IVD Contract Manufacturing Services Market by Type (Assay Development, Manufacturing), Category (Reagents, Systems), Technology (Immunoassay, Molecular Diagnostics, Clinical Chemistry, Hematology, Microbiology, Urinalysis) – Global Forecast to 2031

The IVD Contract Manufacturing Services Market was valued at $14.18 billion in 2023. This market is expected to reach $25.75  billion by 2031, from an estimated $15.26  billion in 2024, at a CAGR of 7.8% during the forecast period 2024-2031.

IVD Contract Manufacturing Services Market Size & Forecast

IVD contract manufacturing services allow organizations to outsource manufacturing processes. Companies outsource a product or part of a product. This is often used to increase production rates or to expand product offerings without investing in new equipment and machinery. The growth of the IVD contract manufacturing services market is driven by several factors, including the rising prevalence of infectious diseases, the shift in focus from centralized laboratories to point-of-care testing services, regulatory complexities faced by IVD companies, and the need for cost-effective manufacturing of IVD tests. Factors such as high economic growth and increased outsourcing to emerging countries serve as an opportunity that would help grow the market in the future. The lack of skilled professionals could be considered a challenge for the IVD contract manufacturing services market. However, the maintenance of product quality and protection of proprietary information could restrain the growth of the market.

Shift in Focus from Centralized Laboratories to Point-of-Care Testing Services

Diagnosis of any disease is required to identify and investigate the disease and reduce the associated mortality rate. Traditionally, testing was conducted exclusively at centralized laboratories. Centralized laboratory testing is very important for the optimal and consistent functioning of diagnostic processes. In recent years, there has been a continuous shift towards point-of-care testing services or decentralized clinical laboratory testing primarily due to cost reduction, convenience to patients and clinicians, reduced waiting time for results, and improved quality of testing.

Point-of-care (POC) testing is majorly performed for diagnosis at or near the site of the patient. POC tests improve patient management in cases of infectious diseases. POC tests for various infectious diseases, such as chlamydia, gonorrhea, and influenza, help provide early diagnosis and treatment. POC testing in decentralized setups helps physicians monitor infectious diseases and improve clinical workflow. Also, advancements in information technology contributed significantly to the decentralization of clinical laboratory testing.

Most importantly, POC instruments must be simple to use since the end users may not be trained lab technicians. Specific POC device features should include minimal maintenance requirements and onboard calibrations to ensure accurate test results, a user-friendly software interface, integration with laboratory and hospital information systems, and easy-to-use disposables that contain all the reagents for sample processing and testing. POC instrumentation should also have a small footprint and, in some cases, be portable since both hospital clinics and physician offices have limited space. While such requirements may seem simple, they present IVD companies with a variety of design and manufacturing challenges. Most notably, a number of POC technologies require more complex disposable cartridges containing multiple reagents to process only one patient sample at a time, compared with simpler disposables in higher-volume laboratory instruments.

With this added complexity, product development teams must work together to ensure a smooth integration of the disposable cartridges with the instrument design and minimize costly redesigns. Working with a contract manufacturing partner who has experience in integrating disposable cartridge technologies with instrument design is the preferred option, hence driving the associated market.

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Need for Cost-Effective Manufacturing of IVD Tests

IVD manufacturing requires significant capital expenditure for in-house manufacturing. In addition to the costs of equipment, the Quality Management System (QMS) also needed to be aligned with all regulatory requirements. The hiring of skilled professionals and the acquisition of appropriate certifications are also needed. Due to the significant capital expenditure requirement, companies are choosing to outsource their manufacturing so that their capital can be used towards growing their business and developing new products. In addition, supply chain disruptions & delays, product or manufacturing changes, lack of manufacturing & packaging expertise, supplier inability to support current or future demand, IVD assay variability, incomplete documentation, specification changes, and regulatory non-compliance are some of the risks experienced by IVD manufacturers. The critical raw materials require risk mitigation for manufacturing continuity, lot-to-lot continuity, regulatory compliance, and clinical test reliability. The quality systems and regulatory expertise of IVD service providers provide solutions for these risks; hence, IVD manufacturers are moving towards IVD outsourcing.

