次世代エネルギー産業・グリーン経済の国際リサーチ情報サイト

次世代生物製剤(Biologics)の世界市場2014-2024年:業界および研究開発動向

Next-Generation Biologics: R&D, Industry and Market 2014-2024

出版元:Visiongain(英国)出版元情報LinkIcon
発行年:2014年4月
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納品形態:PDF by Email
当調査レポートは英文288ページになります。
商品コード:VGN220

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【レポート紹介】
当レポートでは、次世代生物製剤の世界市場規模は2018年に121億7000万ドルに達し、さらに2024年にはその倍の規模へと成長することを予測しています。同市場の2024年に至る市場予測、詳細なセグメント別予測分析、主要製品別売上予測に加え、市場動向、リーディング企業情報などを概略以下の構成でお届けしています。

【レポート構成概要】
・次世代生物製剤の世界市場2014-2024年
・全288ページ、94個のデータ表、55個のチャートで分析定量化
・業界専門家オピニオンインタビュー:
- Dr Fredrik Frejd, CSO, Affibody
- Dr Mike Romanos, CEO, Crescendo Biologics

・セグメント別市場予測2014-2024年VGN220_Next-Generation Biologics R&D, Industry and Market 2014-2024 Cover.jpgレポート表紙
• 再生医療
- 組織再生
- 幹細胞
- 遺伝子療法
・抗体(モノクローナル抗体mAbs含む)
- 薬剤結合抗体
- 二重特異性抗体治療薬
・抗体断片および抗体様たん白質(ALP)
・バイオシミラー(後続たんぱく質製品)
・インスリン
- 超長期作用
- 経口
- 超速効型
・成長ホルモン
・組み換え凝固因子
・その他次世代治療用たんぱく質

・主要7ブランド、製品別売上予測
(※7製品合計で2024年に売上100億ドル規模と推計)
• Adcetris
• Kadcyla
• Gazyva
• Tresiba
• Afrezza
• Plegridy
• Eloctate.

・主要9ヶ国、国別市場予測2014-2024年
• 米国
• 日本
• ドイツ、フランス、英国、イタリア、スペイン(EU主要5ヶ国)
• 中国
• インド

・市場動向分析
• 既存の生物製剤の限界
• 有望視される次世代生物製剤、新製品立ち上げ
• 半減期の伸長:ペグ化、その他技術
• 生物学的療法への需要増大
• 開発ニーズやトレンドに対応する受託製造機関(CMO)
• 需要に影響する病気発生率
• 治療用抗体(細胞傷害性療法を含む)の進化
• 研究開発パイプライン (e.g. イムノトキシン)
• 2015年以降となる見込みのバイオシミラーインスリンと市場への影響
• がん、糖尿病、心血管疾患の罹患率上昇の影響

・リーディング企業情報
• Roche
• Eli Lilly
• Novo Nordisk
• Sanofi
• Pfizer
• Kyowa Hakko Kirin
• Baxter International.

Visiongain is a trading partner with the US Federal Government
【レポート詳細目次は当ページ下を参照ください】

英文詳細目次(table of contents)

【原文詳細目次】

Next-Generation Biologics: R&D, Industry and Market 2014-2024

Table of Contents

1. Executive Summary

1.1 Next-Generation Biologics: World Market Review 2014
1.2 Report Contents
1.2.1 Benefits of this Report
1.3 Research and Analysis Methods
1.3.1 Financial Information in this Report
1.3.2 Who is this Report for?
1.4 An Introduction to Next-Generation Biologics
1.4.1 A Brief History of Biological Drug Development
1.4.2 Limitations to Current Generation Biologics
1.4.3 The Promise of Next-Generation Biologics
1.4.3.1 Defining Next-Generation Biologics
1.4.3.2 A Definition of Regenerative Medicine
1.4.3.3 Extending Half-Life: Pegylation and Other Novel Strategies

2. The World Next-Generation Biologics Market: Outlook and Forecast 2014-2024

2.1 The Next-Generation Biologics Market 2013
2.1.1 Development of the Next-Generation Biologics Market 2008-2013
2.1.2 Rising Demand for Biological Therapies
2.1.3 Next-Generation Drugs as a Share of the Biologics Market 2013
2.1.4 Main Sectors of the Next-Generation Biologics Market: Antibodies and Regenerative Medicine Lead the Way
2.1.5 Leading Companies in the Next-Generation Biologics Market 2013
2.2 The Next-Generation Biologics Market 2014-2024
2.2.1 The Biologics Market Forecast 2014-2024
2.2.1.1 Growth Drivers for Biological Drug Revenues 2014-2024
2.2.2 The Next-Generation Biologics Market Forecast 2014-2024
2.2.3 Product Launches in All Sectors to Drive Market Growth 2014-2024
2.2.4 Next-Generation Biologics: Market Restraints 2014-2024
2.2.5 Rising Market Shares for Next-Generation Insulins 2014-2024

