Biosimilars in Emerging Economies - Advanced Recombinant Technology Platforms and Low Cost Manufacturing Put India and China at a Strategic Advantage in Biosimilar Production

Date: June 25, 2012
Pages: 88
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Publisher: GBI Research
Report type: Strategic Report
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Biosimilars in Emerging Economies - Advanced Recombinant Technology Platforms and Low Cost Manufacturing Put India and China at a Strategic Advantage in Biosimilar Production
Biosimilars in Emerging Economies - Advanced Recombinant Technology Platforms and Low Cost Manufacturing Put India and China at a Strategic Advantage in Biosimilar Production

Summary

GBI Research, the leading business intelligence provider, has released its latest report, “Biosimilars in Emerging Economies - Advanced Recombinant Technology Platforms and Low Cost Manufacturing Put India and China at a Strategic Advantage in Biosimilar Production” that provides key data, information and analysis of the major trends and issues that affect the emerging biosimilars market. The report provides a comprehensive insight into the biosimilars market, with regional market forecasts for biosimilars in India and China, and analysis of the drivers and restraints that affect the market. The report looks at key market companies in the emerging biosimilars industry through profiles and analysis of their strengths, weaknesses, opportunities and threats. The report also provides information on the global biosimilars pipeline. Also discussed in detail are success factors for the emerging biosimilar industry and the regulatory environment in emerging markets with respect to biosimilars. At the end, the report provides an analysis on major deals that have taken place in the industry from 2007 to 2011.

This report is built using data and information sourced from proprietary databases, primary and secondary research, and in house analysis by GBI Research’s team of industry experts.

The emerging biosimilars market has grown significantly in the recent past and has the ability to grow in the future due to the expiry of patents for major biological drugs, pressure on governments in emerging economies to reduce healthcare costs, and the savings that can be obtained with biosimilars over branded biologics. The emerging biosimilars market was valued at $0.3 billion in 2002 and increased to a value of $3.3 billion in 2010, at a CAGR of 34%. The market is expected to increase to a value of $8 billion in 2018 at a CAGR of 12%. Strategic consolidations, such as M&As, licensing agreements and co-developments, are actively pursued by major pharmaceutical companies, many of which are from India. The launch of a number of biosimilars that are presently in the late stage of development in the R&D pipeline, and government initiatives to develop the biosimilars market in emerging economies, will also drive growth.

Major pharmaceutical companies such as Dr. Reddy’s, Biocon and Intas Biopharmaceuticals (IBPL) from India, along with 3SBio from China, have created a strong position for themselves in the emerging biosimilars market, with a number of biosimilar products launched and generating revenue. Companies such as Cipla, Ranbaxy and Lupin have shown interest in the opportunities offered by the emerging biosimilars market and have taken initiatives to enter the market through strategic consolidations and biosimilars R&D. However, the regulatory guidelines for biosimilars require strengthening in most emerging economies in order to meet international standards and increase coverage to include all types of biosimilars.

Scope
  • Data and analysis on biosimilars markets in emerging economies
  • Market forecasts for the emerging biosimilars market to 2018, with regional market forecasts for India and China.
  • Key drivers and restraints that have had a significant impact on the emerging biosimilars market.
  • The regulatory environment for biosimilars in India, China and other emerging economies.
  • Analysis of key companies in the industry, with profiles of major companies in the emerging biosimilars market.
  • Analysis of the biosimilars R&D pipeline across various stages of development.
  • Key M&A activities, licensing agreements and co-developments that have taken place in the emerging biosimilar market
Reasons to buy
  • Make more informed business decisions from the insightful and in-depth analysis of the emerging biosimilars market and the factors that shape it.
  • Identify key areas of deal making through an understanding of the deals landscape in the emerging biosimilars market.
  • Build effective strategies to launch pipeline products by identifying potential target regions.
  • Identify prominent companies from emerging economies and their capabilities for collaborations.
  • Exploit in-licensing and out-licensing opportunities by identifying products that might fill your portfolio gaps.
1 TABLE OF CONTENTS

