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市場調査レポート

生物学的治療薬:技術および世界市場

Biologic Therapeutic Drugs: Technologies and Global Markets

発行 BCC Research 商品コード 144345
出版日 ページ情報 英文 172 Pages
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生物学的治療薬:技術および世界市場 Biologic Therapeutic Drugs: Technologies and Global Markets
出版日: 2015年01月01日 ページ情報: 英文 172 Pages
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概要

生物製剤またはバイオ医薬品による治療は実に多岐に渡っており、将来の医薬の発展および産業の発展に重要な意味合いを持っています。有効な戦略を持った企業には市場機会が開かれています。市場成長は、より広範なパイプラインを求める医薬品事業者のニーズや、困難な疾患に対する標的の存在、バイオシミラーとコストを削減し収益性の高い製品の製造を実現する技術を追求する企業の取り組みなどによってもたらされています。

当レポートでは、世界の生物学的治療薬の技術および市場について調査分析し、生物学的治療薬の産業構造と主な薬剤クラス、製品カテゴリー別の市場予測、主要企業および製品の収益実績、バイオシミラーの影響分析、パイプラインおよび臨床試験の動向、製造プロセスおよび技術の動向、主要企業のプロファイルなどをまとめてお届けします。

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

  • 生物製剤:疾患治療の新製品
  • モノクローナル抗体
  • 治療用タンパク質
  • 主な生物製剤のクラス
  • RNAiの課題
  • オーファンドラッグ指定

第4章 バイオ医薬品産業と競合分析

  • 産業構造
  • バイオテクノロジーの起源
  • 大手製薬会社の参入

第5章 生物製剤市場の概要

  • バイオ医薬品売上上位25製品
  • FDA 認可の生物製剤(上半期)
  • 売上ベスト25医薬品(前年度)
  • モノクローナル抗体
  • 大手製薬会社とバイオ医薬品事業者
  • 大手製薬会社のコンソーシウム
  • 治療用タンパク質

第6章 バイオシミラーの生物製剤市場に与える影響

  • バイオシミラーの生物製剤市場に与える影響
  • バイオシミラーの開発の根拠
  • バイオシミラーのもたらす市場機会と脅威
  • 市場動向:成長推進因子・阻害因子
  • バイオシミラー:最新の法規制状況

第7章 バイオシミラーおよび生物製剤の主要企業

  • モノクローナル抗体
  • 治療用タンパク質
  • ワクチン

第8章 生物製剤市場の地理的分布

  • 地域市場

第9章 パイプライン分析

第10章 生物製剤の臨床試験

  • 癌治療用生物製剤
  • 胃腸関連の疾患
  • 神経疾患

第11章 生物製剤部門のM&A

第12章 生物製剤の特許

  • モノクローナル抗体
  • 治療用タンパク質
  • ワクチン

第13章 生物製剤の製造

  • 生物製剤の製造
  • バイオ医薬品製造プロセス
  • 哺乳類細胞治療用タンパク質の製造
  • 新しい製造プロセス
  • トランスジェニックタンパク質の製造システム

第14章 企業プロファイル

図表

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目次
Product Code: BIO079C

The global biologics market totaled $200.6 billion in 2013 and is expected to grow to nearly $234 billion in 2014. The total market is expected to grow to $386.7 billion by the end of 2019 at compound annual growth rate (CAGR) of 10.6%.

This report provides:

  • An overview of the global market for biologic therapeutic drugs
  • Analyses of global market trends, with data from 2013, estimates for 2014, and projections of compound annual growth rates (CAGRs) through 2019
  • Coverage of large market segments such as monoclonal antibodies (mAb), therapeutic proteins, and vaccines
  • Examination of the competitive environment with a special focus on how new products and technologies are influencing the current standard of care
  • Comprehensive profiles of current market leaders, as well as companies with innovative products poised to advance within the forecast period.

