【レポートの概要（一部）】
1. Report Overview
1.1 Biologics Overview
1.2 Why you Should Read this Report
1.3 How this Report Delivers
1.4 Main Questions Answered by this Report
1.5 Who is this Report for?
1.6 Research and Analysis Methods
1.7 Frequently Asked Questions (FAQ)
1.8 Some Associated Reports
1.9 About Visiongain
2. Introduction to the Biologics Market and Key Concepts
2.1 Biologics: Large and Complex Products
2.2 A Brief History of Biological Drug Development
2.3 Why are Biologics the Most Lucrative Products in the Global Pharmaceutical Market?
2.4 What are Biosimilars?
2.4.1 Brief History of Biosimilars
2.4.2 What are Interchangeable Biological Products and how do they Differ from Biosimilars?
2.4.3 Prescription of Interchangeables vs Biosimilars and how this sets the FDA apart from the EMA
2.4.4 What Share of the Overall Biologics Market do they Currently Hold?
2.5 What are Next-Generation Biologics / Biobetters? What Share of the Overall Biologics Market do they Currently Hold?
2.6 Marginal Cases
2.7 Vaccines Market
3. The Global Biologics Market, 2015-2025
3.1 Global Biologics Market Forecast, 2015-2025
3.2 What Factors Will Drive Growth in the Biologics Market?
3.3 Ageing Population and the Rise of Chronic Disease
3.4 Seven of the Top Ten Best-Selling Drugs are Biologics
3.5 Biologics Constitute 19% of the Global Pharmaceutical Market – Further Launches will Drive Market
3.6 Biosimilars – Both an Opportunity and a Threat
3.7 What Factors will Restrain Growth in the Biologics Market?
3.8 High Costs in the Face of Declining National Healthcare Budgets
3.9 In Some Areas, Clinical Efficacy is not Superior Enough to Justify the Price Gap
3.10 Over $67bn worth of Biologic Patents due to Expire by 2020
3.11 Administration is often not as Convenient as that for Conventional Drugs
3.12 Biologics Market: Submarket Forecasts, 2015-2025
4. Protein Therapeutics Submarket, 2015-2025
4.1 Largest and Most Diverse Submarket
4.2 Proteins have been used Medicinally since the 19th Century
4.2.1 Recombinant DNA Technology – The Major Breakthrough in the use of Protein Drugs
4.3 Protein Therapeutics Submarket Forecast, 2015-2025
4.4 Insulin Submarket, 2015-2025
4.4.1 The First Protein Therapeutic
4.4.2 430 Million People Expected to be Diagnosed with Diabetes by 2030
4.4.3 Novo Nordisk, Sanofi and Eli Lilly Dominate the Insulin Segment
4.4.3.1 Sanofi: Releases Long-Acting Version of Lantus, as Patents for that Drug Expires
4.4.3.2 Eli Lilly: Portfolio Includes Human Insulin and Analogues
4.4.3.3 Novo Nordisk: Leader in Human Insulin Production
4.4.4 Duration of Action is the Major Differentiator for Insulins
4.4.5 New Approvals in the Insulin Market
4.4.5.1 Long-Awaited US Approval of Tresiba Could Come in October this Year
4.4.5.2 IDegLira / Xultrophy – Another Way to Sell Tresiba in the EU, Superior Results to Lantus in Phase 3
4.4.5.3 Toujeo – Sanofi’s Successor to Lantus, Already Launched in the US and Has Received Approval in Europe
4.4.6 Insulin Pipeline
4.4.6.1 BIL / LY2605541 (Eli Lilly) – Holds Promise, What Will More Testing Bring?
4.4.6.2 FIAsp / NN1218 – Novo Nordisk’s Late Stage Faster-Acting Insulin Aspart
4.4.7 Biosimilar Insulin
4.4.7.1 Approved Insulin Biosimilars
4.4.7.2 Abasaglar / Insulin Glargine BS – The First Insulin Biosimilars to be Approved in Developed Markets
4.4.7.3 Insulin Glargine is the Main Biosimilar Target
4.4.8 Insulin Submarket Forecast, 2015-2025
4.5 Other Recombinant Hormones: Erythropoietins, G-CSF and Human Growth Hormone
