バイオ後発医薬品の市場：市場発展の牽引要因と障害

Introduction

With several blockbuster biological products approaching patent expiry, the biogenerics segment represents an attractive opportunity for companies looking to escape intensifying competition in the commodity generics sector. The generics industry is pushing for establishment of an approval pathway for generic biologics, but even once this is in place, barriers to market entry will be high.

Scope of this report

• Evaluation of developments in the regulatory environment for biogenerics in the US and EU
• Analysis of market entry strategies of likely key biogenerics players
• Assessment of the market potential of biogenerics, and the barriers to companies wishing to exploit this

Research and analysis highlights

While the US represents the major market for regular generics, in the case of biogenerics, Europe is leading the development of the Western market, with the issue having been addressed as part of a restructuring of pharmaceutical legislation, making Europe the first market to establish a legal framework for authorization of biogenerics.

Despite the high potential, relatively few companies are expected to enter Western biogenerics markets due to high barriers to entry. Companies may try to overcome these barriers by entering the superbiogenerics market, where higher returns are achievable.

Players in the biogenerics market fall into two key categories: biotech start-ups such as Cangene, Microbix and GeneMedix, and established generics companies looking to expand their existing portfolios such as Stada, Teva, and Sandoz.

Key reasons to read this report

• Evaluate the strategies of key biogenerics contenders, and assess their threat to your business
• Understand the key regulatory issues surrounding approval of biogenerics
• Assess the barriers to entry in the biogenerics sector, as well as the market potential

Table of Contents

CHAPTER 1 KEY FINDINGS

CHAPTER 2 THE REGULATORY ENVIRONMENT FOR BIOGENERICS

Moving toward a regulatory pathway for biogenerics

"Bioequivalence vs. product comparability" and "process makes the product"

Growing demand for biogenerics

US - does the FDA have the right to apply 505(b)(2)?

Europe - is the EMEA a step ahead?

Rest of World - an attractive launchpad?

Implications for biogenerics manufacturers

CHAPTER 3 BIOGENERICS MARKET POTENTIAL

Biogenerics : risk versus return

Drivers of biogenerics market development

Resistors to biogenerics market development

Superbiogenerics

CHAPTER 4 KEY CONTENDERS

Key characteristics for a well positioned biogenerics company

List of Tables

Table 1: Key biological product patent expiries

Table 2: Product classes in the pipelines of 14 biogenerics companies

Table 3: Sales of SICOR's biogenerics portfolio, 2001-02

Table 4: SICOR's biogenerics pipeline, 2003

Table 5: Stada's biogenerics pipeline, 2003

List of Figures

Figure 1: Analysis of classes most at risk from biogeneric competition

Figure 2: Biogenerics capabilities of selected companies

Figure 3: Alliances of selected biogenerics players

Figure 4: BioGeneriX's partnering strategy