The growth of the mAbs market is primarily driven by the production of mAb-based medications aimed at treating a variety of diseases.
Monoclonal antibodies (mAbs) are uniform collections of antibodies that specifically target designated antigens. The manufacturing of therapeutic mAbs necessitates a mammalian expression system, which provides the necessary cellular machinery for glycosylation, proper folding, orientation, and covalent bonding of antibody peptide chains, resulting in fully functional biological molecules. Recent advancements in antibody modalities, such as bispecific and trispecific antibodies, allow for the recognition of multiple epitopes on a single antigen, while single-domain antibodies can penetrate tissues more effectively. These innovative antibody types enhance the efficacy of therapeutic applications, broadening their potential uses. Additionally, these antibodies can be utilized to create antibody-drug conjugates (ADCs), which improve the targeting of chemotherapy agents to specific cell types. The ongoing development of mAb-based drugs for various diseases is a key factor fueling market growth. Furthermore, the introduction of combination therapies that incorporate mAbs is emerging as a significant trend within the mAbs therapeutic market.
Market Opportunities
Innovative Product Launches Through Strategic Developments by Manufacturers
The mAbs market is expected to benefit from organic growth driven by new product launches by manufacturers. For instance, in March 2022, Adagio Therapeutics, Inc. introduced ADG20 (ADINTREVIMAB), the first monoclonal antibody to achieve statistically significant primary endpoints in both pre- and post-exposure prophylaxis and treatment for COVID-19, seeking Emergency Use Authorization (EUA) in the United States.
In addition to organic growth, inorganic strategies such as mergers and acquisitions are likely to introduce new therapeutic mAbs into the market. A notable example is Eli Lilly's acquisition of Versanis in July 2023, a private biopharmaceutical company focused on cardiometabolic diseases. This acquisition allows Eli Lilly to access Versanis's product portfolio, including the monoclonal antibody bimagrumab, which is currently under evaluation in the "BELIEVE Phase 2b study" as a standalone treatment and in combination with semaglutide to enhance fat mass reduction and muscle preservation in patients with obesity and related complications. These developments are expected to significantly influence the growth trajectory of the monoclonal antibody therapeutics market in the near future.
Monoclonal Antibody Therapeutics (mAbs) Market Trends
Combination Drugs Containing Monoclonal Antibodies (mAbs)
According to a 2021 report from the National Institute of Health (NIH), pharmaceutical companies Roche and Regeneron have initiated a phase 2/3 clinical trial to assess the efficacy of combined monoclonal antibodies for patients with mild to moderate COVID-19. They are testing "REGN-COV2," a cocktail of two monoclonal antibodies?casirivimab and imdevimab?aimed at treating COVID-19. The expectation is that this combination will reduce hospitalization rates by 70% and prove particularly effective for children over 12 years old who weigh more than 40 kg. Researchers are actively exploring additional therapeutic combinations of monoclonal antibodies. For example, the combination of bamlanivimab and etesevimab developed by Eli Lilly has shown promising clinical outcomes for COVID-19 in 2022. Thus, the trend of developing combination drugs utilizing monoclonal antibodies to address various diseases is likely to gain momentum in the coming years, establishing itself as a significant trend in the mAbs therapeutic market.
Product-Based Insights
From a product perspective, the recombinant mAbs segment dominated the monoclonal antibody therapeutics market in 2022. The antibody-drug conjugates segment is projected to experience the highest growth rate, with a CAGR of 18.5% during the forecast period. As reported by ACS Publications, therapeutic recombinant monoclonal antibodies represent cutting-edge biomedical research aimed at devising effective strategies for treating a wide array of diseases lacking effective therapies. An example of a recombinant mAb is tocilizumab, used to treat conditions such as arthritis and rheumatoid arthritis (RA). Additionally, recombinant mAbs are applicable in treating autoimmune diseases and various cancers. Bevacizumab is another recombinant mAb currently employed in the treatment of breast, lung, and colorectal cancers, as well as infections caused by HIV-1, bacterial toxins, and viruses like SARS-CoV-2 and Ebola.
Antibody-drug conjugates (ADCs) are an emerging class of therapeutic agents that combine chemotherapy with immunotherapy. According to NIH reports, ADCs are primarily based on immunoglobulin G (IgG), with 13 ADCs already approved by the US Food and Drug Administration (FDA) and over 90 ADCs currently undergoing clinical trials.
Approved ADCs and Their Disease Indications
Product (Approved ADCs) | Disease Indication |
---|---|
Mylotarg | Relapsed acute myelogenous leukemia |
Adcetris | Relapsed Hodgkin lymphoma and relapsed systemic anaplastic large cell lymphomas |
Kadcyla | HER2-positive metastatic breast cancer |
Besponsa | Relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia |
Lumoxiti | Relapsed or refractory hairy cell leukemia |
Polivy | Relapsed or refractory diffuse large B-cell lymphoma |
Padcev | Metastatic urothelial cancer |
Enhertu | Metastatic HER2-positive breast cancer |
Trodelvy | Metastatic triple-negative breast cancer |
Blenrep | Relapsed or refractory multiple myeloma |
Zynlota | Large B-cell lymphoma |
Tivdak | Recurrent or metastatic cervical cancer therapy |
Elahere | Platinum-resistant ovarian cancer |
In conclusion, the regulatory approvals of ADCs and the ongoing clinical trials for rare disease treatments are expected to significantly contribute to the growth of the monoclonal antibody therapeutics market, particularly within the antibody-drug conjugates segment during the forecast period.
Competitive Landscape and Key Companies
Prominent players in the monoclonal antibody therapeutics market include GlaxoSmithKline, F. Hoffmann-La Roche, Bayer AG, Amgen, Novartis, AbbVie, Bristol-Myers Squibb, Janssen Pharmaceutical, Merck KGaA, and AstraZeneca. These companies are focused on adopting new technologies, enhancing existing products, and expanding geographically to meet the increasing global demand.