이중 특이성 항체 시장 : 치료 영역별, 작용기전별, 표적 항원별, 항체 포맷별, 주요 지역별, 주요 기업별 - 업계 동향과 세계 예측(- 2035년)

Bispecific Antibodies Market by Therapeutic Area, Mechanism of Action Target Antigen, Antibody Format, Key Geographical Regions and Key Players: Industry Trends and Global Forecasts, Till 2035

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한글목차

세계 이중 특이성 항체 시장 규모는 2035년까지 예측 기간 동안 9.5%의 연평균 복합 성장률(CAGR)로 확대되어 현재 56억 달러에서 2035년까지 168억 달러로 성장할 것으로 예상됩니다.

단일 클론 항체의 치료 가능성이 발견되고 수많은 질병을 성공적으로 치료하면서 제약 산업은 혁명을 일으켰습니다. 현재 치료 성적을 더욱 향상시키기 위해 항체 치료제의 공학적인 연구가 활발히 진행되고 있습니다. 수십년전, 단클론 항체에 항원 결합 부위를 추가하여 2가 항체가 처음으로 개발되었습니다. 이러한 2가 분자의 주요 목적은 지금까지 항체 의존성 세포 매개 세포 손상(ADCC) 및 면역 이펙터 세포에 의해 매개되는 다른 세포 독성 메커니즘에 의한 종양 세포 사멸을 강화하기 위해 세포 독성 면역 이펙터 세포의 방향을 전환하는 것이었습니다. 이 개량형 항체 기반 치료제는 현재 크고 작은 제약사들로부터 큰 관심을 받고 있습니다. 최근 임상시험에서 새로운 이중 특이성 항체 치료제가 광범위한 적응증에 대한 치료 효과를 입증하고 있어, 이러한 치료제 개발에 참여하는 기업들에게 유리한 기회를 제공합니다.

이중 특이성 항체 치료제의 상황은 지난 10년간 꾸준히 발전해 왔으며, 전 세계 120개 이상의 제약회사에서 400개 이상의 임상/전임상 후보물질이 평가되고 있습니다.

현재 파이프라인에는 다양한 생물학적 항원을 표적으로 하여 여러 적응증을 치료할 수 있는 잠재력을 가진 임상 단계의 이중 특이성 항체 의약품 후보물질이 다수 존재합니다. 실제로 업계 관계자들은 85개 이상의 이중 특이성 항체 기술 플랫폼 개발에 참여하고 있으며, 이러한 치료와 관련된 기존 제조상의 문제를 완화하는 것을 목표로 하고 있습니다. 이러한 관심은 제휴 활동이 활발해지고, 기업들이 이중 특이성 항체 포트폴리오를 확장하기 위해 적극적으로 전략적 계약을 체결하는 등 2010년 이후 다양한 이중 특이성 항체 치료제의 안전성과 효능을 평가하기 위해 약 280건의 임상시험이 등록되었으며, 대부분 미국 내에서 진행되고 있습니다. 이들 임상시험의 대부분은 미국 내에서 진행되고 있습니다. 이러한 치료법을 효율적으로 보급하기 위해 의약품 개발 기업들은 시장에서의 지위를 유지하기 위해 다양한 홍보 전략을 적극적으로 모색하고 있습니다. 개발 파이프라인에 대한 관심 증가와 유망한 임상 결과들로 인해 향후 10년간 연평균 9.5% 이상의 성장이 예상됩니다.

세계의 이중 특이성 항체 시장에 대해 조사했으며, 시장 개요와 함께 치료 영역별/작용기전별/표적 항원별, 항체 형식별, 주요 지역별, 주요 기업별/지역별 동향, 시장 진출기업 프로파일 등의 정보를 정리하여 전해드립니다.

목차

제1장 서문

제2장 주요 요약

제3장 서론

제4장 승인 획득 치료 및 임상 치료 시장 구도

제5장 전임상 치료 시장 구도

제6장 주요 인사이트

제7장 기술 평가 프레임워크

제8장 대형 제약 기업 : 벤치마킹 분석

제9장 기업 개요

• 본 장의 개요
• Akeso Biopharma
• Alphamab Oncology
• Amgen
• Merck
• Regeneron
• Roche
• Xencor

제10장 파트너십 및 협업

제11장 이중 특이성 항체 치료제 계약 서비스

제12장 임상시험 분석

제13장 사례 연구 : 이중 특이성 항체 규제 가이드라인

제14장 사례 연구 : 프로모션/마케팅 전략

제15장 시장 예측과 기회 분석

제16장 SWOT 분석

제17장 결론

제18장 주요 인사이트

제19장 부록 1 : 표 형식 데이터

제20장 부록 2 : 기업 및 단체 리스트

LSH

영문 목차

영문목차

BISPECIFIC ANTIBODIES MARKET OVERVIEW

As per Roots Analysis, the global bispecific antibodies market is estimated to grow from USD 5.6 billion in the current year to USD 16.8 billion by 2035, at a CAGR of 9.5% during the forecast period, till 2035.

