PDF Cover

Immunoassay Analyzers Market

The market for Immunoassay Analyzers was estimated at $8.0 billion in 2025; it is anticipated to increase to $10.3 billion by 2030, with projections indicating growth to around $13.3 billion by 2035.

Report ID:DS1801050
Author:Debadatta Patel - Senior Consultant
Published Date:
Datatree
Life Science
Medical Device
Immunoassay Analyzers
Share
Report Summary
Market Data
Methodology
Table of Contents

Global Immunoassay Analyzers Market Outlook

Revenue, 2025

$8.0B

Forecast, 2035

$13.3B

CAGR, 2026 - 2035

5.3%

The Immunoassay Analyzers industry revenue is expected to be around $8.0 billion in 2026 and expected to showcase growth with 5.3% CAGR between 2026 and 2035. Automated immunoassay systems are now a vital component in the global in vitro diagnostics sector with this positive outlook indicating the extent to which Immunoassay Analyzers are used. Healthcare providers depend on these systems for the prompt and precise detection of biomarkers in order to make informed decisions. The main drivers of demand are the rising incidence of cancer and of infectious diseases, the latter and former combining to make up 67.5% of the market demand. This high demand is because of the need for treatments, for monitoring and for screening. Sales of benchtop immunoassay analysers totalled $5.78 billion last year with their popularity boosted by their suitability for laboratories and near patient testing and their compact size which enables easy integration into automated laboratory workflows in various care settings.

Immunoassays are sophisticated diagnostic equipment used to test for a variety of substances, including the antigen antibody reaction which can be facilitated by either ELISA or chemiluminescent immunoassay, providing accurate results. The equipment allows laboratories to easily manage large amounts of tests through high throughput screening capabilities, a variety of assay tests, simple to use software and the ability to interface with a laboratorys computer system. Examples of current applications include infectious disease, cancer monitoring, cardiology, endocrinology and the monitoring of medicinal drugs, with current developments in region's such as portable analyser equipment, multi test assays and diagnostic devices situated at the point of treatment. The clinical utility of Immunoassay analysers is being increased by the on going development of Immunoassay analysers, the automation of Immunoassay analysers and data analysis techniques. These factors are ensuring that Immunoassay analysers remain the cornerstone of in vitro diagnostics today.

Immunoassay Analyzers market outlook with forecast trends, drivers, opportunities, supply chain, and competition 2025-2035
Immunoassay Analyzers Market Outlook

Market Key Insights

  • Projected to reach $13.3 billion by 2035, the Immunoassay Analyzers industry will have expanded from $8 billion by 2025. There has been a compound annual growth rate of 5.3% a rise caused by increased demand for products from both the pharmaceutical and clinical diagnostics sectors and from biotechnology and research companies and institutes.

  • This market is dominated by major players including Siemens Healthineers AG, Abbott and Ortho Clinical Diagnostics.

  • The US and Germany are the largest markets in the immunoassay analyzers sector. These markets are expected to grow at a rate between 3.4% and 5.1% per annum from 2025.

  • China, Brazil and India are predicted to have the fastest growth with compound annual growth rates ranging from 6.1% to 7.3%.

  • Digital transformation is likely to have a major impact on the value chain of the immunoassay analyser market in both the US and Germany. By 2030, it should be worth approximately $265 million on top of the Immunoassay Analyser market.

  • Over the period of 2025 to 2035, the Immunoassay Analyzers sector is due to add $5.4 billion in value. Growth is expected to come from those businesses who produce equipment which is used for cardiology and oncology.

  • Growing rates of chronic conditions combined with advancements in diagnostic technology means that the market for immunoassay analysers will grow by 68% between 2025 and 2035.

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

Opportunities in the Immunoassay Analyzers

Growing use of healthcare services over the internet is also at the moment encouraging the rollout of point of care testing in pharmacies and other community clinics. Portable immunoassay analyzers for cardiac markers, infectious diseases and drug monitoring are set to grow at a compound annual growth rate of 6.1% over the next five years, from $2.18 billion in 2025 to $2.93 billion by 2030. The devices that can be connected to a network and which are used in conjunction with electronic health records as well as cloud computing are likely to be most popular in retail clinic chains and primary care clinics.

