The global monoclonal antibody therapeutics market size is calculated at USD 233.19 billion in 2024 and is expected to reach around USD 919.06 billion by 2033, registering a solid CAGR of 14.7% between 2024 and 2033. Monoclonal antibodies (mAbs) are crucial reagents in biomedical research, disease diagnostics, and the treatment of conditions such as infections and cancer.
Produced through cell lines or clones derived from immunized animals, mAbs play a vital role in advancing medical science and therapeutic interventions. Their broad applicability and effectiveness in targeting specific disease markers and pathogens drive significant growth in the monoclonal antibody market. The continued development and deployment of mAbs in diverse research and clinical settings underscore their importance as a key growth factor in the industry.
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Monoclonal Antibody Therapeutics Market Key Takeaways
- North America accounted for the largest share of the monoclonal antibody therapeutics industry in 2023
- In-Vitro segment held a dominant share in production method segment in the monoclonal antibody therapeutics industry
- Human segment held a dominant share in source segment in the monoclonal antibody therapeutics industry
- Oncology is likely to grow at significant CAGR in the monoclonal antibody therapeutics industry
- The hospitals segment of the monoclonal antibody therapeutics industry is expected to register fastest growth during the forecast period.
Growth Dynamics of the Monoclonal Antibody Therapeutics Market: Potential, Opportunities and Breakthroughs
The monoclonal antibody therapeutics market is experiencing rapid growth due to the increasing adoption of these precision treatments. Monoclonal antibodies, laboratory-engineered proteins that mimic the immune system’s natural antibodies, are primarily administered as intravenous (IV) solutions, often within infusion centers where multiple patients receive treatment concurrently. These therapies are designed to precisely target and engage specific proteins on cancer cells or other unwanted cells, offering improved effectiveness and reduced side effects compared to conventional treatments.
The consistency in monoclonal antibody quality across production batches is critical for both therapeutic and diagnostic applications. With many monoclonal antibodies now approved for various cancer types, their role in enhancing, restoring, and modifying the immune response underscores their growing significance in the therapeutic landscape, driving the market’s expansion.
· In August 2023, Regeneron Pharmaceuticals, Inc. announced that the Biomedical Advanced Research and Development Authority (BARDA) had entered into an agreement to support the clinical development, manufacturing, and regulatory licensure of a next-generation COVID-19 monoclonal antibody therapy for preventing SARS-CoV-2 infection.
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Top Companies in the Monoclonal Antibody Therapeutics Market and Their Recent Innovation
- Merck & Co.’s ongoing R&D efforts led to numerous publications and presentations at major oncology conferences, showcasing new data on Keytruda’s effectiveness.
- AstraZeneca showed positive results from Phase III trials led to increased confidence in Imfinzi’s efficacy and expanded its use in clinical practice.
- Bristol-Myers Squibb showed successful trials of Opdivo in combination with Yervoy (Ipilimumab) and other therapies led to new approvals and enhanced treatment protocols.
Leading the Way: North America’s Pivotal Role in the Monoclonal Antibody Therapeutics Market
In North America, the monoclonal antibody therapeutics market holds a dominant position, driven by significant healthcare expenditures, particularly in the United States, where spending far exceeds that of other nations without necessarily translating into superior healthcare outcomes. Healthcare spending in the U.S. is influenced by both high service prices and utilization rates, leading to increased overall costs. In Canada, the medical sector is also robust and dynamic, bolstered by cutting-edge research, technological advancements, and escalating demand for healthcare services. This vibrant evolution in Canada’s healthcare landscape further reinforces the region’s strong market presence and growth potential in the monoclonal antibody therapeutics sector.
· In January 2022, GSK and Vir Biotechnology announced a United States government agreement to purchase an additional supply of sotrovimab, authorized for the early treatment of COVID-19.
Monoclonal Antibody Therapeutics Market Led by In-Vitro Segment, Driven by Cutting-Edge Research and Development
The in-vitro segment commands a dominant share in the production methods of the monoclonal antibody therapeutics market. In-vitro antibody production is a crucial technique in immunology research and therapeutic development, utilizing controlled laboratory conditions to generate antibodies. These immunoglobulins are proteins produced by the immune system in response to foreign substances such as viruses, bacteria, and tumor cells. The precision and scalability of in-vitro methods make them essential for advancing monoclonal antibody therapies, reinforcing their leading role in the market’s production landscape.
Human Segment Takes Command of Monoclonal Antibody Therapeutics Market, Spearheading New Therapies
The human segment holds a dominant position in the monoclonal antibody therapeutics market. Monoclonal antibodies derived from human sources are highly advantageous for a range of app22lications, including tumor immunotherapy, imaging, and the neutralization of toxins, viruses, and drug overdoses. These human-origin mABs offer superior efficacy and safety profiles compared to their mouse-derived counterparts, which often elicit human anti-mouse antibody responses upon administration. The preference for human-origin monoclonal antibodies underscores their pivotal role in advancing therapeutic interventions and ensuring optimal patient outcomes across various medical fields.
Cancer Treatments Propel Oncology to Forefront of the Market
The oncology segment is the leading therapy area in the monoclonal antibody therapeutics market. Monoclonal antibodies (mABs) serve as a form of targeted drug therapy, specifically designed to identify and bind to unique proteins on cancer cells. This targeted approach allows mABs to either directly kill cancer cells or inhibit their growth. The market features a diverse range of mABs, with some tailored for specific cancer types while others are effective across multiple cancer indications. The broad applicability and effectiveness of mABs in oncology underscore their dominant role in the market, driving significant advancements and growth in cancer treatment strategies.