The market sizing and opportunity analysis has been segmented across the following parameters:

Therapeutic Area

• Autoimmune Disorders
• Genetic Disorders
• Hematological Malignancies
• Ophthalmic Disorders
• Skin Cancers
• Solid Tumors

Mechanism of Action

• Cytokines Retargeting / Neutralization
• Dual Ligands Blocking
• Resistance Factors Co-targeting
• Targeting Tumor Angiogenesis
• T-Cell Retargeting / Activation
• Others

Target Antigen

• C5-Albumin
• CD20 x CD3
• CD3 x BCMA
• CD3 x CD19
• EGFR x cMET
• EpCAM x CD3
• Factor IXa x Factor X
• gp100 x CD3
• HER2 x HER2
• PD-1 x CTLA-4
• PD-L1 x TGFB
• TNF-a x HSA
• VEGF x DLL4
• VEGF-A x ANG2

Antibody Format

• Asymmetric
• Fragments

Geography

• North America (US, Canada, Rest of North America)
• Europe (Germany, France, Italy, Spain, UK, Rest of Europe)
• Asia (India, China, Japan, South Korea, Rest of Asia)
• Rest of the World

BISPECIFIC ANTIBODIES MARKET: GROWTH AND TRENDS

The discovery of the therapeutic potential of monoclonal antibodies and its successful implementation in the treatment of myriads of diseases has revolutionized the pharmaceutical industry. Presently, significant research is being carried out into engineering antibody therapeutics to further improve treatment-related outcomes. A few decades ago, bispecific antibodies were first developed by the incorporation of additional antigen binding sites into monoclonal antibodies. The primary objective of such bivalent molecules has, so far, been to redirect cytotoxic immune effector cells for augmenting the killing of tumor cells by antibody-dependent cell-mediated cytotoxicity (ADCC) and other cytotoxic mechanisms mediated by the immune effector cells. This modified form of antibody-based therapeutics is currently gaining a lot of attention from both large and small pharmaceutical companies. In the recent past, clinical trials have demonstrated enormous benefits offered by novel bispecific antibody therapeutics for the treatment of a wide range of target indications, presenting lucrative opportunities for the players engaged in the development of these therapies.

BISPECIFIC ANTIBODIES MARKET: KEY INSIGHTS

The report delves into the current state of the bispecific antibodies market and identifies potential growth opportunities within the industry. Some key findings from the report include:

• The landscape of bispecific antibody therapeutics has steadily evolved in the past decade; over 400 clinical / preclinical candidates are being evaluated by over 120 drug developers worldwide.

• The current pipeline features a number of clinical stage bispecific antibody drug candidates, capable of targeting a range of biological antigens in order to potentially treat multiple target indications.
• In fact, industry stakeholders are engaged in the development of over 85 bispecific antibody technology platforms, aiming to mitigate the existing manufacturing challenges associated with such therapies.
• The growing interest is evident from the rise in partnership activity; companies are actively entering into strategic agreements in order to expand their bispecific antibody portfolio.
• Since 2010, nearly 280 clinical trials have been registered to evaluate the safety and efficacy of various bispecific antibody therapeutics; majority of these studies are being conducted across sites in the US.
• In order to efficiently promote these therapies, drug developers are actively exploring diverse promotional strategies with an aim to sustain their position in the market.
• With the growing focus on development pipeline and encouraging clinical results, the market is anticipated to witness an annualized growth rate of over 9.5%, during the next decade.

BISPECIFIC ANTIBODIES MARKET: KEY SEGMENTS

Hematological Malignancies are the Fastest Growing Segment of the Bispecific Antibodies Market During the Forecast Period

Based on the therapeutic area, the market is segmented into autoimmune disorders, genetic disorders, hematological malignancies, ophthalmic disorders, skin cancers and solid tumors. At present, genetic disorders hold the maximum share of the bispecific antibodies market. It is worth highlighting that the bispecific antibodies market for hematological malignancies is likely to grow at a relatively higher CAGR.