3. Leading National Submarkets for Next-Generation Biologics 2014-2024

3.1 Leading National Submarkets for Next-Generation Biologics 2013
3.1.1 National Submarket Forecasts 2014-2024
3.1.2 How Will National Submarket Shares Change to 2024?
3.2 Rising Disease Incidence in Major Markets 2014-2024
3.3 Approval of Next-Generation Biologics in Major National Submarkets
3.4 The US Will be the Largest Submarket for Next-Generation Biologics 2014-2024
3.4.1 US Submarket Forecast 2014-2024
3.5 Next-Generation Biologics in Japan 2014-2024
3.5.1. National Expertise in Stem Cell Research
3.5.2 Japanese Submarket Forecast 2014-2024
3.6 Next-Generation Biologics in Leading EU Nations 2014-2024
3.6.1 Regenerative Medicine Development in the EU
3.6.2 Market Access for Next-Generation Biologics in the EU
3.6.3 Germany: Submarket Forecast 2014-2024
3.6.4 France: Submarket Forecast 2014-2024
3.6.5 UK: Submarket Forecast 2014-2024
3.6.6 Italy and Spain: Submarket Forecasts 2014-2024
3.7 Next-Generation Biologics in Emerging Markets 2014-2024
3.7.1 Next-Generation Biologics Development in Emerging Markets
3.7.2 Chinese Submarket Forecast 2014-2024
3.7.3 Indian Submarket Forecast 2014-2024

4. Next-Generation Antibodies Submarket Outlook 2014-2024

4.1 Strategies for Improving Antibody Therapies
4.1.1 Antibody-Drug Conjugates: Targeted Cytotoxic Therapies
4.1.2 Engineering Antibodies for Improved Potency
4.1.3 Bispecific Antibodies
4.2 Next-Generation Antibody Therapy Submarket 2012-2013
4.3 Next-Generation Antibody Therapy Submarket 2014-2024
4.3.1 Strong Revenue Growth for Next-Generation Antibodies 2014-2024
4.3.2 Blockbuster Potential Will Drive Growth to 2024
4.3.3 Next-Generation Antibodies: Submarket Restraints 2014-2024
4.4 Antibody-Drug Conjugates Submarket 2014-2024
4.4.1 Antibody-Drug Conjugates Submarket Forecast 2014-2024
4.4.1.1 Kadcyla and Adcetris: Revenue Forecast 2014-2024
4.4.2 What Will Drive Growth for ADCs to 2024?
4.4.3 A Long Pipeline of ADCs in Clinical Development
4.4.3.1 CMC544: NHL Development Halted but Trials in ALL Continue
4.4.3.2 CDX-011: Potential for Accelerated Approval in Breast Cancer
4.5 Engineered Antibodies Submarket 2014-2024
4.5.1 Engineered Antibodies Submarket Forecast 2014-2024
4.5.1.1 Gazyva Will Lead the Submarket in 2024
4.5.2 Portfolio Management to Drive Growth 2014-2024
4.5.3 Engineered Antibodies Pipeline 2014
4.5.3.1 Benralizumab (MedImmune/Kyowa Hakko Kirin)
4.6 Bispecific Antibodies Submarket 2014-2024
4.6.1 Bispecific Antibodies Submarket Forecast 2014-2024
4.6.2 Bispecific Antibodies: Submarket Drivers and Restraints 2014-2024
4.6.3 One Phase III and Two Phase II Bispecific Antibodies in 2014
4.6.3.1 Blinatumomab (Amgen): The Only Phase III Bispecific Antibody

