Diagnostic Specialty Antibodies Market Report 2025

The diagnostic specialty antibodies market size has grown strongly in recent years. It will grow from $29.62 billion in 2024 to $31.26 billion in 2025 at a compound annual growth rate (CAGR) of 5.6%. The growth in the historic period can be attributed to advancements in biotechnology, emergence of personalized medicine, increased disease understanding, immunoassay and diagnostic techniques, rise of companion diagnostics.

The diagnostic specialty antibodies market size is expected to see strong growth in the next few years. It will grow to $40.49 billion in 2029 at a compound annual growth rate (CAGR) of 6.7%. The growth in the forecast period can be attributed to expanding disease biomarkers, rapid point-of-care testing, emerging infectious diseases, biosimilar and generic development, ai and machine learning integration. Major trends in the forecast period include technological advancements in assay development, integration of nanotechnology, enhanced specificity and selectivity, integration with wearable devices, continuous assay miniaturization.

The increasing number of patients being diagnosed with HIV is expected to drive the growth of the diagnostic specialty antibodies market in the future. This expanding patient pool refers to a rising number of individuals diagnosed with Human Immunodeficiency Virus (HIV). As more people are diagnosed, the demand for diagnostic specialty antibodies grows, creating opportunities for manufacturers to develop and supply specialized antibody-based products for HIV testing. These products facilitate the detection of specific biomarkers associated with the virus, aiding in early detection and monitoring of HIV infections. For instance, a report from the UK Health Security Agency in October 2024 indicated that between 2022 and 2023, the HIV testing rate increased by 11%. In 2023, the highest testing rate was recorded among gay, bisexual, and other men who have sex with men (GBMSM), reaching 52,255 per 100,000. In contrast, the rates for heterosexual men and heterosexual and bisexual women were significantly lower, at 1,894 and 3,106 per 100,000, respectively. Thus, the growing patient pool of HIV diagnoses is fueling the expansion of the diagnostic specialty antibodies market.

The rising incidence of cancer is expected to drive the growth of the diagnostic specialty antibodies market in the future. Cancer encompasses a group of diseases marked by the uncontrolled division and growth of abnormal cells that can invade and damage surrounding tissues. Diagnostic specialty antibodies play a crucial role in identifying specific cancer markers and assisting in the diagnosis and monitoring of the disease. For example, reports from the World Health Organization in February 2024 indicated that in 2022, there were approximately 20 million new cancer cases and 9.7 million deaths attributed to the disease. The estimated number of individuals living five years after a cancer diagnosis was around 53.5 million. Notably, about one in five people will develop cancer in their lifetime, with roughly one in nine men and one in twelve women succumbing to the disease. Thus, the increasing incidence of cancer is significantly driving the diagnostic specialty antibodies market.

Major companies focusing on the introduction of novel products and solutions to consolidate their market position. A case in point is Creative Diagnostics, a US-based company in the biotechnology industry, which, in January 2023, launched 1,000 new targets. This includes carrier-free formulations and conjugated antibodies, expanding the company's monoclonal antibody capabilities and product offerings on a global scale. The newly introduced monoclonal antibodies are designed to be versatile and high-performing tools applicable in various scenarios, such as ELISA (enzyme-linked immunoassay) detection methods. Their single-epitope recognition ensures improved specificity. These antibodies, having undergone rigorous validation, are suitable for applications such as Western blotting (WB), flow cytometry (FC), immunohistochemistry (IHC), immunocytochemistry (ICC), immunofluorescence (IF), and immunoprecipitation (IP).

Major players in the diagnostic specialty antibodies market are concentrating on the development of innovative assays, specifically antibody assays, for diagnosing rare bleeding disorders and gaining a competitive advantage. An antibody assay is a laboratory technique used to identify and measure the presence and concentration of antibodies in a biological sample. For instance, in May 2023, Versiti, a US-based nonprofit organization, launched the Anti-von Willebrand Factor (VWF) Antibody Assay. This groundbreaking assay aids clinicians in identifying patients suspected of having acquired von Willebrand Disease (aVWD) by detecting both inhibitory and non-inhibitory antibodies binding to VWF, providing additional pathways for anti-VWF antibody detection.

In October 2022, Sebia, a France-based specialty diagnostic company, made an undisclosed acquisition of Zeus Scientific Inc. Through this strategic move, Sebia aims to enhance its capability to deliver high-value solutions to customers and patients while strengthening its foothold and operations in the United States. Zeus Scientific Inc. is a US-based in vitro diagnostic (IVD) company with expertise in antibody tests for autoimmune and infectious diseases.

Major companies operating in the diagnostic specialty antibodies market include F. Hoffmann-La Roche AG, Sanofi SA, Thermo Fisher Scientific Inc., Abbott Laboratories, Danaher Corporation, Boehringer Ingelheim International GmbH, Merck KGaA, Becton Dickinson and Company, Regeneron Pharmaceuticals Inc, Agilent Technologies Inc., Sartorius AG, Bio-Rad Laboratories Inc., Quest Diagnostics Inc., STEMCELL Technologies Inc., Abcam PLC, Telix Pharmaceuticals Limited, Aytu BioScience Inc., Enzo Life Sciences Inc., Rockland Immunochemicals Inc., Santa Cruz Biotechnology Inc., Creative Diagnostics, Novus Biologicals LLC, Precirix NV, Creative Biolabs Inc., Polymun Scientific ImmunbiologischeForschung GmbH.

North America was the largest region in the diagnostic specialty antibodies market in 2024. Asia-Pacific is expected to be the fastest-growing region in the diagnostic specialty antibodies market report during the forecast period. The regions covered in the diagnostic specialty antibodies market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the diagnostic specialty antibodies market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Diagnostic specialty antibodies are specifically engineered for diagnostic purposes, employed in various tests to detect and identify specific biomarkers, antigens, or pathogens in patient samples. They encompass monoclonal antibodies, which are produced from a single clone of immune cells, and polyclonal antibodies, which are derived from multiple cell lineages.

The primary types of diagnostic specialty antibodies encompass monoclonal antibodies, polyclonal antibodies, and recombinant polyclonal antibodies. Monoclonal antibodies, derived from a single clone of immune cells, yield a uniform population of antibodies that target a specific antigen. These antibodies are employed across various applications, including diagnostics for hepatitis, tuberculosis, dengue, oncology, human immunodeficiency virus (HIV), infectious diseases, and more. Diagnostic laboratories and hospitals serve as key end users utilizing these antibodies.

The diagnostic specialty antibodies research report is one of a series of new reports that provides diagnostic specialty antibodies market statistics, including the diagnostic specialty antibodies industry's global market size, regional shares, competitors with a diagnostic specialty antibodies market share, detailed diagnostic specialty antibodies market segments, market trends and opportunities, and any further data you may need to thrive in the diagnostic specialty antibodies industry. This diagnostic specialty antibodies market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

The diagnostic specialty antibodies market consists of sales of chimeric antibodies, single-chain antibodies, and bispecific antibodies. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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