Immunoassay Global Market Report 2025

Immunoassay Market Overview

• Immunoassay market size has reached to $35.81 billion in 2024

• Expected to grow to $49.4 billion in 2029 at a compound annual growth rate (CAGR) of 7.3%

• Growth Driver: Rising Infectious And Chronic Diseases Drive Immunoassay Market Growth

• Market Trend: Product Innovation Reshapes Immunoassay Market Landscape

• North America was the largest region in 2024 and Asia-Pacific is the fastest growing region.

What Is Covered Under Immunoassay Market?

Immunoassay is a bioanalytical test that employs antibody attachment to antigens to detect and quantify specific chemicals. Diseases can be diagnosed using immunoassays. Furthermore, information from test findings concerning an illness may be used to establish a course of therapy. This technique relies primarily on a competitive binding response for a finite number of receptors on an extremely specific anti-analyte antibody between a set quantity of labeled versions of an analyte and a substantial portion of an unmarked sample analyte.

The main immunoassay product types are reagents and kits, analyzers or instruments, and software and services. A reagent is a material or product that can accelerate a reaction and is utilized in the majority of commonly used tests. The various specimens are blood, saliva, urine, and others applied to therapeutic drug monitoring, oncology, cardiology, endocrinology, infectious disease testing, autoimmune diseases and others. The end users are research and academic laboratories, home care settings, pharmaceutical and biotechnology companies and CROs, blood banks, hospitals and clinics, and clinical laboratories.

What Is The Immunoassay Market Size 2025 And Growth Rate?

The immunoassay market size has grown strongly in recent years. It will grow from $35.81 billion in 2024 to $37.32 billion in 2025 at a compound annual growth rate (CAGR) of 4.2%. The growth in the historic period can be attributed to disease prevalence, aging population, infectious disease outbreaks, point-of-care testing, increased research funding.

What’s The Trade War Impact On Medical Equipment Industry?

The fast surge in U.S. tariffs and the trade tensions that followed in spring 2025 are heavily affecting the medical equipment sector, particularly for imported imaging machine components, surgical-grade stainless steel, and plastic disposables. Hospitals and clinics resist price hikes, pressuring manufacturers’ margins. Regulatory hurdles compound the problem, as tariff-related supplier changes often require re-certification of devices, delaying time-to-market. Companies are mitigating risks by dual-sourcing critical parts, expanding domestic production of commoditized items, and accelerating R&D in cost-efficient materials.

How Is The Immunoassay Market Segmented?

1) By Product: Reagents And Kits, Analyzers Or Instruments, Software And Services

2) By Specimen: Blood, Saliva, Urine, Other Specimens

3) By Application: Therapeutic Drug Monitoring, Oncology, Cardiology, Endocrinology, Infectious Disease Testing, Autoimmune Diseases, Other Applications

4) By End User: Research And Academic Laboratories, Home Care Settings, Pharmaceutical And Biotechnology Companies And CROs, Blood Banks, Hospitals And Clinics, Clinical Laboratories

Subsegments:

1) By Reagents And Kits: ELISA Kits, Rapid Test Kits, Control Reagents, Assay Development Reagents

2) By Analyzers Or Instruments: Automated Analyzers, Point-Of-Care Testing Devices, Microplate Readers, Luminometers

3) By Software And Services: Data Management Software, Analytical Software, Support And Maintenance Services, Consulting Services

What Is Driving The Immunoassay Market? Rising Infectious And Chronic Diseases Drive Immunoassay Market Growth

The increasing numbers of infectious and chronic illnesses are expected to propel the growth of the immunoassay market in the coming future. Chronic illnesses are characterized generically as those that persist for a year or more, need continuous medical care, restrict everyday activities, or both. Infectious illnesses are ailments caused by organisms such as bacteria, viruses, fungi, or parasites. Numerous creatures inhabit and dwell on the human body. Several infectious illnesses can be transmitted from person to person. Immunoassay is employed to detect several infectious and chronic diseases. For instance, according to a report published by the National Institutes of Health (NIH), a US-based biomedical research agency, in 2023, in the United States, the number of people aged 50 and older with at least one chronic illness is predicted to rise by 99.5%, from 71.522 million in 2020 to 142.66 million in 2050. Additionally, the number of people with multimorbidity would rise by 91.16% from 7.8304 million in 2020 to 14.968 million in 2050. Therefore, the increasing number of infectious and chronic illnesses is driving the market.

