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次世代生物製剤市場の予測:2018年〜2028年

Next-Generation Biologics Market 2018-2028: Revenue Forecasts and R&D Trends for Therapeutic Antibody Technologies, Insulins, Growth Hormones, Recombinant Coagulation Factors and Regenerative Medicine

発行 Visiongain Ltd 商品コード 298719
出版日 ページ情報 英文 262 Pages
納期: 即日から翌営業日
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次世代生物製剤市場の予測:2018年〜2028年 Next-Generation Biologics Market 2018-2028: Revenue Forecasts and R&D Trends for Therapeutic Antibody Technologies, Insulins, Growth Hormones, Recombinant Coagulation Factors and Regenerative Medicine
出版日: 2018年03月12日 ページ情報: 英文 262 Pages
概要

当レポートでは、世界の次世代生物製剤市場について調査分析し、主要企業の分析、市場の見通しと分析、地域別の市場予測など、体系的な情報を提供しています。

第1章 レポート概要

第2章 次世代生物製剤のイントロダクション

  • 生物製剤の開発の歴史
  • 次世代生物製剤の明るい見通し

第3章 世界の次世代生物製剤市場:見通しと予測

  • 次世代生物製剤市場
  • 次世代生物製剤市場 (予測)

第4章 主要国の次世代生物製剤二次市場

  • 主要国の次世代生物製剤二次市場
  • 重要市場における病気の発生率の上昇
  • 主要国二次市場における次世代生物製剤の承認
  • 米国が次世代生物製剤の最大二次市場
  • 日本における次世代生物製剤
  • EU主要国における次世代生物製剤
  • 新興市場における次世代生物製剤

第5章 次世代抗体:二次市場の見通し

  • 抗体治療の改善戦略
  • 次世代抗体治療二次市場
  • 次世代抗体治療二次市場 (予測)
  • 抗体医薬複合体 (ADC) 二次市場
  • 改変抗体二次市場
  • 二重特異性抗体二次市場

第6章 抗体フラグメントと新しい抗体様医薬品:商業的可能性

  • 次世代抗体フラグメント:ファブフラグメントを超えて
  • 抗体フラグメントとALP二次市場
  • 次世代抗体フラグメントの見通し
  • 抗体様タンパク質二次市場
  • 次世代抗毒素が市場を変える?

第7章 次世代インスリン二次市場:見通し

  • 次世代インスリンの開発戦略
  • 次世代インスリン二次市場
  • 経口インスリン二次市場
  • 超長時間作用型インスリン二次市場

第8章 その他の組み換えタンパク向け次世代開発

  • その他の組み換えタンパク部門向け次世代の定義
  • 次世代組み換え凝固因子
  • 次世代成長ホルモン

第9章 再生医療:商業的可能性

  • 再生医療二次市場
  • 再生医療二次市場:収益予測
  • 幹細胞治療二次市場
  • ヒト組織工学の見通し
  • 遺伝子治療二次市場

第10章 次世代生物製剤:産業動向

  • 次世代生物製剤:市場の強み
  • 次世代生物製剤:市場の弱み
  • 次世代生物製剤:STEP分析
  • 次世代生物製剤:開発動向
  • 次世代生物製剤の製造上の課題と機会
  • 次世代生物製剤の商業化
  • 次世代生物製剤開発の提携

第11章 結論

目次
Product Code: PHA0294

Next Generation Biologics Market Report 2018-2028: Forecasts by Market and Segments

  • Do you need definitive Next Generation Biologics market data?
  • Do you want to understand clear demarcation between next generation biologics and traditional biologics?
  • Next Generation Biologics and sub-segment market analysis?
  • Key drivers and constrains accompanied by this market?
  • Clear leaders and lagers?
  • Next wave of blockbusters and drivers impacting them?

Read on to discover how this definitive report can transform your own research and save you time.

The introduction of new pipeline drugs in Next generation biologics, has led visiongain to publish this timey report. The Next generation biologics market is expected to flourish in the next few years because of emergence of new phase III as well as marketed candidates which are going change the course of the market. Not only new candidates, but the technology (drug delivery as well as the mechanism of action) are novel which make the report a worth find and insightful.

