Diagnostic Contract Manufacturing

Global Diagnostic Contract Manufacturing Market to Reach US$44.3 Billion by 2030

The global market for Diagnostic Contract Manufacturing estimated at US$27.8 Billion in the year 2024, is expected to reach US$44.3 Billion by 2030, growing at a CAGR of 8.1% over the analysis period 2024-2030. In-Vitro Diagnostic Devices, one of the segments analyzed in the report, is expected to record a 8.8% CAGR and reach US$25.5 Billion by the end of the analysis period. Growth in the Diagnostics Imaging Devices segment is estimated at 6.7% CAGR over the analysis period.

The U.S. Market is Estimated at US$7.6 Billion While China is Forecast to Grow at 12.7% CAGR

The Diagnostic Contract Manufacturing market in the U.S. is estimated at US$7.6 Billion in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$9.6 Billion by the year 2030 trailing a CAGR of 12.7% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 4.0% and 7.8% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 5.4% CAGR.

Global Diagnostic Contract Manufacturing Market – Key Trends & Drivers Summarized

Why Is Contract Manufacturing Becoming Essential in the Diagnostics Industry?

Contract manufacturing has become a pivotal component of the diagnostics industry, enabling diagnostic companies to rapidly scale production, reduce time-to-market, and optimize operational costs. As diagnostic technologies diversify—ranging from point-of-care (PoC) and molecular diagnostics to immunoassays and rapid antigen tests—the complexity and volume of production have increased significantly. Outsourcing manufacturing allows diagnostic developers to focus on core competencies such as assay development, regulatory approvals, and commercialization while leveraging the technical, regulatory, and supply chain expertise of specialized contract manufacturing organizations (CMOs).

The surge in demand for diagnostic kits and devices—particularly in the wake of global public health emergencies—has intensified reliance on CMOs for high-capacity, scalable, and quality-controlled production. Smaller diagnostic startups, as well as established in-vitro diagnostics (IVD) companies, are increasingly partnering with contract manufacturers to access advanced infrastructure, reduce capital investment, and maintain regulatory compliance in multiple geographies. This outsourcing model also supports rapid response to emerging disease outbreaks and ensures manufacturing continuity across fluctuating demand cycles.

How Are Technological Capabilities and Regulatory Expertise Enhancing CMO Value Propositions?

Modern CMOs offer end-to-end diagnostic manufacturing services that span reagent formulation, lyophilization, kit assembly, device fabrication, packaging, sterilization, and logistics. These services are supported by advanced technologies such as microfluidics integration, automated filling and sealing systems, lab-on-a-chip platform assembly, and cleanroom-based production environments. Such capabilities enable the production of highly sensitive and complex diagnostic tools, including lateral flow assays, PCR-based test kits, and digital diagnostic devices.

In addition to technical capabilities, regulatory compliance is a critical advantage provided by leading CMOs. Manufacturers with ISO 13485 certification and FDA-registered facilities ensure adherence to Good Manufacturing Practices (GMP), Quality System Regulations (QSR), and country-specific regulatory protocols. Their familiarity with CE marking, EUA procedures, and IVD regulatory frameworks across global markets reduces the burden on diagnostic companies and helps accelerate time-to-market. Integrated quality assurance, validation, and documentation services also support product audits and clinical trial material production.

What Market Trends Are Shaping Demand for Diagnostic Contract Manufacturing Services?

The rise of decentralized diagnostics—driven by trends such as at-home testing, wearable diagnostics, and mobile-connected PoC solutions—is expanding the complexity of manufacturing requirements. Diagnostic firms are now outsourcing the production of compact, user-friendly, and digitally integrated testing kits that require specialized expertise in electronics, biosensors, and packaging engineering. Additionally, the expansion of multiplex diagnostics and combination testing (e.g., flu-COVID panels) is pushing CMOs to handle intricate reagent formulations and multi-analyte test formats.

Pharma-diagnostics collaborations are also driving demand, particularly for companion diagnostics (CDx) that must be co-developed and co-manufactured alongside therapeutic agents. These require stringent coordination, precision manufacturing, and regulatory alignment. Furthermore, global supply chain disruptions have highlighted the need for geographically diversified and risk-resilient manufacturing networks, prompting diagnostic companies to adopt multi-site and dual-sourcing strategies—frequently supported through CMO partnerships.

What Are the Key Drivers Accelerating Growth in the Diagnostic Contract Manufacturing Market?

The growth in the diagnostic contract manufacturing market is driven by several factors, including rising demand for scalable and compliant manufacturing solutions, rapid advancements in diagnostic technologies, and the increasing outsourcing of non-core functions by diagnostic companies. As the global IVD and PoC testing markets continue to expand—fueled by infectious disease surveillance, chronic disease monitoring, and personalized medicine—the need for high-throughput, quality-assured manufacturing infrastructure is growing.

Cost optimization, faster product deployment, and reduced regulatory risks are prompting diagnostic firms to outsource development and production processes. The emergence of small and mid-sized diagnostic innovators, supported by venture funding and technology accelerators, further expands the addressable market for CMOs. Additionally, regulatory tightening across major markets has increased the importance of specialized manufacturing partners with proven compliance records. As diagnostics become more integrated into public health, disease prevention, and precision medicine, the diagnostic contract manufacturing sector is poised for robust, sustained growth globally.

SCOPE OF STUDY:

The report analyzes the Diagnostic Contract Manufacturing market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:
Product (In-Vitro Diagnostic Devices, Diagnostics Imaging Devices, Other Products); Service (Device Development & Manufacturing Service, Quality management Services, Packing & Assembly Services, Other Services); Application (Infectious Disease Application, Diabetes Application, Oncology Application, Cardiology Application, Other Applications)

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa.

Select Competitors (Total 34 Featured) -

• Abbott Laboratories
• Abingdon Health
• Almac Group
• ANP Technologies
• Argonaut Manufacturing Services
• Avioq Inc.
• Becton Dickinson and Company (BD)
• Bio-Rad Laboratories
• Biokit S.A.
• Celestica Inc.
• Cenogenics Corporation
• Flex Ltd.
• Fujirebio Inc.
• Invetech Pty. Ltd.
• Jabil Inc.
• KMC Systems
• Meridian Bioscience Inc.
• Nolato AB
• Philips-Medisize Corporation
• Thermo Fisher Scientific Inc.

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