By End User, Hospitals to Pave the Way in the Market
The hospital segment remains the dominant end-user in the monoclonal antibody therapeutics market. This advanced treatment offers critical protection to patients with mild to moderate symptoms, preventing further deterioration and potential hospitalization. Administered via a single-dose infusion, monoclonal antibody treatments can be delivered either intravenously or subcutaneously on an outpatient basis within the hospital setting. The effectiveness of this approach in managing symptoms and reducing hospitalization rates underscores the significant role of hospitals in the deployment and growth of monoclonal antibody therapies.
Monoclonal antibodies (mABs) represent the latest generation of pharmaceuticals, with approval rates surpassing those of small molecules and commanding premium prices. Primarily utilized for treating tumors and chronic illnesses, mABs are expected to see significant market growth due to their alignment with the personalized medicine (PM) paradigm. The pharmaceutical industry anticipates that biological markers—molecules in the human body indicative of normal or abnormal processes—will play a crucial role in optimizing mAB treatments in clinical practice. This anticipated integration of biological markers into treatment protocols is a key driver of expansion in the monoclonal antibody therapeutics market.
· In March 2023, BioNTech and OncoC4 announced a strategic collaboration to co-develop and commercialize a novel checkpoint antibody for multiple solid tumor indications.
Risk of Infusion Reactions to Hamper the Market’s Growth
Monoclonal antibodies, administered intravenously, are proteins that can occasionally induce infusion reactions similar to allergic responses, particularly during initial administration. These reactions can manifest as fever, chills, weakness, headache, nausea, vomiting, diarrhea, low blood pressure, and rashes. The incidence of such adverse effects poses a challenge to the growth of the monoclonal antibody therapeutics market, as it impacts patient comfort and treatment acceptance. Managing these infusion reactions remains a critical consideration in the development and administration of monoclonal antibody therapies, potentially limiting market expansion and adoption.
Advancements in Monoclonal Antibody Technologies to Create an Opportunity
Hybridoma technology remains the cornerstone for monoclonal antibody (mAb) generation; recent advancements such as electrofusion, B cell immortalization, transgenic animals, nucleic acid encoded mAbs, and single B cell antibody technologies have significantly enhanced mAb production. These innovations have improved specificity, reduced immunogenicity, and revolutionized mAb development. Next-generation antibodies offer substantial benefits over conventional mAbs, including enhanced precision, the ability to target multiple antigens, resistance to pathogen mutations, simplified manufacturing processes, reduced immunogenicity, extended half-lives, and versatile administration options. As these technologies advance, they are expected to transform the field of immunotherapies, increasing their effectiveness and accessibility. This evolution presents significant growth opportunities for the monoclonal antibody therapeutics market.
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Monoclonal Antibody Therapeutics Market Top Key Companies:
- F. Hoffmann-La Roche Ltd (Switzerland)
- Abbvie Inc. (US)
- Johnson & Johnson Services, Inc. (US)
- Merck & Co., Inc. (US)
- Bristol Myers Squibb Company (US)
- AstraZeneca (UK)
- Sanofi (France)
- Novartis AG (Switzerland)
- Amgen Inc. (US)
- Takeda Pharmaceutical Company Limited (Japan)
- GSK plc. (UK)
- Eli Lilly and Company (US)
- Regeneron Pharmaceuticals Inc. (US)
- Biogen (US)
- UCB S.A. (Belgium)
- Boehringer Ingelheim International GmbH (Germany)
- Y-mAbs Therapeutics Inc. (US)
- Teva Pharmaceutical Industries Ltd. (Israel) and among others.
Major Breakthroughs in the Monoclonal Antibody Therapeutics Market:
· In August 2023, Pfizer received U.S. FDA accelerated approval for ELREXFIO (elranatamab-bcmm) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy.
· In August 2023, Janssen Pharmaceutical Companies of Johnson & Johnson received U.S. FDA accelerated approval for TALVEY (talquetamab-tgvs), a first-in-class bispecific antibody for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy,
· In February 2024, AbbVie and OSE Immunotherapeutics announced a partnership to develop a novel monoclonal antibody for treating chronic inflammation.
· In September 2023, HHS announced details of a partnership with Regeneron to develop life-saving monoclonal antibodies.
· In May 2024, CStone and Ewopharma entered into a strategic partnership for Sugemalimab in Central Eastern Europe and Switzerland.
· In April 2024, Acumen Pharmaceuticals collaborated with Lonza to advance Sabirnetug for the treatment of Alzheimer’s disease.
Monoclonal Antibody Therapeutics Market Report Segmentation
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Monoclonal Antibody Therapeutics market.
By Production Method
- In-Vitro
- In-Vivo
By Sources
- Human
- Humanized
- Chimeric
- Other Sources
By Route of Administration
- Intravenous
- Subcutaneous
- Other Route of Administration
By Therapy Area
- Autoimmune & Inflammatory Disorders
- Oncology
- Hematology
- Ophthalmology
- Other Therapy Areas
By End User
- Hospitals
- Long-term Care Facilities
- Other End Users
By Region
- North America
- Europe
- Asia-Pacific
- Latin America
- Middle East & Africa (MEA)
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Cancer Monoclonal Antibodies Market Size and Forecast : The global cancer monoclonal antibodies market size was exhibited at USD 75.81 billion in 2023 and is projected to hit around USD 405.26 billion by 2033, growing at a CAGR of 18.25% during the forecast period 2024 to 2033.
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