PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 1464687
PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 1464687
Diagnostic Contract Manufacturing Market size was valued at USD 26,120.21 Million in 2023, expanding at a CAGR of 11.91% from 2024 to 2032.
Diagnostic contract manufacturing refers to the practice of outsourcing the production, assembly, and packaging of diagnostic devices, kits, and Product Types to specialized manufacturing firms. These firms offer comprehensive manufacturing services tailored to the specific requirements of diagnostic companies, including design for manufacturability (DFM), prototyping, process optimization, regulatory compliance, and scale-up production. Leveraging their expertise, infrastructure, and quality systems, diagnostic contract manufacturers efficiently and cost-effectively produce high-quality diagnostic products, allowing diagnostic companies to focus on research, development, marketing, and distribution.
Diagnostic Contract Manufacturing Market- Market Dynamics
Ongoing innovations in diagnostic technologies are driving the necessity for specialized manufacturing capabilities, with IVD contract manufacturers to propel market demand
The IVD field has witnessed significant adoption of contract manufacturing services as companies aim to broaden their customer base by offering competitively priced products. A multitude of Contract Manufacturing Organizations (CMOs) is emerging in the Asia Pacific region, presenting vast opportunities for Original Equipment Manufacturers (OEMs) in the IVD sector. As per the Medical Device Outsourcing Association (MDOA), over 70% of medical device companies explored outsourcing in 2021. Consequently, the high expenses associated with in-house manufacturing of IVD products have prompted companies to consider outsourcing manufacturing. The increasing prevalence of diseases and the growing emphasis on early detection are driving a surge in demand for in vitro diagnostics (IVD), thereby fostering the expansion of the contract manufacturing market. Ongoing innovations in diagnostic technologies are driving the necessity for specialized manufacturing capabilities, with IVD contract manufacturers playing a crucial role in producing state-of-the-art diagnostic tools and equipment. The demographic transition toward an aging population is boosting the demand for diagnostic testing, creating a favorable environment for the growth of IVD contract manufacturing services The broadening scope of diagnostic tests, including molecular diagnostics and point-of-care testing, is intensifying the need for contract manufacturing services tailored to diverse and specialized diagnostic requirements. Stringent regulatory requirements in the healthcare sector are compelling IVD companies to engage contract manufacturers with established quality management systems, ensuring compliance and market access. Companies are increasingly turning to outsourcing manufacturing to streamline processes, reduce costs, and enhance operational efficiency, thereby propelling the growth of the IVD contract manufacturing market.
Diagnostic Contract Manufacturing Market- Key Insights
As per the analysis shared by our research analyst, the global market is estimated to grow annually at a CAGR of around 11.91% over the forecast period (2024-2032)
Based on Product Type segmentation, in vitro diagnostic devices was predicted to show maximum market share in the year 2023
Based on Services segmentation, device development and manufacturing services was the leading type in 2023
On the basis of region, North America was the leading revenue generator in 2023
The Global Diagnostic Contract Manufacturing Market is segmented on the basis of Product Type, Application, Services, and Region.
The market is divided into two categories based on Product Type: In vitro diagnostic devices, and diagnostic imaging devices. In vitro diagnostic devices are expected to capture the largest share of the diagnostic contract manufacturing industry by product. IVD equipment and devices are utilized for conducting laboratory tests to diagnose diseases, medical conditions, and monitor patient status, thereby commanding the highest market share during the forecast period. The accelerated development rate can be credited to the boosted acceptance of automated diagnostic tools.
The market is divided into four categories based on Services: device development and manufacturing services, quality management services, packaging and assembly services, and other services. In 2023, the device development and manufacturing services segment is projected to dominate the diagnostic devices industry by service. Diagnostic device manufacturers face significant pressure to expedite the introduction of new devices to the market and reduce production costs. Consequently, medical device manufacturing service providers are continually refining their services and exploring novel approaches to enhance production efficiency.
Diagnostic Contract Manufacturing Market- Geographical Insights
Geographically, this market is widespread into the regions of North America, Latin America, Europe, Asia Pacific, and the Middle East and Africa. These regions are further divided as per the nations bringing business.
In the Diagnostic Contract Manufacturing market, strategies revolve around providing value-added services, upholding quality standards, and cultivating long-term partnerships with diagnostic companies. Strategic partnerships entail close collaboration with clients throughout the product lifecycle, from initial concept development to commercialization, ensuring alignment with project requirements, timelines, and budget constraints. This collaborative approach enables diagnostic contract manufacturers to offer flexible manufacturing solutions, rapid prototyping, and agile responses to changing market demands. Moreover, investments in advanced manufacturing technologies, automation, and quality management systems are crucial for ensuring compliance with regulatory standards (such as FDA, ISO, and CE) and delivering consistent, high-quality products. Additionally, differentiation through specialization in niche areas, such as microfluidics, molecular diagnostics, or point-of-care testing, allows diagnostic contract manufacturers to provide specialized expertise and added value to clients. Furthermore, strategic alliances with raw material suppliers, equipment manufacturers, and distribution channels enhance supply chain efficiency, reduce lead times, and ensure reliable access to critical Product Types and resources.
In 2022, IdentifySensors Biologics collaborated with Jabil Inc. to create techniques for the dependable and resilient manufacture of portable devices that promptly identify a broad variety of illnesses at the molecular level with more accuracy than PCR testing.
GLOBAL DIAGNOSTIC CONTRACT MANUFACTURING MARKET KEY PLAYERS- DETAILED COMPETITIVE INSIGHT
Thermo Fisher Scientific Inc.
Siemens Healthineers AG
Danaher Corporation
Roche Diagnostics
Ortho Clinical Diagnostics
Abbott Laboratories
Bio-Rad Laboratories, Inc.
Sysmex Corporation
Quidel Corporation
BioMerieux SA
PerkinElmer Inc.
DiaSorin S.p.A.
Luminex Corporation
Becton, Dickinson and Company (BD)
Meridian Bioscience, Inc.
Others