Immunodiagnostics Market (Product, Clinical Indication) to Gain $29.52 Bn by 2028 with Booming CAGR Value of 7.4% | The Insight Partners

According to The Insight Partners latest study on "Immunodiagnostics Market Size, Share, Growth, Trends and Forecast to 2028 – COVID-19 Impact and Global Analysis – by Product, Clinical Indication, End User, and Geography," the market is expected to grow from USD 17.94 billion in 2021 to USD 29.52 billion by 2028; it is estimated to grow at a CAGR of 7.4% from 2022 to 2028. North America dominated the immunodiagnostics market in 2021.


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Global Immunodiagnostics Market Report Scope, Segmentations, Regional & Country Scope:

Report Coverage


Market Size Value in

USD 17.94 Billion in 2021

Market Size Value by

USD 29.52 Billion by 2028

Growth rate

CAGR of 7.4% from 2022 to 2028

Forecast Period


Base Year


No. of Pages


No. of Tables


No. of Charts & Figures


Historical data available


Segments covered

Product, Clinical Indication, End User, and Geography

Regional scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country scope

US, Canada, Mexico, UK, Germany, Spain, Italy, France, India, China, Japan, South Korea, Australia, UAE, Saudi Arabia, South Africa, Brazil, Argentina

Report coverage

Revenue forecast, company ranking, competitive landscape, growth factors, and trends

Companies Covered

Abbott Laboratories; F. Hoffmann-La Roche Ltd; DiaSorin S.p.A.; 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


In recent years, there has been unprecedented growth in innovative and improved medical technologies in the US. This growth resulted in the development of advanced diagnostics that catalyzed developments and advancements in the healthcare industry. Moreover, the US is home to various companies that are developing advanced products for point-of-care diagnosis. For instance, in April 2020, Bio-Rad Laboratories in the US launched a blood-based immunoassay kit to identify antibodies to SARS-CoV-2. Thus, owing to the aforementioned factors, the US immunodiagnostics market is anticipated to grow in the coming years.


Impact of COVID-19 Pandemic on Global Immunodiagnostics Market:

The COVID-19 pandemic led to various changes in the diagnostics & healthcare industry. The rising number of COVID-19 patients boosted the use of immunodiagnostics. According to the American Society for Clinical Pathology, in March 2020, the Cepheid Xpert Xpress SARS-CoV-2 test became the first POC COVID-19 detection assay to receive Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). In March 2021, Eurofins' Clinical Enterprise, Inc. obtained an Emergency Use Authorization (EUA) from the FDA for a direct-to-consumer (DTC) version of its EmpowerDX COVID-19 Home Collection Kit. The Eurofins at-home COVID-19 nasal PCR kit is one of the first over-the-counter SARS-CoV-2 at-home test kits. Similarly, in March 2020, the FDA issued EUA to Abbott for its fastest available molecular point-of-care test to detect SARS-CoV-2, which delivers positive results in approximately 5 minutes and negative results in ~13 minutes. Therefore, the COVID-19 pandemic positively influenced the immunodiagnostics market growth.


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Global Immunodiagnostics Market Analysis: Competitive Landscape and Key Developments

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 are a few of the key companies operating in the immunodiagnostics market. The market leaders focus on new product launches, expansion and diversification, and acquisition strategies, which allow them to tap into prevailing business opportunities.

  • In September 2022, Mindray launched the ToRCH Panel. With this panel, the company offers high-quality assays to meet different clinical needs. Mindray ToRCH kits support diverse sample types with low quality control and volume, which ensures significant ease and convenience during clinical detection.
  • In May 2022, Thermo Fisher Scientific announced that the Phadia 2500+ series of instruments are available for autoimmune testing in the US. The family of high-capacity, intuitive lab instruments supplied by Thermo Fisher Scientific—the world leader in serving science offers reliable and unparalleled high throughput for allergy diagnostics and autoimmune testing.
  • In May 2022, Abbott announced the launch of the HBsAg Next Qualitative Assay for early detection of the Hepatitis B virus (HBV) in India. The launch of HBsAg Next Qualitative assay is expected to improve patient outcomes which will boost the revenue of the company.     
  • In May 2021, China-based Shenzhen Mindray Bio-Medical Electronics acquired Finland-based diagnostic test material supplier HyTest for ~US$ 661 million.
  • In February 2021, Thermo Fisher Scientific announced a partnership with Mindray. Under this partnership, two clinical chemistry analyzers will be available in the US and Canada for drug screening in clinical and drug court laboratories.


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Increasing Prevalence of Infectious Diseases to Influence Market Growth

Diagnostics play a vital role in determining the direction of any medical treatment. Immunodiagnostics help diagnose diseases that severely impact the immune system. The diagnosis and management of several ever-growing infectious diseases caused by infectious agents such as viruses, fungi, bacteria, parasites, or their toxic products are increasing the number of prescriptions for immunodiagnostic tests, including complement fixation, precipitation tests, agglutination tests, line blot assays, western blot assays, enzyme immunoassays (EIA), and immunofluorescence tests. Thus, the surge in diagnostic tests with the high prevalence of infectious diseases fuels the demand for immunodiagnostic products.


Global Immunodiagnostics Market: Segmental Overview

Based on the product, the immunodiagnostics market is segmented into enzyme-linked immunosorbent assays (ELISA), chemiluminescence immunoassays (CLIA), radioimmunoassays (RIA), and others. In 2021, the enzyme-linked immunosorbent assays (ELISA) segment accounted for the largest share of the market. However, the chemiluminescence immunoassays (CLIA) segment is anticipated to register the highest CAGR during the forecast period. Based on clinical indications, the immunodiagnostics market is categorized into infectious diseases, Hepatitis+HIV, endocrinology, gastrointestinal, metabolic, and others. In 2021, the infectious diseases segment held the largest share of the market, and it is expected to register the highest CAGR from 2022 to 2028. Based on end user, the immunodiagnostics market is categorized into hospitals, clinics, diagnostic laboratories, academic and research institutes, and others. In 2021, the hospitals segment held the largest share of the market. However, the clinics segment is expected to register the highest CAGR from 2022 to 2028.


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