BIOSIMILARS - Regulatory Framework and Pipeline Analysis

  • ID: 3301910
  • Report
  • Region: Global
  • 94 Pages
  • CBR Pharma Insights
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Global Biosimilars Market Value Could Hit $55 Billion by 2020


Biosimilars are copied versions of biologics that offer a 20-50% reduction in cost compared with innovative biologic products. Biosimilars are getting the world wide attention as the cost of the innovative biologics are enormously high and even minimal reduction in price will reduce the healthcare spending substantially.

All the countries are focusing on reducing the healthcare expenditure and biosimilars compliments to this goal. Biologic products are complex in structure and follow a complex manufacturing process thus, some variation exists between the reference product and its biosimilar. It is very important to assess the variations in biosimilars by comparing with reference product to ensure quality, non-clinical, and clinical properties, which has given rise to the regulatory requirements for biosimilars.

Regulatory requirement for approving biosimilars varies across different regulatory bodies. However, all the countries have derived the basic theme from EMA and WHO guidelines for framing their regulatory structure. There is a need to harmonize the nomenclature of biosimilars, extrapolation of indications, and interchangeability of biosimilars with reference products across the regulatory bodies. Biosimilars market is developing and it could be well established with the pipeline that is poised to deliver a wave of biosimilars in the market in the near future.

Scope

The scope of the report includes:

- Introduction
- Market dynamics: Trends, Drivers, and Barriers
- WHO guidance for biosimilars
- Regulatory overview, biosimilar guidelines, regulatory framework for biosimilars, and market outlook for: Europe, USA, India, South Korea, Japan and China.
- Key players
- Pipeline Analysis
- Overview
- By Stage of Development / Molecule / Therapy Area / Indication
- Late-Stage / Phase II / Phase I Pipeline Biosimilars

Key Reasons to Purchase

The report will enhance your decision-making capability by allowing you to:

- Understand the regulatory requirement and regulatory framework that facilitates effective product development strategy as biosimilars industry is currently highly focused, growing, and outpacing the growth rate of small molecule pharmaceutical market
- Targeting geographies would be easy by comparing different regulatory frameworks; this would also provide a base for designing a strategy to enter the developed markets. Biosimilars are of interest in developed countries to reduce the healthcare expenditure
- With the recent approvals of biosimilars by USFDA, the biosimilars market is going to grow and this report examines the post approval market landscape
- Examine the biosimilars pipeline and specifies the products that are highly targeted, it also includes analysis of highly focused indications, mechanism of actions, and therapy areas in the pipeline
- Analyze the details of the clinical pipeline that includes late stage products, Phase II, and Phase I products. Detailed understanding of the pipeline will help in targeting the products for development, rate the current products and predict the competition

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1. Executive Summary
1.1 Introduction

2. Biosimilars Industry Dynamics
2.1 Trends
2.2 Drivers
2.3 Restraints
2.4 Biosimilars Regulation: WHO's Guidance

3. Biosimilars in Europe
3.1 Overview
3.2 Regulatory Framework
3.3 Market Outlook

4. Biosimilars in the US
4.1 Overview
4.2 Regulatory Framework
4.3 Market Outlook

5. Biosimilars in India
5.1 Overview
5.2 Regulatory Framework
5.3 Market Outlook

6.Biosimilars in South Korea
6.1 Overview
6.2 Regulatory Framework
6.3 Market Outlook

7. Biosimilars in Japan
7.1 Overview
7.2 Regulatory Framework
7.3 Market Outlook

8. Biosimilars in China
8.1 Overview
8.2 Regulatory Framework
8.3 Market Outlook
8.4 Key Market Players

9. Biosimilars Pipeline Analysis
9.1 Overview
9.2 By Stage of Development
9.3 By Molecule
9.3 By Therapy Area
9.4 By Indication
9.5 By MoA/RoA
9.6 Late-Stage Pipeline Biosimilars
9.7 Phase II Pipeline Biosimilars
9.8 Phase I Pipeline Biosimilars

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The global biosimilars market value is expected to reach $20 billion by the end of 2015 and could hit $55 billion by 2020, with growth primarily driven by a promising pipeline in active development and government efforts to reduce healthcare spending.

This report states that biologics currently account for between 17–20% of the pharmaceutical arena, with a value of nearly $200 billion, and these products may replace 70% of chemical drugs in the next two decades.

The report also states that while a regulatory framework for biosimilars has been established in all major markets, some aspects, such as interchangeability, naming conventions and extrapolation across indications, need to be harmonized.

The report adds that the US biologics space is twice the size of its European equivalent by value, but the uptake of biosimilars in Europe is nearly four times higher, indicating the significant future potential of biosimilars in the US.

This report provides a regulatory overview and market outlook for biosimilars, both globally and across the major markets of Europe, the US, India, South Korea, Japan, and China. It includes market dynamics, analysis of key players and an evaluation of the pipeline.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis.
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