Unlocking Potential: Immunoassay Market Insights on Industry Size, Key Trends, Emerging Demands, and Prospects Extending to (2023-2028)

In August 2023, Abbott received FDA approval for its Alinity h-series hematology system, enabling laboratories nationwide to run complete blood counts (CBC).


Northbrook, IL 60062 -- (SBWIRE) -- 11/28/2023 -- The immunoassay industry is poised for remarkable advancements in the near future. With rapid developments in biotechnology, automation, and data analytics, immunoassays are expected to become even more sensitive, specific, and accessible. This progress will not only revolutionize diagnostics and healthcare by enabling earlier disease detection and personalized treatments but also find applications in various sectors, including pharmaceuticals and environmental monitoring. The integration of cutting-edge technologies like microfluidics and artificial intelligence will streamline immunoassay processes, making them faster and more cost-effective. Furthermore, the industry will continue to contribute to global health by facilitating the monitoring of infectious diseases, autoimmune disorders, and cancer, making it an essential player in the ever-evolving landscape of modern medicine.

Immunoassay Market in terms of revenue was estimated to be worth $35.0 Billion in 2023 and is poised to reach $46.7 Billion by 2028, growing at a CAGR of 5.9% from 2023 to 2028 according to a new report by MarketsandMarkets™. The immunoassay market is driven by the increasing incidence of infectious and chronic diseases, increasing adoption of immunoassay-based POC testing and rapid testing, and introduction of innovative products by leading players operating in the immunoassay market. Growth in emerging countries and development of condition specific biomarkers and tests are anticipated to offer lucrative growth opportunities for the immunoassay market.

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The reagents & kits accounted for the largest share of the immunoassay market, by product segment, in 2022.

The global immunoassay market is segmented into analyzers and reagents & kits based on product. High consumption of consumables such as kits and reagents and their repeated purchases along with the increasing number of immunoassay tests performed across the globe, are the factors supporting the growth of the reagents & kits product segment.

The hospitals & clinics segment accounted for the largest share of the immunoassay market, by end user, in 2022.

The increasing prevalence of chronic and infectious diseases and the availability of advanced technologies for their detection have led to significant growth of the hospitals & clinics end user segment. The segment is also anticipated to register the highest growth rate during the forecast period, owing to better testing facilities.

North America is the largest regional market for immunoassay market.

The global immunoassay market has been segmented into five major regions—North America, Europe, the Asia Pacific, the Middle East & Africa, and Latin America. In 2022, North America dominated the global immunoassay market in 2022. The large share of the North American market is primarily driven by the increasing geriatric population and the subsequent prevalence of chronic diseases, and the easy accessibility of technologically advanced instruments.

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Immunoassay Market Dynamics:


1. Growth in the biotechnology and biopharmaceutical industries


1. Stringent requirements for the approval of immunoassay instruments and consumables


1. Growth opportunities in emerging economies


1. Design challenges, complexities, and the quality of antibodies

Key Market Players of Immunoassay Industry:

The major players operating in this market are Abbott Laboratories (US), F. Hoffmann-La Roche (Switzerland), and Siemens Healthineers (Germany).

Recent Developments:

- In August 2023, Abbott received FDA approval for its Alinity h-series hematology system, enabling laboratories nationwide to run complete blood counts (CBC).

- In July 2023, Siemens received FDA clearance and launched its Atellica CI Analyzer for immunoassay and clinical chemistry in the world's major markets.

- In June 2023, DiaSorin launched its CE marked LIAISON B·R·A·H·M·S MR-proADM assay to be used for the diagnosis of conditions, such as kidney diseases, sepsis, septic shock, lower respiratory and urinary tract infections.

- In December 2022, QuidelOrtho received approval from Health Canada for use of the Quidel TriageTrue High-Sensitivity Troponin I (hsTnl) Test to aid in the diagnosis of myocardial infarction.

- In October 2022, Roche received U.S. FDA granted Emergency Use Authorization (EUA) for its cobas MPXV for use on the cobas 6800/8800 immunoassay Systems.

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Immunoassay Market Advantages:

- High Sensitivity and Specificity: Immunoassays are known for their exceptional sensitivity and specificity, making them ideal for detecting and quantifying even low concentrations of target molecules, such as biomarkers and antibodies.

- Broad Application: Immunoassays have diverse applications in fields like clinical diagnostics, pharmaceutical research, food safety testing, and environmental monitoring, making them versatile tools for various industries.

- Rapid Results: Many immunoassays provide fast results, which is crucial for timely diagnosis and decision-making in healthcare settings.

- Non-Invasive: They often require minimally invasive sample collection methods, reducing patient discomfort and risk of infection.

- Quantitative Data: Immunoassays can provide quantitative data, allowing for precise measurements of analyte concentrations, which is essential for treatment decisions and research.

- Automation: Many immunoassay processes can be automated, leading to reduced human error, increased throughput, and cost savings in high-throughput settings.

- Long Shelf Life: Immunoassay reagents and kits generally have a longer shelf life, improving their practicality for labs and healthcare facilities.

- Customization: Assays can be tailored to target specific molecules or markers, enabling a wide range of applications and customization for research or clinical needs.

- Clinical Significance: Immunoassays are pivotal in diagnosing and monitoring a wide array of diseases, from infectious diseases to autoimmune disorders and cancer, contributing significantly to improved patient care.

- Research and Development: They play a vital role in drug development and validation, helping researchers study the pharmacokinetics and pharmacodynamics of new drugs.

- Quality Control: In industries like food and beverage and pharmaceuticals, immunoassays are crucial for quality control and ensuring product safety.

- Environmental Monitoring: Immunoassays are valuable in monitoring pollutants and contaminants in the environment, contributing to ecological conservation and public health.

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