Automatic Immunoassay Analyzer Market Outlook:
Automatic Immunoassay Analyzer Market size was over USD 6.9 billion in 2024 and is set to reach USD 15.8 billion by the end of 2037, growing at around 7.9% CAGR during the forecast period i.e., between 2025-2037. In 2025, the industry size of automatic immunoassay analyzer is evaluated at USD 7.4 billion.
The global market is steadily expanding, since there is an expanded patient pool requiring diagnostic testing, especially for chronic and infectious diseases. As stated in the World Health Organization report, the burden of infectious diseases led to 17.5% deaths in 2023, and the chronic conditions, such as diabetes and cardiovascular diseases, are at a surge, augmenting the demand for high-throughput immunoassay systems. Besides, the U.S. CDC notes that above 44% of adults in the country are diagnosed with at least one chronic condition necessitating frequent diagnosis. Therefore, this has created an increased necessity, positively influencing the market across all nations.
Furthermore, the global burden led to increased procurement of automated analyzers in healthcare facilities, with over 58% of clinical labs in the U.S. currently relying on high-volume immunoassay platforms. On the other hand, the trade data from the U.S. International Trade Commission notes that China and Mexico are leading exporters of immunoassay analyzer subcomponents; simultaneously, the U.S. and EU are reported to be leading in finished device imports, thereby making a standard contribution towards the market upliftment.
Automatic Immunoassay Analyzer Market - Growth Drivers and Challenges
Growth Drivers
-
Advanced technologies: The implementation of innovations in terms of advanced technologies appreciably drives growth in the market. For instance, Abbott’s hallmark product, called Alinity HQ, which is an AI-based analyzer, reduces operational costs in labs by 26% that capturing 16.5% revenue share in 2024. Besides, the collaboration between Siemens and Dantari developed affordable ELISA analyzers, thereby boosting sales by 13.4%.
-
Unmet medical needs in emerging nations: The existence of unmet medical needs and healthcare disparities in emerging nations drives growth in the market. In this regard, MHLW in 2024 unveiled that over 38% of rural clinics in Japan lack immunoassay systems, which encourages international players to establish their footprint in the country. Further, in India, only 29% of labs comprise automated systems, creating a USD 1.2 billion opportunity for the leaders.
Historical Patient Growth and Its Impact on Market Expansion
The global market witnessed notable expansion, constituting an expanded patient base with the growing burden of chronic and infectious diseases over the last decade. There has been a surge in the patient pool requiring routine diagnostic immunoassays across the U.S., Europe, and Asia Pacific owing to the presence of aging populations, disease screening initiatives, and advancements in automated testing technologies. Hence, this has created a significant opportunity for the market with laboratory automation becoming a priority for healthcare facilities.
Historical Patient Growth (2010–2020) in Key Markets
|
Country |
2010 |
2020 |
CAGR (2010–2020) |
|
U.S. |
28.7 |
42.9 |
4.5% |
|
Germany |
8.5 |
12.2 |
4.2% |
|
France |
6.9 |
9.7 |
3.7% |
|
Spain |
4.3 |
6.6 |
4.5% |
|
Australia |
2.2 |
3.5 |
4.8% |
|
Japan |
15.6 |
22.3 |
3.8% |
|
India |
13.2 |
27.6 |
8.1% |
|
China |
32.8 |
64.3 |
7.2% |
Manufacturer Strategies Driving Market Expansion in Automatic Immunoassay Analyzers
The market comprises the presence of key manufacturers constantly making efforts to strengthen their global ecosystems. Key tactical strategies adopted by the firms include well-planned partnerships, product differentiation, and geographic expansion into emerging nations. For instance, in 2023, the U.S. FDA reported that Roche Diagnostics launched AI-integrated Cobas Pro systems that reduce processing time by 32.5%, and it captured 20.4% market share growth, reflecting a heightened adoption. Further, the future growth of the market relies on cost optimization and regulatory compliance, thereby creating an optimistic opportunity for manufacturers across the world.
