Next-Generation Biologics: R&D, Industry and Market Forecasts 2015-2025

次世代生物製剤の世界市場:抗体、再生医療、抗体断片/ALP、インスリン、組換え型血液凝固因子、成長ホルモン

◆タイトル:Next-Generation Biologics: R&D, Industry and Market Forecasts 2015-2025
◆商品コード:VGAIN5052608
◆調査・発行会社:visiongain
◆発行日:2015年5月
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【レポートの概要】

当調査レポートでは、次世代生物製剤の世界市場について調査・分析し、以下の構成でお届けいたします。

・レポートの概要
・イントロダクション
・次世代生物製剤の世界市場
 (市場規模予測、市場の成長要因・阻害要因など)
・次世代生物製剤の世界市場:セグメント別市場分析
 - 抗体市場
 - 再生医療市場
 - 抗体断片/ALP市場
 - インスリン市場
 - 組換え型血液凝固因子市場
 - 成長ホルモン市場
・地域別市場分析、市場規模予測
・市場環境分析
・専門家の見解
・主要企業分析
・結論

Emerging Biological Drugs – This New Study Reveals Selling Opportunities and Revenue Prospects to Help You Stay Ahead
What’s the future of biologics, especially new drug classes? Now get the latest technological and commercial analysis. Staying ahead in data and knowledge, you benefit your influence. And you explore trends, developments, results, opportunities and sales predictions.

Visiongain’s new study reveals what’s possible for biological drugs – their lucrative next phase. That survey helps you avoid missing out. Instead find developments in that industry and market, discovering expected progress and revenues. Discover where the money lies.

New biotechnological medicines will benefit patients and pharmaceutical companies. Read on to explore those therapies, hearing how high revenues can go.

Forecasting and other information showing the most promising opportunities for treatments
That updated report gives sales forecasts to 2025 at overall world, submarket, product and national level. You see what the future holds, assessing gains for developers and producers.

Many opportunities exist. And besides giving revenue predictions, that new analysis shows recent results, growth rates and market shares. There you discover 90 tables, 49 charts and four interviews with companies in the biopharmaceuticals industry.

There you get intelligence on competitors and their activities, especially products, deals and R&D. And the following sections explain what our new investigation gives you.

Analyses exclusive to that study, showing the most important commercial potentials
In our report you get data found nowhere else. Discover what’s really going on. Our forecasting system goes to the core of the biopharmaceutical industry’s sales potential unlike any other work, giving revenue predictions and their meanings.

That analysis benefits your plans, decisions and influence by interpreting medical needs, R&D and companies’ technologies. You hear what’s happening there, assessing likely gains.

With those analyses you see where potential and money lie, also saving time and effort. And help your reputation for technological and commercial insight.

Prospects for that world market and submarkets – discover what’s possible for those biopharmaceuticals
In our report, see overall world sales to 2025 for those emerging biotherapies, with discussions.

Also get individual revenue predictions to 2025 for seven next-generation biologic submarkets at world level, and further subdivisions:
• Antibodies, including monoclonal antibodies (mAbs), with sub-forecasting for antibody-drug conjugates (ADCs), engineered and bispecific agents
• Regenerative medicine, with submarket breakdowns for tissue engineering, stem cells and gene therapies
• Antibody fragments and antibody-like proteins (ALPs)
• Insulins, also with predictions for ultra-long-acting, ultra-rapid-acting and oral treatments
• Recombinant coagulation factors with extended half lives
• Growth hormones, including oral and nasal formulations and long-acting therapies
• Other next-stage (follow-on) therapeutic proteins.

Next-generation biologics that treat new indications will be launched within 10 years. And you assess outlooks for market expansion, hearing where you could gain.

Our study also explores competition. There you see what’s happening for developers, producers and sellers of new-generation biologics, understanding challenges, trends and outlooks.

That work also splits its overall world market into leading products, showing where you could profit from new and improved biotechnological medicines.

Product forecasts for new forms, variations and uses of biological therapy
How will individual drugs perform to 2025 at world level? Our report predicts revenues of eight top brands:
• Kadcyla
• Adcetris
• Tresiba
• Alprolix
• Eloctate
• Gazyva/Gazyvaro
• Plegridy
• Afrezza


There you explore products and years with highest predicted sales. You also examine competitors. Hear what’s happening, understanding challenges, trends, competition and opportunities.

For treating people and saving lives, you investigate progress, needs and possibilities. Discover how pharma companies satisfy those demands, also assessing expected financial gains.

That work also shows you geographical revenue forecasts.

Demand in national markets – what outlooks for business in new biopharma products?
Advances in biotechnology and healthcare expand use of novel biological drugs in developed and developing countries. Many opportunities exist for new, improved treatments.

