Monoclonal Antibody Therapy Market Size, Share & Industry Analysis, By Type (Human mAb, Humanized mAb, Chimeric mAb, and Murine mAb), By Application (Cancer, Autoimmune Diseases, and Others), By Distribution Channel (Hospital Pharmacy, Retail Pharmacy, and Online Pharmacy), and Regional Forecast, 2024-2032

The global monoclonal antibody therapy market size was USD 230.87 billion in 2023. The market is projected to grow from USD 263.28 billion in 2024 to USD 792.37 billion by 2032 at a CAGR of 14.8% over the forecast period. North America dominated the global market with a share of 47.91% in 2023.

In the current scenario, monoclonal antibody therapy is growing at an unprecedented success, revenue growth, accelerated research, and traction owing to their effective clinical outcomes. Monoclonal antibodies such as Remicade, Rituxan, Remicade, Humira, and Herceptin have emerged as blockbuster drugs, which are in turn boosting the market. Apart from this, the market is being flooded by numerous biosimilars owing to less cost, easy approval process, and patent expiry. This is also driving the growth of the market.

Increasing research and development funding for the development of novel monoclonal antibodies is expected to favor the market during the forecast period. For instance, according to an article published by BioProcess International in August 2022, out of the total commercialized biopharmaceutical products, monoclonal antibodies dominate the market with around 50% share. This is expected to positively impact the global market.

Due to the unprecedented occurrence of the coronavirus pandemic, the healthcare industry underwent a major setback at the initial stage of the supply chain. The key players in the monoclonal antibodies therapeutics market experienced a decline in the sales growth for their products. Amid the pandemic, the top-selling drug in the market, Humira, witnessed a positive growth of 4% as compared to the year 2019. However, some drugs such as Roche’s Herceptin, Avastin as well as J&J’s Remicade observed a decline in the revenues owing to the lower demand as compared to the year 2019.

In a different scenario, the COVID-19 pandemic had boosted the R&D sector of the companies with an aim to launch mAbs-based COVID-19 treatment in the market. For instance, in November 2020, U.S FDA granted emergency use authorization (EUA) to Regeneron Pharmaceuticals monoclonal antibodies casirivimab and imdevimab for treatment of COVID-19. Therefore, such innovations impacted the sales of the global market during the forecast period. Furthermore, the continued launch of innovative monoclonal antibody therapies is anticipated to contribute to the market growth during the forecast period of 2024-2032.

Monoclonal Antibody Therapy Market Trends

Strategic Research Collaborations Will Open New Growth Opportunities

With the growing focus of operating entities toward the development of mAb therapies for different indications, various strategic initiatives have been undertaken by these players. Along with this, increasing R&D investments in this sector have boosted these collaborations in the past few years, which in turn is becoming a significant market trend. Also, owing to the increasing adoption of these novel drugs, new manufacturers want to enter the highly competitive market, and strategic collaborations can be a useful tool to sustain their position. For instance, in February 2024, OSE Immunotherapeutics SA collaborated with Abbvie Inc. for the development of novel monoclonal antibody therapy to treat chronic and severe inflammation. This drug is currently in the pre-clinical development stage.

Monoclonal Antibody Therapy Market Growth Factors

Significant Investment in Development of Novel Therapeutics to Boost Growth

Monoclonal antibody therapy is a fast emerging extraordinary tool as a treatment option for chronic diseases, especially cancer. Preference towards these drugs is gradually rising, resulting in blockbuster sales of few products such as Herceptin and Humira, among others. This, in turn, has encouraged major pharmaceutical companies for huge research investments in the field of monoclonal antibodies. Along with the operating players, various government agencies such as the U.S. Department of Human Health Services (HHS) are also providing funds for the development of innovative mAb products. For instance, in August 2023, HHS awarded a funding of more than USD 1.4 billion for the Project NextGen. This project includes the development of monoclonal antibodies along with other therapies.

Apart from this, green signals from the regulatory authorities for the entry of biosimilars of existing products are further fostering the global market value.

Rising Prevalence of Chronic Diseases to Favor Market Growth

The increasing prevalence of chronic diseases such as cancer is one of the major factors augmenting the growth of the global market. Chronic diseases pose a major burden across the globe which is propelling the governments of various countries to put efforts in reducing the cost burden pertaining to their spread. According to the Centers for Disease Control and Prevention, 6 in every ten adults in the U.S. are suffering from a chronic disease, leading to an annual healthcare cost of USD 3.5 trillion. Furthermore, unmet patient needs and improving health reimbursement policies for therapeutic monoclonal antibodies used as a treatment option for chronic diseases are projected to fuel the monoclonal antibody therapy market growth.

RESTRAINING FACTORS

Stringent Regulatory Policies for Approval Process to Hamper Market Growth

Despite promising results for monoclonal antibodies in the treatment of various diseases, the long and strict regulations for approval and launch will be a major hindrance to the monoclonal antibodies therapy revenue. Many clinical studies are withdrawn mainly due to failure to meet the stringent regulations and end results framed by the regulatory authorities. The manufacturing process of all mAb products must adhere to the stringent regulatory guidelines to ensure the high quality of the final product. The filling of the final drug product must fulfill the requirements related to integrity, sterility, operational safety, and others. In addition to this, potential side effects of these drugs are other factors restricting the monoclonal antibody therapy market growth.

Monoclonal Antibody Therapy Market Segmentation Analysis

By Type Analysis

Human Monoclonal Antibody Segment to Dominate Market Owing to High Humira Sales

On the basis of type, the global market is segmented into human mAb, humanized mAb, chimeric mAb, and murine mAb.

