"Global Biosimilar Pipeline and Market Prospects: Addressing Production Complexities Through Risk Management and Quality by Design＂published in April 2017. It is a professional and in-depth study.
Summary
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.
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Scope
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?
Reasons to buy
– 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
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