Report highlights

140 quantitative tables, charts, and graphs

Analysis of key players in Next generation biologics Market

  • Abbvie
  • Roche/ Genentech
  • Amgen
  • GSK
  • Eli Lilly
  • Sanofi Aventis
  • Novo Nordisk
  • Seattle Genetics

Global next generation biologics market outlook and analysis from 2018-2028

Regional Next generation biologics market forecasts from 2018-2028

  • US forecast 2018-2028,
  • Japan forecast 2018-2028
  • India forecast 2018-2028
  • Germany forecast 2018-2028
  • UK forecast 2018-2028
  • France forecast 2018-2028
  • Italy forecast 2018-2028
  • Spain forecast 2018-2028
  • China forecast 2018-2028

Key questions answered

  • What does the future hold for the next generation biologics?
  • Where should you target your business strategy?
  • Which applications should you focus upon?
  • Which disruptive technologies should you invest in?
  • Which companies should you form strategic alliances with?
  • Which company is likely to success and why?
  • What business models should you adopt?
  • What industry trends should you be aware of?

Target audience

  • Leading Pharmaceutical companies
  • Suppliers
  • Contractors
  • Technologists
  • R&D staff
  • Consultants
  • Analysts
  • CEO's
  • CIO's
  • COO's
  • Business development managers
  • Investors
  • Governments
  • Agencies
  • Industry organisations
  • Banks

Visiongain is a trading partner with the US Federal Government.

Table of Contents

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 2017-2028

  • 3.1. The Next-Generation Biologics Market 2017
    • 3.1.1. Development of the Next-Generation Biologics Market 2009-2016
    • 3.1.2. Rising Demand for Biological Therapies
    • 3.1.3. Next-Generation Drugs as a Share of the Biologics Market 2016
    • 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 2017
  • 3.2. The Next-Generation Biologics Market 2017-2028
    • 3.2.1. Growth Drivers for Biological Drug Revenues 2017-2028
    • 3.2.2. The Next-Generation Biologics Market Forecast 2017-2028
    • 3.2.3. Product Launches in All Sectors to Drive Market Growth 2017-2028
    • 3.2.4. Next-Generation Biologics: Market Restraints 2017-2028
    • 3.2.5. Rising Market Shares for Next-Generation Insulins 2017-2028

4. Leading National Submarkets for Next-Generation Biologics 2017-2028

  • 4.1. Leading National Submarkets for Next-Generation Biologics, 2017
    • 4.1.1. National Submarket Forecasts 2017-2028
    • 4.1.2. How Will National Submarket Shares Change to 2028?
  • 4.2. Rising Disease Incidence in Important Markets 2017-2028
  • 4.3. Approval of Next-Generation Biologics in Leading National Submarkets
  • 4.4. The US Will be the Largest Submarket for Next-Generation Biologics 2017-2028
    • 4.4.1. US Submarket Forecast 2017-2028
  • 4.5. Next-Generation Biologics in Japan 2017-2028
    • 4.5.1. National Expertise in Stem Cell Research
    • 4.5.2. Japanese Submarket Forecast 2017-2028
  • 4.6. Next-Generation Biologics in Leading EU Countries 2017-2028
    • 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 2017-2027
    • 4.6.4. France: Submarket Forecast 2017-2028
    • 4.6.5. UK: Submarket Forecast 2017-2028
    • 4.6.6. Italy and Spain: Submarket Forecasts 2017-2028
  • 4.7. Next-Generation Biologics in Emerging Markets 2017-2028
    • 4.7.1. Next-Generation Biologics Development in Emerging Countries
    • 4.7.2. Chinese Submarket Forecast 2017-2028
    • 4.7.3. Indian Submarket Forecast 2017-2028

