The bispecific antibody therapeutics market is projected to grow at an annualized rate of ~16%
Roots Analysis has done a detailedstudy on Bispecific AntibodyTherapeutics Market (4th Edition), 2020-2030, covering keyaspects of the industry’s evolution and identifying potential future growthopportunities.
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Key Market Insights
§ With two approveddrugs and close to 300 clinical / preclinical product candidates, thebispecific antibody therapeutics pipeline has evolved significantly over thepast few years
§ The pipeline featuresdrug candidates that target a wide range of biological antigens based ondifferent antibody formats through novel mechanisms of action; more than 50% ofthese act by retargeting or activation of T-Cells
§ To gain a competitiveedge in the market, developers are actively exploring novel biological targetsand mechanisms of action to treat diverse disease indications
§ Although start-upsand mid-sized firms are spearheading the innovation, several big pharmaceuticalcompanies are also actively engaged
§ In order to cater tothe evolving needs of developers, technology providers have establishedpresence across different regions; the US and EU have emerged as the key hubs
§ Close to 50,000patients were estimated to have been enrolled in clinical trials evaluatingbispecific antibody therapeutics, across various geographical locations andphases of development
§ The increasinginterest of stakeholders in this domain can also be gauged by the risingproduct development / commercialization, R&D and technology licensing dealsbeing signed across various regions
§ Given thecomplexities associated with the development of bispecific antibodies, contractorganizations have become an indispensable part of the development andmanufacturing process of antibody therapeutics
§ In order to keeppatients and healthcare professionals informed and aware of the developments,companies are deploying diverse promotional strategies for their respectiveproducts
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Table of Contents
1. PREFACE
1.1. Chapter Outlines
1.2. Research Methodology
1.3. Chapter Outlines
2. EXECUTIVESUMMARY
3. INTRODUCTION
3.1. Chapter Overview
3.2. Concept of an Antibody
3.3. Structure of an Antibody
3.4. Functions of an Antibody
3.5. Mechanism of Action of an Antibody
3.6. Concept of Monoclonal Antibodies
3.7. Antibody Therapeutics
3.8. Historical Evolution of AntibodyTherapeutics
3.9. Types of Advanced AntibodyTherapeutics
3.9.1. FcEngineered and Glycoengineered Antibodies
3.9.2. AntibodyFragments
3.9.3. FusionProteins
3.9.4. Intrabodies
3.9.5. BispecificAntibodies
3.10. BispecificAntibody Formats
3.10.1. Single-Chain-basedFormats (Fc Independent Antibody Formats)
3.10.1.1. TandemscFvs (single-chain variable fragments) and Triple bodies
3.10.1.2. BispecificSingle-Domain Antibody Fusion Proteins
3.10.1.3. Diabodies/ Diabody Derivatives
3.10.1.4. FusionProteins
3.10.1.5. FusionProteins Devoid of Fc Regions
3.10.2. ImmunoglobulinG (IgG)-based Formats (Fc Dependent Antibody Formats)
3.10.2.1. Quadromas
3.10.2.2. Knobs-Into-Holes
3.10.2.3. DualVariable Domain Ig
3.10.2.4. IgG-scFv
3.10.2.5. Two-in-oneor Dual Action Fab (DAF) Antibodies
3.10.2.6. HalfMolecule Exchange
3.10.2.7. κλ-Bodies
3.11. Mechanisms of Action of BispecificAntibodies
3.11.1. Retargeting Immune Effectors (NKCells and T Cells) to Tumor Cells
3.11.2. DirectlyTargeting Malignant / Tumor Cells
3.11.3. Retargetingof Toxins
3.11.5. TargetingTumor Angiogenesis
3.11.6. OtherMechanisms
3.12. Applicationsof Bispecific Antibodies
4 MARKET OVERVIEW
4.1. ChapterOverview
4.2. BispecificAntibody Therapeutics: Developer Landscape
4.2.1. Analysisby Year of Establishment
4.2.2. Analysisby Company Size
4.2.3. Analysisby Geographical Location
4.3. BispecificAntibody Therapeutics: Clinical Pipeline
4.3.1. Analysisby Phase of Development
4.3.2. Analysisby Target Antigen
4.3.3. Analysisby Type of Antibody Format
4.3.4. Analysisby Mechanism of Action
4.3.5. Analysisby Disease Indication
4.3.6. Analysisby Therapeutic Area
4.3.7. Analysisby Broader Disease Segment
4.3.8. Analysisby Route of Administration
4.3.9. Analysisby Mode of Administration
4.3.10. Analysisby Patient Segment
4.4. BispecificAntibody Therapeutics: Early Stage Pipeline
4.4.1. Analysisby Phase of Development
4.4.2. Analysisby Target Antigen
4.4.4. Analysisby Mechanism of Action
4.4.5. Analysisby Therapeutic Area
4.4.6. Analysisby Broader Disease Segment
4.6. BispecificAntibody Therapeutics: Combination Therapy Candidates
4.7. BispecificAntibody Therapeutics: Non-Industry Players
4.8. EmergingNovel Antibody Therapeutic Modalities
5 Bispecific Antibody Therapeutics:Technology Platforms
5.1. ChapterOverview
5.2. BispecificAntibody Therapeutics: List of Technology Platforms
5.3. BispecificAntibody Therapeutics: Technology Platform Profiles
5.3.1. BispecificT-cell Engager (BiTE®) (Amgen)
5.3.1.1. Overview
5.3.1.2. Technology Details
5.3.1.3. Structure of BiTE® BispecificAntibodies
5.3.1.4. Pipeline of BiTE® BispecificAntibodies
5.3.1.5. Advantages of BiTE® BispecificAntibodies
5.3.1.6. Partnerships and Collaborations
5.3.2. DuoBody®(Genmab)
5.3.2.1. Overview
5.3.2.2. Technology Details
5.3.2.3. Structure of DuoBody® BispecificAntibodies
5.3.2.4. Pipeline of DuoBody® BispecificAntibodies
5.3.2.5. Advantages of DuoBody® BispecificAntibodies
5.3.2.6. Partnerships and Collaborations
5.3.3. Xmab™Antibody Engineering Platform (Xencor)
5.3.3.1. Overview
5.3.3.2. Technology Details
5.3.3.3. Pipeline of Xmab™ BispecificAntibodies
5.3.3.4. Advantages of Xmab™ BispecificAntibodies
5.3.3.5. Partnerships and Collaborations
5.3.4. WuXibodyTMBispecific Engineering Platform (WuXi Biologics)
5.3.4.1. Overview
5.3.4.2. Pipeline of WuXibodyTM BispecificAntibodies
5.3.4.3. Advantages of WuXibodyTM BispecificAntibodies
5.3.4.4. Partnerships and Collaborations
5.3.5. Anticalin®(Pieris Pharmaceuticals)
5.3.5.1. Overview
5.3.5.2. Structure of Anticalin® BispecificFusion Proteins
5.3.5.3. Pipeline of Anticalin® BispecificFusion Proteins
5.3.5.4. Advantages of Anticalin® Bispecificantibody Platform
5.3.5.5. Partnerships and Collaborations
5.3.6. Azymetric™(Zymeworks)
5.3.6.1. Overview
5.3.6.2. Technology Details
5.3.6.3. Structure of Azymetric™ BispecificAntibodies
5.3.6.4. Pipeline of Azymetric™ BispecificAntibodies
5.3.6.5. Advantages of the AzymetricTMBispecific Antibodies
5.3.6.6. Partnerships and Collaborations
5.4. Geographical Distribution ofTechnology Providers
5.5. BispecificAntibody Technology Platforms: Comparative Analysis
6 DRUG PROFILES
6.1. ChapterOverview
6.2. MarketedDrug Profiles
6.2.1. Blincyto™/ Blinatumomab / AMG103 / MT103 (Amgen)
6.2.1.1. Company Overview
6.2.1.1.1. FinancialPerformance
6.2.1.2. Drug Overview
6.2.1.2.1. Mechanismof Action and Targets
6.2.1.2.2. Dosage
6.2.1.2.3. CurrentDevelopment Status
6.2.1.2.4. DevelopmentProcess
6.2.1.2.5. AnnualSales
6.2.2. Hemlibra® / Emicizumab / RG6013 /ACE910 / RO5534262 (Chugai Pharmaceutical / Roche)
6.2.2.1. Company Overview
6.2.2.1.1. FinancialPerformance
6.2.2.2. Drug Overview
6.2.2.2.1. Mechanismof Action and Targets
6.2.2.2.2. Dosage
6.2.2.2.4. DevelopmentProcess
6.2.2.2.5. AnnualSales
6.3. LateStage Drug Profiles
6.4. RG7716 / RO6867461 / Faricimab(Roche / Genentech)
6.4.1 Drug Overview
6.5. Ozoralizumab / TS-152 / ATN103(Ablynx / Eddingpharm / Taisho Pharmaceuticals)
6.5.1 Drug Overview
6.6. ABT-165 (AbbVie)
