The immunoassay CDMO market is estimated to reach USD 11,274.0 million in 2025. It is estimated that revenue will increase at a CAGR of 8.9% between 2025 and 2035. The market is anticipated to reach USD 26,528.5 million by 2035.
The Immunoassay CDMO industry is set to witness remarkable growth as demand for high quality diagnostics surges. With infectious diseases and chronic illnesses on rise along with personalized medicine shaping healthcare, manufacturers are relying more on CDMOs to develop and produce innovative immunoassays efficiently and in large scale.
The need for faster and more accurate diagnostic solutions will push CDMOs to enhance their production capabilities in high-throughput screening, automation, and assay development. As chemiluminescence, multiplex assays, and point-of-care testing gaining traction, CDMOs will play a pivotal role in delivering flexible, scalable solutions that meet market demands.
At the same time, regulatory requirements will become more stringent, compelling CDMOs to invest in GMP-certified facilities with advanced biomanufacturing techniques and stringent quality control measures. With the shift toward biomarker-driven therapies and companion diagnostics, CDMOs will expand their service offerings, providing end-to-end solutions from custom assay development to reagent formulation and validation.
Immunoassay CDMO Industry Analysis
| Metric | Value |
|---|---|
| Industry Size (2025E) | USD 11,274.0 million |
| Industry Value (2035F) | USD 26,528.5 million |
| CAGR (2025 to 2035) | 8.9% |
An Immunoassay CDMO provides custom services such as assay development, reagent formulation, analytical validation, large-scale manufacturing, and regulatory compliance support that help companies bring diagnostic products to market efficiently.
These CDMOs provide necessary focused expertise and resources for the pharmaceutical company and healthcare organization to develop quality, reliable diagnostic tests. Increasing prevalence of chronic diseases along with the rising demand for diagnostic tests that are accurate and fast contribute to the significant growth of the market.
Preference given to the immunoassay CDMO for manufacturing and development of new products aims to seek cost-effective and time-saving diagnostic solutions. Pharmaceutical companies are increasingly relying on outsourcing CDMOs, as they emphasizes on continuous developments of new drug products.
Moreover, new approaches in antibody development, biomarkers, and diagnostic technologies, have created a demand for specialized manufacturing in biotech industry. These CDMOs also facilitate the speedy development of their products by meeting regulatory requirements, and reaching the market quickly at low costs.
Therefore, increased adoption of automation of technology that provides high-throughput enhances the need of these services, which propels their market growth.
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Strategic Collaborations Driving Innovation and Market Expansion
Strategic cooperation among market players, for expanding the scope of application for Automated Immunoassay Systems in different diseases, significantly anticipates the growth of the immunoassay CDMO market. These collaboration allows sharing resources, and technologies, which accelerates innovation in diagnostic solutions for different diseases, such as emerging and complex conditions.
These factors allows faster responses to new health challenges and aid in scaling up of production and research and development of new drug molecules. They also encourage the development of more efficient, cost-effective manufacturing processes, which improve market competitiveness.
For CDMOs, such collaborations result in expanded service offerings, new customer acquisition, and an enhanced reputation in diverse therapeutic areas, which drives both growth and market expansion. This collective effort helps address evolving global healthcare needs and strengthens the overall immunoassay market.
Pharma Companies Tapping into Immunoassay CDMO Expertise Through Acquisitions
Strategic acquisitions in the immunoassay CDMO sector have turned out to be a focus for pharmaceutical companies as it aid in expanding their capabilities within diagnostics and biologics. Acquisitions made by pharmaceutical companies of immunoassay CDMOs, aid them in leveraging advanced technologies with specialized expertise allowing them a quicker times to market for new immunoassay tests and therapeutic solutions.
Increasing demand for immunoassays due to chronic diseases, cancer, and infections that have increased worldwide and require specific and reliable diagnostic testing. These acquisitions facilitates pharmaceutical companies with modern manufacturing facilities without making any heavy capital investments for R&D.
For instance, in July 2024, Olon Group, a company engaged in the development and production of active pharmaceutical ingredients (APIs) acquired GTP Bioways Group. GTP Bioways Group, operates as a Biotech CDMO which focus includes biologics manufacturing, along with focus on analytical development including HCP and immuno assay.
Therefore, the synergy of R&D capabilities of pharma companies and the manufacturing expertise of the immunoassay CDMOs anticipates the further acceleration of the market.