And our analyses show you individual revenue forecasts to 2025 for nine national markets:
• United States (US)
• Germany, France, the United Kingdom (UK), Italy and Spain (EU5 countries)
• Japan
• India
• China.

There you hear about the best sales potentials, appraising national opportunities for next-generation biologicals. See where and how you can profit.

And what events influence the biological drugs industry? What’s the outlook for tackling serious diseases? Our work shows you, discussing trends, challenges and opportunities.

Market forces and issues – what affects biopharma developers, producers and sellers?
The report explains trends, processes and events affecting the follow-on biopharmaceuticals industry and market from 2015, including these forces:
• Demands and needs rising for biological therapies
• Limitations of existing medicines
• Promise of next-generation biologics and product launches
• Extension of half-life – pegylation and other technologies
• Contract manufacturers (CMOs) serving those developmental needs and trends.

And you explore these influences, among others:
• Disease incidence and prevalence affecting demand for those new medicines
• Improvements in therapeutic antibodies and variants, including targeted cytotoxic therapies
• R&D pipelines – e.g. for immunotoxins – including agents in clinical development
• Biosimilars and other follow-on protein agents transforming the biologicals market
• Effects of rising incidence rates in diabetes, cardiovascular disorders and cancer.

There discover what the future holds. That way you investigate political, economic, social and technological questions. And you find how R&D helps companies benefit patients.

That way explore what progress, trends and opportunities mean. And discover what helps and hinders participants in that biomedical industry, affecting companies’ results.

Biological drug technology and applications – companies and 2019 market value
What happens next? From 2015, novel and biosimilar treatments will benefit patients, healthcare providers and biomedical companies. Those advances will encourage investments, progress and higher revenues from more-advanced biological drugs.

And our study predicts the next-generation biologics market will reach $20bn worldwide in 2019 with strong revenue growth to 2025. See what’s possible and how you can gain.

That work also explores activities of these leading companies, among many other firms:
• Novo Nordisk
• Eli Lilly
• Allergan
• Molecular Partners
• Kyowa Hakko Kirin
• Biogen Idec
• Bayer
• Sanofi
• Pfizer

【レポートの目次】

1. Report Overview
1.1 Overview of the World Next-Generation Biologics Market
1.2 Why Should You Read This Report
1.3 How This Report Delivers
1.4 Main Questions Answered by This Analysis
1.5 Who Is This Study For?
1.6 Methods of Research and Analysis
1.7 Frequently Asked Questions (FAQs)
1.8 Some 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 Biologics
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 2015-2025
3.1 The Next-Generation Biologics Market 2014
3.1.1 Development of the Next-Generation Biologics Market 2008-2014
3.1.2 Rising Demand for Biological Therapies
3.1.3 Next-Generation Drugs as a Share of the Biologics Market 2014
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 2014
3.2 The Next-Generation Biologics Market 2015-2025
3.2.1 Growth Drivers for Biological Drug Revenues 2015-2025
3.2.2 The Next-Generation Biologics Market Forecast 2015-2025
3.2.3 Product Launches in All Sectors to Drive Market Growth 2015-2025
3.2.4 Next-Generation Biologics: Market Restraints 2015-2025
3.2.5 Rising Market Shares for Next-Generation Insulins 2015-2025

4. Leading National Submarkets for Next-Generation Biologics 2015-2025
4.1 Leading National Submarkets for Next-Generation Biologics 2014
4.1.1 National Submarket Forecasts 2015-2025
4.1.2 How Will National Submarket Shares Change to 2025?
4.2 Rising Disease Incidence in Important Markets 2015-2025
4.3 Approval of Next-Generation Biologics in Leading National Submarkets
4.4 The US Will be the Largest Submarket for Next-Generation Biologics 2015-2025
4.4.1 US Submarket Forecast 2015-2025
4.5 Next-Generation Biologics in Japan 2015-2025
4.5.1 National Expertise in Stem Cell Research
4.5.2 Japanese Submarket Forecast 2015-2025
4.6 Next-Generation Biologics in Leading EU Countries 2015-2025
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 2015-2025
4.6.4 France: Submarket Forecast 2015-2025
4.6.5 UK: Submarket Forecast 2015-2025
4.6.6 Italy and Spain: Submarket Forecasts 2015-2025
4.7 Next-Generation Biologics in Emerging Markets 2015-2025
4.7.1 Next-Generation Biologics Development in Emerging Countries
4.7.2 Chinese Submarket Forecast 2015-2025
4.7.3 Indian Submarket Forecast 2015-2025

