Monoclonal antibodies (MAbs) are important diagnostic reagents used in biomedical research, microbiological research, in diagnosis of chlamydia, hepatitis, herpes simplex, HIV, and influenza infections, and also for the treatment of diseases such as cancer.a
Monoclonal antibodies play a valuable role in diagnostic medicine during tests to determine the concentration of specific proteins in blood or urine. For instance, high blood level of a prostate-specific antigen, measured by its interaction with a monoclonal antibody, provides an early warning for prostate cancer. Antibodies to target biomarkers are widely used for detecting carcinogenic-embryonic antigen (colorectal cancer), prostate specific antigen (expressed in prostate cancer), CA125 (ovarian cancer), CA19-9 (gastrointestinal cancer), CA15-3 antigen, and HER-2/neu proteins (breast cancer).
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Increasing use of monoclonal antibodies in various R&D applications, cancer therapies, and immunological disorders is expected to drive growth of the global monoclonal antibody diagnostic reagents market size. Monoclonal antibody diagnostic kits are increasingly used to detect communicable diseases including transfusion transmissible infections (TTI). According to World Health Organization (WHO) data of 2017, each year about 15 million people die due to infectious diseases in emerging economies.
Non-infectious diseases are the leading cause of mortality and morbidity worldwide. As per the WHO 2017 data, around 40 million individuals suffering from cardiovascular diseases, cancer, chronic respiratory diseases, diabetes, and stroke die every year across the globe. Prevailing cancer incidence rate are expected to fuel demand for disease diagnosis. According to International Agency for Research on Cancer (IARC), the incidence of cancer is expected to reach to 26.8 million new cases and 17.1 million deaths annually by the year 2030.
Monoclonal antibodies are effective biological reagents in immunodiagnostic assays due to their binding accuracy to many pathogens, thereby, making it an important research tool. Despite many advantages and applications offered by monoclonal antibodies, it is difficult to get the right antibodies and attach a compound to it. Monoclonal antibodies need considerable amount of time, money, and manpower to produce them which can hinder the market size to some extent.
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The global monoclonal antibody diagnostic reagents market in 2026 in terms of revenue share, owing to the presence of well-established healthcare infrastructure and increasing government funding for cancer research and technology for development of new diagnostics procedures. In 2016, National Cancer Institute (NCI) received a total funding of $4.952.6 billion, reflecting an increase of five percent, or $262.1 million from 2015. The number of monoclonal antibody products approved for commercial sale in the U.S. and Europe has grown steadily for the last several years.
According to WHO data, non-communicable diseases deaths are projected to increase by 15% between 2010 and 2020, with the highest numbers predicted in the Western Pacific (12.3 million deaths) and South-East Asia (10.4 million deaths) regions.
Key players operating in the monoclonal antibody diagnostic reagents market include AnaSpec, BioGenex, Bio-Rad, Biocare Medical, BioVision, Celltrion, Creative Diagnostics, GenWay Biotech, Innovent Biologics, Medix Biochemica, Qiagen, and Teva Pharmaceutical Ltd.
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