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市場調査レポート

バイオシミラーの世界市場

Biosimilars

発行 Global Industry Analysts, Inc. 商品コード 240198
出版日 ページ情報 英文 278 Pages
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バイオシミラーの世界市場 Biosimilars
出版日: 2016年07月01日 ページ情報: 英文 278 Pages
概要

当レポートでは、バイオシミラーの世界市場を分析し、米国/日本/欧州/その他の地域についての包括的な地域別分析を提供し、2008-2017年間の年間業績を推定/予測しながら主要/ニッチプレーヤ55社の企業プロファイルを盛り込み、概略下記の構成でお届けいたします。

第1章 イントロダクション、方法論、製品定義

第2章 エグゼクティブサマリ

第3章 市場概要

  • バイオシミラー:製薬業界の新たなダイナマイト
  • 主要市場におけるバイオシミラーへの規制的枠組み
  • バイオシミラー競争では欧州連合が先んじる
  • 欧州はバイオシミラー・モノクローナル抗体のガイドラインを設定する
  • 地域市場における主要バイオシミラーの可用性
  • 米国はようやくバイオシミラーの進路を開く法案を可決
  • バイオシミラー取引の急増

第4章 市場展望

  • 無数の要因が予言するバイオシミラー製品の市場浸透率の低下
  • 問題はさておき、バイオシミラーはかなり有望
  • バイオシミラーの豊富な機会

第5章 市場トレンド

  • 米国において注目を浴びるバイオシミラー
  • 新興市場において一層成長するバイオシミラー
  • バイオシミラーの将来の機会
  • 近年特許を喪失する主要バイオシミラー製品
  • 市場の課題と展望

第6章 市場動態

  • 製薬企業はバイオシミラーの機会に注目する
  • 小規模かつ新規のバイオシミラーに焦点を当てた企業は足掛かりを得る
  • 西欧市場におけるインド企業の急浮上
  • 中国製造業者は、少なくとも近い将来では、世界的に大きな脅威ではない
  • ヒトインスリン・バイオシミラーに注目する企業
  • インスリン製造業者は欧州と米国のバイオシミラー市場に参入しようと計画中
  • バイオシミラー参入への障害:地域ごとの変化
  • 主要世界市場におけるバイオジェネリックへの参入障害の比較
  • 市場導入への障害
  • バイオシミラーにおいて企業生存を支援する戦略
  • バイオベターが提供するバイオシミラー市場への代替の参入

第7章 市場発展/阻害要因

  • 市場発展要因
  • 成長阻害要因

第8章 競合的シナリオ

  • バイオシミラー市場の競争は続く
  • 承認済み/パイプライン中のバイオシミラー医薬品を有する市場プレーヤ
  • 大手製薬会社とジェネリック製造業者間の競争激化
  • ブランド医薬品製造業者の防衛戦略

第9章 世界の生物製剤市場

  • 世界のバイオ製薬市場:入門
  • 北米:世界最大の生物製剤市場
  • バイオシミラー市場をけん引する生物製剤の比率増加
  • 上位10社のバイオ技術医薬品数のリスト:2008
  • 世界の製薬市場における存在感を強める生物製剤:2015
  • 純粋な生物製剤生産のコスト効果の高い方法

第10章 製品概要

  • イントロダクション
  • バイオシミラーの特性
  • 生物製剤
  • 生物製剤の製造プロセス
  • バイオシミラーの開発サイクル
  • 業界参入企業
  • 世界のバイオシミラー市場における既存能力に基づく製薬企業の分類

第11章 製品承認/紹介

第12章 製品承認/紹介:歴史的展望材料

第13章 世界のバイオシミラー分野における企業戦略

第14章 戦略的企業発展:歴史的展望材料

第15章 主要市場プレーヤへの焦点

第16章 世界市場分析

  • 米国
  • 日本
  • 欧州
  • その他の地域

第17章 競合状況

このページに掲載されている内容は最新版と異なる場合があります。詳細はお問い合わせください。

目次
Product Code: MCP-6201

This report analyzes the worldwide markets for Biosimilars in US$ Million. The report provides separate comprehensive analytics for the US, Japan, Europe, and Rest of World. Annual estimates and forecasts are provided for the period 2015 through 2022. Also, a six-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs. The report profiles 71 companies including many key and niche players such as -

Amgen Inc.
Allergan Plc
Biocon Ltd.
Biopartners GmbH
Boehringer Ingelheim GmbH

Table of Contents

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

  • Study Reliability and Reporting Limitations
  • Disclaimers
  • Data Interpretation & Reporting Level
    • Quantitative Techniques & Analytics
  • Product Definitions and Scope of Study

