Immunoassay Market Trends

  • Report ID: 6001
  • Published Date: Sep 17, 2025
  • Report Format: PDF, PPT

Immunoassay Market Growth Drivers and Challenges:

Growth Drivers

  • Growing Product Launch & Approval - Several strategic initiatives are adopted by companies including geographic expansion, product collaborations, and strategic agreements for expansion of product portfolio to boost their market share. Moreover, industry key players are focusing on collaborations, acquisitions and mergers, and product approval to sustain their existence in the market. For instance, the development of automated laboratory instruments and equipment has grown for quick testing and results. This automation guides laboratories by boosting efficiency and limiting the necessity for space and labor. Therefore, the market is growing rapidly, since a large number of players in pharmaceuticals offer compact, portable automated laboratory systems and point-of-care tests.

  • Surging Growth in the Biotechnology & Pharmaceutical Sector - There has been a surge in the biotechnology & pharmaceutical sector owing to growing investment in R&D along with the development of drugs. Additionally, there have been growing virtual trials conducted by this sector which is also boosting the growth of this sector. Furthermore, the launch of various strict regulations is also projected to influence the biotechnology & pharmaceutical growth. Hence, the factors that are boosting the growth of the biotechnology & pharmaceutical sector are also estimated to drive the market demand for immunoassay.

  • Rising Geriatric Population  - The geriatric population in the world has risen steadily in recent years. This shift in demographic is greatly owing to improved health care and living standards, leading to longer life expectancies.   According to the WHO predictions, 1 in 6 people in the globe is estimated to be aged 60 years or more by 2030. By 2050, the population aged 60 years and older is predicted to double (2.1 billion). Hence, with this, the prevalence of disease among them is also growing. This is since, the older people are greatly receptive to different age-related diseases, including cardiovascular diseases, and neurodegenerative disorders. Moreover, the recognition of the genetic risk elements for various diseases is made possible with the adoption of immunoassays, hence authorizing preventive measures and targeted screening. 

Challenges

  • Technical Issues in Immunoassay - Immunoassay kits constitute a notable threat to the growth of the global immunoassay sector owing to growing technical issues during the coming years. These challenges may be displayed in various forms, including cross-reactivity, assay variability, or interference from substances in the sample. The precision and reliability of test results are compromised owing to such issues, causing an absence of confidence among end-users, such as research facilities and clinical laboratories. Furthermore, these technical challenges translate into rising operational costs and damage to potential reputational manufacturers. Moreover, laboratories depending on immunoassay kits request compatible performance and accuracy to make certain reliable outcomes of patients and affirm regulatory compliance. Hence, the market for immunoassays is predicted to be hindered over the coming years. 

  • High Price of Immunoassay

  • Strict Approval for Immunoassay Instruments

Base Year

2025

Forecast Period

2026-2035

CAGR

5.1%

Base Year Market Size (2025)

USD 33.31 billion

Forecast Year Market Size (2035)

USD 54.78 billion

Regional Scope

  • North America (U.S. and Canada)
  • Asia Pacific (Japan, China, India, Indonesia, Malaysia, Australia, South Korea, Rest of Asia Pacific)
  • Europe (UK, Germany, France, Italy, Spain, Russia, NORDIC, Rest of Europe)
  • Latin America (Mexico, Argentina, Brazil, Rest of Latin America)
  • Middle East and Africa (Israel, GCC, North Africa, South Africa, Rest of the Middle East and Africa)

Browse key industry insights with market data tables & charts from the report:

Frequently Asked Questions (FAQ)

In the year 2026, the industry size of immunoassay is estimated at USD 34.84 billion.

The global immunoassay market size was more than USD 33.31 billion in 2025 and is anticipated to witness a CAGR of over 5.1%, crossing USD 54.78 billion revenue by 2035.

North America immunoassay market will secure over 41% share by 2035, driven by growing healthcare investment and advanced technologies.

Key players in the market include Abbott, Beckman Coulter, Inc., QuidelOrtho Corporation, Bio-Rad Laboratories, Inc., Becton, Dickinson, and Company, BIOMÉRIEUX, F. Hoffmann-La Roche AG, Thermo Fisher Scientific, Inc., Siemens Healthinners AG, Merck KGaA, Hologic, Inc., Shenzhen Mindray Bio-Medical Electronics Co., Ltd., MIZUHO MEDY Co., Ltd., Immunosens Co., Ltd., Immuno-Biological Laboratories Co, Ltd., H.U. Group Holdings, Inc., Sysmex Corporation, Sumitomo Bakelite Co., Ltd.
Inquiry Before Buying Request Free Sample PDF
footer-bottom-logos