表紙
市場調査レポート

世界のバイオシミラー市場

Biosimilars: Global Markets

発行 BCC Research 商品コード 242224
出版日 ページ情報 英文 136 Pages
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世界のバイオシミラー市場 Biosimilars: Global Markets
出版日: 2015年01月28日 ページ情報: 英文 136 Pages
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概要

世界のバイオシミラー市場は2013年に18億ドル、2014年には約20億ドルの規模を記録しました。2014年から2019年にかけては15%のCAGRで推移し、2019年には40億ドルに近い規模に成長すると予測されています

当レポートでは、世界のバイオシミラー市場の現状と見通しについて調査し、バイオシミラーの発展・開発の経緯、関連法規制、承認済み製品、一般的な標的、技術動向、製品区分別の収益予測、主要企業と市場シェア、産業動向、特許情報、主要企業のプロファイルなどをまとめています。

第1章 イントロダクション

第2章 エグゼクティブサマリー

第3章 概要

  • バイオシミラー関連の用語(WHO)
  • バイオシミラー関連の用語(FDA)
  • 生物製剤の製造
  • バイオシミラーの開発
  • 承認済みバイオシミラーのクラス

第4章 法規制

  • 欧州
  • 米国
  • 新興市場
    • 日本
    • インド
  • バイオシミラーのネーミング
  • 主な法規制上の動き

第5章 新たな発展

  • もっとも一般的な標的
    • ADALIMUMAB
    • INFLIXIMAB
    • RITUXIMAB
    • BEVACIZUMAB
    • TRASTUZUMAB
    • 臨床試験中のその他のバイオシミラー

第6章 技術動向

  • バイオシミラーの製造プロセスにおける新しい動向
  • ポリアクリルアミドゲル電気泳動(PAGE)・ウェスタンブロッティング
  • 等電点電気泳動(IEF)/タンパク質ブロッティング
  • キャピラリーゾーン電気泳動(CZE)
  • 高速液体クロマトグラフィー(HPLC)
  • 分光分析
  • 質量分光(MS)
  • インビトロアッセイ
  • エピトープマッピング
  • 示差走査熱量測定(DSC)

第7章 市場分析

  • タイプ別市場
    • 市場概要
    • 市場収益
    • 市場シェア
  • 地域別市場
    • 市場概要
    • 市場収益
    • 市場シェア
  • エリスロポエチン(EPO)
    • 市場概要
    • 市場収益
    • 市場シェア
  • Hヒト成長ホルモン(HGH)
    • 市場概要
    • 市場収益
    • 市場シェア
  • 顆粒球コロニー刺激因子(G-CSF)
    • 市場概要
    • 市場収益
    • 市場シェア
  • 低分子量ヘパリン(LMWH)
    • 市場概要
    • 市場収益
    • 市場シェア
  • その他
    • 市場概要
    • 市場収益
    • 市場シェア

第8章 産業構造

  • エリスロポエチン
    • 市場のリーダー
    • 市場シェア
  • ヒト成長ホルモン
    • 市場のリーダー
    • 市場シェア
  • 顆粒球コロニー刺激因子
    • 市場のリーダー
    • 市場シェア
  • 低分子量ヘパリン
    • 市場のリーダー
    • 市場シェア
  • その他
    • 市場のリーダー
    • 市場シェア

第9章 特許分析

第10章 現状

  • 疾患負荷の増大による市場の推進
  • 高齢化
  • 強力な政府支援
  • 特許の失効
  • 提携・協力
  • エレクトロニクス企業によるバイオシミラー部門への参入と巨額の投資
  • 新興市場における市場因子