II. EXECUTIVE SUMMARY

1. MARKET OVERVIEW

  • Introduction to Biosimilars
  • Biosimilars Set to Revolutionize Healthcare Sector
  • Biosimilars Offer Great Promise despite Challenges
  • Specific Guidelines for Biosimilars in Various Countries with Year of Publication
  • List of Approved Biosimilars & Pending Biosimilar Applications in the EU
  • List of Approved Biosimilars & Pending Biosimilar Applications in the US
  • List of Approved Biosimilars in South Korea
  • Biosimilars Find More Growth in Emerging Markets
  • Comparison of Entry Barriers for Biogenerics in Select Global Markets
  • Market Drivers
  • Patent Expiry of Leading Biopharmaceuticals Leads Way for Biosimilars
    • Patent Expiries of Major Biopharmaceutical Drugs in the US and Europe
  • Cost Containment Measures
    • Table 1: Per-Capita Healthcare Expenditure in Select Regions: 2013 (includes corresponding Graph/Chart)
    • Table 2: Leading Countries with the Highest Healthcare Spending as a Percentage of GDP (2012) (includes corresponding Graph/Chart)
  • Growing Aging Population
    • Table 3: Global Population Statistics for the 65+ Age Group (2013) (includes corresponding Graph/Chart)
    • Table 4: Elderly Population (65+ Years) as a % of Total Population (2000 & 2025) (includes corresponding Graph/Chart)
    • Table 5: Percentage of Population Aged 65 and Above in EU-27 Countries, US and Japan (1960-2030) (includes corresponding Graph/Chart)
  • Presence of Major Players
  • Growth Restraints
  • Uncertain Regulations
  • High Lead-time
  • High Manufacturing Costs
  • Delivery and Commercialization
  • Automatic Substitution
  • Other Impediments to Market Acceptance
  • Strategies to Aid Survival of Companies

2. RECENT BIOSIMILAR APPROVALS AND PIPELINE ANALYSIS

  • Biosimilar Approvals in 2016, 2015, & 2014
  • Select Biosimilar Candidates in Late-Stage Pipeline: 2016
  • Biosimilars in Pipeline for Major Biologic Drugs: 2016
  • Increasing Collaborations, Licensing Routes and Partnerships
  • Indian & Chinese Companies to Emerge Strong in Western Markets
  • Improved Regulatory Framework
  • European Union Ahead in the Biosimilars Race
  • Biosimilars Regulatory Agencies in Select Regional Markets
  • US Passes Act to Create Biosimilars Pathway, Finally

3. MARKET DYNAMICS & TRENDS

  • Increased Penetration of Biosimilars - Implications for Manufacturers
  • Efforts to Push Up Biosimilar Adoption
  • Improvements in Nomenclature and Interchangeability
  • Contract Manufacturing Favored by Emerging & Major Biosimilar Players
  • Companies Eye Human Insulin Biosimilars
    • Table 6: Global Basal Insulin Market by Brand (2016E, 2018E & 2020E): Percentage Market Share Breakdown of Revenues for Basalgar, Lantus, Levemir, Peg Lispro, Toujeo, and Tresiba (includes corresponding Graph/Chart)
  • Monoclonal Antibodies - A Key Growth Segment for Biosimilars
  • Approved Monoclonal Antibodies for Therapeutic Use: 1986-2014
  • Biobetters: Potential Industry Challenge?
  • High Cost of Biologics - Favorable for Biosimilars
    • Table 7: Treatment Costs by Drug (2015): Comparative Analysis of Daily Treatment costs with Branded Small-molecule Drug, Generic Small-molecule Drug, and Biologics (Humira, Kadcyla, & Cerezyme) (includes corresponding Graph/Chart)
  • R&D Funding Crucial
    • Table 8: Global Biopharmaceutical R&D Expenditure: 2010-2015E (includes corresponding Graph/Chart)
  • Growing Biosimilars Market - A Clear Advantage for Bioseparation Technologies

4. GLOBAL BIOLOGICS MARKET

  • Global Biopharmaceutical Drug Market - A Primer
    • Table 9: Increasing Share of Biologics in the Global Pharmaceutical Market: 2013-2020 (includes corresponding Graph/Chart)
  • US - The Largest Biologics Market Worldwide
    • Table 10: Global Biologics Market by Region: Percentage Share Breakdown for US, Canada, Japan, Europe, Asia-Pacific, and Rest of World for 2007, 2015 and 2020 (includes corresponding Graph/Chart)
  • Increasing Share of Biotechnological Drugs to Drive Biosimilars Market
  • Intensifying Consolidation Activity
  • Recent M&A Activity in the Biologics Industry: 2014 & 2015

5. PRODUCT OVERVIEW

  • Introduction
  • Characteristics of Biosimilars
  • Biological Drugs
  • Biological Drugs Manufacturing Process
  • Development Cycle of Biosimilars
  • Industry Participants