Growth Opportunities in North America and Asia-Pacific

The adoption of immunoassay analyzers in North America is primarily driven by the hospitals with high test volumes in their in house laboratories. Additionally, hospitals are adopting automated immunoassay systems capable of testing on demand. This is mainly due to a well established clinical diagnostics system in the region. Applications for oncology immunoassays are likely to be highly significant, due to the factors of a high cancer incidence rate, stringent screening procedures and strong reimbursement rates for sensitive tumour markers and for companion diagnostic tools in cardiology and endocrinology. Key region's of focus lie in the development of high volume testing systems which offer sophisticated chemiluminescence immunoassays, a streamlined menu and good connectivity with laboratory information systems for hospital laboratories and other large health care organisations. The competitive intensity in this market is escalating, with large scale manufacturers trying to differentiate themselves by introducing innovative assays, offering faster analysis turnaround times and other service agreements that add value. Smaller regional companies focus on niche products and low to mid volume labs in order to avoid direct price competition. The regions market is driven by the need to adhere to strict regulations, the need to automate processes due to staff shortages and the need for analyzers that can produce data that can be used in analytics, particularly in cancer treatment and in managing complex long term health conditions.
The Asia Pacific market for immunoassay analyzers is driven by an increase in the availability of healthcare, by government organised screening programs and the growing need for clinical diagnostic equipment in urban and secondary care hospitals. Given the regions high incidence of infectious diseases and the emphasis placed on monitoring, the region is poised for major growth in the infectious disease region. There will also be significant growth in endocrinology and cardiology testing due to the regions increasing chronic disease burden. The development of cost effective and dependable automated immunoassay systems with the capability to be scaled up represents a prime region for growth. A good illustration of this is mid range technology and compact devices which can be deployed in region's where resources are limited. These instruments still produce robust chemiluminescent immunoassay results. The market for biological kits is characterised by a mix of small, local companies which are growing rapidly and multinational firms. Competition is increasing from local companies who are capable of competing on the price of their products, on service which is tailored to a region and on the price of the reagents used. Factors which are likely to drive demand in this market are a rise in the healthcare infrastructure, an increase in private laboratory networks, the growing awareness of the need for early diagnosis and the growing use of Immunoassay Analyzers. These Immunoassay Analyzers allow laboratories which are centralised to be connected to those which are decentralised or near patients across the Asia Pacific region.

Market Dynamics and Supply Chain

01

Driver: Increased Prevalence of Chronic Diseases, and Growth in the Elderly Population

The increase in the Immunoassay Analyzers industry is also largely fueled by the growing occurrence of long term diseases like cancer, autoimmune disorders and infectious diseases worldwide. These ailments necessitate monitoring and examination leading to an increased need, for immunoassay analyzers. The increasing number of individuals globally is also a key factor contributing to this trend. As people age their susceptibility to illnesses rises, leading to a demand, for state of the art diagnostic equipment thereby propelling the Immunoassay Analyzers market forward.
Technological progress like automation alongside high throughput screening combined with results is also driving the immunoassay analyzer market ahead too. The latest tools not only improve effectiveness but also help reduce mistakes making them greatly preferred for use in labs as well, as diagnostic facilities.
02

Restraint: High Equipment and Maintenance Costs

Many healthcare facilities in developing countries find it costly to buy Immunoassay Analyzers well as maintain them over time due, to budget limitations which can hinder market growth for these devices in cost conscious markets.
03

Opportunity: Infectious disease diagnostics expansion in India and Southeast Asia using Immunoassay Analyzers and High-throughput oncology and drug monitoring in developed healthcare system reference laboratories worldwide

In India and Southeast Asia many hospitals which are public and also private are in the process of expanding diagnostic processes in the clinical field, but one instrument that has seen little use is the automated immunoassay analyser in cities beyond the first tier. Rapid increases in demand for laboratory developed testing for infectious diseases, HIV, hepatitis and cancer biomarkers is presently outstripping central lab infrastructure. Benchtop immunoassay systems which can be automated, designed for low maintenance and high humidity environments, offer the greatest growth potential. This potential is increased through training of laboratory staff in emerging markets, partnerships with distributors and reagent rental schemes.
These are increasing calls for reference and commercial laboratories to develop more standardized, high throughput immunoassay work flows due to the greater complexity of oncology biomarkers and the rising use of biologic based treatments. The market for benchtop chemiluminescent immunoassay analyzers is expected to rise with the use of automation technology in laboratory settings. Benchtop analyser sales are projected to rise from 5.78 billion in 2025 to 7.37 billion by 2030 at a compound annual growth rate of 4.99 %. Pharmaceutical companies and hospital networks will be favourably disposed towards analysers that offer a range of tests and high standards of quality control.
04