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REPORT SCOPE

SCOPE OF REPORT

Current and projected product forecasts during the forecast period (2014 to 2019) are discussed. In addition, new products approved in 2013 and 2014 by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), as well as those products expected to be approved within the forecast period are projected within their respective segment. Figures for 2014 are projected estimates, except where actual results have been reported due to the release timing of the report. For large markets segments such as monoclonal antibodies (mAb), therapeutic proteins and vaccines, specific mechanisms of action are discussed in detail. For example, the trend of increased use of vascular endothelial growth factor (VEGF) inhibitors as a first-line therapy for multiple disease states such as colorectal cancer and the ophthalmic disease wet age-related macular degeneration (AMD) are discussed.

The report includes analysis of leading and emerging competitors in the current worldwide market. Profiles of manufacturers of leading products as well as biotechnology companies with novel products in development are analyzed to define their specific product strategies employed. This report also assesses companies poised to introduce products during the forecast period and discusses how these introductions will change the face of the competitive environment. The competitive environment is examined with a special focus on how new products and technologies are influencing the current standard of care. Detailed profiles of current market leaders are discussed, as well as companies with innovative products poised to advance within the forecast period.

Market figures are based on revenues at the manufacturers' level and are projected at 2014 dollar value. Inflation is not computed into the projection figures. Trends are assessed based on projected sales for existing products, new product introductions, expanded indications for existing products, and projected changes in the prevalence, diagnosis, and scripting rates for certain diseases.

Included in this report are forecasts by product, product category and by company from 2014 through 2019. The study is arranged to offer an overview of the biologics market accompanied by product, company, geography and mechanism of action with forecasts broken down and covered by geographic region or country. The revenues stated in the tables represent only actual sales of biologic drug products. They do not contain revenues from reagents, special administration equipment/devices, or other services associated with the use of the drug. Virtually the entire globe is covered to include prevalence data for each disease subsegment.

Excluded from this report are over-the-counter (OTC) medications and other consumables that do not require a physician's prescription.

Sales figures are reported in U.S. dollars and in each case reflect currency fluctuations within the performance of revenue change. Revenue figures do not account for variation in local currencies.

All market share data presented are on a global basis unless specifically noted.

DISCLAIMER

The information developed in this report is intended to be as reliable as possible at the time of publication and is of a professional nature. This information does not constitute managerial, legal or accounting advice, nor should it be considered as a corporate policy guide, laboratory manual or an endorsement of any product, as much of the information is speculative in nature. BCC Research and the author assume no responsibility for any loss or damage that might result from reliance on the reported information or from its use.

Table of Contents

CHAPTER 1 INTRODUCTION

  • STUDY GOALS AND OBJECTIVES
  • REASONS FOR DOING THE STUDY
  • SCOPE OF REPORT
  • INTENDED AUDIENCE
  • METHODOLOGY AND INFORMATION SOURCES
  • ANALYST'S CREDENTIALS
  • RELATED BCC RESEARCH REPORTS
  • BCC RESEARCH WEBSITE
  • DISCLAIMER

CHAPTER 2 EXECUTIVE SUMMARY

  • SUMMARY TABLE GLOBAL BIOLOGICS MARKET FORECAST BY TYPE OF PRODUCT, THROUGH 2019 ($ MILLIONS)
  • SUMMARY FIGURE GLOBAL BIOLOGICS MARKET FORECAST BY TYPE OF PRODUCT, 2012-2019 ($ MILLIONS)

CHAPTER 3 OVERVIEW

  • BIOLOGICS NEW PRODUCTS IN DISEASE TREATMENT
  • TABLE 1 SUBCLASSES OF BIOLOGICS DRUGS
  • MONOCLONAL ANTIBODIES
  • FIGURE 1 DIAGRAM OF TYPICAL ANTIBODY STRUCTURE
  • THERAPEUTIC PROTEINS
    • HEMOPOIETIC GROWTH FACTORS (HGFS)
      • Cytokines
      • Blood Factors
    • VACCINES
      • Traditional Vaccines
      • Novel Vaccine Technologies
      • Nanoparticle Delivery of Vaccines
  • MAJOR BIOLOGICS PRODUCT CLASSES
  • TABLE 2 MONOCLONAL ANTIBODY AND THERAPEUTIC PROTEIN DRUGS SUBCLASSES
  • TABLE 3 GLOBAL BIOLOGICS MARKET REVENUE, THROUGH 2019 ($ MILLIONS)
  • CHALLENGES WITH RNAI
  • ORPHAN DRUG DESIGNATION