6. PRODUCT APPROVALS/INTRODUCTIONS

  • Mylan and Biocon Co-develop trastuzumab Biosimilar
  • EC Approves Remicade Biosimilar Flixabi(r) Developed by Samsung Bioepis
  • Samsung's BLA for Remicade Biosimilar Accepted by USFDA
  • EMA Approves rituximab Biosimilar Developed by Sandoz
  • EC Approves New Route of Administration for Sandoz's Biosimilar Binocrit
  • USFDA Approves INFLECTRA, Celltrion's Biosimilar to Remicade
  • Japanese Ministry Approves Biocon's Biosimilar Insulin Glargine
  • EMA Accepts Sandoz's MAA for Neulasta Biosimilar
  • FDA Accepts Amgen's BLA for ABP-501
  • EC Approves Benepali (Enbrel Biosimilar) Developed by Samsung Bioepis
  • Torrent Pharmaceuticals Launches adalimumab Biosimilar
  • EMA Accepts Sandoz's MAA for Enbrel Biosimilar
  • RENFLEXIS(r) by Samsung Bioepis Approved by Korea's MFDS
  • Amgen Submits ABP-501 Marketing Authorization Application to EMA
  • FDA Approves Sandoz's BLA for Proposed Enbrel Biosimilar
  • Amgen and Allergan Announce Positive Phase 3 Study Results for Biosimilar ABP 215
  • Korean Ministry Approves BRENZYS(tm) Co-developed by Merck and Samsung
  • Intas Pharmaceuticals Launches Biosimilar to Lucentis
  • USFDA Approves First Biosimilar Zarxio(tm) from Sandoz
  • Mundipharma Launches Biosimilar MAb Remsima(r) in 6 European Markets
  • Intas Pharmaceuticals Launches filgrastim Biosimilar Accofil
  • Cadila Launches adalimumab Biosimilar
  • EPIRUS Biopharmaceuticals Launches infliximab Biosimilar
  • Celltrion Receives Japan's MHLW Approval for Remsima
  • Cipla Launches Biosimilar Darbepoetin alfa Under Actorise Brand
  • Celltrion Announces Approval of biosimilar mAb Herzuma by MFDS

7. RECENT INDUSTRY ACTIVITY

  • Alvotech Acquires Baliopharm GmbH
  • Dr. Reddy's Inks Collaboration Agreement with TR-Pharm
  • Premier and Oncobiologics Collaborate to Enhance Biosimilars Adoption
  • Sandoz Acquires Rights to infliximab Biosimilar from Pfizer
  • Sandoz Enters into Exclusive License Agreement with Kyowa Hakko Kirin
  • Mylan Enters Into Biosimilars Development Partnership with Momenta Pharmaceuticals
  • Merck to Bring Biosimilars to Canada through its Agreement with Samsung
  • EPIRUS Biopharmaceuticals to Expand Biosimilar Pipeline through Acquisition of Bioceros
  • Pfizer Acquires Hospira
  • Astrazeneca Enters into JV with Fujifilm Kyowa Kirin Biologics
  • STADA and Richter Sign License/Disribution Agreement for Pegfilgrastim Biosimilar
  • Coherus and Baxter Amend Collaboration Agreement for CHS-0214
  • Torrent Pharmaceuticals Enters into Licensing Agreement with Reliance Life Sciences
  • Mabion Ext,mends Agreement with Altiora for rituximab Biosimilar MabionCD20
  • STADA and mAbxience Enter Into In-licensing Agreement for Humira Biosimilar
  • Xbrane Bioscience Signs Agreement with Indian Pharmaceutical Major
  • Cipla Acquires Mabpharm
  • EPIRUS Biopharmaceuticals Merges with Zalicus
  • mAbxience Acquires Genhelix
  • Ipca and Oncobiologics Enter into Alliance for Development of Biosimilar MAbs
  • Lupin and Yoshindo Form Joint Venture YLB for Biosimilar Commercialization
  • Bionovis and Merck Sign Agreement
  • Catalent Signs Agreement with HISUN
  • Aurobindo Pharma Acquires Western European Operations of Actavis
  • Samsung and Merck Expand Collaboration to Develop MK-1293 Insulin Glargine Biosimilar

8. FOCUS ON SELECT MARKET PLAYERS

  • Amgen Inc. (US)
  • Allergan Plc. (Ireland)
  • Biocon Ltd. (India)
  • Biopartners GmbH (Switzerland)
  • Boehringer Ingelheim GmbH (Germany)
  • Celltrion Inc. (South Korea)
  • Cipla Ltd. (India)
  • Cipla BioTec Private Ltd. (India)
  • Dr. Reddy's Laboratories Ltd. (India)
  • Eli Lilly and Company (US)
  • EPIRUS Biopharmaceuticals, Inc. (US)
  • Hospira, Inc. (US)
  • Intas Biopharmaceuticals Ltd. (India)
  • Merck KGaA (Germany)
  • Mylan N.V. (US)
  • Pfizer Inc. (US)
  • Samsung Bioepis Co., Ltd. (Korea)
  • Sandoz International GmbH (Germany)
  • STADA Arzneimittel AG (Germany)
  • Teva Pharmaceutical Industries Ltd. (Israel)

