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市場調查報告書

抗體藥物複合體 (ADC) 的展望及市場機會:開發平台、相關利益者、商務分析 2016年

Antibody-Drug Conjugates 2016: Perspectives & Opportunities - A Pipeline, Technology, Stakeholder & Business Analysis

出版商 La Merie Publishing 商品編碼 294276
出版日期 內容資訊 英文 470 Pages
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抗體藥物複合體 (ADC) 的展望及市場機會:開發平台、相關利益者、商務分析 2016年 Antibody-Drug Conjugates 2016: Perspectives & Opportunities - A Pipeline, Technology, Stakeholder & Business Analysis
出版日期: 2015年11月30日 內容資訊: 英文 470 Pages
簡介

已透過核准、已上市ADC製劑的Adcetris及Kadcyla,預計2015年達到第一次超過10億美元的銷售額規模。

本報告提供抗體藥物複合體 (ADC) 的開發情形、技術趨勢、商業化的展望的相關調查、開發的各階段的ADC狀況、傳統技術及新興技術相關趨勢、相關經營者趨勢、商業化與企業化的策略、主要製劑與主要企業的簡介等彙整。

第1章 摘要整理

第2章 抗體藥物複合體 (ADC):開發平台分析

  • 概要
  • 將上市的ADC
  • 將上市的免疫複合體
  • 臨床開發初期的ADC
  • IND申請的研究階段的ADC
  • 前臨床R&D階段的ADC
  • 同一目標的ADC間的競爭
  • 實驗中止的ADC、臨床脫落率

第3章 ADC技術分析

  • 概要
  • 傳統、新興ADC技術
  • Probody與新的臨床階段分期
  • 載波系統
  • 抗體工程的部位特異性複合技術
  • 抗體工程之外的部位特異性複合技術

第4章 ADC相關利益者分析

  • 大醫藥品、生物科技企業
  • 中小規模的生物醫藥品企業
  • ADC技術、開發平台企業
  • 新的酬載技術的企業
  • 連接試劑、複合、載波技術的企業
  • 持有替代靶標部分的企業

第5章 ADC產業分析

  • ADC的商業機會與展望:概要
  • 已透過核准ADC的商業化
  • 資金籌措
  • M&A
  • 聯盟、授權契約:製藥&生物科技企業
  • 聯盟、授權契約:生物科技企業間

第6章 ADC藥物簡介

  • 臨床階段的ADC藥簡介
  • 前IND、前臨床階段的ADC藥簡介
  • 免疫複合體簡介
  • 開發中止的ADC藥簡介

第7章 ADC企業簡介

  • 大醫藥品、生物科技企業
  • 中小規模生物醫藥品企業
  • ADC技術、開發平台企業
  • ADC酬載相關企業
  • ADC連接試劑、載波、複合技術企業
  • 持有替代靶標部分的企業

第8章 文件

第9章 附錄

第10章 圖表

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目錄
Product Code: LMFR0016

This report describes and analyzes the situation of antibody-drug conjugates as of November 2015 regarding:

  • ADC pipeline,
  • ADC technologies,
  • ADC stakeholders and
  • ADC business opportunities and commercial perspectives.

Although the initial enthusiasm about antibody-drug conjugates has made room for a more realistic understanding, the prospects for success of ADC drug candidates remain good and are based on a well-filled pipeline, increasing adoption of next generation ADC technologies, lessons learned from failures, a balanced mixture of stakeholders and a variety of options for funding of ADC developments. About 70 ADCs are in clinical and pre-IND stages of development and at least the same number of ADC programs are in preclinical R&D.

For the first time in 2015, combined sales of the approved and marketed ADC products Adcetris and Kadcyla will surpass the sales limit of US$ 1 billion. The pipeline of ADCs and immunoconjugates in advanced clinical development gives the chance of approval of further ADCs in the near- and mid-term future. The clinical attrition rate of ADCs is lower, i.e. better, than that of conventional, naked antibodies in oncology. The availability of next generation ADC technologies allows to select case by case the appropriate linker and payload. Site-specific conjugation technologies with and without engineering of the antibody generate homogenous products. Novel payloads provide the basis for enhanced antitumor activity. Prodrug concepts and polymeric carrier systems may not only contribute to a higher therapeutic index, but also boost efficacy by targeted delivery of a higher number of payloads than in conventional ADCs. Competition by ADCs directed against the same target is relatively low, except for clinically and commercially validated Her2 which is ideal to validate new technologies. However, targets are still a bottleneck with the attractive consequence that companies with successful target identification capabilities are highly rewarded by investors and business partners.

