生物製剤の世界市場動向・予測2016-2026

◆英語タイトル:Biologics Market Trends and Forecasts 2016-2026
◆商品コード:VGAIN81922
◆発行会社(調査会社):visiongain
◆発行日:2016年7月
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◆レポート言語:英語
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当調査レポートでは、生物製剤の世界市場について調査・分析し、生物製剤の世界市場規模、市場動向、市場予測、市場環境分析、専門家の見解、関連企業情報などを含め、以下の構成でお届けいたします。
1. レポート概要

2. 生物製剤市場の概要とキーコンセプト

3. 生物製剤の世界市場

4. タンパク質治療2次市場

5. モノクローナル抗体2次市場

6. 融合タンパク質2次市場

7. 再生医療2次市場

8. 生物製剤の主要国市場

9. 生物製剤市場の定性分析

10. 結論
【レポートの概要】

Biological Drugs – Discover Revenue Potentials Now, Benefiting Your Authority
Do you want to find how high biological drug sales can go? Visiongain’s new analysis gives you those revenue forecasts to 2026 at overall world market, therapeutic class and national level. For biologics you discover data, opportunities, R&D and sales potentials.

Our updated report gives you multilevel revenue predictions for biopharmaceutical products from 2016, helping you stay ahead. There you investigate trends, results, technologies and expected products, benefiting your reputation for technological and commercial insight.

With our study you also assess the influence of biosimilars and other emerging treatments on that lucrative, expanding pharmaceutical industry and market.

Read on, then, to explore the biologics market, also seeing revenue prediction.

Forecasts and other analysis show you where the best sales opportunities exist
Our new report shows revenue forecasting to 2026, results, sales growth rates and market shares. In that 274 page study you explore quantitative and qualitative analyses, assessing sales potentials and R&D. You get 103 tables and 50 charts, gaining original research and analysis.

That way you assess clinical, technological and commercial trends, results and potentials such as these issues:
• Why will the biologics market achieve revenue growth from 2016 to 2026, and what sales are possible from existing drugs and R&D?
• When will that industry achieve worldwide revenues exceeding $300bn?
• What treatment classes give the most commercial promise?
• Who are the best-placed companies in the biopharma industry?
• Where are the most important and promising countries for selling those treatments, and what future sales can leading national markets give?
• How will biological drug producers serve regulators, doctors, patients and payers from 2016 to 2026, also benefiting the pharma industry?

Opportunities in biologics to enrich drug developers, producers and marketers
In 2015 eight of the top ten best-selling drugs were biologics. Many opportunities remain for products based on proteins and related biopharma technologies.

Our study lets you discover what segments are most likely to prosper, from 2016 to 2026, through forecasted sales. See what the future holds and how you can gain.

Why struggle to find data to help your work? Instead help your research, analyses, plans, proposals and presentations now. With visiongain’s new investigation see how you could save time and benefit your reputation for commercial insight.

The following sections show how our new investigation benefits your work.

Predictions for that world market, submarkets and products
Along with revenue prediction for the overall world market for biologics, our study shows forecasts from 2016 to 2026 for 13 individual submarkets:
• Protein therapeutics, with sub-forecasting for insulin, other recombinant hormones, plasma and recombinant coagulating factors, interferons, enzyme replacement and other agents
• Monoclonal antibodies (mAbs)
• Fusion proteins
• Regenerative medicine, with sub-forecasting for stem cell treatment, tissue engineering and gene therapy
• Vaccines.

In addition you gain revenue forecasts for 18 leading products, including Lantus, Humalog, Avonex, Rebif, Humira, Remicade, Herceptin and Enbrel.

Our new investigation also discusses what stimulates and restrains sales of biologics. You explore that industry, seeing what segments and products can achieve the most success. Discover, from 2016, how pharmaceutical companies, patients and healthcare providers can benefit.

That study also divides its overall world forecast into geographical segments.

National markets for biopharmaceuticals – what does the future hold for sales?
Our report predicts rising demand for biological drugs in developed and developing countries. Discover what sales results and expansion are possible from 2016.

The analyses show you overall biologic revenue forecasts to 2026 for 11 national markets:
• United States
• Japan
• Germany, France, United Kingdom, Italy and Spain (EU5)
• Brazil, Russia, India and China (BRIC).

In our study you assess the biologic industry’s future – needs, developments, demands and opportunities.

Our work explores issues affecting biopharma companies, influencing their results.

Forces affecting the biological drugs industry – what shapes its present and future?
The new report discusses pressures, opportunities and other events affecting the biologics industry and market from 2016, including these influences:
• Research and development, especially potentials of recombinant DNA technology and emerging processes to benefit patients
• Needs and opportunities for developing biologics, including rising prevalence of cancers, autoimmune and neurodegenerative disorders
• Data exclusivity and patent challenges for biopharmaceuticals
• New products, including Tresiba, Toujeo and Abasaglar
• Next-generation biologics – explore competition, technological races and challenges, seeing what is possible.