第11章 企業プロファイル

  • 3SBIO INC.
  • ACTAVIS INC. LTD.
  • AMOYTOP BIOTECH CO., LTD.
  • ANHUI ANKE BIOTECHNOLOGY (GROUP) CO. LTD.
  • APOTEX INC.
  • AVESTHAGEN LIMITED
  • BHARAT SERUMS AND VACCINES LTD.
  • BIOCON LTD.
  • BIOXPRESS THERAPEUTICS SA
  • BIOTON S. A.
  • BLAU FARMACEUTICA S/A
  • BOEHRINGER INGELHEIM
  • CELLTRION GROUP
  • CHINA NATIONAL BIOTECH CORP. (CNBC)
  • CIPLA LIMITED
  • CINNAGEN
  • CJSC BIOCAD
  • DONG-A PHARMACEUTICAL CO. LTD.
  • DR. REDDY'S LABORATORIES LTD.
  • EMCURE PHARMACEUTICALS LTD.
  • FERON LIMITED
  • FINOX BIOTECH
  • FUJIFILM DIOSYNTH BIOTECHNOLOGIES
  • GEDEON RICHTER PLC
  • GENESCIENCE PHARMACEUTICALS CO. LTD.
  • GENEXINE INC.
  • GH GENHELIX S A
  • GREEN CROSS LIFE SCIENCE CORP.
  • HANALL PHARMACEUTICALS
  • HANGZHOU JIUYUAN GENE ENGINEERING CO. LTD.
  • HANWHA CHEMICAL CORP.
  • HOSPIRA INC.
  • INTAS BIOPHARMACEUTICALS LTD
  • JCR PHARMACEUTICALS CO. LTD.
  • キッセイ薬品工業
  • LG LIFE SCIENCES
  • MEDICE ARZNEIMITTEL PUTTER GMBH AND CO. KG
  • MERCK BIOVENTURES
  • MJ BIOPHARM PVT. LTD.
  • MOMENTA PHARMACEUTICALS
  • MYCENAX BIOTECH INC.
  • NANOGEN BIOPHARMACEUTICAL
  • NCPC GENETECH BIOTECHNOLOGY CO. LTD.
  • NEUCLONE
  • 日本化薬
  • PHARMAPARK LLC
  • PLANTFORM CORP.
  • PROBIOMED, S.A. DE C.V.
  • RANBAXY LABORATORIES LTD.
  • RELIANCE LIFE SCIENCES
  • SAMSUNG BIOLOGICS
  • SANDOZ INTERNATIONAL GMBH
  • SCINOPHARM TAIWAN LTD.
  • SOTEX PHARMACEUTICALS
  • STADA ARZNEIMITTEL AG
  • TEVA PHARMACEUTICALS INDUSTRIES LTD
  • TIANJIN HUALIDA BIOTECHNOLOGY LTD
  • USV LIMITED
  • WOCKHARDT LIMITED
  • ZHONGSHANHYGENE BIOPHARMA CO. LTD.

第12章 付録

図表

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目次
Product Code: BIO090B

REPORT HIGHLIGHTS

The global biosimilars market was valued at $1.8 billion in 2013 and nearly $2.0 billion in 2014. The market is expected to reach nearly $4.0 billion by 2019, with a compound annual growth rate (CAGR) of 15% from 2014 through 2019.

This report provides:

  • An overview of the global market for biosimilars.
  • Analyses of global market trends, with data from 2012 through 2014, and projections of CAGRs through 2019.
  • A look at biosimilar product classes in various regions worldwide, as well as the worldwide pipeline for biosimilars.
  • Detailed analysis of the emerging regulatory framework in regulated markets as well as comparisons of biosimilar guidelines in Europe, the U.S., Japan, Canada, and the guidelines developed by WHO.
  • Technology trends and patent analysis.
  • Comprehensive profiles of key players in the market.

SCOPE OF THE STUDY

The scope of this study encompasses biosimilars in pharmaceutical and biotechnology markets. BCC Research analyzes each market and its applications, regulatory environment, technology, market projections, and market shares.

In semi- and unregulated markets, various copies of biologics were sold for many years before the establishment of biosimilar guidelines by the European Medicines Agency (EMA). The regulatory processes are considerably less stringent in less regulated markets as compared to that of EMA; hence, a number of biosimilars are available in these regions. However, manufacturers are now targeting regulated markets, and are adopting various strategies to enter highly regulated markets such as Europe and the U.S. Therefore, the report includes all the products for which EMA has already published guidelines for market authorization or for which guidelines are under development.

This report includes product segments such as somatropin, erythropoietin, colony-stimulating factors (CSFs), interferons, interleukins, insulin and insulin analogues, follicle-stimulating hormones (FSHs), monoclonal antibodies (MAbs) and low-molecular-weight heparins (LMWHs). This report is a comprehensive study on the demand for biosimilar drugs that have entered the market worldwide. Technological issues include the latest trends and developments.

The emerging markets for biosimilars include countries such as India, China, Japan, Korea, Taiwan, Canada, Africa, Australia and New Zealand.

ANALYSTS' CREDENTIALS

A team of professionals in the biotechnology industry carried out this study. The project manager is Shalini S. Dewan, who holds a master's degree in pharmaceutical chemistry and has more than 14 years of industry experience. Among the research topics she has covered are studies on compounds of potential pharmaceutical interest, from ibuprofen to 2-naphthyl acetic acid. She was awarded a Gold Medal by the Prime Minister of India for her work and has worked with top companies in India and in the U.S.

Table of Contents

CHAPTER 1 - INTRODUCTION

  • STUDY OBJECTIVES
  • REASONS FOR DOING THIS STUDY
  • INTENDED AUDIENCE
  • SCOPE OF THE STUDY
  • METHODOLOGY
  • INFORMATION SOURCES
  • ANALYSTS' CREDENTIALS
  • RELATED BCC RESEARCH REPORTS
  • BCC RESEARCH WEBSITE
  • DISCLAIMER

CHAPTER 2 - EXECUTIVE SUMMARY

  • SUMMARY TABLE: GLOBAL REVENUES FOR BIOSIMILARS BY TYPE, THROUGH 2 ($ MILLIONS)
  • SUMMARY FIGURE: GLOBAL REVENUES FOR BIOSIMILARS BY TYPE, 2012-2019 ($ MILLIONS)

