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Global Biosimilars Market - Increasingly Lucrative Market Fueled by Constrained Payer Environment and Patent Expiries for Best-Selling Biologics

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Global Biosimilars Market - Increasingly Lucrative Market Fueled by Constrained Payer Environment and Patent Expiries for Best-Selling Biologics
Published: January 1, 2019 Content info: 108 Pages

The Global Biosimilar market by product is projected to grow at a compound annual growth rate (CAGR) of 45.22%. The market is driven mainly by a constrained payer environment and patent expiration of several best-selling biologics. However, developmental cost and complexities, strategies from originators and interchangeability concerns pose a challenge to market growth.

A biosimilar is a biotherapeutic that is clinically highly similar to an approved original biologic (reference product) in terms of active ingredients and has no meaningful differences in efficacy and safety. Biosimilars are also known as follow-on biologics or subsequent entry biologics.

A total of 492 products are in development. The Preclinical stage contains the largest number of pipeline products: 232. The late-stage pipeline (Phase III and Pre-registration) account for 24% of the overall pipeline, with 120 products. The global biosimilar pipeline is dominated by companies from emerging markets. The most active companies in the early-stage pipeline are from India and China. South Korean companies such as Celltrion and Samsung Bioepis and Indian companies such as Biocon and Dr. Reddy's Laboratories have a strong late-stage pipeline. Pfizer and Amgen have a strong late-stage pipeline as well.

There exist enormous commercial opportunities for biosimilar manufacturers over the coming years, given the number of high-revenue-generating biologics that will go off patent in the next five years, and promising revenue forecasts for biosimilars in late-stage development. There exist a diverse number of biosimilars in the pipeline for a wide range of therapy areas, with several of these in the later stages of development. Government support for biosimilars is increasing in key mature and emerging markets, given the cost-saving opportunities that these products represent for national healthcare budgets.

The latest report, "Global Biosimilars Market - Increasingly Lucrative Market Fueled by Constrained Payer Environment and Patent Expiries for Best-Selling Biologics" provides an in-depth assessment of the current developments and trends in the global biosimilars market. This report also assesses the state of the biosimilar R&D and commercial landscape through multilevel analytics that include data split by therapy area, stage of development, molecule, and company. Global revenue forecasts to 2024 for biosimilars with strong market potential, both in development and in the market, are provided.

The report also details out current biosimilar regulatory frameworks and guidelines implemented in the US, Europe, Japan, China, South Korea, India and Brazil, and recent developments in the landscape within these markets


  • How does the global biosimilar pipeline look like in 2018?
  • What is the distribution of pipeline biosimilars by stage of development?
  • Which are the therapy areas set to benefit the most from biosimilar drugs in development?
  • Which biosimilars are commonly targeted in the pipeline?
  • How many companies are currently involved in biosimilar drug development? Which are the most active in the pipeline?
  • What is the size of the global biosimilar market?
  • How much revenue will promising biosimilar drugs in the market, and in development, record to 2024?
  • What are the key factors driving growth in the global biosimilars market?
  • What are the factors restraining the growth of global biosimilar market?
  • How does legislation regarding biosimilar interchangeability differ among key geographical markets?
  • How will legal or political changes in the landscape affect the biosimilar market?
  • What are the key differences in biosimilar regulatory pathways between US, Europe, Japan, South Korea, China, Brazil, and India?
  • What are the regulatory evidence requirements in each country?

Reasons to buy:

  • Develop an overview of the current biosimilar landscape in key markets
  • Learn how regulatory or legal changes will affect the market
  • Identify market prospects
Table of Contents
Product Code: GBI096CBR

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

  • 2.1. Increasing Cost of Drug Development
  • 2.2. Most Drugs Fail to Recuperate R&D Costs
  • 2.3. Contracting Life Cycles for Approved Products
  • 2.4. The Case for First-in-Class Pharmaceutical Innovation
  • 2.5. Status of Innovation in Rare Diseases
  • 2.6. Conclusion

3. Assessment of Pharmaceutical Industry Pipeline

  • 3.1. Pipeline and Clinical Trials Landscape by Therapy Area
  • 3.2. Pipeline by Stage of Development
  • 3.3. Pipeline by Molecule Type
  • 3.4. Key Therapy Areas by Indication
    • 3.4.1. Oncology
    • 3.4.2. Infectious Diseases
    • 3.4.3. Central Nervous System
    • 3.4.4. Immunology
  • 3.5. Conclusion

4. Assessment of Innovation in the Pharmaceutical Industry Pipeline

  • 4.1. First-in-Class Innovation by Stage of Development
  • 4.2. Key Therapy Areas by Indication
    • 4.2.1. Oncology
    • 4.2.2. Infectious Diseases
    • 4.2.3. Central Nervous System
    • 4.2.4. Immunology
  • 4.3. Conclusion

5. Appendix

  • 5.1. References
  • 5.2. Abbreviations
  • 5.3. Contact Us
  • 5.4. Disclaimer
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