Revenue Opportunities for Manufacturers (2023–2025)
|
Company |
Strategy |
Revenue Impact (2023) |
Market Share Change |
|
Roche Diagnostics |
AI-driven Cobas Pro launch |
+$582.3 million |
+20.4% |
|
Siemens Healthineers |
APAC manufacturing expansion |
+$422.5 million |
+10.3% |
|
Abbott Laboratories |
Alinity HQ adoption in U.S. labs |
+$312.4 million |
+13.7% |
|
Beckman Coulter |
DxC 500 reagent efficiency |
+$192.7 million |
+7.8% |
|
Ortho Clinical |
CE-IVDR-compliant Vitros 3600 |
+$153.8 million |
+8.3% |
Challenges
-
Delay in regulatory approvals: The complicated procedures involved in the regulatory approvals create substantial barriers for the market to capture an optimal manufacturing base. For instance, in 2023 in Japan, the PMDA backlog led to six months of delayed approval timelines owing to a stringent clinical review duration. Further, the EU’s IVDR transition created a measurable impact on 32% of niche manufacturers, with a risk of non-compliance threatening supply chain stability.
-
Barriers in terms of patient affordability: This is yet another factor negatively impacting the expansion of the market. ICMR report in 2024 notes that in India, over 58% of patients spend USD 60 to USD 250 per immunoassay, making it challenging for patients to afford them. However, to tackle this, Abbott introduced affordable tests with 43% reduced prices in Brazil with domestic production of the Alinity HQ system, there beneficial for the overall market.
Automatic Immunoassay Analyzer Market size and Forecast:
| Report Attribute | Details |
|---|---|
|
Base Year |
2024 |
|
Forecast Year |
2025-2037 |
|
CAGR |
7.9% |
|
Base Year Market Size (2024) |
USD 6.9 billion |
|
Forecast Year Market Size (2037) |
USD 15.8 billion |
|
Regional Scope |
|
Automatic Immunoassay Analyzer Market Segmentation:
Product Type Segment Analysis
The chemiluminescence immunoassay segment is expected to garner the largest share of 48.5% in the market by the end of 2037. The dominance of the segment is attributable to its enhanced sensitivity, speed, and automation compatibility, making it standard for high-volume diagnostic testing. Further, this technology provides users with reduced detection limits when compared to traditional ELISA, thereby enabling quick disease detection, especially in the case of infectious diseases and cancer. NIH clinical study found CLIA is an affordable solution in automated systems, reducing labor costs and human error, remarkably improving workflow efficiency.
Application Segment Analysis
The infectious diseases segment is anticipated to capture the second-largest share of 35.3% in the market during the assessed timeframe. The growth in the segment is highly subject to the pandemic threats, i.e., increasing antibiotic resistance and the need for rapid diagnostics. Besides, WHO data in 2023 notes that the expanded access to high-sensitivity immunoassays for conditions such as COVID-19, influenza, and emerging pathogens enables quick and reliable results. Further, the U.S. FDA is extending its support with clearance for CLA-based tests such as multiplex panels for respiratory and tropical diseases, improving the profitability of the segment.
Our in-depth analysis of the global market includes the following segments:
|
Segment |
Subsegment |
|
Product Type |
|
|
Application |
|
|
End user |
|
Vishnu Nair
Head - Global Business DevelopmentCustomize this report to your requirements — connect with our consultant for personalized insights and options.
Automatic Immunoassay Analyzer Market - Regional Analysis
North America Market Insights
The North America automatic immunoassay analyzer market is anticipated to garner the highest market share of 40.5% along with a growth rate of 7.3% by the end of the forecast timeline. The growth in the region is facilitated by the presence of key players who are making constant efforts to position North America as a global leader in the automatic immunoassay analyzer sector. The CDC data in 2023 states that there is a deliberate adoption of CLIA, with over 46% of labs in the U.S. utilizing the system. The regulatory support in terms of 20 new approvals has captured the interest of manufacturers to invest in the merchandise, creating a prolific opportunity for the market to expand more.
U.S. dominates the regional automatic immunoassay analyzer market with a substantial 32.3% global share by the end of 2037. The progress in the country is attributable to the enhanced healthcare expenditure and the demand for infectious disease testing. For instance, in 2024 CDC reports that the federal system allocated USD 5.3 billion for this sector. Simultaneously, Medicare offers its mounting support, covering over 82% of high-throughput systems. Moreover, NIH made a significant investment of USD 302 million in AI-based analyzers, reflecting a suitable market development.