CHAPTER 3 - OVERVIEW

  • WHO TERMINOLOGY RELATED TO BIOSIMILARS
    • BIOSIMILAR
    • BIOSIMILARITY
    • COMPARABILITY EXERCISE
    • EQUIVALENT
    • HEAD-TO-HEAD COMPARISON
    • ORIGINATOR PRODUCT
    • PHARMACOVIGILANCE
    • REFERENCE BIOTHERAPEUTIC PRODUCT (RBP)
    • SIMILAR BIOTHERAPEUTIC PRODUCT (SBP)
    • WELL-ESTABLISHED BIOTHERAPEUTIC PRODUCT
  • FDA TERMINOLOGY RELATED TO BIOSIMILARS
    • BIOLOGIC LICENSE APPLICATION (BLA)
    • BIOLOGICAL PRODUCT
    • BIOSIMILAR
    • BRAND NAME
    • THERAPEUTIC BIOLOGICAL PRODUCT
    • THERAPEUTIC EQUIVALENCE (TE)
      • TABLE 1: BIOSIMILARS TERMINOLOGY
    • DIFFERENCES BETWEEN SMALL-MOLECULE DRUGS AND BIOLOGICS
      • TABLE 2: DIFFERENCES BETWEEN SMALL MOLECULES AND BIOLOGICS
    • BIOSIMILARS VERSUS GENERICS
      • TABLE 3: BIOSIMILARS VERSUS SMALL MOLECULE GENERICS
  • MANUFACTURING OF BIOLOGICS
    • NATURAL SOURCING AND EXTRACTION
    • MICROBIAL FERMENTATION
    • TRANSGENICS
    • CELL CULTURE
      • Mammalian Cell Culture
      • Other Cell Culture Systems
  • DEVELOPMENT OF BIOSIMILARS
    • DEVELOPMENT OF A HIGHLY SIMILAR PRODUCT
    • VALIDATING A BIOSIMILAR
  • CLASSES OF APPROVED BIOSIMILARS
    • HUMAN GROWTH HORMONES
      • TABLE 4: BIOSIMILAR HUMAN GROWTH HORMONES
    • GRANULOCYTE COLONY-STIMULATING FACTOR
      • TABLE 5: G-CSF BIOSIMILARS
    • ERYTHROPOIETIN
      • TABLE 6: ERYTHROPOIETIN BIOSIMILARS
    • INSULIN
      • TABLE 7: INSULIN BIOSIMILARS
    • MONOCLONAL ANTIBODIES
      • TABLE 8: MONOCLONAL ANTIBODY BIOSIMILARS
    • FOLLICLE-STIMULATING HORMONE
      • TABLE 9: FSH BIOSIMILAR

CHAPTER 4 - REGULATORY ASPECTS

  • EUROPE REGULATIONS
  • UNITED STATES REGULATIONS
  • BIOSIMILAR REGULATIONS IN EMERGING MARKETS
    • GUIDELINES FOR BIOSIMILAR DEVELOPMENT IN JAPAN
    • GUIDELINES FOR BIOSIMILAR DEVELOPMENT IN INDIA
  • NAMING OF BIOSIMILARS
  • SIGNIFICANT REGULATORY ACTIVITIES
    • TABLE 10: NEW MARKETING AUTHORIZATION OF BIOSIMILARS IN THE EUROPEAN UNION, 2010-AUGUST 2014

CHAPTER 5 - NEW DEVELOPMENTS

  • TABLE 11: COMPANIES WITH BIOSIMILARS IN THE PIPELINE
  • MOST POPULAR BIOSIMILAR TARGETS
    • ADALIMUMAB
      • TABLE 12: HUMIRA (ADALIMUMAB) BIOSIMILARS IN CLINICAL TRIALS
    • INFLIXIMAB
      • TABLE 13: REMICADE (INFLIXIMAB) BIOSIMILARS IN CLINICAL TRIALS
    • RITUXIMAB
      • TABLE 14: RITUXAN (RITUXIMAB) BIOSIMILARS IN CLINICAL TRIALS
    • BEVACIZUMAB
      • TABLE 15: AVASTIN (BEVACIZUMAB) BIOSIMILARS IN CLINICAL TRIALS
    • TRASTUZUMAB
      • TABLE 16: HERCEPTIN (TRASTUZUMAB) BIOSIMILARS IN CLINICAL TRIALS
    • OTHER BIOSIMILARS IN CLINICAL TRIALS
      • TABLE 17 OTHER BIOSIMILARS IN CLINICAL TRIALS

