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Immunoassay Market

Immunoassay Market

The market for Immunoassay was estimated at $34.2 billion in 2024; it is anticipated to increase to $49.9 billion by 2030, with projections indicating growth to around $68.4 billion by 2035.

Report ID:DS1801618
Author:Debadatta Patel - Senior Consultant
Published Date:
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Life Science
Medical Device
Immunoassay
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Report Price: $4,200
Report Summary
Market Data
Methodology
Table of Contents

Global Immunoassay Market Outlook

Revenue, 2024

$34.2B

Forecast, 2034

$64.2B

CAGR, 2025 - 2034

6.5%

The Immunoassay industry revenue is expected to be around $36.4 billion in 2025 and expected to showcase growth with 6.5% CAGR between 2025 and 2034. The immunoassay industry continues to expand because these tests serve as essential tools for disease diagnosis and patient health monitoring and treatment planning. The growing number of people with chronic diseases together with the need for fast diagnostic methods has made immunoassays more important in the market. The immunoassay industry maintains its importance because of new technological developments in immunoassay systems and the creation of highly sensitive and specific assays.

The bioanalytical method of Immunoassay depends on antigen antibody binding specificity to detect and quantify analytes in samples. The technology operates across multiple industries which include pharmaceutical companies and diagnostic facilities and research institutions. The main uses of immunoassay technology include medical condition identification and drug screening and drug level monitoring in patients. The immunoassay industry experiences growing demand because of automated systems and smaller device designs and new biomarker discoveries. The product segment generated $0 billion in revenue during 2024 while other applications and markets collectively accounted for 9.4% of the market.

Immunoassay market outlook with forecast trends, drivers, opportunities, supply chain, and competition 2024-2034
Immunoassay Market Outlook

Market Key Insights

  • The Immunoassay market will expand from $34.2 billion in 2024 to reach $64.2 billion during the period from 2024 to 2034. The market will expand at a 6.5% annual rate because of increasing requirements for Infectious Diseases and Endocrinology and Oncology applications.

  • Abbott, F. Hoffmann-La Roche AG, and Siemens Healthineers are among the leading players in this market, shaping its competitive landscape.

  • The Immunoassay market shows the United States and Germany as its leading markets which will experience CAGR growth rates of 4.2% to 6.2% during 2024 to 2030.

  • The market research predicts Brazil, India and South Africa will experience the highest growth rates at 7.5% to 9.0% CAGR.

  • Transition like Automation in Immunoassays has greater influence in U.S. and Germany market's value chain; and is expected to add $2 billion of additional value to Immunoassay industry revenue by 2030.

    .

  • The Immunoassay market will experience $30.0 billion growth during 2024-2034 while Endocrinology & Oncology Application manufacturers will dominate market expansion.

  • The Immunoassay market will experience an 88% growth from 2024 to 2034 because of increasing chronic disease cases and better immunoassay instruments and rising Point-of-Care Testing adoption.

immunoassay market size with pie charts of major and emerging country share, CAGR, trends for 2025 and 2032
Immunoassay - Country Share Analysis

Opportunities in the Immunoassay

The immunoassay analyzers market shows increasing growth because of new technological developments. The market growth of immunoassay tests occurs because new technologies improve their testing speed and precision for medical applications. The analyzer market will also achieve significant expansion through 2030 with a projected CAGR between 2025 and 2030.

Growth Opportunities in North America and Europe

The North American market leads the immunoassay market with $3.21 billion projected revenue for 2024. The market expansion in North America stems from its high incidence of chronic diseases including oncology and endocrinology and cardiology which require immunoassay technologies for proper diagnosis and treatment. The market growth benefits from North America's sophisticated healthcare system and its position as home to major companies Abbott and BD. The North American market shows rising demand for immunoassay applications in infectious disease testing and blood screening and drug monitoring and testing which creates substantial business prospects for market participants. The market faces intense competition because of its strong competition in allergy diagnostics and autoimmune disorder testing. The region will maintain its growth trajectory at 6.87% annual rate from 2025 to 2030 because of advancing technologies and expanding healthcare use of immunoassay systems.
The immunoassay market in Europe shows significant demand for immunoassay technologies which find their main applications in oncology and endocrinology and cardiology. The established European healthcare system supports major players F. Hoffmann La Roche AG and Siemens Healthineers to operate in this market.

Market Dynamics and Supply Chain

01

Driver: The Rising Prevalence of Chronic Diseases and Technological Advancements in Immunoassay Instruments

The worldwide immunoassay market also experiences growth because of rising numbers of people who develop chronic diseases including cancer and diabetes. The need for early disease detection in these conditions also drives up immunoassay demand because proper treatment also depends on early diagnosis. The market expansion results from new technological developments which improve immunoassay instrument performance. The introduction of high throughput automated immunoassay systems has also enhanced test efficiency and precision which makes them the preferred choice for medical disease diagnosis.

The market for immunoassays also experiences growth because healthcare facilities now use point of care testing more frequently. The rapid on site testing capabilities of POC systems make them essential for emergency medical situations. The market for immunoassays expands because hospitals and clinics adopt POC immunoassays for their fast and convenient testing capabilities. Additionally, increasing demand for immediate diagnostic results, improved patient management, and streamlined workflow efficiency further also drives the adoption of these rapid immunoassay solutions across healthcare settings.