CHAPTER 4 BIOPHARMACEUTICAL INDUSTRY AND COMPETITIVE ANALYSIS

  • BIOPHARMACEUTICAL INDUSTRY STRUCTURE
  • THE ORIGINS OF BIOTECHNOLOGY
  • INVOLVEMENT OF LARGE PHARMACEUTICAL COMPANIES

CHAPTER 5 BIOLOGICS MARKET OVERVIEW 2

  • TABLE 4 MAJOR PHARMA/BIOPHARMA PLAYERS BY REVENUE, 2013 ($ MILLIONS)
  • TABLE 5 FDA CLEARED BIOPHARMACEUTICAL PRODUCTS AS OF 2013
  • TOP 25 BIOPHARMACEUTICAL PRODUCT REVENUES
  • TABLE 6 GLOBAL TOP 25 REVENUE GENERATING BIOPHARMACEUTICAL PRODUCTS, 2011-2013 ($MILLIONS)
  • FDA APPROVED BIOLOGICALS FIRST HALF 2014
  • TABLE 7 FDA APPROVED BIOLOGICALS, JAN. TO JULY 2014
  • TOP 25 BEST SELLING DRUGS 2013
  • TABLE 8 TOP 25 BEST SELLING DRUGS, 2013 ($ MILLIONS)
  • MONOCLONAL ANTIBODIES
  • TABLE 9 GLOBAL MARKET FORECAST FOR MABS, THROUGH 2019 ($ MILLIONS)
  • TABLE 10 TOP FIVE LEADING MONOCLONAL ANTIBODY PRODUCTS, 2013 ($ MILLIONS)
  • TABLE 11 VOLUME OF MAMMALIAN CELL CULTURE PRODUCED MABS, 2014 AND 2019
    • CONJUGATED ANTIBODIES
    • ANTIBODY FRAGMENTS
  • LARGE PHARMACEUTICAL COMPANIES AND BIOPHARMA
  • LARGE PHARMACEUTICAL COMPANY CONSORTIUM FORMED
  • THERAPEUTIC PROTEINS
  • TABLE 12 REVENUE FOR THERAPEUTIC PROTEINS SEGMENT OF BIOLOGICS MARKET, THROUGH 2019 ($ MILLIONS)
    • HEMOPOIETIC GROWTH FACTORS
    • TABLE 13 LEADING HEMOPOIETIC GROWTH FACTOR BIOLOGIC PRODUCTS, 2013 ($ MILLIONS)
      • Hemopoietic Growth Factor Clinical Trials
      • TABLE 14 CLINICAL TRIALS ON G-CSF RECEPTORS, 2013-2014
    • CYTOKINES
      • Cytokine Clinical Trials
      • TABLE 15 CLINICAL TRIALS ON CYTOKINES IN 2013 AND 2014
    • ANTIHEMOPHILIA PRODUCTS
    • TABLE 16 TOP REVENUE-GENERATING THERAPEUTIC PROTEIN PRODUCTS, 2013 ($ MILLIONS)
    • VACCINES
      • Vaccine Market Revenues
      • TABLE 17 VACCINE REVENUES, THROUGH 2019 ($ MILLIONS)
      • Vaccine Clinical Trials
      • TABLE 18 CLINICAL TRIALS ON VACCINES, 2013-2014