CHAPTER 6 - TECHNOLOGY TRENDS

  • EMERGING TRENDS IN BIOSIMILAR MANUFACTURING PROCESSES
    • EMERGING TRENDS IN ANALYTICAL TECHNOLOGIES
      • TABLE 18: ANALYTICAL METHODS RECOGNIZED BY REGULATORY BODIES FOR COMPARABILITY EXERCISE AND RISK MITIGATION
  • POLYACRYLAMIDE GEL ELECTROPHORESIS (PAGE) AND WESTERN BLOTTING
  • ISOELECTRIC FOCUSING (IEF)/PROTEIN BLOTTING
  • CAPILLARY ZONE ELECTROPHORESIS (CZE)
  • HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC)
  • SPECTROSCOPIC TECHNIQUES
  • MASS SPECTROMETRY (MS)
  • IN VITRO ASSAYS
  • EPITOPE MAPPING
  • DIFFERENTIAL SCANNING CALORIMETRY (DSC)

CHAPTER 7 - MARKET ANALYSIS

  • MARKET BY TYPE
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 19: GLOBAL REVENUES FOR BIOSIMILARS BY TYPE, THROUGH 2019 ($ MILLIONS)
      • FIGURE 1: GLOBAL REVENUES FOR BIOSIMILARS BY TYPE, 2012-2019 ($ MILLIONS)
    • MARKET SHARE
      • TABLE 20: MARKET SHARE OF BIOSIMILARS BY TYPE, IN 2013 (%)
      • FIGURE 2: MARKET SHARE OF BIOSIMILARS BY TYPE, IN 2013 (%)
  • MARKET BY REGION
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 21: GLOBAL REVENUES FOR BIOSIMILARS BY REGION, THROUGH 2019 ($ MILLIONS)
      • FIGURE 3: GLOBAL REVENUES FOR BIOSIMILARS BY REGION, 2012-2019 ($ MILLIONS)
    • MARKET SHARE
      • TABLE 22: MARKET SHARE OF BIOSIMILARS BY REGION, IN 2013 (%)
      • FIGURE 4: MARKET SHARE OF BIOSIMILARS BY REGION, IN 2013 (%)
  • ERYTHROPOIETINS (EPO)
    • Market Overview
    • Market Revenue
      • TABLE 23: REVENUE FOR BIOSIMILAR ERYTHROPOIETINS BY REGION, THROUGH 2019 ($ MILLIONS)
      • FIGURE 5: REVENUE FOR BIOSIMILAR ERYTHROPOIETINS BY REGION, 2012-2019 ($ MILLIONS)
    • Market Share
      • TABLE 24: MARKET SHARE OF BIOSIMILAR ERYTHROPOIETINS BY REGION, 2013 (%)
      • FIGURE 6: MARKET SHARE OF BIOSIMILAR ERYTHROPOIETINS BY REGION, 2013 (%)
  • HUMAN GROWTH HORMONES (HGH)
    • Market Overview
    • Market Revenue
      • TABLE 25: REVENUE FOR BIOSIMILAR HUMAN GROWTH HORMONES BY REGION, THROUGH 2019 ($ MILLIONS)
      • FIGURE 7: REVENUE FOR BIOSIMILAR HUMAN GROWTH HORMONES BY REGION, 2012-2019 ($ MILLIONS)
    • Market Shares
      • TABLE 26: MARKET SHARE OF BIOSIMILAR HUMAN GROWTH HORMONES BY REGION, 2013 (%)
      • FIGURE 8: MARKET SHARE OF BIOSIMILAR HUMAN GROWTH HORMONES BY REGION, 2013 (%)
  • GRANULOCYTE COLONY-STIMULATING FACTORS (G-CSF)
    • Market Overview
    • Market Revenue
      • TABLE 27: REVENUE FOR G-CSF BY REGION, THROUGH 2019 ($ MILLIONS)
      • FIGURE 9: REVENUE FOR G-CSF BY REGION, 2012-2019 ($ MILLIONS)
    • Market Share
      • TABLE 28: MARKET SHARE OF BIOSIMILAR G-CSF BY REGION, IN 2013 (%)
      • FIGURE 10: MARKET SHARE OF BIOSIMILAR G-CSF BY REGION, IN 2013 (%)
  • LOW-MOLECULAR-WEIGHT HEPARIN (LMWH)
    • Market Overview
    • Market Revenue
      • TABLE 29: REVENUE FOR LMWH BY REGION, THROUGH 2019 ($ MILLIONS)
      • FIGURE 11: REVENUE FOR LMWH BY REGION, THROUGH 2019 ($ MILLIONS)
    • Market Share
      • TABLE 30: MARKET SHARE OF BIOSIMILAR LMWH BY REGION, 2013 (%)
      • FIGURE 12: MARKET SHARE OF BIOSIMILAR LMWH BY REGION, 2013 (%)
  • OTHER BIOSIMILARS
    • Market Overview
    • Market Revenue
      • TABLE 31: REVENUE FOR OTHER BIOSIMILARS BY REGION, THROUGH 2019 ($ MILLIONS)
      • FIGURE 13: REVENUE FOR OTHER BIOSIMILARS BY REGION, THROUGH 2019 ($ MILLIONS)
    • Market Share
      • TABLE 32: MARKET SHARE OF OTHER BIOSIMILARS BY REGION, 2013 (%)
      • FIGURE 14: MARKET SHARE OF OTHER BIOSIMILARS BY REGION, 2013 (%)

