IVD Contract Manufacturing Market Report Scope & Overview:

IVD Contract Manufacturing Market was valued at USD 21.61 billion in 2025E and is expected to reach USD 43.79 billion by 2033, growing at a CAGR of 9.31% from 2026-2033. 

The IVD Contract Manufacturing Market is growing due to increasing demand for in vitro diagnostic products and the rising trend of outsourcing production to specialized manufacturers. Growth is driven by the need to reduce costs, improve efficiency, and accelerate time-to-market for diagnostic kits and devices. Advancements in automation, quality control, and regulatory compliance, coupled with rising prevalence of chronic diseases and infectious conditions, are further boosting adoption of contract manufacturing services across the healthcare and diagnostics industry.

In 2024, global IVD contract manufacturing grew by 16%, with 60% of diagnostic firms outsourcing production to cut costs by 25% and accelerate launch timelines by 35%, fueled by rising chronic and infectious disease testing needs.

IVD Contract Manufacturing Market Size and Forecast

• Market Size in 2025E: USD 21.61 Billion

• Market Size by 2033: USD 43.79 Billion

• CAGR: 9.31% from 2026 to 2033

• Base Year: 2025E

• Forecast Period: 2026–2033

• Historical Data: 2022–2024

IVD Contract Manufacturing Market Trends

• Growing outsourcing of assay development and instrument production as IVD companies prioritize faster commercialization and reduced internal manufacturing burden

• Rising demand for customized reagent formulation and bulk consumables driven by expansion of molecular diagnostics and point-of-care testing

• Increasing adoption of automation and robotics in contract facilities to support high-volume, precision-driven diagnostic manufacturing workflows

• Expansion of OEM partnerships for end-to-end services, including design, prototyping, validation, regulatory support, and scalable production

• High focus on quality management and regulatory compliance as global manufacturers align with evolving FDA and IVDR requirements

• Growth of contract manufacturing for infectious disease, oncology, and genetic testing owing to increased clinical testing volumes

U.S. IVD Contract Manufacturing Market was valued at USD 8.09 billion in 2025E and is expected to reach USD 16.05 billion by 2033, growing at a CAGR of 9.01% from 2026-2033. 

Growth in the U.S. IVD Contract Manufacturing Market is driven by increasing demand for in vitro diagnostic products and the outsourcing of manufacturing to reduce costs and accelerate time-to-market. Advancements in automation, quality standards, and rising prevalence of chronic and infectious diseases are further supporting market expansion.

IVD Contract Manufacturing Market Growth Drivers:

• Rising demand for diagnostic tests and increasing outsourcing by IVD companies to reduce development costs and accelerate time-to-market are driving contract manufacturing growth

The global surge in demand for diagnostic testing especially for infectious diseases, chronic conditions, and preventive screening has led IVD manufacturers to rely more heavily on outsourcing partners. Contract manufacturing helps companies reduce operational costs, streamline product development, and shorten regulatory timelines. With rising pressure to introduce new test kits and instruments rapidly, outsourcing offers scalability, access to specialized technologies, and efficient production capabilities. This collaborative model enables IVD developers to focus on core competencies like R&D and commercialization while delegating high-precision manufacturing to specialized partners, accelerating global market growth.

In 2024, over 55% of IVD companies increased outsourcing to contract manufacturers, reducing development costs by up to 25% and cutting time-to-market by 35% amid surging global diagnostic test demand.

• Growing prevalence of chronic and infectious diseases worldwide is boosting production of reagents, consumables, and analyzers through specialized IVD contract manufacturers

Increasing rates of diabetes, cancer, cardiovascular disorders, and infectious diseases have significantly increased demand for advanced diagnostics to enable early and accurate disease detection. This surge has expanded the need for test kits, reagents, and automated analyzers manufactured through cost-efficient outsourcing partnerships. Contract manufacturers offer expertise in high-volume production while adhering to strict regulatory guidelines and quality standards. As hospitals, laboratories, and point-of-care settings adopt more diagnostic tools, IVD manufacturing partners are playing a critical role in meeting global supply needs and supporting scalable production.

In 2024, global demand for IVD reagents and analyzers rose by 18%, driven by surging chronic and infectious disease testing, with specialized contract manufacturers reporting a 30% increase in production volumes to meet diagnostic needs.