5. Next-Generation Antibodies: Submarket Outlooks 2017-2028

  • 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 2017-2028
    • 5.3.1. Strong Revenue Growth for Next-Generation Antibodies 2017-2028
    • 5.3.2. Blockbuster Potential Will Drive Growth to 2028: Kadcyla, Adcetris and Cosentyx
    • 5.3.3. Next-Generation Antibodies: Submarket Restraints 2017-2028
  • 5.4. Antibody-Drug Conjugates (ADC) Submarket 2017-2028
    • 5.4.1. Antibody-Drug Conjugates Submarket Forecast 2017-2028
      • 5.4.1.1. Kadcyla and Adcetris: Revenue Forecast 2017-2028
    • 5.4.2. What Will Drive Growth for ACDs to 2028
    • 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. IMGN853(Immunogen): Phase III for Ovarian Cancer
      • 5.4.3.4. SGN-CD33A (Seattle Genetics): Phase III for Acute myeloid leukemia
      • 5.4.3.5. Rova-T (Abbvie): Phase III for SCLC
      • 5.4.3.6. CDX-011: Potential for Accelerated Approval in Breast Cancer
  • 5.5. Engineered Antibodies Submarket 2017-2028
    • 5.5.1. Engineered Antibodies Submarket Forecast 2017-2028
      • 5.5.1.1. Gazvya Will Lead the Submarket in 2028
    • 5.5.2. Portfolio Management to Drive Growth 2017-2028
    • 5.5.3. Engineered Antibodies Pipeline 2016
      • 5.5.3.1. Benralizumab (MedImmune/Kyowa Hakko Kirin)
  • 5.6. Bispecific Antibodies Submarket 2017-2028
    • 5.6.1. Bispecific Antibodies Submarket Forecast 2017-2028
    • 5.6.2. Bispecific Antibodies: Submarket Drivers and Restraints 2017-2028
    • 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 2017-2028

  • 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 2017-2028
    • 6.2.1. Antibody Fragment and ALP Submarket Forecast 2017-2028
    • 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 2028
  • 6.3. Outlook for Next-Generation Antibody Fragments 2017-2028
    • 6.3.1. Next-Generation Antibody Fragment Submarket Forecast 2017-2028
    • 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 2017-2028
    • 6.4.1. Antibody-Like Protein Submarket Forecast 2017-2028
    • 6.4.2. Four ALPs in Clinical Development in 2017
      • 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 2028?
    • 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 2017-2028

  • 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 2017-2028
    • 7.2.1. Tresiba: Approved in the EU and Japan
      • 7.2.1.1. Tresiba: Revenue Forecast 2017-2028
  • 7.3. Next-Generation Insulin Submarket 2016-2027
    • 7.3.1. Next-Generation Insulin Submarket Forecast 2016-2027
    • 7.3.2. Product Launches in the US and EU Will Drive Submarket Growth 2017-2028
    • 7.3.3. Next-Generation Insulin Submarket Restraints 2017-2028
      • 7.3.3.1. Biosimilar Insulins are Available Since 2015
  • 7.4. Oral Insulin Submarket 2017-2028
    • 7.4.1. Oral Insulin Submarket Forecast 2017-2028
    • 7.4.2. Oral Insulin: Submarket Drivers and Restraints 2017-2028
    • 7.4.3. A Limited Clinical-Stage Pipeline for Oral Insulin 2017
      • 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 2017-2028
    • 7.5.1. Ultra-Rapid Acting Insulin Submarket Forecast 2017-2028
      • 7.5.1.1. Will Inhaled Insulins Drive Revenue Growth to 2028?
    • 7.5.2. Other Submarket Drivers and Restraints 2017-2028
    • 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 2017-2028
    • 7.6.1. Ultra-Long Acting Insulin Submarket Forecast 2017-2028
    • 7.6.2. Revenue Growth Driven by Uptake of Tresiba
    • 7.6.3. Ultra-Long Acting Insulin Pipeline 2017
      • 7.6.3.1. Toujeo: Sanofi's Next-Generation Insulin Analogue
      • 7.6.3.2. LAPS-Insulin

8. Next-Generation Developments for Other Recombinant Proteins 2017-2028

  • 8.1. Defining Next-Generation for Other Recombinant Protein Sectors
    • 8.1.1. Next-Generation Interferon Beta: Plegridy Revenue Forecast 2017-2028
      • 8.1.1.1. Plegridy May Compete With Other Long-Acting Interferon Beta Therapies 2017-2028
    • 8.1.2. Next-Generation G-CSF: Teva Expands its Filgrastim Franchise
      • 8.1.2.1. Other Clinical-Stages Advances in Filgrastim Therapy 2017
  • 8.2. Next-Generation Recombinant Coagulation Factors 2017-2028
    • 8.2.1. Next-Generation Recombinant Coagulation Factors Submarket Forecast 2017-2028
    • 8.2.2. Submarket Drivers and Restraints 2017-2028
    • 8.2.3. Clinical Pipeline for Recombinant Coagulation Factors 2017-2028
      • 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 2017-2028
    • 8.3.1. Next-Generation Growth Hormone Submarket Forecast 2017-2028
    • 8.3.2. Brand Loyalty Will Restrain Uptake of Next-Generation Hormone 2017-2028
    • 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 2017-2028