CHAPTER 6 IMPACT OF BIOSIMILAR DRUGS ON BIOLOGICS MARKET

  • IMPACT OF BIOSIMILAR DRUGS ON BIOLOGICS MARKET
  • TABLE 19 PATENT AND MARKETING EXCLUSIVITY EXPIRATION FOR TOP SELLING BIOLOGICS, 2009-2018
  • TABLE 20 NUMBER OF BIOSIMILARS PREDICTED TO BE LAUNCHED DURING 2014-2019
  • TABLE 21 TOP 10 BIOLOGICS DRUGS IN WITH GREATEST LEVEL OF BIOSIMILAR COMPETITION, 2013 ($ MILLIONS)
  • RATIONALE FOR BIOSIMILAR DEVELOPMENT
    • ERYTHROPOIETIN
    • GRANULOCYTE-COLONY STIMULATING FACTOR
    • INTERFERONS
    • HUMAN GROWTH HORMONE
  • OPPORTUNITY AND THREAT FROM BIOSIMILARS
  • MARKET TRENDS: GROWTH DRIVERS AND RESISTORS
  • BIOSIMILARS: REGULATORY UPDATE
    • U.S. FDA
    • EUROPEAN BIOSIMILAR REGULATORY GUIDANCE
      • Comparability Testing
      • Potential Problems

CHAPTER 7 MAJOR PLAYERS IN BIOLOGIC AND BIOSIMILARS DRUG MARKET

  • MONOCLONAL ANTIBODIES
  • TABLE 22 TOP 10 SELLING MABS, 2013 ($ MILLIONS)
  • TABLE 23 MAJOR PLAYERS IN MAB MARKET, BY REVENUE, 2013 ($ MILLIONS)
  • THERAPEUTIC PROTEINS
  • TABLE 24 TOP 10 THERAPEUTIC PROTEIN PRODUCTS, 2013 ($ MILLIONS)
  • TABLE 25 MAJOR PLAYERS IN THE THERAPEUTIC PROTEINS MARKET BY REVENUE, 2013 ($ MILLIONS)
  • VACCINES
  • TABLE 26 TOP 10 VACCINES BY REVENUE, 2013 ($ MILLIONS)

CHAPTER 8 GEOGRAPHIC DISTRIBUTION OF BIOLOGICS MARKET

  • GEOGRAPHIC MARKET ANALYSIS

CHAPTER 9 PIPELINE ANALYSIS

  • TABLE 27 NEW BIOLOGIC DRUGS APPROVED, 2014
  • TABLE 28 BIOLOGIC DRUGS OBTAINING FDA APPROVAL, 2011-2013
  • BIOSIMILAR DRUGS
  • TABLE 29 RECENT EMA APPROVED BIOSIMILAR DRUGS
  • BIOLOGICS/BIOSIMILARS IN COMPANY PIPELINES, 2013
    • AMGEN
    • TABLE 30 AMGEN BIOLOGICS PIPELINE, 2013
    • TABLE 31 MARKETED AMGEN BIOLOGICALS
    • SANDOZ PHARMACEUTICALS
    • TABLE 32 SANDOZ BIOLOGICS PIPELINE, 2013
    • RELIANCE LIFE SCIENCES
    • TABLE 33 RELIANCE LIFE SCIENCES PIPELINE, 2013
    • BOEHRINGER INGELHEIM
    • TABLE 34 BOEHRINGER INGELHEIM BIOLOGICS PIPELINE, 2013
    • MERCK
    • TABLE 35 MERCK BIOLOGICS PIPELINE, 2013
    • PFIZER
    • TABLE 36 PFIZER BIOLOGICS PIPELINE, 2013
    • SAMSUNG BIOEPIS
    • TABLE 37 SAMSUNG BIOEPIS BIOLOGICS PIPELINE, 2013
    • CLINICAL TRIALS ON BIOLOGICS/BIOSIMILARS
    • TABLE 38 BIOLOGICAL/BIOSIMILAR DRUGS IN CLINICAL TRIALS, 2013-2014

CHAPTER 10 BIOLOGICS CLINICAL TRIALS

  • TABLE 39 DESCRIPTION OF PHASES OF CLINICAL TRIALS REQUIRED FOR NEW DRUG APPROVAL (PERCENTAGE SUCCESS RATE)
  • CANCER BIOLOGIC DRUGS
  • TABLE 40 LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR CANCER TREATMENT, 2013-2014
  • GASTROINTESTINAL AND RELATED DISEASES
  • TABLE 41 LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR GI AND RELATED DISEASE TREATMENT, 2013-2014
  • NEUROLOGICAL DISEASE
  • TABLE 42 LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR NEUROLOGICAL DISEASE TREATMENT, 2013-2014