Bispecific Antibodies Acting Through T-Cell Retargeting / Activation Occupy the Largest Share of the Bispecific Antibodies Market

Based on the mechanism of action, the market is segmented into cytokines retargeting / neutralization, dual ligands blocking, resistance factors co-targeting, targeting tumor angiogenesis, T-cell retargeting / activation and others. Currently, T-cell retargeting / activation holds the maximum share of the bispecific antibodies market. However, bispecific antibodies acting through cytokines retargeting / neutralization are anticipated to capture the highest market in the near future.

Bispecific Antibodies Targeting CD3 x BCMA is the Fastest Growing Segment of the Market During the Forecast Period

Based on target antigen, the market is segmented into C5-Albumin, CD20 x CD3, CD3 x BCMA, CD3 x CD19, EGFR x cMET, EpCAM x CD3, Factor IXa x Factor X, gp100 x CD3, HER2 x HER2, PD-1 x CTLA-4, PD-L1 x TGFB, TNF-a x HSA, VEGF x DLL4 and VEGF-A x ANG2. At present, therapies targeting factor IXa x factor X holds the maximum share of the bispecific antibodies market. It is worth highlighting that the drugs intended to target CD3 x BCMA are likely to grow at a relatively higher CAGR.

Asymmetric Bispecific Antibodies are Likely to Dominate the Bispecific Antibodies Market During the Forecast Period

Based on the antibody format, the market is segmented into asymmetric and fragments. Currently, asymmetric antibodies hold the maximum share of the bispecific antibodies market. This trend is unlikely to change in the foreseeable future.

North America Accounts for the Largest Share of the Market

Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific and Rest of the World. Majority share is expected to be captured by players based in North America. It is worth highlighting that, over the years, the market in Europe is expected to grow at a higher CAGR.

Example Players in the Bispecific Antibodies Market

• Akeso Biopharma
• Alexion
• Amgen
• Genmab
• Immunocore
• Janssen Research & Development
• Linton Pharm
• Merck
• OncXerna Therapeutics
• Pfizer
• Roche
• Taisho Pharmaceutical
• Zymeworks

Primary Research Overview

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders. The research report features detailed transcripts of interviews held with the following industry stakeholders:

• Senior Scientist, Immunai
• Business Development Consultant, F-star
• Director (GMP Clinical Manufacturing), Innovent Biologics
• Former Senior Director, Business Development, CytomX Therapeutics
• Founder and Chief Scientific Officer and Chief Executive Officer, SYNIMMUNE
• PhD Student, University of Freiburg

BISPECIFIC ANTIBODIES MARKET: RESEARCH COVERAGE

• Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the bispecific antibodies market, focusing on key market segments, including [A] therapeutic area, [B] mechanism of action, [C] target antigen, [D] antibody format and [E] Key geographical regions.
• Market Landscape 1: A comprehensive evaluation of bispecific antibodies that are either approved or being evaluated in different stages of clinical development, considering various parameters, such as [A] developer company, [B] phase of development, [C] target antigen, [D] type of therapy, [E] route of administration, [F] method of administration, [G] target indication, [H] therapeutic area, [I] disease segment, [J] year of establishment, [K] company size and [L] location of headquarter.
• Market Landscape 2: A comprehensive evaluation of bispecific antibodies that are currently being evaluated in preclinical studies, considering various parameters, such as [A] developer company, [B] stage of development, [C] target antigen, [D] therapeutic area, [E] disease segment, [F] year of establishment, [G] company size and [H] location of headquarters of the developer.
• Key Insights: A detailed analysis, encompassing the contemporary bispecific antibody therapeutics market trends, based on relevant parameters, such as [A] phase of development and route of administration, [B] phase of development and disease segment, and [C] phase of development and location of their headquarters. In addition, this chapter includes various representations of preclinical stage bispecific antibody therapeutics based on [D] stage of development and disease segment, and [E] stage of development and location of their headquarters. Further, the chapter also includes representation of the developers of bispecific antibody therapeutics based on [F] stage of development (preclinical, clinical and preclinical and clinical) of their drug candidates and [G] location of their headquarters.
• Technology Assessment Framework: A detailed assessment of technology platforms being developed / used by various drug developers for the production of bispecific antibody therapeutics, based on multiple relevant parameters, such as [A] clinical / preclinical pipeline strength, [B] developer's years of experience, [C] company size and [D] location of headquarters of developers.
• Big Pharma Analysis: A comprehensive examination of various initiatives focused on bispecific antibody therapeutics undertaken by major pharmaceutical companies. This analysis includes heat map visualizations that illustrate the distribution of leading pharmaceutical firms, as well as spider web diagrams that compare their initiatives across multiple relevant parameters.
• Company Profiles: In-depth profiles of key industry players engaged in the development of bispecific antibodies across various geographies, focusing on [A] company overviews, [B] financial information (if available), [C] drug portfolio, [D] recent developments and [E] an informed future outlook.
• Partnerships and Collaborations: An analysis of partnerships established in this sector, since 2016, based on several parameters, such as [A] year of partnership, [B] type of partnership, [C] disease segment, [D] type of payment model employed, [E] deal amount, [F] most active players (in terms of number of deals inked), [G] most popular technologies (in terms of number of deals inked for technologies). This section also highlights the regional distribution of partnership activity in this market.
• Contract Services for Bispecific Antibody Therapeutics: A review on the key steps involved and challenges associated with the manufacturing of bispecific antibodies. In addition, this section includes a list of contract manufacturing organizations (CMOs) and biologics contract research organization (CROs), highlighting the key considerations for bispecific antibody developers, while selecting a suitable CRO / CMO.
• Clinical Trial Analysis: Examination of completed, ongoing, and planned clinical studies of various bispecific antibody therapeutics based on parameters like [A] trial registration year, [B] trial phase, [C] trial recruitment status, [D] enrolled patient population, [E] type of study, [F] study design, [G] type of sponsor / collaborator, [H] leading industry and non-industry players, [I] key focus areas and [J] geographical location of trials.
• Case Study 1: A discussion on general regulatory guidelines issued by the ICH, WHO and FDA for the development of bispecific antibodies. In addition, it provides details related to the responses of various pharmaceutical industries to the FDA guidelines.
• Case Study 2: A review of different channels used for promoting marketed bispecific antibodies , along with examples of players that have undertaken such initiatives, elaborating on the various promotional strategies being adopted by developers of two approved bispecific antibodies, namely Blincyto(R) and Hemlibra(R), and comparison of both the drugs based on information available on their respective websites.
• SWOT Analysis: A SWOT analysis, focusing on key drivers and challenges that are likely to impact the industry's evolution. Further, it includes a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall industry.