5. Next-Generation Antibodies Submarket Outlooks 2015-2025
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 2013-2014
5.3 Next-Generation Antibody Therapy Submarket 2015-2025
5.3.1 Strong Revenue Growth for Next-Generation Antibodies 2015-2025
5.3.2 Blockbuster Potential Will Drive Growth to 2025: Kadcyla, Adcetris and Cosentyx
5.3.3 Next-Generation Antibodies: Submarket Restraints 2015-2025
5.4 Antibody-Drug Conjugates (ADC) Submarket 2015-2025
5.4.1 Antibody-Drug Conjugates Submarket Forecast 2015-2025
5.4.1.1 Kadcyla and Adcetris: Revenue Forecast 2015-2025
5.4.2 What Will Drive Growth for ADCs to 2025?
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 2015-2025
5.5.1 Engineered Antibodies Submarket Forecast 2015-2025
5.5.1.1 Gazyva Will Lead the Submarket in 2025
5.5.2 Portfolio Management to Drive Growth 2015-2025
5.5.3 Engineered Antibodies Pipeline 2015
5.5.3.1 Benralizumab (MedImmune/Kyowa Hakko Kirin)
5.6 Bispecific Antibodies Submarket 2015-2025
5.6.1 Bispecific Antibodies Submarket Forecast 2015-2025
5.6.2 Bispecific Antibodies: Submarket Drivers and Restraints 2015-2025
5.6.3 One New Approval and Two Phase II Bispecific Antibodies in 2015
5.6.3.1 Blincyto (Amgen): The Second Approved Bispecific Antibody

6. Antibody Fragments and Novel Antibody-Like Drugs: Commercial Potential 2015-2025
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 2015-2025
6.2.1 Antibody Fragment and ALP Submarket Forecast 2015-2025
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 2025
6.3 Outlook for Next-Generation Antibody Fragments 2015-2025
6.3.1 Next-Generation Antibody Fragment Submarket Forecast 2015-2025
6.3.2 One Platform Leads the Pipeline in 2015
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 2015-2025
6.4.1 Antibody-Like Protein Submarket Forecast 2015-2025
6.4.2 Four ALPs in Clinical Development in 2014
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 2025?
6.5.1 Challenges with First Generation Immunotoxins
6.5.2 Fusion Protein Conjugates: Pipeline 2014
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 2015-2025
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 2012-2014
7.2.1 Tresiba: Approved in the EU and Japan
7.2.1.1 Tresiba: Revenue Forecast 2015-2025
7.3 Next-Generation Insulin Submarket 2015-2025
7.3.1 Next-Generation Insulin Submarket Forecast 2015-2025
7.3.2 Product Launches in the US and EU Will Drive Submarket Growth 2015-2025
7.3.3 Next-Generation Insulin Submarket Restraints 2015-2025
7.3.3.1 Biosimilar Insulins Will be Available from 2015
7.4 Oral Insulin Submarket 2015-2025
7.4.1 Oral Insulin Submarket Forecast 2015-2025
7.4.2 Oral Insulin: Submarket Drivers and Restraints 2015-2025
7.4.3 A Limited Clinical-Stage Pipeline for Oral Insulin 2014
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 2015-2025
7.5.1 Ultra-Rapid Acting Insulin Submarket Forecast 2015-2025
7.5.1.1 Will Inhaled Insulins Drive Revenue Growth to 2025?
7.5.2 Other Submarket Drivers and Restraints 2015-2025
7.5.3 Ultra-Rapid Acting Insulin Pipeline 2014
7.5.3.1 FIAsp (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 2015-2025
7.6.1 Ultra-Long Acting Insulin Submarket Forecast 2015-2025
7.6.2 Revenue Growth Driven by Uptake of Tresiba
7.6.3 Ultra-Long Acting Insulin Pipeline 2015
7.6.3.1 Toujeo: Sanofi’s Next-Generation Insulin Analogue
7.6.3.2 LY2605541 (Eli Lilly)
7.6.3.3 FT-105 (Flamel Technologies)
7.6.3.4 LAPS-Insulin

