IVD Contract Manufacturing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Device Type (IVD Equipment, IVD Consumables), By Technology (Immunoassay, Clinical Chemistry, Molecular Diagnostics, Microbiology, Hematology, Coagulation & Hemostasis, Others), By Service Type (Manufacturing Services, Assay Development Services, Other Services), By Region, and By Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 19.52 Billion
CAGR (2026-2031)	11.71%
Fastest Growing Segment	Immunoassay
Largest Market	North America
Market Size (2031)	USD 37.93 Billion

Market Overview

The Global IVD Contract Manufacturing Market will grow from USD 19.52 Billion in 2025 to USD 37.93 Billion by 2031 at a 11.71% CAGR. The Global IVD Contract Manufacturing Market entails the outsourcing of production processes for in vitro diagnostic tests, reagents, and instruments to specialized third-party entities to ensure regulatory compliance and operational efficiency. The primary drivers supporting market growth include the rising global prevalence of chronic and infectious diseases, which necessitates scalable testing solutions and high-volume production capabilities. Additionally, original equipment manufacturers are increasingly motivated by cost pressures to engage external partners, thereby reducing capital expenditure on facilities while mitigating supply chain risks.

However, a significant challenge impeding market expansion is the intensifying stringency of international regulatory frameworks, which creates compliance bottlenecks and financial strain. The transition to rigorous standards demands extensive clinical evidence and documentation, disproportionately affecting manufacturing timelines. According to MedTech Europe, in 2024, certification and maintenance costs under the new In Vitro Diagnostic Regulation escalated by up to 100% compared to previous directives. This substantial increase in regulatory expenditure forces manufacturers to divert critical resources, potentially stalling innovation and delaying the entry of essential diagnostic products into the market.

Key Market Drivers

Escalating prevalence of chronic and infectious diseases serves as a critical growth engine for the Global IVD Contract Manufacturing Market, necessitating unprecedented scalability in diagnostic production. As the burden of non-communicable diseases and viral outbreaks intensifies, original equipment manufacturers are compelled to leverage contract manufacturing organizations to manage surging testing volumes without overextending internal capacities. This demand is quantitatively evidenced by the rising trajectory of disease incidence. According to the American Cancer Society, January 2024, in the 'Cancer Facts & Figures 2024', new cancer cases in the United States are projected to cross the 2 million mark for the first time. Such elevated disease burdens directly translate into higher manufacturing throughput requirements for diagnostic assays and reagents, solidifying the role of third-party producers in ensuring continuous market supply.

Simultaneously, a strategic OEM shift towards core competencies and R&D optimization is fundamentally reshaping the sector, as companies seek cost efficiency by outsourcing fabrication. Manufacturers are increasingly decoupling innovation from production to allocate financial resources toward high-value discovery phases rather than fixed manufacturing assets. According to Roche, February 2024, in the 'Annual Report 2023', the Diagnostics Division allocated CHF 1.7 billion specifically to research and development to accelerate portfolio expansion. This heavy investment in intellectual property compels firms to utilize external partners for operational execution to maintain balance sheet flexibility. Furthermore, infrastructure expansion reflects this broader industry push for capacity; according to Sysmex Corporation, in 2024, the company announced the establishment of a new reagent manufacturing facility in India with an investment of approximately 3 billion JPY, highlighting the growing scale of diagnostic production networks.

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Key Market Challenges

The intensifying stringency of international regulatory frameworks presents a formidable obstacle to the growth of the Global IVD Contract Manufacturing Market. As regulatory bodies enforce more rigorous standards, contract manufacturing organizations are compelled to invest heavily in upgraded quality management systems and extensive documentation capabilities to maintain compliance. This necessity diverts capital and personnel away from production scalability and technological enhancements, directly impacting operational efficiency. Consequently, the onboarding process for new diagnostic products becomes protracted, causing significant delays in the transition from development to mass production and limiting the agility of manufacturers to respond to urgent health demands.

These regulatory bottlenecks create prolonged periods of uncertainty where manufacturing capacity remains underutilized while awaiting approvals, effectively freezing potential revenue streams. According to MedTech Europe, in 2024, the average time required for in vitro diagnostic manufacturers to complete Quality Management System or Technical Documentation Assessment certification was approximately 18 months. This extended duration restricts the ability of contract manufacturers to execute high-volume orders promptly, thereby stalling market momentum and reducing the attractiveness of outsourcing for original equipment manufacturers who require rapid speed-to-market for their diagnostic solutions.

Key Market Trends

The Implementation of Smart Factory Automation and Industry 4.0 Technologies is revolutionizing production lines by integrating robotics and real-time data analytics to enhance precision and minimize human error. Contract manufacturing organizations are increasingly deploying interconnected systems that monitor critical quality attributes during the fabrication of complex diagnostic kits, ensuring strict adherence to release criteria without compromising throughput speed. This technological evolution is driven by the necessity to handle micro-volume reagents and intricate assembly processes with absolute reproducibility, moving beyond traditional mechanization. According to bioMérieux, March 2025, in the '2024 Financial Results', the company reported capital expenditures of €346 million, with a significant portion allocated specifically to the expansion and automation of its manufacturing capacities in the United States to support operational advancement.

