Bispecific Antibodies Market (5th Edition), 2023-2035

Bispecific Antibodies Market (5th Edition), 2023-2035



OVERVIEW

Bispecific antibodies (BsAbs) represent a novel class of antibodies that act by simultaneously attaching to two separate / distinct antigens or different epitopes of the same antigen. These drugs primarily function by redirecting immune effector cells to effectively eliminate cancer cells using various mechanisms, such as antibody-dependent cell mediated cytotoxicity (ADCC), antibody dependent cellular phagocytosis (ADCP), and complement dependent cytotoxicity (CDC). Further, bispecific antibody drugs possess unique biological and pharmacological characteristics and are available in a wide range of formats, making them a promising option for therapeutic use. It is worth mentioning that, till date, nine bispecific antibodies have been approved for therapeutic use; these are (arranged in reverse chronological order of their initial approval) Tecvayli™ (October 2022), Nanozora® (September 2022), AK104 (June 2022), Lunsumio® (June 2022), VABYSMO™ (February 2022), KIMMTRAK® (January 2022), RYBREVANT™ (May 2021), Hemlibra® (November 2017) and Blincyto® (December 2014). Additionally, in the last few years, a definite surge in clinical trials being conducted to evaluate bispecific antibodies has been observed, given the rising popularity and potential therapeutic benefits of such candidates. In the foreseen future, as more such therapeutic candidates move into the clinical stage and / or receive approval, we anticipate the bispecific antibody therapeutics market to witness healthy growth.

KEY MARKET INSIGHTS

The Bispecific Antibodies Market (5th Edition): Distribution by Therapeutic Area (Autoimmune Disorders, Genetic Disorders, Hematological Malignancies, Ophthalmic Disorders, Skin Cancers And Solid Tumors), Mechanism of Action (Cytokines Retargeting / Neutralization, Dual Ligands Blocking, Resistance Factors Co-Targeting, Targeting Tumor Angiogenesis, T-Cell Retargeting / Activation and 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 TGFβ, TNF-α x HAS, VEGF x DLL4 and VEGF-A x ANG2), Antibody Format (Asymmetric And Fragments), Key Players (Akeso Biopharma, Alexion, Amgen, Genmab, Immunocore, Janssen Research & Development, Linton Pharm, Merck, OncXerna Therapeutics, Pfizer, Roche, Taisho Pharmaceutical and Zymeworks) and Key Geographical Regions (North America, Europe, Asia and Rest of the World): Industry Trends and Global Forecasts, 2023-2035 report features an extensive study of the current market landscape and future opportunity for the players involved in the development and manufacturing of bispecific therapeutic antibodies for treating various oncological and non-oncological disorders. The report answers many key questions related to this domain.

Rising Interest in Bispecific Antibody Therapeutics

The growing pipeline of bispecific antibodies and the increasing number of associated clinical trials to evaluate the effectiveness of such candidates indicate a high level of interest and investment in this field. The recent approval of several bispecific antibodies by regulatory agencies has increased the interest and confidence of stakeholders in this approach. 2022 saw approval of six bispecific antibodies, with Janssen being the latest to receive FDA approval for Tecvayli™ (in October 2022) for the treatment of multiple myeloma. It is worth mentioning that the potential advantages of bispecific antibodies over traditional monoclonal antibodies, such as increased efficacy and specificity, have made them an attractive option for the treatment of a wide range of diseases.

Pipeline Analysis of Bispecific Antibodies

Bispecific antibody landscape features the presence of over 120 large, mid-sized and small drug developers. It is worth mentioning that, currently, over 220 bispecific antibodies are either approved or being evaluated in clinical stages of development, whereas over 180 candidates are in preclinical stages of development. In addition, we came across various contract manufacturing / research organizations that are engaged in this domain.

Bispecific Antibodies are Mainly Targeting Cancer

The increasing prevalence of chronic diseases, such as oncological disorders, autoimmune disorders and infectious diseases, is expected to drive the market for bispecific antibody therapeutics. Such therapeutics offer a promising approach by targeting multiple disease pathways, simultaneously. Currently, there are more than 15 bispecific antibodies in development for the treatment of gastric cancer. In March 2023, Akeso Biopharma announced the completion of enrollment for a phase III trial for Cadonilimab for use in combination with chemotherapy as first-line therapy for advanced gastric or gastroesophageal junction cancer. It is also worth highlighting that the most recent approval of Tecvayli™ for relapsed or refractory multiple myeloma has expanded the target indications where bispecific antibodies have proven their efficacy.

Market Size of the Bispecific Antibodies Market

Driven by the rising interest in R&D activities and growing demand for effective therapeutics, the bispecific antibody therapeutics market is anticipated to witness an annualized growth rate of over 9.5%, during the period 2023-2035. Specifically, in terms of therapeutic areas, the market is anticipated to be driven by drugs targeting oncology disorders. In addition, presently, close to 64% of the market is captured by players based in North America and Europe.

Key Players in the Bispecific Antibodies Market

Examples of key players engaged in this domain (which have also been captured in this report, arranged in alphabetical order) include Akeso Biopharma, Amgen, Astrazeneca, Genmab, Immunocore, Janssen Research & Development, Merck, Roche and Zymeworks. Roche is playing a key role in taking the bispecific antibodies from development to commercialization, with three approvals to date. Two of these approvals came in 2022 – Vabysmo™ in February 2022 and Tecvayli™ in October 2022. Another of Roche’s bispecific antibody, Glofitamab, received priority review from FDA for the treatment of relapsed or refractory large b-cell lymphoma and is likely to receive approval soon.

Big Pharma Showing Keen Interest in Bispecific Antibody

Examples of recent partnerships signed by big pharma players engaged in this domain (which have also been captured in this report, arranged in reverse chronological order of the agreement year) include a product licensing agreement between GSK and Wuxi Biologics (January 2023), a product commercialization agreement signed between Genentech and Biogen (December 2022), a product licensing agreement between Sanofi and Innate Pharma (December 2022) and a product development and commercialization agreement signed between Regeneron and CytomX Therapeutics (November 2022).

SCOPE OF THE REPORT

Global Bispecific Antibodies Market: Market Segmentations

Key Report Attributes

Details

Forecast Period

2023-2035

Therapeutic Areas

Autoimmune Disorders

Genetic Disorders

Hematological Malignancies

Ophthalmic Disorders

Skin Cancers

Solid Tumors

Mechanisms of Action

Cytokines Retargeting / Neutralization

Dual Ligands Blocking

Resistance Factors Co-targeting

Targeting Tumor Angiogenesis

T-Cell Retargeting / Activation

Others

Target Antigens

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 TGFβ

TNF-α x HSA

VEGF x DLL4

VEGF-A x ANG2

Antibody Formats

Asymmetric

Fragments

Key Players

Akeso Biopharma

Alexion

Amgen

Genmab

Immunocore

Janssen Research & Development

Linton Pharm

Merck

OncXerna Therapeutics

Pfizer

Roche

Taisho Pharmaceutical

Zymeworks

Key Geographical Regions

North America

Europe

Asia

Rest of the World

Source: Roots Analysis

The report features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. Amongst other elements, the report includes:

An executive summary of the key insights captured during our research, offering a high-level view on the current state of the bispecific antibodies market and its likely evolution in the short to mid and long term.

A brief introduction to bispecific antibodies, highlighting their historical background, as well as information on their structure, different types available, unique antibody formats, mechanisms of action of various products and their applications.

A detailed review of the market landscape of over 220 bispecific antibodies that are either approved or being evaluated in different stages of clinical development, based on several relevant parameters, such as developer company, phase of development, target antigen, type of therapy, route of administration, method of administration, target indication, therapeutic area, disease segment, year of establishment, company size and location of headquarters of the developer.

An in-depth assessment of the market landscape of over 180 bispecific antibodies that are currently being evaluated in preclinical studies, based on several relevant parameters, such as developer company, stage of development, target antigen, therapeutic area, disease segment, year of establishment, company size and location of headquarters of the developer.

An insightful analysis, highlighting the contemporary market trends in the bispecific antibody therapeutics domain, through six different graphical representations, including various representations of clinical and approved bispecific antibodies based on phase of development and route of administration, phase of development and disease segment and phase of development and location of their headquarters. In addition, this chapter includes various representations of preclinical stage bispecific antibody therapeutics based on stage of development and disease segment and stage of development and location of their headquarters; the chapter also includes representation of the developers of bispecific antibody therapeutics based on stage of development (preclinical, clinical and preclinical and clinical) of their drug candidates and location of their headquarters.