5. Antibody Fragments and Novel Antibody-Like Drugs: Commercial Potential 2014-2024

5.1 Next-Generation Antibody Fragments: Beyond Fab Fragments
5.1.1 Antibody-Like Proteins Mimic Antibody Therapies
5.1.2 There Are Advantages to Using Fragments and Novel Scaffolds
5.2 Antibody Fragment and ALP Submarket 2014-2024
5.2.1 Antibody Fragment and ALP Submarket Forecast 2014-2024
5.2.2 Pharma Is Investing Strongly in Antibody Fragments and ALPs
5.2.3 Limited Late-Stage Pipeline to Restrain Growth to 2024
5.3 Outlook for Next-Generation Antibody Fragments 2014-2024
5.3.1 Next-Generation Antibody Fragment Submarket Forecast 2014-2024
5.3.2 One Platform Leads the Pipeline in 2014
5.3.2.1 Three Nanobodies in Development for Rheumatoid Arthritis
5.3.2.2 Caplacizumab (Ablynx): Targeting an Orphan Indication
5.4 The Antibody-Like Protein Submarket 2014-2024
5.4.1 Antibody-Like Protein Submarket Forecast 2014-2024
5.4.2 Four ALPs in Clinical Development in 2014
5.4.2.1 AGN-150998: Development of the Lead Clinical ALP Delayed
5.5 Will Next-Generation Immunotoxins Impact the Market to 2024?
5.5.1 Challenges with First Generation Immunotoxins
5.5.2 Fusion Protein Conjugates: Pipeline 2014
5.5.2.1 Moxetumomab Pasudotox
5.5.3 Humanised Immunotoxins
5.5.3.1 Using Granzyme B in Immunotoxins
5.5.3.2 Immunornases: A Future Development Opportunity for Immunotoxins

6. Next-Generation Insulin Submarket: Outlook 2014-2024

6.1 Strategies for Next-Generation Insulin Development
6.1.1 Reformulating Insulin for Convenient Administration
6.1.1.1 Oral Insulin
6.1.1.2 Inhaled Insulin
6.1.1.3 Exubera: A Failed Attempt at Reformulated Insulin
6.2 Next-Generation Insulin Submarket 2012-2013
6.2.1 Tresiba: Approved in the EU and Japan
6.2.1.1 Tresiba: Revenue Forecast 2014-2024
6.3 Next-Generation Insulin Submarket 2014-2024
6.3.1 Next-Generation Insulin Submarket Forecast 2014-2024
6.3.2 Product Launches in the US and EU Will Drive Submarket Growth 2014-2024
6.3.3 Next-Generation Insulin Submarket Restraints 2014-2024
6.3.3.1 Biosimilar Insulins Will be Available from 2015
6.4 Oral Insulin Submarket 2014-2024
6.4.1 Oral Insulin Submarket Forecast 2014-2024
6.4.2 Oral Insulin: Submarket Drivers and Restraints 2014-2024
6.4.3 A Limited Clinical-Stage Pipeline for Oral Insulin 2014
6.4.3.1 Oramed Pharmaceuticals: Oral Insulin in Phase II
6.4.3.2 Novo Nordisk
6.4.3.3 IN-105: Biocon Partners with Bristol-Myers Squibb for Development
6.4.3.4 Diabetology: Multiple Deals Signed for Emerging Markets
6.5 Ultra-Rapid Acting Insulin Submarket 2014-2024
6.5.1 Ultra-Rapid Acting Insulin Submarket Forecast 2014-2024
6.5.1.1 Will Inhaled Insulins Drive Revenue Growth to 2024?
6.5.2 Other Submarket Drivers and Restraints 2014-2024
6.5.3 Ultra-Rapid Acting Insulin Pipeline 2014
6.5.3.1 FIAsp (Novo Nordisk)
6.5.3.2 Adocia: Eli Lilly Opts to Discontinue Partnership
6.5.3.3 Halozyme Therapeutics
6.5.3.4 Biodel: Multiple Ultra Rapid Acting Candidates
6.5.3.5 Afrezza: Inhaled Insulin Nearing the Market
6.5.3.6 Adagio: A Second-Generation Inhaled Insulin
6.6 Ultra-Long Acting Insulin Submarket 2014-2024
6.6.1 Ultra-Long Acting Insulin Submarket Forecast 2014-2024
6.6.2 Revenue Growth Driven by Uptake of Tresiba
6.6.3 Ultra-Long Acting Insulin Pipeline 2014
6.6.3.1 U300: Sanofi’s Next-Generation Insulin Analogue
6.6.3.2 LY2605541 (Eli Lilly)
6.6.3.3 FT-105 (Flamel Technologies)
6.6.3.4 LAPS-Insulin