Nearly all major pharma and biotech companies have ADC programs, although with different strategies of how to gain access to ADC technologies. Few have established proprietary in-house capabilities, most still rely on outside technology providers. However, the duopoly of conventional ADC technology providers is converting into a more differentiated, heterogenous field of ADC technologies and technology providers.

This report entitled “Antibody-Drug Conjugates 2016: Perspectives & Opportunities - a Pipeline, Technology, Stakeholder & Business Analysis” is based on the analysis of more than 90 companies, more than 100 ADC drug profiles and more than 26 ADC technologies and components. Sources of information are provided by 274 scientific references and numerous non-scientific references, e.g. press releases, stock exchange disclosures, presentations, annual reports, fact sheets (with hyperlinks leading to source of information). The report also describes and analyzes business deals in the ADC field, e.g. collaboration and license agreements, mergers and acquisitions, financial transactions (divestments, public offerings, private equity and venture capital fund-raising).

Coverage of this ADC report:

  • Next-to-market ADCs
  • ADC Drug Profiles: clinical, pre-IND, preclinical
  • Target Competition by ADCs
  • ADC Development Failures
  • Conventional & Emerging ADC Technologies
  • Polymeric ADC Carriers
  • Novel ADC Payloads & Linkers
  • Site-specific ADC Conjugation Technologies
  • Major Pharma & Biotech Companies with ADC Programs
  • Small and Medium Biopharmaceutical Companies with ADC Programs
  • Integrated ADC Technology & Pipeline Companies
  • Companies with Linker, Payload, Carrier and Conjugation Technologies
  • Commercial Opportunities and Perspectives with ADCs
  • Commericalization of Approved ADCs
  • Fund-Raising for ADC Companies
  • Pharma-Biotech & Biotech-Biotech Collaboration & Licensing Agreements

Companies Described in the Text:

  • 3SBio
  • AbbVie
  • Ablynx
  • ACES Pharma
  • ADC Therapeutics
  • Affilogic
  • Affitech
  • Alethia Biotherapeutics
  • Alteogen
  • Ambrx
  • Amgen
  • Angiochem
  • Antikor Biopharma
  • APO-T
  • Asana Biosciences
  • Astellas Pharma
  • AstraZeneca
  • Bayer HealthCare Pharmaceuticals
  • Bicycle Therapeutics
  • BIND Therapeutics
  • Biotest
  • Blend Therapeutics
  • Bristol-Myers Sqibb
  • Catalent Pharma Solutions (Redwood Bioscience)
  • Celgene
  • Celldex Pharmaceuticals
  • Centrose
  • CureMeta
  • CytomX Therapeutics
  • CytRx
  • Daiichi Sankyo
  • Delenex Therapeutics
  • Dophen Biomed
  • Eisai
  • Eli Lilly
  • Endocyte
  • Formation Biologics
  • Fosun Pharma
  • Genmab
  • GlaxoSmithKline
  • Glycotope
  • Hanwha Chemical
  • Heidelberg Pharma
  • Helix BioPharma
  • Igenica Biotherapeutics
  • Immune Pharmaceuticals
  • ImmunoGen
  • Immunomedics
  • Innate Pharma
  • Janssen (Johnson & Johnson)
  • Kairos Therapeutics
  • LegoChem Biosciences
  • LinXis
  • Meditope Biosciences
  • Menarini
  • Merck Serono
  • Merrimack Pharmaceuticals
  • Mersana Therapeutics
  • Mistubishi Tanabe Pharma
  • MultiCell Immunotherapeutics
  • NanoCarrier
  • NBE Therapeutics
  • Nerviano Medical Sciences
  • Novartis
  • OntoChem
  • Oxford BioTherapeutics
  • Oxis Biotech
  • Pfizer
  • Pharmamar
  • Philogen
  • Polytherics (Abzena)
  • Progenics Pharmaceuticals
  • Quanta Biodesign
  • Regeneron Pharmaceuticals
  • Roche
  • Sanofi
  • Scil Proteins
  • Seattle Genetics
  • Serina Therapeutics
  • Sorrento Therapeutics (Concortis Biosystems)
  • Stemcentrx
  • Sutro Biopharma
  • SynAffix
  • Synta Pharmaceuticals
  • Synthon Biopharmaceuticals
  • Takeda Pharmaceutical Co
  • WuXi PharmaTech
  • Zhejiang Medicine Co.
  • Zova Biotherapeutics
  • Zymeworks

