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Monoclonal Antibody Diagnostic Reagents are reagents that use monoclonal antibodies as active components to identify infectious pathogens, aberrant cells, or parts of the body's reaction to sickness. In 2022, the global monoclonal antibody diagnostic reagent market was valued at US$8.85 billion, and is probable to reach US$18.63 billion by 2028.
The market is also expected to boost in the future as a robust pipeline of monoclonal antibody therapeutics is being developed for the treatment of a wide range of ailments, including cancer, autoimmune disorders, and infectious diseases. Furthermore, significant technological advances have been made in the synthesis and purification of monoclonal antibodies. This has reduced the cost and availability of monoclonal antibody diagnostic reagents while also broadening their applications. The global monoclonal antibody diagnostic reagent market value is projected to grow at a CAGR of 13.25%, during the forecast period of 2023-2028.
Market Segmentation Analysis:
By Tests: According to the report, the global monoclonal antibody diagnostic reagent market is segmented into four tests: Enzyme Linked Immunosorbent, Double Antigen Sandwich Chemiluminescence Method, Assay Recombinant Immunoblot and Dot-immunogold Filtration Assay. Enzyme Linked Immunosorbent segment acquired majority of share in the market in 2022, because this test is a popular biochemical technique for identifying specific proteins, antibodies, antigens, or other compounds in biological samples. Whereas, the same segment has the fastest CAGR due to the increasing prevalence of chronic diseases, such as cancer, infectious diseases, and autoimmune disorders, which can be diagnosed and monitored using ELISA tests.
By Application: According to the report, the global monoclonal antibody diagnostic reagent market is segmented into four applications: Tumor Monitoring, Virus Detection, Hormones Diagnosis and Others. Tumor Monitoring segment acquired majority of share in the market in 2022 as they can be used to detect tumor markers, image tumors, and target tumors for therapy. This can help to improve the diagnosis, treatment, and monitoring of cancer. Whereas, virus detection segment has the fastest CAGR because monoclonal antibodies are highly specific to their target antigens, which means that they can be used to detect very small amounts of the antigen. This is important for virus detection, as viruses are often present in low levels in the body.
By Region: The report provides insight into the monoclonal antibody diagnostic reagent market based on the geographical operations, namely North America, Europe, Asia Pacific, and Rest of the World. North America monoclonal antibody diagnostic reagent market enjoyed the highest market share in 2022, due to rising R&D spending by businesses and government funding for cancer research has facilitated the development of innovative monoclonal antibody treatments.
The US, has one of the highest healthcare spending rates globally. This substantial investment in healthcare infrastructure has driven the adoption of advanced diagnostic technologies, including monoclonal antibody-based diagnostic reagents.
Further, Asia Pacific monoclonal antibody diagnostic reagent is expected to grow at the fastest CAGR due to governments and private organizations in the region are investing heavily in healthcare. This is leading to the development of new diagnostic facilities and the adoption of new technologies, such as monoclonal antibody diagnostic reagents.
Global Monoclonal Antibody Diagnostic Reagent Market Dynamics:
Growth Drivers: Monoclonal antibody diagnostic reagents aid in the early identification and accurate diagnosis of many cancers. Early detection is crucial because it enables timely intervention and potentially life-saving therapy. Monoclonal antibodies are particularly designed to target cancer-related antigens or biomarkers found in patient samples such as blood, tissue, or urine. Further, the market is expected to increase due to aging population, amplified disposable income, growing healthcare expenditure, growth in investments in biotech companies, extensive R&D efforts to develop novel therapies, etc.
Challenges: The market's expansion is projected to be hampered by high cost. This pricing barrier affects many areas of monoclonal antibody-based diagnostics, including accessibility, affordability, and sustainability. Monoclonal antibody diagnostic reagents are typically more expensive than other types of diagnostic reagents. The other challenges that monoclonal antibody diagnostic reagent market faces include limited availability.
Trends: One of the most distinct and pervasive trends observed in the global monoclonal antibody diagnostic reagent market is increasing availability of point-of-care testing (POCT). Point-of-care testing (POCT) allows for the testing of patients at the point of care, such as in doctor's offices or clinics. This is convenient for patients and can help to improve patient outcomes. Monoclonal antibody diagnostic reagents are well-suited for POCT applications. POCT is emerging as a significant trend in the monoclonal antibody diagnostic reagent market. More trends in the market are believed to augment the growth of monoclonal antibody diagnostic reagent market during the forecasted period include, growing use of multiplexed assays, technological advancements and development of new monoclonal antibody-based therapies, etc.
Impact Analysis of COVID-19 and Way Forward:
The COVID-19 pandemic has a positive impact on the global market because the pandemic has had a significant impact on the discovery, manufacture, and use of monoclonal antibody diagnostic reagents. Several monoclonal antibody diagnostic reagents have been developed for COVID-19. These reagents are being used in clinical trials and are expected to be available for widespread use in the near future. The pandemic has also led to increased funding for research and development of monoclonal antibody diagnostic reagents. The impact of COVID-19 on the market is likely to be long-lasting.
Competitive Landscape and Recent Developments:
Global monoclonal antibody diagnostic reagent market is fragmented. Key players of global monoclonal antibody diagnostic reagent market are:
Becton, Dickinson and Company (BD Biosciences)
Merck & Co., Inc.
Qiagen
Bio-Rad Laboratories, Inc.
Abcam Plc., (BioVision)
Innovent Biologics, Inc.
Celltrion, Inc.
Eurogentec (AnaSpec)
BioGenex
Biocare Medical LLC
Aviva Systems Biology
Medix Biochemica
Creative Diagnostics
Cell Signaling Technology
The key players are constantly investing in strategic initiatives, such as new product launches, introducing their products to emerging markets and more, to maintain a competitive edge in this market. For instance, in January 2022, Ono Pharmaceutical Co., Ltd. Collaborated with Neuroimmune AG to develop the mAb drug against novel therapeutic targets for neurodegenerative diseases.