4.5.1 Erythropoietin
4.5.1.1 First-Generation Therapies Launched in the 1980s
4.5.1.2 Three Products Lead the Market
4.5.1.3 Mircera (Roche) Provides Competition for Market Leader Amgen
4.5.1.4 Safety Concerns for Erythropoietin-Stimulating Agents is Leading to Decreased Demand
4.5.1.5 The Challenge from Oral Therapies is Coming
4.5.1.6 Treating Anaemia in Patients with CKD – The Leading Use of EPO Therapies
4.5.1.7 Many Biosimilar Epoetins Approved Around the World
4.5.2 G-CSF
4.5.2.1 G-CSF: Discovered 1983. Recombinant Forms Available Since 1991
4.5.2.2 Amgen Leads the Market
4.5.2.3 Teva Aiming to Challenge Amgen’s Dominance
4.5.2.4 Facing Much Biosimilar Competition Around the World
4.5.3 Human Growth Hormone
4.5.3.1 Human Growth Hormone: First Extracted in 1958
4.5.3.2 Novo Nordisk Dominates Market
4.5.3.3 Novo Nordisk Aiming to Retain Dominance Through FlexPro Device and NN8640 Somatropin Candidate
4.5.3.4 Multiple Biosimilars Available – Omnitrope (Sandoz) is Market Leader
4.5.4 Other Recombinant Hormones Submarket Forecast, 2015-2025
4.6 Plasma and Recombinant Coagulating Factors
4.6.1 Discovery of Plasma and Clotting Proteins
4.6.2 Types of Recombinant Factor
4.6.3 Clotting Factor Deficiency Diseases
4.6.4 Baxter: Entered the Bleeding Disorders Market in 1992, Markets Various Leading Products
4.6.4.1 Baxter: New Product Launches Include Rixubis and Obizur
4.6.5 Novo Nordisk: Committed to Remaining a Leading Company in the Bleeding Disorders Market
4.6.5.1 Novo Nordisk: Developing Long-Acting Therapies – N8-GP and N9-GP
4.6.6 Bayer: Markets Kogenate, Kogenate FS, and has Submitted BAY 81-8973 for FDA Approval
4.6.7 Limited Opportunities for Biosimilar Challenge
4.6.8 Plasma and Recombinant Coagulating Factors Submarket Forecast, 2015-2025
4.7 Interferons
4.7.1 Interferons: Key Antiviral and MS Therapies Since the 1990s
4.7.2 Leading Interferon Brands in 2014
4.7.3 Interferons for Treating Hepatitis: Its Influence is Decreasing
4.7.4 Competition from Oral Protease and Polymerase Inhibitors
4.7.4.1 Oral Therapies are Expensive
4.7.5 Competition in the MS Therapy Market – Further Challenges for Interferons
4.7.6 Biosimilar Interferons: None Approved in Developed Markets, but Many Available in Emerging Nations
4.7.7 Biogen Launches Pegylated Form of Drug
4.7.8 Interferon Submarket Forecast, 2015-2025
4.8 Enzyme Replacement and Other Protein Therapies Submarket
4.8.1 Cerezyme: Genzyme’s Leading Enzyme Replacement Therapy
4.8.2 Myozyme and Lumizyme
4.8.3 Fabrazyme and Aldurazyme
4.8.4 Botulinum Toxin Brands Include Botox, Dysport and Xeomin
4.8.5 Other Protein Therapeutics Pipeline
4.8.5.1 Athera Buys Sollpura from Eli Lilly and Has Initiated Phase 3 Trials
4.8.5.2 Multikine (CEL-SCI)
4.8.5.3 Vonapantiase (Proteon Therapeutics)
4.8.6 Enzyme Replacement and Other Protein Therapeutics Submarket Forecast, 2015-2025
5. Monoclonal Antibodies Submarket, 2015-2025
5.1 Monoclonal Antibodies Submarket: Scientific and Historical Background
5.1.1 Natural Antibodies: Key to the Immune System
5.1.2 From Serum Therapy to Monoclonal Antibodies
5.1.3 Humanising the mAb
5.1.4 MAbs have found Success in Treating Autoimmune Disorders, Cancers and Others Diseases – Great Potential for the Future
5.1.5 MAbs for All? Technologies Come Off Patent
5.2 Five out of the Top-Ten Best-Selling Pharmaceuticals are mAbs
5.3 Autoimmune mAbs
5.3.1 Past Approvals
5.3.2 Humira (AbbVie) – The World’s Best-Selling Prescription Drug
