Abstract
Overview
Introduction
With 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
- Overview of the biosimilars competitive landscape, examining how the key
players dominate the environment
- Update of in-depth profiles of the top-12 biosimilar developers
- Identification of licensing and collaboration trends shaping the
biosimilars environment
- Analysis of biosimilar development trends in terms of target protein
class, drug delivery and reformulation technology, and geographical launch
market
Report Highlights
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
biosimilars 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
- Evaluate the competitive landscape of the top-12 biosimilar developers
- Identify the trends shaping biosimilar product development among the
top-12 biosimilar developers
- Understand the drivers for licensing and M&A deals being conducted by the
top-12 biosimilar developers
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
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