次世代生物学的製剤の世界市場2016-2026

◆英語タイトル:Next-Generation Biologics Market 2016-2026
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【レポートの概要】

Emerging Biological Drugs – This New Study Reveals Selling Opportunities and Revenue Prospects to Help You Stay Ahead What is 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 is 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, seeing how high revenues can go.

Forecasting and other information showing the most promising opportunities for treatments
Our updated report gives sales forecasts to 2026 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, our analysis shows you recent results, growth rates and market shares. In that report you discover 127 tables, 47 charts and four interviews with companies. See, from 2016, what is possible.

In our study you get intelligence on competitors and their activities, especially products, deals and R&D. The following sections explain what that 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 is happening and what is possible from 2016.

Our analysis benefits your plans, decisions and influence by interpreting medical needs, R&D and companies’ technologies. There you hear what is happening, assessing opportunities and likely gains.

With those analyses you see where potential and money lie, also saving time and effort. That way you can also benefit your reputation for technological and commercial insight. The following sections explain how our study helps your work.

Prospects for that world market and submarkets – discover what is possible for next-generation biopharmaceuticals
In our report you see overall world sales to 2026 for those emerging biotherapies, exploring our discussions.

Also you gain individual revenue predictions to 2026 for six next-generation biologic submarkets at world level and their further subdivisions:
• Next-generation antibody therapies, including the subsectors of antibody-drug conjugates (ADCs), engineered antibodies and bispecific treatments
• Next-generation antibody fragments and antibody-like proteins (ALPs)
• Next-generation insulins, including submarkets assessing oral insulins, ultra-long and ultra-rapid acting therapies
• Next-generation recombinant coagulation factors
• Next-generation growth hormones
• Regenerative medicine, including tissue engineering, gene therapies and stem cells.

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

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 2026 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 is 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 from 2016.

Our 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.

Our analyses show you individual revenue forecasts to 2026 for nine national markets:
• United States
• Japan
• Germany, France, United Kingdom, Italy and Spain
• China
• India.

Next-Generation Biologics Market 2016-2026: Revenue Forecasts and R&D Trends for Therapeutic Antibody Technologies, Insulins, Growth Hormones, Recombinant Coagulation Factors and Regenerative Medicine

There you hear about the best sales potentials, appraising national opportunities for next-generation biologics. See where revenues can rise, finding how you could gain.

And what events influence the biological drugs industry? What is 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 2016, including these forces:
• Demands and needs for new 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 biologics 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.

With our study you explore what progress, trends and opportunities mean. And you discover what helps and hinders participants in the biomedical industry, affecting companies’ results.

Biological drug technology and applications – companies and 2020 market value
What happens next? From 2016, novel follow-on treatments will benefit patients, healthcare providers and biomedical companies. Those advances will encourage investments, progress and higher revenues from more-advanced biological drugs. Discover what is possible.

Our study predicts the next-generation biologics market will reach $21.3bn worldwide in 2020, with strong revenue growth to 2026. See what the future holds for those products.

That work explores activities of these leading companies, among many other biopharmaceutical developers and producers:
• Novo Nordisk
• Eli Lilly
• Bayer
• Sanofi
• Pfizer.

In that market large pharmaceutical corporations and smaller biopharma specialists can win. See how, exploring what is possible.

You also gain interviews with four companies – Ablynx, Crescendo Biologics, Sorrento Therapeutics and Affibody – helping you stay ahead in knowledge. Discover what is happening. See what organisations shaping that industry do, helping you succeed.

5 Ways Next-Generation Biologics Market 2016-2026 helps your analyses, plans and decisions
In these five main ways our new investigation helps you gain recognition for insight, benefiting your authority:
• Revenues to 2026 at world level, for 17 market segments and 8 products – explore outlooks for R&D, production, marketing and sales
• Forecasts to 2026 for 9 national markets in North America, Europe and Asia – assess countries for revenues and sales growth opportunities
• Prospects for established competitors, rising companies and new entrants – investigate R&D, product portfolios, results and strategies
• Analysis of what stimulates and restrains that industry and market – assess challenges and strengths, helping you compete and gain advantages
• Interviews with 4 companies shaping that industry – discover what authorities say and do, helping you stay ahead in knowledge and succeed.

There you gain competitive intelligence found only in our analysis, finding sales potentials. Benefit your influence by exploring commercial progress, opportunities and prospects.

