IVD Contract Manufacturing Services Market to be Worth $25.80 Billion by 2031 - Exclusive Report by Meticulous Research®

REDDING, Calif., June 26, 2024 /PRNewswire/ -- According to a new market research report, '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', published by Meticulous Research^®, the IVD contract manufacturing services market is projected to reach $25.80 billion by 2031, at a CAGR of 7.8% from 2024 to 2031.

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IVD contract manufacturing services allow organizations to outsource manufacturing processes. Companies outsource a product or a 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, a 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 in emerging countries are opportunities 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, maintaining product quality and protection of proprietary information restrains the growth of the market.

The report also includes an extensive assessment of the product portfolio, geographic analysis, and key growth strategies adopted by leading market players in the last three to four years. In recent years, the IVD contract manufacturing services market has witnessed several organic and inorganic strategic developments. 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.).

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Regulatory Complexities Faced by IVD Companies

Although IVD holds excellent potential for early diagnosis, the regulatory approval processes for these devices or tests are tedious. Regulatory approvals include a review of the clinical data, calibration, manufacturing methods, quality control, risk assessment, and other factors to ensure the reproducibility and safety of the devices/tests. Despite this, the primary regulatory hurdle for diagnostic devices is complexity. The monitoring and controlling of the quality of components and assembly during the transition of diagnostic assays to full-scale production is important. Also, supply chain management and risk mitigation strategies become critical. To keep the final assay product compliant and sellable, quality management systems (QMS) and careful documentation of production processes according to ISO and other regulatory guidelines become necessary. To verify safety and quality compliance, government bodies conduct scheduled and unscheduled audits of all manufacturing facilities.

Manufacturers found that developing tests for point-of-care settings is difficult compared to laboratory tests due to the high standards of the FDA. For instance, the FDA determines CLIA status through a point scoring system (1-3, low to high complexity). Devices with a cumulative score greater than 12 are categorized as high-complexity devices. Devices with an aggregate score of less than 12 are classified as moderate-complexity devices. Low-complexity tests can be used in any POC setting due to the low risk of enormous results. On the other hand, it is mandated by the FDA that high and moderate complexity tests must be performed in CLIA-certified labs by qualified personnel. Thus, manufacturers find the bar high and, hence, difficult to develop POC tests.

IVD companies are trying to optimize resources due to regulatory complexities, prompting industry participants to adopt innovative, integrated business models. In such situations, contract manufacturing services are positioning themselves as one-stop-shop solution providers. Their services help IVD companies overcome regulatory complexities, thus driving market growth.

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The IVD contract manufacturing services market is segmented by Type (Assay Development Services, Manufacturing Services, and Other Services), Category (Reagents & Consumables and Instruments & Systems), Technology (Immunoassay, Molecular Diagnostics, Clinical Chemistry, Hematology, Microbiology, and Urinalysis), and Geography. The study also evaluates industry competitors and analyzes the regional and country-level markets.

Based on type, in 2024, the manufacturing services segment is expected to account for the largest share of the market. Manufacturing services are FDA-registered and include ISO-certified manufacturing facilities that allow them to provide everything, from small-scale pilot batch manufacture to full commercial production. These facilities carry out full project and production management, quality and regulatory support, and flexibility in scale and process, which results in an increased demand for manufacturing services, hence driving the growth of the segment.

Based on category, in 2024, the reagents & consumables segment is expected to account for the largest share of the market. Reagents & consumables provide high standards of innovation and quality in R&D and manufacturing of IVD assays. This results in laboratory efficiency and better clinical outcomes for patients, therefore driving the growth of the market. Apart from this, the rising prevalence of infectious diseases and the growing demand for POC diagnostic kits also consequently increase the use of reagents & consumables used in diagnosis. 

Based on technology, in 2024, the immunoassay segment is expected to account for the largest share of the market. Immunoassay technologies utilize antigen-antibody reactions for the detection of causative agents. Radioimmunoassay and ELISA are the most widely used immunoassay techniques for the diagnosis of infectious diseases. These tests are used frequently for immunodiagnostics owing to their inherent specificity, high throughput, and the emergence of advanced diagnostic immunoassay formats. Furthermore, the increasing use of immunoassays in Point of Care (PoC) infectious disease testing and the rising trend of automation in immunoassay instruments is propelling the growth of this segment.

Based on geography, in 2024, the market in North America is expected to account for the largest share of the market. The growth of this regional market is primarily driven by the rising prevalence of various infectious diseases, the growing healthcare sector, increasing awareness regarding early disease diagnosis, the growing adoption of advanced diagnostic products, and increasing funding activities coupled with novel advanced diagnostic technologies.

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Scope of the Report:

IVD Contract Manufacturing Services Market—by Type

• Manufacturing Services
• Assay Development Services
• Other Services

(Other Services primarily include product design and lyophilization)

IVD Contract Manufacturing Services Market—by Category

• Reagents & Consumables
• Instruments & Systems

IVD Contract Manufacturing Services Market—by Technology

• Immunoassay
• Molecular Diagnostics
• Clinical Chemistry
• Hematology
• Microbiology
• Urinalysis

IVD Contract Manufacturing Services Market—by Geography

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • France
  • U.K.
  • Italy
  • Spain
  • Rest of Europe (RoE)
• Asia-Pacific
  • China
  • Japan
  • India
  • Rest of APAC (RoAPAC)
• Latin America
• Middle East & Africa

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