1.1 List of Tables
1.2 List of Figures

2 INTRODUCTION

3 BIOSIMILARS IN EMERGING ECONOMIES – MARKET OVERVIEW

3.1 Biosimilars
  3.1.1 Types of Biosimilars
3.2 Comparison of Biosimilars with Biologics and Generics
  3.2.1 Structural Differences between Biologics, Generics and Biosimilars
3.3 Development of Biosimilars
3.4 Manufacturing of Biosimilars
  3.4.1 Establishing a New Biosimilar Manufacturing Facility
3.5 Drivers and Restraints
  3.5.1 Drivers
  3.5.2 Restraints
3.6 Top 10 Biologics in 2011
3.7 Patent Expiries of Leading Biologics
3.8 Price Comparison of Biosimilars and Reference Products

4 BIOSIMILARS IN EMERGING ECONOMIES – MARKET CHARACTERIZATION

4.1 Biosimilars Market Size and Forecast for Emerging Economies
4.2 Major Marketed Biosimilars in Emerging Economies

5 BIOSIMILARS IN EMERGING ECONOMIES – INDIA

5.1 Biosimilars Market Overview
5.2 Key Market and R&D Trends
  5.2.1 Biocon’s Deal to Commercialize Biosimilar Versions of Insulin Products with Pfizer Cancelled
5.3 Regulatory Landscape in India
  5.3.1 Regulatory Framework for Biosimilars
5.4 Challenges and Opportunities
  5.4.1 Challenges
  5.4.2 Opportunities
5.5 Key Companies
  5.5.1 Dr. Reddy’s Laboratories (DRL)
  5.5.2 Biocon
  5.5.3 Intas Biopharmaceuticals (IBPL)
  5.5.4 Reliance Life Sciences
  5.5.5 Wockhardt
  5.5.6 Lupin
  5.5.7 Cipla

6 BIOSIMILARS IN EMERGING ECONOMIES – CHINA

6.1 Biosimilars Market Overview
  6.1.1 Marketed Biosimilars in China
6.2 Regulatory Landscape in China
  6.2.1 Regulatory Framework for Biosimilars
6.3 Challenges and Opportunities
  6.3.1 Challenges
6.4 Key Companies
  6.4.1 3SBio
  6.4.2 Shanghai CP Guojian Pharmaceutical Co. Ltd.
  6.4.3 Biotech Pharma

7 BIOSIMILARS IN EMERGING ECONOMIES – OTHER EMERGING ECONOMIES

7.1 Brazil
  7.1.1 Biosimilars Regulatory Framework and Approval Process
  7.1.2 Biosimilars Coverage and Availability at Reduced Cost
  7.1.3 Biosimilars Market Opportunity
  7.1.4 Major Challenge
7.2 Russia
7.3 Mexico
7.4 Turkey
  7.4.1 Biosimilar Guidelines in Turkey
  7.4.2 Risk Management Plan
  7.4.3 New Pharmacovigilance Legislation
  7.4.4 Actavis and Bioton Collaborate for Insulin
7.5 Argentina
  7.5.1 Major Challenge
7.6 South Africa
  7.6.1 Guidelines for Similar Biological Medicines
  7.6.2 Genius Biotherapeutics
  7.6.3 Major Challenges
7.7 Venezuela
7.8 Vietnam
  7.8.1 Innogene Kalbiotech
  7.8.2 Major Challenge
7.9 Thailand
  7.9.1 Major Challenges

8 BIOSIMILARS IN EMERGING ECONOMIES – PIPELINE ANALYSIS

8.1 Introduction
8.2 R&D Pipeline – Filed
8.3 R&D Pipeline – Phase III
8.4 R&D Pipeline – Phase II
8.5 R&D Pipeline – Phase I
8.6 R&D Pipeline – Pre-clinical
8.7 R&D Pipeline – Discovery
8.8 R&D Pipeline – IND Filed

9 BIOSIMILARS IN EMERGING ECONOMIES – INDUSTRY DYNAMICS

9.1 Strategies Adopted By Branded Biologic Companies to Beat Generic Competition
  9.1.1 Introduction
  9.1.2 Second Generation Biologics
  9.1.3 New Formulation
  9.1.4 Combination Products
  9.1.5 New Approved Indications
9.2 Industry Dynamics: Strategies to Be Adopted by Companies to Enter the Biosimilars Market
  9.2.1 Product
  9.2.2 Price
  9.2.3 Place
  9.2.4 Promotion
  9.2.5 People