KEY QUESTIONS ANSWERED IN THIS REPORT

• How many companies are currently engaged in this market?
• Which are the leading companies in this market?
• What kind of partnership models are commonly adopted by industry stakeholders?
• What are the factors that are likely to influence the evolution of this market?
• What is the current and future market size?
• What is the CAGR of this market?
• How is the current and future market opportunity likely to be distributed across key market segments?

REASONS TO BUY THIS REPORT

• The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
• Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
• The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.

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TABLE OF CONTENTS

1. PREFACE

• 1.1. Introduction
• 1.2. Key Market Insights
• 1.3. Scope of the Report
• 1.4. Research Methodology
• 1.5. Frequently Asked Questions
• 1.6. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION

• 3.1. Chapter Overview
• 3.2. Introduction to Antibodies
  • 3.2.1. Structure
  • 3.2.2. Functions
  • 3.2.3. Mechanism of Action
• 3.3. Antibody Therapeutics
  • 3.3.1. Historical Evolution of Antibody Therapeutics
  • 3.3.2. Key Approved Antibody Therapeutics
  • 3.3.3. Advanced Antibody Therapeutics
    • 3.3.3.1. Fc Engineered and Glycoengineered Antibodies
    • 3.3.3.2. Antibody Fragments
    • 3.3.3.3. Fusion Proteins
    • 3.3.3.4. Intrabodies
    • 3.3.3.5. Bispecific Antibodies
• 3.4. Bispecific Antibody Formats
  • 3.4.1. Single-Chain-based Formats (Fc Independent Antibody Formats)
    • 3.4.1.1. Tandem scFvs (single-chain variable fragments) and Triple bodies
    • 3.4.1.2. Bispecific Single-Domain Antibody Fusion Proteins
    • 3.4.1.3. Diabodies / Diabody Derivatives
    • 3.4.1.4. Fusion Proteins
    • 3.4.1.5. Fusion Proteins Devoid of Fc Regions
  • 3.4.2. Immunoglobulin G Based Formats (Fc Dependent Antibody Formats)
    • 3.4.2.1. Quadromas
    • 3.4.2.2. Knobs-Into-Holes
    • 3.4.2.3. Dual Variable Domain Ig
    • 3.4.2.4. IgG-scFv
    • 3.4.2.5. Two-in-one or Dual Action Fab (DAF) Antibodies
    • 3.4.2.6. Half Molecule Exchange
    • 3.4.2.7. κλ- Bodies
• 3.5. Mechanism of Action of Bispecific Antibody Therapeutics
  • 3.5.1. Retargeting Immune Effectors (NK Cells and T Cells) to Tumor Cells
  • 3.5.2. Directly Targeting Malignant / Tumor Cells
  • 3.5.3. Retargeting of Toxins
  • 3.5.4. Targeting Tumor Angiogenesis
  • 3.5.5. Other Mechanisms
• 3.6. Applications of Bispecific Antibodies

4. MARKET LANDSCAPE OF APPROVED AND CLINICAL THERAPIES

• 4.1. Chapter Overview
• 4.2. Approved and Clinical Bispecific Antibody Therapeutics: Overall Market Landscape
  • 4.2.1. Analysis by Phase of Development
  • 4.2.2. Analysis by Target Antigen
  • 4.2.3. Analysis by Type of Therapy
  • 4.2.4. Analysis by Route of Administration
  • 4.2.5. Analysis by Method of Administration
  • 4.2.6. Analysis by Target Indication
  • 4.2.7. Analysis by Therapeutic Area
  • 4.2.8. Analysis by Disease Segment
• 4.3. Approved and Clinical Bispecific Antibody Therapeutics: Overall Developer Landscape
  • 4.3.1. Analysis by Year of Establishment
  • 4.3.2. Analysis by Company Size
  • 4.3.3. Analysis by Location of Headquarters

5. MARKET LANDSCAPE OF PRECLINICAL THERAPIES

• 5.1. Chapter Overview
• 5.2. Preclinical Bispecific Antibody Therapeutics: Overall Market Landscape
  • 5.2.1. Analysis by Stage of Development
  • 5.2.2. Analysis by Target Antigen
  • 5.2.3. Analysis by Therapeutic Area and Disease Segment
• 5.3. Preclinical Bispecific Antibody Therapeutics: Overall Developer Landscape
  • 5.3.1. Analysis by Year of Establishment
  • 5.3.2. Analysis by Company Size
  • 5.3.3. Analysis by Location of Headquarters

6. KEY INSIGHTS

• 6.1. Chapter Overview
• 6.2. Approved and Clinical Stage Bispecific Antibody Therapeutics Landscape: Key Insights
  • 6.2.1. Analysis by Phase of Development and Route of Administration
  • 6.2.2. Analysis by Phase of Development and Disease Segment
  • 6.2.3. Analysis by Phase of Development and Location of Developer's Headquarters
• 6.3. Preclinical Stage Bispecific Antibody Therapeutics Landscape: Key Insights
  • 6.3.1. Analysis by Stage of Development and Therapeutic Area
  • 6.3.2. Analysis by Stage of Development and Location of Developer Headquarters
• 6.4. Bispecific Antibody Therapeutic Developers Landscape: Key Insights
  • 6.4.1. Distribution by Stage of Development
  • 6.4.2. Distribution by Stage of Development and Region of Developer Headquarters

7. TECHNOLOGY ASSESSMENT FRAMEWORK

• 7.1. Chapter Overview
• 7.2. Bispecific Antibody Therapeutics: List of Technology Platforms
• 7.3. Bispecific Antibody Technology Platforms: Comparative Analysis
  • 7.3.1. Analysis by Technologies for Approved and Clinical Drugs
  • 7.3.2. Analysis by Technologies for Preclinical Drugs
• 7.4. Most Popular Technology Platforms: Analysis by Stage of Development
• 7.5. Bispecific Antibody Technology Platform Developers: Analysis by Location of Headquarters

8. BIG PHARMA PLAYERS: BENCHMARKING ANALYSIS

• 8.1. Chapter Overview
• 8.2. Big Pharma Players: Benchmarking Analysis (Spider Web Representation)
• 8.3. Big Pharma Players: Comparative Clinical Pipeline Analysis
  • 8.3.1. Analysis by Target Antigen
  • 8.3.2. Analysis by Antibody Format
  • 8.3.3. Analysis by Mechanism of Action
  • 8.3.4. Analysis by Therapeutic Area

9. COMPANY PROFILES

• 9.1. Chapter Overview
• 9.2. Akeso Biopharma
  • 9.2.1. Company Overview
  • 9.2.2. Financial Performance
  • 9.2.3. Drug Portfolio
  • 9.2.4. Recent Developments and Future Outlook
• 9.3. Alphamab Oncology
  • 9.3.1. Company Overview
  • 9.3.2. Financial Performance
  • 9.3.3. Drug Portfolio
  • 9.3.4. Recent Developments and Future Outlook
• 9.4. Amgen
  • 9.4.1. Company Overview
  • 9.4.2. Financial Performance
  • 9.4.3. Drug Portfolio
  • 9.4.4. Recent Developments and Future Outlook
• 9.5. Merck
  • 9.5.1. Company Overview
  • 9.5.2. Financial Performance
  • 9.5.3. Drug Portfolio
  • 9.5.4. Recent Developments and Future Outlook
• 9.6. Regeneron
  • 9.6.1. Company Overview
  • 9.6.2. Financial Performance
  • 9.6.3. Drug Portfolio
  • 9.6.4. Recent Developments and Future Outlook
• 9.7. Roche
  • 9.7.1. Company Overview
  • 9.7.2. Financial Performance
  • 9.7.3. Drug Portfolio
  • 9.7.4. Recent Developments and Future Outlook
• 9.8. Xencor
  • 9.8.1. Company Overview
  • 9.8.2. Financial Performance
  • 9.8.3. Drug Portfolio
  • 9.8.4. Recent Developments and Future Outlook

10. PARTNERSHIPS AND COLLABORATIONS

• 10.1. Chapter Overview
• 10.2. Partnership Models
• 10.3. Bispecific Antibody Therapeutics: Partnerships and Collaborations
  • 10.3.1. Analysis by Year of Partnership
  • 10.3.2. Analysis by Type of Partnership
  • 10.3.3. Analysis by Year and Type of Partnership
  • 10.3.4. Analysis by Disease Segment
  • 10.3.5. Analysis by Type of Payment Model Employed and Deal Amount
  • 10.3.6. Analysis by Year of Agreement, Type of Payment Model Employed and Deal Amount
  • 10.3.7. Analysis by Disease Segment, Type of Payment Model Employed and Deal Amount
  • 10.3.8. Most Active Players: Analysis by Number of Partnership Instances
  • 10.3.9. Most Popular Technologies: Analysis by Number of Partnership Instances
  • 10.3.10. Analysis by Region
  • 10.3.11. Intercontinental and Intracontinental Agreements

11. CONTRACT SERVICES FOR BISPECIFIC ANTIBODY THERAPEUTICS

• 11.1. Chapter Overview
• 11.2. Manufacturing of Bispecific Antibody Therapeutics
  • 11.2.1. Key Considerations for Manufacturing and Associated Challenges
  • 11.2.2. Contract Manufacturing Organizations (CMOs)
    • 11.2.2.1. Bispecific Antibody Therapeutics: List of CMOs
  • 11.2.3. Contract Research Organizations (CROs)
    • 11.2.3.1. Bispecific Antibody Therapeutics: List of CROs
• 11.3. Key Considerations for Selecting a Suitable CMO / CRO Partner

12. CLINICAL TRIAL ANALYSIS

• 12.1. Chapter Overview
• 12.2. Key Assumptions and Methodology
• 12.3. Bispecific Antibody Therapeutics: Clinical Trial Analysis
  • 12.3.1. Analysis by Trial Registration Year
  • 12.3.2. Analysis of Enrolled Patient Population by Trial Registration Year
  • 12.3.3. Analysis by Trial Phase
  • 12.3.4. Analysis of Enrolled Patient Population by Trial Phase
  • 12.3.5. Analysis by Trial Recruitment Status
  • 12.3.6. Analysis by Trial Registration Year and Trial Recruitment Status
  • 12.3.7. Analysis by Type of Study
  • 12.3.8. Analysis by Study Design
  • 12.3.9. Analysis by Type of Sponsor / Collaborator
  • 12.3.10. Leading Industry Players: Analysis by Number of Registered Trials
  • 12.3.11. Leading Non-Industry Players: Analysis by Number of Registered Trials
  • 12.3.12. Clinical Trial Analysis: Key Focus Areas (Word Cloud Representation)
  • 12.3.13. Analysis by Geography
  • 12.3.14. Analysis by Trial Recruitment Status and Geography
  • 12.3.15. Analysis of Enrolled Patient Population by Trial Recruitment Status and Geography

13. CASE STUDY: REGULATORY GUIDELINES FOR BISPECIFIC ANTIBODIES

• 13.1. Chapter Overview
• 13.2. Guidelines Issued by Regulatory Authorities
  • 13.2.1. US Food and Drug Administration (FDA)
    • 13.2.1.1. Pharma Companies' Response to the FDA Draft Guidance
  • 13.2.2. World Health Organization (WHO)

14. CASE STUDY: PROMOTIONAL / MARKETING STRATEGIES

• 14.1. Chapter Overview
• 14.2. Key Channels Used for Promotional Campaigns
  • 14.2.1. Product Websites
  • 14.2.2. Patient Assistance Programs
  • 14.2.3. Participation in Conferences
  • 14.2.4. Collaboration with Stakeholders
  • 14.2.5. Drug Approval Across Multiple Geographies
• 14.3. Other Channels Used for Promotional and Marketing Strategies
• 14.4. Summary: Promotional and Marketing Strategy Leveraged by Bispecific