What Is Driving The Immunoassay Market? Government-Led Healthcare Research And Development Initiatives A Boost For Immunoassay

Government initiatives for research and development in healthcare are expected to propel the growth of the growth of the immunoassay market going forward. Government initiatives refer to specific actions, programs, policies, or projects undertaken by government authorities at various levels (local, regional, national, or international) to address specific issues, achieve certain goals, or create positive changes in society. These initiatives have focused on improving access to diagnostic testing, enhancing the quality of healthcare services, and addressing public health challenges, driving the demand for immunoassay. For instance, in 2022, according to the Department of Health and Social Care, a UK-based government authority, the UK government announced £260 million (US $270.65) million in funding to boost healthcare research and manufacturing. This was committed by BEIS and DHSC to support NHS-led health research into diagnostics and treatment through new privacy-preserving platforms and clinical research services, and £60 million (US $63.60 million) to help expand life sciences manufacturing in the UK. Therefore, increasing government initiatives for healthcare activities drives the immunoassay industry.

Who Are The Major Players In The Global Immunoassay Market?

Major companies operating in the immunoassay market include Siemens Healthineers GmbH, bioMérieux, Abbott, Beckman Coulter Inc., Quidel Corporation, Ortho Clinical Diagnostics, Sysmex Corporation, Bio-Rad Laboratories Inc., Becton Dickinson and Company, F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific Inc., Merck KGaA, Agilent Technologies Inc., PerkinElmer Inc, WAK-Chemie Medical GmbH, J Mitra & Co Pvt Ltd, Kamiya Biomedical Company, Tosoh Corporation, Gyros Protein Technologies AB, BioCheck Inc., Bio-Techn, DiaSorin S.p.A, Meso Scale Diagnostics LLC, QIAGE, Randox Laboratories Ltd., Shenzhen Mindray Bio-Medical Electronics Co Ltd, Danaher Corporation, Hologic Inc., Tecan Trading AG, Eurofins Scientific, Abcam plc, Enzo Biochem Inc., Luminex Corporation, Quanterix Corporation, Roche Diagnostics, ZEUS Scientific Inc.

What Are The Key Trends Of The Global Immunoassay Market? Product Innovation Reshapes Immunoassay Market Landscape

Product innovation is the key trend gaining popularity in the immunoassay market. Major companies operating in the immunoassay market are focused on developing innovative products to strengthen their position in the market. For instance, in November 2022, Getein Biotech Inc., a China-based biotechnological company involved in the manufacturing, sales, service, and research and development of in vitro diagnostic reagents and tools, launched MAGICL 6000 at MEDICA 2022. MAGICL 6000 is a portable, cutting-edge chemiluminescence immunoassay analyzer that is the best option for labs with mid- to high-workflow requirements for a one-step chemiluminescence solution. The instrument is extremely efficient and small, allows for completely automated operation, and has the quickest assessment frequency of any device of its size.

What Are The Key Trends Of The Global Immunoassay Market? Immunoassay Analyzers Are Gaining Traction In The Market

Major companies operating in the immunoassay market are introducing innovative immunoassay analyzers to gain a competitive edge in the market. Immunoassay analyzers are laboratory instruments designed to automate and facilitate the detection and quantification of biological molecules, such as proteins or hormones, by utilizing immunological reactions. For instance, in May 2023, Beckman Coulter Diagnostics, a US-based company that develops products that simplify, automate, and innovate upon complex biomedical testing, launched the DxI 9000 Access Immunoassay Analyzer. DxI 9000 Access Immunoassay Analyzer addresses the demands of clinical laboratories for speed, reliability, reproducibility, quality, and menu expansion. It has shown the capability to develop increasingly sensitive and clinically relevant assays, amplifying the impact of new pharmaceutical therapies and ultimately improving patient outcomes. It features innovations such as new analyte processing and detection technology, precision sensors, smart algorithms, and remote real-time system monitoring, and is the only immunoassay analyzer system with no daily maintenance.

Immunoassay Market Merger And Acquisition: Thermo Fisher Scientific Inc. Strengthens Molecular Diagnostics Portfolio With Mesa Biotech Inc.

In January 2023, Heska Corporation a US-based biotechnology company acquired MBio Diagnostics, Inc. for an undisclosed amount. With this acquisition,Heska Corporation aims to enhance its research and development and manufacturing capabilities, mainly through integrating LightDeck's innovative point-of-care technology, which will support the launch of advanced diagnostic platforms, including a canine cancer screening product. MBio Diagnostics, Inc. is a US-based company thatoffers immunoassays.

Regional Analysis For The Global Immunoassay Market

North America was the largest region in the immunoassay market in 2024. Asia-Pacific is expected to be the fastest-growing region in the immunoassay market report during the forecast period. The regions covered in this market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa

The countries covered in this market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

What Defines the Immunoassay Market?

The immunoassay market includes revenues earned by entities by supplying immunoassay kits, analyzers, and reagents. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

How is Market Value Defined and Measured?

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

What is the Market Assessment and Strategic Outlook for the Immunoassay Industry?

The immunoassay market research report is one of a series of new reports from The Business Research Company that provides market statistics, including industry global market size, regional shares, competitors with the market share, detailed market segments, market trends and opportunities, and any further data you may need to thrive in the immunoassay industry. The market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future state of the industry.