Increasing Adoption of Nearshoring and Localized Manufacturing Strategies is fundamentally altering the geographic footprint of the market as companies prioritize supply chain resilience over purely low-cost labor models. To mitigate the risks associated with cross-border logistics and geopolitical instability, original equipment manufacturers are establishing regional production hubs that reside closer to end-users, thereby drastically reducing lead times and inventory vulnerabilities. This strategic decentralization allows firms to respond more swiftly to regional health crises and changing local regulatory requirements compared to centralized global models. According to Thermo Fisher Scientific, April 2025, in a press release detailing strategic growth, the firm committed an additional $2 billion investment in the United States over four years specifically to enhance domestic manufacturing operations and support a resilient local healthcare supply chain.

Segmental Insights

The Immunoassay segment currently represents the fastest-growing category within the Global IVD Contract Manufacturing Market, driven by the escalating demand for high-sensitivity diagnostic testing for infectious diseases and oncology. Original Equipment Manufacturers are increasingly outsourcing production to leverage the specialized technical expertise required for complex formats such as ELISA and lateral flow assays. Furthermore, strict quality compliance mandates from regulatory bodies like the US Food and Drug Administration necessitate partnerships with established contract manufacturers who possess the requisite validated facilities. This strategic outsourcing enables diagnostic companies to accelerate time-to-market while managing operational costs effectively.

Regional Insights

North America maintains a leading position in the Global IVD Contract Manufacturing Market, driven by a concentration of major original equipment manufacturers and established healthcare infrastructure. The region benefits from high demand for diagnostic testing and rigid quality standards enforced by the U.S. Food and Drug Administration, prompting companies to outsource production to compliant partners. Additionally, significant investment in research and development within the United States fosters reliance on contract manufacturers to navigate complex regulatory pathways and accelerate product availability without compromising quality.

Recent Developments

• In September 2024, the parent company of Phillips-Medisize announced a definitive agreement to acquire Vectura Group Limited, a specialist in inhalation drug delivery solutions. This acquisition was strategically designed to enhance Phillips-Medisize's existing capabilities in the contract development and manufacturing of drug delivery devices and in vitro diagnostic products. By integrating Vectura’s expertise in formulation and device design, the company aimed to offer a comprehensive suite of services to pharmaceutical and medtech customers, ranging from initial concept to commercial production. This move represented a significant expansion of its technical competencies and global footprint within the regulated medical manufacturing market.
• In August 2024, STRATEC SE reported the successful achievement of a concluding development milestone for customer products in the field of transfusion diagnostics. The company, a specialized partner for the development and manufacturing of analyzer systems, highlighted this technical breakthrough as a key component of its progress in the first half of the year. This milestone was part of a broader effort to advance automation solutions for the in vitro diagnostics industry. Furthermore, the company disclosed that it had pressed ahead with numerous other projects and entered into new agreements for development cooperations, reinforcing its role in driving innovation for its OEM partners.
• In April 2024, Sysmex Corporation and Siemens Healthineers announced the commencement of a mutual Original Equipment Manufacturer (OEM) supply initiative to distribute their combined portfolio of hemostasis testing solutions. Under this arrangement, both companies began distributing hemostasis instruments and reagents under their respective brands in the United States and European Union countries. This operational launch followed a global OEM agreement concluded the previous year and was intended to strengthen their market presence by leveraging complementary manufacturing strengths. The collaboration aimed to provide clinical laboratories with a broader range of effective hemostasis diagnostic products through a unified global supply chain strategy.
• In January 2024, Fujirebio Holdings, Inc. and Agappe Diagnostics Ltd entered into a strategic Contract Development and Manufacturing Organization (CDMO) partnership aimed at advancing cartridge-based CLIA system reagents. This collaboration was established to combine Fujirebio’s expertise in equipment and raw materials with Agappe’s reagent development and manufacturing capabilities, specifically to serve the growing Indian market. The initiative was designed to expedite the launch of a complete chemiluminescence solution under the Agappe brand, incorporating novel biomarkers for neurodegenerative diseases. This partnership underscored the increasing reliance on CDMO collaborations to expand advanced immunoassay solutions in rapidly developing global regions.

Key Market Players

• Thermo Fisher Scientific Inc.
• Siemens Healthineers AG
• Danaher Corporation
• F. Hoffmann-La Roche Ltd.
• Ortho Clinical Diagnostics
• Abbott Laboratories
• Bio-Rad Laboratories, Inc.
• Sysmex Corporation
• Quidel Corporation
• BioMérieux SA

By Device Type	By Technology	By Service Type	By Region
IVD Equipment IVD Consumables	Immunoassay Clinical Chemistry Molecular Diagnostics Microbiology Hematology Coagulation & Hemostasis Others	Manufacturing Services Assay Development Services Other Services	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global IVD Contract Manufacturing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• IVD Contract Manufacturing Market, By Device Type:

• IVD Equipment
• IVD Consumables

• IVD Contract Manufacturing Market, By Technology:

• Immunoassay
• Clinical Chemistry
• Molecular Diagnostics
• Microbiology
• Hematology
• Coagulation & Hemostasis
• Others

• IVD Contract Manufacturing Market, By Service Type:

• Manufacturing Services
• Assay Development Services
• Other Services

• IVD Contract Manufacturing Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE