【レポートの概要（一部）】
1. Report Overview
1.1 Overview of the Next-Generation Biologics Market
1.2 Why You Should Read This Report
1.3 How This Report Delivers
1.4 Main Questions Answered by This Analytical Study
1.5 Who is This Report For?
1.6 Methodology
1.7 Frequently Asked Questions (FAQ)
1.8 Associated Reports
1.9 About Visiongain
2. Introduction to Next-Generation Biologics
2.1 Brief History of Biological Drug Development
2.1.1 Limitations of Present-Generation Biological Drugs
2.2 The Promise of Next-Generation Biologics
2.2.1 Defining Next-Generation Biologics
2.2.1.1 A Definition of Regenerative Medicine
2.2.1.2 Extending Half-Life: Pegylation and Other Novel Strategies
3. World Next-Generation Biologics Market: Outlook and Forecast 2016-2026
3.1 The Next-Generation Biologics Market 2015
3.1.1 Development of the Next-Generation Biologics Market 2008-2015
3.1.2 Rising Demand for Biological Therapies
3.1.3 Next-Generation Drugs as a Share of the Biologics Market 2015
3.1.4 Main Sectors of the Next-Generation Biologics Market: Antibodies and Regenerative Medicine Lead the Way
3.1.5 Leading Companies in the Next-Generation Biologics Market 2015
3.2 The Next-Generation Biologics Market 2016-2026
3.2.1 Growth Drivers for Biological Drug Revenues 2016-2026
3.2.2 The Next-Generation Biologics Market Forecast 2016-2026
3.2.3 Product Launches in All Sectors to Drive Market Growth 2016-2026
3.2.4 Next-Generation Biologics: Market Restraints 2016-2026
3.2.5 Rising Market Shares for Next-Generation Insulins 2016-2026
4. Leading National Submarkets for Next-Generation Biologics 2016-2026
4.1 Leading National Submarkets for Next-Generation Biologics, 2015
4.1.1 National Submarket Forecasts 2016-2026
4.1.2 How Will National Submarket Shares Change to 2026?
4.2 Rising Disease Incidence in Important Markets 2016-2026
4.3 Approval of Next-Generation Biologics in Leading National Submarkets
4.4 The US Will be the Largest Submarket for Next-Generation Biologics 2016-2026
4.4.1 US Submarket Forecast 2016-2026
4.5 Next-Generation Biologics in Japan 2016-2026
4.5.1 National Expertise in Stem Cell Research
4.5.2 Japanese Submarket Forecast 2016-2026
4.6 Next-Generation Biologics in Leading EU Countries 2016-2026
4.6.1 Regenerative Medicine Development in the EU
4.6.2 Market Access for Next-Generation Biologics in the EU
4.6.3 Germany: Submarket Forecast 2016-2026
4.6.4 France: Submarket Forecast 2016-2026
4.6.5 UK: Submarket Forecast 2016-2026
4.6.6 Italy and Spain: Submarket Forecasts 2016-2026
4.7 Next-Generation Biologics in Emerging Markets 2016-2026
4.7.1 Next-Generation Biologics Development in Emerging Countries
4.7.2 Chinese Submarket Forecast 2016-2026
4.7.3 Indian Submarket Forecast 2016-2026
5. Next-Generation Antibodies: Submarket Outlooks 2016-2026
5.1 Strategies for Improving Antibody Therapies
5.1.1 Antibody-Drug Conjugates: Targeted Cytotoxic Therapies
5.1.2 Engineering Antibodies for Improved Potency
5.1.3 Bispecific Antibodies
5.2 Next-Generation Antibody Therapy Submarket
5.3 Next-Generation Antibody Therapy Submarket 2016-2026
5.3.1 Strong Revenue Growth for Next-Generation Antibodies 2016-2026
5.3.2 Blockbuster Potential Will Drive Growth to 2026: Kadcyla, Adcetris and Cosentyx
5.3.3 Next-Generation Antibodies: Submarket Restraints 2016-2026
5.4 Antibody-Drug Conjugates (ADC) Submarket 2016-2026
5.4.1 Antibody-Drug Conjugates Submarket Forecast 2016-2026
5.4.1.1 Kadcyla and Adcetris: Revenue Forecast 2016-2026
5.4.2 What Will Drive Growth for ACDs to 2026?
5.4.3 A Long Pipeline of ADCs in Clinical Development
5.4.3.1 CMC544 (Pfizer): NHL Development Halted but Trials in ALL Continue
5.4.3.2 NKTR-102 (Nektar Therapeutics): Phase III for Metastatic Breast Cancer
5.4.3.3 CDX-011: Potential for Accelerated Approval in Breast Cancer
5.5 Engineered Antibodies Submarket 2016-2026
5.5.1 Engineered Antibodies Submarket Forecast 2016-2026
5.5.1.1 Gazvya Will Lead the Submarket in 2026
5.5.2 Portfolio Management to Drive Growth 2016-2026
5.5.3 Engineered Antibodies Pipeline 2016
5.5.3.1 Benralizumab (MedImmune/Kyowa Hakko Kirin)
5.6 Bispecific Antibodies Submarket 2016-2026
5.6.1 Bispecific Antibodies Submarket Forecast 2016-2026
5.6.2 Bispecific Antibodies: Submarket Drivers and Restraints 2016-2026
5.6.3 One New Approval and Two Phase II Bispecific Antibodies in 2016
5.6.3.1 Blincyto (Amgen): The Second Approved Bispecific Antibody
6. Antibody Fragments and Novel Antibody-like Drugs: Commercial Potential 2016-2026
6.1 Next-Generation Antibody Fragments: Beyond Fab Fragments
6.1.1 Antibody-Like Proteins Mimic Antibody Therapies
6.1.2 There are Advantages to Using Fragments and Novel Scaffolds
6.2 Antibody Fragment and ALP Submarket 2016-2026
6.2.1 Antibody Fragment and ALP Submarket Forecast 2016-2026
6.2.2 Pharma is Investing Strongly in Antibody Fragments and ALPs
6.2.3 Limited Late-Stage R&D Pipeline to Restrain Growth to 2026
6.3 Outlook for Next-Generation Antibody Fragments 2016-2026
6.3.1 Next-Generation Antibody Fragment Submarket Forecast 2016-2026
6.3.2 One Platform Leads the Pipeline in 2016
6.3.2.1 Three Nanobodies in Development for Rheumatoid Arthritis
6.3.2.2 Caplacizumab (Ablynx): Targeting an Orphan Indication
6.4 The Antibody-Like Protein Submarket 2016-2026
6.4.1 Antibody-Like Protein Submarket Forecast 2016-2026
6.4.2 Four ALPs in Clinical Development in 2016
6.4.2.1 Abicipar Pegol (Allergan/Molecular Partners): Development of the Lead Clinical ALP Delayed
6.5 Will Next-Generation Immunotoxins Change the Market to 2026?
6.5.1 Challenges With First Generation Immunotoxins
6.5.2 Fusion Protein Conjugates: Pipeline 2016
6.5.2.1 Moxetumomab Pasudotox
6.5.3 Humanised Immunotoxins
6.5.3.1 Using Granzyme B in Immunotoxins
6.5.3.2 Immunornases: A Future Development Opportunity for Immunotoxins
7. Next-Generation Insulin Submarket: Outlook 2016-2026
7.1 Strategies for Next-Generation Insulin Development
7.1.1 Reformulating Insulin for Convenient Administration