CHAPTER 11 MERGERS AND ACQUISITIONS IN BIOLOGICS AREA

  • TABLE 43 LICENSING, DEVELOPMENT AGREEMENTS, ACQUISITIONS AND PARTNERSHIPS IN BIOLOGICS, 2014 (YTD)
  • TABLE 44 LICENSING, DEVELOPMENT AGREEMENTS, ACQUISITIONS AND PARTNERSHIPS IN BIOLOGICS, 2013

CHAPTER 12 PATENTS FOR BIOLOGIC DRUGS

  • MONOCLONAL ANTIBODY PATENTS
  • TABLE 45 U.S. PATENTS FOR MONOCLONAL ANTIBODIES
  • THERAPEUTIC PROTEIN PATENTS
  • TABLE 46 PATENTS ISSUED FOR THERAPEUTIC PROTEINS
  • VACCINE PATENTS
  • TABLE 47 PATENTS ISSUED FOR VACCINES (OR VACCINE RELATED PRODUCTS) ASSOCIATED WITH BIOLOGICALS

CHAPTER 13 BIOLOGICS MANUFACTURING

  • BIOLOGICS MANUFACTURING
  • BIOPHARMACEUTICAL MANUFACTURING PROCESS
    • THE PREPARATION PROCESS
      • Cell Banking and Seed Culture
      • Production
      • Cell Culture Formats
      • Batch and Continuous Processing
      • Perfusion and Fed-Batch Mode
      • TABLE 48 BIOLOGICS PRODUCTS USING PERFUSION METHOD
      • Perfusion Methods
      • Fed-Batch Methods
      • TABLE 49 BIOLOGICS THERAPEUTIC PRODUCTS USING FED-BATCH METHOD
      • Harvest and Concentration
    • THE FINISHING PROCESS
    • PURIFICATION OF BIOPHARMACEUTICALS
    • AUTOMATED PROCESSING SYSTEMS-SKIDS
    • FORMULATION
      • Lyophilization
      • Cryogranulation
      • Spray Drying
      • Undercooling
    • PROCESS INTEGRATION: THE CRITICAL ACTIVITY
    • EXPRESSION SYSTEMS FOR THERAPEUTIC PROTEIN PRODUCTION
    • MICROBIAL THERAPEUTIC PROTEIN PRODUCTION
    • E. COLI ADVANTAGES FOR MICROBIAL PRODUCTION
      • Fast Accumulation
      • Safety Advantage
      • Growth on Inexpensive Carbon Sources
      • Propensity for High-Cell-Density Fermentations
      • Simple Process Scale-Up
      • TABLE 50 MARKETED BIOPHARMACEUTICALS USING E. COLI EXPRESSION SYSTEM, 1997-2014
  • MAMMALIAN CELL THERAPEUTIC PROTEIN PRODUCTION
  • TABLE 51 MARKETED BIOPHARMACEUTICALS USING ANIMAL CELL LINE EXPRESSION SYSTEM
  • EMERGING PRODUCTION SYSTEMS
  • PICHIA AND FILAMENTOUS FUNGI
  • TRANSGENIC PROTEIN PRODUCTION SYSTEMS
    • TRANSGENIC PLANTS
    • TABLE 52 PLANT-BASED TRANSGENIC COMPANIES AND THEIR PIPELINES OF RECOMBINANT PROTEINS
    • TRANSGENIC ANIMALS
    • TABLE 53 THERAPEUTIC PROTEINS PRODUCED IN TRANSGENIC ANIMALS
    • TABLE 54 MARKETED BIOPHARMACEUTICALS USING MURINE (MOUSE) HYBRIDOMA EXPRESSION SYSTEM