Trying our study now lets you discover biological drug trends, opportunities and forecasts
With our new report, by visiongain’s UK-based in-house analysts, you discover analysis to help you stay ahead in knowledge. See there what the future holds for developers, producers and sellers of next-generation biomedicines. Find data you get nowhere else.

Our investigation is for everyone analysing biopharmaceuticals. There you discover data and forecasts for next-phase biopharmaceuticals. Avoid missing out and falling behind in knowledge. Instead please get our new report here now.

【レポートの目次】

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

Table 2.1 First Approvals for Recombinant Protein Therapies, 1982-1997
Table 3.1 Top Ten Bestselling Prescription Pharmaceuticals: Revenues ($bn), 2015
Table 3.2 Next-Generation Biologics Market: Revenues by Sector ($bn), 2015
Table 3.3 Biological Drugs Market: Drivers and Restraints, 2016-2026
Table 3.4 Next-Generation Biologics Market: Overall Market Forecast and Revenue Forecasts ($bn) by Sector, 2015-2020
Table 3.5 Next-Generation Biologics Market: Overall Market Forecast and Revenue Forecasts ($bn) by Sector, 2021-2026
Table 3.6 Next-Generation Biologics: Market Shares (%) by Sector, 2015, 2020 and 2026
Table 4.1 Next-Generation Biologics Market: Revenues ($bn) by National Submarket, 2015
Table 4.2 Next-Generation Biologics Market: Revenues ($bn) by National Submarket, 2015-2020
Table 4.3 Next-Generation Biologics Market: Revenues ($bn) by National Submarket, 2021-2026, Part 1
Table 4.4 Next-Generation Biologics Market: Revenues ($bn) by National Submarket, 2021-2026, Part 2
Table 4.5 Next-Generation Biologics: Market Shares (%) by National Submarket, 2020 and 2026
Table 4.6 National Incidence and Prevalence of Leading Indications Treated with Biologics (millions of patients), 2015
Table 4.7 Main Approval Dates for Next-Generation Biologics in Leading National Submarkets, 2003-2013
Table 4.8 US Next-Generation Biologics Submarket Forecast ($bn), 2015-2020
Table 4.9 US Next-Generation Biologics Submarket Forecast ($bn), 2021-2026
Table 4.10 Biosimilars Approved and Marketed in Japan, 2015
Table 4.11 Japanese Next-Generation Biologics Submarket Forecast ($bn), 2015-2020
Table 4.12 Japanese Next-Generation Biologics Submarket Forecast ($bn), 2021-2026
Table 4.13 Next-Generation Biologics Submarkets in the EU5 Nations: Revenues ($bn), 2015
Table 4.14 German Next-Generation Biologics Submarket Forecast ($bn), 2015-2020
Table 4.15 German Next-Generation Biologics Submarket Forecast ($bn), 2021-2026
Table 4.16 French Next-Generation Biologics Submarket Forecast ($bn), 2015-2020
Table 4.17 French Next-Generation Biologics Submarket Forecast ($bn), 2021-2026
Table 4.18 UK Next-Generation Biologics Submarket Forecast ($bn), 2015-2020
Table 4.19 UK Next-Generation Biologics Submarket Forecast ($bn), 2021-2026
Table 4.20 Italian Next-Generation Biologics Submarket Forecast ($bn), 2015-2020
Table 4.21 Italian Next-Generation Biologics Submarket Forecast ($bn), 2021-2026
Table 4.22 Spanish Next-Generation Biologics Submarket Forecast ($bn), 2015-2020
Table 4.23 Spanish Next-Generation Biologics Submarket Forecast ($bn), 2021-2026
Table 4.24 Chinese Next-Generation Biologics Submarket Forecast ($bn), 2015-2020
Table 4.25 Chinese Next-Generation Biologics Submarket Forecast ($bn), 2021-2026
Table 4.26 Indian Next-Generation Biologics Submarket Forecast ($bn), 2015-2020
Table 4.27 Indian Next-Generation Biologics Submarket Forecast ($bn), 2021-2026
Table 5.1 Monoclonal Antibodies Submarket: Leading Drug Revenues ($bn), 2015
