Monoclonal Antibodies Market Size (2024 - 2030)

As of 2023, the Monoclonal Antibodies Market attained a valuation of $254.38 Billion and is poised to achieve a market size of $534.9 Billion by 2030. Across the forecast span from 2024 to 2030, the market anticipates a compound annual growth rate (CAGR) of 11.2%.

MONOCLONAL

The utilization of monoclonal antibodies (mAb) as a form of immunotherapy involves their attachment to specific cells or proteins, representing a pivotal therapeutic approach. These antibodies, originating from identical immune cell clones of a singular progenitor cell, exhibit a monovalent affinity, effectively binding to a designated antigen. Demonstrating remarkable site-specificity, monoclonal antibodies serve as valuable tools in molecular biology, biochemistry, and medical applications. Their utility extends to modulating immune responses and treating various ailments such as cancer, cardiovascular diseases, and neurological disorders. Notably, the industry encompasses anti-cancer monoclonal antibodies impeding cell proliferation, neuropharmacological and immunological monoclonal antibodies, along with anti-infective monoclonal antibodies, catering to both human and veterinary domains.

The escalating incidence of cancer and chronic disorders, coupled with surging demand for biologics, cost-effective biosimilar monoclonal antibodies, and intensified genomics research activities, including advancements in genetic platforms such as next-generation sequencing, are primary drivers propelling market expansion. Additionally, heightened awareness among patients and healthcare practitioners regarding the therapeutic efficacy of monoclonal antibody (mAb) therapy, collaborative research endeavors fostering a robust drug pipeline, and regulatory approvals for diverse applications further underpin market growth.

MARKET DRIVERS:

Intensive research and development initiatives targeting novel product innovation and widespread product launches propel the expansion of the monoclonal antibodies market.

A concerted focus on pioneering monoclonal antibody therapeutics, tailored to address intricate and severe ailments, bolsters market growth. Augmented by governmental backing and regulatory endorsements, this endeavor gains momentum, exemplified by the European Commission's authorization of Bristol Myers Squibb's OPDIVO and Yervoy combination therapy for malignant pleural mesothelioma treatment in June 2021, extending the product portfolio's market presence.

Pervasive applications of monoclonal antibodies and extensive adoption of mAb therapies in oncology fuel market growth.

The versatility of monoclonal antibodies in targeting multiple cancer types augments their demand, particularly amidst rising cancer prevalence. The proliferation of cost-effective biosimilar monoclonal antibodies further amplifies market dynamics. Noteworthy research and development endeavors by key market players underscore the segment's potential for exponential growth, aligned with the escalating disease burden.

MARKET RESTRAINTS:

Stringent regulatory protocols governing the approval process pose a potential hindrance to market expansion.

Despite the therapeutic efficacy demonstrated across various diseases, the rigorous approval and launch requisites for monoclonal antibody therapy present formidable obstacles. Challenges in meeting regulatory standards and clinical study outcomes impede market revenue, compounded by potential adverse effects associated with these medications.

The exorbitant manufacturing costs associated with certain monoclonal antibody therapeutics present a market challenge.

Therapeutic monoclonal antibodies (mAbs) rank among the costliest medications, primarily attributed to the elaborate manufacturing process necessitating large-scale mammalian cell cultures and stringent purification under GMP conditions. The resulting high production costs have impeded their widespread adoption. Innovative approaches such as plant-based mAb manufacturing offer potential cost mitigation avenues, leveraging plants as bioreactors to produce therapeutic antibodies economically at scale.

Monoclonal Antibodies Market – By Source:

• Murine
• Humanized
• Chimeric
• Human

Categorized by source, the Monoclonal Antibodies Market comprises Murine, Humanized, Chimeric, and Human variants. Human monoclonal antibodies, constituting more than half of the market share in 2021, emerge as the largest revenue contributor, expected to sustain significant growth momentum. The segment benefits from advancements such as phage or yeast display technologies and transgenic mice, facilitating the generation of human monoclonal antibodies. Additionally, factors such as enhanced genetic engineering techniques, a surge in product approvals, and governmental support for infection management fuel the market's expansion.

Humanized mAbs capture a notable revenue share, driven by their extensive application in treating conditions like cancer, autoimmune disorders, and inflammatory ailments. The market growth is further propelled by sophisticated genetic engineering methodologies integrated into their production processes.

Monoclonal Antibodies Market – By Indication:

• Oncology
• Inflammatory Diseases
• Infectious Diseases
• Autoimmune Diseases
• Others

Segmented by indication, the Monoclonal Antibodies Market encompasses Oncology, Inflammatory Diseases, Infectious Diseases, Autoimmune Diseases, and Others. Oncology emerges as the dominant sector, primarily fueled by the rising cancer prevalence and the widespread adoption of monoclonal antibodies in cancer therapeutics. Additionally, a burgeoning drug pipeline, increased awareness among patients regarding cancer treatment modalities, and the demand for biosimilar monoclonal antibodies collectively drive market growth. Monoclonal antibodies have established themselves as superior options for cancer treatment compared to traditional medications and chemotherapy due to their minimal side effects. These therapeutic antibodies find applications across various cancers, including non-small cell lung cancer, breast cancer, brain tumors, ovarian cancer, colorectal cancer, melanoma, gastric cancer, Hodgkin's lymphoma, among others.