7. Next-Generation Developments for Other Recombinant Proteins 2014-2024

7.1 Defining Next-Generation for Other Recombinant Protein Sectors
7.1.1 Next-Generation Interferon Beta: Plegridy Set for Approval in 2014
7.1.1.1 Plegridy: Revenue Forecast 2014-2024
7.1.1.2 Plegridy May Compete with Other Long-Acting Interferon Beta Therapies 2014-2024
7.1.2 Next-Generation G-CSF: Teva Expands its Filgrastim Franchise
7.1.2.1 Other Clinical-Stages Advances in Filgrastim Therapy 2014
7.2 Next-Generation Recombinant Coagulation Factors 2014-2024
7.2.1 Next-Generation Recombinant Coagulation Factors Submarket Forecast 2014-2024
7.2.2 Submarket Drivers and Restraints 2014-2024
7.2.3 Clinical Pipeline for Recombinant Coagulation Factors 2014-2024
7.2.3.1 BAX 855 (Baxter)
7.2.3.2 BAY94-9027 (Bayer)
7.2.3.3 N8-GP for Haemophilia A
7.2.3.4 N9-GP for Haemophilia B
7.2.3.5 Fused Factors: Biogen Idec’s Eloctate and Alprolix
7.2.3.6 rIX-FP (CSL Behring): Albumin-Bound Coagulation Factors
7.2.4 Gene Therapy as a New Treatment Option for Haemophilia
7.3 Next-Generation Growth Hormones 2014-2024
7.3.1 Next-Generation Growth Hormone Submarket Forecast 2014-2024
7.3.2 Brand Loyalty Will Restrain Uptake of Next-Generation Hormones 2014-2024
7.3.3 Long-Acting Growth Hormones
7.3.3.1 Biopartners/LG Life Sciences: The First Long-Acting Growth Hormone
7.3.3.2 Prolor Biotech/OPKO Health
7.3.3.3 Novo Nordisk: Looking to Extend its Market-Leading Position
7.3.3.4 Versartis: XTEN Technology for Half-Life Extension
7.3.4 Reformulated Growth Hormones: Offering Convenient Dosing for Paediatric Patients
7.3.4.1 Critical Pharmaceuticals: Nasal Delivery of Somatropin

8. Regenerative Medicine: Commercial Outlook 2014-2024

8.1 The Regenerative Medicine Submarket 2012-2013
8.1.1 Defining Regenerative Medicine
8.2 The Regenerative Medicine Submarket: Revenue Projections 2014-2024
8.2.1 Stem Cell and Gene Therapy Launches to Drive Growth 2014-2024
8.3 The Stem Cell Therapies Submarket 2014-2024
8.3.1 Prochymal (Mesoblast) for GvHD
8.3.1.1 The Future for Prochymal: Approval in Crohn’s Disease?
8.3.2 A Note on Stem Cell Transplants
8.3.3 Stem Cell Therapies Submarket Forecast 2014-2024
8.3.4 Stem Cell Therapies: Submarket Drivers and Restraints 2014-2024
8.3.4.1 Will iPSCs Prove Effective for Stem Cell Therapy?
8.3.5 Stem Cell Therapies Late-Stage Pipeline 2014
8.3.5.1 Cx601 (TiGenix)
8.3.5.2 Mesoblast: Mesenchymal Stem Cell Therapies
8.3.5.3 Baxter Pharmaceuticals: A Leading Cardiovascular Candidate
8.3.5.4 StemEx (Gamida Cell)
8.4 The Gene Therapies Submarket 2014-2024
8.4.1 Glybera Approved and Set for Launch in the EU
8.4.2 Gene Therapies Submarket: Revenue Projections 2014-2024
8.4.3 Glybera’s Approval to Drive Submarket Growth from 2014
8.4.4 There Are More Than Five Gene Therapies in Late-Stage Development
8.4.4.1 ProstAtak: Gene Therapy for Prostate Cancer
8.4.4.2 TVEC (Amgen)
8.4.4.3 Generx (Cardium Therapeutics)
8.4.4.4 Spark Therapeutics: Established in 2013 for Ophthalmic Gene Therapy
8.5 Outlook for Tissue Engineering 2014-2024
8.5.1 Two Sectors Lead the Market: Wound and Cartilage Repair
8.5.1.1 Apligraf Leads the Wound Repair Submarket
8.5.1.2 Organogenesis Will Market Apligraf and Dermagraft from 2014
8.5.2 Tissue Engineering Submarket Forecast 2014-2024
8.5.3 Tissue Engineering: Submarket Drivers and Restraints 2014-2024
8.5.4 Future Developments in Cartilage Repair: Pipeline 2014
8.5.5 Organ Repair and Engineering: The Next Step in Tissue Engineering?
8.5.5.1 Engineered Skin
8.5.5.2 Engineered Veins
8.5.5.3 Organ Transplant: A Long-Term Tissue Engineering Opportunity