5.3.2.1 AbbVie Plans to Drive Growth Through New Indications and Sales in Emerging Markets
5.3.2.2 Humira Undergoing Phase 3 Trials for Treatment of Uveitis, and Positive Opinion from EMA for Hidradenitis Suppurativa
5.3.2.3 Biosimilar Adalimumab: Patents Protect Humira in Developed Markets but Pipeline is Strong
5.3.3 Remicade (J&J / Merck): Second Only to Humira
5.3.3.1 Biosimilar Infliximab: Inflectra / Remsima Launched in Europe
5.3.4 Simponi: J&J’s Update to Remicade
5.3.5 Stelara (J&J): Reaches Double Blockbuster Status
5.3.6 Tysabri: Biogen Purchases Remaining Rights from Partner to Gain Full Control of Blockbuster Drug
5.3.7 Other Leading Autoimmune mAbs include Xolair, Actemra and Others
5.3.7.1 Leading Companies in the Autoimmune mAbs Sector
5.3.8 Autoimmune mAbs Pipeline: RA is the Main Target
5.3.8.1 Sarilumab (REGN88 / SAR153191) by Regeneron and Sanofi: Likely to be Submitted for Approval This Year
5.3.8.2 Sirukumab (CNTO-136) by J&J and GSK: Multiple Phase 3 Studies Around the World
5.3.8.3 Clazakizumab by Alder Biopharmaceuticals: Bristol-Myers Squibb Opts out of Co-Development
5.3.8.4 Tregalizumab (BT-061) by Biotest: AbbVie Backs out After Poor Results
5.3.8.5 Mavrilimumab by AstraZeneca: Approaching Phase 3
5.3.8.6 Zinbryta by AbbVie and Biogen: FDA and EMA have Accepted Application, Should be Approved Soon
5.3.8.7 Lebrikizumab by Roche: Undergoing Phase 3 After Positive Phase 2b Results
5.3.8.8 Sifalimumab (MEDI-545) by AstraZeneca: Treatment Targeting SLE
5.4 Oncology mAbs
5.4.1 Past Approvals
5.4.2 Rising Incidence of Cancer will Drive Demand
5.4.3 Rituxan: The World’s Leading Anti-Cancer mAb
5.4.3.1 Biosimilar Rituximab
5.4.4 Gazyva: Roche’s Successor to Rituxan, Will Help to Retain Revenues in Face of Biosimilar Competition
5.4.4.1 Approval for NHL Could Allow it to Reach its Blockbuster Potential
5.4.5 Avastin: Second in Roche’s Trio of Leading Cancer mAbs
5.4.5.1 Controversy over Off-Label Avastin use
5.4.5.2 Biosimilar Bevacizumab: Late Patent Expiry is a Blessing for Roche
5.4.6 Herceptin: Completes Roche’s Trio of Leading Cancer mAbs
5.4.7 Roche Builds Franchise of Anti-HER2 mAbs around Herceptin with Perjeta and Kadcyla
5.4.8 Challenges for Kadcyla
5.4.9 Perjeta has Already Reached Blockbuster Status
5.4.10 Biosimilar Trastuzumab: Two Biosimilars Already Available and Plenty more in the Pipeline
5.4.11 Yervoy: Bristol-Myers Squibb’s Leading Anti-Cancer mAb Reaches Blockbuster Status
5.4.12 Opdivo: Big Potential for Bristol-Myer Squibb’s PD-1 Inhibitor
5.4.13 Erbitux: Bristol-Myers Squibb Hands Over North American Marketing Responsibilities to Eli Lilly
5.4.14 Oncology mAbs: New Approvals and Pipeline
5.4.14.1 Elotuzumab (Bristol-Myers Squibb and AbbVie): Granted Breakthrough Therapy Designation
5.4.14.2 Avelumab: Pfizer and Merck KGaA Team Up to Develop Their Own Anti-PD mAb
5.4.14.3 Unituxin (United Therapeutics) Receives FDA Approval
5.4.14.4 Cyramza (Eli Lilly): Approved in Three Additional Indications Since its First Approval in April 2014
5.4.14.5 Coltuximab Ravtansine: Sanofi’s Anti-CD19 ADC mAb Candidate
5.5 MAbs in Other Therapeutics Areas
5.5.1 Lucentis (Novartis and Roche): Large Revenues and New Indication, but Also Part of Controversy
5.5.2 Soliris by Alexion Pharmaceuticals
5.5.3 Prolia by Amgen
5.6 Monoclonal Antibodies Submarket Forecast, 2015-2025
6. Fusion Proteins Submarket, 2015-2025
6.1 Scientific and Historical Background
6.2 Differentiating Fusion Proteins
