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新興市場国のバイオシミラー市場:高度な組み換え技術プラットフォームと低コスト生産による、インド・中国のバイオシミラー生産における戦略的優位性

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

発行 GBI Research 商品コード 245749
出版日 ページ情報 英文 88 Pages
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新興市場国のバイオシミラー市場:高度な組み換え技術プラットフォームと低コスト生産による、インド・中国のバイオシミラー生産における戦略的優位性 Biosimilars in Emerging Economies - Advanced Recombinant Technology Platforms and Low Cost Manufacturing Put India and China at a Strategic Advantage in Biosimilar Production
出版日: 2012年06月25日 ページ情報: 英文 88 Pages
概要

新興市場国のバイオシミラー市場は、2002年の3億米ドルから、2010年には33億米ドルへ、年平均(CAGR)34%もの非常に速い速度で成長しました。また、今後(2010〜2018年)も年平均12%の速度で成長すると予測されています。政府の支援策や先発生物製剤の特許失効、増加し続ける人口へより安い医薬品を届ける必要性、新たな疾患の流行などが、市場の成長促進要因となっています。

当レポートでは、新興市場国(インド・中国など)におけるバイオシミラー市場について分析し、バイオシミラー市場全体の構造や特徴、各国市場(インド・中国など)の詳細動向、現在治験中の製品のパイプライン情報、関連企業への戦略提言、資本取引動向といった情報を取りまとめて、概略以下の構成でお届けします。

第1章 目次

第2章 イントロダクション

第3章 市場概況

  • バイオシミラー
  • バイオシミラーと生物製剤・ジェネリック医薬品の比較
  • バイオシミラーの開発
  • バイオシミラーの製造
  • 市場促進・抑制要因
  • 代表的な生物製剤上位10種類(2010年)
  • 主な生物製剤の特許失効
  • バイオシミラーと関連製品の価格比較

第4章 市場の特徴

  • 新興市場国のバイオシミラーの市場規模予測
  • 新興市場国の主な市販バイオシミラー

第5章 インド

  • バイオシミラー市場の概要
  • 市場・研究開発(R&D)の主な傾向
  • 規制環境
  • 課題と機会
  • 主要企業
    • Dr. Reddy's Laboratories (DRL)
    • Biocon
    • Intas Biopharmaceuticals (IBPL)
    • Reliance Life Sciences
    • Wockhardt
    • Lupin
    • Cipla

第6章 中国

  • バイオシミラー市場の概要
  • 規制環境
  • 課題と機会
  • 主要企業
    • 3SBio
    • Shanghai CP Guojian Pharmaceutical Co. Ltd.
    • Biotech Pharma

第7章 その他の新興市場国

  • ブラジル
  • ロシア
  • メキシコ
  • トルコ
  • アルゼンチン
  • 南アフリカ
  • ベネズエラ
  • ベトナム
  • タイ

第8章 パイプライン分析

  • イントロダクション
  • 登録済みパイプライン
  • フェーズIIIパイプライン
  • フェーズIIパイプライン
  • フェーズIパイプライン
  • 前臨床パイプライン
  • 創薬パイプライン
  • IND申請済みパイプライン

第9章 産業のダイナミクス

  • ジェネリック医薬品との競争に打ち勝つために、先発生物製剤企業が採用した戦略
  • バイオシミラー市場に参入する企業向けの戦略

第10章 取引分析

  • 企業合併・買収(M&A)
  • ライセンス契約
  • 共同開発

第11章 付録

図表一覧

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目次
Product Code: GBIHC209MR

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.

Table of Contents

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
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