CHAPTER 14 COMPANY PROFILES

  • ABBVIE INC.
    • BIOLOGICAL PRODUCTS
  • ABBOTT LABORATORIES
    • BIOLOGICAL PRODUCTS
  • ADVAXIS INC.
    • BIOLOGICAL PRODUCTS
  • AGENNIX AG
  • AKEBIA THERAPEUTICS INC.
    • BIOLOGICAL PRODUCTS
  • AMGEN INC.
    • BIOLOGICAL PRODUCTS
  • APOGENIX
    • BIOLOGICAL PRODUCTS
  • APTALIS PHARMACEUTICAL
    • BIOLOGICAL PRODUCTS
  • CHINA BIOLOGIC PRODUCTS
    • BIOLOGICAL PRODUCTS
  • BAXTER BIOSCIENCE INC.
    • BIOLOGICAL PRODUCTS
  • BAYER SCHERING PHARMA AG
    • BIOLOGICAL PRODUCTS
  • BIOGEN IDEC INC.
    • BIOLOGICAL PRODUCTS
  • BIOINVENT INTERNATIONAL AB
    • BIOLOGICAL PRODUCTS
  • BIOVITRUM AB (SWEDISH ORPHAN BIOVITRUM AB, SOBI)
    • BIOLOGICAL PRODUCTS
  • CELLDEX THERAPEUTICS INC.
    • BIOLOGICAL PRODUCTS
  • CHUGAI PHARMACEUTICALS
    • BIOLOGICAL PRODUCTS
  • CSL BEHRING
    • BIOLOGICAL PRODUCTS
  • DEBIOPHARM GROUP
    • BIOLOGICAL PRODUCTS
  • DENDREON CORP.
    • BIOLOGICAL PRODUCTS
  • DYAX CORP.
    • BIOLOGICAL PRODUCTS
  • ELI LILLY & CO.
    • BIOLOGICAL PRODUCTS
  • ERYTECH PHARMA
    • BIOLOGICAL PRODUCTS
  • GENENTECH INC.
    • BIOLOGICAL PRODUCTS
  • GENMAB A/S
    • BIOLOGICAL PRODUCTS
  • GENZYME
    • BIOLOGICAL PRODUCTS
  • GLAXOSMITHKLINE
    • BIOLOGICAL PRODUCTS
  • GLYCOTOPE GMBH
    • BIOLOGICAL PRODUCTS
  • H. LUNDBECK A/S
    • CURRENT PRODUCTS
  • HAWAII BIOTECH INC.
  • HELIX BIOPHARMA CORP.
    • BIOLOGICAL PRODUCTS
  • HUMAN GENOME SCIENCES INC.
    • BIOLOGICAL PRODUCTS
  • IMCLONE SYSTEMS INC.
    • BIOLOGICAL PRODUCTS
  • IMMUNOGEN INC.
    • BIOLOGICAL PRODUCTS
  • IMMUNOVACCINE TECHNOLOGIES INC.
    • BIOLOGICAL PRODUCTS
  • IMMUTEP S.A.
    • BIOLOGICAL PRODUCTS
  • INNATE PHARMA
    • BIOLOGICAL PRODUCTS
  • INTERCELL AG
    • BIOLOGICAL PRODUCTS
  • IPSEN
    • BIOLOGICAL PRODUCTS
  • JANSSEN PHARMACEUTICALS
    • BIOLOGICAL PRODUCTS
  • MEDAREX INC.
    • BIOLOGICAL PRODUCTS
  • MERCK
    • BIOLOGICAL PRODUCTS
  • MERCK SERONO
    • BIOLOGICAL PRODUCTS
  • NOVARTIS AG
    • BIOLOGICAL PRODUCTS
  • NOVO NORDISK A/S
    • BIOLOGICAL PRODUCTS
  • OCTAPHARMA AG
    • BIOLOGICAL PRODUCTS
  • PFIZER INC.
    • BIOLOGICAL PRODUCTS
  • PHARMASTANDARD JSC
    • BIOLOGICAL PRODUCTS
  • PHOSPHAGENICS LTD.
    • BIOLOGICAL PRODUCTS
  • PROTEON THERAPEUTICS INC.
  • RELIANCE LIFE SCIENCES
    • BIOLOGICAL PRODUCTS
  • ROCHE LTD.
    • BIOLOGICAL PRODUCTS
  • SAMSUNG BIOPESIS
    • BIOLOGICAL PRODUCTS
  • SANOFI-AVENTIS
    • BIOLOGICAL PRODUCTS
  • SEATTLE GENETICS INC.
    • BIOLOGICAL PRODUCTS
  • SHIRE PLC
    • BIOLOGICAL PRODUCTS
  • TEVA PHARMACEUTICAL INDUSTRIES LTD.
    • BIOLOGICAL PRODUCTS
  • THROMBOGENICS NV
    • BIOLOGICAL PRODUCTS
  • UCB S.A.
    • BIOLOGICAL PRODUCTS
  • WILEX AG
  • XCELLEREX INC.
  • ZYMOGENETICS INC.
    • BIOLOGICAL PRODUCTS