  • 9.1. The Regenerative Medicine Submarket in 2017
    • 9.1.1. Defining Regenerative Medicine
  • 9.2. The Regenerative Medicine Submarket: Revenue Projections 2017-2028
    • 9.2.1. Stem Cell and Gene Therapy Launches to Drive Growth 2017-2028
  • 9.3. The Stem Cell Therapies Submarket 2017-2028
    • 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 2017-2028
    • 9.3.3. Stem Cell Therapies: Submarket Drivers and Restraints 2017-2028
      • 9.3.3.1. Will iPSCs Prove Effective for Stem Cell Therapy?
    • 9.3.4. Stem Cell Therapies Late-Stage Pipeline 2017
      • 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 2017-2028
    • 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 2017-2028
    • 9.4.3. Tissue Engineering: Submarket Drivers and Restraints 2017-2028
  • 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 2017-2028
    • 9.5.1. Glybera Approved and Set for Launch in the EU
    • 9.5.2. Gene Therapies Submarket: Revenue Projections 2017-2028
    • 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 2017-2028

  • 10.1. Next-Generation Biologics: Market Strengths 2017
  • 10.2. Next-Generation Biologics: Market Weakness 2017
  • 10.3. The Next-Generation Biologics Market: STEP Analysis 2017-2028
    • 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 2017-2028
    • 10.3.3. Economic Pressures 2017-2028
      • 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 2017-2028
  • 10.4. Next-Generation Biologics: Development Trends 2017-2028
    • 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 2017-2028
  • 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. Conclusions from Our Research and Analysis

  • 11.1. The Next-Generation Biologics Market Will Grow Strongly to 2028
  • 11.2. Next-Generation Antibody Development Will Lead the Market
  • 11.3. New Treatment Regimens Will Drive Demand for Next-Generation Biologics
  • 11.4. Leading Regional Markets
  • 11.5. Challenges Remain in Developing and Commercialising Next-Generation Biologics
  • Associated Reports
  • Visiongain Report Sales Order Form
  • About Visiongain
  • Visiongain Report Evaluation Form

