Immunodiagnostics Market Size, Share, Growth by 2030

The immunodiagnostics sector is projected to grow significantly, reaching a market size of approximately US$ 34,487.80 million by 2030, up from US$ 19,218.89 million in 2022, reflecting a compound annual growth rate (CAGR) of 7.6% during the period from 2022 to 2030.

Immunodiagnostics encompasses a range of diagnostic techniques that primarily rely on the interaction between antigens and antibodies for detection purposes. Specific antibodies can be tagged with radiolabels, fluorescent markers, or enzymes that produce color changes, serving as probes to identify the target antigens. The rapidity, precision, and ease of these tests have facilitated the emergence of swift diagnostic methods for various diseases, pathogens, and even illicit substances in living organisms.

Point-of-care testing (POCT) has become essential in patient-centered healthcare, driven by the demand for quick diagnostic results that enable timely and accurate treatment decisions. The transition from centralized to decentralized testing has made these diagnostic tools more accessible. Immunoassays play a crucial role in monitoring chronic diseases and identifying pathogens, including bacteria and viruses. Cutting-edge point-of-care devices can conduct rapid screenings of multiple components from a single sample. Furthermore, the integration of mobile healthcare (mH) technologies into point-of-care diagnostics is set to transform personalized healthcare management, leading to the development of next-generation POCT solutions. The management of infectious diseases can be greatly enhanced through POCT, especially in developing regions where timely medical intervention is often hindered by inadequate healthcare infrastructure. Additionally, advancements in diagnostic kits that minimize manual errors are driving growth in the immunodiagnostics market. Numerous companies are innovating within this space. For example, Thermo Fisher Scientific has introduced a variety of immunodiagnostic products, including enzyme-linked immunoassay (ELISA) reagents, antibodies, detection probes, and various supporting services such as bioconjugation and detection. In September 2020, Roche launched the SARS-CoV-2 Rapid Antigen Test, designed for point-of-care settings, enabling healthcare professionals to identify infections in suspected cases within a mere 15 minutes.

In April 2021, DiaSorin unveiled the LIAISON IQ, a new immunodiagnostic point-of-care reader, alongside the LIAISON QuickDetect COVID TrimericS Ab test, developed in collaboration with Lumos Diagnostics for CE Mark-accepting countries. This test, which utilizes a fingerstick of human capillary blood, can detect specific IgG antibodies against the SARS-CoV-2 Spike Protein in just 10 minutes.

Also in April 2021, Chembio Diagnostics, Inc. launched a rapid point-of-care COVID-19/Flu A&B test, which received FDA Emergency Use Authorization. This rapid immunoassay requires no specialized equipment and delivers results in 15 minutes.

The World Health Organization (WHO) commended the developers of these test kits for their innovative responses to the urgent needs arising during the COVID-19 pandemic. In March 2020, the Cepheid Xpert Xpress SARS-CoV-2 test became the first point-of-care COVID-19 detection assay to receive Emergency Use Authorization from the US Food and Drug Administration (FDA), as noted by the American Society for Clinical Pathology.

The application of immunodiagnostics is also expanding in oncology. In cancer treatment, immunodiagnostic tests can confirm the presence of solid tumors by detecting specific tumor-associated antigens or antibodies. These benefits are contributing to the growth of the immunodiagnostics market.

The immunodiagnostics market is categorized by product types, including enzyme-linked immunosorbent assays (ELISA), chemiluminescence immunoassays (CLIA), radioimmunoassays (RIA), and others. Clinical indications for these products include infectious diseases, Hepatitis and HIV, endocrinology, gastrointestinal issues, metabolic disorders, and more. The end-user segments comprise hospitals, clinics, diagnostic laboratories, academic and research institutions, among others. Geographically, the market is divided into regions such as North America (including the US, Canada, and Mexico), Europe (covering France, Germany, the UK, Spain, Italy, and other European nations), Asia Pacific (including China, India, Japan, Australia, South Korea, and the rest of the APAC region), the Middle East and Africa (Saudi Arabia, the UAE, South Africa, and others), and South and Central America (Brazil, Argentina, and others).

Key organizations such as the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), the Industrial Biotechnology Leadership Forum (IBLF), the International Diabetes Federation (IDF), and the Ministry of Health and Prevention (MoHaP) are among the primary and secondary sources referenced in the analysis of the immunodiagnostics market.

The immunodiagnostics market is further segmented by product types, with enzyme-linked immunosorbent assays (ELISA) holding the largest market share in 2022. The chemiluminescence immunoassays (CLIA) segment is expected to experience significant growth during the forecast period. ELISA is commonly used to measure antibodies, proteins, antigens, and glycoproteins in biological samples, playing a vital role in HIV diagnosis, pregnancy testing, and cytokine measurement. It has largely replaced radioimmunoassay (RIA) as a reliable diagnostic tool. Moreover, advancements in ELISA technology have led to the development of quantitative PCR, fluorogenic, and electro-chemiluminescent reporters for signal generation. During the COVID-19 pandemic, ELISA and lateral flow immunoassays were extensively utilized to identify individuals with antibodies against SARS-CoV-2, further propelling the growth of the immunodiagnostics market.

Immunodiagnostics Market: Competitive Landscape and Key Developments

Key players in the immunodiagnostics market include Abbott Laboratories, F. Hoffmann-La Roche Ltd, DiaSorin SpA, Danaher Corp, Thermo Fisher Scientific Inc, PerkinElmer Inc, Shenzhen Mindray Bio-Medical Electronics Co Ltd, bioMerieux SA, Svar Life Science AB, and Siemens Healthineers AG. These companies focus on product innovation to meet the evolving demands of customers, thereby maintaining their competitive edge.

Recent developments in the global immunodiagnostics market include:

- In May 2023, Thermo Fisher Scientific announced that the US FDA had cleared its immunoassays, B?R?A?H?M?S PlGF plus KRYPTOR and B?R?A?H?M?S sFlt-1 KRYPTOR novel biomarkers, which assess risks and clinical management of preeclampsia, a serious pregnancy complication.

- In April 2023, Thermo Fisher Scientific partnered with ALPCO-GeneProof, a leader in diagnostics, to introduce TaqPath Menu | GeneProof PCR kits to the market.

- In July 2022, Abbott Diagnostics showcased its diagnostic systems and analyzers at the American Association for Clinical Chemistry (AACC) 2022 exhibition.

- In May 2022, Roche collaborated with The Global Fund to enhance diagnostic capacity and pandemic preparedness in low- and middle-income countries combating HIV and tuberculosis (TB).

- In September 2022, Mindray launched the ToRCH Panel, providing high-quality assays tailored to various clinical needs, supporting diverse sample types with minimal quality controls and sample volumes for ease of clinical detection.

- In May 2022, Thermo Fisher Scientific announced the availability of the Phadia 2500+ series of instruments for autoimmune testing in the US, offering high throughput for allergy diagnostics and autoimmune testing.

- In July 2022, Roche introduced the Elecsys HCV Duo immunoassay in CE Mark-accepting countries, enabling earlier diagnosis of active HCV infections, facilitating timely patient care to halt disease progression and transmission.