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MedTech Outlook | Friday, June 17, 2022
The in-vitro diagnostics market is expected to reach USD 96.07 billion by 2025. The development of condition-specific markers and tests, the growing significance of companion diagnostics, and point-of-care tests with multiplexing capabilities are the factors that are expected to provide significant growth opportunities in the coming years.
FREMONT, CA: Expert panellists in the Markets and Markets In Vitro Diagnostics highlighted the most promising opportunities in the IVD ecosystem, emerging technologies and approaches, and the key factors and considerations that IVD companies should concentrate on in the coming decade. One of the speakers among the panellists discussed the burgeoning fields of biosensors, software as medical devices, and microarrays as a potential possibility for IVD firms. For instance, developments in microfluidic technology, next-generation sequencing, and microarrays over the last two decades, such as using one plate to evaluate all of a person's genes with minimal work and time were pointed out. It was also examined how the industry is now at a stage where future outcomes and prognosis of cancer and genetic disorders can be predicted using precision medicine as companion diagnostics in monitoring and identifying therapeutic responses of drugs, and also how the industry is now at a stage where prognosis of cancer and genetic disorders can be diagnosed. Overall, technical developments are allowing the sector to progress beyond the level of diagnosis. Not just in identifying symptoms and diagnosing them, but also in patient monitoring, personalised medicine, hospital management, and assisting physicians, clinicians, and patients, the IVD sector has become increasingly important.
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There is no one-size-fits-all technique for improving sensitivity and specificity; certain tests may have low sensitivity, while others may have low specificity. While newer technologies such as molecular diagnostics have great specificity and sensitivity, there is room for advancement in other types of quick tests, particularly those used for confirmation. POC tests, for example, are suggested for disease identification rather than disease confirmation in several countries. If they have a high sensitivity and specificity, they may be recommended for confirmatory testing and no further testing is necessary. As per assessments, the majority of errors occur during the pre-analytical or post-analytical stages. However, according to Kumar, some pre-analytical variables are already being handled by some manufacturers, such as barcoding sample tubes to prevent misplacement and following recommendations to ensure specimen stability during sample transportation. A general lack of standardisation of specificity and sensitivity leads to the considerable effort being put into research and development for analytical validation and verifications adhering to international standards such as the International Organization for Standardization (ISO)/Clinical and Laboratory Standards Institute (CLSI) to bring good products to market.
Laboratory identification tests are now more expensive than standard diagnostics, and there is a need to strike a balance between the expense of the tests and the accuracy of the results for the patient. Manufacturers and laboratories can take several initiatives to make molecular diagnostics more economical. Manufacturers can, for example, ponder about:
• Multiplexing capabilities and high sample throughput are provided.
• Automation and lean manufacturing are used to optimise processes.
• To lower test costs, open systems that allow the client and laboratory to choose their reagents and kits are used.
Overall, it's evident that the IVD ecosystem is becoming more innovative, as technology innovations continue to play an increasingly important role in diagnosis, benefiting both clinicians and patients.
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