Table of Contents

0. Abbreviations

1. Executive Summary

2. ADC Pipeline Analysis

  • 2.1. Overview
  • 2.2. Next-to-market ADCs
  • 2.3. Next-to-market Immunoconjugates
  • 2.4. ADCs in Early Clinical Development
  • 2.5. ADCs in IND-Enabling Studies
  • 2.6. ADCs in Preclinical R&D
  • 2.7. Competition among ADCs for the Same Target
  • 2.8. Discontinued ADCs and Clinical Attrition Rate

3. ADC Technology Analysis

  • 3.1. Overview
  • 3.2. Conventional and Emerging ADC Technologies
  • 3.3. Probodies and Novel Preclinical Stage Carriers
  • 3.4. Carrier Systems
  • 3.5. Site-Specific Conjugation Technologies with Antibody Engineering
  • 3.6. Site-Specific Conjugation Technologies without Antibody Engineering

4. ADC Stakeholder Analysis

  • 4.1. Major Pharma and Biotech Companies
  • 4.2. Small and Medium Biopharmaceutical Companies
  • 4.3. ADC Technology and Pipeline Companies
  • 4.4. Companies with Novel Payload Technologies
  • 4.5. Companies with Linker, Conjugation & Carrier Technologies
  • 4.6. Companies with Alternative Targeting Moieties

5. ADC Business Analysis

  • 5.1. Overview of Commercial Opportunities and Perspectives with ADCs
  • 5.2. Commercialization of Approved ADCs
  • 5.3. Fund-Raising
  • 5.4. Mergers and Acquisitions
  • 5.5. Pharma - Biotech Collaboration & Licensing Deals
  • 5.6. Biotech - Biotech Collaboration & Licensing Deals

6. ADC Drug Profiles

  • 6.1. Clinical Stage ADC Drug Profiles
  • 6.2. Pre-IND and Preclinical Stage ADC Drug Profiles
  • 6.3. Immunoconjugate Drug Profiles
  • 6.4. Discontinued ADC Drug Profiles

7. ADC Company Profiles

  • 7.1. Major Pharma and Biotech Companies
  • 7.2. Small and Medium Biopharmaceutical Companies
  • 7.3. ADC Technology & Pipeline Companies
  • 7.4. ADC Payload Companies
  • 7.5. ADC Linker, Carrier & Conjugation Technology Companies
  • 7.6. Companies with Alternative Targeting Moieties

8. References

9. ADDENDUM

  • 9.1. Addendum 1: ADCs in Advanced Clinical Development
  • 9.2. Addendum 2: ADCs in Early Clinical Development
  • 9.3. Addendum 3:
  • 9.4. Addendum 4:

