Biosimilars: Benchmarking the key players

Biosimilars: Benchmarking the key players

With increasing regulatory clarity and high revenue potential, interest in biosimilars increases

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

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 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

• 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

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)
  • 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

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