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Market Research Report

The Evolving Landscape in Biosimilars

Published by Datamonitor Healthcare Product code 342055
Published Content info 59 Pages
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The Evolving Landscape in Biosimilars
Published: March 6, 2015 Content info: 59 Pages
Description

The outlook for biosimilars has changed dramatically over the last five years, due to product development progress, regulatory guidance, and new company strategies. Biosimilars have now moved well past proof of concept, but due to the levels of competition anticipated, only the most suitable will be profitable in the long run. This analysis describes the changes that have occurred and gives insight into expectations going forward.

Table of Contents
Product Code: DMKC0136967

Table of Contents

LIST OF FIGURES

EXECUTIVE SUMMARY

  • Analysis headlines and metrics
  • Notes and caveats

PAST DEVELOPMENTS

  • What has changed over 2009-14?
  • Bibliography

COMPANY STRATEGIES

  • Greater competition in biosimilars expected following major new entrants
  • Strengthening through deals
  • Bibliography

PIPELINE PROGRESS

  • Major market Phase III trials triggered by EU pathway implementation
  • Second wave and into the US
  • Sandoz is the leading player in terms of product development
  • Bibliography

PROFITABILITY AND CHALLENGES

  • Investment by new entrants means lower returns for all
  • Litigation will impact time to market in many cases
  • Interchangeability remains an unknown
  • Bibliography

NEXT TARGET OPPORTUNITIES

  • Biosimilars are dependent upon expiring reference brands
  • Insight from the overall development status of biosimilars
  • Next-wave target reference products
  • Bibliography

LONGER-TERM OUTLOOK AND CONSIDERATIONS

  • Near-term drivers and resistors of biosimilars
  • Longer-term factors
  • Bibliography

List of Tables and Figures

  • Figure 1: Key summary facts and figures
  • Figure 2: Datamonitor Healthcare's biosimilars survey: views on the overall outlook
  • Figure 3: Datamonitor Healthcare's biosimilars survey: views on expected level of biosimilar usage in 2020 compared to views five years ago, by respondents
  • Figure 4: Datamonitor Healthcare's biosimilars survey: views on the number of companies in the biosimilars space in 2014
  • Figure 5: The shift towards major pharmaceutical companies in biosimilars
  • Figure 6: Global deals in biosimilars, 1999-2014
  • Figure 7: Mentions of biosimilars in annual reports across selected major pharmaceutical companies, 2003-13
  • Figure 8: Mentions of biosimilars in annual reports - Teva, 2003-13
  • Figure 9: Mentions of biosimilars in annual reports - Merck & Co, 2003-13
  • Figure 10: Mentions of biosimilars in annual reports - Pfizer, 2003-13
  • Figure 11: Mentions of biosimilars in annual reports - Biogen Idec, 2003-13
  • Figure 12: Mentions of biosimilars in annual reports - Amgen, 2003-13
  • Figure 13: Mentions of biosimilars in annual reports - Boehringer Ingelheim, 2003-13
  • Figure 14: Major market Phase III clinical trials of biosimilars to 2010
  • Figure 15: Cumulative major market Phase III clinical trials of biosimilars, by molecule type, 2000-15
  • Figure 16: US/EU Phase III biosimilar trial count and FDA biosimilar program metrics
  • Figure 17: Major market Phase III clinical trials of biosimilars, by reference product, 2001-19
  • Figure 18: US/EU Phase III clinical trials of biosimilars, by company and status
  • Figure 19: Datamonitor Healthcare's biosimilars survey: more competition in major markets
  • Figure 20: Price discounts for generics (actual) and biosimilars (estimated)
  • Figure 21: Global adalimumab biosimilars pipeline, by stage and region
  • Figure 22: The role of patent protection and challenges in determining biosimilar launch timing
  • Figure 23: The impact on biosimilar opportunity of market share loss to next-generation innovator products
  • Figure 24: Datamonitor Healthcare's biosimilars survey: reduced expectation for implementation of automatic substitution
  • Figure 25: Expiry dates of US biologic molecule exclusivity periods, 1998-2026
  • Figure 26: Biosimilar development versus reference product peak sales - example guide to the charts
  • Figure 27: Comparison of biosimilar development status in major markets versus rest of world/global markets
  • Figure 28: Companies with biosimilars in any stage of major market development versus clinical stages only
  • Figure 29: Biosimilar opportunities timeline, 1998-2026
  • Figure 30: Datamonitor Healthcare's biosimilars survey: threats and drivers
  • Table 1: Analysis headlines
  • Table 2: Standout events in the biosimilars landscape, 2008-14
  • Table 3: Key major biosimilar market deals, 2008-14
  • Table 4: Longer-term drivers and resistors of biosimilars
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