CHAPTER 8 - INDUSTRY STRUCTURE

  • ERYTHROPOIETINS
    • MARKET LEADERS
      • TABLE 33: LEADING MANUFACTURERS/ SUPPLIERS OF ERYTHROPOIETIN (EPO) BIOSIMILARS, 2013
    • MARKET SHARE
      • TABLE 34: MARKET SHARES OF MANUFACTURERS/SUPPLIERS FOR EPO BIOSIMILARS, 2013 (%)
      • FIGURE 15: MARKET SHARES OF MANUFACTURERS/SUPPLIERS FOR EPO BIOSIMILARS, 2013 (%)
  • HUMAN GROWTH HORMONES
    • MARKET LEADERS
      • TABLE 35: LEADING MANUFACTURERS/SUPPLIERS OF HUMAN GROWTH HORMONES (HGH) BIOSIMILARS, 2013
    • MARKET SHARE
      • TABLE 36: MARKET SHARES OF MANUFACTURERS/SUPPLIERS FOR HGH BIOSIMILARS, 2013 (%)
      • FIGURE 16: MARKET SHARES OF MANUFACTURERS/SUPPLIERS FOR HGH BIOSIMILARS, 2013 (%)
  • GRANULOCYTE COLONY-STIMULATING FACTOR
    • MARKET LEADERS
      • TABLE 37: LEADING MANUFACTURERS/ SUPPLIERS OF G-CSF BIOSIMILARS, 2013
    • MARKET SHARE
      • TABLE 38: MARKET SHARES OF MANUFACTURERS/ SUPPLIERS FOR G-CSF BIOSIMILARS, 2013 (%)
      • FIGURE 17: MARKET SHARES OF MANUFACTURERS/ SUPPLIERS FOR G-CSF BIOSIMILARS, 2013 (%)
  • LOW-MOLECULAR-WEIGHT HEPARINS
    • MARKET LEADERS
      • TABLE 39: LEADING MANUFACTURERS/SUPPLIERS OF LMWH BIOSIMILARS, 2013
    • MARKET SHARES
      • TABLE 40: MARKET SHARES OF MANUFACTURERS/SUPPLIERS FOR LMWH BIOSIMILARS, 2013 (%)
      • FIGURE 18: MARKET SHARES OF MANUFACTURERS/ SUPPLIERS FOR LMWH BIOSIMILARS, 2013 (%)
  • OTHER BIOSIMILARS
    • MARKET LEADERS
      • TABLE 41: LEADING MANUFACTURERS/SUPPLIERS OF OTHER BIOSIMILARS, 2013
    • MARKET SHARES
      • TABLE 42: MARKET SHARES OF MANUFACTURERS/SUPPLIERS FOR OTHER BIOSIMILARS, 2013 (%)
      • FIGURE 19: MARKET SHARES OF MANUFACTURERS/ SUPPLIERS FOR OTHER BIOSIMILARS, 2013 (%)

CHAPTER 9 - PATENT ANALYSIS

  • UNITED STATES PATENTS
    • PATENTS BY YEAR
      • TABLE 43: NUMBER OF SIGNIFICANT PATENTS BY YEAR, JANUARY 2010-AUGUST 2014
      • FIGURE 20: NUMBER OF SIGNIFICANT PATENTS BY YEAR, JANUARY 2010-AUGUST 2014
    • PATENTS BY TYPE/CATEGORY
      • TABLE 44: NUMBER OF U.S. PATENTS BY CATEGORY, JANUARY 2010-AUGUST 2014
      • FIGURE 21: NUMBER OF U.S. PATENTS BY CATEGORY, JANUARY 2010-AUGUST 2014
    • PATENTS BY COMPANY
      • TABLE 45: NUMBER OF U.S. PATENTS BY COMPANY, JANUARY 2010-AUGUST 2014
    • PATENTS BY COUNTRY
      • TABLE 46: NUMBER OF U.S. PATENTS BY COUNTRY, JANUARY 2010-AUGUST 2014
      • TABLE 47: PATENT SHARES BY COUNTRY, JANUARY 2010-AUGUST 2014 (NO./%)
      • FIGURE 22: PATENT SHARES BY COUNTRY, JANUARY 2010-AUGUST 2014 (%)
  • EUROPEAN PATENTS
    • PATENTS BY YEAR
      • TABLE 48: NUMBER OF SIGNIFICANT PATENTS BY YEAR, JANUARY 2010-AUGUST 2014
      • FIGURE 23: NUMBER OF SIGNIFICANT PATENTS BY YEAR, JANUARY 2010-AUGUST 2014
    • PATENTS BY TYPE/ CATEGORY
      • TABLE 49: NUMBER OF PATENTS BY CATEGORY, JANUARY 2010-AUGUST 2014
    • PATENTS BY COMPANY
      • TABLE 50: NUMBER OF PATENTS BY COMPANY, JANUARY 2010-AUGUST 2014
    • PATENTS BY COUNTRY
      • TABLE 51: NUMBER OF PATENTS BY COUNTRY, JANUARY 2010-AUGUST 2014
      • TABLE 52: PATENT SHARES BY COUNTRY, JANUARY 2010-AUGUST 2014 (NO./%)
      • FIGURE 24: PATENT SHARES BY COUNTRY, JANUARY 2010-AUGUST 2014 (%)

