Immunodiagnostics is referred as a diagnostic methodology that primarily uses antigen-antibody reaction as its primary means of detection. Antibodies specific for a desired antigen can be conjugated with a radiolabel, fluorescent label, or color-forming enzyme and are used as a probe to detect it. The speed, accuracy, and simplicity of such tests has led to the development of rapid techniques for the diagnosis of disease, microbes, and even illegal drugs in vivo.
Rising Focus on R&D Investment and Expansion by Key Players Will Likely Offer Opportunities for Immunodiagnostics Market Growth
Research and development (R&D) has been the crucial part of the pharmaceutical business. It enables companies to develop new products with significant medical and commercial potential for various diagnostic applications. Due to the surging prevalence of infectious diseases, companies invest and generate huge revenues for expansion activities. During the COVID-19 pandemic, Thermo Fisher Scientific Inc. witnessed a 48% increase in the sales of its specialty diagnostics segment (sub-segmented into clinical diagnostics, immunodiagnostics, microbiology, transplant diagnostics, and healthcare market channel) in 2020. The segmental revenue of the company further increased in 2021 due to higher demand and sales of immunodiagnostic products used in COVID-19 treatment. In May 2021, PerkinElmer announced that it agreed to acquire UK-based in-vitro diagnostics company, Immunodiagnostic Systems (IDS), for ~US$ 155 million to expand the diagnostics business and immunodiagnostics division. Siemens Healthineers announced the investment of over US$ 32 million in its Glasgow Laboratory Diagnostics Manufacturing Facility in Newark, Delaware, in September 2021. The investment extending over 24 months enabled the company to add over 20 diagnostic tests in Delaware manufacturing capabilities. This initiative boosted the productivity of companies by maintaining stability across their diagnostic supply chains.
The extensive R&D for introducing innovative products opens several opportunities for small players and start-ups. The table below shows the annual support level for various research and disease categories based on contracts, grants, and other funding mechanisms used across the National Institutes of Health (NIH):
Infectious Diseases and Funding
| Research/Disease Areas (US$ Million) | 2019 | 2020 | 2021 | 2022 |
| Emerging Infectious Diseases | US$ 2,950 | US$ 4,867 | US$ 5,069 | US$ 4,318 |
| Infectious Diseases | US$ 6,313 | US$ 8,301 | US$ 8,599 | US$ 8,019 |
| Sexually Transmitted Infections | US$ 354 | US$ 394 | US$ 404 | US$ 419 |
Source: Annual Reports and The Insight Partners Analysis.
Manufacturers have also made a few key investments in the last few years. Cisco Systems, a global technology leader, invested US$ 225 million to combat the COVID-19 pandemic. This enabled the company to expand significantly and encourage new players to enter the market.
Impact of COVID-19 Pandemic on Immunodiagnostics Market
The medical industry across the globe witnessed a chaotic situation, with increased demand for clinical diagnostics and therapeutic systems in hospitals. With the increasing infection rate and the rising demand for diagnosis caused by the COVID-19 pandemic, the market experienced a positive impact across the world. Healthcare facilities, clinical laboratories, and pharmaceutical and biotech companies preferred advanced diagnostic techniques and systems to handle the burden of COVID-19.
The rising number of COVID-19 patients led to a positive impact on the market. In March 2021, Eurofins’ Clinical Enterprise, Inc. obtained an Emergency Use Authorization (EUA) from the US Food and Drug Administration (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 US FDA issued Emergency Use Authorization (EUA) to Abbott for its fastest available molecular point-of-care test to detect novel coronavirus (COVID-19), which delivers positive results in approximately 5 minutes and negative results in around 13 minutes. Thus, the rise in product launches is supporting the immunodiagnostics market growth.
Immunodiagnostics Market: 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 key companies operating in the immunodiagnostics market. These companies adopt product innovation strategies to meet evolving customer demands, which allows them to maintain their brand name.
A few of the recent developments in the global immunodiagnostics market are mentioned below:
- 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. These immunoassays assess risks and clinical management of preeclampsia, a severe pregnancy complication.
- In April 2023, Thermo Fisher Scientific announced a partnership with ALPCO-GeneProof, a global leader in diagnostics. The partnership has helped to bring TaqPath Menu | GeneProof PCR kits into the market.
- In July 2022, Abbott Diagnostics announced its participation in American Association for Clinical Chemistry (AACC) 2022. In the exhibition, the company demonstrated its diagnostics systems and analyzers.
- In May 2022, Roche and The Global Fund to Fight AIDS, Tuberculosis and Malaria joined forces to build and strengthen diagnostic capacity and pandemic preparedness in low-and middle-income countries fighting against HIV and tuberculosis (TB).
- 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 less quality controls and sample volumes, which ensures great 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 both allergy diagnostics and autoimmune testing.
- In July 2022, Roche announced the launch of the Elecsys HCV Duo immunoassay in countries that accept the CE Mark. The Elecsys HCV Duo immunoassay enables a significantly earlier diagnosis of active HCV infection, making it possible to get patients appropriate care sooner to stop both the disease progression and transmission.