7.1.1.1 Oral Insulin
7.1.1.2 Inhaled Insulin
7.1.1.3 Exubera: A Failed Attempt at Reformulated Insulin
7.2 Next-Generation Insulin Submarket 2016-2026
7.2.1 Tresiba: Approved in the EU and Japan
7.2.1.1 Tresiba: Revenue Forecast 2016-2026
7.3 Next-Generation Insulin Submarket 2016-2026
7.3.1 Next-Generation Insulin Submarket Forecast 2016-2026
7.3.2 Product Launches in the US and EU Will Drive Submarket Growth 2016-2026
7.3.3 Next-Generation Insulin Submarket Restraints 2016-2026
7.3.3.1 Biosimilar Insulins are Available Since 2015
7.4 Oral Insulin Submarket 2016-2026
7.4.1 Oral Insulin Submarket Forecast 2016-2026
7.4.2 Oral Insulin: Submarket Drivers and Restraints 2016-2026
7.4.3 A Limited Clinical-Stage Pipeline for Oral Insulin 2016
7.4.3.1 Oramed Pharmaceuticals: Oral Insulin in Phase II
7.4.3.2 Oshadi Icp: Phase II Currently Recruiting
7.4.3.3 IN-105: Biocon Partners with Bristol-Myers Squibb for Development
7.4.3.4 Diabetology: Multiple Deals Signed for Emerging Markets
7.4.3.5 Novo Nordisk: NN-1953
7.5 Ultra-Rapid Acting Insulin Submarket 2016-2026
7.5.1 Ultra-Rapid Acting Insulin Submarket Forecast 2016-2026
7.5.1.1 Will Inhaled Insulins Drive Revenue Growth to 2026?
7.5.2 Other Submarket Drivers and Restraints 2016-2026
7.5.3 Ultra-Rapid Acting Insulin Pipeline 2016
7.5.3.1 FlAsp (Novo Nordisk)
7.5.3.2 Adocia: Eli Lilly Opts to Discontinue Partnership
7.5.3.3 Halozyme Therapeutics
7.5.3.4 Biodel: Multiple Ultra Rapid Acting Candidates
7.5.3.5 Afrezza: Inhaled Insulin Nearing the Market
7.5.3.6 Adagio: A Second-Generation Inhaled Insulin
7.6 Ultra-Long Acting Insulin Submarket 2016-2026
7.6.1 Ultra-Long Acting Insulin Submarket Forecast 2016-2026
7.6.2 Revenue Growth Driven by Uptake of Tresiba
7.6.3 Ultra-Long Acting Insulin Pipeline 2016
7.6.3.1 Toujeo: Sanofi’s Next-Generation Insulin Analogue
7.6.3.2 LY2605541 (Eli Lilly)
7.6.3.3 LAPS-Insulin
8. Next-Generation Developments for Other Recombinant Proteins 2016-2026
8.1 Defining Next-Generation for Other Recombinant Protein Sectors
8.1.1 Next-Generation Interferon Beta: Plegridy Revenue Forecast 2016-2026
8.1.1.1 Plegridy May Compete With Other Long-Acting Interferon Beta Therapies 2016-2026
8.1.2 Next-Generation G-CSF: Teva Expands its Filgrastim Franchise
8.1.2.1 Other Clinical-Stages Advances in Filgrastim Therapy 2016
8.2 Next-Generation Recombinant Coagulation Factors 2016-2026
8.2.1 Next-Generation Recombinant Coagulation Factors Submarket Forecast 2016-2026
8.2.2 Submarket Drivers and Restraints 2016-2026
8.2.3 Clinical Pipeline for Recombinant Coagulation Factors 2016-2026
8.2.3.1 Fused Factors: Biogen Idec’s Eloctate and Alprolix
8.2.3.2 Baxter’s BAX 855
8.2.3.3 CSL Behring’s rlX-FP: Albumin-Bound Coagulation Factors
8.2.3.4 Bayer’s BAY94-9027
8.2.3.5 Novo Nordisk’s N8-GP for Haemophilia A
8.2.3.6 Novo Nordisk’s N9-GP for Haemophilia B
8.2.4 Gene Therapy as a New Treatment Option for Haemophilia
8.3 Next-Generation Growth Hormones 2016-2026
