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市場調査レポート
将来のバイオシミラー：主な機会と新興の治療法
The Future of Biosimilars: Key opportunities & emerging therapies
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Abstract
Biotechnological products are continuing to exhibit substantial revenue gains,
with the top 12 biologics registering sales growth of 20%in 2006, amassing a
market share of $64 billion. However, the impending patent expiry of many
leading products has created a number of highly attractive market
opportunities for biosimilars. To exploit this significant potential, a
complex route to market must first be negotiated, including numerous barriers
to entry and regulatory hurdles. Prominent obstacles include the sizeable
investments in time and expertise associated with biosimilars development, in
addition to the fundamentally higher levels of cost and risk incurred by
manufacturers.
Legislative restraints in the US and a recently established regulatory
framework in the EU have also contributed to industrial obtrusiveness, but for
those developers who persevere, biosimilars are set to offer lucrative
returns. The Future of Biosimilars: Key opportunities and emerging therapies
is a new report published by Business Insights, examining the current market
and regulatory environment for biosimilars in Europe, India, China and the US,
whilst identifying the trends that will shape future market development.
Table of Contents
Executive Summary
- Introduction to biosimilars
- Market landscape for biosimilars: Europe and USA
- Emerging market landscape for biosimilars: China and India
- Competitive landscape
- Case studies
- Future trends in biosimilars
Chapter 1 Introduction to biosimilars
- Summary
- Introduction
- Biosimilars vs generic pharmaceuticals
- The nomenclature debate
- Market opportunities
- Key trends in biosimilar product development
- Industry profile
- Challenges faced by biosimilar developers
- Pre-marketing hurdles
- Post-marketing challenges
- Future trends
Chapter 2 Market landscape: Europe and USA
- Summary
- Introduction
- Features of the EU market for biosimilars
- Regulatory framework
- Experience with EU framework
- National laws
- Drivers and constraints for biosimilars in the EU market
- Features of the US market for biosimilars
- Regulatory framework
- Follow-on biotech drugs
- Follow-on biologicals
- Experience with US regulatory mechanisms
- Drivers and constraints for biosimilars in the US market
Chapter 3 Emerging market landscape for biosimilars: China and India
- Summary
- Introduction
- Features of the Chinese market for biosimilars
- Regulatory framework
- Biopharmaceutical market
- Biopharmaceutical industry
- Features of the Indian market for biosimilars
- Regulatory framework
- Biopharmaceutical industry
- Conclusion
Chapter 4 Competitive landscape
- Summary
- Introduction
- Leading biosimilars players
- Teva
- Sandoz
- Barr/Pliva
- Biopartners/Bioton
- Stada/Bioceuticals
- BioGeneriX/ratiopharm
- Niche players
- CoGenesys
- Maxygen
- Viropro
- Trends in the biosimilars industry
Chapter 5 Case studies
- Summary
- Introduction
- Sandoz' Omnitrope: a regulatory saga
- Comparison of EU approval routes for Omnitrope and Valtropin
- Conclusions
- Targeting superbiosimilars: Neose Technologies
- EPO market
- G-CSF market
- Conclusions
- Taking developed products to market: SciGen
- Manufacturing risks
- Marketing strategy
- Pipeline growth
- Conclusions
Chapter 6 Future trends in biosimilars
- Summary
- Introduction
- Main product opportunities
- Product development issues
- Pricing trends
- Market impact of biosimilars
- Factors affecting biosimilar penetration
- Interchangeability/substitution policies
- Product differentiation
- Marketing strategies
- Competition
Chapter 7 Appendix
- Primary research methodology
- Glossary
- Index
List of Figures
- Figure 1.1: Product groups most affected by biosimilars by 2010
- Figure 1.2: Major challenges faced by biosimilar companies
- Figure 3.3: Markets with highest potential for biosimilar penetration
- Figure 3.4: Development of Chinese biopharmaceutical market, 2001-2006
- Figure 4.5: Types of partnerships favored by biosimilar companies
- Figure 5.6: Global EPO market
- Figure 5.7: Global G-CSF market
- Figure 6.8: Price differential between original brand and biosimilar
- Figure 6.9: Penetration of biosimilars in biotech market by 2010
List of Tables
- Table 1.1: Sales trends of leading biologics by product category, 2006
- Table 1.2: Patent status of key categories
- Table 1.3: Marketed biosimilars by product group
- Table 1.4: Summary of leading companies' biosimilar projects
- Table 4.5: Teva' s biosimilar products
- Table 4.6: Stada' s geographical sales distribution
- Table 6.7: Selected target products for biosimilar developers
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