8. Next-Generation Developments for Other Recombinant Proteins 2015-2025
8.1 Defining Next-Generation for Other Recombinant Protein Sectors
8.1.1 Next-Generation Interferon Beta: Plegridy Set for Approval in 2014
8.1.1.1 Plegridy: Revenue Forecast 2015-2025
8.1.1.2 Plegridy May Compete with Other Long-Acting Interferon Beta Therapies 2015-2025
8.1.2 Next-Generation G-CSF: Teva Expands its Filgrastim Franchise
8.1.2.1 Other Clinical-Stages Advances in Filgrastim Therapy 2014
8.2 Next-Generation Recombinant Coagulation Factors 2015-2025
8.2.1 Next-Generation Recombinant Coagulation Factors Submarket Forecast 2015-2025
8.2.2 Submarket Drivers and Restraints 2015-2025
8.2.3 Clinical Pipeline for Recombinant Coagulation Factors 2015-2025
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 rIX-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 2015-2025
8.3.1 Next-Generation Growth Hormone Submarket Forecast 2015-2025
8.3.2 Brand Loyalty Will Restrain Uptake of Next-Generation Hormones 2015-2025
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 2015-2025
9.1 The Regenerative Medicine Submarket 2012-2014
9.1.1 Defining Regenerative Medicine
9.2 The Regenerative Medicine Submarket: Revenue Projections 2015-2025
9.2.1 Stem Cell and Gene Therapy Launches to Drive Growth 2015-2025
9.3 The Stem Cell Therapies Submarket 2015-2025
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 2015-2025
9.3.3 Stem Cell Therapies: Submarket Drivers and Restraints 2015-2025
9.3.3.1 Will iPSCs Prove Effective for Stem Cell Therapy?
9.3.4 Stem Cell Therapies Late-Stage Pipeline 2015
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 2015-2025
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 Will Market Apligraf and Dermagraft from 2014
9.4.2 Tissue Engineering Submarket Forecast 2015-2025
9.4.3 Tissue Engineering: Submarket Drivers and Restraints 2015-2025
9.4.4 Future Developments in Cartilage Repair: Pipeline 2015
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 2015-2025
9.5.1 Glybera Approved and Set for Launch in the EU
9.5.2 Gene Therapies Submarket: Revenue Projections 2015-2025
9.5.3 Glybera’s Approval to Drive Submarket Growth from 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 2015-2025
10.1 Next-Generation Biologics: Market Strengths 2014
10.2 Next-Generation Biologics: Market Weaknesses 2014
10.3 The Next-Generation Biologics Market: STEP Analysis 2015-2025
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 2015-2025
10.3.3 Economic Pressures 2015-2025
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 2015-2025
10.4 Next-Generation Biologics: Development Trends 2015-2025
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 2015-2025
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 Challenges with Current Biological Therapies
11.1.5 The Next-Generation Biologics Market, 2015-2025
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 and 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 the Research and Analysis
12.1 The Next-Generation Biologics Market Will Grow Strongly to 2025
12.1.1 Next-Generation Antibody Development Will Lead the Market
12.2 New Treatment Regimens Will Drive Demand for Next-Generation Biologics
12.3 Challenges Remain in Developing and Commercialising Next-Generation Biologics

