Although molecular diagnostics 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, complexity is the primary regulatory hurdle for molecular diagnostic devices. Monitoring and controlling the quality of components and assembly during the transition of a diagnostic assay to full-scale production is important. Also, supply chain management and risk mitigation strategies become critical. Quality management systems (QMS) and careful documentation of production processes according to ISO and other regulatory guidelines become necessary to keep the final assay product compliant and marketable. Government bodies conduct scheduled and unscheduled audits of all IVD manufacturing facilities to verify safety and quality compliance.
Further, IVD manufacturing requires significant capital expenditure for in-house manufacturing. In addition to equipment costs, Quality Management System (QMS) is also necessary to be aligned with all regulatory requirements. The hiring of skilled professionals and the acquisition of appropriate certifications are also required. Due to the significant capital expenditure required, 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’s 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.
Furthermore, 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 launches 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 cost-effectively and efficiently deliver new products to the market is mounting.
Therefore, in order to reduce costs and shorten product development cycles, numerous large and start-up IVD companies are turning to contract developers and manufacturers for their services and relevant experience to overcome common development challenges.
Thus, the IVD contract manufacturing services help to overcome the regulatory complexities, thereby accelerating the IVD contract manufacturing services market at a CAGR of 7.7% to reach USD 20.6 billion by 2028, according to Meticulous Research®.
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