Digital Transformation in IVD Contract Manufacturing Services

Digital Transformation in IVD Contract Manufacturing Services

Meticulous Research^®—a leading market research company, published a research report titled, '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’

According to this latest publication from Meticulous Research^®, the IVD contract manufacturing services market is projected to reach $25.80 billion by 2030, at a CAGR of 7.8% from 2024 to 2031. 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.

Factors such as the lack of skilled professionals could be considered as a challenge for the IVD contract manufacturing services market. However, maintaining product quality and protection of proprietary information restrains the growth of the 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.).

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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

o    U.S.

o    Canada

·         Europe

o    Germany

o    France

o    U.K.

o    Italy

o    Spain

o    Rest of Europe (RoE)

·         Asia-Pacific

o    China

o    Japan

o    India

o    Rest of APAC (RoAPAC)

·         Latin America

·         Middle East & Africa

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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 services that include ISO-certified manufacturing facilities that allow them to carry out full project and production management, quality and regulatory support, and flexibility in scale and process, which results in increased demand for manufacturing services.

Based on category, in 2024, the reagents & consumables segment is expected to account for the largest share of the market. Reagents & consumables are products that are used for the in-vitro examination of specimens derived from the human body during disease diagnosis, treatment monitoring, prognosis, and evaluation of the patient’s health status. The large market share of the segment is attributed to factors such as increasing virulence of infectious diseases, growth of companion diagnostics, and rapid growth in molecular testing, which leads to an increased demand for POC diagnostic kits, therefore increasing the use of reagents & consumables used in the tests.

Based on technology, in 2024, the immunoassay segment is expected to account for the largest share of the market. The large share of the segment is attributed to factors such as a higher preference for immunodiagnostics owing to its inherent specificity, high throughput, and the emergence of advanced diagnostic immunoassay formats. Further, the increasing use of immunoassays in Point of Care (PoC) infectious disease testing, the need for developing novel tests, increasing usage of miniaturized devices, rising demand attributed to an aging population, and the rising trend of automation in immunoassay instruments are driving the growth of this segment.

This research report analyzes major geographies and provides a comprehensive analysis of North America (U.S., Canada), Europe (Germany, France, U.K., Italy, Spain, and the Rest of Europe), Asia-Pacific (China, Japan, India, and Rest of Asia-Pacific), Latin America and the Middle East & Africa. In 2024, North America is expected to account for the largest share of the IVD contract manufacturing services market, followed by Europe and Asia-Pacific. North America’s major market share is attributed to the rising prevalence of various infectious diseases, the growing healthcare sector, increasing awareness regarding early disease diagnosis, growing adoption of advanced innovative products, and increasing funding activities coupled with novel advanced diagnostic technologies.

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Key questions answered in the report:

·         Which are the high-growth market segments in terms of IVD contract manufacturing services type, category, technology, and geography?

·         What was the historical market for IVD contract manufacturing services across the globe?

·         What are the market forecasts and estimates for the period 2024–2031?

·         What are the major drivers, restraints, opportunities, and challenges in the IVD contract manufacturing services market?

·         Who are the major players in the IVD contract manufacturing services market?

·         What is the competitive landscape, and who are the market leaders in the IVD contract manufacturing services market?

·         What are the recent developments in the global IVD contract manufacturing services market?

·         What are the different strategies adopted by the major players in the global IVD contract manufacturing services market?

·         What are the geographical trends and high-growth regions/countries?

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