Monoclonal Antibody Diagnostic Reagent Market Research Report and Outlook by 2028

The monoclonal antibody diagnostic reagent market is projected to expand significantly, increasing from approximately US$ 7,654.06 million in 2021 to around US$ 18,507.20 million by 2028. This growth represents a compound annual growth rate (CAGR) of 13.5% from 2022 to 2028.

Several key factors are driving this market expansion, including the rising incidence of cancer and other chronic illnesses, substantial research and development initiatives aimed at creating innovative therapies, and a robust pipeline of drugs currently undergoing clinical trials.

According to a report by the American Cancer Society, the number of cancer survivors in the United States is anticipated to rise from approximately 16.9 million (as of January 2019) to 22.1 million by January 2030, largely due to an aging population. This increase in cancer prevalence is fueling the demand for biologics, particularly monoclonal antibodies (mAbs), which are essential in the treatment of various cancers and chronic diseases. Biologics are integral to many therapeutic regimens and offer cost-effective treatment options for patients.

Licensed mAbs are primarily effective against noncommunicable diseases, including various cancers and autoimmune disorders. Notably, successful immunotherapies utilizing over 40 licensed mAbs have transformed cancer treatment, significantly enhancing both overall and long-term survival rates compared to traditional therapies like chemotherapy.

The International AIDS Vaccine Initiative (IAVI) highlights that the development of mAbs is among the fastest-growing areas in biomedical research. In the past six years, more than 50 mAbs have received licensing, and in 2019, seven of the top ten best-selling novel drugs for cancer and autoimmune diseases were mAbs. The demand for these antibodies continues to rise, driven by the increasing prevalence of both noncommunicable and infectious diseases where mAbs may serve as effective treatments. The primary markets for mAbs are in the United States, Canada, and Europe, while India stands out as a significant player in the middle-income category due to its extensive biosimilar manufacturing capabilities.

Additionally, various countries are implementing measures to expedite the regulatory approval process for mAbs that are effective against chronic diseases. For instance, in 2017, the Chinese Food and Drug Administration (CFDA) initiated a partnership with the International Council for Harmonization to streamline regulatory processes in line with international standards, leading to the annual approval of numerous mAbs. In early 2019, the CFDA approved three mAbs from domestic developers and ten from multinational pharmaceutical firms. Such initiatives are enhancing the adoption of mAbs, thereby contributing to the growth of the monoclonal antibody diagnostic reagent market.

Test Insights

The monoclonal antibody diagnostic reagent market is categorized based on testing methods, including the double antigen sandwich chemiluminescence method, enzyme-linked immunosorbent assay (ELISA), recombinant immunoblot assay, and dot-immunogold filtration assay. The ELISA segment is expected to dominate the market share in 2022 and is projected to exhibit the highest CAGR during the forecast period. The increasing prevalence of chronic diseases is driving the demand for ELISA tests, which are crucial for diagnosing conditions such as hepatitis, AIDS, influenza, herpes simplex, chlamydia infections, and cancer.

Application-Based Insights

In terms of application, the monoclonal antibody diagnostic reagent market is divided into segments such as hormone diagnosis, tumor monitoring, virus detection, and others. The tumor monitoring segment is anticipated to capture the largest market share in 2022 and is expected to experience the highest CAGR from 2022 to 2028. Monoclonal antibody diagnostic reagents are extensively utilized in cancer diagnostics, where antibodies conjugated with fluorescent dyes or enzymes facilitate the detection of cancer and help identify its type. These factors are propelling the growth of the tumor monitoring segment.

Key sources of information for this report on the monoclonal antibody diagnostic reagent market include the National Center for Biotechnology Information (NCBI), the Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO), the Food and Drug Administration (FDA), the American Society of Clinical Oncology (ASCO), Canadian Cancer Statistics, Germany Trade and Invest (GTAI), the Health Ministry of Spain, Business Monitor International, the National Institute of Population and Social Security Research in Japan, the Department of Health in Abu Dhabi, Globocan, the Department of Emergency Medicine, and the International AIDS Vaccine Initiative (IAVI).