9. GLOBAL MARKET PERSPECTIVE

    • Table 11: World Recent Past, Current, and Future Analysis for Biosimilars by Geographic Region - US, Japan, Europe and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
    • Table 12: World 7-Year Perspective for Biosimilars by Geographic Region - Percentage Breakdown of Dollar Revenues for US, Japan, Europe and Rest of World Markets for Years 2016 & 2022 (includes corresponding Graph/Chart)

III. MARKET

1. THE UNITED STATES

  • A. Market Analysis
    • Market Overview
    • Latest Developments in the Biosimilars Space
    • Slow Take-Off in the US Market
      • List of Approved Biosimilars & Pending Biosimilar Applications in the US
    • Challenges in the US Drug Approval Pathway for Biosimilars
    • Growing Legal Challenges in the Domestic Market
    • Need to Cut Down Prices for Increased Adoption
    • Patent Expiry of Leading Biopharmaceuticals Presents Ray of Hope
      • Patent Expiries of Major Biopharmaceutical Drugs in the US
    • Significant Biosimilar Pipeline Products
    • Product Introductions
    • Strategic Corporate Developments
    • Select Key Players
  • B. Market Analytics
    • Table 13: The US Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

2. JAPAN

  • A. Market Analysis
    • Growing Market for Biosimilars
    • Product Introductions
    • Strategic Corporate Developments
  • B. Market Analytics
    • Table 14: Japanese Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

3. EUROPE

  • A. Market Analysis
    • List of Approved Biosimilars & Pending Biosimilar Applications in the EU
    • Patent Expiry of Leading Biopharmaceuticals Leads Way for Biosimilars
      • Patent Expiries of Major Biopharmaceutical Drugs in Europe
    • Biosimilar Pricing Competition to Intensify Further
    • Clarity Needed Regarding Extrapolation of Biosimilars for Other Indications
    • Demand for Rituximab Biosimilars
    • Nascent UK Biosimilars Market
      • NICE's Latest Ruling Bodes Well for Biosimilars
    • Spanish Biosimilars Market: A Brief Review
    • Biosimilar-related Developments in Russia
    • Biosimilars Regulatory Framework: Well-Established
      • Biosimilar Regulatory Timeline from Legislation to Approval in the EU
    • Growth Drivers
      • Payers Eye Biosimilars to Curtail Costs
    • Challenges Ahead
      • Heavy Investment and Regulations
      • Complex Production Process
      • Biocapacity
    • Product Introductions
    • Strategic Corporate Developments
    • Select Key Players
  • B. Market Analytics
    • Table 15: European Recent Past, Current & Future Analysis for Biosimilars by Geographic Region - France, Germany, Italy, UK, Spain and Rest of Europe Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
    • Table 16: European 7-Year Perspective for Biosimilars by Geographic Region - Percentage Breakdown of Dollar Revenues for France, Germany, Italy, UK, Spain and Rest of Europe Markets for Years 2016 & 2022 (includes corresponding Graph/Chart)

3a. FRANCE

  • Market Analysis
    • Table 17: French Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

3b. GERMANY

  • Market Analysis
    • Table 18: German Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

3c. ITALY

  • Market Analysis
    • Table 19: Italian Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

3d. UNITED KINGDOM

  • Market Analysis
    • Table 20: The UK Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

3e. SPAIN

  • Market Analysis
    • Table 21: Spanish Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

3f. REST OF EUROPE

  • Market Analysis
    • Table 22: Rest of European Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

4. REST OF WORLD

  • A. Market Analysis
    • Asia-Pacific: Market with High Potential
    • Regulatory Framework
      • Asia-Pacific
      • List of Approved Biosimilars in South Korea
      • Latin America
      • Middle East and North Africa
      • Sub-Saharan Africa
    • High Costs and Counteractive Measures
    • Indian Biopharmaceutical Industry Makes Rapid Progress
      • Competition from Western Counterparts in Biosimilar Development
    • China Issues New Guidelines on Biosimilars
    • Overview of Biosimilars in Sub-Saharan Africa
    • Canada
      • Biosimilars Set to Register Gains in Pharmaceutical Sector
      • Future Scenario
      • Regulatory Framework
    • Product Introductions
    • Strategic Corporate Developments
    • Select Key Players
  • B. Market Analytics
    • Table 23: Rest of World Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

COMPETITIVE LANDSCAPE

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