Challenge: Lack of Skilled Workforce

A significant challenge in the Immunoassay Analyzers industry is the shortage of staff members to handle these sophisticated instruments effectively; technicians with the necessary expertise to operate them correctly are in high demand, for their ability to maintain the equipment properly while accurately interpreting the test results.

Supply Chain Landscape

1

Reagent Components

Thermo Fisher ScientificMerck KGaADanaher
2

Immunoassay Analyzers

Roche DiagnosticsAbbottSiemens Healthineers AG
3

IVD Distribution

Cardinal HealthMcKessonHenry Schein
4

Clinical Diagnostics

HospitalsClinical diagnostic laboratoriesResearch institutes
Immunoassay Analyzers - Supply Chain

Use Cases of Immunoassay Analyzers in Clinical Diagnostics & Academic

Clinical Diagnostics : Immunoassay analyzers play a role in clinical diagnostics by detecting specific antigens or antibodies in the body to help identify diseases such as cancer or heart conditions efficiently. They also assist in the diagnosis of infectious diseases swiftly with precise measurements provided by top industry leaders, like Roche Diagnostics and Siemens Healthineers.
Pharmaceutical and Biotechnology Companies : In pharmaceutical and biotechnology industries well as research settings immunoassay analyzers play a crucial role in drug development processes through screening for efficiency along with detailed analysis that helps cut down time and expenses involved in developing new drugs. Major players, in this market include Abbott Laboratories and Thermo Fisher Scientific.
Academic and Research Institutes : In research settings as well immunoassay analyzers play a vital role. They help in disease processes innovating new treatments and exploring immune responses. Their speediness, in analyzing samples brings about research results.

Recent Developments

The market for Immunoassay Analyzers has experienced growth in the past few years due to advancements in technology that have improved their ability to detect pathogens more accurately. A notable trend in this market is the growing focus on automation as the healthcare sector aims for enhanced efficiency precision. Automated immunoassay analyzers have now become the norm, in the industry reflecting theindustry'sdrive towards greater efficiency accuracy.

December 2024 : Roche Diagnostics has introduced an immunoassay analyzer called Elecsys Procleix EIA that is designed to improve automation capabilities.
October 2024 : Siemens Healthineers has unveiled the Atellica IM 1300. A smaller immunoassay analyzer aimed at boosting efficiency, for laboratories.
August 2024 : Beckman Coulter Inc revealed a collaboration, with LabCorp to enhance immunoassay analyzers using cutting edge AI tools for better diagnostic precision.

Impact of Industry Transitions on the Immunoassay Analyzers Market

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

Digital Transformation in Immunoassay Analyzers

The immunoassay analyser industry is seeing its main expansion driver move towards digital transformation, where clinical procedures and the creation of value throughout the supply chain are altered by diagnostic techniques aided by AI and by software analytics. Automated immunoassay analysers are seeing a significant rise in the US and Germany, places where integration with connected hospital IT systems, digital pathology and laboratory automation is significantly reducing turnaround times and clinical diagnostics accuracy. The trend towards the development of sophisticated, automated immunoassay equipment is expected to enhance testing efficiency in both high volume laboratories and medical facilities where patients are tested on site. This is predicted to lead to an increase of approximately $265 million in annual revenue for the industry by 2030. Organisations that are the first to integrate AI, predictive maintenance and remote monitoring in their immunoassay analyzers will reap significant benefits from the growing diagnostics markets. They will set new standards in patient care and diagnostic efficiency.
02

Advent of Multiplexed Immunoassay Analyzers

The multi analyte immunoassay technology trend which is prevalent in the immunoassay analyzers industry, involves the simultaneous analysis of several markers at the same time. This can ultimately lead to a significant reduction in testing time.