IVD Contract Manufacturing Market Restraints:

• Strict regulatory approvals, complex compliance requirements, and frequent quality audits increase operational challenges and time delays for IVD contract manufacturers

IVD manufacturing operates under stringent regulatory environments across regions, including FDA, EU IVDR, and other national standards. Compliance requires extensive documentation, validation, audits, and continuous quality control, adding complexity and increasing overall cost and lead time. These regulations also lengthen product development cycles and demand significant investment in regulatory expertise and facility upgrades. Any delay or non-compliance can lead to product recalls or approval rejection, reducing profitability. Consequently, the regulatory burden acts as a major barrier for manufacturers and slows down entry for new and smaller firms.

In 2024, 70% of IVD contract manufacturers faced delays of 4 months due to stringent regulatory reviews, with compliance and audit-related costs consuming up to 25% of operational budgets globally.

• High capital investment in advanced manufacturing facilities and skilled workforce limits market entry and expansion for small and mid-sized manufacturers

IVD manufacturing requires sophisticated equipment, clean-room setups, precision robotics, and biotechnology-trained talent to ensure accuracy and regulatory compliance. Establishing and maintaining such infrastructure demands heavy capital expenditure, which can be prohibitive for small and mid-sized companies. Additionally, global competition and the constant need for technological upgrades further strain financial resources. Without substantial investment, smaller organizations struggle to secure large-scale contracts, limiting their growth and participation in the market. This challenge contributes to the dominance of large contract manufacturers and slows industry diversification.

In 2024, over 50% of small and mid-sized IVD manufacturers cited capital costs exceeding USD10 million for advanced facilities and shortages of skilled labor as key barriers to scaling or entering the market.

IVD Contract Manufacturing Market Opportunities:

• Rising adoption of molecular diagnostics, point-of-care testing, and personalized medicine creates new opportunities for specialized IVD contract manufacturing services

Advancements in genomic profiling, rapid diagnostics, and decentralized testing have opened strong growth prospects for contract manufacturers specializing in next-generation technologies. Molecular diagnostics and personalized medicine require high-precision production of reagents and devices tailored to individual patient profiles. Point-of-care systems further demand compact, user-friendly platforms with fast turnaround times. IVD manufacturers with expertise in microfluidics, biomarker detection, assay development, and multiplex testing are well-positioned to secure long-term partnerships. Demand is accelerating as healthcare systems shift toward early disease detection, remote monitoring, and preventive care.

In 2024, 60% of IVD contract manufacturers expanded capabilities in molecular and POC diagnostics, with demand for personalized medicine driving a 35% increase in specialized outsourcing partnerships globally.

• Growing demand for automation, smart manufacturing, and digital quality control enables IVD manufacturers to scale globally and improve production efficiency

Technologies such as AI-driven process monitoring, robotics, IoT-enabled equipment tracking, and digital batch record systems are transforming IVD production. These systems improve accuracy, reduce manual errors, and accelerate regulatory documentation while lowering operational costs. Automation also allows manufacturers to rapidly scale production to meet fluctuating global demand—especially for high-volume consumables and rapid diagnostic kits. Digital platforms enhance traceability, support predictive maintenance, and streamline supply chain coordination. As diagnostic companies seek cost-efficient, high-throughput partners, contract manufacturers adopting advanced automation stand to gain significant competitive advantages.

In 2024, 65% of IVD manufacturers invested in smart manufacturing, achieving 30% higher production efficiency and 25% faster time-to-market through automated, AI-driven quality control and digital workflow integration.

IVD Contract Manufacturing Market Segment Highlights

• By Product: In 2025, Reagents & Consumables dominated the market with 62% share, while Software & Services is projected to grow at the fastest CAGR from 2026–2033.

• By Service: In 2025, Manufacturing Services dominated the market with 68% share, while Assay Development Services is projected to grow at the fastest CAGR from 2026–2033.

• By Technology: In 2025, Immunoassays dominated the market with 32% share, while Molecular Diagnostics is projected to grow at the fastest CAGR from 2026–2033.

• By End-use: In 2025, Medical Device Companies dominated the market with 78% share, while Others (Startups/New Entrants) is projected to grow at the fastest CAGR from 2026–2033.

