Although IVD holds excellent potential for early diagnosis, the regulatory approval processes for these devices or tests are tedious. The strict documentation and quality auditing requirements of regulatory bodies for high- or moderate-complexity tests lead to complexities in regulatory approvals and hinder their approval processes.
IVD companies are continuously looking at new ways to optimize resources due to regulatory complexities. Strict quality norms are required to be followed by the companies at various stages. Upon the successful transition of a diagnostic assay to full-scale production, the developers aim at monitoring and controlling the quality of components and assembly. Supply chain management becomes critical, and risk mitigation strategies are devised to ensure business continuity in the event of manufacturing disruptions. Quality management systems (QMS) and careful documentation of production processes according to ISO and other regulatory guidelines are required for final assay products to be compliant and marketable. As IVD contract manufacturing companies are specialized in managing this regulation, IVD contract manufacturing services are increasing.
Meticulous Research®, in its latest publication on IVD Contract Manufacturing Services, states that the global IVD contract manufacturing services market is expected to grow at a CAGR of 7.7% from 2021 to 2028 to reach $20.6 billion by 2028.
The growth of the global IVD contract manufacturing services market is mainly attributed to the increasing need for IVD devices due to 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. In addition, high economic and increased outsourcing to emerging countries serves as a significant growth opportunity for the growth of this market. However, maintaining product quality and protection of proprietary knowledge hinders the growth of this market.
To provide efficient analysis, Meticulous Research® has segmented this market by Service Type (Assay Development Services, Manufacturing Services, Other Services), Category (Reagents & Consumables, Instruments & Systems), Technology (Immunoassay, Molecular Diagnostics, Clinical Chemistry, Microbiology, Hematology, Urinalysis), and Geography (North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa).
Based on geography, North America is expected to account for the largest share of the IVD contract manufacturing services market in 2021, closely followed by Europe and Asia-Pacific. However, the Asia-Pacific region is slated to register the highest growth during the forecast period. The high market growth rate in this region is attributed to the continuous improvements in healthcare infrastructure, growing government investments, rapid urbanization, the rising need to manage the increasing burden of infectious diseases, increasing efforts to improve the accessibility of diagnostic services to enhance prevention by developing products or platforms required for the diagnosis of infectious diseases, and rising awareness towards overall health and treatment.
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Based on service type, the manufacturing services segment is expected to account for the largest share of the IVD contract manufacturing services market in 2021. The growing demand for IVD devices results in IVD companies outsourcing the manufacturing of these devices as these services are cost-effective and provide quality and regulatory support, which contributes to the market growth of this segment.
Based on technology, the immunoassay segment is expected to register the highest growth during the forecast period. The rising usage of immunodiagnostics tests by practitioners, increasing use of immunoassays in Point of Care (PoC) infectious disease testing, the growing necessity for developing novel tests, and rising demands attributed to the aging population are some of the major factors contributing to the growth of this segment.
Scope of the Report:
IVD Contract Manufacturing Services Market, by Type
- Manufacturing Services
- Assay Development Services
- Other Services
IVD Contract Manufacturing Services Market, by Category
- Reagents & Consumables
- Instruments & Systems
IVD Contract Manufacturing Services Market, by Technology
- Molecular Diagnostics
- Clinical Chemistry
IVD Contract Manufacturing Services Market, by Geography
- North America
- Rest of Europe (RoE)
- Asia-Pacific (APAC)
- Rest of APAC (RoAPAC)
- Latin America
- Middle East & Africa
The report provides competitive intelligence in terms of financials, growth strategies, product portfolios, and geographical presence on the key players in this market, including Savyon Diagnostics (Israel), KMC Systems, Inc. (U.S.), Cenogenics Corporation (U.S.), Nova Biomedical (U.S.), Cone Bioproducts (U.S.), Invetech, Inc. (Australia), Avioq, Inc. (U.S.), Meridian Bioscience, Inc. (U.S.), In Vitro Diagnostics Developers Inc. (U.S.), LRE Medical (Germany), TCS Biosciences Ltd (U.K.), Affinity Life Sciences, Inc. (U.S.), CorisBioConcept (Belgium), 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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