6.6.1 Overview of Drug, CurrentDevelopment Status and Clinical Results
6.7. ABY-035 (Affibody)
6.7.1. Drug Overview
6.8. AFM13 (Affimed)
6.8.1 Drug Overview
6.9. AMG 570 / MEDI0700 (Amgen)
6.9.1. Drug Overview
6.10. KN026 (Alphamab)
6.10.1. Drug Overview
6.11. KN046(Alphamab)
6.11.1. Drug Overview
6.12. M1095 / ALX-0761 (Merck / Ablynx /Avillion)
6.12.1. Drug Overview
6.13. M7824 / Bintrafusp Alfa (Merck /GlaxoSmithKline)
6.13.1. Drug Overview
6.14. MCLA-128 (Merus)
6.14.1. Drug Overview
6.15. MEDI3902 / Gremubamab (MedImmune/AstraZeneca)
6.15.1. Drug Overview
6.16. Drug Overview
6.17. REGN1979 (Regeneron)
6.17.1. Drug Overview 6.18. ZW25 (Zymeworks)
6.18.1. DrugOverview
7 KEY INSIGHTS
7.1. ChapterOverview
7.2. BispecificAntibody Therapeutics: Analysis by Therapeutic Area and Phase of Development
7.3. Bispecific Antibody Therapeutics:Spider-Web Analysis based on Mechanism of Action
7.4. BispecificAntibody Therapeutics: Two-Dimensional Scatter Plot Analysis based on TargetCombinations
7.4.1 Key Parameters
7.5. Logo Landscape: Analysis ofDevelopers by Company Size
8 BENCHMARK ANALYSIS: BIG PHARMA PLAYERS
8.1. ChapterOverview
8.2. TopPharmaceutical Companies
8.2.1. Analysisby Target Antigen
8.2.2. Analysisby Type of Antibody Format
8.2.3. Analysisby Mechanism of Action
8.2.4. Analysisby Therapeutic Area
8.2.5. Analysisby Type of Partnership
9 PARTNERSHIPS AND COLLABORATIONS
9.1. ChapterOverview
9.2. PartnershipModels
9.3. BispecificAntibody Therapeutics: Partnerships and Collaborations
9.3.1. Analysisby Year of Partnership
9.3.2. Analysisby Type of Partnership
9.3.3. Analysisby Therapeutic Area
9.3.4. MostActive Developers: Analysis by Number of Partnerships
9.3.5. Most Active Contract Manufacturers:Analysis by Number of Manufacturing Agreements
9.3.6. RegionalAnalysis
9.3.7. Intercontinentaland Intracontinental Agreements
10 CONTRACTSERVICES FOR BISPECIFIC ANTIBODY THERAPEUTICS
10.1. ChapterOverview
10.2. Manufacturingof Bispecific Antibody Therapeutics
10.2.1. Key Manufacturing Considerations andChallenges
10.2.2. ContractManufacturing Organizations (CMOs)
10.2.2.1. Introductionto CMOs
10.2.2.2. BispecificAntibody Therapeutics: List of CMOs
10.2.3. ContractResearch Organizations (CROs)
10.2.3.1. Introductionto CROs
10.2.3.2. BispecificAntibody Therapeutics: List of CROs
10.3. KeyConsiderations for Selecting a Suitable CMO / CRO Partner
11 CLINICAL TRIAL ANALYSIS
11.1. ChapterOverview
11.2. Methodology
11.3. Bispecific Antibody Therapeutics:Clinical Trial Analysis
11.3.1. Analysisby Trial Registration Year
11.3.2. Analysisby Trial Recruitment Status
11.3.3. Analysisby Trial Phase
11.3.4. Analysisby Trial Design
11.3.5. Analysisby Disease Indication
11.3.6. Analysisby Therapeutic Area
11.3.7. MostActive Players
11.3.8. Analysisby Number of Clinical Trials and Geography
11.3.9. Analysisby Enrolled Patient Population and Geography
12 CASE STUDY:REGULATORY GUIDELINES FOR BISPECIFIC ANTIBODIES
12.1. ChapterOverview
12.2. GuidelinesIssued by Regulatory Authorities
12.2.1. USFood and Drug Administration (FDA)
12.2.1.1. PharmaCompanies Response to the FDA Draft Guidance
12.2.2. WorldHealth Organization (WHO)
12.2.3. TheInternational Council for Harmonization of Technical Requirements forPharmaceuticals for Human Use
13 CASE STUDY: PROMOTIONAL / MARKETING STRATEGIES
13.1. ChapterOverview
13.2. Overviewof Channels Used for Promotional Campaigns
13.3. Summary:Product Website Analysis
13.4. Summary:Patient Support Services and Informative Downloads
13.5. PromotionalAnalysis: Blincyto™
13.5.1. DrugOverview
13.5.2. ProductWebsite analysis
13.5.2.1. Messagesfor Healthcare Professionals
13.5.2.1.1. ForMRD Positive B‑cell precursor ALL
13.5.2.1.2. ForRelapsed or Refractory B-cell precursor ALL
