Bispecific Antibodies Market by Therapeutic Area

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 TGFβ

TNF-α 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 TGFβ, TNF-α 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® and Hemlibra®, 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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