Monoclonal Antibodies Market – By End User:

• Research Institutes
• Hospitals
• Others

Categorized by end-user, the Monoclonal Antibodies Market comprises Research Institutes, Hospitals, and Others. Hospitals emerge as a significant segment, expected to reach approximately USD 77 billion in 2021, driven by the increasing hospitalizations for diverse chronic ailments. Patient preferences are swayed by the availability of advanced medication therapies within hospital settings. The demand for monoclonal antibodies in hospitals is bolstered by the presence of skilled professionals offering specialized treatments, particularly for conditions like cancer and autoimmune disorders. The escalating incidence of chronic diseases, coupled with rising healthcare expenditures, positions hospitals to dominate the end-use segment in the forecast period.

Monoclonal Antibodies Market - By Region:

• North America
• Europe
• Asia-Pacific
• Rest of the World

Geographically, North America leads the Monoclonal Antibodies Market, capturing over 48% of the revenue share in 2021, attributed to the robust presence of key market players and a surge in product approvals. The regional market's demand for monoclonal antibodies is propelled by increased product adoption for effective disease management. Moreover, substantial R&D investments and governmental support for cancer research drive innovation in monoclonal antibody therapies. Well-established healthcare infrastructure enhances population access to treatments, further augmenting product demand.

The Asia Pacific Monoclonal Antibodies Market is poised for rapid growth, attributed to initiatives and government funding for monoclonal antibody therapy research, alongside a surge in product approvals. The region benefits from ongoing advancements in monoclonal antibodies, availability of modern healthcare systems, increasing patient awareness, and growing demand for advanced healthcare facilities. Key market players are strategically expanding their geographical presence to tap into emerging markets.

Major Key Players in the Market:

Prominent players in the global monoclonal antibodies market include:

1. AbbVie Inc.
2. Bristol Myers Squibb
3. Amgen
4. F. Hoffmann-La Roche
5. Bristol Myers Squibb
6. Merck & Co., Inc.
7. Regeneron Pharmaceuticals Inc.
8. AstraZeneca
9. Johnson & Johnson
10. Eli Lilly and Company
11. Takeda Pharmaceutical Company Limited
12. GlaxoSmithKline plc
13. Novartis AG, among others

These market players employ diverse growth strategies such as product launches, mergers and acquisitions, expansion, diversification, and research collaborations to fortify their product portfolios and expand market presence.

Key Developments in the Global Monoclonal Antibodies Market:

• Collaboration - In January 2021, Eli Lilly & Company, Vir Biotechnology, Inc., and GlaxoSmithKline plc collaborated to evaluate a combination of two COVID-19 therapeutics in low-risk COVID-19 patients. This collaboration marked the first instance of monoclonal antibodies from different companies being combined for potential therapeutic outcomes.
• Product Approval - In May 2021, Roche India received Emergency Use Authorization (EUA) from the Central Drugs Standards Control Organisation for their antibody cocktail (CDSCO), facilitating expanded product availability in the country.
• Collaboration - In May 2021, GlaxoSmithKline plc and Vir Biotechnology, Inc. obtained FDA approval for Emergency Use Authorization (EUA) for sotrovimab, an investigational single-dose monoclonal antibody, for treating mild-to-moderate COVID-19 in adults and pediatric patients.
• Collaboration - In June 2021, Amgen and Kyowa Kirin Co. Ltd. announced collaboration on the development and commercialization of KHK4083, a fully human monoclonal antibody for atopic dermatitis treatment, enhancing their market presence.
• Product Approval - In July 2021, Roche announced the approval of "Ronapreve" (casirivimab and indevimab) for intravenous infusion treatment of patients with mild to moderate COVID-19, contributing to the expanded therapeutic options for COVID-19 management.

Impact of COVID-19 Pandemic on Monoclonal Antibodies Market:

The COVID-19 pandemic has positively influenced the monoclonal antibody market, particularly for the development of COVID-19 monoclonal antibody therapy. The urgent need for effective treatments amid surging COVID-19 cases propelled the rapid development of monoclonal antibody therapies. Regulatory approvals for monoclonal antibody therapies for outpatient treatment of symptomatic COVID-19 patients were swiftly issued by regulatory bodies like the FDA. Increased clinical trials and pharmaceutical approvals for emergency use further accelerated market expansion, addressing the pressing healthcare needs during the pandemic.