The human mAb segment accounted for the dominating position in 2023. This can be attributed to the higher sales and demand for Humira. Moreover, the entry of Adalimumab biosimilars is expected to augment the segment during 2024-2032. For example, in February 2024, dalimumab biosimilar (AVT02; Simlandi) was launched by Alvotech.

The humanized monoclonal antibody segment is poised to surge owing to the increased number of humanized mAb therapies and rising research funding by pharmaceutical companies. Genentech, a company of Roche, is conducting research on Obinutuzumab, a humanized anti-CD20 monoclonal antibody for the treatment of end-stage renal disease. This is likely to render remarkable growth to the humanized mAb segment. Technological advancement to develop a molecular-level understanding of diseases, rising aging population, and expanding applications of monoclonal antibodies are factors contributing to the expansion of the chimeric monoclonal antibody and murine monoclonal antibody segments.

By Application Analysis

Cancer Segment to Hold Largest Share Backed by Surging Number of Potential Pipeline Candidates

Based on application, the global market is segmented into type cancer, autoimmune diseases, and others. The cancer segment accounted for the maximum portion of the market and is estimated to dominate the market throughout the forecast period. The rising prevalence of cancer, improving health reimbursement policies, and potential pipeline candidates are the major factors that contributed to the growth of the segment. According to the WHO, the number of cancer cases in the world is estimated to increase from 18.0 million in 2018 to 24.1 million by 2030. This is expected to augment the cancer segment.

The autoimmune disease segment is expected to grow owing to the rising incidences of rheumatoid arthritis, rapid adoption of biological therapies, and new product launches. The other segment is projected to expand during the forecast period owing to the emerging use of monoclonal antibody therapy for migraines, eczema, respiratory diseases, and others.

By Distribution Channel Analysis

Hospital Pharmacy Segment to Account for Major Portion of This Market

In terms of distribution channels, the global market is segmented into hospital pharmacy, retail pharmacy, and online pharmacy.

The hospital pharmacy segment generated the maximum revenue in 2023 owing to the improving guidelines, favoring health reimbursement policies, and active government interventions for chronic diseases. The retail pharmacy segment is anticipated to grow during the forecast period mainly due to the increasing focus by manufacturers to expand distribution networks, a significant increase in the number of cancer cases, and improving health infrastructure. Growth of the online stores segment is likely to propel owing to the improving patient convenience, rising adoption of online channels, and attractive discounts and coupons on online sales.

REGIONAL INSIGHTS

The market size in North America stood at USD 110.62 billion in 2023. Factors attributed to the dominant share of North America are new product launches, increasing research funding and collaborations, and the increasing prevalence of chronic diseases. According to the American Cancer Society, the number of individuals with cancer diagnosis in 2022 was estimated to be more than 1.9 million. This is estimated to increase the demand for monoclonal antibody based therapeutics in North America. In Europe, the market is poised to surge owing to favorable health reimbursement and easy approval and launch of biosimilars.

In October 2018, Biogen announced the launch of Imraldi, an adalimumab biosimilar, which will help the market to flourish in Europe. Rising incidences of arthritis and inflammatory diseases, increasing geriatric population, and growing preference for biosimilars are primary reasons for the expansion of the market in Asia Pacific. The market in the Middle East & Africa and Latin America is expected to gain significant momentum owing to the increased focus of manufacturers towards emerging countries, unmet patient needs, and improving health spending.

List of Key Companies in Monoclonal Antibody Therapy Market

AbbVie and F. Hoffmann-La Roche Ltd. to Hold Leading Position in This Market

In the global market, F. Hoffmann-La Roche Ltd., accounted for the maximum share, which can be attributed to the increasing sale of Herceptin. AbbVie, on the other hand, is ranked second in the market owing to the increased sales of Humira. In 2018, the company generated a sale of USD 19.0 billion in 2019. Though Humira still has exclusivity in the U.S., the launch of adalimumab biosimilars in Europe is expected to affect the position of AbbVie.

LIST OF KEY COMPANIES PROFILED:

• AbbVie Inc. (U.S.)


• Merck & Co., Inc. (U.S.)


• F.Hoffmann-La Roche Ltd. (Switzerland)


• Bristol-Myers Squibb Company (U.S.)


• Johnson & Johnson Services, Inc. (U.S.)


• Daiichi Sankyo Company, Limited (Japan)


• Novartis AG (Switzerland)


• AstraZeneca (U.S.)


• Amgen Inc. (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• November 2023 - Almirall S.A.’s EBGLYSS (lebrikizumab) received an approval from the European Commission (EC). The product is used to treat moderate-to-severe atopic dermatitis (AD).


• March 2023 - OncoC4, Inc. and BioNTech SE announced a strategic collaboration for the co-development of monoclonal antibody candidate.


• September 2022 - AstraZeneca's Evusheld received the European Union (EU) approval for usag in the treatment of COVID.


• December 2021 - Xevudy (sotrovimab), manufactured by Vir Biotechnology, Inc., and GlaxoSmithKline plc received approval from the European Commission (EC) to treat COVID-19.


• December 2019 - CARsgen Therapeutics received Investigational New Drug (IND) clearance in China for AB011, a humanized mAb, for the treatment of gastric and pancreatic adenocarcinoma

REPORT COVERAGE

The global monoclonal antibody therapy market research report offers a detailed analysis of numerous factors affecting the market. These include opportunities, growth drivers, threats, key developments, competitive landscape, and restraints. In addition to this, the report further helps in analyzing, segmenting, and defining the market based on different segments such as type, application, and distribution channel. It strategically analyzes several strategies and provides various key insights such as the prevalence of major diseases for key countries, patent snapshot, pipeline analysis, new product launches, key mergers & acquisitions, joint ventures, and others.

Report Scope & Segmentation