North America Monoclonal Antibodies Market size crossed USD 87 billion in 2021 and is poised to expand at a CAGR of 12.8% between 2022 and 2028.

Monoclonal antibodies also referred as MoAbs or mAbs, are identical immunoglobulins developed from a single B-cell clone. mAbs identify unique epitopes on a single antigen. Monoclonal antibodies have been widely accepted and approved for treatment of various life-threatening conditions owing to its specificity.  

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Extensive product pipeline with potential effective therapies catering to diverse range of diseases is anticipated to propel the market growth. Regulatory approvals for innovative mAb products will positively influence the industry revenue. Further, growing usage of advanced genetic technologies will offer faster discovery and product development. Moreover, extensive R&D activities by the several organizations will favor new product launches in the region. Further, high prevalence of chronic diseases including cancer and infections across the region will create need for product innovation.

Increase in number of approved monoclonal antibodies for cancer treatment has offered revenue growth opportunities to the market. Additionally, technological advancements in product development technologies have resulted into expanding applications of monoclonal antibodies as immunotherapeutic. Thus, increasing product adoption to minimize disease-associated mortality rate will excel the industry growth. Further, government initiatives, high healthcare expenditure will stimulate the market growth.

The COVID-19 pandemic has positively impacted on North America monoclonal antibodies market growth. High need for effective therapeutics to combat high incidence rate and High mortality risk associated with the COVID-19 infection has driven market growth potential. Moreover, several organizations involved in development of highly effective therapies for COVID-19 treatment has propelled industry demand. Furthermore, government fundings for R&D activities as well as favourable regulatory scenario have fuelled overall market expansion during pandemic.

 North America Market, By Type

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The fully human monoclonal antibodies segment held over 51% North America monoclonal antibodies market share in 2021, due to rapid surge in product developments for fully human mAb products. Further, technological proliferation in biological industry will positively influence the market revenue. Further, large availability of advanced fully human mAbs with wide applications in immunology will drive the market size.

 North America Monoclonal Antibodies Market, By Application

The autoimmune diseases segment accounted for USD 27 billion revenue in 2021, owing to growing patient pool related to autoimmune diseases in the region. For instance, according to the Autoimmune Registry Inc (ARI), 15 to 30 million individuals were suffering from autoimmune diseases in the year 2021. Growing adoption of novel mAb therapeutics in treatment of several autoimmune disorders will offer substantial growth opportunities to the segment.

 North America Market, By End-use

The hospitals segment will observe around 13.2% growth rate during the forecast timeline. Expanding accessibility to sophisticated healthcare infrastructure along with enhanced availability of innovative medicines in hospitals will spur the segment revenue share. In addition, growing hospital admissions and high chronic disease burden in the region will accelerate the market value.

 North America Market, By Country

U.S. monoclonal antibodies market size exceeded USD 82 billion in 2021, credited to high prevalence rate of several chronic diseases in the country. Also, several mAbs candidates are being rapidly approved by the U.S. FDA.

Further, emergence of COVID-19 virus has boosted new product development and approvals. For instance, the U.S. FDA has announced an emergency use authorization for the sotrovimab, an investigational monoclonal antibody therapy to treat COVID-19 patients with mild-to-moderate infections.

 Competitive Industry Landscape

Major players operating in the North America monoclonal antibodies market include F. Hoffmann-La Roche, AbbVie Inc., Bristol Myers Squibb, Johnson & Johnson, Amgen, Regeneron, and Novartis AG.

These companies are undertaking numerous growth strategies such as partnerships, collaborations, acquisitions, and product launches to gain competitive edge over others. For instance, in June 2021, Janssen, a subsidiary firm of Johnson & Johnson, received product grant as ‘Breakthrough Therapy Designation’ by the U.S. FDA for teclistamab used in the treatment of relapsed or refractory multiple myeloma. This will further strengthen its current offerings in the market.