List of Tables
Table 1.1 Next-Generation Biologics Market Forecast, 2014-2025
Table 1.2 Foreign Currency Exchange Rates: Average Exchange Rate to USD, 2013 and 2014
Table 2.1 First Approvals for Recombinant Protein Therapies, 1982-1997
Table 2.2 Filgrastim Market: Revenues by Drug ($bn), 2014
Table 3.1 Top Ten Bestselling Prescription Pharmaceuticals: Revenues ($bn), 2014
Table 3.2 Next-Generation Biologics Market: Revenues by Sector ($bn), 2014
Table 3.3 Biological Drugs Market: Drivers and Restraints, 2015-2025
Table 3.4 Next-Generation Biologics Market: Overall Market Forecast and Revenue Forecasts ($bn) by Sector, 2014-2025
Table 3.5 Next-Generation Biologics: Market Shares (%) by Sector, 2014, 2019 and 2025
Table 4.1 Next-Generation Biologics Market: Revenues ($bn) by National Submarket, 2014
Table 4.2 Next-Generation Biologics Market: Overall Market Forecast and Revenue Forecasts ($bn) by National Submarket, 2014-2025
Table 4.3 Next-Generation Biologics: Market Shares (%) by National Submarket, 2019 and 2025
Table 4.4 National Incidence and Prevalence of Leading Indications Treated with Biologics, 2014
Table 4.5 Main Approval Dates for Next-Generation Biologics in Leading National Submarkets, 2003-2013
Table 4.6 US Next-Generation Biologics Submarket Forecast ($bn), 2014-2025
Table 4.7 Biosimilars Approved and Marketed in Japan, 2014
Table 4.8 Japanese Next-Generation Biologics Submarket Forecast ($bn), 2014-2025
Table 4.9 Next-Generation Biologics Submarkets in the EU5 Nations: Revenues ($bn), 2014
Table 4.10 German Next-Generation Biologics Submarket Forecast ($bn), 2014-2025
Table 4.11 French Next-Generation Biologics Submarket Forecast ($bn), 2014-2025
Table 4.12 UK Next-Generation Biologics Submarket Forecast ($bn), 2014-2025
Table 4.13 Italian and Spanish Next-Generation Biologics Submarket Forecasts ($bn), 2014-2025
Table 4.14 Chinese Next-Generation Biologics Submarket Forecast ($bn), 2014-2025
Table 4.15 Indian Next-Generation Biologics Submarket Forecast ($bn), 2014-2025
Table 5.1 Monoclonal Antibodies Submarket: Leading Drug Revenues ($bn), 2014
Table 5.2 Selected Clinical and Pre-Clinical ADC Platforms, 2015
Table 5.3 Selected Clinical and Pre-Clinical Engineered Antibody Platforms, 2015
Table 5.4 Next-Generation Antibodies Submarket: Revenues by Sector ($bn), 2014
Table 5.5 Next-Generation Antibodies Submarket: Overall Submarket Forecast and Revenue Forecasts ($bn) by Sector, 2014-2025
Table 5.6 Next-Generation Antibodies Submarket: Drivers and Restraints, 2015-2025
Table 5.7 Antibody Drug Conjugates Submarket: Revenues ($bn) and Submarket Shares (%) by Drug, 2014
Table 5.8 Antibody-Drug Conjugates Submarket Forecast ($bn), 2014-2025
Table 5.9 Kadcyla and Adcetris: Revenue Forecasts ($bn), 2014-2025
Table 5.10 Antibody-Drug Conjugates Submarket: Drivers and Restraints, 2015-2025
Table 5.11 Selected Antibody-Drug Conjugates in Phase II and III Development, 2015
Table 5.12 Selected Antibody-Drug Conjugates in Phase I and I/II Development, 2015
Table 5.13 Engineered Antibodies Submarket Forecast ($bn), 2014-2025
Table 5.14 Gazyva/Gazyvaro: Revenue Forecast ($bn), 2014-2025
Table 5.15 Engineered Antibodies Submarket: Drivers and Restraints, 2015-2025
Table 5.16 Selected Engineered Antibodies in Phase II and III Development, 2015
Table 5.17 Bispecific Antibodies Submarket Forecast ($bn), 2014-2025
Table 5.18 Bispecific Antibodies Submarket: Drivers and Restraints, 2015-2025
Table 5.19 Bispecific Antibodies in Phase I and II Development, 2014
Table 6.1 Selected Next-Generation Antibody Fragment Platforms, 2015
Table 6.2 Selected Antibody-Like Protein Platforms, 2015