02

Restraint: High Costs Associated with Immunoassay Procedures

The expensive nature of immunoassay procedures creates barriers for healthcare providers to adopt these tests because developing countries lack sufficient resources. The high costs of immunoassay procedures might reduce market demand and technological advancement in this field. Furthermore, limited funding for laboratory infrastructure, expensive reagents, and specialized equipment requirements exacerbate these challenges, restraining wider adoption and slowing growth potential in emerging markets for immunoassay technologies.

03

Opportunity: Rising Demand for Immunoassay in Diagnostic Laboratories and Strategic Collaborations Stimulating Immunoassay Market Growth

The worldwide rise of chronic diseases requires diagnostic tools that operate at higher efficiency levels. Diagnostic laboratories now prefer immunoassay because it provides excellent sensitivity and specificity levels. The reagents & kits segment achieved substantial revenue in 2024 and experts predict it will continue to expand because of these market developments.

The immunoassay market experiences expansion because major companies form strategic alliances with each other. The partnerships between companies focus on creating new immunoassay products which meet customer requirements and enter unexplored market areas. The market trend will drive substantial expansion of the immunoassay market throughout the next few years.

04

Challenge: Stringent Regulatory Guidelines and Standards

The immunoassay market faces restrictions because of strict regulatory standards which control its operations. The approval process for new immunoassay products becomes longer because of these regulations, which creates market challenges that could slow down industry expansion. Additionally, compliance with quality control, safety protocols, and certification requirements increases development costs and time to market, further restraining innovation and limiting the ability of manufacturers to rapidly introduce new and advanced immunoassay solutions.

Supply Chain Landscape

1

Raw Material Suppliers

Merck KGaAThermo Fisher Scientific
2

Manufacturers

AbbottF. Hoffmann-La Roche AGSiemens Healthineers
3

Distributors & Suppliers

BDDanaher Corporation
4

End Users

HospitalsDiagnostic LaboratoriesBiotechnology Companies
Immunoassay - Supply Chain

Applications of Immunoassay in Infectious Diseases, Oncology & Endocrinology

Infectious Diseases : The detection and diagnosis of infectious diseases heavily depends on Immunoassay technology. The Enzyme-Linked Immunosorbent Assay stands as the preferred choice because it delivers both sensitive and specific results. The development of advanced immunoassay systems by Abbott and F. Hoffmann La Roche AG has led to faster and more precise test results which enhance medical care and decrease healthcare expenses.
Endocrinology : The detection of hormonal imbalances in endocrinology depends heavily on immunoassays as a fundamental tool. Radioimmunoassay serves as a preferred method because it provides precise and dependable results. Siemens Healthineers stands as a top company which provides complete immunoassay systems that produce dependable results to help doctors identify and manage endocrine disorders.
Oncology : The detection of tumor markers in oncology depends heavily on immunoassays which use chemiluminescent immunoassay for their high sensitivity and fast results. The two leading companies BD and Danaher Corporation develop advanced immunoassay products which help doctors detect cancers at an early stage and track their progression for better patient outcomes.

Recent Developments

The immunoassay market has experienced major developments since 2010 because of new technologies and rising need for fast diagnostic solutions. The market has seen major progress through automation integration in immunoassay systems which improves both speed and precision of diagnostic tests. The industry has experienced a major transformation through multiplex immunoassays which allow researchers to test multiple analytes from one sample at the same time.

September 2025 : Abbott Laboratories introduced an innovative immunoassay system which delivered faster and more precise diagnostic results.
June 2025 : The diagnostic industry market share of F. Hoffmann La Roche AG expanded through its launch of a high throughput analyzer which added to their immunoassay portfolio.
March 2024 : Siemens Healthineers joined forces with Danaher Corporation to create a joint venture which combined their knowledge for developing sophisticated immunoassay technologies.

Impact of Industry Transitions on the Immunoassay Market

As a core segment of the Medical Device industry, the Immunoassay market develops in line with broader industry shifts. Over recent years, transitions such as Automation in Immunoassays and Advancements in Immunoassay Technologies have redefined priorities across the Medical Device sector, influencing how the Immunoassay market evolves in terms of demand, applications and competitive dynamics. These transitions highlight the structural changes shaping long-term growth opportunities.
01

Automation in Immunoassays

The immunoassay industry underwent a transformation when automation technology became available. Automated immunoassay analyzers have enhanced both speed and precision of immunoassay tests which results in shorter testing periods and lower operational expenses. The healthcare industry faces changes because fast and exact diagnostic outcomes play an essential role in delivering proper patient treatment. The automated immunoassay process enables healthcare organizations to perform more tests which results in better service delivery for their patients. This industry transition is expected to add $2 billion in the industry revenue between 2024 and 2030.
02

Advancements in Immunoassay Technologies

The immunoassay industry has experienced major technological progress through the creation of multiplex immunoassays. The advanced immunoassays enable researchers to detect multiple analytes from a single sample which produces complete diagnostic results. The pharmaceutical industry has experienced major changes because multiplex immunoassays now serve as essential tools for drug development research. The technology allows researchers to measure multiple biomarkers at once which speeds up the drug development process.

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