Our study discusses other aspects of biologics too, including these forces:
• Anti-cancer agents, erythropoietins, G-CSF and human growth hormones – investigate prospects for therapeutic classes
• Treatments for haemophilia, diabetes, anaemia, bleeding disorders, wet AMD, multiple sclerosis, arthritis and other chronic diseases
• Pricing, reimbursement, clinical efficacy and other challenges – explore regulators’ and other healthcare payers’ demands for biologics, including biosimilars and interchangeable biological products
• Collaborations, partnerships and networks shaping biopharma.

With our new analysis you assess that industry’s strengths, weaknesses, opportunities and threats. See what is happening. That way you explore what restricts and stimulates companies developing, manufacturing, marketing and selling biological medicines.

Companies and 2020 market forecast – what overall revenue potential?
From 2016, biological product launches hold great potential for investments, demand and sales. Our study predicts the world market for those drugs will reach $248 billion in 2020, with strong revenue expansion from 2016 to 2026. See how high revenues can go.

With our study you assess what biotechnologies, products and companies hold most potential, including these organisations:
• Amgen
• Bayer
• Eli Lilly
• GSK
• Johnson & Johnson
• Merck & Co.
• Novartis
• Novo Nordisk
• Pfizer
• Roche
• Sanofi.

Biologics constitute 19% of the global pharmaceutical market. From 2016 there will arise many more opportunities, especially from drug launches. See what is possible.

Our work shows you commercial possibilities for biological drugs, helping you stay ahead in knowledge and succeed.

5 main ways Biologics Market Trends and Forecasts 2016-2026 helps your work
In these five main ways, our new study benefits your research, analyses, decisions, proposals and presentations:
• Revenues to 2026 for biologics at overall world level – discover outlooks for development, production, marketing and sales
• 13 submarkets’ and 18 leading products’ revenues to 2026 – investigate segments at world level, finding the most lucrative and fast-rising products
• Forecasts to 2026 for 11 national markets in the Americas, Europe and Asia – assess developed and developing countries for potential revenues
• Prospects for established competitors and rising companies – explore portfolios, results, strategies, R&D, partnerships and outlooks for success
• Analysis of what stimulates and restrains biologic producers – investigate challenges, strengths and competition, helping you stay ahead and succeed.

【レポートの目次】

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 Why Many Nations Oppose Automatic Substitution of Reference Biologics with Biosimilars
2.4.4 What Share of the Overall Biologics Market do they Currently Hold?
2.5 What are Next-Generation Biologics? What Share of the Overall Biologics Market do they Currently Hold?
2.6 Marginal Cases
2.7 Vaccines Market

3. The Global Biologics Market 2016-2026
3.1 The Global Biologics Market Forecast, 2016-2026
3.2 What Factors Will Drive Growth in the Biologics Market?
3.3 Ageing Population and the Rise of Chronic Disease
3.4 Eight of the Top Ten Best-Selling Drugs in 2015 were 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
3.12 Biologics Market: Submarket Forecasts 2016-2026

4. Protein Therapeutics Submarket 2016-2026
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 2016-2026
4.4 Insulin Submarket 2016-2026
4.4.1 The First Protein Therapeutic
4.4.2 430 Million People Expected to be Diagnosed with Diabetes by 2030
4.4.3 The Status of the Market in 2015: Novo Nordisk, Sanofi and Eli Lilly Dominate
4.4.4 Insulin Submarket Forecast 2016-2026
4.4.5 Lantus: The Market Leading Drug by Far
4.4.5.1 Lantus Revenue Forecast 2016-2026
4.4.6 NovoLog/NovoRapid Revenue Forecast 2016-2026
4.4.7 Humalog Revenue Forecast 2016-2026
4.4.8 New Approvals and Pipeline
4.4.8.1 Tresiba (Novo Nordisk)
4.4.8.2 BIOD-123 (Biodel)
4.5 Biosimilar Insulin
4.5.1 Approved Insulin Biosimilars
4.5.2 Abasaglar/Basaglar/Insulin Glargine BS – The First Insulin Biosimilars to be Approved in Developed Markets. Delayed in the US
4.5.3 Insulin Glargine in the Main Biosimilar Target – and there is Limited Development for the Other Targets
4.6 Other Recombinant Hormones: Erythropoietins, G-CSF and Human Growth Hormone
4.6.1 Erythropoietin
4.6.2 First-Generation Therapies Launched in the 1980s
4.6.2.1 Aranesp: Slowly Growing
4.6.2.2 Epogen: Increases in Selling Price are No Longer Enough to Ward off Decline
4.6.2.3 Procrit/Eprex: In Decline Since 2013
4.6.2.4 NeoRecormon and Mircera (Roche) Provides Competition for Market Leader Amgen
4.6.2.5 Safety Concerns for Erythropoietin-Stimulating Agents is Leading to Decreased Demand
4.6.2.6 The Challenge from Oral Therapies is Coming
4.6.2.7 Treating Anaemia in Patients with CKD – The Leading Use of EPO Therapies
4.6.2.8 Many Biosimilar Epoetins Approved Around the World
4.6.3 G-CSF
4.6.3.1 G-CSF: Discovered 1983. Recombinant Forms Available Since 1991
4.6.3.2 Amgen Leads the Market
4.6.3.3 Neupogen and Neulasta Revenues, and the Onpro Kit
4.6.3.4 Teva Aiming to Challenge Amgen’s Dominance
4.6.3.5 Facing Much Biosimilar Competition Around the World
4.6.4 Human Growth Hormone
4.6.4.1 Human Growth Hormone: First Extracted in 1958
4.6.4.2 Novo Nordisk Dominates Market
4.6.4.3 Novo Nordisk Aiming to Retain Dominance Through FlexPro Device and NN8640 Somatropin Candidate
4.6.4.4 Multiple Biosimilars Available – Omnitrope is Market Leader
4.6.4.5 Biosimilar Growth Hormones in Asia
4.6.5 Other Recombinant Hormones Submarket Forecast 2016-2026
4.7 Plasma and Recombinant Coagulating Factors
4.7.1 Discovery of Plasma and Clotting Proteins
4.7.2 Types of Recombinant Factor
4.7.3 Clotting Factor Deficiency Diseases
4.7.4 Baxter/Baxalta: Entered the Bleeding Disorders Market in 1992, Markets Various Leading Products
4.7.4.1 Baxter: New Product Launches Include Rixubis and Obizur
4.7.5 Novo Nordisk: Committed to Remaining a Leading Company in the Bleeding Disorders Market
4.7.5.1 Novo Nordisk: Has filed for Approval for N9-GP and NovoEight is Doing Well
4.7.6 Bayer: Markets Kogenate, Kogenate FS, and has Received FDA Approval for Kovaltry
4.7.7 Limited Opportunities for Biosimilar Challenge
4.7.8 Plasma and Recombinant Coagulating Factors Submarket Forecast 2016-2026
4.8 Interferons
4.8.1 Interferons: Key Antiviral and MS Therapies Since the 1990s
4.8.2 Interferons for Treating Hepatitis: Its Influence is Decreasing
4.8.3 Competition from Oral Protease and Polymerase Inhibitors
4.8.3.1 Oral Therapies are Expensive
4.8.4 Avonex: The Leading Interferon Therapy
4.8.4.1 Avonex Revenue Forecast 2016-2026
4.8.5 Rebif: Merck Attempting to Differentiate Rebif from Other Interferon Therapies
4.8.5.1 Rebif Revenue Forecast 2016-2026
4.8.6 Betaseron
4.8.7 Plegridy: New Therapy with High Potential
4.8.8 Biosimilar Interferons: None Approved in Developed Markets, but Many Available in Emerging Nations
4.8.9 Interferon Submarket Forecast 2016-2026
4.9 Enzyme Replacement and Other Protein Therapies Submarket
4.9.1 Cerezyme: Genzyme’s Leading Enzyme Replacement Therapy
4.9.2 Myozyme and Lumizyme
4.9.3 Fabrazyme and Aldurazyme
4.9.4 Botulinum Toxin Brands Include Botox, Dysport and Xeomin
4.9.5 Other Protein Therapeutics Pipeline
4.9.5.1 Anthera Buys Sollpura from Eli Lilly, Phase 3 Results Expected Q4 2016
4.9.5.2 Multikine (CEL-SCI)
4.9.5.3 Vonapantiase (Proteon Therapeutics)
4.9.6 Enzyme Replacement and Other Protein Therapeutics Submarket Forecast 2016-2026

5. Monoclonal Antibodies Submarket 2016-2026
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 Three out of the Top Five Best-Selling Drugs are mAbs
5.3 Autoimmune mAbs
5.3.1 Past Approvals
5.3.2 Humira – The World’s Best-Selling Prescription Drug
5.3.2.1 AbbVie Plans to Drive Growth Through New Indications
5.3.2.2 Positive Opinion from CHMP for Treatment of Non-Infectious Uveitis
5.3.2.3 Recently Approved for Hidradenitis Suppurativa in the US and Europe
5.3.2.4 Biosimilar Adalimumab: Patents Protect Humira in Developed Markets for Now
5.3.2.5 Humira Revenue Forecast 2016-2026
5.3.3 Remicade: Second Only to Humira
5.3.3.1 2015 Revenue for J&J and Merck
5.3.3.2 Has Defended Revenues well but now has to Deal with Biosimilar Competition
5.3.3.3 Patent Dance in US
5.3.3.4 Biosimilar Infliximab: Multiple Launches
5.3.3.5 Remicade Revenue Forecast 2016-2026
5.3.4 Stelara: Double Blockbuster
5.3.4.1 Stelara Revenues 2013-2015
5.3.4.2 Orphan Drug Designation for paediatric Crohn’s Disease
5.3.5 Simponi and Simponi Aria: Another Blockbuster mAb for J&J and Merck & Co.
5.3.5.1 2015 and 2014 Revenue Breakdown
5.3.6 Tysabri: Blockbuster Drug’s High Efficacy Offsets its Risks
5.3.6.1 Tysabri: Revenues 2011-2015
5.3.6.2 Tysabri Revenue Forecast 2016-2026
5.3.7 Xolair: New Indication, and Revenue Breakdown
5.3.8 Actemra/RoActemra: Strong Growth in All Regions
5.3.9 Cimzia: Blockbuster Which has been Used by Over 90,000 Patients
5.3.10 Autoimmune mAbs Pipeline: RA is the Main Target
5.3.10.1 Sarilumab (REGN88/SAR153191) by Regeneron and Sanofi: BLA Accepted for Review and Decision Expected by November 2016
5.3.10.2 Sirukumab (CNTO-136) by J&J and GSK: Multiple Phase 3 Studies Around the World
5.3.10.3 Clazakizumab: Developed by Alder Biopharmaceuticals and BMS but now Licensed to Vitaeris
5.3.10.4 Tregalizumab (BT-061) by Biotest: AbbVie Backs out After Poor Results
5.3.10.5 Mavrilimumab by AstraZeneca: Approaching Phase 3
5.3.10.6 Zinbryta (daclizumab high-yield process) by Biogen and AbbVie: Positive Opinion from CHMP
5.3.10.7 Lebrikizumab by Roche: Undergoing Phase 3 After Positive Phase 2b Results
5.3.10.8 Sifalimumab (MEDI-545) by AstraZeneca: Hasn’t made the cut for Phase 3
5.3.10.9 Anifrolumab by AstraZeneca
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
5.4.4 Biosimilar Rituximab: Two Candidates Await Approval in Europe
5.4.5 Gazyva: Roche’s Successor to Rituxan, Will Help to Retain Revenues in Face of Biosimilar Competition
5.4.5.1 Approval for Follicular Lymphoma and Being Investigated for Other Indications
5.4.6 Avastin: Growing under CER, Through New Indications
5.4.6.1 Controversy over Off-Label Avastin use: Roche is Backed up by Incidents in India, and Opinion of EFPIA
5.4.6.2 Biosimilar Bevacizumab: Late Patent Expiry is a Blessing for Roche, Although Various Biosimilars in Development
5.4.7 Herceptin: Breast Cancer Blockbuster
5.4.7.1 Pricing Challenges in Emerging Markets, and 2015 Revenues
5.4.7.2 Roche Builds Franchise of Anti-HER2 mAbs Around Herceptin
5.4.7.3 Herceptin Revenue Forecast 2016-2026
5.4.7.4 Biosimilar Trastuzumab
5.4.8 Kadcyla
5.4.8.1 Mixed Results from Different Clinical Trials
5.4.8.2 Kadcyla Sales Forecast 2016-2026
5.4.9 Perjeta
5.4.9.1 Positive Results from Different Clinical Trials
5.4.9.2 Perjeta Revenue Forecast 2016-2026
5.4.10 Yervoy: Bristol-Myers Squibb’s Leading Anti-Cancer mAb, Keeps High Revenues, but with Decline over 2014
5.4.11 Opdivo: Big Potential for Bristol-Myer Squibb’s PD-1 Inhibitor
5.4.11.1 Good News and Bad News for NSCLC from CheckMate Trials
5.4.11.2 Cyramza (Eli Lilly): Approved in Three Additional Indications Since its First Approval in April 2014
5.4.12 Oncology mAbs: New Approvals and Pipeline
5.4.12.1 Empliciti (Elotuzumab) by Bristol-Myers Squibb and AbbVie): Recently Approved
5.4.12.2 Avelumab: Pfizer and Merck KGaA Team Up to Develop Their Own Anti-PD mAb
5.4.12.3 Unituxin (United Therapeutics) Receives FDA Approval March 2015
5.4.12.4 SAR3419 (coltuximab ravtansine) (anti-CD19, Sanofi)
5.5 Monoclonal Antibodies Submarket Forecast 2016-2026

6. Fusion Proteins Submarket 2016-2026
6.1 Scientific and Historical Background
6.2 Differentiating Fusion Proteins
6.3 Enbrel: The First FP to be Approved, in 1998
6.3.1 Gradually Approved for Additional Indications
6.3.2 The Leading Fusion Protein
6.3.3 Enbrel Granted Extended Patent Protection in the US, Patent has Expired in EU
6.3.4 Multiple Biosimilars Available in Emerging Markets
6.3.5 Enbrel Revenue Forecast 2016-2026
6.4 Eylea: Blockbuster FP Treatment for Wet AMD
6.4.1 Eylea Revenue Forecast 2016-2026
6.5 Orencia: Grows Blockbuster Revenues by 14% for Second Year in a Row
6.6 Nplate: Generates Half a Billion in Revenues for Amgen
6.7 Eloctate: Approved 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: For Very Rare Conditions
6.10 Fusion Proteins Pipeline
6.10.1 Trebananib (Amgen)
6.10.2 Sotatercept by Acceleron Pharma and Celgene Corporation – Currently Undergoing Eight Clinical Trials
6.10.3 Blisibimod (Anthera Pharmaceuticals) for the Treatment of Various Autoimmune Diseases, in Late Stage Development
6.11 Fusion Protein Submarket Forecast 2016-2026

7. Regenerative Medicines Submarket 2016-2026
7.1 Regenerative Medicines Market Breakdown
7.2 Regenerative Medicines Submarket Forecast, 2016-2026
7.3 Stem Cell Therapies Submarket, 2016-2026
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: The Leading Stem Cell Orthobiologic
7.3.4.1 Osteocel Plus Revenue Forecast 2016-2026
7.3.5 Trinity Evolution and Trinity Elite
7.3.5.1 Trinity Evolution and Trinity Elite Revenue Forecast 2016-2026
7.3.6 MSC-100-IV (Previously Known as Prochymal): World’s First Approved Stem Cell Drug Outside of South Korea
7.3.6.1 An Important Role to Play in the Future of HSCT, and also Wins Approval in Japan through Partner
7.3.7 CARTISTEM (MEDIPOST): The World’s First Allogeneic Stem Cell Drug
7.3.8 Hearticellgram-AMI (Pharmicell): One of the First Approved Cardiovascular Stem Cell Treatments in the World
7.3.9 Stem Cell Therapies Pipeline
7.3.9.1 Cx601 by TiGenix: Marketing Authorisation Application has been Submitted to EMA
7.3.9.2 CardiAMP (BioCardia) for Heart Failure: Undergoing Phase 3 Trial and has Received Grant from MSCRF
7.3.9.3 NurOwn (BrainStorm Cell Therapeutics): Neurotrophic Factor -Releasing Stem Cells for ALS in Phase 2 and Due to end Soon
7.3.9.4 Agenmestencel-T (Apceth): Phase 1/2 Due to end Soon
7.3.10 Stem Cell Therapies Submarket Forecast 2016-2026
7.4 Tissue Engineering Therapies Submarket 2016-2026
7.4.1 Tissue Engineering – In Vitro Manipulation for Therapeutic Purposes
7.4.2 Current Status of the Market
7.4.3 Apligraf: The Leading Product
7.4.3.1 Apligraf Revenue Forecast 2016-2026
7.4.4 Dermagraft: Organogenesis Further Strengthens Position Through this 2014 Acquisition
7.4.4.1 Dermagraft Revenue Forecast 2016-2026
7.4.5 ReCell
7.4.6 MySkin and CyroSkin
7.4.7 Tissue Engineering Therapies Pipeline
7.4.7.1 NeoCart by Histogenics: Undergoing Phase 3 Trial for Knee Cartilage Repair
7.4.7.2 Extracorporeal Bio-Artificial Liver Therapy by Vital Therapies
7.4.7.3 StrataGraft by Stratatech Corporation Demonstrates Positive Top-Line Results
7.4.8 Tissue Engineering Therapies Submarket Forecast 2016-2026
7.5 Gene Therapies Submarket 2016-2026
7.5.1 Gene Therapy: Historical and Scientific Background
7.5.2 Harnessing Infectivity: Viral Vectors in Gene Therapy
7.5.3 Approved Gene Therapy Products
7.5.3.1 Gendicine: The World’s First Commercial Gene Therapy Product
7.5.3.2 Oncorine: First Oncolytic Viral Therapy
7.5.3.3 Neovasculgen: Russia’s First Gene Therapy
7.5.3.4 Neovasculgen: Drop in Revenues in 2015, but HSCI Predicts Notable Increases as Product is Added to VED List
7.5.3.5 Glybera: The First Gene Therapy for Western Markets, Although Has Abandoned Hope of Receiving FDA-Approval
7.5.3.6 IMLYGIC
7.5.3.7 IMLYGIC: Clinical Trials and Development Efforts
7.5.3.8 IMLYGIC: Revenue Forecast 2016-2026
7.5.4 Gene Therapies Pipeline
7.5.4.1 AAV2-hRPE65v2 (Spark Therapeutics): Undergoing Phase 3 Trial
7.5.4.2 AdV-tk/ProstAtak (Advantagene): Phase 3
7.5.4.3 Collategene (beperminogene perplasmid, AMG0001) – (AnGes MG/Vical)
7.5.5 Gene Therapy Submarket Forecast 2016-2026

8. Leading National Markets for Biologics 2016-2026
8.1 Regional Forecasts for the Global Biologics Market 2016-2026
8.2 US Biologics Market 2016-2026
8.2.1 The Major National Market
8.2.2 Value-Based Pricing in the US
8.2.3 Regulation of Biologics in the US
8.2.4 US Biosimilars Market
8.2.4.1 FDA Finalises Biosimilar Guidelines and Biosimilar Naming
8.2.5 US Biologics Market Forecast 2016-2026
8.3 EU5 Biologics Market 2016-2026
8.3.1 Current Composition and Future Outlook
8.3.2 European Biosimilar Market
8.3.2.1 History of EMA Guidelines and Updates
8.3.3 EU5 Market Forecast by Nation 2016-2026
8.4 Japanese Biologics Market 2016-2026
8.4.1 Current Status of the Japanese Biologics Market
8.4.2 Japanese Biosimilar Market
8.4.3 Japanese Biologics Market Forecast 2016-2026
8.5 BRIC National Biologic Markets 2016-2026
8.5.1 BRIC Markets Overview
8.5.2 BRIC Biologic Market Forecast 2016-2026
8.5.2.1 Unique Challenges Faced by the Biologics Industry have led to Current Composition of the BRIC Biologic Market
8.5.2.2 Future Outlook
8.5.2.3 BRIC Nation Market Shares in the Global Biologics Market will Nearly Double During the Forecast Period
8.5.3 Brazil: Disproportionately High Government Spending on Biologics
8.5.3.1 Brazilian Government Eager to Promote Domestic Biologic and Biosimilar Development
8.5.4 Russia: Another Government Which is Eager to Increase Domestic Biological Drug Development
8.5.5 India: Biologics Market Behind that of Other BRIC Nations, but Biosimilars Submarket Thriving
8.5.5.1 CDSCO Guidelines Released in 2012
8.5.6 China: Expected to the Largest BRIC Market for Biologics by 2020
8.5.6.1 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
10.1 Biologics Market to Achieve Steady Growth Throughout 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
10.5 Some Associated Reports

List of Tables
Table 1.1 Currency Exchange Rates: Average Exchange Rate to USD for 2014 and 2015
Table 2.1 First Approvals for Recombinant Protein Therapies, 1982-1993
Table 3.1 Global Biologics Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2015-2020
Table 3.2 Global Biologics Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2021-2026
Table 3.3 Top Ten Best-Selling Drugs in 2015: Revenue ($bn), Share of Biologics Market (%)
Table 3.4 Patent Status of Selected Leading Biologics
Table 3.5 Submarkets within the Biologics Market, Forecast: Revenues ($bn), AGR (%), CAGR (%), Market Share (%), 2015-2020
Table 3.6 Submarkets within the Biologics Market, Forecast: Revenues ($bn), AGR (%), CAGR (%), Market Share (%), 2021-2026
Table 4.1 First Approvals for Recombinant Protein Therapies, 1982-1993
Table 4.2 Protein Therapeutics Submarket Forecast: Revenues ($bn), AGR (%), CAGR (%), 2015-2020
Table 4.3 Protein Therapeutics Submarket Forecast: Revenues ($bn), AGR (%), CAGR (%), 2021-2026
Table 4.4 Diabetes Prevalence in Leading National Markets, 2014
Table 4.5 Insulin Submarket Forecast: Revenues ($bn), AGR (%), CAGR (%), 2015-2020
Table 4.6 Insulin Submarket Forecast: Revenues ($bn), AGR (%), CAGR (%), 2021-2026
Table 4.7 Lantus Revenue Forecast: Revenues ($bn), AGR (%), CAGR (%), 2015-2020
Table 4.8 Lantus Revenue Forecast: Revenues ($bn), AGR (%), CAGR (%), 2021-2026
Table 4.9 NovoLog/NovoRapid Revenue Forecast: Revenues ($bn), AGR (%), CAGR (%), 2015-2020
Table 4.10 NovoLog/NovoRapid Revenue Forecast: Revenues ($bn), AGR (%), CAGR (%), 2021-2026
Table 4.11 Humalog Revenue Forecast: Revenues ($bn), AGR (%), CAGR (%), 2015-2020
Table 4.12 Humalog Revenue Forecast: Revenues ($bn), AGR (%), CAGR (%), 2021-2026
Table 4.13 Selected Insulin Biosimilars which have been Approved and Launched
Table 4.14 Selected EPO Biosimilars Approved in India
Table 4.15 European Biosimilar Approvals: G-CSF
Table 4.16 Selected Filgrastim Biosimilars Approved Worldwide, 2016
Table 4.17 Other Recombinant Hormones Submarket Forecast: Revenues ($bn), AGR (%), CAGR (%), 2015-2020
Table 4.18 Other Recombinant Hormones Submarket Forecast: Revenues ($bn), AGR (%), CAGR (%), Market Share (%), 2021-2026
Table 4.19 Selected Coagulating Factors Significant in Segment
Table 4.20 Plasma and Recombinant Coagulating Factors Submarket Forecast: Revenues ($bn), AGR (%), CAGR (%), 2015-2020
Table 4.21 Plasma and Recombinant Coagulating Factors Submarket Forecast: Revenues ($bn), AGR (%), CAGR (%), 2021-2026
Table 4.22 Selected Approved Branded Interferon Therapies
Table 4.23 Avonex Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2015-2020
Table 4.24 Avonex Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
Table 4.25 Rebif Revenue Forecast: Revenue ($m), AGR (%), CAGR (%), 2015-2020
Table 4.26 Rebif Revenue Forecast: Revenue ($m), AGR (%), CAGR (%), 2021-2026
Table 4.27 Selected Interferon Alfa Biosimilars Approved Worldwide, 2016
Table 4.28 Selected Interferon Beta Biosimilars Approved Worldwide, 2016
Table 4.29 Interferon Submarket Forecast: Revenues ($bn), AGR (%), CAGR (%), 2015-2020
Table 4.30 Interferon Submarket Forecast: Revenues ($bn), AGR (%), CAGR (%), 2021-2026
Table 4.31 Enzyme Replacement and Other Protein Therapeutics Submarket Forecast: Revenues ($bn), AGR (%), CAGR (%), 2015-2020
Table 4.32 Enzyme Replacement and Other Protein Therapeutics Submarket Forecast: Revenues ($bn), AGR (%), CAGR (%), 2021-2026
Table 5.1 Regions of an Antibody
Table 5.2 Natural Antibody Mechanisms of Action
Table 5.3 Top Five Best-Selling Drugs, 2015: Revenue ($bn)
Table 5.4 Selected Biosimilar Adalimumab Candidates
Table 5.5 Humira Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2015-2020
Table 5.6 Humira Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
Table 5.7 Remicade 2015 Revenue Breakdown: Revenue ($bn), Percentage Change over 2014 (%)
Table 5.8 Remicade Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2015-2020
Table 5.9 Remicade Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
Table 5.10 Stelara Revenue 2013-2015: Revenue ($bn), AGR (%),
Table 5.11 Total Tysabri Revenues 2011-2015, Revenues ($bn), AGR (%), CAGR (%)
Table 5.12 Tysabri Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2015-2020
Table 5.13 Tysabri Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
Table 5.14 Xolair Revenue Breakdown (between Roche and Novartis): Revenue ($bn), AGR (%), 2014-2015
Table 5.15 Selected Ongoing Sirukumab (CNTO-136) Clinical Trials, 2016
Table 5.16 Selected Ongoing Lebrikizumab Clinical Trials, 2016
Table 5.17 Selected Ongoing Anifrolumab Clinical Trials, 2016
Table 5.18 Herceptin Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2015-2020
Table 5.19 Herceptin Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
Table 5.20 Kadcyla Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2015-2020
Table 5.21 Kadcyla Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
Table 5.22 Perjeta Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2015-2020
Table 5.23 Perjeta Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
Table 5.24 FDA-Approved Indications for Cyramza
Table 5.25 Monoclonal Antibodies Submarket Forecast: Revenue ($bn), AGR (%), CAGR (%), 2015-2020
Table 5.26 Monoclonal Antibodies Submarket Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
Table 6.1 Amgen’s US Patents and Expiry Dates for Enbrel
Table 6.2 Enbrel Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2015-2020
Table 6.3 Enbrel Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
Table 6.4 Eylea Revenue Breakdown 2015: Regeneron and Bayer
Table 6.5 Eylea Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2015-2020
Table 6.6 Eylea Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
Table 6.7 Fusion Proteins Submarket Forecast: Revenue ($bn), AGR (%), CAGR (%), 2015-2020
Table 6.8 Fusion Proteins Submarket Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
Table 7.1 Regenerative Medicines Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2015-2020
Table 7.2 Regenerative Medicines Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
Table 7.3 Potency and Source of Stem Cells
Table 7.4 Osteocel Plus Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2015-2020
Table 7.5 Osteocel Plus Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
Table 7.6 Trinity Evolution and Trinity Elite Revenue Forecast: Revenue ($m), AGR (%), CAGR (%), 2015-2020
Table 7.7 Trinity Evolution and Trinity Elite Revenue Forecast: Revenue ($m), AGR (%), CAGR (%), 2021-2026
Table 7.8 Stem Cell Therapies Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2015-2020
Table 7.9 Stem Cell Therapies Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
Table 7.10 Apligraf Revenue Forecast: Revenue ($m), AGR (%), CAGR (%), 2015-2020
Table 7.11 Apligraf Revenue Forecast: Revenue ($m), AGR (%), CAGR (%), 2021-2026
Table 7.12 Dermagraft Revenue Forecast: Revenue ($m), AGR (%), CAGR (%), 2015-2020
Table 7.13 Dermagraft Revenue Forecast: Revenue ($m), AGR (%), CAGR (%), 2021-2026
Table 7.14 Tissue Engineering Therapies Submarket: Revenues ($bn), AGR (%), CAGR (%), 2015-2020
Table 7.15 Tissue Engineering Therapies Submarket: Revenues ($bn), AGR (%), CAGR (%), 2021-2026
Table 7.16 IMLYGIC Revenue Forecast: Revenue ($m), AGR (%), CAGR (%), 2015-2020
Table 7.17 IMLYGIC Revenue Forecast: Revenue ($m), AGR (%), CAGR (%), 2021-2026
Table 7.18 Gene Therapies Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2015-2020
Table 7.19 Gene Therapies Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
Table 8.1 Regional Forecasts for the Global Biologics Market: Revenues ($bn), AGR (%), CAGR (%), Market Share (%), 2015-2020
Table 8.2 Regional Forecasts for the Global Biologics Market: Revenues ($bn), AGR (%), CAGR (%), Market Share (%), 2021-2026
Table 8.3 US Biologics Market: Revenues ($bn), AGR (%), CAGR (%), Global Market Share (%), 2015-2020
Table 8.4 US Biologics Market: Revenues ($bn), AGR (%), CAGR (%), Global Market Share (%), 2021-2026
Table 8.5 European Biosimilar Approvals, 2006-2016
Table 8.6 EU5 Biologics Market: Revenues ($bn), AGR (%), CAGR (%), EU5 Market Share (%), 2015-2020
Table 8.7 EU5 Biologics Market: Revenues ($bn), AGR (%), CAGR (%), EU5 Market Share (%), 2021-2026
Table 8.8 Japanese Biologics Market: Revenues ($bn), AGR (%), CAGR (%), Global Market Share (%), 2015-2020
Table 8.9 Japanese Biologics Market: Revenues ($bn), AGR (%), CAGR (%), Global Market Share (%), 2021-2026
Table 8.10 BRIC Biologics Market: Revenues ($bn), AGR (%), CAGR (%), BRIC Market Share (%), 2015-2020
Table 8.11 BRIC Biologics Market: Revenues ($bn), AGR (%), CAGR (%), BRIC Market Share (%), 2021-2026