9. Next-Generation Biologics: Industry Trends 2014-2024

9.1 Next-Generation Biologics: Market Strengths 2014
9.2 Next-Generation Biologics: Market Weaknesses 2014
9.3 The Next-Generation Biologics Market: STEP Analysis 2014-2024
9.3.1 Social Factors: Rising Disease Incidence and Demands for Convenience
9.3.1.1 Rising Incidence in Cancer, Diabetes and Cardiovascular Disease
9.3.1.2 Next-Generation Biologic Development in Emerging Markets
9.3.2 Technological Developments 2014-2024
9.3.3 Economic Pressures 2014-2024
9.3.3.1 High Drug Costs and Healthcare Spending
9.3.3.2 Limited Commercial Potential in Emerging Markets?
9.3.4 Political Issues: Regulatory Developments 2014-2024
9.4 Next-Generation Biologics: Development Trends 2014-2024
9.4.1 Improving Patient Convenience
9.4.2 Sustained Release Biologics: Pegylation and Beyond
9.4.3 Therapeutic Focus for Next-Generation Biologics
9.4.4 Next-Generation Biologics as Personalised Medicine
9.5 Manufacturing Challenges and Opportunities for Next-Generation Biologics
9.5.1 Contract Manufacturers Invest to Follow Development Trends
9.6 Commercialising Next-Generation Biologics
9.6.1 Product Lifecycle Management for First Generation Biologics
9.6.2 Proving Benefit in Next-Generation Products
9.6.3 Biosimilars as a Challenger 2014-2024
9.7 Partnering for Next-Generation Biologic Development
9.7.1 The Role of Big Pharma in the Next-Generation Biologics Market
9.7.2 Most Development Platforms Stem from Small Biotechs

10. Research Interviews from Our Survey

10.1 Dr Fredrik Frejd, CSO, Affibody
10.1.1 Affibody
10.1.2 Challenges with Current Biological Therapies
10.1.2.1 Current Half-Life Extension Technologies
10.1.3 The Benefits of Affibodies Over Current Antibody Therapies
10.1.4 Focus on Inflammation and Autoimmune Diseases
10.1.5 Development of SOBI002
10.1.6 Regulatory Challenges for Novel Biologics
10.2 Dr Mike Romanos, CEO, Crescendo Biologics
10.2.1 Crescendo Biologics
10.2.2 The Benefits in Antibody Fragment Therapies
10.2.3 Treatment of Inflammation Indications with Antibody Fragments
10.2.4 Crescendo’s Fragment Pipeline
10.2.5 Development and Production Platforms for Antibody Therapies

11. Conclusions to Our Study

11.1 The Next-Generation Biologics Market Will Grow Strongly to 2024
11.2 Next-Generation Antibody Development Will Lead the Market
11.3 New Treatment Regimens Will Drive Demand for Next-Generation Biologics
11.4 Challenges Remain in Developing and Commercialising Next-Generation Biologics