Table 5.2 Next-Generation Antibodies Submarket: Approved Drug Revenues ($bn), 2015
Table 5.3 Selected Clinical and Pre-Clinical ADC Platforms, 2016
Table 5.4 Selected Clinical and Pre-Clinical Engineered Antibody Platforms, 2016
Table 5.5 Next-Generation Antibodies Submarket: Revenues by Sector ($bn), 2015
Table 5.6 Next-Generation Antibodies Submarket: Overall Submarket Forecast and Revenue Forecasts ($bn) by Sector, 2015-2020
Table 5.7 Next-Generation Antibodies Submarket: Overall Submarket Forecast and Revenue Forecasts ($bn) by Sector, 2021-2026
Table 5.8 Next-Generation Antibodies Submarket: Drivers and Restraints, 2016-2026
Table 5.9 Antibody Drug Conjugates Submarket: Revenues ($bn) and Submarket Shares (%) by Drug, 2015
Table 5.10 Antibody-Drug Conjugates Submarket Forecast ($bn), 2015-2020
Table 5.11 Antibody-Drug Conjugates Submarket Forecast ($bn), 2021-2026
Table 5.12 Kadcyla and Adcetris: Revenue Forecasts ($bn), 2015-2020
Table 5.13 Kadcyla and Adcetris: Revenue Forecasts ($bn), 2021-2026
Table 5.14 Antibody-Drug Conjugates Submarket: Drivers and Restraints, 2016-2026
Table 5.15 Selected Antibody-Drug Conjugates in Phase III Development, 2015
Table 5.16 Selected Antibody-Drug Conjugates in Phase II Development, 2015
Table 5.17 Selected Antibody-Drug Conjugates in Phase I Development, 2015
Table 5.18 Engineered Antibodies Submarket Forecast ($bn), 2015-2020
Table 5.19 Engineered Antibodies Submarket Forecast ($bn), 2021-2026
Table 5.20 Gazyva/Gazyvaro: Revenue Forecast ($bn), 2015-2020
Table 5.21 Gazyva/Gazyvaro: Revenue Forecast ($bn), 2021-2026
Table 5.22 Engineered Antibodies Submarket: Drivers and Restraints, 2016-2026
Table 5.23 Selected Engineered Antibodies in Phase II and III Development, 2016
Table 5.24 Bispecific Antibodies Submarket Forecast ($bn), 2015-2020
Table 5.25 Bispecific Antibodies Submarket Forecast ($bn), 2021-2026
Table 5.26 Bispecific Antibodies Submarket: Drivers and Restraints, 2021-2026
Table 5.27 Bispecific Antibodies in Phase I and II Development, 2015
Table 6.1 Selected Next-Generation Antibody Fragment Platforms, 2016
Table 6.2 Selected Antibody-Like Protein Platforms, 2016
Table 6.3 Next-Generation Antibody Fragment and ALP Submarket: Overall Submarket Forecast and Revenue Forecasts ($bn) by Sector, 2015-2020
Table 6.4 Next-Generation Antibody Fragment and ALP Submarket: Overall Submarket Forecast and Revenue Forecasts ($bn) by Sector, 2021-2026
Table 6.5 Next-Generation Antibody Fragment and ALP Submarket: Drivers and Restraints, 2016-2026
Table 6.6 Next-Generation Antibody Fragment Submarket Forecast ($bn), 2015-2020
Table 6.7 Next-Generation Antibody Fragment Submarket Forecast ($bn), 2021-2026
Table 6.8 Next-Generation Antibody Fragment Submarket: Clinical Pipeline, 2016
Table 6.9 Next-Generation Antibody-Like Protein Submarket Forecast ($bn), 2015-2020
Table 6.10 Next-Generation Antibody-Like Protein Submarket Forecast ($bn), 2021-2026
Table 6.11 Next-Generation Antibody-Like Protein Submarket: Clinical Pipeline, 2016
Table 7.1 Tresiba: Revenue Forecast ($bn), 2015-2020
Table 7.2 Tresiba: Revenue Forecast ($bn), 2021-2026
Table 7.3 Next-Generation Insulin Submarket: Overall Submarket Forecast and Revenue Forecasts ($bn) by Sector, 2015-2020
Table 7.4 Next-Generation Insulin Submarket: Overall Submarket Forecast and Revenue Forecasts ($bn) by Sector, 2021-2026
Table 7.5 Next-Generation Insulin Submarket: Drivers and Restraints, 2016-2026
Table 7.6 Diabetes: Prevalence and Proportion of Population Affected, 2015
Table 7.7 Leading Insulin Analogues: US and EU Patent Expiries, 2013-2018