Antibody Developers

• 14.5. Promotional Analysis: Blincyto(R)
  • 14.5.1. Drug Overview
  • 14.5.2. Product Website analysis
    • 14.5.2.1. Messages for Healthcare Professionals
      • 14.5.2.1.1. For MRD Positive B cell precursor ALL
      • 14.5.2.1.2. For Relapsed or Refractory B-cell precursor ALL
    • 14.5.2.2. Messages for Patients
  • 14.5.3. Patient Support Services and Informative Downloads
  • 14.5.4. Other Promotional Strategies
    • 14.5.4.1. Presence in Conferences
• 14.6. Promotional Analysis: Hemlibra(R)
  • 14.6.1. Drug Overview
  • 14.6.2. Product Website Analysis
    • 14.6.2.1. Messages for Healthcare Professionals
      • 14.6.2.1.1. For Hemophilia A without Factor VIII Inhibitors
      • 14.6.2.1.2. For Hemophilia A with Factor VIII Inhibitors
    • 14.6.2.2. Messages for Patients
  • 14.6.3. Patient Support Services and Informative Downloads
    • 14.6.3.1. Co-pay Program
    • 14.6.3.2. Independent Co-pay Assistance Foundation
    • 14.6.3.3. Genentech Patient Foundation
  • 14.6.4. Other Promotional Strategies
    • 14.6.4.1. Presence in Conferences

15. MARKET FORECAST AND OPPORTUNITY ANALYSIS

• 15.1. Chapter Overview
• 15.2. Scope and Limitations
• 15.3. Forecast Methodology and Key Assumptions
• 15.4. Bispecific Antibody Therapeutics Market, till 2035
  • 15.4.1. Bispecific Antibody Therapeutics Market: Analysis by Therapeutic Area, Current Year and 2035
  • 15.4.2. Bispecific Antibody Therapeutics Market: Analysis by Mechanism of Action, Current Year and 2035
  • 15.4.3. Bispecific Antibody Therapeutics Market: Analysis by Target Antigen, Current Year and 2035
  • 15.4.4. Bispecific Antibody Therapeutics Market: Analysis by Antibody Format, Current Year and 2035
  • 15.4.5. Bispecific Antibody Therapeutics Market: Analysis by Key Players, Current Year and 2035
  • 15.4.6. Bispecific Antibody Therapeutics Market: Analysis by Geography, Current Year and 2035
• 15.5. Bispecific Antibody Market: Value Creation Analysis
• 15.6. Bispecific Antibody Therapeutics Market: Product-wise Sales Forecasts
  • 15.6.1. AK104 (Akeso Biopharma)
    • 15.6.1.1. Target Patient Population
    • 15.6.1.2. Sales Forecast
    • 15.6.1.3. Net Present Value
    • 15.6.1.4. Value Creation Analysis
  • 15.6.2. Blincyto(TM) (Amgen)
    • 15.6.2.1. Target Patient Population
    • 15.6.2.2. Sales Forecast
    • 15.6.2.3. Net Present Value
    • 15.6.2.4. Value Creation Analysis
  • 15.6.3. Hemlibra(R) (Roche)
    • 15.6.3.1. Target Patient Population
    • 15.6.3.2. Sales Forecast
    • 15.6.3.3. Net Present Value
    • 15.6.3.4. Value Creation Analysis
  • 15.6.4. Kimmtrak(R) (Immunocore)
    • 15.6.4.1. Target Patient Population
    • 15.6.4.2. Sales Forecast
    • 15.6.4.3. Net Present Value
    • 15.6.4.4. Value Creation Analysis
  • 15.6.5. Lunsumio(R) (Roche)
    • 15.6.5.1. Target Patient Population
    • 15.6.5.2. Sales Forecast
    • 15.6.5.3. Net Present Value
    • 15.6.5.4. Value Creation Analysis
  • 15.6.6. Nanozora(R) (Taisho Pharmaceutical)
    • 15.6.6.1. Target Patient Population
    • 15.6.6.2. Sales Forecast
    • 15.6.6.3. Net Present Value
    • 15.6.6.4. Value Creation Analysis
  • 15.6.7. Rybrevant(TM) (Janssen Research & Development)
    • 15.6.7.1. Target patient Population
    • 15.6.7.2. Sales Forecast
    • 15.6.7.3. Net Present Value
    • 15.6.7.4. Value Creation Analysis
  • 15.6.8. Tecvayli(TM) (Janssen Research & Development)
    • 15.6.8.1. Target Patient Population
    • 15.6.8.2. Sales Forecast
    • 15.6.8.3. Net Present Value
    • 15.6.8.4. Value Creation Analysis
  • 15.6.9. Vabysmo(TM) (Roche)
    • 15.6.9.1. Target Patient Population
    • 15.6.9.2. Sales Forecast
    • 15.6.9.3. Net Present Value
    • 15.6.9.4. Value Creation Analysis
  • 15.6.10. AK112 (Akeso Biopharma)
    • 15.6.10.1. Target Patient Population
    • 15.6.10.2. Sales Forecast
    • 15.6.10.3. Net Present Value
    • 15.6.10.4. Value Creation Analysis
  • 15.6.11. ALXN1720 (Alexion)
    • 15.6.11.1. Target Patient Population
    • 15.6.11.2. Sales Forecast
    • 15.6.11.3. Net Present Value
    • 15.6.11.4. Value Creation Analysis
  • 15.6.12. GEN3013 (Genmab)
    • 15.6.12.1. Target Patient Population
    • 15.6.12.2. Sales Forecast
    • 15.6.12.3. Net Present Value
    • 15.6.12.4. Value Creation Analysis
  • 15.6.13. Glofitamab (Roche)
    • 15.6.13.1. Target Patient Population
    • 15.6.13.2. Sales Forecast
    • 15.6.13.3. Net Present Value
    • 15.6.13.4. Value Creation Analysis
  • 15.6.14. LP000 (Linton Pharm)
    • 15.6.14.1. Target Patient Population
    • 15.6.14.2. Sales Forecast
    • 15.6.14.3. Net Present Value
    • 15.6.14.4. Value Creation Analysis
  • 15.6.15. M7824 (Merck)
    • 15.6.15.1. Target Patient Population
    • 15.6.15.2. Sales Forecast
    • 15.6.15.3. Net Present Value
    • 15.6.15.4. Value Creation Analysis
  • 15.6.16. OMP 305B83 (Mereo BioPharma)
    • 15.6.16.1. Target Patient Population
    • 15.6.16.2. Sales Forecast
    • 15.6.16.3. Net Present Value
    • 15.6.16.4. Value Creation Analysis
  • 15.6.17. PF-06863135 (Pfizer)
    • 15.6.17.1. Target Patient Population
    • 15.6.17.2. Sales Forecast
    • 15.6.17.3. Net Present Value
    • 15.6.17.4. Value Creation Analysis
  • 15.6.18. ZW25 (Zymeworks)
    • 15.6.18.1. Target Patient Population
    • 15.6.18.2. Sales Forecast
    • 15.6.18.3. Net Present Value
    • 15.6.18.4. Value Creation Analysis
• 15.7. Concluding Remarks