List of Tables

Table 1.1 Currency Exchange Rates, 2013
Table 1.2 First Approvals for Recombinant Protein Therapies, 1982-1997
Table 1.3 Filgrastim Market: Revenues by Drug ($bn), 2013
Table 2.1 Next-Generation Biologics Market: Revenues ($bn), 2008-2013
Table 2.2 Top Ten Bestselling Prescription Pharmaceuticals: Revenues ($bn), 2013
Table 2.3 Biologics Market: Revenues by Sector ($bn), 2013
Table 2.4 Next-Generation Biologics Market: Revenues by Sector ($bn), 2013
Table 2.5 Biological Drugs Market: Revenue Forecast ($bn), 2013-2024
Table 2.6 Biological Drugs Market: Drivers and Restraints, 2014-2024
Table 2.7 Next-Generation Biologics Market: Overall Market Forecast and Revenue Forecasts ($bn) by Sector, 2013-2024
Table 2.8 Next-Generation Biologics: Revenues ($bn) and Biologics Market Share (%), 2013-2024
Table 2.9 Next-Generation Biologics: Market Shares (%) by Sector, 2013-2024
Table 3.1 Next-Generation Biologics Market: Revenues ($bn) by National Submarket, 2013
Table 3.2 Next-Generation Biologics Market: Overall Market Forecast and Revenue Forecasts ($bn) by National Submarket, 2013-2024
Table 3.3 Next-Generation Biologics: Market Shares (%) by National Submarket, 2013-2024
Table 3.4 National Incidence and Prevalence of Leading Indications Treated with Biologics, 2014
Table 3.5 Key Approval Dates for Next-Generation Biologics in Leading National Submarkets, 2003-2014
Table 3.6 US Next-Generation Biologics Submarket Forecast ($bn), 2013-2024
Table 3.7 Biosimilars Approved and Marketed in Japan, 2014
Table 3.8 Japanese Next-Generation Biologics Submarket Forecast ($bn), 2013-2024
Table 3.9 Next-Generation Biologics Submarkets in the EU5 Nations: Revenues ($bn), 2013
Table 3.10 German Next-Generation Biologics Submarket Forecast ($bn), 2013-2024
Table 3.11 French Next-Generation Biologics Submarket Forecast ($bn), 2013-2024
Table 3.12 UK Next-Generation Biologics Submarket Forecast ($bn), 2013-2024
Table 3.13 Italian and Spanish Next-Generation Biologics Submarket Forecasts ($bn), 2013-2024
Table 3.14 Chinese Next-Generation Biologics Submarket Forecast ($bn), 2013-2024
Table 3.15 Indian Next-Generation Biologics Submarket Forecast ($bn), 2013-2024
Table 4.1 Monoclonal Antibodies Submarket: Leading Drug Revenues ($bn), 2013
Table 4.2 Selected Clinical and Pre-Clinical ADC Platforms, 2014
Table 4.3 Selected Clinical and Pre-Clinical Engineered Antibody Platforms, 2014
Table 4.4 Next-Generation Antibodies Submarket: Revenues by Sector ($bn), 2013
Table 4.5 Next-Generation Antibodies Submarket: Overall Submarket Forecast and Revenue Forecasts ($bn) by Sector, 2013-2024
Table 4.6 Next-Generation Antibodies Submarket: Drivers and Restraints, 2014-2024
Table 4.7 Antibody Drug Conjugates Submarket: Revenues ($bn) and Submarket Shares (%) by Drug, 2013
Table 4.8 Antibody-Drug Conjugates Submarket Forecast ($bn), 2013-2024
Table 4.9 Kadcyla and Adcetris: Revenue Forecasts ($bn), 2013-2024
Table 4.10 Antibody-Drug Conjugates Submarket: Drivers and Restraints, 2014-2024
Table 4.11 Antibody-Drug Conjugates in Phase II and III Development, 2014
Table 4.12 Engineered Antibodies Submarket Forecast ($bn), 2013-2024
Table 4.13 Gazyva: Revenue Forecast ($bn), 2013-2024
Table 4.14 Engineered Antibodies Submarket: Drivers and Restraints, 2014-2024
Table 4.15 Engineered Antibodies in Phase II and III Development, 2014
Table 4.16 Bispecific Antibodies Submarket Forecast ($bn), 2013-2024
Table 4.17 Bispecific Antibodies Submarket: Drivers and Restraints, 2014-2024
Table 4.18 Bispecific Antibodies in Phase I/II, II and III Development, 2014
Table 5.1 Selected Next-Generation Antibody Fragment Platforms, 2014
Table 5.2 Selected Antibody-Like Protein Platforms, 2014
