Diagnostic Contract Manufacturing Market Report 2025 – For Visionary Product and Strategy Executives

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What is the projected market size of the diagnostic contract manufacturing industry, and what is its expected CAGR?
The diagnostic contract manufacturing market size has grown rapidly in recent years. It will grow from $31.29 billion in 2024 to $35.91 billion in 2025 at a compound annual growth rate (CAGR) of 14.7%. The growth in the historic period can be attributed to increasing demand for outsourcing, cost efficiency achieved through outsourcing manufacturing, increasing regulatory requirements for quality and compliance in the diagnostic industry, shortened product lifecycles in the diagnostic market necessitated flexible manufacturing solutions, and globalization of diagnostic companies' operations and supply chains increasing.

The diagnostic contract manufacturing market size is expected to see rapid growth in the next few years. It will grow to $61.46 billion in 2029 at a compound annual growth rate (CAGR) of 14.4%. The growth in the forecast period can be attributed to increasing demand for personalized diagnostic tests and companion diagnostics, expansion of point-of-care testing and decentralized diagnostic platforms, tightening regulatory requirements for diagnostic products, increase in outsourcing of specialty testing, such as molecular diagnostics and immunoassays, and shift towards flexible manufacturing. Major trends in the forecast period include adoption of automation and robotics in diagnostic manufacturing processes, utilization of 3D printing technologies for rapid prototyping and customization of diagnostic devices, integration of artificial intelligence (AI) and data analytics into diagnostic manufacturing processes, and implementation of digital twin technology to simulate and optimize manufacturing processes in the virtual environment before physical implementation.

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What external factors are influencing the diagnostic contract manufacturing market’s growth momentum?
An increasing focus on preventive healthcare is expected to propel the growth of the diagnostic contract manufacturing market going forward. Preventive healthcare refers to measures taken to prevent the occurrence or development of disease, illness, or injury. The focus on preventive healthcare is due to rising healthcare costs, shifts in healthcare priorities, a rise in chronic diseases, and population aging. Diagnostic contract manufacturing contributes to increasing the focus on preventive healthcare by providing essential diagnostic tools and tests, offering customized solutions, ensuring quality and regulatory compliance, supporting scalability, and enabling cost-effective solutions for disease prevention and early intervention. For instance, in March 2022, according to the 2021–2030 National Health Expenditure (NHE) report published by the Centers for Medicare & Medicaid Services, a US-based Department of Health and Human Services department, the annual increase in national health spending was predicted to average 5.1% between 2021 and 2030, reaching approximately $6.8 trillion by 2030. Therefore, an increasing focus on preventive healthcare drives the diagnostic contract manufacturing market.

What are the major market segments driving the growth of the diagnostic contract manufacturing industry?
The diagnostic contract manufacturing market covered in this report is segmented –

1) By Service: Device Development And Manufacturing Services, Quality Management Services, Packaging And Assembly Services, Other Services
2) By Application: In Vitro Diagnostic Devices, Diagnostic Imaging Devices, Other Applications
3) By End User: Medical Device Companies, Pharmaceutical And Biopharmaceutical Companies, Other End Users

Subsegments:
1) By Device Development And Manufacturing Services: Product Design And Prototyping, Regulatory Affairs And Compliance, Manufacturing And Assembly, Testing And Validation
2) By Quality Management Services: Quality Control And Assurance, Auditing And Inspection Services, Risk Management, Compliance And Certification Support
3) By Packaging And Assembly Services: Primary Packaging, Secondary Packaging, Sterilization Services, Custom Packaging Solutions
4) By Other Services: Supply Chain Management, Inventory Management, Logistics And Distribution, Aftermarket Services


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How are emerging trends transforming the diagnostic contract manufacturing market dynamics?
Major companies operating in the diagnostic contract manufacturing market are adopting a strategic partnership approach to support the production of diagnostic equipment and gain a competitive advantage. A strategic partnership typically refers to a collaborative relationship between two or more organizations combining their resources, expertise, and efforts to achieve common goals or objectives. For instance, in July 2022, Highfield Diagnostics Ltd., a UK-based diagnostics company, collaborated with SCIENION GmbH, a Germany-based bio convergence company offering diagnostic contract manufacturing services, for the development and deployment of equipment for mass manufacturing lateral flow tests (LFTs) incorporating HDx's flowDx technology. The collaboration aims to utilize SCIENION's manufacturing capabilities to finalize equipment designs and manufacturing processes for cost-effective and high-throughput production of flowDx-enabled LFTs. flowDx technology, developed over seven years of academic research, enables precise control of fluidic flows in LFTs, allowing for parallel multiplexing, enhanced accuracy, and semi-quantitative results.

Who are the key market players contributing to the growth of the diagnostic contract manufacturing industry?
Major companies operating in the diagnostic contract manufacturing market are Thermo Fisher Scientific Inc., Abbott Laboratories, Jabil Inc., Flex Ltd., Becton Dickinson and Company (BD), TE Connectivity Ltd., Sekisui Diagnostics LLC, Sanmina Corporation, Celestica Inc., Nipro Medical Corporation, Philips-Medisize Corporation, Plexus Corp, West Pharmaceutical Services Inc., Benchmark Electronics Inc., Bio-Rad Laboratories, QIAGEN N.V., Kimball Electronics Inc., Integer Holdings Corporation, Bio-Techne Corporation, Nolato AB, Nova Biomedical Corporation, Meridian Bioscience Inc., Fujirebio Inc., Biokit S.A., Invetech Pty. Ltd., KMC Systems, Savyon Diagnostics Ltd., Prestige Diagnostics U.K. Ltd., Cenogenic Corporation, Avioq Inc.

Which regions are leading the growth of the diagnostic contract manufacturing market globally?
North America was the largest region in the diagnostic contract manufacturing market in 2023. The regions covered in the diagnostic contract manufacturing market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

How Can Companies Use The Diagnostic Contract Manufacturing Market Report to Drive Business Results?
This report provides actionable insights tailored for business use—not academic analysis. Companies can leverage the data to:
• Time market entry or expansion using growth forecasts and CAGR trends.
• Develop competitive products by tracking key technology shifts and user preferences.
• Tailor regional strategies with in-depth geographic data and local market dynamics.
• Benchmark and plan partnerships using competitive landscape insights.

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