IVD Contract Manufacturing Market Segment Analysis

By Product: Reagents & Consumables segment led in 2025; Software & Services segment expected fastest growth 2026–2033

Reagents & Consumables segment dominated the IVD Contract Manufacturing Market with the highest revenue share of about 62% in 2025 due to their constant demand in diagnostic testing, high-volume clinical applications, and recurring replenishment needs. Growing infectious disease testing, routine laboratory diagnostics, and the critical role of high-quality consumables in ensuring assay accuracy have reinforced this segment’s dominance across global IVD manufacturing operations.

Software & Services segment is expected to grow at the fastest CAGR from 2026-2033 due to rising adoption of digital diagnostics, cloud-based data management, and laboratory automation. Integration of advanced analytics, AI-driven workflows, and remote diagnostic monitoring solutions is accelerating demand. Increased emphasis on smart laboratories, workflow efficiency, and interoperability among IVD platforms drives rapid market expansion in this segment.

By Service: Manufacturing Services segment led in 2025; Assay Development Services segment expected fastest growth 2026–2033

Manufacturing Services segment dominated the IVD Contract Manufacturing Market with the highest revenue share of about 68% in 2025 due to strong outsourcing trends among diagnostic companies seeking scalable, cost-efficient production. Contract manufacturers provide regulatory compliance, technical expertise, and high-volume manufacturing capabilities, enabling global IVD suppliers to optimize operations, reduce operational costs, and meet growing diagnostic demands efficiently.

Assay Development Services segment is expected to grow at the fastest CAGR from 2026-2033 due to increasing demand for customized biomarker-based tests, rapid disease screening solutions, and personalized medicine applications. Rising investments in R&D, the emergence of new pathogens, and partnerships for innovative assay design are fueling growth, making assay development a critical and fast-growing segment within IVD contract manufacturing.

By Technology: Immunoassays segment led in 2025; Molecular Diagnostics segment expected fastest growth 2026–2033

Immunoassays segment dominated the IVD Contract Manufacturing Market with the highest revenue share of about 32% in 2025 due to their broad application across infectious diseases, oncology, autoimmune disorders, and chronic disease diagnostics. High sensitivity, reproducibility, and widespread adoption in routine laboratory testing have ensured their strong market presence and continued preference among diagnostic laboratories globally.

Molecular Diagnostics segment is expected to grow at the fastest CAGR from 2026-2033 driven by increasing adoption of PCR, next-generation sequencing, and genetic testing for early disease detection and precision medicine. Rising use in oncology, infectious disease screening, and personalized treatment approaches is accelerating market demand for molecular diagnostic contract manufacturing solutions worldwide.

By End-use: Medical Device Companies segment led in 2025; Others (Startups/New Entrants) segment expected fastest growth 2026–2033

Medical Device Companies segment dominated the IVD Contract Manufacturing Market with the highest revenue share of about 78% in 2025 due to large-scale outsourcing by major diagnostic manufacturers. Outsourcing helps reduce operational costs, accelerate time-to-market, and maintain compliance with stringent regulatory standards. High-volume production requirements and product diversification have reinforced their dominant share in contract manufacturing services.

Others (Startups/New Entrants) segment is expected to grow at the fastest CAGR from 2026-2033 due to increasing outsourcing by research laboratories, biotech start-ups, and academic institutes. Limited in-house manufacturing capabilities, the need for innovative diagnostic solutions, and growing adoption of specialty assays are driving demand, making this segment a fast-growing contributor to the IVD contract manufacturing market.

IVD Contract Manufacturing Market Regional Analysis

North America IVD Contract Manufacturing Market Insights

North America dominated the IVD Contract Manufacturing Market with a 43% share in 2025 due to the presence of leading in vitro diagnostic manufacturers, advanced healthcare infrastructure, and high adoption of outsourced manufacturing solutions. Strong R&D capabilities, favorable regulatory support, and growing demand for diagnostic tests further reinforced the region’s market leadership.