6.3 Enbrel (Amgen / Pfizer): The First FP to be Approved, in 1998
6.3.1 Gradually Approved for Additional Indications
6.3.2 The Leading FP and the Fifth Best-Selling Pharmaceutical Product
6.3.3 Enbrel Granted Extended Patent Protection in the US
6.3.4 However, Biosimilars are Available in Emerging Markets and Patents Due to Expire soon in EU and Japan
6.4 Eylea: Blockbuster FP Treatment for Wet AMD
6.4.1 Approved in Additional Indications in 2014 and 2015
6.4.2 Breakdown of Revenues Between Regeneron and Bayer
6.5 Orencia: Grows Blockbuster Revenues by 14%
6.6 Nplate: Generates Half a Billion in Revenues for Amgen
6.7 Eloctate: Approved Recently in June 2014, Fulfils Unmet Need in the Haemophilia Community
6.8 Nulojix: Bristol-Myers Squibb’s Therapy for Preventing Organ Rejection
6.9 Arcalyst by Regeneron Pharmaceuticals
6.10 Fusion Proteins Pipeline
6.10.1 Merck KGaA Developing Atacicept to Treat SLE
6.10.2 Trebananib (Amgen): Underwhelming Results in One Phase 3 Trial, but Not the End of the Road Yet
6.10.3 Sotatercept by Acceleron Pharma and Celgene Corporation – Currently Undergoing Eight Clinical Trials
6.10.4 Blisibimod (Anthera Pharmaceuticals) for the Treatment of Various Autoimmune Diseases, in Late Stage Development
6.11 Fusion Protein Submarket Forecast, 2015-2025
7. Regenerative Medicines Submarket, 2015-2025
7.1 Regenerative Medicines Market Breakdown
7.2 Regenerative Medicines Submarket Forecast, 2015-2025
7.3 Stem Cell Therapies Submarket, 2015-2025
7.3.1 Stem Cells: Scientific Breakdown
7.3.2 Stem Cell Therapies Submarket Breakdown
7.3.3 Haematopoietic Stem Cell Transplantation: Over 80,000 Carried out in 2014
7.3.3.1 From Procedures to Products: Cord Blood Stem Cell Approvals
7.3.4 Osteocel Plus (NuVasive): Has Been Used in over 50,000 Spinal Solid Fusion Cases Worldwide
7.3.4.1 The Road from Osteocel to Osteocel Plus
7.3.5 Trinity Elite and Trinity Evolution (Orthofix): Over 90,000 Procedures to Date
7.3.6 MSC-100-IV / Prochymal by Mesoblast
7.3.6.1 MSC-100-IV’s History and Current Status – Expected US Launch 2017, has already been filed for Approval in Japan
7.3.6.2 Also Being Evaluated for Crohn’s Disease
7.3.7 Cartistem by Medipost – Has Been Used to Treat over 2,000 Patients Thus Far
7.3.8 Hearticellgram-AMI, One of the First Approved Cardiovascular Stem Cell Treatments
7.3.9 Stem Cell Therapies Pipeline
7.3.10 Cx601 (TiGenix): European Phase 3 Trial Completed July 2015
7.3.10.1 TiGenix Partners with Lonza, Will Conduct Another Phase 3 Trial in the US
7.3.11 MyoCell (Bioheart): Being Developed for Improvement of Cardiac Functions after Heart Damage
7.3.12 NBS10 (Formerly Known as AMR-001) – NeoStem’s Lead Candidate, Initial Phase 2 Results Promising
7.3.13 NSI-566 (Neuralstem) First Phase 2 Trial Demonstrates Promising Results, a Larger Phase 2 Trial is Planned 2015
7.3.14 Stem Cell Therapies Submarket Forecast, 2015-2025
7.4 Tissue Engineering Therapies Submarket, 2015-2025
7.4.1 What is Tissue Engineering? History and Science
7.4.1.1 Current Market Status
7.4.2 Apligraf by Organogenesis: The Leading Product
7.4.3 Dermagraft: Organogenesis Acquires Product from Shire in 2014
7.4.4 ReCell by Alvita Medical
7.4.5 MySkin and Cryoskin by Regenerys
7.4.6 Tissue Engineering Therapies Pipeline
7.4.6.1 NeoCart by Histogenics is Undergoing Phase 3 Trial for Knee Cartilage Repair
7.4.6.2 Extracorporeal Bio-Artificial Liver Therapy by Vital Therapies: Undergoing Two Phase 3 Clinical Trials