CHAPTER 10 - CURRENT SITUATION

  • INCREASING DISEASE BURDEN DRIVING THE MARKET
  • AGING POPULATION
  • STRONG GOVERNMENT SUPPORT
  • PATENT EXPIRATION
    • TABLE 53: SIGNIFICANT PATENT EXPIRATIONS OF BIOLOGICS
  • COLLABORATIONS/ PARTNERSHIPS
  • ELECTRONIC COMPANIES ENTERING THE BIOSIMILARS SECTOR WITH SIGNIFICANT INVESTMENTS
  • MARKET FACTORS IN EMERGING MARKETS
    • LESS STRINGENT REGULATORY REQUIREMENTS
    • COMPETITION
    • HIGH COST AND AVAILABILITY ISSUES
    • LACK OF EXPERTISE IN THE PRODUCTION OF HIGHLY DEMANDING PRODUCTS SUCH AS MONOCLONAL ANTIBODIES
    • RISING INVESTMENTS IN INDIAN BIOSIMILARS SECTOR

CHAPTER 11 - COMPANY PROFILES

  • 3SBIO INC.
  • ACTAVIS INC. LTD.
  • AMOYTOP BIOTECH CO., LTD.
  • ANHUI ANKE BIOTECHNOLOGY (GROUP) CO. LTD.
  • APOTEX INC.
  • AVESTHAGEN LIMITED
  • BHARAT SERUMS AND VACCINES LTD.
  • BIOCON LTD.
  • BIOXPRESS THERAPEUTICS SA
  • BIOTON S. A.
  • BLAU FARMACEUTICA S/A
  • BOEHRINGER INGELHEIM
  • CELLTRION GROUP
  • CHINA NATIONAL BIOTECH CORP. (CNBC)
  • CIPLA LIMITED
  • CINNAGEN
  • CJSC BIOCAD
  • DONG-A PHARMACEUTICAL CO. LTD.
  • DR. REDDY'S LABORATORIES LTD.
  • EMCURE PHARMACEUTICALS LTD.
  • FERON LIMITED
  • FINOX BIOTECH
  • FUJIFILM DIOSYNTH BIOTECHNOLOGIES
  • GEDEON RICHTER PLC
  • GENESCIENCE PHARMACEUTICALS CO. LTD.
  • GENEXINE INC.
  • GH GENHELIX S A
  • GREEN CROSS LIFE SCIENCE CORP.
  • HANALL PHARMACEUTICALS
  • HANGZHOU JIUYUAN GENE ENGINEERING CO. LTD.
  • HANWHA CHEMICAL CORP.
  • HOSPIRA INC.
  • INTAS BIOPHARMACEUTICALS LTD
  • JCR PHARMACEUTICALS CO. LTD.
  • KISSEI PHARMACEUTICAL CO. LTD.
  • LG LIFE SCIENCES
  • MEDICE ARZNEIMITTEL PUTTER GMBH AND CO. KG
  • MERCK BIOVENTURES
  • MJ BIOPHARM PVT. LTD.
  • MOMENTA PHARMACEUTICALS
  • MYCENAX BIOTECH INC.
  • NANOGEN BIOPHARMACEUTICAL
  • NCPC GENETECH BIOTECHNOLOGY CO. LTD.
  • NEUCLONE
  • NIPPON KAYAKU CO. LTD.
  • PHARMAPARK LLC
  • PLANTFORM CORP.
  • PROBIOMED, S.A. DE C.V.
  • RANBAXY LABORATORIES LTD.
  • RELIANCE LIFE SCIENCES
  • SAMSUNG BIOLOGICS
  • SANDOZ INTERNATIONAL GMBH
  • SCINOPHARM TAIWAN LTD.
  • SOTEX PHARMACEUTICALS
  • STADA ARZNEIMITTEL AG
  • TEVA PHARMACEUTICALS INDUSTRIES LTD
  • TIANJIN HUALIDA BIOTECHNOLOGY LTD
  • USV LIMITED
  • WOCKHARDT LIMITED
  • ZHONGSHANHYGENE BIOPHARMA CO. LTD.