Table 6.3 Next-Generation Antibody Fragment and ALP Submarket: Overall Submarket Forecast and Revenue Forecasts ($bn) by Sector, 2014-2025
Table 6.4 Next-Generation Antibody Fragment and ALP Submarket: Drivers and Restraints, 2015-2025
Table 6.5 Next-Generation Antibody Fragment Submarket Forecast ($bn), 2014-2025
Table 6.6 Next-Generation Antibody Fragment Submarket: Clinical Pipeline, 2015
Table 6.7 Antibody-Like Protein Submarket Forecast ($bn), 2014-2025
Table 6.8 Antibody-Like Protein Submarket: Clinical Pipeline, 2015
Table 7.1 Tresiba: Revenue Forecast ($bn), 2014-2025
Table 7.2 Next-Generation Insulin Submarket: Overall Submarket Forecast and Revenue Forecasts ($bn) by Sector, 2014-2025
Table 7.3 Next-Generation Insulin Submarket: Drivers and Restraints, 2015-2025
Table 7.4 Diabetes: Prevalence and Proportion of Population Affected, 2014
Table 7.5 Leading Insulin Analogues: US and EU Patent Expiries, 2013-2018
Table 7.6 Oral Insulin Submarket Forecast ($bn), 2014-2025
Table 7.7 Oral Insulin Submarket: Drivers and Restraints, 2015-2025
Table 7.8 Oral Insulin: Selected Pre-Clinical and Clinical-Stage Pipeline, 2015
Table 7.9 Ultra-Rapid-Acting Insulin Submarket Forecast ($bn), 2014-2025
Table 7.10 Ultra-Rapid-Acting Insulin Submarket: Drivers and Restraints, 2015-2025
Table 7.11 Ultra-Rapid Acting Insulin: Pre-Clinical and Clinical-Stage Pipeline, 2015
Table 7.12 Afrezza: Revenue Forecast ($bn), 2014-2025
Table 7.13 Ultra-Long Acting Insulin Forecast ($bn), 2014-2025
Table 7.14 Ultra-Long Acting Insulin Submarket: Drivers and Restraints, 2015-2025
Table 7.15 Selected Ultra-Long Acting Insulin: Clinical-Stage Pipeline, 2015
Table 7.16 LY2605541: Active Phase III Clinical Trials, 2014
Table 8.1 Plegridy: Revenue Forecast ($bn), 2014-2025
Table 8.2 Recombinant Coagulation Factor Half-Lives and Target Populations, 2014
Table 8.3 Next-Generation Recombinant Coagulation Factors Submarket Forecast ($bn), 2014-2025
Table 8.4 Next-Generation Recombinant Coagulation Factors Submarket: Drivers and Restraints, 2015-2025
Table 8.5 Long-Acting Recombinant Factors VIII and IX in Late-Stage Clinical Development, 2014
Table 8.6 Eloctate: Revenue Forecast ($bn), 2014-2025
Table 8.7 Alprolix: Revenue Forecast ($bn), 2014-2025
Table 8.8 Next-Generation Growth Hormones Submarket Forecast ($bn), 2014-2025
Table 8.9 Next-Generation Growth Hormones Submarket: Drivers and Restraints, 2015-2025
Table 8.10 Selected Next-Generation Growth Hormones in Clinical Development, 2015
Table 9.1 Regenerative Medicine Submarket: Revenues by Sector ($bn), 2014
Table 9.2 Regenerative Medicine Submarket: Overall Submarket Forecast and Revenue Forecasts ($bn) by Sector, 2014-2025
Table 9.3 Regenerative Medicine Submarket: Drivers and Restraints, 2015-2025
Table 9.4 Stem Cell Therapies Submarket Forecast ($bn), 2014-2025
Table 9.5 Stem Cell Therapies Submarket: Drivers and Restraints, 2015-2025
Table 9.6 Selected Stem Cell Therapies in Phase II and III Clinical Trials, 2015
Table 9.7 Selected Stem Cell Therapies in Phase I/II Development, 2015
Table 9.8 Tissue Engineering Submarket Forecast ($bn), 2014-2025
Table 9.9 Tissue Engineering Submarket: Drivers and Restraints, 2015-2025
Table 9.10 Gene Therapies Submarket Forecast ($bn), 2014-2025
Table 9.11 Gene Therapies Submarket: Drivers and Restraints, 2015-2025
Table 9.12 Gene Therapies in Phase II and III Clinical Trials, 2015
Table 10.1 Next-Generation Biologics: STEP Analysis, 2015-2025
Table 10.2 Selected CMO Investments in Next-Generation Biologics, 2005-2014
Table 12.1 Next-Generation Biologics Market: Submarket Forecasts ($bn) and Market Shares (%), 2014, 2019 and 2025

