Monoclonal Antibody Therapeutics (mABs) Market

The market for monoclonal antibody therapeutics (mABs) is anticipated to expand from US$ 249.14 million in 2024 to US$ 619.6 million by 2031, reflecting a projected CAGR of 13.9% from 2025 to 2031.

Market Insights and Analyst Perspective:

Intensive research and development efforts, along with a rising incidence of chronic diseases, are expected to significantly influence the forecast for the monoclonal antibody therapeutics (mABs) market in the upcoming years.

A monoclonal antibody (mAbs) is a uniform collection of antibodies that specifically target designated antigens. The manufacturing of therapeutic mAbs necessitates a mammalian expression system that provides the cellular machinery required for glycosylation, proper folding, orientation, and covalent binding of antibody peptide chains to create complete and biologically active molecules. Innovative antibody modalities, such as bispecific and trispecific antibodies, can recognize multiple epitopes on a single antigen, while single-domain antibodies can more easily penetrate tissues. These advanced antibody types can improve the efficacy of antibody therapeutics, thereby broadening their application areas. Additionally, these antibodies can form antibody-drug conjugates to enhance the targeting efficiency of chemotherapy agents towards specific cell types. The production of mAB-based drugs for various diseases is driving market growth. Strategic product launches by manufacturers present lucrative opportunities in the market. Moreover, the trend of combination drugs that include mABs is gaining traction in the mAbs therapeutic market.

Market Driver

Growth in Production of mAB-Based Drugs for Various Diseases

Monoclonal antibody therapeutics (mABs) are utilized to treat a diverse array of diseases, including cancer, autoimmune disorders, and metabolic conditions. These drugs, developed by biopharmaceutical companies and research institutions, have garnered significant attention in the global market due to their high specificity, effective targeting capabilities, and minimal toxicity and side effects. Consequently, an increase in the production capacity of mAB therapeutics is expected to propel the growth of the monoclonal antibody therapeutics (mABs) market.

Approved Therapeutic mABs in the European Union (EU) and the US

Products

Brand Name

Disease Indication

Approval Year: EU

Approval Year: US

Pozelimab

VEOPOZ

CHAPLE disease

NA

2023

Elranatamab

Elrexfio

Multiple myeloma

2023

2023

Rozanolixizumab

RYSTIGGO

Generalized myasthenia gravis

2024

2023

Talquetamab

TALVEY

Multiple myeloma

2023

2023

Epcoritamab

EPKINLY

Diffuse large B-cell lymphoma

2023

2023

Mirikizumab

Omvoh

Ulcerative colitis

2023

2023

Source: Antibody Society

Market Opportunity

Innovative Product Launches Through Strategic Developments by Manufacturers

Organic growth through product launches by manufacturers of therapeutic mABs is likely to enhance the monoclonal antibody therapeutics (mABs) market in the near future. In March 2022, Adagio Therapeutics, Inc. announced the launch of ADG20 (ADINTREVIMAB), the first monoclonal antibody to achieve primary endpoints with statistical significance for both pre-and post-exposure prophylaxis and treatment of COVID-19, seeking US Emergency Use Authorization (EUA).

Additionally, inorganic growth through mergers and acquisitions is expected to lead to the introduction of new therapeutic mABs. For example, in July 2023, Eli Lilly announced the acquisition of Versanis, a private clinical-stage biopharmaceutical company focused on treating cardiometabolic diseases. This acquisition allows Eli Lilly to access Versanis's core product portfolio, which includes a monoclonal antibody product named bimagrumab, currently being evaluated in the BELIEVE Phase 2b study as a standalone treatment and in combination with semaglutide for its potential to reduce fat mass, preserve muscle mass, and improve outcomes for individuals with obesity and related complications. These factors are anticipated to significantly contribute to the growth of the monoclonal antibody therapeutics (mABs) market in the coming years.

Monoclonal Antibody Therapeutics (mABs) Market Trends

Combination Drugs Featuring Monoclonal Antibodies (mABs)

As per the National Institute of Health (NIH) 2021 report, Roche and Regeneron (pharmaceutical companies) initiated a phase 2/3 clinical trial to assess combination monoclonal antibodies for patients with mild to moderate COVID-19. They are evaluating REGN-COV2, a cocktail drug that combines two monoclonal antibodies - casirivimab and imdevimab - for COVID-19 treatment. These companies anticipate that this combination mAB drug could reduce hospitalization by 70% and be particularly effective for children over 12 years old (weighing more than 40 kg). Researchers are actively exploring more therapeutic combinations of monoclonal antibodies. For instance, bamlanivimab and etesevimab developed by Eli Lilly demonstrated positive clinical outcomes for COVID-19 in 2022. Therefore, the trend of combination drugs utilizing monoclonal antibodies for various diseases is expected to gain significant traction in the monoclonal antibody therapeutics (mABs) market in the coming years.

Strategic Insights

Report Segmentation and Scope:

The analysis of the monoclonal antibody therapeutics (mABs) market has been conducted by considering the following segments: product, application, and distribution channel.

The market is categorized by product into recombinant mABs, antibody-drug conjugates, bispecific and multispecific mABs, biosimilars, and others. By application, the monoclonal antibody therapeutics (mABs) market is segmented into oncology, autoimmune diseases, and others. The autoimmune diseases segment is further divided into rheumatoid arthritis, psoriasis, ulcerative colitis, and others. The distribution channel segmentation includes hospital pharmacies, retail pharmacies, and others.

In terms of product, the recombinant mABs segment held the largest share of the monoclonal antibody therapeutics (mABs) market in 2022. The antibody-drug conjugates segment is projected to exhibit the fastest CAGR of 18.5% during the forecast period. According to a report by ACS Publications, therapeutic recombinant monoclonal antibodies represent cutting-edge biomedical research aimed at developing effective strategies to treat a wide range of diseases for which no effective treatments currently exist. Tocilizumab is an example of a recombinant mAB used to treat arthritis, idiopathic arthritis, and rheumatoid arthritis (RA). Furthermore, recombinant mABs can also be utilized for treating autoimmune diseases and cancer. Bevacizumab is a recombinant mAB currently employed in the treatment of breast, lung, and colorectal cancers, as well as HIV-1, bacterial toxin infections/reactions, and infections from SARS-CoV-2 and the Ebola virus.

Antibody-drug conjugates (ADCs) are a rapidly emerging class of therapeutic agents that combine chemotherapy and immunotherapy. According to a NIH report, ADCs are primarily based on immunoglobulin G (IgG), with 13 ADCs having received approval from the US Food and Drug Administration (FDA) to date. Additionally, over 90 ADCs are currently in clinical development or trials.

Sr. No.

Product (Approved ADCs)

Disease Indication

1

Mylotarg

Relapsed acute myelogenous leukemia

2

Adcetris

Relapsed Hodgkin lymphoma and relapsed systemic anaplastic large cell lymphomas

3

Kadcyla

HER2-positive metastatic breast cancer

4

Besponsa

Relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia

5

Lumoxiti

Relapsed or refractory hairy cell leukemia or HCL

6

Polivy

Relapsed or refractory (R/R) diffuse large B-cell lymphoma or DLBCL

7

Padcev

Metastatic urothelial cancer

8

Enhertu

Metastatic HER2-positive breast cancer

9

Trodelvy

Metastatic triple-negative breast cancer

10

Blenrep

Relapsed or refractory multiple myeloma

11

Zynlota

Large B-cell lymphoma

12

Tivdak

Recurrent or metastatic cervical cancer therapy

13

Elahere

Platinum-resistant ovarian cancer

Source: Single Use Support Article

Thus, the regulatory approvals of ADCs and ongoing clinical trials for treatment strategies targeting rare diseases are expected to drive the growth of the monoclonal antibody therapeutics (mABs) market, particularly in the antibody-drug conjugates segment during the forecast period.

Regional Analysis:

Geographically, the Monoclonal Antibody Therapeutics (mABs) market report encompasses North America, Europe, Asia Pacific, the Middle East & Africa, and South & Central America. In 2022, North America held the largest share of the global monoclonal antibody therapeutics (mABs) market. The Asia Pacific region is projected to experience the highest CAGR from 2022 to 2030. Within North America, the US represents the largest market share, benefiting from expedited product approval processes for mAB therapeutics. As of December 2019, 79 therapeutic mABs had been approved by the US FDA, according to a study published in the BioMed Central journal. Among these, 30 are intended for cancer treatment. In May 2021, the FDA granted EUA for a new therapeutic mAB - Sotrovimab - designed for outpatient use in treating individuals with severe COVID-19. In February 2022, the FDA issued EUA for bebtelovimab, developed by Eli Lilly and Company, targeting the Omicron variant. Additionally, etesevimab is another example of therapeutic mABs approved by the US FDA.

Monoclonal Antibody Therapeutics (mABs) Market Report Scope: Industry Developments and Future Opportunities:

Several strategic initiatives by leading players in the monoclonal antibody therapeutics (mABs) market are outlined below:

1. In January 2023, AstraZeneca received approval for Evusheld in the European Union (EU). Evusheld is a combination of two long-acting antibodies - tixagevimab (AZD8895) and cilgavimab (AZD1061). The US government supported the development of this product through federal funding from the Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and the Biomedical Advanced Research and Development Authority.
2. In August 2023, Regeneron Pharmaceuticals, Inc. entered into an agreement with the Biomedical Advanced Research and Development Authority (BARDA) to facilitate clinical development, manufacturing, and regulatory licensure for next-generation monoclonal antibody therapy against COVID-19. Under this agreement, Regeneron aims to collaborate with BARDA to evaluate, further develop, and manufacture this therapy, as well as conduct regulatory activities.

Competitive Landscape and Key Companies:

Prominent companies in the monoclonal antibody therapeutics (mABs) market include GlaxoSmithKline, F. Hoffmann-La Roche, Bayer AG, Amgen, Novartis, AbbVie, Bristol-Myers Squibb, Janssen Pharmaceutical, Merck KGaA, and AstraZeneca. The monoclonal antibody therapeutics (mABs) market report includes an analysis of company positioning and concentration to assess the performance of key players in the market.

This product will be delivered within 3-5 business days.