7.4.6.3 StrataGraft by Stratatech Corporation Demonstrates Positive Top-Line Results
7.4.7 Tissue Engineering Therapies Submarket Forecast, 2015-2025
7.5 Gene Therapies Submarket, 2015-2025
7.5.1 Gene Therapy: Historical and Scientific Background
7.5.1.1 The Role of Viruses Within Gene Therapy
7.5.2 Approved Gene Therapy Products
7.5.2.1 Genidicine (Benda Pharmaceuticals): World’s First Commercial Gene Therapy
7.5.2.2 Oncorine by Shanghai Sunway Biotech
7.5.2.3 Neovasculgen (Human Stem Cells Institute): Russia’s First Gene Therapy
7.5.2.4 Glybera (UniQure): The First Gene Therapy for Western Markets
7.5.3 Gene Therapies Pipeline
7.5.3.1 AAV2-hRPE65v2 (Spark Therapeutics)
7.5.3.2 AdV-tk / ProstAtak (Advantagene)
7.5.3.3 T-Vec (Amgen)
7.5.4 Gene Therapies Submarket Forecast, 2015-2025
8. Leading National Markets for Biologics, 2015-2025
8.1 Composition of the Market in 2014 and 2025: US Will Remain Dominant
8.2 Regional Forecasts for the Global Biologics Market, 2015-2025
8.3 US Biologics Market, 2015-2025
8.3.1 The Major National Market
8.3.2 Value-Based Pricing in the US
8.3.3 Regulation of Biologics in the US
8.3.4 US Biosimilar Market
8.3.4.1 FDA Finalises Biosimilar Guidelines
8.3.5 US Biologics Market Forecast, 2015-2025
8.4 EU5 Biologics Market, 2015-2025
8.4.1 Current Composition and Future Outlook
8.4.2 European Biosimilars Market
8.4.2.1 EMA Biosimilar Guidelines and Updates 2012-2014
8.4.3 EU5 Market Forecast by Nation, 2015-2025
8.5 Japanese Biologics Market, 2015-2025
8.5.1 Current Status of the Japanese Biologics Market
8.5.2 Japanese Biosimilars Market
8.5.3 Japanese Biologics Market Forecast, 2015-2025
8.6 BRIC National Biologic Markets, 2015-2025
8.6.1 BRIC Markets Overview
8.6.2 BRIC Biologic Market Forecast, 2015-2025
8.6.2.1 Unique Challenges Faced by the Biologics Industry have led to Current Composition of the BRIC Biologic Market
8.6.2.2 Future Outlook
8.6.2.3 BRIC Nation Market Shares in the Global Biologics Market will Nearly Double During the Forecast Period
8.6.3 Brazil: Disproportionately High Government Spending on Biologics
8.6.3.1 Brazilian Government Eager to Promote Domestic Biologic and Biosimilar Development
8.6.4 Russia: Another Government Which is Eager to Increase Domestic Biological Drug Development
8.6.5 India: Biologics Market Behind that of Other BRIC Nations, but Biosimilars Submarket Thriving
8.6.5.1 CDSCO Guidelines Released in 2012
8.6.6 China: Expected to the Largest BRIC Market for Biologics by 2019
8.6.6.1 The Largest National Biosimilar Market in the World
9. Qualitative Analysis of the Biologics Market and Industry
9.1 SWOT Analysis of the Global Biologics Market and Industry
9.1.1 Strengths
9.1.2 Opportunities
9.1.3 Weaknesses
9.1.4 Threats
9.2 STEP Analysis of the Global Biologics Market and Industry
9.2.1 Social Factors
9.2.2 Technological Developments
9.2.3 Economic Pressures
9.2.4 Political Issues
10. Conclusions from the Research and Analysis
10.1 Biologics Market to Achieve Steady Growth Through the Forecast Period
10.2 Changes in Market Composition: mAbs to Become Leading Submarket
10.3 The Emergence of Biosimilars
10.4 Challenges for the Market
【レポート販売概要】
■ タイトル：生物製剤の世界市場：蛋白質療法、単クローン抗体、融合蛋白、再生医療、ワクチン■ 英文：Global Biologics Market, Industry and R&D: Forecasts 2015-2025 : Challenges and Opportunities from Rising Drug Demand and Biosimilar Competition
■ 発行日：2015年8月
■ 調査会社：visiongain
■ 商品コード：VGAIN5081915
■ 調査対象地域：グローバル
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