13.5.2.2. Messagefor Patients
13.5.3. PatientSupport Services and Informative Downloads
13.5.4. OtherPromotional Strategies
13.5.4.1. Presencein Conferences
13.6. PromotionalAnalysis: Hemlibra®
13.6.1. DrugOverview
13.6.2. ProductWebsite Analysis
13.6.2.1. Messagesfor Healthcare Professionals
13.6.2.1.1. ForHemophilia A without Factor VIII Inhibitors
13.6.2.1.2. ForHemophilia A with Factor VIII Inhibitors
13.6.2.3. Messagesfor Patients
13.6.3. PatientSupport Services and Informative Downloads
13.6.3.1. Co-payProgram
13.6.3.2. IndependentCo-pay Assistance Foundation
13.6.3.3. GenentechPatient Foundation
13.6.4. OtherPromotional Strategies
13.6.4.1. Presencein Conferences
14 SWOT ANALYSIS
14.1. ChapterOverview
14.2. Strengths
14.3. Weaknesses
14.4. Opportunities
14.5. Threats
14.6. ConcludingRemarks
15 MARKET FORECAST AND OPPORTUNITY ANALYSIS
15.1. ChapterOverview
15.2. Scopeand Limitations
15.3. ForecastMethodology and Key Assumptions
15.4. OverallBispecific Antibody Therapeutics Market, 2019-2030
15.4.1. BispecificAntibody Therapeutics Market: Analysis by Therapeutic Area
15.4.2. BispecificAntibody Therapeutics Market: Analysis by Mechanism of Action
15.4.3. BispecificAntibody Therapeutics Market: Analysis by Target Antigen
15.4.4. BispecificAntibody Therapeutics Market: Analysis by Antibody Format
15.4.5. BispecificAntibody Therapeutics Market: Analysis by Key Players
15.4.6. BispecificAntibody Therapeutics Market: Analysis by Geography
15.5. BispecificAntibody Market: Value Creation Analysis
15.6. BispecificAntibody Therapeutics Market: Product-wise Sales Forecasts
15.6.1. Blincyto
15.6.1.1. TargetPatient Population
15.6.1.2. SalesForecast
15.6.1.3. NetPresent Value
15.6.1.4. ValueCreation Analysis
15.6.2. Hemlibra
15.6.2.1. TargetPatient Population
15.6.2.2. SalesForecast
15.6.2.3. NetPresent Value
15.6.2.4. ValueCreation Analysis
15.6.3. RG7716
15.6.3.1. Targetpatient Population
15.6.3.2. SalesForecast
15.6.3.3. NetPresent Value
15.6.3.4. ValueCreation Analysis
15.6.4. Ozoralizumab
15.6.4.1. TargetPatient Population
15.6.4.2. SalesForecast
15.6.4.3. NetPresent Value
15.6.4.4. ValueCreation Analysis
15.6.5. ABY-035
15.6.5.1. TargetPatient Population
15.6.5.2. SalesForecast
15.6.5.3. NetPresent Value
15.6.5.4. ValueCreation Analysis
15.6.6. AFM13
15.6.6.1. TargetPatient Population
15.6.6.2. SalesForecast
15.6.6.3. NetPresent Value
15.6.6.4. ValueCreation Analysis
15.6.7. M1095
15.6.7.1. TargetPatient Population
15.6.7.2. SalesForecast
15.6.7.3. NetPresent Value
15.6.7.4. ValueCreation Analysis
15.6.8. MEDI3902
15.6.8.1. TargetPatient Population
15.6.8.2. SalesForecast
15.6.8.3. NetPresent Value
15.6.8.4. ValueCreation Analysis
15.6.9. ABT-981
15.6.9.1. TargetPatient Population
15.6.9.2. SalesForecast
15.6.9.3. NetPresent Value
15.6.9.4. ValueCreation Analysis
15.6.10. SAR156597
15.6.10.1. TargetPatient Population
15.6.10.2. SalesForecast
15.6.10.3. NetPresent Value
15.6.10.4. ValueCreation Analysis
16 CONCLUDINGREMARKS
17 EXECUTIVEINSIGHTS
17.1. Chapter Overview
17.2. CytomX Therapeutics
17.2.1. Company Snapshot
17.2.2. InterviewTranscript: Siobhan Pomeroy, Senior Director, Business Development (Q3 2017)
17.3. F-star
17.3.1. Company Snapshot
17.3.2. Interview Transcript: Jane Dancer,Chief Business Officer (Q3 2017)
17.4. Innovent Biologics
17.4.1. Company Snapshot
17.4.2. Interview Transcript: Yinjue Wang,Associate Director, Process Development (Q3 2017)
17.5. Synimmune
17.4.1. Company Snapshot
17.4.2. InterviewTranscript: Ludger Große-Hovest, Chief Scientific Officer, and Martin Steiner,Chief Executive Officer
18. APPENDIX1: TABULATED DATA
19. APPENDIX2: LIST OF COMPANIES AND ORGANIZATIONS
Contact Details
Gaurav Chaudhary
+1 (415) 800 3415