LIST OF TABLES

  • SUMMARY TABLE GLOBAL BIOLOGICS MARKET FORECAST BY TYPE OF PRODUCT, THROUGH 2019 ($ MILLIONS)
  • TABLE 1 SUBCLASSES OF BIOLOGICS DRUGS
  • TABLE 2 MONOCLONAL ANTIBODY AND THERAPEUTIC PROTEIN DRUGS SUBCLASSES
  • TABLE 3 GLOBAL BIOLOGICS MARKET REVENUE, THROUGH 2019 ($ MILLIONS)
  • TABLE 4 MAJOR PHARMA/BIOPHARMA PLAYERS BY REVENUE, 2013 ($ MILLIONS)
  • TABLE 5 FDA CLEARED BIOPHARMACEUTICAL PRODUCTS AS OF 2013
  • TABLE 6 GLOBAL TOP 25 REVENUE GENERATING BIOPHARMACEUTICAL PRODUCTS, 2011-2013 ($MILLIONS)
  • TABLE 7 FDA APPROVED BIOLOGICALS, JAN. TO JULY 2014
  • TABLE 8 TOP 25 BEST SELLING DRUGS, 2013 ($ MILLIONS)
  • TABLE 9 GLOBAL MARKET FORECAST FOR MABS, THROUGH 2019 ($ MILLIONS)
  • TABLE 10 TOP FIVE LEADING MONOCLONAL ANTIBODY PRODUCTS, 2013 ($ MILLIONS)
  • TABLE 11 VOLUME OF MAMMALIAN CELL CULTURE PRODUCED MABS, 2014 AND 2019
  • TABLE 12 REVENUE FOR THERAPEUTIC PROTEINS SEGMENT OF BIOLOGICS MARKET, THROUGH 2019 ($ MILLIONS)
  • TABLE 13 LEADING HEMOPOIETIC GROWTH FACTOR BIOLOGIC PRODUCTS, 2013 ($ MILLIONS)
  • TABLE 14 CLINICAL TRIALS ON G-CSF RECEPTORS, 2013-2014
  • TABLE 15 CLINICAL TRIALS ON CYTOKINES IN 2013 AND 2014
  • TABLE 16 TOP REVENUE-GENERATING THERAPEUTIC PROTEIN PRODUCTS, 2013 ($ MILLIONS)
  • TABLE 17 VACCINE REVENUES, THROUGH 2019 ($ MILLIONS)
  • TABLE 18 CLINICAL TRIALS ON VACCINES, 2013-2014
  • TABLE 19 PATENT AND MARKETING EXCLUSIVITY EXPIRATION FOR TOP SELLING BIOLOGICS, 2009-2018
  • TABLE 20 NUMBER OF BIOSIMILARS PREDICTED TO BE LAUNCHED DURING 2014-2019
  • TABLE 21 TOP 10 BIOLOGICS DRUGS IN WITH GREATEST LEVEL OF BIOSIMILAR COMPETITION, 2013 ($ MILLIONS)
  • TABLE 22 TOP 10 SELLING MABS, 2013 ($ MILLIONS)
  • TABLE 23 MAJOR PLAYERS IN MAB MARKET, BY REVENUE, 2013 ($ MILLIONS)
  • TABLE 24 TOP 10 THERAPEUTIC PROTEIN PRODUCTS, 2013 ($ MILLIONS)
  • TABLE 25 MAJOR PLAYERS IN THE THERAPEUTIC PROTEINS MARKET BY REVENUE, 2013 ($ MILLIONS)
  • TABLE 26 TOP 10 VACCINES BY REVENUE, 2013 ($ MILLIONS)
  • TABLE 27 NEW BIOLOGIC DRUGS APPROVED, 2014
  • TABLE 28 BIOLOGIC DRUGS OBTAINING FDA APPROVAL, 2011-2013