10 BIOSIMILARS IN EMERGING ECONOMIES – DEALS ANALYSIS

10.1 Mergers and Acquisitions
  10.1.1 M&A by Year
  10.1.2 M&A by Value
  10.1.3 M&A by Type
  10.1.4 M&A Deals
10.2 Licensing Agreements
10.3 Co-developments

11 BIOSIMILARS IN EMERGING ECONOMIES – APPENDIX

11.1 Market Definitions
11.2 Abbreviations
11.3 Bibliography
11.4 Research Methodology
  11.4.1 Market Overview
  11.4.2 Market Characterization
  11.4.3 India
  11.4.4 China
  11.4.5 Other Emerging Economies
  11.4.6 Pipeline Analysis
  11.4.7 Industry Dynamics
  11.4.8 Deals Analysis
11.5 Contact Us
11.6 Disclaimer

LIST OF TABLES

Table 1: Biosimilars in Emerging Economies, Key Patent Expiries of Leading Biologics From 2011–2018
Table 2: Biosimilars in Emerging Economies, Revenue ($bn), 2002–2011
Table 3: Biosimilars in Emerging Economies, Revenue Forecasts ($bn), 2011–2018
Table 4: Biosimilars in Emerging Economies, Marketed Biosimilar Products, India, 2012
Table 5: Biosimilars in Emerging Economies, Marketed Biosimilar Products, China, 2012
Table 6: Biosimilars in Emerging Economies, Marketed Biosimilar Products, Other Emerging Economies, 2012
Table 7: Biosimilars in Emerging Economies, India, Revenue ($bn), 2002–2011
Table 8: Biosimilars in Emerging Economies, India, Revenue Forecasts ($bn), 2011–2018
Table 9: Biosimilars in Emerging Economies, Marketed Biosimilar Products, Dr. Reddy’s, 2012
Table 10: Biosimilars in Emerging Economies, Marketed Biosimilar Products, Biocon, 2012
Table 11: Biosimilars in Emerging Economies, Pipeline Molecules, Biocon, 2012
Table 12: Biosimilars in Emerging Economies, Marketed Biosimilar Products, IBPL, 2012
Table 13: Biosimilars in Emerging Economies, Marketed Biosimilar Products, Reliance Life Sciences, 2012
Table 14: Biosimilars in Emerging Economies, Pipeline Molecules, Reliance Life Sciences, 2012
Table 15: Biosimilars in Emerging Economies, Marketed Biosimilar Products, Wockhardt, 2012
Table 16: Biosimilars in Emerging Economies, Pipeline Molecules, Lupin, 2012
Table 17: Biosimilars in Emerging Economies, Pipeline Molecules, Cipla, 2012
Table 18: Biosimilars in Emerging Economies, China, Revenue ($bn), 2002–2011
Table 19: Biosimilars in Emerging Economies, China, Revenue Forecasts ($bn), 2011–2018
Table 20: Biosimilars in Emerging Economies, Marketed Biosimilar Products, China, 2012
Table 21: Biosimilars in Emerging Economies, Marketed Biosimilar Products, 3SBio, 2012
Table 22: Biosimilars in Emerging Economies, Pipeline Molecules, 3SBio, 2012
Table 23: Biosimilars in Emerging Economies, Marketed Biosimilar Products, CPGJ, 2012
Table 24: Biosimilars in Emerging Economies, Pipeline Molecules, CPGJ, 2012
Table 25: Biosimilars in Emerging Economies, Marketed Biosimilar Products, Biotech Pharma, 2012
Table 26: Biosimilars in Emerging Economies, Pipeline Molecules, Filed, 2011
Table 27: Biosimilars in Emerging Economies, Pipeline Molecules, Phase III, 2011
Table 28: Biosimilars in Emerging Economies, Pipeline Molecules, Phase II, 2011
Table 29: Biosimilars in Emerging Economies, Pipeline Molecules, Phase I, 2011
Table 30: Biosimilars in Emerging Economies, Pipeline Molecules, Pre-clinical, 2011
Table 31: Biosimilars in Emerging Economies, Pipeline Molecules, Discovery, 2011
Table 32: Biosimilars in Emerging Economies, Pipeline Molecules, IND Filed, 2011
Table 33: Biosimilars in Emerging Economies, Pipeline Molecules, Unknown Phase, 2011
Table 34: Biosimilars in Emerging Economies, M&A by Year, 2007–2011
Table 35: Biosimilars in Emerging Economies, M&A by Value ($m), 2007–2011
Table 36: Biosimilars in Emerging Economies, M&A Deals, 2007–2011
Table 37: Biosimilars in Emerging Economies, Licensing Agreements, 2007–2011
Table 38: Biosimilars in Emerging Economies, Co-developments, 2007–2011