The automatic immunoassay analyzer market in Canada is gaining immense exposure, fueled by the spending from federal and provincial healthcare allocations. Health Canada is leading with provincial investments of USD 3.3 billion, reflecting extended support. Besides, PHAC data in 2024 notes that the adoption of CLIA grew, with over 42% of labs in the country adopting them. Furthermore, Ontario is leading with 20.4% increased spending targeting automation in rural areas, thereby creating an optimistic outlook for market expansion.
APAC Market Insights
The Asia Pacific automatic immunoassay analyzer market is expected to grow at the fastest rate, with a considerable share of 25.6% in the global market during the assessed timeframe. The prosperity of the region is highly subject to the increasing burden of infectious diseases, healthcare modernization, and expanded government investments in diagnostics. China leads the regional market with 40.3% share, followed by Japan and India with 25.3% and 18.7%. Furthermore, emerging nations such as South Korea and Malaysia prioritize point-of-care testing with 21.5% annual growth in rapid immunoassays.
China is a global leader in the automatic immunoassay analyzer market, growing at a CAGR of 8.6% and is estimated to reach USD 5.3 billion by the end of 2037. The aspect of government healthcare expenditure and focus on domestic production are fostering a favorable business environment in the country. In this regard NMPA 2024 report notes that there is a 15.5% increase in the spending for over 10,000 automated analyzers, reflecting an exceptional opportunity for domestic and foreign firms. Further domestic production by Mindray covers approximately 70% of the demand in the country, reducing reliance on imports.
The automatic immunoassay analyzer market in India is vigorously undergoing transformations, owing to the 9.3% CAGR, which is estimated to reach USD 1.9 billion during the forecast timeline. The presence of favorable healthcare schemes, such as the Ayushman Bharat scheme, fosters 19.3% growth alongside affordable solutions. For example, the ICMR study in 2024 states that the Tata MD labs process over 1.2 million immunoassays annually, which underscores the expanded demand, thereby denoting a positive market outlook.
Key Automatic Immunoassay Analyzer Market Players:
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
The global market presents a highly consolidated landscape with leading firms such as Roche, Abbott, and Siemens taking up the maximum market share. Key strategies adopted, aiming to witness a measurable success, include the incorporation of AI and automation for predictive diagnostics, and market penetration with affordable solutions. Moreover, the business in the sector is driven by well-planned government collaborations coupled with mergers and acquisitions.
Here is the list of some prominent players in the industry:
|
Company Name |
Country |
Market Share (2024) |
|
Roche Diagnostics |
Switzerland |
23.9% |
|
Abbott Laboratories |
U.S. |
19.2% |
|
Siemens Healthineers |
Germany |
17.4% |
|
Danaher (Beckman Coulter) |
U.S. |
13.7% |
|
Thermo Fisher Scientific |
U.S. |
10.2% |
|
bioMérieux |
France |
xx% |
|
Sysmex Corporation |
Japan |
xx% |
|
Ortho Clinical Diagnostics |
U.S. |
xx% |
|
Mindray |
China |
xx% |
|
Snibe Diagnostic |
China |
xx% |
|
DiaSorin |
Italy |
xx% |
|
Becton Dickinson |
U.S. |
xx% |
|
QuidelOrtho |
U.S. |
xx% |
|
Randox Laboratories |
UK |
xx% |
Below are the areas covered for each company under the top 15 global manufacturers:
Recent Developments
- In May 2024, Abbott Laboratories introduced the Alinity i+ CLIA analyzer, which is particularly designed for mid-sized labs, offering 20% lower reagent consumption and 15% higher throughput.
- In March 2024, Roche Diagnostics launched cobas pro integrated solutions, which is a fully automated, high-throughput immunoassay system with AI-driven predictive maintenance.
- Report ID: 6383
- Published Date: Jun 25, 2025
- Report Format: PDF, PPT
Have specific data needs or budget constraints?
Reach out to us for a customized quote or to learn more about our special pricing
for startups and universities
Frequently Asked Questions (FAQ)
FREE Sample Copy includes market overview, growth trends, statistical charts & tables, forecast estimates, and much more.
Connect with our Expert