List of Figures
Figure 3.1 Next-Generation Biologics: Market Shares (%) by Sector, 2014
Figure 3.2 Next-Generation Biologics Market: Revenue Forecast ($bn), 2014-2025
Figure 3.3 Next-Generation Biologics: Market Drivers, 2015-2025
Figure 3.4 Next-Generation Biologics: Market Restraints, 2015-2025
Figure 3.5 Next-Generation Biologics: Market Shares (%) by Sector, 2019
Figure 3.6 Next-Generation Biologics: Market Shares (%) by Sector, 2025
Figure 4.1 Next-Generation Biologics: Market Shares (%) by Country, 2014
Figure 4.2 Next-Generation Biologics: Market Shares (%) by Country, 2019
Figure 4.3 Next-Generation Biologics: Market Shares (%) by Country, 2025
Figure 4.4 US Next-Generation Biologics Submarket Forecast ($bn), 2014-2025
Figure 4.5 Japanese Next-Generation Biologics Submarket Forecast ($bn), 2014-2025
Figure 4.6 EU5 Nations: Next-Generation Biologics Submarket Shares (%), 2014
Figure 4.7 German Next-Generation Biologics Submarket Forecast ($bn), 2014-2025
Figure 4.8 French Next-Generation Biologics Submarket Forecast ($bn), 2014-2025
Figure 4.9 UK Next-Generation Biologics Submarket Forecast ($bn), 2014-2025
Figure 4.10 Italian and Spanish Next-Generation Biologics Submarket Forecasts ($bn), 2014-2025
Figure 4.11 Biosimilar Approvals in India, 2001-2014
Figure 4.12 Chinese Next-Generation Biologics Submarket Forecast ($bn), 2014-2025
Figure 4.13 Indian Next-Generation Biologics Submarket Forecast ($bn), 2014-2025
Figure 5.1 Next-Generation Antibodies: Submarket Shares (%) by Sector, 2014
Figure 5.2 Next-Generation Antibodies Submarket Forecast ($bn), 2014-2025
Figure 5.3 Antibody-Drug Conjugates: Submarket Shares (%) by Drug, 2014
Figure 5.4 Antibody-Drug Conjugates Submarket Forecast ($bn), 2014-2025
Figure 5.5 Kadcyla and Adcetris: Revenue Forecasts ($bn), 2014-2025
Figure 5.6 Engineered Antibodies Submarket Forecast ($bn), 2014-2025
Figure 5.7 Gazyva: Revenue Forecast ($bn), 2014-2025
Figure 5.8 Bispecific Antibodies Submarket Forecast ($bn), 2014-2025
Figure 6.1 Next-Generation Antibody Fragment and ALP Submarket Forecast ($bn), 2014-2025
Figure 6.2 Next-Generation Antibody Fragment Submarket Forecast ($bn), 2014-2025
Figure 6.3 Antibody-Like Protein Submarket Forecast ($bn), 2014-2025
Figure 7.1 Tresiba: Revenue Forecast ($bn), 2014-2025
Figure 7.2 Next-Generation Insulin Submarket Forecast ($bn), 2014-2025
Figure 7.3 Diabetes: Proportion of Population Affected, 2014
Figure 7.4 Oral Insulin Submarket Forecast ($bn), 2014-2025
Figure 7.5 Ultra-Rapid Acting Insulin Submarket Forecast ($bn), 2014-2025
Figure 7.6 Afrezza: Revenue Forecast ($bn), 2014-2025
Figure 7.7 Ultra-Long Acting Insulin Submarket Forecast ($bn), 2014-2025
Figure 8.1 Plegridy: Revenue Forecast ($bn), 2014-2025
Figure 8.2 Next-Generation Recombinant Coagulation Factors Submarket Forecast ($bn), 2014-2025
Figure 8.3 Eloctate: Revenue Forecast ($bn), 2014-2025
Figure 8.4 Alprolix: Revenue Forecast ($bn), 2014-2025
Figure 8.5 Next-Generation Growth Hormones Submarket Forecast ($bn), 2014-2025
Figure 9.1 Regenerative Medicine: Submarket Shares (%) by Sector, 2014
Figure 9.2 Regenerative Medicine Submarket Forecast ($bn), 2014-2025
Figure 9.3 Stem Cell Therapies Submarket Forecast ($bn), 2014-2025
Figure 9.4 Tissue Engineering Submarket Forecast ($bn), 2014-2025
Figure 9.5 Gene Therapies Submarket Forecast ($bn), 2014-2025
Figure 10.1 Big Pharma Partnering Opportunities for Next-Generation Biologics Development, 2015
Figure 12.1 Next-Generation Biologics: Market Forecast ($bn) by Sector, 2014, 2019 and 2025