10. Tables

List of Tables

  • Table 1: Overview of Development Stages of ADCs
  • Table 2: Characteristics of Next-to-Market ADCs in Advanced Clinical Development
  • Table 3: Next-to-Market Immunoconjugates
  • Table 4: Characteristics of ADCs in Early Clinical Development
  • Table 5: Characteristics of ADCs in IND-Enabling Studies
  • Table 6: Characteristics of ADCs in Preclinical R&D
  • Table 7: Target Competition of ADCs
  • Table 8: Overview of ADCs Discontinued from Clinical Development
  • Table 9: Reasons for failure of ADCs compared with naked antibodies
  • Table 10: Number of ADC Molecules in Development at Major Pharma & Biotech
  • Table 11: Targets of Clinical Stage ADC Molecules in Development at Major Pharma & Biotech
  • Table 12: Technology Licenses for ADCs by Major Pharma & Biotech
  • Table 13: New ADC Technology Partners of Big Pharma Companies
  • Table 14: Number of ADC Molecules in Development at Small & Medium Biopharmaceutical Companies
  • Table 15: Targets and Origin of ADCs at Small & Medium Biopharma
  • Table 16: Novel ADC Technology In-Licensed by Biopharma Companies
  • Table 17: Technology Used in ADC Molecules in Development at ADC Technology Companies
  • Table 18: Number of ADC Molecules in Development at ADC Technology Companies
  • Table 19: Targets of ADC Molecules in Development at ADC Technology Companies
  • Table 20: Companies with Novel Payload Technologies
  • Table 21: Overview of Companies with Linker, Carrier & Conjugation Technologies
  • Table 22: Companies with Linker, Carrier & Conjugation Technologies
  • Table 23: Companies with Alternative Targeting Moieties
  • Table 24: Fund-Raising by ADC Technology and Product Companies in 2014 and 2015
  • Table 25: Agreements between pharma and biotech companies for ADCs 2014-2015
  • Table 26: Agreements between biotech and biotech companies for ADCs 2014-2015
  • Table 27: Clinical Studies with ABT-414
  • Table 28: Sales of Adcetris
  • Table 29: Phase III Clinical Studies with Adcetris
  • Table 30: Actively Recruiting Phase II Clinical Studies with Adcetris
  • Table 31: Clinical Studies with CDX-011
  • Table 32: Clinical Study Program of BT062
  • Table 33: Advanced Phase Clinical Studies with Kadcyla
  • Table 34: Phase Ib/II Studies with Polatuzumab Vedotin
  • Table 35: Interim phase II efficacy results of IMMU-132
  • Table 36: AbbVie's ADC Pipeline
  • Table 37: Amgen's Clinical ADC Pipeline
  • Table 38: Astellas Pharma's ADC Pipeline
  • Table 39: AstraZeneca's Pipeline of PBD and Tubulysin ADCs
  • Table 40: Bayer's ADC Pipeline
  • Table 41: Novartis ADC Pipeline
  • Table 42: Pfizer's Clinical Stage ADC Pipeline
  • Table 43: Roche Pipeline of Clinical Stage ADCs
  • Table 44: Roche ADCs Discontinued from Clinical Development
  • Table 45: Sanofi Clinical Stage ADC Pipeline
  • Table 46: ADC Pipeline of ADC Therapeutics
  • Table 47: Asana Biosciences' ADC Pipeline
  • Table 48: ADC Pipeline of Celldex Therapeutics
  • Table 49: Genmab' ADCs in development
  • Table 50: ADC Pipeline of Oxford BioTherapeutics
  • Table 51: Preclinical ADC Pipeline of Oxis Biotech
  • Table 52: Ambrx' ADC Pipeline
  • Table 53: ImmunoGen's in-house ADC Pipeline
  • Table 54: ImmunoGen's Partnered ADC Programs in Clinical Development
  • Table 55: Discontinued Clinical Stage ADCs with ImmunoGen Technology
  • Table 56: Reasons for Failure of TAP-based ADCs Compared with Naked Antibodies
  • Table 57: Immunomedics' Clinical ADC Pipeline
  • Table 58: Sales of Adcetris
  • Table 59: Seattle Genetics' Adcetris Pipeline of Additional Indications
  • Table 60: Seattle Genetics' in-house ADC Pipeline
  • Table 61: Seattle Genetics' Collaborator ADC Pipeline
  • Table 62: Discontinued ADCs Based on Technology from Seattle Genetics
  • Table 63: Stemcentrx' Discovered ADC Programs in Clinical Development
  • Table 64: Centrose's EDC Pipeline
  • Table 65: Mersana's Proprietary Fleximer ADC Pipeline
  • Table 66: Sorrento's Proprietary ADC Pipeline
  • Table 67: Angiopep's Oncology Pipeline
  • Table 68: Endocyte's Pipeline of Small Molecule Drug Conjugates (SMDCs)
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