8.3.1 Next-Generation Growth Hormone Submarket Forecast 2016-2026
8.3.2 Brand Loyalty Will Restrain Uptake of Next-Generation Hormone 2016-2026
8.3.3 Long-Acting Growth Hormones
8.3.3.1 Biopartners/LG Life Sciences: The First Long-Acting Growth Hormone
8.3.3.2 Prolor Biotech/OPKO Health
8.3.3.3 Novo Nordisk: Looking to Extend its Market-Leading Position
8.3.3.4 Versartis: XTEN Technology for Half-Life Extension
8.3.4 Reformulated Growth Hormones: Offering Convenient Dosing for Paediatric Patients
8.3.4.1 Critical Pharmaceuticals: Nasal Delivery of Somatropin
9. Regenerative Medicine: Commercial Outlook 2016-2026
9.1 The Regenerative Medicine Submarket in 2015
9.1.1 Defining Regenerative Medicine
9.2 The Regenerative Medicine Submarket: Revenue Projections 2016-2026
9.2.1 Stem Cell and Gene Therapy Launches to Drive Growth 2016-2026
9.3 The Stem Cell Therapies Submarket 2016-2026
9.3.1 Prochymal (Mesoblast) for GvHD
9.3.1.1 The Future for Prochymal: Approval in Crohn’s Disease?
9.3.1.2 A Note on Stem Cell Transplants
9.3.2 Stem Cell Therapies Submarket Forecast 2016-2026
9.3.3 Stem Cell Therapies: Submarket Drivers and Restraints 2016-2026
9.3.3.1 Will iPSCs Prove Effective for Stem Cell Therapy?
9.3.4 Stem Cell Therapies Late-Stage Pipeline 2016
9.3.4.1 Cx601 (TiGenix)
9.3.4.2 Mesoblast: Mesenchymal Stem Cell Therapies
9.3.4.3 Baxter Pharmaceuticals: A Leading Cardiovascular Candidate
9.3.4.4 StemEx (Gamida Cell)
9.4 Outlook for Tissue Engineering 2016-2026
9.4.1 Two Sectors Lead the Market: Wound and Cartilage Repair
9.4.1.1 Apligraf Leads the Wound Repair Submarket
9.4.1.2 Organogenesis Markets Apligraf and Dermagraft from 2014
9.4.2 Tissue Engineering Submarket Forecast 2016-2026
9.4.3 Tissue Engineering: Submarket Drivers and Restraints 2016-2026
9.4.4 Future Developments in Cartilage Repair: Pipeline 2016
9.4.5 Organ Repair and Engineering: The Next Step in Tissue Engineering?
9.4.5.1 Engineered Skin
9.4.5.2 Engineered Veins
9.4.5.3 Organ Transplant: A Long-Term Tissue Engineering Opportunity
9.5 The Gene Therapies Submarket 2016-2026
9.5.1 Glybera Approved and Set for Launch in the EU
9.5.2 Gene Therapies Submarket: Revenue Projections 2016-2026
9.5.3 Glybera’s Approval Driving Submarket Growth Since 2014
9.5.4 There are More Than Five Gene Therapies in Late-Stage Development
9.5.4.1 ProstAtak: Gene Therapy for Prostate Cancer
9.5.4.2 TVEC (Amgen)
9.5.4.3 Generx (Cardium Therapeutics)
9.5.4.4 Spark Therapeutics: Established in 2013 for Ophthalmic Gene Therapy
10. Next-Generation Biologics: Industry Trends 2016-2026
10.1 Next-Generation Biologics: Market Strengths 2016
10.2 Next-Generation Biologics: Market Weakness 2016
10.3 The Next-Generation Biologics Market: STEP Analysis 2016-2026
10.3.1 Social Factors: Rising Disease Incidence and Demands for Convenience
10.3.1.1 Rising Incidence in Cardiovascular Disease, Cancer and Diabetes
10.3.1.2 Next-Generation Biologic Development in Emerging Markets
10.3.2 Technological Developments 2016-2026
10.3.3 Economic Pressures 2016-2026
