Monoclonal Antibody Diagnostic Reagent Market Size & Share

The global monoclonal antibody diagnostic reagent market was valued US$ 7,654.06 million in 2021; it is estimated to grow at a CAGR of 13.5% from 2022 to 2028.

Monoclonal antibodies (mAb) are important diagnostic reagents that are being used in biomedical research; microbiological research; in the diagnosis of Hepatitis, AIDs, influenza, herpes simplex, chlamydia infections; and in the treatment of infections and cancer. The monoclonal antibodies being directed at single epitopes are highly specific, homogeneous, and can be produced in unlimited quantities. The hybridoma-derived or bacterially cloned monoclonal antibody technology has enabled the mass production of highly specific probes for antigenic sites, whether on hormones, enzymes, receptors, or microbial products. Major factors driving the growth of this market include the rising prevalence of cancer and other chronic diseases, presence of strong pipeline of drugs under trial, and extensive R&D efforts to develop novel therapies.

The report offers insights and in-depth analysis of the global monoclonal antibody diagnostic reagent market, emphasizing various parameters, including market trends, technological advancements, market dynamics, and competitive landscape analysis of global leading market players. It also includes the impact of the COVID-19 pandemic on the market across all regions.

The overall impact of the COVID-19 pandemic on the monoclonal antibody diagnostic reagent market was positive; hence, the market continues to gain traction and is expected to grow in the coming years. Celltrion Group has announced that the Korean Ministry of Food and Drug Safety (MFDS) has approved regdanvimab (CT-P59), a monoclonal antibody for the treatment of COVID-19 for the prolonged use in elderly patients aged 50 years and over, or with at least one underlying medical condition such as obesity, cardiovascular disease, chronic lung disease, diabetes, chronic kidney disease, chronic liver disease, and patients with immunosuppressive agents with mild symptoms of COVID-19, and adult patients with moderate symptoms of COVID-19. Further, monoclonal antibody therapy, which has been successfully used in other countries to treat COVID-19 patients with mild or moderate symptoms, has now been approved by the Drugs Controller General of India (DCGI) for use in India.

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Monoclonal Antibody Diagnostic Reagent Market: Strategic Insights

Monoclonal Antibody Diagnostic Reagent Market

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  CAGR (2021 - 2028)

  13.5%
• Market Size 2021
  US$ 7.65 Billion
• Market Size 2028
  US$ 18.51 Billion

Market Dynamics

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FUTURE TRENDS

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OPPORTUNITIES

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Key Players

• BioGenex
• Bio Rad Laboratories Inc
• Biocare Medical LLC
• Celltrion Healthcare Co Ltd
• Creative Diagnostics
• GenWay Biotech
• Thermo Fisher Scientific Inc
• ABclonal Inc
• Apto Gen

Regional Overview

• North America
• Europe
• Asia-Pacific
• South and Central America
• Middle East and Africa

Market Segmentation

Tests

• Enzyme Linked Immunosorbent
• Double Antigen Sandwich Chemiluminescence Method
• Recombinant Immunoblot Assay
• Dot-immunogold Filtration Assay

Application

• Tumor Monitoring
• Virus Detection
• Hormones Diagnosis

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Geography-Based Insights

By geography, the global monoclonal antibody diagnostic reagent market is segmented into North America (the US, Canada, and Mexico), Europe (France, Germany, the UK, Spain, Russia, Italy, and the Rest of Europe), Asia Pacific (China, India, Japan, Australia, South Korea, Kazakhstan, and the Rest of APAC), the Middle East & Africa (Saudi Arabia, the UAE, South Africa, and the Rest of Middle East & Africa), and South & Central America (Brazil, Argentina, and the Rest of South & Central America).

Market Insights

Extensive R&D Efforts to Develop Novel Therapies

The numerous application of mAbs involves the prevention, diagnosis, and treatment of disease. The application of mAbs in diagnosis is the most advanced, particularly for tests performed on the body fluids such as urine and blood. Additionally, mAbs diagnostic application includes techniques such as ELISA, western blot, immunoblot blot, flow cytometry, immunohistochemistry, radioimmunology assay, and electron microscopy. Also, mAbs intended for diagnostic application can detect antigens and antibodies against viral and fungal diseases of livestock and parasitic diseases.

Further, mAbs are valued reagents intended for abundant applications due to its selectivity, high binding affinity, and immunogenicity/low toxicity; mAbs are best suited for clinical, environmental, and elemental research. The diagnostic applications of mAbs also include medical devices, vitro tests, and medical imaging

Moreover, the utility of mAbs expanded for understanding a range of diseases by contributing to developing new immunotherapy treatments. For example, cancer therapies benefitted from research with mAbs, most probably for the development of RituximAb, proving an effective treatment for many cancers. Also, many mAbs are now recognized by the US Food and Drug Administration (FDA) as safe for utilization in commercial therapeutics. Such factors mentioned above are expected to contribute to the monoclonal antibody diagnostic reagent market growth during the forecast period.

Monoclonal Antibody Diagnostic Reagent Market Report Scope

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Tests-Based Insights

Based on tests, the global monoclonal antibody diagnostic reagent market is segmented into double antigen sandwich chemiluminescence method, enzyme linked immunosorbent assay, recombinant immunoblot assay, and dot-immunogold filtration assay. In 2021, the enzyme-linked immunosorbent assay segment accounted for the largest market share, and it is anticipated to register the highest CAGR from 2022 to 2028.

Application-Based Insights

Based on application, the global monoclonal antibody diagnostic reagent market is segmented into hormones diagnosis, tumor monitoring, virus detection, and other application. The tumor monitoring segment held the largest market share in 2021, and it is expected to register the highest CAGR during the forecast period.

The global monoclonal antibody diagnostic reagent market players are adopting organic strategies, including product launch and expansion, to expand their footprint and product portfolio worldwide and meet the growing product demand. A few of the key players operating in the market are BioGenex; Bio-Rad Laboratories, Inc.; Biocare Medical, LLC; Celltrion Healthcare Co., Ltd.; Creative Diagnostics; GenWay Biotech; Thermo Fisher Scientific Inc.; ABclonal, Inc.; Apto-Gen; and Abcam plc.