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Global Biosimilar Pipeline and Market Prospects: Addressing Production Complexities Through Risk Management and Quality by Design

Published By :

GBI Research

Published Date : Mar 2017

Category :


No. of Pages : 117 Pages

GBI Research’s latest report, ""Global Biosimilar Pipeline and Market Prospects: Addressing Production Complexities Through Risk Management and Quality by Design"" provides an in-depth assessment of the current trends in the global biosimilars market, with a particular focus on manufacturing complexities and the strategies being implemented to overcome them. 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, molecular target, clinical trials and company. Global revenue forecasts to 2022 for biosimilars with strong market potential, both in development and in the market, are provided.

The complex requirements of manufacturing biological drugs also apply to biosimilars, and these have been a significant barrier to the further expansion of the biosimilars market. A key challenge has been the knowledge gap under which biosimilars are developed, which arises from the fact that innovator product information remains proprietary and biosimilar manufacturers must adopt a reverse engineering process. Our new study assesses this and other significant manufacturing challenges, and how strategies based on quality initiatives and risk management can help address these issues.

Data analyses from our study show there will be enormous commercial opportunities for biosimilar developers over the coming years, given the number of high-revenue-generating biologics that will go off patent before 2020, and promising revenue forecasts for biosimilars in late-stage development. Information leveraged from our robust industry-leading database highlights 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. Case studies showcasing strategies adopted by leading pharmaceutical companies to compete in the biosimilars market are also provided.

Government support for biosimilars is increasing in key geographical markets, given the cost saving opportunities that these products represent for national healthcare budgets. Our study details current biosimilar regulatory frameworks and guidelines implemented in the US, Europe, Japan and China, recent updates regarding the key issue of interchangeability, and case studies of successful biosimilar approvals in recent years.

GBI Research conducted extensive research efforts in order to provide a comprehensive view of the global biosimilar market. This new report adds to our unique portfolio of trusted industry analyses that enable our clients to assess the most promising commercial areas in the market and exploit key business opportunities.


Global biosimilar pipeline in 2017

  • 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?
  • In biosimilar development, what are the most common molecular targets for key therapy areas?
  • How many companies are currently involved in biosimilar drug development, which are the most active and what is the level of specialization across the development landscape?

Global biosimilar clinical trials in 2017

  • What was the volume of biosimilar clinical trials from 2006 to 2016, by therapy area and stage of development?
  • What is the average biosimilar clinical trial size and duration across different stages of development, and across the immunology and oncology therapy areas?
  • How much revenue will promising biosimilar drugs in the market, and in development, record to 2022?
  • What are the key factors driving growth in the global biosimilars market?
  • How important are the cost saving opportunities for national healthcare budgets?
  • How much will biosimilar manufacturers benefit from the biologic drugs patent cliff?
  • How does legislation regarding biosimilar interchangeability differ among key geographical markets?
  • What are the factors restraining the growth of global biosimilar market?
  • How do manufacturing challenges affect the market?
  • What are the legal issues impacting the biosimilar market?
  • How are competition and patient recruitment issues slowing growth in the market?
  • What are the regulatory pathways for biosimilars in the US, Europe, Japan and China?

Manufacturing processes for biosimilar drugs

  • How does molecular weight and complexity pose a challenge to biosimilar production? 
  • What is the impact of environmental factors on production complexity?
  • How significant is the knowledge gap in the process of manufacturing a biosimilar drug?
  • What are the best practice guidelines and strategies to overcome production complexities?   
  • How do development timelines and costs differ between biologics and biosimilars? 
  • What is the impact of immunogenicity in the production process?

Reasons to buy

This report will allow you to - 

  • Gain insightful analyses and comprehensive understanding of the global biosimilar R&D and commercial landscape
  • Assess biosimilar production processes, key issues and ways to mitigate development risk
  • Understand the most important driving and restraining forces in the global biosimilars market
  • Learn about biosimilar strategies being adopted by leading pharmaceutical companies.
  • Understand the future outlook and prospects for biosimilar drugs

Table of contents

1. Executive Summary

2. Introduction

2.1 Defining Biosimilars
2.2 Biosimilar Product Categories
2.3 Comparative Analysis: Biosimilars versus Generics
2.4 Biobetters versus Biosimilars
2.5 What Key Factors Are Driving the Need for Biosimilars?

3. Key Drivers of Growth in the Global Biosimilars Market
3.1 Cost Saving Potential
3.2 Biologics Patent Cliff
3.3 Increasing Clinical Evidence of Product Effectiveness

4. Key Barriers to Growth in the Global Biosimilars Market
4.1 Complexity of Expertise
4.2 Legal Issues
4.3 Biosimilar Interchangeability and Automatic Substitution
4.4 Patient Recruitment
4.5 Competition

5. Biosimilar Regulatory Frameworks in Key Geographies
5.1 EU
5.2 US
5.3 Japan
5.4 China
5.5 Case Studies of Successful Biosimilar Approvals in Key Markets

6. Biosimilar Manufacturing Process
6.1 Biologics 
6.2 Biosimilars 
6.3 GMP for large molecules 
6.4 Biosimilars versus Biologics: Typical Development Timelines and Costs 

7. Key Production Issues and Challenges 
7.1 Molecular Weight and Complexity 
7.3 Environmental Factors 
7.4 Knowledge Gap 
7.5 Immunogenicity 

8. Approaches to Addressing Biosimilar Manufacturing Complexity 
8.1 QbD 
8.1.1 Reducing Biosimilar Development Risk through QbD 
8.2 DoE 
8.3 PAT 
8.4 Safety and Risk Management 
8.5 Production Best Practices 
8.6 Alternative Expression System 

9. Commercial Strategies for Biosimilars Adopted by Big Pharma 
9.1 Big Pharma Biosimilar Strategies 
9.2 Entry Strategies for Emerging Markets 
9.3 Recommendations

10. Global Biosimilar Pipeline Analysis 2017
10.1 Global Biosimilar Pipeline by Stage of Development
10.2 Global Biosimilar Pipeline by Therapy Area
10.3 Global Biosimilar Pipeline by Molecular Target
10.4 Global Biosimilar Pipeline Company Analysis
10.5 Most Active Companies in the Global Biosimilar Pipeline: Volume of Products by Stage of Development
10.6 Most Active Companies in the Global Biosimilar Pipeline: Volume of Product by Therapy Area
10.7 Biosimilar Clinical Trials by Stage of Development: Average Size of Trials
10.8 Biosimilar Clinical Trials by Stage of Development: Average Trial Duration
10.9 Volume of Biosimilar Clinical Trials 2006–2016
10.10 Volume of Biosimilar Clinical Trials by Phase and Therapy Area

11. Global Biosimilar Market 2017–2022
11.1 Basaglar Global Sales Forecast 2015–2022
11.2 Inflectra Global Sales Forecast 2016–2022
11.3 Benepali Global Sales Forecast 2016–2022
11.4 Rituximab Biosimilar Global Sales Forecast 2019–2022
11.5 Trastuzumab Biosimilar Global Sales Forecast 2019–2022
11.6 Adalimumab Biosimilar Global Sales Forecast 2019–2022
11.7 Bevacizumab Biosimilar Global Sales Forecast 2019–2022

12. Future Outlook

13. Conclusion

List of Table


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