LIST OF FIGURES

Figure 1: Biosimilars in Emerging Economies, EPO Biosimilars Marketed Outside the US and EU, 2011
Figure 2: Biosimilars in Emerging Economies, G-CSF Biosimilars Marketed Outside the US and EU, 2011
Figure 3: Biosimilars in Emerging Economies, INF Alpha Biosimilars Marketed Outside the US and EU, 2011
Figure 4: Biosimilars in Emerging Economies, Biosimilars Comparison With Biologics and Generic, 2012
Figure 5: Biosimilars in Emerging Economies, Size and Complexity, Small Molecule Drugs and Proteins, 2012
Figure 6: Biosimilars in Emerging Economies, Cost and Timeline for Biosimilar Development, 2011
Figure 7: Biosimilars in Emerging Economies, Biosimilars Development, 2011
Figure 8: Biosimilars in Emerging Economies, Drivers and Barriers, 2011
Figure 9: Biosimilars in Emerging Economies, Top 10 Biologics, 2011
Figure 10: Biosimilars in Emerging Economies, Revenue Forecasts ($bn), 2002–2018
Figure 11: Biosimilars in Emerging Economies, India, Revenue Forecasts ($bn), 2002–2018
Figure 12: Biosimilars in Emerging Economies, DRL, SWOT Analysis, 2012
Figure 13: Biosimilars in Emerging Economies, Biocon, SWOT Analysis, 2012
Figure 14: Biosimilars in Emerging Economies, IBPL, SWOT Analysis, 2012
Figure 15: Biosimilars in Emerging Economies, Reliance Life Sciences, SWOT Analysis, 2012
Figure 16: Biosimilars in Emerging Economies, Wockhardt, SWOT Analysis, 2012
Figure 17: Biosimilars in Emerging Economies, Lupin, SWOT Analysis, 2012
Figure 18: Biosimilars in Emerging Economies, Cipla, SWOT Analysis, 2012
Figure 19: Biosimilars in Emerging Economies, China, Revenue Forecasts ($bn), 2002–2018
Figure 20: Biosimilars in Emerging Economies, 3SBio, SWOT Analysis, 2012
Figure 21: Biosimilars in Emerging Economies, CPGJ, SWOT Analysis, 2012
Figure 22: Biosimilars in Emerging Economies, Biotech Pharma, SWOT Analysis, 2012
Figure 23: Biosimilars in Emerging Economies, Steps of Risk Management, Turkey, 2012
Figure 24: Biosimilars in Emerging Economies, R&D Pipeline by Phase (%), 2011
Figure 25: Biosimilars in Emerging Economies, R&D Pipeline by Therapy Class (%), 2011
Figure 26: Biosimilars in Emerging Economies, Strategies Adopted By Branded Biologic Companies to Beat Generic Competition, 2011
Figure 27: Biosimilars in Emerging Economies, Industry Dynamics, Strategies To Be Adopted by Companies to Enter the Biosimilars Market
Figure 28: Biosimilars in Emerging Economies, M&A by Year, 2007–2011
Figure 29: Biosimilars in Emerging Economies, M&A by Value ($m), 2007–2011

COMPANIES MENTIONED

Dr. Reddy’s Laboratories (DRL)
Biocon
Intas Biopharmaceuticals (IBPL)
Reliance Life Sciences
Wockhardt
Lupin
Cipla
3SBio
Shanghai CP Guojian Pharmaceutical Co. Ltd.
Biotech Pharma

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