In-vitro diagnostics – A peep into the future

In-vitro diagnostics (IVD) is an extremely important resource, widely used for detecting disease, and influence 70 percent of all clinical decisions. It plays a crucial role in the integrated healthcare system, enabling operational efficiencies and cost-savings across all healthcare systems, including public and private sectors. Moreover, it is vital in deciding the line of treatment, monitoring response to treatment, prognosis, or to figure out whether there is a cure or not.

The global in-vitro diagnostics (IVD) market is expected to reach USD 144.7 billion by 2027, at a compound annual growth rate (CAGR) of 4.6 percent according to Research and Markets report. The Indian IVD market is likely to reach USD 1.8 billion mark by 2025 according to the same report.

Growth opportunities for IVD. Expertise-driven personalized and preventative healthcare has led the path of evolving innovations, thus civilizing diagnosis and building future prospects to alter the position of diagnostics in healthcare ecosystems. Growing sectors of artificial intelligence (AI), biosensors, microfluidics technologies, software-as-medical-devices, liquid biopsies, next-generation sequencing (NGS), CRISPR-based diagnostics, microarrays, multiplex assays, digital pathology, and wearable devices are all growth opportunities for in-vitro diagnostics.

Escalated demand for point-of-care testing, especially post-Covid, growing awareness of importance of early disease detection, surge in willingness to pay for preventive healthcare, and increasing prevalence of chronic diseases are other factors driving inflated demand for rapid diagnostics. With the advancements in CRISPR-based diagnostics, microarrays, NGS and microfluidics, the risk of disease can be quantified on a per-patient basis with a limited effort and time. With all these advancements and awareness, rapid tests segment and precision medicine will account for the largest share in IVD.

Considering the medical specialties, oncology is a vital area of focus in this sphere, sharing a significant space. Other major areas include developing technologies in the field of neurodegenerative disorders, endocrinology, and infectious diseases.

Requirements for expansion. Coronavirus pandemic ushered in the significance of screening and prompt diagnosis to the spearhead. Ample support from the government, powerful public-private relationship, and monetary assistance in the form of increased budget allotments are imperative.

The government needs to take requisite measures to expand the diagnostics in Indian market. Increased number of alliances between the diagnostics and technological universities are required with quality training of paramedical staff and sales and purchase departments. Defining of simple and logical rules by the authorities with clear understanding and classification of products is also recommended. Reduction of tariffs on medical devices, increased investments, and further compliance with foreign regulatory requirements, export support and post-market vigilance are added requisitions. Removal of GST from diagnostics equipment and consumables and providing export-related premiums to motivate manufacturers of medical devices and equipment will be advantageous.

For the consumers of the in-vitro diagnostic services, intensification of healthcare insurance premium exemption, an increase in tax exclusion on preventive health checks and packages and increased healthcare awareness programs will add to value.

Challenges. In today’s state of affairs it is extremely imperative to identify the hurdles that the diagnostic industry is facing, and to conquer them for improved healthcare outcomes tomorrow. In-vitro diagnostics amount to only ~2 percent of global healthcare expenditure in spite of the fact that it is critical for 70 percent of clinical decision-making, treatment, and prognosis. The growing demand for healthcare, shortage of resources, rapid advancements in science and technology, and cost constraints have led to growing backlogs for both service providers and consumers. Challenges like regulatory barriers, budget constraints, advancement of lower-cost providers and difficult re-imbursements persists.

Outlook. The healthcare industry has observed remarkable evolvement in the in-vitro diagnostics over the past decade. Moreover, the IVD market continues to be the largest segment within the worldwide medical devices industry with existence of the right set of circumstances for wider growth. Converting challenges into positive outcomes is of key significance to guarantee a more dynamic and rational time ahead for the industry.