Table 7.8 Oral Insulin Submarket Forecast ($bn), 2015-2020
Table 7.9 Oral Insulin Submarket Forecast ($bn), 2021-2026
Table 7.10 Oral Insulin Submarket: Drivers and Restraints, 2016-2026
Table 7.11 Oral Insulin: Selected Pre-Clinical and Clinical-Stage Pipeline, 2016
Table 7.12 Ultra-Rapid Acting Insulin Submarket Forecast ($bn), 2015-2020
Table 7.13 Ultra-Rapid Acting Insulin Submarket Forecast ($bn), 2021-2026
Table 7.14 Ultra-Rapid Acting Insulin Submarket: Drivers and Restraints, 2016-2026
Table 7.15 Ultra-Rapid Acting Insulin: Pre-Clinical and Clinical-Stage Pipeline, 2016
Table 7.16 Afrezza: Revenue Forecast ($bn), 2015-2020
Table 7.17 Afrezza: Revenue Forecast ($bn), 2021-2026
Table 7.18 Ultra-Long Acting Insulin Forecast ($bn), 2015-2020
Table 7.19 Ultra-Long Acting Insulin Forecast ($bn), 2021-2026
Table 7.20 Ultra-Long Acting Insulin Submarket: Drivers and Restraints, 2016-2026
Table 7.21 Selected Ultra-Long Acting Insulin: Clinical-Stage Pipeline, 2016
Table 8.1 Plegridy: Revenue Forecast ($bn), 2015-2020
Table 8.2 Plegridy: Revenue Forecast ($bn), 2021-2026
Table 8.3 Recombinant Coagulation Factor Half-Lives and Target Populations, 2015
Table 8.4 Next-Generation Recombinant Coagulation Factors Submarket Forecast ($bn), 2015-2020
Table 8.5 Next-Generation Recombinant Coagulation Factors Submarket Forecast ($bn), 2021-2026
Table 8.6 Next-Generation Recombinant Coagulation Factors Submarket: Drivers and Restraints, 2016-2026
Table 8.7 Long-Acting Recombinant Factors VIII and IX in Late-Stage Clinical Development, 2016
Table 8.8 Eloctate: Revenue Forecast ($bn), 2015-2020
Table 8.9 Eloctate: Revenue Forecast ($bn), 2021-2026
Table 8.10 Alprolix: Revenue Forecast ($bn), 2015-2020
Table 8.11 Alprolix: Revenue Forecast ($bn), 2021-2026
Table 8.12 Next-Generation Growth Hormones Submarket Forecast ($bn), 2015-2020
Table 8.13 Next-Generation Growth Hormones Submarket Forecast ($bn), 2021-2026
Table 8.14 Next-Generation Growth Hormones Submarket: Drivers and Restraints, 2016-2026
Table 8.15 Selected Next-Generation Growth Hormones in Clinical Development, 2016
Table 9.1 Regenerative Medicine Submarket: Revenues by Sector ($bn), 2015
Table 9.2 Regenerative Medicine Submarket: Overall Submarket Forecast and Revenue Forecasts ($bn) by Sector, 2015-2020
Table 9.3 Regenerative Medicine Submarket: Overall Submarket Forecast and Revenue Forecasts ($bn) by Sector, 2021-2026
Table 9.4 Regenerative Medicine Submarket: Drivers and Restraints, 2016-2026
Table 9.5 Stem Cell Therapies Submarket Forecast ($bn), 2015-2020
Table 9.6 Stem Cell Therapies Submarket Forecast ($bn), 2021-2026
Table 9.7 Stem Cell Therapies Submarket: Drivers and Restraints, 2016-2026
Table 9.8 Selected Stem Cell Therapies in Phase II and III Clinical Trials, 2016
Table 9.9 Selected Stem Cell Therapies in Phase I/II Development, 2016
Table 9.10 Tissue Engineering Submarket Forecast ($bn), 2015-2020
Table 9.11 Tissue Engineering Submarket Forecast ($bn), 2021-2026
Table 9.12 Tissue Engineering Submarket: Drivers and Restraints, 2016-2026
Table 9.13 Gene Therapies Submarket Forecast ($bn), 2015-2020
Table 9.14 Gene Therapies Submarket Forecast ($bn), 2021-2026
Table 9.15 Gene Therapies Submarket: Drivers and Restraints, 2016-2026
Table 9.16 Gene Therapies in Phase II and III Clinical Trials, 2016
Table 10.1 Next-Generation Biologics: STEP Analysis, 2016-2026
Table 10.2 Selected CMO Investments in Next-Generation Biologics, 2005-2015
Table 12.1 Next-Generation Biologics Market: Submarket Forecasts ($bn) and Market Shares (%), 2015, 2020 and 2026

Figure 1.1 Next-Generation Biologic Market Segmentation, 2016
Figure 3.1 Next-Generation Biologics: Market Shares (%) by Sector, 2015
Figure 3.2 Next-Generation Biologics Market: Revenue Forecast ($bn), 2015-2026
Figure 3.3 Next-Generation Biologics: Market Drivers, 2016-2026
Figure 3.4 Next-Generation Biologics: Market Restraints, 2016-2026
Figure 3.5 Next-Generation Biologics: Market Shares (%) by Sector, 2020
Figure 3.6 Next-Generation Biologics: Market Shares (%) by Sector, 2026
Figure 4.1 Next-Generation Biologics: Market Shares (%) by Country, 2015
Figure 4.2 Next-Generation Biologics: Market Shares (%) by Country, 2020
Figure 4.3 Next-Generation Biologics: Market Shares (%) by Country, 2026
Figure 4.4 US Next-Generation Biologics Submarket Forecast ($bn), 2015-2026
Figure 4.5 Japanese Next-Generation Biologics Submarket Forecast ($bn), 2015-2026
Figure 4.6 EU5 Nations: Next-Generation Biologics Submarket Shares (%), 2015
Figure 4.7 German Next-Generation Biologics Submarket Forecast ($bn), 2015-2026
Figure 4.8 French Next-Generation Biologics Submarket Forecast ($bn), 2015-2026
Figure 4.9 UK Next-Generation Biologics Submarket Forecast ($bn), 2015-2026
Figure 4.10 Italian Next-Generation Biologics Submarket Forecast ($bn), 2015-2026
Figure 4.11 Spanish Next-Generation Biologics Submarket Forecast ($bn), 2015-2026
Figure 4.12 Biosimilar Approvals in India, 2001-2015
Figure 4.13 Chinese Next-Generation Biologics Submarket Forecast ($bn), 2015-2026
Figure 4.14 Indian Next-Generation Biologics Submarket Forecast ($bn), 2015-2026
Figure 5.1 Next-Generation Antibodies: Submarket Shares (%) by Sector, 2015
Figure 5.2 Next-Generation Antibodies Submarket Forecast ($bn), 2015-2026
Figure 5.3 Antibody-Drug Conjugates: Submarket Shares (%) by Drug, 2015
Figure 5.4 Kadcyla and Adcetris: Revenue Forecasts ($bn), 2015-2026
Figure 5.5 Engineered Antibodies Submarket Forecast ($bn), 2015-2026
Figure 5.6 Bispecific Antibodies Submarket Forecast ($bn), 2015-2026
Figure 6.1 Next-Generation Antibody Fragment and ALP Submarket Forecast ($bn), 2015-2026
Figure 6.2 Next-Generation Antibody Fragment Submarket Forecast ($bn), 2015-2026
Figure 6.3 Next-Generation Antibody-Like Protein Submarket Forecast ($bn), 2015-2026
Figure 7.1 Tresiba: Revenue Forecast ($bn), 2015-2026
Figure 7.2 Next-Generation Insulin Submarket Revenue Forecast ($bn), 2015-2026
Figure 7.3 Diabetes: Proportion of Population Affected, 2015
Figure 7.4 Oral Insulin Submarket Forecast ($bn), 2015-2026
Figure 7.5 Ultra-Rapid Acting Insulin Submarket Forecast ($bn), 2015-2026
Figure 7.6 Afrezza: Revenue Forecast ($bn), 2015-2026
Figure 7.7 Ultra-Long Acting Insulin Submarket Forecast ($bn), 2015-2026
Figure 8.1 Plegridy: Revenue Forecast ($bn), 2015-2026
Figure 8.2 Next-Generation Recombinant Coagulation Factors Submarket Forecast ($bn), 2015-2026
Figure 8.3 Eloctate: Revenue Forecast ($bn), 2015-2026
Figure 8.4 Alprolix: Revenue Forecast ($bn), 2015-2026
Figure 8.5 Next-Generation Growth Hormones Submarket Forecast ($bn), 2015-2026
Figure 9.1 Regenerative Medicine: Submarket Shares (%) by Sector, 2015
Figure 9.2 Regenerative Medicine Submarket Forecast ($bn), 2015-2026
Figure 9.3 Stem Cell Therapies Submarket Forecast ($bn), 2015-2026
Figure 9.4 Tissue Engineering Submarket Forecast ($bn), 2015-2026
Figure 9.5 Gene Therapies Submarket Forecast ($bn), 2015-2026
Figure 10.1 Big Pharma Partnering Opportunities for Next-Generation Biologics Development, 2016

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