Market Report Source

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

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

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)

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