List of Figures
Figure 1.1 Forecasted Submarkets of the Biologics Market
Figure 3.1 Global Biologics Market Forecast: Revenues ($bn), 2015-2026
Figure 3.2 Submarkets within the Biologics Market, Forecast: Revenues ($bn), 2015-2026
Figure 4.1 Protein Therapeutics Submarket Forecast: Revenues ($bn), 2015-2026
Figure 4.2 Diabetes Prevalence in Leading National Markets, 2014
Figure 4.3 Insulin Submarket Forecast: Revenues ($bn), 2015-2026
Figure 4.4 Lantus Revenue Forecast: Revenues ($bn), 2015-2026
Figure 4.5 NovoLog/NovoRapid Revenue Forecast: Revenues ($bn), 2015-2026
Figure 4.6 Humalog Revenue Forecast: Revenues ($bn), 2015-2026
Figure 4.7 Other Recombinant Hormones Submarket Forecast: Revenues ($bn), 2015-2026
Figure 4.8 Plasma and Recombinant Coagulating Factors Submarket Forecast: Revenues ($bn), 2015-2026
Figure 4.9 Avonex Revenue Forecast: Revenue ($m), 2015-2026
Figure 4.10 Rebif Revenue Forecast: Revenue ($bn), 2015-2026
Figure 4.11 Interferon Submarket Forecast: Revenues ($bn), 2015-2026
Figure 4.12 Enzyme Replacement and Other Protein Therapeutics Submarket Forecast: Revenues ($bn), 2015-2026
Figure 5.1 Humira Revenue Forecast: Revenue ($bn), 2015-2026
Figure 5.2 Remicade Revenue Forecast: Revenue ($bn), 2015-2026
Figure 5.3 Stelara Revenue 2013-2015: Revenue ($bn)
Figure 5.4 Total Tysabri Revenues 2011-2015, Revenues ($m)
Figure 5.5 Tysabri Revenue Forecast: Revenue ($m), 2015-2026
Figure 5.6 Herceptin Revenue Forecast: Revenue ($bn), 2015-2026
Figure 5.7 Kadcyla Revenue Forecast: Revenue ($m), 2015-2026
Figure 5.8 Perjeta Revenue Forecast: Revenue ($bn), 2015-2026
Figure 5.9 Monoclonal Antibodies Submarket Forecast: Revenue ($bn), 2015-2026
Figure 6.1 Enbrel Revenue Forecast: Revenue ($bn), 2015-2026
Figure 6.2 Eylea Revenue Forecast: Revenue ($bn), 2015-2026
Figure 6.3 Fusion Proteins Forecast: Revenue ($bn), 2015-2026
Figure 7.1 Regenerative Medicines Market Forecast: Revenue ($bn), 2015-2026
Figure 7.2 Osteocel Plus Revenue Forecast: Revenue ($bn), 2015-2026
Figure 7.3 Trinity Evolution and Trinity Elite Revenue Forecast: Revenue ($m), 2015-2026
Figure 7.4 Stem Cell Therapies Market Forecast: Revenue ($bn), 2015-2026
Figure 7.5 Apligraf Revenue Forecast: Revenue ($m), 2015-2026
Figure 7.6 Dermagraft Revenue Forecast: Revenue ($m), 2015-2026
Figure 7.7 Tissue Engineering Therapies Submarket: Revenues ($bn), 2015-2026
Figure 7.8 IMLYGIC Revenue Forecast: Revenue ($m), 2015-2026
Figure 7.9 Gene Therapies Market Forecast: Revenue ($bn), 2015-2026
Figure 8.1 Regional Breakdown of Global Biologics Market: Revenues ($bn), Market Share (%), 2015
Figure 8.2 Regional Breakdown of Global Biologics Market: Revenues ($bn), Market Share (%), 2026
Figure 8.3 Regional Forecasts for Global Biologics Market: Revenues ($bn), 2015-2026
Figure 8.4 US Biologics Market: Revenues ($bn), 2015-2026
Figure 8.5 EU5 Market Breakdown: Market Share (%), 2015
Figure 8.6 EU5 Biologics Market: Revenues ($bn), 2015-2026
Figure 8.7 Japanese Biologics Market: Revenues ($bn), 2015-2026
Figure 8.8 Biologics Market Breakdown: Revenues ($bn), Market Share (%), 2015
Figure 8.9 BRIC Biologics Market: Revenues ($bn), 2015-2026
Figure 8.10 Biologics Market Breakdown: Revenues ($bn), Market Share (%), 2026
Figure 9.1 SWOT Analysis of Biologics Market and Industry, 2016-2026
Figure 9.2 STEP Analysis of Biologics Market and Industry, 2016-2026
Figure 10.1 Global Biologics Market Forecast: Revenues ($bn), Annual Growth Rate (%), 2015-2026
Figure 10.2 Breakdown by Submarket: Revenues ($bn), 2015-2026

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