A detailed assessment of over 80 technology platforms being developed / used by various drug developers for the production of bispecific antibody therapeutics, featuring a 3-D comparative bubble analyses of bispecific antibody technology platforms based on multiple relevant parameters, such as clinical / preclinical pipeline strength, developer’s years of experience, company size and location of headquarters of developers.

An in-depth analysis of big pharma players engaged in this domain, featuring insightful spider web analyses of such players, based on clinical stage competition, marketed drugs competition, clinical trial activity, partnership activity and technology portfolio strength. Additionally, it features heat map analyses, highlighting the comparison of big pharma players based on various relevant parameters, such as target antigen, antibody format, mechanism of action and target therapeutic area.

Elaborate profiles of prominent drug developers engaged in the development of bispecific antibodies , featuring a brief overview of the company, along with information on year of establishment, number of employees, location of headquarters, key members of the executive team, financial details / information (if available), drug portfolio, recent developments and an informed future outlook.

An insightful analysis of various partnerships inked between stakeholders engaged within the bispecific antibody therapeutics domain, during the period 2016-2023, based on several relevant parameters, such as year of partnership, type of partnership, disease segment, type of payment model employed, deal amount, most active players (in terms of number of deals inked), most popular technologies (in terms of number of deals inked for technologies) and regional distribution of partnership activity.

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 contract research organizations (CROs), highlighting the key considerations for bispecific antibody developers, while selecting a suitable CRO / CMO.

An in-depth analysis of ongoing and planned studies related to bispecific antibody therapeutics, which were registered till April 2023, taking into consideration several relevant parameters, such as trial registration year, trial phase, trial recruitment status, enrolled patient population, type of study, study design, type of sponsor / collaborator, leading industry and non-industry players, key focus areas and geographical location of trials.

A review of 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.

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 (chosen based on their popularity in this domain), namely Blincyto® and Hemlibra®, and comparison of both the drugs based on information available on their respective websites.

A comprehensive market forecast analysis, including future sales projections of bispecific antibodies that are either marketed or under phase III of clinical development, till the year 2035, presenting a detailed market segmentation on the basis of therapeutic areas (autoimmune disorders, genetic disorders, hematological malignancies, ophthalmic disorders, skin cancers and solid tumors), mechanism of action (cytokines retargeting / neutralization, dual ligands blocking, resistance factors co-targeting, targeting tumor angiogenesis, t-cell retargeting / activation and 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 TGFβ, TNF-α x HAS, VEGF x DLL4 and VEGF-A x ANG2), antibody format (asymmetric and fragments), key players (Akeso Biopharma, Alexion, Amgen, Genmab, Immunocore, Janssen Research & Development, Linton Pharm, Merck, OncXerna Therapeutics, Pfizer, Roche, Taisho Pharmaceutical and Zymeworks) and key geographical regions (North America, Europe, Asia and Rest of the World).

A discussion on important, industry-specific trends, key market drivers and challenges, under a SWOT framework, featuring a qualitative Harvey ball analysis highlighting the relative impact of each SWOT parameter on the overall market.

The opinions and insights presented in the report were influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders (in alphabetical order of company name):

Siobhan Pomeroy (Former Senior Director, Business Development, CytomX Therapeutics)

Jane Dancer (Business Development Consultant, F-star)

Ran Salomon (Senior Scientist, Immunai)

Yinjue Wang (Director, GMP Clinical Manufacturing, Innovent Biologics)

Ludger Große-Hovest (Founder and Chief Scientific Officer, SYNIMMUNE) and Martin Steiner (Chief Executive Officer, SYNIMMUNE)

Francesca Rosato (PhD Student, University of Freiburg)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY

The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:

Annual reports

Investor presentations

SEC filings

Industry databases

News releases from company websites

Government policy documents

Industry analysts’ views

While the focus has been on forecasting the market over the coming 13 years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

FREQUENTLY ASKED QUESTIONS

Question 1: What is a bispecific antibody?

Answer: Bispecific antibody refers to a novel antibody that possesses the dual action ability to attach to two different epitopes, or antigens, at the same time.

Question 2: What are the key factors driving bispecific antibodies market?

Answer: Recent approval of several bispecific antibody therapeutics, increased efficacy / specificity compared to traditional monoclonal antibodies, rising prevalence of chronic disorders, growing number of clinical trials evaluating such drugs and high partnership activity in this domain are expected to drive the bispecific antibody therapeutics market in the coming decade.

Question 3: Which are the top players in bispecific antibody therapeutics market?

Answer: Top players in bispecific antibodies market include include Akeso Biopharma, Amgen, Astrazeneca, Genmab, Immunocore, Janssen Research & Development, Merck, Roche and Zymeworks.

Question 4: What are the most common antigens targeted by bispecific antibody therapeutics?

Answer: Target antigens, such as CD20 x CD3, PD-1 x CTLA-4 and PD-L1 x CTLA-4, emerged as the most popular antigens targeted by various bispecific antibody drugs.

Question 5: What are the most popular technology platforms being employed for the development of bispecific antibody therapeutics?

Answer: Currently, over 80 antibody technology platforms are being employed for the development of such therapeutics. Among such platforms, BiTE® (Amgen), CRIB™ (Alphamab Oncology), CrossMab™ (Roche), DuoBody® (Genmab), Knobs-into-Holes (Genentech) and XmAb® (Xencor) emerged as the most popular antibody technology platforms.

Question 6: What is the global market size of the bispecific antibody therapies market, in 2035?

Answer: Bispecific antibody therapies market is anticipated to have a market size of over USD 16 billion in 2035.

Question 7: What is the growth rate (CAGR) of the bispecific antibody therapies market?

Answer: Bispecific antibody therapies market is anticipated to grow at a CAGR of over 9.5%, during the period 2023-2035.

Question 8: Which region has the highest growth rate in bispecific antibody therapeutics market?

Answer: In terms of regions, Asia is likely to grow at the highest CAGR during the period 2023-2035.

Question 9: What are the most common therapeutic area(s) targeted by bispecific antibody therapeutics?

Answer: Based on current and future market trends, majority of bispecific antibody therapeutics are to be developed for the treatment of oncological disorders.

Question 10: What are the partnership and collaboration trends in bispecific antibody therapeutics domain?

Answer: Currently, product development and commercialization agreements, and R&D agreements are the most common types of partnerships being inked by stakeholders engaged in the bispecific antibody therapeutics domain.

Question 11: What are the upcoming trends in bispecific antibody therapies market?

The industry is presently witnessing the rising interest towards bispecific antibody therapies which is evident from the fact that seven such drug candidates have been approved in the past year. In the future, more such approvals in the market are expected to happen, as a number of drug candidates, currently in phase III clinical studies, have shown promising results.

CHAPTER OUTLINES

Chapter 2 is an executive summary of the key insights captured during our research, offering a high-level view on the current state of the bispecific antibodies market and its likely evolution in the short to mid and long term.

Chapter 3 provides a general overview of antibodies, highlighting their historical background, as well as information on their structure, and different types of antibodies available in the market. In addition, the chapter highlights the key development milestones of antibody-based therapeutics over the last few years. It also features a discussion on bispecific antibodies, elaborating on the available bispecific formats, mechanisms of action of various products and their applications.

Chapter 4 features a detailed assessment of the overall market landscape of over 220 bispecific antibodies that are either approved or being evaluated in different stages of clinical development, based on several relevant parameters, such as phase of development (phase I, phase I / II, phase II, phase II / III, phase III and approved), target antigens (CD20 x CD3, CD3 x BCMA, CD3 x PSMA, EGFR x cMET, EGFR x HER3, HER2 x HER2, PD-1 x CTLA-4, PD-L1 x CTLA-4, PD-L1 x TGFβ, VEGF x DLL4 and others), type of therapy (monotherapy and combination therapy), route of administration (intravenous, subcutaneous and others), method of administration (infusion and injection), target indication (B-cell non Hodgkin lymphoma, chronic lymphoblastic leukemia, esophageal cancer, gastric cancer, non-small cell lung cancer, solid tumors (unspecified), small cell lung cancer and others), therapeutic area (autoimmune disorders, inflammatory disorders, infectious diseases, ophthalmic disorders, renal disorders, skin cancers, solid tumors and other disorders) and disease segment (oncology and non-oncology). Further, it features an analysis of drug developers, engaged in the development of approved and clinical bispecific antibody therapeutics, on the basis of various parameters, such as year of establishment, company size and location of headquarters.