List of Figures

  • Figure 1.1: Next-Generation Biologic Market Segmentation, 2017
  • Figure 3.1: Next-Generation Biologics: Market Shares (%) by Sector, 2017
  • Figure 3.2: Next-Generation Biologics Market: Revenue Forecast ($bn), 2017-2028
  • Figure 3.3: Next-Generation Biologics: Market Drivers, 2018-2028
  • Figure 3.4: Next-Generation Biologics: Market Restraints, 2017-2028
  • Figure 3.5: Next-Generation Biologics: Market Shares (%) by Sector, 2023
  • Figure 3.6: Next-Generation Biologics: Market Shares (%) by Sector, 2028
  • Figure 4.1: Next-Generation Biologics: Market Shares (%) by Country, 2017
  • Figure 4.2: Next-Generation Biologics: Market Shares (%) by Country, 2023
  • Figure 4.3: Next-Generation Biologics: Market Shares (%) by Country, 2028
  • Figure 4.4: US Next-Generation Biologics Submarket Forecast ($bn) & AGR (%), 2017-2028
  • Figure 4.5: Japanese Next-Generation Biologics Submarket Forecast ($bn) & AGR (%), 2017-2028
  • Figure 4.6: EU5 Nations: Next-Generation Biologics Submarket Shares (%), 2017
  • Figure 4.7: German Next-Generation Biologics Submarket Forecast ($bn) & AGR (%), 2017-2028
  • Figure 4.8: French Next-Generation Biologics Submarket Forecast ($bn) & AGR (%), 2017-2028
  • Figure 4.9: UK Next-Generation Biologics Submarket Forecast ($bn) & AGR (%), 2017-2028
  • Figure 4.10: Italian Next-Generation Biologics Submarket Forecast ($bn), 2017-2028
  • Figure 4.11: Spanish Next-Generation Biologics Submarket Forecast ($bn) & AGR (%), 2017-2028
  • Figure 4.12: Biosimilar Approvals in India, 2001-2015
  • Figure 4.13: Chinese Next-Generation Biologics Submarket Forecast ($bn) &AGR (%), 2017-2028
  • Figure 4.14: Indian Next-Generation Biologics Submarket Forecast ($bn) & AGR (%), 2017-2028
  • Figure 5.1: Next-Generation Antibodies: Submarket Shares (%) by Sector, 2017
  • Figure 5.2: Next-Generation Antibodies Submarket Forecast ($bn), 2017-2028
  • Figure 5.3: Antibody-Drug Conjugates: Submarket Shares (%) by Drug, 2017
  • Figure 5.4: Adcetris: Revenue Forecasts ($bn) & AGR (%), 2017-2028
  • Figure 5.4: Kadcyla Revenue Forecasts ($bn) & AGR (%), 2017-2028
  • Figure 6.1: Next-Generation Antibody Fragment and ALP Submarket Forecast ($bn) & AGR (%), 2017-2028
  • Figure 6.2: Next-Generation Antibody Fragment Submarket Forecast ($bn), 2017-2028
  • Figure 6.3: Next-Generation Antibody-Like Protein Submarket Forecast ($bn), 2017-2028
  • Figure 7.1: Tresiba: Revenue Forecast ($bn), & AGR (%), 2017-2028
  • Figure 7.2: Next-Generation Insulin Submarket Revenue Forecast ($bn), 2017-2028
  • Figure 7.3: Diabetes: Proportion of Population Affected, 2016
  • Figure 7.4: Oral Insulin Submarket Forecast ($bn), 2017-2028
  • Figure 7.5: Ultra-Rapid Acting Insulin Submarket Forecast ($bn), 2017-2028
  • Figure 7.6: Afrezza: Revenue Forecast ($bn), 2017-2028
  • Figure 7.7: Ultra-Long Acting Insulin Submarket Forecast ($bn) & AGR (%), 2017-2028
  • Figure 8.1: Plegridy: Revenue Forecast ($bn) & AGR (%), 2017-2028
  • Figure 8.2: Next-Generation Recombinant Coagulation Factors Submarket Forecast ($bn) & AGR (%), 2017-2028
  • Figure 8.3: Eloctate: Revenue Forecast ($bn), 2017-2028
  • Figure 8.4: Alprolix: Revenue Forecast ($bn), 2017-2028
  • Figure 8.5: Next-Generation Growth Hormones Submarket Forecast ($bn), 2017-2028
  • Figure 9.1: Regenerative Medicine: Submarket Shares (%) by Sector, 2016
  • Figure 9.2: Regenerative Medicine Submarket Forecast ($bn) & AGR (%), 2017-2028
  • Figure 9.3: Stem Cell Therapies Submarket Forecast ($bn) & AGR (%), 2017-2028
  • Figure 9.4: Tissue Engineering Submarket Forecast ($bn) & AGR (%), 2017-2028
  • Figure 9.5: Gene Therapies Submarket Forecast ($bn) & AGR (%), 2017-2028
  • Figure 10.1: Big Pharma Partnering Opportunities for Next-Generation Biologics Development, 2017

