Biologics Price Competition and Innovation (BPCI) Act - Industry Trends Creating Demand for Biosimilars

Date: September 23, 2011
Pages: 13
Price:
US$ 500.00
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Publisher: GlobalData
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: BAEC7749787EN
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Biologics Price Competition and Innovation (BPCI) Act - Industry Trends Creating Demand for Biosimilars
Biologics Price Competition and Innovation (BPCI) Act - Industry Trends Creating Demand for Biosimilars

Summary

GlobalData, the industry analysis specialist, has released its new report, 'Biologics Price Competition and Innovation (BPCI) Act - Industry Trends Creating Demand for Biosimilars”. The report is an essential source of information and analysis on the global biosimilar market opportunity. The report identifies the key trends shaping and driving the global biosimilars market. The report also provides insights on the major revenue generating product segments, regulatory environement and the key events expected to significantly alter the market positioning of the biopharmaceuticals. Most importantly, the report provides valuable insights on the industry trends expected to occur within the biosimilar space following the successful implementation of new legislations in the US. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData’s team of industry experts.

Scope

The report provides information on the key drivers and challenges of the biosimilars market. Its scope includes -
  • Annualized market opportunity for biosimilars industry, market revenues data from 2005 to 2010, forecast for eight years to 2020.
  • Monitoring of biopharmacetical industry performance that covers high revenue generating product classes and top brands.
  • Review on the regulatory landscape and legislation laws in the US and the Europe.
  • Analysis on the biosimilar adoption and pricing in the five major European countries and the US.
  • Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide a qualitative analysis of its implications.
  • Key topics covered include biopharmaceutical market performance, regulatory landscape, market opportunity for biosimilars and adoption of biosimilars.

Reasons to buy

The report will enhance your decision making capability. It will allow you to -
  • Develop and design your in-licensing and out-licensing strategies through a review of biosimilar products.
  • Develop business strategies by understanding the trends shaping and driving the global biosimilar market.
  • Formulate effective sales and marketing strategies by understanding the regulatory landscape and by analyzing the performance of various competitors.
1 TABLE OF CONTENTS

1.1 List of Tables
1.2 List of Figures

2 SUMMARY

3 INTRODUCTION

4 INDUSTRY EVENTS TRIGGERING THE DEMAND FOR BIOSIMILARS

4.1 Increased Healthcare Spending
4.2 Generics Account for More than Half of the Total Prescriptions
4.3 Presence of Biologic Brands Across Multiple Indications
4.4 Lucrative Market for Investment
4.5 Top Ten Biologic Brands are to Lose Patents by 2020
4.6 Need for More Affordable Biologic Drugs

5 REGULATORY ENVIRONMENT

5.1 Europe: Ahead of the US in Regulatory Frameworks
5.2 The US: Establishment of Regulatory Frameworks had a Long Journey

6 BIOLOGICS PRICE COMPETITION AND INNOVATION (BPCI) ACT

6.1 Bio“similar” vs. Interchangeable:
6.2 How Different is this Legislation from the Hatch-Waxman Act?
6.3 Potential Savings Expected from Biosimilars – Lessons from Traditional Chemical Drugs

7 BIOSIMILARS MARKET

7.1 Market Penetration of New Entrants
7.2 Adoption of Biosimilars in Major Countries
7.3 Biosimilar Prices

8 INDUSTRY EVENTS AND ISSUES EXPECTED FOLLOWING SUCCESSFUL IMPLEMENTATION OF BIOSIMILAR LAW

8.1 Switching from Chemotherapy to Biologics
8.2 Mergers and Acquisitions to Rise
8.3 Licensing and Marketing Deals to Soar
8.4 “Exclusivity” Definition is Critical to the Industry
8.5 Concern over Drug Switching by Physicians
8.6 Requirement for Sufficient Data
8.7 Industry Expects Positive News on Reimbursement

9 APPENDIX

9.1 Methodology
9.2 Contact Us
9.3 Disclaimer
9.4 Bibliography

LIST OF TABLES

Table 1: Biologics Market, Global, Revenue ($m), 2007–2010
Table 2: Top 10 Biologic Products, Sales ($m), 2009-2010
Table 3: Biotech Drugs With High Cost of Therapy
Table 4: Biosimilars Approved by the EMEA
Table 5: Key Events of the US Biosimilar Regulatory Pathway Bill
Table 6: Market Opportunity for Biosimilars – Biologics Off-Patent by Year, 2013-2020
Table 7: Comparison of Structural Complexity of Chemical vs. Biologic Drugs
Table 8: Launch of G-CSF Innovator vs. Biosimilars in Major European Countries
Table 9: Launch of EPO Innovator vs. Biosimilars in Major European Countries
Table 10: Expected Price Discounts of Biosimilars on Their Branded Counterparts

LIST OF FIGURES

Figure 1: Trend of FDA Approvals – NME vs BLA, 1996-2010
Figure 2: Biologics Market, Global, Revenue ($bn), 2007–2010
Figure 3: Overview of Regulatory Landscape for Biosimilars – Europe vs. the US
Figure 4: Market Opportunity for Biosimilars – Biologics Off-Patent by Year, 2013-2020

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Biologics Price Competition and Innovation (BPCI) Act - Industry Trends Creating Demand for Biosimilars
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