Table 5.3 Next-Generation Antibody Fragment and ALP Submarket: Overall Submarket Forecast and Revenue Forecasts ($bn) by Sector, 2013-2024
Table 5.4 Next-Generation Antibody Fragment and ALP Submarket: Drivers and Restraints, 2014-2024
Table 5.5 Next-Generation Antibody Fragment Submarket Forecast ($bn), 2013-2024
Table 5.6 Next-Generation Antibody Fragment Submarket: Clinical Pipeline, 2014
Table 5.7 Antibody-Like Protein Submarket Forecast ($bn), 2013-2024
Table 5.8 Antibody-Like Protein Submarket: Clinical Pipeline, 2014
Table 6.1 Tresiba: Revenue Forecast ($bn), 2013-2024
Table 6.2 Next-Generation Insulin Submarket: Overall Submarket Forecast and Revenue Forecasts ($bn) by Sector, 2013-2024
Table 6.3 Next-Generation Insulin Submarket: Drivers and Restraints, 2014-2024
Table 6.4 Diabetes: Incidence and Proportion of Population Affected, 2014
Table 6.5 Leading Insulin Analogues: US and EU Patent Expiries, 2013-2018
Table 6.6 Oral Insulin Submarket Forecast ($bn), 2013-2024
Table 6.7 Oral Insulin Submarket: Drivers and Restraints, 2014-2024
Table 6.8 Oral Insulin: Pre-Clinical and Clinical-Stage Pipeline, 2014
Table 6.9 Ultra-Rapid Acting Insulin Submarket Forecast ($bn), 2013-2024
Table 6.10 Ultra-Rapid Acting Insulin Submarket: Drivers and Restraints, 2014-2024
Table 6.11 Ultra-Rapid Acting Insulin: Pre-Clinical and Clinical-Stage Pipeline, 2014
Table 6.12 Afrezza: Revenue Forecast ($bn), 2013-2024
Table 6.13 Ultra-Long Acting Insulin Forecast ($bn), 2013-2024
Table 6.14 Ultra-Long Acting Insulin Submarket: Drivers and Restraints, 2014-2024
Table 6.15 Ultra-Long Acting Insulin: Clinical-Stage Pipeline, 2014
Table 6.16 LY2605541: Active Phase III Clinical Trials, 2014
Table 7.1 Plegridy: Revenue Forecast ($bn), 2013-2024
Table 7.2 Recombinant Coagulation Factor Half-Lives and Target Populations, 2014
Table 7.3 Next-Generation Recombinant Coagulation Factors Submarket Forecast ($bn), 2013-2024
Table 7.4 Next-Generation Recombinant Coagulation Factors Submarket: Drivers and Restraints, 2014-2024
Table 7.5 Long-Acting Recombinant Factors VIII and IX in Late-Stage Clinical Development, 2014
Table 7.6 Eloctate: Revenue Forecast ($bn), 2013-2024
Table 7.7 Next-Generation Growth Hormones Submarket Forecast ($bn), 2013-2024
Table 7.8 Next-Generation Growth Hormones Submarket: Drivers and Restraints, 2014-2024
Table 7.9 Selected Next-Generation Growth Hormones in Clinical Development, 2014
Table 8.1 Regenerative Medicine Submarket: Revenues by Sector ($bn), 2013
Table 8.2 Regenerative Medicine Submarket: Overall Submarket Forecast and Revenue Forecasts ($bn) by Sector, 2013-2024
Table 8.3 Regenerative Medicine Submarket: Drivers and Restraints, 2014-2024
Table 8.4 Stem Cell Therapies Submarket Forecast ($bn), 2013-2024
Table 8.5 Stem Cell Therapies Submarket: Drivers and Restraints, 2014-2024
Table 8.6 Stem Cell Therapies in Phase II and III Clinical Trials, 2014
Table 8.7 Selected Stem Cell Therapies in Phase I and I/II Development, 2014
Table 8.8 Gene Therapies Submarket Forecast ($bn), 2013-2024
Table 8.9 Gene Therapies Submarket: Drivers and Restraints, 2014-2024
Table 8.10 Gene Therapies in Phase II and III Clinical Trials, 2014
Table 8.11 Tissue Engineering Submarket Forecast ($bn), 2013-2024
Table 8.12 Tissue Engineering Submarket: Drivers and Restraints, 2014-2024
Table 9.1 Next-Generation Biologics: STEP Analysis, 2014-2024
Table 9.2 Next-Generation Antibodies Pipeline by Therapeutic Area, 2014
Table 9.3 CMO Investments in Next-Generation Biologics, 2005-2013
Table 9.4 Biosimilar Market: Revenue Forecast ($bn), 2013-2024
Table 11.1 Next-Generation Biologics Market: Submarket Forecasts ($bn) and Market Shares (%), 2013-2024