List of Tables

  • Table 2.1: First Approvals for Recombinant Protein Therapies, 1982-1997
  • Table 2.1: First Approvals for Recombinant Protein Therapies, 1982-1997
  • Table 3.1: Top Ten Bestselling Prescription Pharmaceuticals: Revenues ($bn), 2016
  • Table 3.2: Next-Generation Biologics Market: Revenues ($bn) & Market Share (%) by Sector, 2017
  • Table 3.3: Biological Drugs Market: Drivers and Restraints, 2017-2028
  • Table 3.4: Next-Generation Biologics Market: Overall Market Forecast and Revenue Forecasts ($bn), AGR (%), & CAGR (%) by Sector, 2017-2028
  • Table 3.5: Next-Generation Biologics: Market Shares (%) by Sector, 2018, 2023 and 2028
  • Table 4.1: Next-Generation Biologics Market: Revenues ($bn) by National Submarket, 2017
  • Table 4.2: Next-Generation Biologics Market: Revenues ($bn), AGR (%), & CAGR (%) by National Submarket, 2017-2028
  • Table 4.2: Next-Generation Biologics Market: Revenues ($bn), AGR (%), & CAGR (%) by National Submarket, 2017-2028 (continued)
  • Table 4.3: Next-Generation Biologics: Revenue ($bn) & Market Shares (%) by National Submarket, 2023 and 2028
  • Table 4.4: National Incidence and Prevalence of Leading Indications Treated with Biologics (millions of patients), 2016
  • Table 4.5: Main Approval Dates for Next-Generation Biologics in Leading National Submarkets, 2003-2013
  • Table 4.6: US Next-Generation Biologics Submarket Forecast ($bn), AGR (%), & CAGR (%), 2017-2028
  • Table 4.7: Biosimilars Approved and Marketed in Japan, 2016
  • Table 4.8: Japanese Next-Generation Biologics Submarket Forecast ($bn), AGR (%), & CAGR (%), 2017-2028
  • Table 4.9 : ext-Generation Biologics Submarkets in the EU5 Nations: Revenues ($bn) & Market Share (%) 2017
  • Table 4.10: German Next-Generation Biologics Submarket Forecast ($bn), AGR (%), & CAGR (%), 2017-2028
  • Table 4.11: France Next-Generation Biologics Submarket Forecast ($bn), AGR (%), & CAGR (%), 2017-2028
  • Table 4.12: UK Next-Generation Biologics Submarket Forecast ($bn), AGR (%), & CAGR (%), 2017-2028
  • Table 4.13: Italian Next-Generation Biologics Submarket Forecast ($bn), AGR (%), & CAGR (%), 2017-2028
  • Table 4.14: Spanish Next-Generation Biologics Submarket Forecast ($bn), AGR (%), & CAGR (%) 2017-2028
  • Table 4.15: Chinese Next-Generation Biologics Submarket Forecast ($bn), AGR (%), & CAGR (%), 2017-2028
  • Table 4.16: Indian Next-Generation Biologics Submarket Forecast ($bn), AGR (%), & CAGR (%), 2017-2028
  • Table 5.1: Monoclonal Antibodies Submarket: Leading Drug Revenues ($bn), 2016
  • Table 5.2: Next-Generation Antibodies Submarket: Approved Drug Revenues ($bn), 2016
  • Table 5.3: Selected Clinical and Pre-Clinical ADC Platforms, 2016
  • Table 5.4: Selected Clinical and Pre-Clinical Engineered Antibody Platforms, 2016
  • Table 5.5: Next-Generation Antibodies Submarket: Revenues by Sector ($bn) & Market Share (%), 2017
  • Table 5.6: Next-Generation Antibodies Submarket: Overall Submarket Forecast and Revenue Forecasts ($bn), AGR (%), & CAGR (%), by Sector, 2018-2028
  • Table 5.7: Next-Generation Antibodies Submarket: Drivers and Restraints, 2017-2028
  • Table 5.8: Antibody Drug Conjugates Submarket: Revenues ($bn) and Submarket Shares (%) by Drug, 2017
  • Table 5.9: Antibody-Drug Conjugates Submarket Forecast ($bn), AGR (%), & CAGR (%), 2017-2028
  • Table 5.10: Kadcyla and Adcetris: Revenue Forecasts ($bn), 2023-2028
  • Table 5.11: Antibody-Drug Conjugates Submarket: Drivers and Restraints, 2017-2028
  • Table 5.12: Selected Antibody-Drug Conjugates in Phase III Development, 2016
  • Table 5.13: Selected Antibody-Drug Conjugates in Phase II Development, 2016
  • Table 5.14: Selected Antibody-Drug Conjugates in Phase I Development, 2016
  • Table 5.15: Engineered Antibodies Submarket Forecast ($bn), 2017-2028
  • Table 5.16: Gazyva/Gazyvaro: Revenue Forecast ($bn), 2017-2022
  • Table 5.17: Engineered Antibodies Submarket: Drivers and Restraints, 2017-2028
  • Table 5.18: Selected Engineered Antibodies in Phase II and III Development, 2016
  • Table 5.19: Bispecific Antibodies Submarket Forecast ($bn), 2017-2022
  • Table 5.20: Bispecific Antibodies Submarket: Drivers and Restraints, 2017-2028
  • Table 5.21: Bispecific Antibodies in Phase I and II Development, 2016
