products already marketed in India
    • Table 15: 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