Automation Revolutionizing Immunoassay Development and Manufacturing for Large-Scale Diagnostics
Fully automated assays offer enhanced efficiency, accuracy, and scalability that are highly appealing to pharmaceutical companies and healthcare providers. This is because such facilities reduce manual intervention and human error, resulting in improved consistency and greater throughput, making them ideal for high-volume diagnostics, particularly in clinical and research settings.
Automation is often the strategic route towards capturing such demand for value-added and high-performance diagnostic solutions. As diagnostics is an increasingly automated discipline, for example, immunoassay CDMOs find a place in offering custom development and manufacturing services toward the development of next-generation automated assay platforms. Active pharmaceutical and biotech companies continuously emphasizes on simplifying their operations in order to address growing global demand for diagnostics.
Furthermore, these assays significantly lower the cost per test, which makes them very attractive for mass-market applications such as point-of-care and population screening. For instance, in July 2024, Fujirebio launched the fully automated Lumipulse G GFAP assay. This assay is available for research purpose and only available in Japan and USA.
Therefore, with automation at the forefront of the evolution of immunoassay technologies, CDMOs are in a position to establish themselves as key partners in the emerging demand for efficient large-scale diagnostic solutions, opening new avenues for business growth.
High Investment Cost along with Market Saturation Hinders the Growth of the Market
High investment costs coupled with saturation levels in the markets are critical for the market expansion of the immunoassay CDMO. In a bid to engineer and manufacture the immunoassays, very high investments must be put towards equipment. These result in strain for those smaller-sized companies or emerging organizations.
The requirement to invest heavily into these stringent standards based on regulation that is expensive while maintaining high technological facilities. Smaller players find it difficult to compete with larger, well-established organizations that have more access to funding, thereby limiting the overall diversity in the market.
Market saturation further complicates growth prospects. With so many companies competing for a share of the growing immunoassay demand, competition becomes fierce, often driving down profit margins. Overcapacities from service providers in the immunoassay CDMO industry contribute to price competition, which becomes a challenge for CDMOs to differentiate and find market positions without specialized capabilities or innovative solutions.
Therefore, the combination of high operational costs and intense competition in the market restricts the opportunities for the existing players and stifles innovation, limiting the overall expansion of the immunoassay CDMO market.
The immunoassay CDMO industry recorded a CAGR of 8.1% between 2020 and 2024. According to the industry, immunoassay CDMO generated USD 10,200.3 million in 2024, up from USD 7,476.5 million in 2020.
Immunoassay CDMOs are playing a crucial role in supporting pharmaceutical and diagnostic companies. They offer everything from early-stage assay development and validation to clinical trial support and large-scale manufacturing that support manufacturers to bring new drugs and diagnostics products to market.
Recent advances in biotechnology, and expanding pharmaceutical and diagnostic industries has significantly contributed to the growth of the market as they ensure the accuracy and safety of diagnostics, navigating the complex approval processes. Few other factors that have contributed to the growth of the market are increasing chronic diseases and the emergence of biologics and precision medicine.
Some of the recent developments taken up by immunoassay CDMOs include the introduction of automation, high-throughput screening platforms that have the ability to accelerate the accuracy of immunoassays. Another key trend is that point-of-care diagnostics and at-home testing, catalyzed by the COVID-19 pandemic, are highly in demand, which is making CDMOs focus on infectious disease and chronic condition diagnostics with the ability to provide fast results
The movement toward multiplex assays, which test for multiple biomarkers at once, and the use of next-generation sequencing techniques have made the immunoassays more sophisticated in the detection of complex diseases further surges the market growth.
Looking ahead, the rising tide of chronic diseases, the unabated march toward personalized medicine, advances in assay sensitivity, miniaturization, and automation anticipates and continues to drive the growth of immunoassay CDMOs. These, in addition to the growing need for speed and cost-economical diagnostic solutions, position immunoassay CDMOs for continued growth.
Companies in the Tier 1 sector account for 56.8% of the global market, ranking them as the dominant players in the industry. Tier 1 players offer a wide range of services compared to other emerging players, have an established industry presence, offer continuous innovation, and have a significant influence in the field. Their strong financial resources enables them to enhance their research and development efforts and expand into new markets.