  • Table 6.1: Selected Next-Generation Antibody Fragment Platforms, 2018
  • Table 6.2: Selected Antibody-Like Protein Platforms, 2017
  • Table 6.3: Next-Generation Antibody Fragment and ALP Submarket: Overall Submarket Forecast and Revenue Forecasts ($bn), AGR (%) & CAGR (%), by Sector, 2017-2028
  • Table 6.4: Next-Generation Antibody Fragment and ALP Submarket: Drivers and Restraints, 2017-2028
  • Table 6.6: Next-Generation Antibody Fragment Submarket Forecast ($bn), AGR (%) & CAGR (%), 2017-2028
  • Table 6.8: Next-Generation Antibody Fragment Submarket: Clinical Pipeline, 2017
  • Table 6.9: Next-Generation Antibody-Like Protein Submarket Forecast ($bn), 2018-2028
  • Table 6.10: Next-Generation Antibody-Like Protein Submarket: Clinical Pipeline, 2016
  • Table 7.1: Tresiba: Revenue Forecast ($bn), AGR (%) & CAGR (%), 2017-2028
  • Table 7.2: Next-Generation Insulin Submarket: Overall Submarket Forecast and Revenue Forecasts ($bn) by Sector, 2017-2028
  • Table 7.3: Next-Generation Insulin Submarket: Drivers and Restraints, 2017-2028
  • Table 7.4: Diabetes: Prevalence and Proportion of Population Affected, 2016
  • Table 7.5: Leading Insulin Analogues: US and EU Patent Expiries, 2013-2019
  • Table 7.6: Oral Insulin Submarket Forecast ($bn), 2023-2028
  • Table 7.7: Oral Insulin Submarket: Drivers and Restraints, 2017-2028
  • Table 7.8: Oral Insulin: Selected Pre-Clinical and Clinical-Stage Pipeline, 2017
  • Table 7.9: Ultra-Rapid Acting Insulin Submarket Forecast ($bn), 2017-2028
  • Table 7.10: Ultra-Rapid Acting Insulin Submarket: Drivers and Restraints, 2017-2028
  • Table 7.11: Ultra-Rapid Acting Insulin: Pre-Clinical and Clinical-Stage Pipeline, 2016
  • Table 7.12: Afrezza: Revenue Forecast ($bn), AGR (%) & CAGR (%), 2017-2028
  • Table 7.13: Ultra-Long Acting Insulin Forecast ($bn) AGR (%) & CAGR (%), 2018-2028
  • Table 7.14: Ultra-Long Acting Insulin Submarket: Drivers and Restraints, 2017-2028
  • Table 7.15: Selected Ultra-Long Acting Insulin: Clinical-Stage Pipeline, 2017
  • Table 8.1: Plegridy: Revenue Forecast ($bn), AGR (%) & CAGR (%), 2018-2028
  • Table 8.2: Recombinant Coagulation Factor Half-Lives and Target Populations, 2017
  • Table 8.3: Next-Generation Recombinant Coagulation Factors Submarket Forecast ($bn), AGR (%) & CAGR (%), 2017-2028
  • Table 8.4: Next-Generation Recombinant Coagulation Factors Submarket: Drivers and Restraints, 2017-2028
  • Table 8.5: Eloctate: Revenue Forecast ($bn), AGR (%) & CAGR (%), 2017-2028
  • Table 8.5: Long-Acting Recombinant Factors VIII and IX in Late-Stage Clinical Development, 2017
  • Table 8.6: Alprolix: Revenue Forecast ($bn), 2017-2022
  • Table 8.7: Next-Generation Growth Hormones Submarket Forecast ($bn), 2017-2022
  • Table 8.8: Next-Generation Growth Hormones Submarket: Drivers and Restraints, 2017-2028
  • Table 8.9: Selected Next-Generation Growth Hormones in Clinical Development, 2016
  • Table 9.1: Regenerative Medicine Submarket: Revenues by Sector ($bn) & Submarket Share (%) 2017
  • Table 9.2: Regenerative Medicine Submarket: Overall Submarket Forecast and Revenue Forecasts ($bn), AGR (%) and CAGR (%) by Sector, 2018-2028
  • Table 9.3: Regenerative Medicine Submarket: Drivers and Restraints, 2017-2028
  • Table 9.4: Stem Cell Therapies Submarket Forecast ($bn), AGR (%) & CAGR (%), 2017-2022
  • Table 9.5: Stem Cell Therapies Submarket: Drivers and Restraints, 2017-2028
  • Table 9.6: Selected Stem Cell Therapies in Phase II and III Clinical Trials, 2017
  • Table 9.7: Selected Stem Cell Therapies in Phase I/II Development, 2017
  • Table 9.8: Tissue Engineering Submarket Forecast ($bn), AGR (%) & CAGR (%), 2017-2028
  • Table 9.9: Tissue Engineering Submarket: Drivers and Restraints, 2017-2028
  • Table 9.10: Gene Therapies Submarket Forecast ($bn), AGR (%) & CAGR (%), 2017-2028
  • Table 9.11: Gene Therapies Submarket: Drivers and Restraints, 2017-2028
  • Table 9.12: Gene Therapies in Phase II and III Clinical Trials, 2017
  • Table 10.1: Next-Generation Biologics: STEP Analysis, 2017-2028
  • Table 10.2: Selected CMO Investments in Next-Generation Biologics, to 2017
  • Table 12.1: Next-Generation Biologics Market: Submarket Forecasts ($bn) and Market Shares (%), 2017, 2023 and 2028

