将来のバイオシミラー：主な機会と新興の治療法

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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Primary research methodology
• Glossary
• Index

• 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

• 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