  • TABLE 29 RECENT EMA APPROVED BIOSIMILAR DRUGS
  • TABLE 30 AMGEN BIOLOGICS PIPELINE, 2013
  • TABLE 31 MARKETED AMGEN BIOLOGICALS
  • TABLE 32 SANDOZ BIOLOGICS PIPELINE, 2013
  • TABLE 33 RELIANCE LIFE SCIENCES PIPELINE, 2013
  • TABLE 34 BOEHRINGER INGELHEIM BIOLOGICS PIPELINE, 2013
  • TABLE 35 MERCK BIOLOGICS PIPELINE, 2013
  • TABLE 36 PFIZER BIOLOGICS PIPELINE, 2013
  • TABLE 37 SAMSUNG BIOEPIS BIOLOGICS PIPELINE, 2013
  • TABLE 38 BIOLOGICAL/BIOSIMILAR DRUGS IN CLINICAL TRIALS, 2013-2014
  • TABLE 39 DESCRIPTION OF PHASES OF CLINICAL TRIALS REQUIRED FOR NEW DRUG APPROVAL (PERCENTAGE SUCCESS RATE)
  • TABLE 40 LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR CANCER TREATMENT, 2013-2014
  • TABLE 41 LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR GI AND RELATED DISEASE TREATMENT, 2013-2014
  • TABLE 42 LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR NEUROLOGICAL DISEASE TREATMENT, 2013-2014
  • TABLE 43 LICENSING, DEVELOPMENT AGREEMENTS, ACQUISITIONS AND PARTNERSHIPS IN BIOLOGICS, 2014 (YTD)
  • TABLE 44 LICENSING, DEVELOPMENT AGREEMENTS, ACQUISITIONS AND PARTNERSHIPS IN BIOLOGICS, 2013
  • TABLE 45 U.S. PATENTS FOR MONOCLONAL ANTIBODIES
  • TABLE 46 PATENTS ISSUED FOR THERAPEUTIC PROTEINS
  • TABLE 47 PATENTS ISSUED FOR VACCINES (OR VACCINE RELATED PRODUCTS) ASSOCIATED WITH BIOLOGICALS
  • TABLE 48 BIOLOGICS PRODUCTS USING PERFUSION METHOD
  • TABLE 49 BIOLOGICS THERAPEUTIC PRODUCTS USING FED-BATCH METHOD
  • TABLE 50 MARKETED BIOPHARMACEUTICALS USING E. COLI EXPRESSION SYSTEM, 1997-2014
  • TABLE 51 MARKETED BIOPHARMACEUTICALS USING ANIMAL CELL LINE EXPRESSION SYSTEM
  • TABLE 52 PLANT-BASED TRANSGENIC COMPANIES AND THEIR PIPELINES OF RECOMBINANT PROTEINS
  • TABLE 53 THERAPEUTIC PROTEINS PRODUCED IN TRANSGENIC ANIMALS
  • TABLE 54 MARKETED BIOPHARMACEUTICALS USING MURINE (MOUSE) HYBRIDOMA EXPRESSION SYSTEM

LIST OF FIGURES

  • SUMMARY FIGURE GLOBAL BIOLOGICS MARKET FORECAST BY TYPE OF PRODUCT, 2012-2019 ($ MILLIONS)
  • FIGURE 1 DIAGRAM OF TYPICAL ANTIBODY STRUCTURE
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