The changes in the IVD industry are being driven by increased laboratory test volumes and growing pressure to lower test turnaround times (TAT) with fewer skilled lab technicians. Any new product launch must be able to address this demanding environment. Such sweeping demands in the industry are accelerating the development of three specific areas of advancement: point-of-care (POC) technologies, automation, and graphical user interfaces. With the IVD market changing rapidly, the pressure to deliver less expensive and more efficient new products is mounting. To reduce costs and shorten product development cycles, many large and start-up IVD companies have been turning to contract developers and manufacturers for their services and relevant experience to overcome common development challenges.

Key Findings of the IVD Contract Manufacturing Services Market Study

The Manufacturing Services Segment is Expected to Account for the Largest Share of the Market in 2024

Based on type, in 2024, the manufacturing services segment is expected to account for the largest share of the market. Manufacturing services include ISO-certified manufacturing facilities and carrying out full projects and production management, quality and regulatory support, and flexibility in scale and process, which results in increased demand for manufacturing services. Other factors that contribute to the growth of this segment include the growing demand for IVD devices, and IVD companies are therefore outsourcing manufacturing of these devices as these services are cost-effective and also provide quality and regulatory support.

The Reagents & Consumables Segment is Expected to Account for the Largest Share of the Market in 2024

Based on category, in 2024, the reagents & consumables segment is expected to account for the largest share of the market. IVD reagents are used for the in-vitro examination of specimens derived from a human body during disease diagnosis, treatment monitoring, prognosis, and evaluation of the patient’s health. Reagents & consumables provide high standards of innovation and quality in R&D and manufacturing of IVD assays. Some major factors contributing to the growth of this segment include the rising prevalence of infectious diseases and hence, the continuous need for IVD reagents and consumables for diagnosis of these diseases.

The Immunoassay Segment is Expected to Account for the Largest Share of the Market in 2024

Based on technology, in 2024, the immunoassay segment is expected to account for the largest share of the market. A wide variety of immunoassays have been developed, with ELISA, lateral flow immunoassay, radioimmunoassay, immunofluorescence, immunohistochemistry, immunocytochemistry, microarray, and western blotting being amongst the most well-known. Immunoassays find application in cancer marker identification/testing, infectious diseases diagnostics, cardiac analysis, therapeutic drug monitoring, and allergen tests. This growth of the segment is attributed to factors such as higher preference for immunodiagnostics owing to its inherent specificity, high throughput, and the emergence of advanced diagnostic immunoassay formats.

North America: Largest Regional Market

The growth of this market is primarily driven by the rising prevalence of various infectious diseases, the growing healthcare sector, increasing awareness regarding early disease diagnosis, growing adoption of advanced diagnostic products, and increasing funding activities coupled with novel advanced diagnostic technologies.

IVD Contract Manufacturing Services Market: Key Players

The key players profiled in the IVD contract manufacturing services market report are Cenogenics Corporation (U.S.), In-Vitro Diagnostic Developers, Inc. (IDxDI) (U.S.), Savyon Diagnostics (Israel), KMS Systems, Inc. (U.S.), Nova Biomedical (U.S.), LRE Medical (Germany), Cone Bioproducts (U.S.), Invetech, Inc. (Australia), Avioq, Inc. (U.S.), TCS Biosciences Ltd. (U.K.), Affinity Life Sciences, Inc. (U.S.), Coris BioConcept (Belgium), Meridian Bioscience, Inc. (U.S.), Affinity Biologicals, Inc. (Canada), Biokit S.A. (Spain), Merck KgaA (Germany), Thermo Fisher Scientific, Inc. (U.S.), and Maxim Biomedical, Inc. (U.S.).

The report includes a competitive landscape based on an extensive assessment of the market based on type, category, technology, and geography. The report also provides insights into the geographic presence of major market players and their key growth strategies in the last three to four years.

IVD Contract Manufacturing Services Market Report Summary:

Key questions answered in the report: