Market Size
The Global Monoclonal Antibody Therapeutics Market reached USD 190,698.3 million in 2022 and is projected to witness lucrative growth by reaching up to USD 531,314.6 million by 2031. The global monoclonal antibody therapeutics market is expected to exhibit a CAGR of 14.1% during the forecast period (2024-2031). The monoclonal antibody therapeutics market trends show rising demand for these owing to the increasing geriatric population.
A type of immunotherapy known as monoclonal antibody therapy uses monoclonal antibodies (mAb) to bind mono selectively to particular cells or proteins. Therapeutic monoclonal antibodies use the adaptive immune system's highly developed specificity to combat illness. Chronic and severe diseases are being treated with monoclonal antibodies.
Furthermore, the rising incidence of osteoporosis or arthritis, the expansion of the therapeutic pipeline, investments by Biotechnology and pharmaceutical companies in research and development, and the launch of more advanced and novel products are all contributing factors to the growth of the global market for monoclonal antibody therapeutics.
Market Summary
| Metrics | Details |
| CAGR | 14.1% |
| Size Available for Years | 2022-2031 |
| Forecast Period | 2024-2031 |
| Data Availability | Value (USD ) |
| Segments Covered | Product Type, Application, End User and Region |
| Regions Covered | North America, Europe, Asia-Pacific, South America and Middle East & Africa |
| Fastest Growing Region | Asia-Pacific |
| Largest Region | North America |
| Report Insights Covered | Competitive Landscape Analysis, Company Profile Analysis, Market Size, Share, Growth, Demand, Recent Developments, Mergers and Acquisitions, New Product Type Launches, Growth Strategies, Revenue Analysis, Porter’s Analysis, Pricing Analysis, Regulatory Analysis, Supply-Chain Analysis and Other key Insights. |
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Market Dynamics
Increasing Regulatory Approvals and Launch of Therapies Drive the Growth of the Monoclonal Antibody Therapeutics Market
The global monoclonal antibody therapeutics market size is expanding owing to the increasing research studies for monoclonal antibody therapeutics, and increased regulatory office acceptance of monoclonal antibodies which encourages the introduction of novel treatments, which is anticipated to fuel market expansion during the forecast period.
Additionally, another important driver of the market's expansion is the growing number of novel therapies and clinical trials approved around the world by major biopharmaceutical companies. For instance, on October 5, 2022, the main findings presented by GSK plc indicate that the PERLA phase II trial met its primary endpoint of the objective response rate (ORR) utilizing Response Evaluation Criteria in Solid Tumors (RECIST) standards as assessed by blinded independent central review.
In first-line patients suffering from recurrent non-squamous non-small cell lung cancer (NSCLC), the trial compared the effectiveness of dostarlimab in conjunction with chemotherapy vs pembrolizumab together with chemotherapy.
The Growing Investments in Research and Development by Biotechnology Companies Creates Lucrative Monoclonal Antibody Therapeutic Opportunities for Manufacturers
There is a growing monoclonal antibody therapeutic market opportunity owing to growing expenditure or investment in research and development proficiencies by key players or biotechnology companies for novel technological advancements. The rising prevalence of infectious disorders is also a monoclonal antibody therapeutics market trend driving the market.
In April 2023, researchers at the Johns Hopkins Kimmel Cancer Center as well as its BloombergKimmel Institute for Cancer Immunotherapy are currently conducting a phase 2 study to determine the safety of enoblituzumab, a monoclonal antibody, in men with aggressive prostate cancer. If successful, the study could lead to clinical efficacy against cancers of all types.
If results from the following tests are encouraging, enoblituzumab may prove to be the first prostate cancer immunotherapy drug to be effective. As a result, the market is anticipated to expand throughout the forecast period due to the growing investment in research and development by key market players.
Higher Costs and Strict Regulatory Measures will Hamper the Growth of the Market.
However, greater prices and onerous regulatory requirements leading to drawn-out licensing processes may limit industry expansion. Drugs created from mAbs have very specific properties and narrowly defined targets. This is due to the fact that they bind to cells rather than penetrating them.
This has, in part, hurt the global market for monoclonal antibodies. Another issue with employing mAbs is that, unlike small molecule medications, they need to be administered via injection.
The annual cost of hematology or oncology mAbs was approximately D 149,622 more than those utilized for cardiovascular or metabolic disorders, D 98,981 greater than those utilized in immunology, D 128,856 higher compared to those employed in infectious disorders or allergy, and D 106,830 more than those applied in ophthalmology after accounting for variables that can affect production costs.
Market Segment Analysis
The global monoclonal antibody therapeutics market is segmented based on product type, application, production source, end user and region.
Owing to the High Research, The Cancer Application Segment Accounted For Approximately 43.8% Of The Monoclonal Antibody Therapeutics Market Share In 2022.
Due to the rise in cancer cases and the increasing popularity of monoclonal antibody therapies in cancer treatment, the cancer application segment has the largest market share. The World Health Organization estimates that one in five men and one in six women will get cancer at some point in their lives and that one in eight men and one in eleven women will die due to the condition.
The overall number of people alive within five years after a cancer diagnosis, often known as the 5-year prevalence, is reportedly 43.8 million worldwide. Additionally, monoclonal antibody treatments have shown to be a great alternative to medicines and chemotherapy for treating cancer since they minimize the side effects associated with their use. Additionally, it is predicted that the market will have future growth prospects thanks to the expanding medication pipeline, therapy approvals, and clinical trials.
For instance, a vial of 50 mg of the monoclonal antibody Keytruda (Pembrolizumab), which is used to treat various cancers, costs roughly USD 2,250. Additionally, it is anticipated that the loss of patents will impede market expansion within the anticipated time frame. For instance, Genentech, Inc. (Roche)'s Rituximab (Rituxan) medication failed to receive a patent in the United States and Europe.
Source: DataM Intelligence Analysis (2023)
Market Geographical Share
North America Accounted for Approximately 40.2% of the Market Share in 2022, Owing to the Strong Presence of Major Players and Increasing Healthcare Infrastructure Investment
Due to the rising need for monoclonal antibody therapeutics for treatment purposes in healthcare, manufacturers in North America have chance of increasing their operations. There are many producers and suppliers in North America and owing to the quick economic growth of the region, industrial production has expanded, driving the demand for monoclonal antibody therapeutics.
Increasing expenditure on healthcare and rising awareness among people, advancement of technologies for treatment, and increase in biopharmaceutical establishment across the region are also contributing to the market growth in this region.
Rising novel technology launches to support monoclonal antibody therapeutics for the treatment of oncology also drive market growth. The primary healthcare organizations and businesses' joint research endeavors as well as new product development that continuously aims to enhance available treatment options are also expected to contribute to the rising demand. Individuals are becoming more aware of various technologies or therapies being studied for the treatment leading to the expansion of the market in this region.
Source: DataM Intelligence Analysis (2023)
Monoclonal Antibody Therapeutics Companies
The major global players in the monoclonal antibody therapeutics market include F. Hoffmann-La Roche, Novartis AG, Merck & Co. Inc., Pfizer Inc., Eli Lilly and Co. (Lilly), Sanofi, AstraZeneca, Bayer AG, Regeneron Pharmaceuticals Inc., and GSK Plc among others.
Russia Ukraine Conflict Analysis
The Russia-Ukraine conflict is estimated to have a moderate impact on the global monoclonal antibody therapeutics market, owing to the low prevalence and absence of key market players in this region. However, the impact of the import and export of raw materials is expected to have little influence over the global monoclonal antibody therapeutics market growth over the forecast period.
Key Developments
- In May 2023, the U.S. Food and Drug Administration (FDA) granted approval for the investigational novel drug (IND) for the first-in-class anti-CD24 monoclonal antibody compound ATG-031 Phase I study. Antengene Corporation Limited is an inventive, commercial-stage global biopharmaceutical company dedicated to discovering, creating, and marketing first-in-class therapeutics in oncology and hematology.
- In April 2023, a clinical-stage biotechnology business, Prometheus Biosciences, Inc., leading a precision medicine strategy that involves the development, commercialization, and discovery of novel medicinal and companion diagnostic offerings for treating immune-mediated diseases, and Merck, which operates as MSD in countries other than Canada and the United States, announced that the two companies have entered into a binding agreement under which Merck will acquire Prometheus for D 3.3 billion.
- In February 2023, Elranatamab, a B-cell maturation antigen bispecific antibody (BsAb) under research that is directed towards CD3 and manufactured by Pfizer, recently announced about Priority Review grant by the U.S. Food and Drug Administration (FDA) for its Biologics License Application (BLA) for treating patients having relapsed or refractory multiple myeloma (RRMM).
Why Purchase the Report?
- To visualize the global monoclonal antibody therapeutics market segmentation based on product type, application, production source, end user and region, as well as understand key commercial assets and players.
- Identify commercial opportunities by analyzing trends and co-development.
- Excel data sheet with numerous data points of monoclonal antibody therapeutics market-level with all segments.
- PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
- Product mapping available as Excel consisting of key products of all the major players.
The global monoclonal antibody therapeutics market report would provide approximately 53 tables, 54 figures and 195 Pages.
Target Audience 2024
- Manufacturers/ Buyers
- Industry Investors/Investment Bankers
- Research Professionals
- Emerging Companies