CHAPTER 12 - APPENDIX I-ABBREVIATIONS

LIST OF TABLES

  • SUMMARY TABLE GLOBAL REVENUES FOR BIOSIMILARS BY TYPE, THROUGH 2019 ($ MILLIONS)
    • TABLE 1: BIOSIMILARS TERMINOLOGY
    • TABLE 2: DIFFERENCES BETWEEN SMALL MOLECULES AND BIOLOGICS
    • TABLE 3: BIOSIMILARS VERSUS SMALL MOLECULE GENERICS
    • TABLE 4: BIOSIMILAR HUMAN GROWTH HORMONES
    • TABLE 5: G-CSF BIOSIMILARS
    • TABLE 6: ERYTHROPOIETIN BIOSIMILARS
    • TABLE 7: INSULIN BIOSIMILARS
    • TABLE 8: MONOCLONAL ANTIBODY BIOSIMILARS
    • TABLE 9: FSH BIOSIMILAR
    • TABLE 10: NEW MARKETING AUTHORIZATION OF BIOSIMILARS IN THE EUROPEAN UNION, 2010-AUGUST 2014
    • TABLE 11: COMPANIES WITH BIOSIMILARS IN THE PIPELINE
    • TABLE 12: HUMIRA (ADALIMUMAB) BIOSIMILARS IN CLINICAL TRIALS
    • TABLE 13: REMICADE (INFLIXIMAB) BIOSIMILARS IN CLINICAL TRIALS
    • TABLE 14: RITUXAN (RITUXIMAB) BIOSIMILARS IN CLINICAL TRIALS
    • TABLE 15: AVASTIN (BEVACIZUMAB) BIOSIMILARS IN CLINICAL TRIALS
    • TABLE 16: HERCEPTIN (TRASTUZUMAB) BIOSIMILARS IN CLINICAL TRIALS
    • TABLE 17: OTHER BIOSIMILARS IN CLINICAL TRIALS
    • TABLE 18: ANALYTICAL METHODS RECOGNIZED BY REGULATORY BODIES FOR COMPARABILITY EXERCISE AND RISK MITIGATION
    • TABLE 19: GLOBAL REVENUES FOR BIOSIMILARS BY TYPE, THROUGH 2019 ($ MILLIONS)
    • TABLE 20: MARKET SHARE OF BIOSIMILARS BY TYPE, IN 2013 (%)
    • TABLE 21: GLOBAL REVENUES FOR BIOSIMILARS BY REGION, THROUGH 2019 ($ MILLIONS)
    • TABLE 22: MARKET SHARE OF BIOSIMILARS BY REGION, IN 2013 (%)
    • TABLE 23: REVENUE FOR BIOSIMILAR ERYTHROPOIETINS BY REGION, THROUGH 2019 ($ MILLIONS)
    • TABLE 24: MARKET SHARE OF BIOSIMILAR ERYTHROPOIETINS BY REGION, 2013 (%)
    • TABLE 25: REVENUE FOR BIOSIMILAR HUMAN GROWTH HORMONES BY REGION, THROUGH 2019 ($ MILLIONS)
    • TABLE 26: MARKET SHARE OF BIOSIMILAR HUMAN GROWTH HORMONES BY REGION, 2013 (%)
    • TABLE 27: REVENUE FOR G-CSF BY REGION, THROUGH 2019 ($ MILLIONS)
    • TABLE 28: MARKET SHARE OF BIOSIMILAR G-CSF BY REGION, IN 2013 (%)
    • TABLE 29: REVENUE FOR LMWH BY REGION, THROUGH 2019 ($ MILLIONS)
    • TABLE 30: MARKET SHARE OF BIOSIMILAR LMWH BY REGION, 2013 (%)
    • TABLE 31: REVENUE FOR OTHER BIOSIMILARS BY REGION, THROUGH 2019 ($ MILLIONS)
    • TABLE 32: MARKET SHARE OF OTHER BIOSIMILARS BY REGION, 2013 (%)
    • TABLE 33: LEADING MANUFACTURERS/ SUPPLIERS OF ERYTHROPOIETIN (EPO) BIOSIMILARS, 2013
    • TABLE 34: MARKET SHARES OF MANUFACTURERS/SUPPLIERS FOR EPO BIOSIMILARS, 2013 (%)
    • TABLE 35: LEADING MANUFACTURERS/SUPPLIERS OF HUMAN GROWTH HORMONES (HGH) BIOSIMILARS, 2013
    • TABLE 36: MARKET SHARES OF MANUFACTURERS/SUPPLIERS FOR HGH BIOSIMILARS, 2013 (%)
    • TABLE 37: LEADING MANUFACTURERS/ SUPPLIERS OF G-CSF BIOSIMILARS, 2013
    • TABLE 38: MARKET SHARES OF MANUFACTURERS/ SUPPLIERS FOR G-CSF BIOSIMILARS, 2013 (%)
    • TABLE 39: LEADING MANUFACTURERS/SUPPLIERS OF LMWH BIOSIMILARS, 2013
    • TABLE 40: MARKET SHARES OF MANUFACTURERS/SUPPLIERS FOR LMWH BIOSIMILARS, 2013 (%)
    • TABLE 41: LEADING MANUFACTURERS/SUPPLIERS OF OTHER BIOSIMILARS, 2013
    • TABLE 42: MARKET SHARES OF MANUFACTURERS/SUPPLIERS FOR OTHER BIOSIMILARS, 2013 (%)
    • TABLE 43: NUMBER OF SIGNIFICANT PATENTS BY YEAR, JANUARY 2010-AUGUST 2014
    • TABLE 44: NUMBER OF U.S. PATENTS BY CATEGORY, JANUARY 2010-AUGUST 2014
    • TABLE 45: NUMBER OF U.S. PATENTS BY COMPANY, JANUARY 2010-AUGUST 2014
    • TABLE 46: NUMBER OF U.S. PATENTS BY COUNTRY, JANUARY 2010-AUGUST 2014
    • TABLE 47: PATENT SHARES BY COUNTRY, JANUARY 2010-AUGUST 2014 (NO./%)
    • TABLE 48: NUMBER OF SIGNIFICANT PATENTS BY YEAR, JANUARY 2010-AUGUST 2014
    • TABLE 49: NUMBER OF PATENTS BY CATEGORY, JANUARY 2010-AUGUST 2014
    • TABLE 50: NUMBER OF PATENTS BY COMPANY, JANUARY 2010-AUGUST 2014
    • TABLE 51: NUMBER OF PATENTS BY COUNTRY, JANUARY 2010-AUGUST 2014
    • TABLE 52: PATENT SHARES BY COUNTRY, JANUARY 2010-AUGUST 2014 (NO./%)
    • TABLE 53: SIGNIFICANT PATENT EXPIRATIONS OF BIOLOGICS