10.3.3.1 High Drug Costs and Healthcare Spending
10.3.3.2 Limited Commercial Potential in Emerging Markets?
10.3.4 Political Issues: Regulatory Developments 2016-2026
10.4 Next-Generation Biologics: Development Trends 2016-2026
10.4.1 Improving Patient Convenience
10.4.2 Sustained Release Biologics: Pegylation and Beyond
10.4.3 Therapeutic Focus for Next-Generation Biologics
10.4.4 Next-Generation Biologics as Personalised Medicine
10.5 Manufacturing Challenges and Opportunities for Next-Generation Biologics
10.5.1 Contract Manufacturers Invest to Follow Development Trends
10.6 Commercialising Next-Generation Biologics
10.6.1 Product Lifecycle Management for First Generation Biologics
10.6.2 Proving Benefit in Next-Generation Products
10.6.3 Biosimilars as a Challenger 2016-2026
10.7 Partnering for Next-Generation Biologic Development
10.7.1 The Role of Big Pharma in the Next-Generation Biologics Market
10.7.2 Most Development Platforms Stem from Small Biotechs
11. Research Interviews from Our Survey
11.1 Dr Edwin Moses, CEO, Ablynx
11.1.1 Ablynx
11.1.2 Ablynx’s Pipeline and Nanobody Technology
11.1.3 On Caplacizumab
11.1.4 Challenged with Current Biological Therapies
11.1.5 The Next-Generation Biologics Market, 2016-2026
11.2 Dr Mike Romanos, CEO, Crescendo Biologics
11.2.1 Crescendo Biologics
11.2.2 The Benefits in Antibody Fragment Therapies
11.2.3 Treatment of Inflammation Indications with Antibody Fragments
11.2.4 Crescendo’s Fragment Pipeline
11.2.5 Development and Production Platforms for Antibody Therapies
11.2.6 Crescendo’s Humabody ADCs and Multi-Specific T-Cell Engagers
11.2.7 CB001, A Topical Biologic
11.2.8 The Next-Generation Biologics Market, 2015-2025
11.3 Sorrento Therapeutics Inc. Team: Dr Gunnar Kaufmann, VP of Research; Dr Kouros Motamed, VP, Strategic Alliances and Clinical Communications; George Uy, EVP and CCO
11.3.1 Sorrento Therapeutics Inc.
11.3.2 Sorrento’s Pipeline
11.3.3 Drivers and Restraints for Next-Generation Biologics
11.3.4 The Next-Generation Biologics Market, 2015-2025
11.4 Dr Fredrik Frejd, CSO, Affibody
11.4.1 Affibody
11.4.2 Challenges with Current Biological Therapies
11.4.2.1 Current Half-Life Extension Technologies
11.4.3 The Benefits of Affibodies Over Current Antibody Therapies
11.4.4 Focus on Inflammation and Autoimmune Diseases
11.4.5 Development of SOBI002
11.4.6 Regulatory Challenges with Novel Biologics
12. Conclusions from Our Research and Analysis
12.1 The Next-Generation Biologics Market Will Grow Strongly to 2026
12.2 Next-Generation Antibody Development Will Lead the Market
12.3 New Treatment Regimens Will Drive Demand for Next-Generation Biologics
12.4 Leading Regional Markets
12.5 Challenges Remain in Developing and Commercialising Next-Generation Biologics
【レポート販売概要】
■ タイトル：次世代生物学的製剤の世界市場2016-2026■ 英文：Next-Generation Biologics Market 2016-2026
■ 発行日：2016年5月
■ 調査会社：visiongain
■ 商品コード：VGAIN60626
■ 調査対象地域：グローバル
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