【掲載企業】

3SBio
Aastrom Biosciences (now Vericel Corporation)
AbbVie
Abcam
Ablynx
ADC Therapeutics
Adnexus (part of Bristol-Myers Squibb)
Adocia
Advanced Cell Technology (now Ocata Therapeutics)
Advantagene
Affibody
Agence Nationale de sécurité du Médicament et des produits de santé (ANSM)
Agensys (now part of Astellas Pharma)
Alcon (part of Novartis)
Alexion Pharmaceuticals
Alfacell (now Tamir Biotechnology)
Alkermes
Allergan
Allozyne
Ambrx
Amgen
AMRI
AnGes
Applied Genetic Technologies (AGTC)
Ark Therapeutics
Astellas Pharma
AstraZeneca
Athersys
Avita Medical
Babraham Institute
Baxter International
Bayer Healthcare
Belrose Pharma
Benda Pharmaceutical
Biocad
BioCancell Therapeutics
Biocon
Biodel
Biogen Idec
Bioheart
BioMarin Pharmaceutical
Biopartners (part of Bioton)
Biotest Pharmaceuticals
Bioton
BioVex Group (part of Amgen)
BioWa (part of Kyowa Hakko Kirin)
bluebird bio
Boehringer Ingelheim
BrainStorm Cell Therapeutics
Bristol-Myers Squibb
Capricor Therapeutics
Cardio3 BioSciences
Cardium Therapeutics
Catalent Pharma Solutions
Celgene
Celladon
CellCoTec
Celldex Therapeutics
Cellerant Therapeutics
Cellular Dynamics International (CDI)
Centers for Disease Prevention and Control (CDC) [US]
Cephalon (part of Teva)
CEPiA (part of Sanofi)
Ceregene
Chatham Therapeutics
Chiesi Farmaceutici
Children’s Hospital of Philadelphia (CHOP)
China Food and Drug Administration (CFDA)
Chugai (part of Roche)
Civitas Therapeutics
Clayton Biotechnologies
Cold Genesys
Concortis
Covagen
Crescendo Biologics
Critical Pharmaceuticals
CSL Behring
CytoMedix
Cytori Therapeutics
Dance Biopharm
Delenex Therapeutics
Depuy Mitek (part of J&J)
Diabetology
Dr. Reddy’s Laboratories
Duke University
Duke University Hospital
Dyax
Eddingpharm
EGEN
Eisai
Elan Pharmaceuticals (now part of Perrigo Company)
Eli Lilly
EMA’s Committee for Medicinal Products for Human Use (CHMP)
Emisphere
Enzon Pharmaceuticals
EnzymeRx
Epitomics (part of Abcam)
ESBATech (part of Novartis)
European Commission
European Medicines Agency (EMA)
Flamel Technologies
Food and Drug Administration (FDA) [US]
Fresenius Biotech (now named Neovii Biotech, part of Neopharm)
Fuji Pharma
Fujifilm Diosynth Biotechnologies
Gamida Cell
Genentech (part of Roche)
Generex Biotechnology
Genmab
Genzyme (part of Sanofi)
Geron
GlycoExpress
Glycotope
GlaxoSmithKline (GSK)
Halozyme Therapeutics
Hanmi Pharmaceutical
Health Canada
Hikma Pharmaceuticals
Histogenics
Humacyte
Human Stem Cells Institute (HSCI)
Igenica
ImmunoGen
Immunomedics
Innovent Biologics
Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) [Germany]
Integra LifeSciences
International Diabetes Federation (IDF)
Introgen Therapeutics
Johnson & Johnson (J&J)
Jain Foundation
JCR Pharmaceuticals
Juventas Therapeutics
Karolinska Institute
Kyowa Hakko Kirin
LG Life Sciences
LifeCell
Lonza
Loyola University
MacroGenics
MannKind
MedImmune (part of AstraZeneca)
Merck & Co.
Merck KGaA
Merck Serono
Merrimack Pharmaceuticals
Merrion Pharmaceuticals
Mersana Therapeutics
Mesoblast
Micromet (part of Amgen)
Millennium Pharmaceuticals
Ministry of Health, Labor and Welfare (MHLW) [Japan]
Mitsubishi Tanabe Pharma
Mochida Pharmaceutical
Molecular Partners
Moorfields Eye Hospital [UK]
MorphoSys
National Cancer Institute (NCI) [US]
National Health Service (NHS) [UK]
National Institute for Health and Care Excellence (NICE) [UK]
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) [US]
Nektar Therapeutics
Neopharm Group
NeoStem
NeuralStem
Nippon Kayaku
Novartis
Novo Nordisk
Nuron Biotech
NuVasive
Ocata Therapeutics (formerly Advanced Cell Technology)
OncoSec Medical
OPKO Health
Oramed Pharmaceuticals
Organogenesis
Organovo
Orthofix
Osiris Therapeutics
PeriphaGen Holdings
Perrigo Company
Pfizer
Pieris
Piramal Group
Progenics Pharmaceuticals
Prolor Biotech (part of OPKO Health)
Rani Therapeutics
ratiopharm (part of Teva)
Redwood Bioscience
Regeneron Pharmaceuticals
Reliance Life Sciences
ReNeuron
RIKEN [Japan]
Roche
Roche Glycart (part of Roche)
Royal Institute of Technology [Sweden]
Russian Ministry of Healthcare (Minzdrav)
SAFC
Sandoz (part of Novartis)
Sanofi
Scottish Medicines Consortium (SMC)
Seattle Genetics
Shanghai Sunway Biotech
Shenzhen SiBiono GeneTech (part of Benda)
Shreya Life Sciences
SironRX Therapeutics
Skye Orthobiologics
Sorrento Therapeutics
Sotex PharmFirm
Spark Therapeutics
Spectrum Pharmaceuticals
Spirogen (part of AstraZeneca)
Stanford University
Stelis Biopharmaceuticals (part of Strides Arcolab)
StemCells
Stem CentRx
Stempeutics Research
Strativa Pharmaceuticals
Strides Arcolab
Sutro Biopharma
Swedish Orphan Biovitrum (Sobi)
Swiss Federal Institute of Technology
Symphogen
Synthon
Synthon Biopharmaceuticals BV (part of Synthon)
Takeda Pharmaceutical Company
Teva Pharmaceutical Industries
Thermalin Diabetes
Tianjin International Joint Academy of Bio-medicine
TiGenix
TRION Pharma
UCB
UniQure
University of California, San Francisco (UCSF)
University of Chicago
University of Toronto
USV
VBL Therapeutics
Vericel Corporation
Versartis
viDA Therapeutics
Viventia Biotechnologies Inc
VX Pharma
World Bank Group
World Cancer Research Fund (WCRF)
World Health Organization (WHO)
Wyeth (part of Pfizer)
Xencor
Xeris Pharmaceuticals
Yale School of Medicine
Zydus Cadila

【レポートのキーワード】

次世代生物製剤、抗体、抗体薬物複合体(ADC)、モノクローナル抗体、再生医療、抗体断片/ALP、インスリン、組換え型血液凝固因子、成長ホルモン、次世代生物製剤開発、薬物、生物製剤技術

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[次世代生物製剤の世界市場:抗体、再生医療、抗体断片/ALP、インスリン、組換え型血液凝固因子、成長ホルモン] ( Next-Generation Biologics: R&D, Industry and Market Forecasts 2015-2025 / VGAIN5052608) についてEメールでお問い合わせ


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