Companies Listed

  • 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
  • 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
  • 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)
  • Cephalon (part of Teva)
  • CEPiA (part of Sanofi)
  • Ceregene
  • Chatham Therapeutics
  • Chiesi Farmaceutici
  • 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
  • Diasome Pharmaceuticals
  • Dr. Reddy's Laboratories
  • Dyax
  • Eddingpharm
  • EGEN
  • Eisai
  • Elan Pharmaceuticals (now part of Perrigo Company)
  • Eli Lilly
  • Emisphere
  • Enzon Pharmaceuticals
  • EnzymeRx
  • Epitomics (part of Abcam)
  • ESBATech (part of Novartis)
  • Flamel Technologies
  • 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
  • GlaxoSmithKline (GSK)
  • GlycoExpress
  • Glycotope
  • Halozyme Therapeutics
  • Hanmi Pharmaceutical
  • Health Canada
  • Hikma Pharmaceuticals
  • Histogenics
  • Humacyte
  • Human Stem Cells Institute (HSCI)
  • Igenica
  • ImmunoGen
  • Immunomedics
  • Innovent Biologics
  • Integra LifeSciences
  • Introgen Therapeutics
  • Jain Foundation
  • JCR Pharmaceuticals
  • Johnson & Johnson (J&J)
  • 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
  • Mitsubishi Tanabe Pharma
  • Mochida Pharmaceutical
  • Molecular Partners
  • MorphoSys
  • 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)
  • SAFC
  • Sandoz (part of Novartis)
  • Sanofi
  • 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)
  • Stelis Biopharmaceuticals (part of Strides Arcolab)
  • Stem CentRx
  • StemCells
  • Stempeutics Research
  • Strativa Pharmaceuticals
  • Strides Arcolab
  • Sutro Biopharma
  • Swedish Orphan Biovitrum (Sobi)
  • Symphogen
  • Synthon
  • Synthon Biopharmaceuticals BV (part of Synthon)
  • Takeda Pharmaceutical Company
  • Teva Pharmaceutical Industries
  • Thermalin Diabetes
  • TiGenix
  • TRION Pharma
  • UCB
  • UniQure
  • USV
  • VBL Therapeutics
  • Vericel Corporation
  • Versartis
  • viDA Therapeutics
  • Viventia Biotechnologies Inc
  • VX Pharma
  • Wyeth (part of Pfizer)
  • Xencor
  • Xeris Pharmaceuticals
  • Zydus Cadila

List of Organizations:

  • Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM)
  • Babraham Institute
  • Centers for Disease Prevention and Control (CDC) [US]
  • Children's Hospital of Philadelphia (CHOP)
  • China Food and Drug Administration (CFDA)
  • Duke University
  • Duke University Hospital
  • EMA's Committee for Medicinal Products for Human Use (CHMP)
  • European Commission
  • European Medicines Agency (EMA)
  • Food and Drug Administration (FDA) [US]
  • Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) [Germany]
  • International Diabetes Federation (IDF)
  • Ministry of Health, Labor and Welfare (MHLW) [Japan]
  • Moorfields Eye Hospital [UK]
  • 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]
  • Royal Institute of Technology [Sweden]
  • Russian Ministry of Healthcare (Minzdrav)
  • Scottish Medicines Consortium (SMC)
  • Stanford University
  • Swiss Federal Institute of Technology
  • Tianjin International Joint Academy of Bio-medicine
  • University of California, San Francisco (UCSF)
  • University of Chicago
  • University of Toronto
  • World Bank Group
  • World Cancer Research Fund (WCRF)
  • World Health Organization (WHO)
  • Yale School of Medicine)
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