Bispecific Antibodies Market (5th Edition): Distribution by Therapeutic Area, Mechanism of Action, Target Antigen, Antibody Format, Key Players and Key Geographical Regions (North America, Europe, Asia and Rest of the World): Industry Trends and Global Forecasts, 2023-2035

Bispecific Antibody Therapeutics Market 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 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

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.

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?

Answer: 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.