List of Figures

Figure 2.1 Next-Generation Biologics Market: Revenues ($bn), 2008-2013
Figure 2.2 Biologics: Market Shares (%) by Sector, 2013
Figure 2.3 Next-Generation Biologics: Market Shares (%) by Sector, 2013
Figure 2.4 Biological Drugs Market: Revenue Forecast ($bn), 2013-2024
Figure 2.5 Next-Generation Biologics Market: Revenue Forecast ($bn), 2013-2024
Figure 2.6 Biologics Market by Sector: Revenues ($bn), 2013-2024
Figure 2.7 Next-Generation Biologics: Market Drivers, 2014-2024
Figure 2.8 Next-Generation Biologics: Market Restraints, 2014-2024
Figure 2.9 Next-Generation Biologics: Market Shares (%) by Sector, 2018
Figure 2.10 Next-Generation Biologics: Market Shares (%) by Sector, 2024
Figure 3.1 Next-Generation Biologics: Market Shares (%) by Country, 2013
Figure 3.2 Next-Generation Biologics: Market Shares (%) by Country, 2018
Figure 3.3 Next-Generation Biologics: Market Shares (%) by Country, 2024
Figure 3.4 US Next-Generation Biologics Submarket Forecast ($bn), 2013-2024
Figure 3.5 Japanese Next-Generation Biologics Submarket Forecast ($bn), 2013-2024
Figure 3.6 EU5 Nations: Next-Generation Biologics Submarket Shares (%), 2013
Figure 3.7 German Next-Generation Biologics Submarket Forecast ($bn), 2013-2024
Figure 3.8 French Next-Generation Biologics Submarket Forecast ($bn), 2013-2024
Figure 3.9 UK Next-Generation Biologics Submarket Forecast ($bn), 2013-2024
Figure 3.10 Italian and Spanish Next-Generation Biologics Submarket Forecasts ($bn), 2013-2024
Figure 3.11 Biosimilar Approvals in India, 2001-2014
Figure 3.12 Chinese Next-Generation Biologics Submarket Forecast ($bn), 2013-2024
Figure 3.13 Indian Next-Generation Biologics Submarket Forecast ($bn), 2013-2024
Figure 4.1 Monoclonal Antibodies Submarket: Revenue Shares (%) by Drug, 2013
Figure 4.2 Next-Generation Antibodies: Submarket Shares (%) by Sector, 2013
Figure 4.3 Next-Generation Antibodies Submarket Forecast ($bn), 2013-2024
Figure 4.4 Antibody-Drug Conjugates: Submarket Shares (%) by Drug, 2013
Figure 4.5 Antibody-Drug Conjugates Submarket Forecast ($bn), 2013-2024
Figure 4.6 Kadcyla and Adcetris: Revenue Forecasts ($bn), 2013-2024
Figure 4.7 Engineered Antibodies Submarket Forecast ($bn), 2013-2024
Figure 4.8 Gazyva: Revenue Forecast ($bn), 2013-2024
Figure 4.9 Bispecific Antibodies Submarket Forecast ($bn), 2013-2024
Figure 5.1 Next-Generation Antibody Fragment and ALP Submarket Forecast ($bn), 2013-2024
Figure 5.2 Next-Generation Antibody Fragment Submarket Forecast ($bn), 2013-2024
Figure 5.3 Antibody-Like Protein Submarket Forecast ($bn), 2013-2024
Figure 6.1 Tresiba: Revenue Forecast ($bn), 2013-2024
Figure 6.2 Next-Generation Insulin Submarket Forecast ($bn), 2013-2024
Figure 6.3 Diabetes: Proportion of Population Affected, 2014
Figure 6.4 Oral Insulin Submarket Forecast ($bn), 2013-2024
Figure 6.5 Ultra-Rapid Acting Insulin Submarket Forecast ($bn), 2013-2024
Figure 6.6 Afrezza: Revenue Forecast ($bn), 2013-2024
Figure 6.7 Ultra-Long Acting Insulin Submarket Forecast ($bn), 2013-2024
Figure 7.1 Plegridy: Revenue Forecast ($bn), 2013-2024
Figure 7.2 Next-Generation Recombinant Coagulation Factors Submarket Forecast ($bn), 2013-2024
Figure 7.3 Eloctate: Revenue Forecast ($bn), 2013-2024
Figure 7.4 Next-Generation Growth Hormones Submarket Forecast ($bn), 2013-2024
Figure 8.1 Regenerative Medicine: Submarket Shares (%) by Sector, 2013
Figure 8.2 Regenerative Medicine Submarket Forecast ($bn), 2013-2024
Figure 8.3 Stem Cell Therapies Submarket Forecast ($bn), 2013-2024
Figure 8.4 Gene Therapies Submarket Forecast ($bn), 2013-2024
Figure 8.5 Tissue Engineering Submarket Forecast ($bn), 2013-2024
Figure 9.1 Next-Generation Antibodies Pipeline by Therapeutic Area, 2014
Figure 9.2 Biosimilar Market: Revenue Forecast ($bn), 2013-2024
Figure 9.3 Big Pharma Partnering Opportunities for Next-Generation Biologics Development, 2014
Figure 11.1 Next-Generation Biologics: Market Forecast ($bn) by Sector, 2013-2024

掲載企業リスト

Companies Listed

3SBio
Aastrom Biosciences
AbbVie
Abcam
Ablynx
ADC Therapeutics
Adnexus (part of Bristol-Myers Squibb)
Adocia
Advanced Cell Technology
Advantagene
Affibody
Agence Nationale de sécurité du Médicament et des produits de santé (ANSM)
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
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
Genzyme (part of Sanofi)
Geron
GlycoExpress
Glycotope
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
J&J
Jain Foundation
JCR Pharmaceuticals
Juventas Therapeutics
Karolinska Institute
Kyowa Hakko Kirin
LG Life Sciences
LifeCell
Lonza
MacroGenics
MannKind
MedImmune (part of AstraZeneca)
Merck & Co.
Merck KGaA
Merrimack Pharmaceuticals
Merrion Pharmaceuticals
Mersana Therapeutics
Mesoblast
Micromet (part of Amgen)
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]
Neopharm Group
NeoStem
NeuralStem
Nippon Kayaku
Novartis
Novo Nordisk
Nuron Biotech
NuVasive
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
Stempeutics Research
Strativa Pharmaceuticals
Strides Arcolab
Sutro Biopharma
Swedish Orphan Biovitrum (Sobi)
Swiss Federal Institute of Technology
Symphogen
Synthon
Synthon Biopharmaceuticals (part of Synthon)
Takeda Pharmaceutical Company
Teva Pharmaceutical Industries
Thermalin Diabetes
Tianjin International Joint Academy of Bio-medicine
TiGenix
University of Toronto
TRION Pharma
UCB
University of California, San Francisco (UCSF)
UniQure
USV
VBL Therapeutics
Versartis
viDA Therapeutics
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

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