The monoclonal antibody therapeutics (mAbs) market size is expected to grow from US$ 192.043 billion in 2022 to US$ 542.801 billion by 2030; it is expected to grow at a CAGR of 13.9% from 2022 to 2030.

Production of mABs-based drugs to treat several diseases are a few factors driving the monoclonal antibody therapeutics (mAbs) market growth.

A monoclonal antibody (mAbs) drug is a homogenous collection of antibodies having specificity toward selected target antigens. The production process of therapeutic mAbs requires a mammalian expression system offering the cell machinery essential to glycosylate, fold, orient, and covalently bind antibody peptide chains to produce complete and biologically functional molecules. New modality antibodies such as bispecific and trispecific antibodies recognize multiple epitopes on a single antigen, while single-domain antibodies can penetrate tissues with greater ease. Such advanced antibody types can enhance the efficiency of the antibody therapeutics, thereby expanding their application areas. These antibodies can also form antibody-drug conjugates to improve the efficiency of chemotherapy agents in targeting specific cell types. Production of mAB-based drugs to treat several diseases propel the market development. Innovative product launches through strategic developments by the manufacturers act as lucrative market opportunity. Furthermore, combination drugs containing mABs acts as a market trend for mAbs therapeutic market.

Market Opportunity

Innovative Product Launches Through Strategic Developments by Manufacturers

Organic developments such as product launches by the manufacturers of therapeutic mABs are likely to bolster the monoclonal antibody therapeutics (mABs) market in the coming years. In March 2022, Adagio Therapeutics, Inc. announced the launch of ADG20 (ADINTREVIMAB). The newly launched product is the first monoclonal antibody to meet primary endpoints with statistical significance across pre- and post-exposure prophylaxis and treatment for COVID-19 by seeking US Emergency Use Authorization (EUA).

Further, inorganic developments such as mergers and acquisitions would result in the introduction of new therapeutic mABs. For instance, in July 2023, Elli Lilly announced the acquisition of Versanis, a private clinical-stage biopharmaceutical company intended to treat cardiometabolic diseases. Elli Lilly acquired Versanis to access its core product portfolio, including a monoclonal antibody product named bimagrumab. This product is currently being assessed in the "BELIEVE Phase 2b study" as a standalone molecule. It is also being studied in combination with semaglutide for its combined potential to reduce fat mass, preserve muscle mass, and deliver better patient outcomes in people living with obesity and obesity-related complications. The aforementioned factors are responsible for influential monoclonal antibody therapeutics (mABs) market growth in the coming years.

Monoclonal Antibody Therapeutics (mABs) Market Trend

Combination Drugs Containing Monoclonal Antibodies (mABs)

According to the National Institute of Health (NIH) 2021 report, Roche and Regeneron (pharmaceutical companies) initiated the clinical trial phase 2/3 to evaluate combinational monoclonal antibodies for patients suffering from mild to moderate COVID-19. They are investigating "REGN-COV2," a cocktail drug produced by combining two monoclonal antibodies-casirivimab and imdevimab-for the treatment of COVID-19. These companies expect that the combination of this mAB drug would reduce hospitalization by 70%, and it would be more effective on children above 12 years (having a body weight of more than 40 kg). Researchers are strongly looking for more such therapeutic combinations of monoclonal antibodies. For example, bamlanivimab and etesivimab developed by Elli Lilly have shown positive clinical results for COVID-19 in 2022. Therefore, combination drugs of monoclonal antibodies to treat several diseases would gain significant attention in the coming years, thus emerging as a prominent trend in the monoclonal antibody therapeutics (mABs) market.

Product-Based Insights

In terms of product, the recombinant mABs segment held the largest monoclonal antibody therapeutics (mABs) market share in 2022. The antibody-drug conjugates segment is anticipated to record the fastest CAGR of 18.5% during the forecast period. According to the ACS Publications report, therapeutic recombinant monoclonal antibodies reflect state-of-the-art biomedical research conducted by planning effective strategies to treat a wide range of diseases for which no effective treatment is available. Tocilizumab is an example of a recombinant mAB drug administered to treat arthritis, idiopathic arthritis, and rheumatoid arthritis (RA). Additionally, recombinant mABs can also be used to treat diseases such as autoimmune diseases and cancer. Bevacizumab is an example of a recombinant mAB currently used to treat breast, lung, and colorectal cancer; HIV-1; bacterial toxins infections/reactions, and SARS-CoV-2 and ebola virus infections.

Antibody-drug conjugates (ADC) are a rapidly emerging class of therapeutic agents and a new emerging class of highly potent pharmaceutical drugs exploiting a combination of chemotherapy and immunotherapy. According to a report by the NIH, currently, ADCs are predominantly based on immunoglobulin G (IgG), and till now, 13 ADCs have been approved by the US Food and Drug Administration (FDA). Further, more than 90 ADCs are under clinical development/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

Therefore, regulatory approvals of ADCs and ongoing clinical trials for treatment approaches for rare diseases boost the growth of the monoclonal antibody therapeutics (mABs) market for the antibody-drug conjugates segment during the forecast period.

Competitive Landscape and Key Companies:

GlaxoSmithKline, F.Hoffmann-La-Roche, Bayer AG, Amgen, Novartis, AbbVie, Bristol-Myers Squibb, Janssen Pharmaceutical, Merck KgaA, and AstraZeneca are the prominent companies in the monoclonal antibody therapeutics (mAbs) market report. These companies focus on new technologies, upgrading existing products, and geographic expansions to meet the growing consumer demand worldwide.