A strong brand recognition and a loyal customer base provide them with a competitive advantage. Prominent companies within Tier 1 include Sanner GmbH, Stevanato Group, Thermo Fisher Scientific Inc, Phillips Medisize, Merck KgaA, Fujirebio Holdings, Inc and others
Tier 2 players dominate the industry with a 24.4% market share. Tier 2 firms have a strong focus on a specific technologies and a substantial presence in the industry, but they have less influence than Tier 1 firms. The players are more competitive when it comes to pricing and target niche markets.
They constantly focus on introducing new products and services. Tier 2 companies include GTP Bioways©, Firalis Molecular Precision, ProBio Shenzhen, AIVD Biotechnology Co.,LTD., InBios International, Inc and others.
Tier 3 companies many of the times are limited to the local markets due to their limited production capabilities and geographical presence. Those in Tier 3 focus primarily on serving a smaller size diagnostic companies.
An analysis of the immunoassay CDMO industry is provided in various countries. Several regions throughout the world are examined, including North America, Latin America, East Asia, South Asia & Pacific, Western Europe, Eastern Europe, and Middle East & Africa. USA is forecast to remain the leader with a market share of 74.6% in 2024. The market in South Korea is anticipated to grow at a CAGR of 5.3% through 2035.
| Countries | Value CAGR (2025 to 2035) |
|---|---|
| United States | 4.7% |
| Canada | 3.1% |
| United Kingdom | 3.7% |
| Germany | 2.8% |
| India | 5.8% |
| China | 6.2% |
| South Korea | 5.3% |
Increasing demand for diagnostic solutions in the USA, substantially contributes to the growth of the immunoassay CDMO market in the USA Growing number of patients suffering from chronic diseases, infections, and other health disorders, propels demand for accurate, and reliable diagnostic testing. Immunoassays are known for their precision in the detection of specific biomolecules that are important in the diagnosis of infectious diseases, and autoimmune disorders.
With healthcare systems continuing their evolution toward early detection and personalized treatment, the need for sophisticated immunoassay reagents and diagnostic equipment has been correspondingly rising. This situation plays directly into the hands of immunoassay CDMOs, which form an important link in the chain of development, scale-up, and production of these tests.
Their capability for producing high-quality, regulatory-compliance-assured immunoassay components ensures diagnostic tests to the exacting standards of not only healthcare providers but also regulatory bodies such as the FDA.
With diagnostics increasingly becoming a part of mainstream, the focus would be to drive innovation in test sensitivity, speed, and cost. This, in turn, is driving up demand for specialized services offered by immunoassay CDMOs and enabling further growth of the market in the USA.
The increasing focus of immunoassay CDMOs on service portfolio extension for biopharmaceutical companies is considered the major growth factor for the market in France. French biopharmaceutical manufacturers are increasingly seeking the professional development of manufacturing partnerships with the ability to support complex diagnostic and therapeutic solutions, particularly with biologics and biosimilars.
Full-service CDMOs also continue to expand their service offerings, by including value-added services such as custom development of immunoassay reagents, diagnostic kits, and next-generation platforms, positioning themselves as an important enabler in the biopharma sector.
The French market is famous for its strong biopharmaceutical industry, orientated toward precision medicine, immunotherapies, and personalized treatments. This opens up a growing demand for immunoassay CDMOs that can cater to these needs by offering services right from early-stage research and development to large-scale commercial production.
The use of specialized CDMOs that offer comprehensive, flexible services in new drug development and diagnostic innovation continues to increase among biopharma companies. This trend is expected to spur the expansion of immunoassay CDMO market in France and drive further growth in the market.
Collaboration with R&D companies gives the CDMO firsthand access to newly invented immunoassay reagents and related diagnostic equipment. This collaboration creates greater speed in the development of high-value, innovative products where both the reagents and associated devices meet regulatory standards to respond to demand on the market.
These partnerships also let CDMOs implement advanced technologies, simplify production processes, and improve operational efficiency-cost-effective manufacturing.
As Japanese demand becomes more and more focused on rapid diagnostic solutions and increased accuracy, especially with its huge aging population, these partnerships act as catalysts to enable growth and continued innovation in product development and market competitiveness.
For instance, in January 2024, Fujirebio collaborated with Agappe Diagnostics Ltd., and signed a CDMO agreement for Cartridge based CLIA system reagents. The company has planned to sell this products under the brand name of Agappe.