LIST OF FIGURES

  • SUMMARY FIGURE GLOBAL REVENUES FOR BIOSIMILARS BY TYPE, 2012-2019 ($ MILLIONS)
    • FIGURE 1: GLOBAL REVENUES FOR BIOSIMILARS BY TYPE, 2012-2019 ($ MILLIONS)
    • FIGURE 2: MARKET SHARE OF BIOSIMILARS BY TYPE, IN 2013 (%)
    • FIGURE 3: GLOBAL REVENUES FOR BIOSIMILARS BY REGION, 2012-2019 ($ MILLIONS)
    • FIGURE 4: MARKET SHARE OF BIOSIMILARS BY REGION, IN 2013 (%)
    • FIGURE 5: REVENUE FOR BIOSIMILAR ERYTHROPOIETINS BY REGION, 2012-2019 ($ MILLIONS)
    • FIGURE 6: MARKET SHARE OF BIOSIMILAR ERYTHROPOIETINS BY REGION, 2013 (%)
    • FIGURE 7: REVENUE FOR BIOSIMILAR HUMAN GROWTH HORMONES BY REGION, 2012-2019 ($ MILLIONS)
    • FIGURE 8: MARKET SHARE OF BIOSIMILAR HUMAN GROWTH HORMONES BY REGION, 2013 (%)
    • FIGURE 9: REVENUE FOR G-CSF BY REGION, 2012-2019 ($ MILLIONS)
    • FIGURE 10: MARKET SHARE OF BIOSIMILAR G-CSF BY REGION, IN 2013 (%)
    • FIGURE 11: REVENUE FOR LMWH BY REGION, THROUGH 2019 ($ MILLIONS)
    • FIGURE 12: MARKET SHARE OF BIOSIMILAR LMWH BY REGION, 2013 (%)
    • FIGURE 13: REVENUE FOR OTHER BIOSIMILARS BY REGION, THROUGH 2019 ($ MILLIONS)
    • FIGURE 14: MARKET SHARE OF OTHER BIOSIMILARS BY REGION, 2013 (%)
    • FIGURE 15: MARKET SHARES OF MANUFACTURERS/SUPPLIERS FOR EPO BIOSIMILARS, 2013 (%)
    • FIGURE 16: MARKET SHARES OF MANUFACTURERS/SUPPLIERS FOR HGH BIOSIMILARS, 2013 (%)
    • FIGURE 17: MARKET SHARES OF MANUFACTURERS/ SUPPLIERS FOR G-CSF BIOSIMILARS, 2013 (%)
    • FIGURE 18: MARKET SHARES OF MANUFACTURERS/ SUPPLIERS FOR LMWH BIOSIMILARS, 2013 (%)
    • FIGURE 19: MARKET SHARES OF MANUFACTURERS/ SUPPLIERS FOR OTHER BIOSIMILARS, 2013 (%)
    • FIGURE 20: NUMBER OF SIGNIFICANT PATENTS BY YEAR, JANUARY 2010-AUGUST 2014
    • FIGURE 21: NUMBER OF U.S. PATENTS BY CATEGORY, JANUARY 2010-AUGUST 2014
    • FIGURE 22: PATENT SHARES BY COUNTRY, JANUARY 2010-AUGUST 2014 (%)
    • FIGURE 23: NUMBER OF SIGNIFICANT PATENTS BY YEAR, JANUARY 2010-AUGUST 2014
    • FIGURE 24: PATENT SHARES BY COUNTRY, JANUARY 2010-AUGUST 2014 (%)
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