India Biosimilar Market Analysis Sales Revenue Opportunity Report

As the number of patent expiries of biologic drugs is increasing, Indian companies are developing biosimilar manufacturing capabilities. Firms are developing their capabilities by either forming partnerships with R&D-intensive firms or outsourcing to upcoming Indian contract research organizations (CROs). Domestic manufacturers have a cost advantage (lower facility and development costs) than peers in developed countries. Moreover, Indian firms seem keen on repeating their successes achieved in developing and commercializing biosimilars. They are increasingly partnering with large multinational corporations for clinical trials, regulatory approval processes in the EU/US, and marketing to physicians as well as consumers.

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"India Biosimilar Market Analysis" Table of Contents

1. India Biosimilar Market Overview

2. Indian Market for Biosimilar by Drug Class

3. Biosimilar Pipeline Analysis

4. Biosimilar Development Capabilities of Indian Players: Partnerships & Acquisitions
4.1 Mergers & Acquisitions
4.2 Development & Marketing Partnership
4.2.1 Dr. Reddy’s Laboratories & Merck Serono
4.2.2 Biocon & Mylan Inc
4.2.3 Ranbaxy & Pfenex

5. Factors Driving the Market
5.1 Regulatory Framework for Biosimilars
5.2 Cost Advantage of Biosimilar Development
5.3 Biologics Patent Expiration
5.4 Cost Saving to Healthcare System

6. Guidelines for Development & Marketing of Biosimilar
6.1 Fundamental Principles for Manufacturing of Biosimilar
6.1.1 Reference Biologic
6.1.2 Biosimilar Development Process
6.1.3 Quality Considerations for Biosimilar
6.1.4 Quality Comparison Between Biosimilar & Reference Biologic
6.2 Preclinical Pharmacodynamic & Toxicology Studies
6.3 Pharmacokinetic & Pharmacodynamic Studies for Conducting Clinical Trial
6.4 Approval for Marketing of Biosimilar
6.5 Pharmacovigilance & Adverse Drug Reaction Reporting

7. Indian Biosimilar Market Future Outlook
7.1 Domestic Market Expansion
7.2 Contract Manufacturing Opportunity

8. Indian Biosimilar Drugs to Enter the US & European Market

9. Competitive Landscape
9.1 Dr.Reddy s Labs (DRL)
9.2 Intas Pharmaceuticals Ltd.
9.3 Biocon Limited
9.4 Wockhardt Limited
9.5 Shantha Biotech
9.6 Reliance Life Sciences
9.7 Cipla

List of Figures

Figure 1-1: India Biosimilar Market Sales (US$ Million), 2011-2015
Figure 2-1: Biosimilar Market by Segment, 2011

List of Tables

Table 2-1: Biosimilar Product by Indian Company
Table 5-1: Major Drug Patent Expiry by Indications, 2011
Table 5-2: Major Drug Patent Expiry by Indications, 2012
Table 5-3: Major Drug Patent Expiry by Indications, 2013
Table 5-4: Major Drug Patent Expiry by Indications, 2014
Table 5-5: Major Drug Patent Expiry by Indications, 2015
Table 8-1: Approved Biosimilar in Europe

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Neeraj Chawla
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KuicK Research
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