16. SWOT ANALYSIS

• 16.1. Chapter Overview
• 16.2. Strengths
  • 16.2.1. Enhanced Specificity
  • 16.2.2. Diverse Application Areas
  • 16.2.3. Lower Drug Resistance
  • 16.2.4. Success of Approved Products
• 16.3. Weaknesses
  • 16.3.1. Uncertainties with Safety of Therapeutic Candidates
  • 16.3.2. Complex Purification and Downstream Processing
  • 16.3.3. Dimerization in Antibodies with Fc-region
• 16.4. Opportunities
  • 16.4.1. Life Cycle Management of Novel Therapies
  • 16.4.2. Growing Number of High Value Partnerships
  • 16.4.3. Expertise Available with Contract Manufacturing Organizations
  • 16.4.4. Emergence of Advanced Technologies
• 16.5. Threats
  • 16.5.1. Rise in Attrition Rate of Clinical Stage Candidates
• 16.6. Concluding Remarks

17. CONCLUDING REMARKS

18. EXECUTIVE INSIGHTS

• 18.1. Chapter Overview
• 18.2. Immunai
  • 18.2.1. Company Snapshot
  • 18.2.2. Interview Transcript: Senior Scientist
• 18.3. University of Freiburg
  • 18.3.1. Company Snapshot
  • 18.3.2. Interview Transcript: PhD Student
• 18.4. SYNIMMUNE
  • 18.4.1. Company Snapshot
  • 18.4.2. Interview Transcript: Founder and Chief Scientific Officer, and Chief Executive Officer
• 18.5. CytomX Therapeutics
  • 18.5.1. Company Snapshot
  • 18.5.2. Interview Transcript: Former Senior Director, Business Development
• 18.6. F-star
  • 18.6.1. Company Snapshot
  • 18.6.2. Interview Transcript: Business Development Consultant
• 18.7. Innovent Biologics
  • 18.7.1. Company Snapshot
  • 18.7.2. Interview Transcript: Director, GMP Clinical Manufacturing

19. APPENDIX 1: TABULATED DATA

20. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATION

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