Chapter 5 present an in-depth assessment of the overall market landscape of over 180 bispecific antibodies that are currently being evaluated in preclinical studies, based on several relevant parameters, such as stage of development (research, discovery, CMC, toxicology studies, pre-IND and IND enabling study), target antigens (CD47 X TAA, BCMA x CD3, CD3 x CD123, CD3 x CLDN 18.2, Fab-like CD3 x CLDN 18.2, HER2 x 4-1BB and others), therapeutic area (autoimmune disorders, hematological malignancies, inflammatory disorders, infectious diseases, solid tumors and other disorders) and disease segment (oncology and non-oncology). Further, it features an analysis of drug developers, engaged in the development of preclinical bispecific antibody candidates, on the basis of various parameters, such as year of establishment, company size and location of headquarters.

Chapter 6 features an insightful analysis, highlighting the contemporary market trends in the bispecific antibody therapeutics domain, through six different graphical representations, including various representations of clinical and approved bispecific antibody therapeutics based on phase of development and route of administration, phase of development and disease segment and phase of development and location of their headquarters. In addition, the chapter includes various representations of preclinical stage bispecific antibody therapeutics based on stage of development and disease segment and stage of development and location of their headquarters. Further, the chapter includes a representation of the developers of bispecific antibody therapeutics based on stage of development (preclinical, clinical and preclinical and clinical) of their drug candidates and location of their headquarters.

Chapter 7 provides a detailed assessment of over 80 technology platforms being developed / used by various drug developers for the production of bispecific antibody therapeutics. It features 3-D comparative bubble analyses of bispecific antibody technology platforms, which were generated from a proprietary analytical framework, to highlight the relative popularity of such technologies, based on multiple relevant parameters, such as clinical / preclinical pipeline strength, developer’s experience and company size. In addition, it features geographical distribution of bispecific technology platform developers based on their location of headquarters.

Chapter 8 features a comparative in-depth analysis of big pharma players engaged in bispecific antibodies domain, featuring an insightful spider web analysis of such players, based on clinical stage competition, marketed drugs competition, clinical trial activity, partnership activity and technology portfolio strength. Further, it features heat map analyses on various relevant parameters, such as target antigen, antibody format, mechanism of action and therapeutic area.

Chapter 9 features elaborate profiles of prominent drug developers engaged in the development of bispecific antibodies. Each company profile features a brief overview of the company, along with information on year of establishment, number of employees, location of headquarters and key members of the executive team. It also includes details of their financial details / information (if available), drug portfolio, recent developments and an informed future outlook.

Chapter 10 features insightful analysis of various partnerships inked between stakeholders engaged within the bispecific antibody therapeutics domain, during the period 2016-2023, based on several relevant parameters, such as year of partnership, type of partnership (clinical trial agreements, joint ventures, mergers / acquisitions, product development agreements, product commercialization agreements, product development and commercialization agreements, product licensing agreements, R&D agreements, service agreements, technology licensing agreements and others), disease segment (oncology disorders and non-oncology disorders), type of payment model employed (upfront payments, milestone payments and other payments), deal amount, most active players (in terms of number of deals inked), most popular technologies (in terms of number of deals inked for technologies) and regional distribution of partnership activity.

Chapter 11 highlights the key manufacturing steps involved, and challenges associated with the manufacturing of bispecific antibodies. In addition, it consists of a list of CMOs and CROs involved in this domain along with the details on their headquarters, year of establishment and other specific information, such as scale of operation of CMOs and research services offered by CROs. The chapter also highlights the key points that bispecific antibody developers need to consider while selecting a suitable CRO / CMO.

Chapter 12 presents in-depth analysis of various clinical trials related to bispecific antibodies, which were registered across the world till April 2023, on several relevant parameters, such as trial registration year, trial phase, trial recruitment status, enrolled patient population, type of study, study design, type of sponsor / collaborator, leading industry and non-industry players, key focus areas (word cloud representation). Further, it features geographical overview of clinical trials based on number of trials, trial recruitment status and number of patients enrolled.

Chapter 13 features a review of regulatory guidelines issued by the ICH, WHO and FDA related to the development of bispecific antibodies. In addition, it provides details related to the responses of the various pharmaceutical industries to the FDA guidelines.

Chapter 14 highlights different channels used for promotional campaigns by the developers of marketed bispecific antibody therapeutics, along with examples of players that have undertaken such initiatives. In addition, this chapter elaborates on the various promotional strategies being adopted by developers of two approved bispecific antibodies (chosen based on their popularity in this domain), namely Blincyto® and Hemlibra®, and comparison of both the drugs based on the information available on their respective websites. The promotional aspects covered in the chapter include drug overview, details provided on the product website (covering key messages for patients and healthcare professionals), patient support offerings, informative downloadable content, and product visibility in scientific conferences.

Chapter 15 presents a comprehensive market forecast analysis, highlighting the future potential of the market till the year 2035. It includes future sales projections of bispecific antibody therapeutics that are either marketed or under phase III of clinical development. Sales potential and growth opportunity of these candidates were estimated based on the target patient population, likely adoption rates, existing / future competition from other drug classes and the likely price of these candidates. The chapter also presents a detailed market segmentation on the basis of therapeutic areas (autoimmune disorders, genetic disorders, hematological malignancies, ophthalmic disorders, skin cancers and solid tumors), mechanism of action (cytokines retargeting / neutralization, dual ligands blocking, resistance factors co-targeting, targeting tumor angiogenesis, t-cell retargeting / activation and 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 TGFβ, TNF-α x HAS, VEGF x DLL4 and VEGF-A x ANG2), antibody format (asymmetric and fragments), key players (Akeso Biopharma, Alexion, Amgen, Genmab, Immunocore, Janssen Research & Development, Linton Pharm, Merck, OncXerna Therapeutics, Pfizer, Roche, Taisho Pharmaceutical and Zymeworks) and key geographical regions (North America, Europe, Asia and Rest of the World).

Chapter 16 provides a discussion on industry-specific trends, key market drivers and challenges, under a SWOT framework, featuring a qualitative Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall bispecific antibody therapeutic market.

Chapter 17 summarizes the entire report, including a list of key takeaways and offers our independent opinion on the current market scenario. Further, it captures the evolutionary trends that are likely to determine the future of the bispecific antibodies therapeutics industry.

Chapter 18 is a collection of interview transcripts of the discussions held with key stakeholders in this market. The chapter provides details of interviews held with Siobhan Pomeroy (Former Senior Director, Business Development, CytomX Therapeutics), Jane Dancer (Business Development Consultant, F-star), Ran Salomon (Senior Scientist, Immunai), Yinjue Wang (Director, GMP Clinical Manufacturing, Innovent Biologics), Ludger Große-Hovest (Founder and Chief Scientific Officer, SYNIMMUNE), Martin Steiner (Chief Executive Officer, SYNIMMUNE) and Francesca Rosato (PhD Student, University of Freiburg).

Chapter 19 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 20 is an appendix, which contains the list of companies and organizations mentioned in the report.


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 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 Therapeutics 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®
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®
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
14.6.2.3. 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. Global Bispecific Antibody Therapeutics Market, 2023-2035
15.4.1. Bispecific Antibody Therapeutics Market: Analysis By Therapeutic Area, 2023 And 2035
15.4.2. Bispecific Antibody Therapeutics Market: Analysis By Mechanism Of Action, 2023 And 2035
15.4.3. Bispecific Antibody Therapeutics Market: Analysis By Target Antigen, 2023 And 2035
15.4.4. Bispecific Antibody Therapeutics Market: Analysis By Antibody Format, 2023 And 2035
15.4.5. Bispecific Antibody Therapeutics Market: Analysis By Key Players, 2023 And 2035
15.4.6. Bispecific Antibody Therapeutics Market: Analysis By Geography, 2023 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™ (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® (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® (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® (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® (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™ (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™ (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™ (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. Cytomx Therapeutics
18.2.1. Company Snapshot
18.2.2. Interview Transcript: Siobhan Pomeroy, Former Senior Director, Business Development
18.3. F-star
18.3.1. Company Snapshot
18.3.2. Interview Transcript: Jane Dancer, Business Development Consultant
18.4. Immunai
18.4.1. Company Snapshot
18.4.2. Interview Transcript: Ran Salomon, Senior Scientist
18.5. Innovent Biologics
18.5.1. Company Snapshot
18.5.2. Interview Transcript: Yinjue Wang, Director, Gmp Clinical Manufacturing
18.6. Synimmune
18.6.1. Company Snapshot
18.6.2. Interview Transcript: Ludger Große-hovest, Founder And Chief Scientific Officer, And Martin Steiner, Chief Executive Officer
18.7. University Of Freiburg
18.7.1. Company Snapshot
18.7.2. Interview Transcript: Francesca Rosato, Phd Student
19. Appendix 1: Tabulated Data
20. Appendix 2: List Of Companies And Organization

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