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A description of the leading segments in the immunoassay CDMO industry is provided in this section. The manufacturing and production segment held 52.8% of the value share in 2024. Based on the end user, diagnostic companies hold 48.2% of the market in 2024.
| By Services | Value Share (2025) |
|---|---|
| Manufacturing and Production | 52.8% |
The manufacturing and production segment holds the highest market share in the immunoassay CDMO market, as it covers manufacturing and production services associated with large-scale production requirements. Immunoassays cover diagnostic kits, reagents, and testing platforms whose assembly depends on specialized manufacturing processes to address aspects of scalability, consistency, and strict regulatory compliance related to good manufacturing practices.
CDMOs provide critical manufacturing for the synthesis of reagents, formulation of assays, and assembly of kits while maintaining cost-effectiveness and speed to market. This makes manufacturing the prime service for customers in diagnostics, where scale and quality of production are important to reach the increasing diagnostic demands in the global market. Due to this fact, manufacturing and production take the largest share in the immunoassay CDMO market.
| End User | Value Share (2025) |
|---|---|
| Diagnostic Companies | 48.2% |
The diagnostic companies segment accounts for the major share of the immunoassay CDMO market owing to the ever-growing demand for diagnosis tests in different healthcare verticals. Immunoassays play an important role in disease detection, treatment monitoring, and routine testing. The growing demand of diagnostic kit drives up the demand for immunoassay-based diagnostic products.
Outsourcing of manufacturing products, analytical services to CDMOs allows diagnostic companies to access to advanced manufacturing capabilities, and regulatory expertise, at cost-effective rates. It also saves up on their heavy investment required for in-house production.
This factors enables them to a quicker time-to-market and scalability, and allows them to remain competitive in the market. Furthermore, the increasing demand for personalized medicine and point-of-care testing further raises the demand for immunoassay services, making the segment dominant in the market.
These section provides competitive landscape of the immuoassay CDMO industry outlook. Competitor players such as Phillips Medisize, Sanner GmbH, Stevanato Group, Thermo Fisher Scientific Inc and Fujirebio Holdings, Inc. holds the majority of the shares of the market as they are known for their wide range of product portfolio and advanced technologies in the market.
Moreover, Strategic partnerships, acquisitions, and global market reach are key strategies that are being adopted by the other key players operating in the market. Diversification of existing players into providing related services such as contract manufacturing further enhances competitiveness. Whereas, growing adoption of innovative technologies for accelerating the manufacturing and R&D process further anticipates the growth of the market in near future.
Recent Industry Developments in the Immunoassay CDMO Market
In terms of services, the industry is segregated into assay development and optimization, formulation and stability testing, analytical services, manufacturing and production, others
In terms of company size, the industry is segregated into small companies, mid-size companies and large companies
In terms of end user, the industry is segmented into biotech companies, pharmaceutical companies and diagnostic companies
Key countries of North America, Latin America, Western Europe, Eastern Europe, South Asia, East Asia, Middle East, and Africa have been covered in the report.
Immunoassay CDMO are expected to increase at a CAGR of 8.9% between 2025 and 2035.
The manufacturing and production segment is expected to occupy a 52.8% market share in 2024.
The market for immunoassay CDMO is expected to reach USD 26,528.5 million by 2035.
The United States is forecast to see a CAGR of 4.7% during the assessment period.
The key players in the immunoassay CDMO industry include Sanner GmbH, Stevanato Group, Thermo Fisher Scientific Inc, Phillips Medisize, Merck KgaA, Fujirebio Holdings, Inc and others.
| Estimated Market Size, 2024 | USD 24,027.9 million |
|---|---|
| Projected Market Size, 2034 | USD 41,938.9 million |
| Value-based CAGR (2024 to 2034) | 5.8% |
| Market Value (2023) | USD 2,616.1 million |
|---|---|
| Expected Forecast Value (2033) | USD 5,303.1 million |
| Projected CAGR (2023 to 2033) | 7.3% |
| Market Value (2023) | USD 22.5 billion |
|---|---|
| Market Expected Value (2033) | USD 39.4 billion |
| Market Projected CAGR (2023 to 2033) | 5.7% |
| Market Size (2022E) | USD 29.51 Billion |
|---|---|
| Market Projected Size (2032F) | USD 45.78 Billion |
| Value CAGR (2022 to 2032) | 5% CAGR |
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Immunoassay CDMO Market
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