Asia Pacific IVD Contract Manufacturing Market Insights

Asia Pacific is expected to grow at the fastest CAGR of about 11.36% from 2026–2033, driven by rising demand for affordable diagnostic solutions, expanding healthcare infrastructure, and increasing prevalence of chronic and infectious diseases. Growing investments in IVD manufacturing facilities, favorable government initiatives, and expanding medical device outsourcing trends accelerate market growth across the region.

Europe IVD Contract Manufacturing Market Insights

Europe held a significant share in the IVD Contract Manufacturing Market in 2025, supported by a strong presence of established diagnostic companies, advanced healthcare infrastructure, and well-regulated manufacturing standards. High adoption of outsourced production, ongoing R&D in innovative diagnostic assays, and growing demand for high-quality IVD products further strengthened Europe’s market position.

Middle East & Africa and Latin America IVD Contract Manufacturing Market Insights

The Middle East & Africa and Latin America together showed steady growth in the IVD Contract Manufacturing Market in 2025, driven by expanding healthcare infrastructure, rising prevalence of chronic and infectious diseases, and growing demand for affordable diagnostic solutions. Increasing outsourcing of IVD production, government support, and investments in medical technology further strengthened the regions’ emerging market presence.

IVD Contract Manufacturing Market Competitive Landscape:

TCS Biosciences Ltd.

TCS Biosciences Ltd. is a UK-based company specializing in the manufacturing of high-quality biological products, reagents, and kits for the in-vitro diagnostics (IVD) and life sciences markets. The company provides contract manufacturing solutions, including assay development, reagent production, and quality testing, supporting global diagnostic companies. Known for its stringent quality standards, TCS Biosciences emphasizes regulatory compliance and scalable manufacturing. Its services cater to both small biotech firms and large multinational IVD corporations seeking reliable and efficient production partnerships.

• 2024, TCS Biosciences launched “TCS Rapid Path”, a CE-marked point-of-care immunoassay platform for infectious disease testing (including RSV, influenza, and SARS-CoV-2) that delivers lab-quality results in under 15 minutes using a single drop of whole blood.

Invetech Inc.

Invetech Inc., headquartered in the United States, is a leading provider of automated solutions and contract manufacturing services for the in-vitro diagnostics (IVD) industry. The company specializes in instrument development, high-throughput automation, and device assembly, combining engineering expertise with regulatory knowledge to deliver end-to-end manufacturing solutions. Invetech collaborates closely with IVD developers to streamline production, enhance efficiency, and accelerate time-to-market. Its reputation for innovation, flexibility, and adherence to global regulatory standards makes it a trusted partner for diagnostic manufacturers worldwide.

• 2025, Invetech announced the launch of “Invetech Flex Cell”, a modular, GMP-compliant cell therapy manufacturing platform designed for decentralized production of CAR-T and regenerative medicines. The system supports closed, automated workflows for academic medical centers and biotech’s with limited cleanroom space.

Bio-Techne Corp.

Bio-Techne Corporation is a global life sciences company offering a broad portfolio of reagents, instruments, and contract manufacturing services for the in-vitro diagnostics (IVD) and research markets. The company provides custom assay development, protein production, and antibody manufacturing under strict quality and regulatory guidelines. With advanced biomanufacturing capabilities and a focus on innovation, Bio-Techne supports IVD companies in delivering reliable diagnostic products. Its global presence and technical expertise make it a preferred partner for companies seeking scalable, compliant, and high-performance diagnostic solutions.

• 2023, Bio-Techne launched “Simple Western Auto”, an automated capillary-based immunoassay system that enables high-throughput, reproducible protein characterization with 90% less sample volume than traditional Western blotting. The platform is designed for biopharma QC and research labs.

IVD Contract Manufacturing Market Key Players

Some of the IVD Contract Manufacturing Market Companies are:

• Thermo Fisher Scientific

• Jabil Inc.

• Sanmina Corporation

• TE Connectivity Ltd.

• Celestica Inc.

• West Pharmaceutical Services Inc.

• Merck KGaA

• Savyon Diagnostics

• TCS Biosciences Ltd.

• Invetech Inc.

• Bio-Techne Corp.

• Nova Biomedical

• Cone Bioproducts

• Maxim Biomedical Inc.

• Avioq Inc.

• Meridian Bioscience Inc.

• Coris BioConcept

• Cenogenics Corporation

• KMC Systems Inc.

• Fujirebio