IVD in healthcare

The Indian in vitro diagnostics (IVD) market is expected to grow from USD 1.71 billion in 2024 to USD 2.34 billion by 2029, with a compound annual growth rate (CAGR) of 6.58 percent. The government’s focus on diagnostics and universal health coverage, along with an emphasis on self-reliance, innovation, and quality, may lead to a bright future for the industry.

These are absolute impressive and huge figures but let us see how big or small they are in front of total healthcare expenditure, HCE.

In a comparative study The Value of In Vitro Diagnostic Testing in Medical Practice: A Status Report by Ulrich-Peter Rohr, et al., in Plos One in March 2016, it was found that IVD costs account for 2.3 percent and 1.4 percent of total HCE in the US and Germany respectively. Most physicians (81 percent) believed that the actual HCE on IVDs was >5 percent. It is also a fact that 66 percent of decision-making in healthcare was based on IVD. These results not only indicate a poor awareness of actual HCE on IVD, they also exhibit a high attributable value of diagnostic procedures in patient management. New markers should deliver actionable and medically relevant information, to guide decision-making and foster improved patient outcomes.

In vitro diagnostics (IVD) are tests that can detect diseases, conditions, and infections, and are used to monitor a person’s overall health. IVD testing is a vital tool in clinical practice, and is used for diagnosing and monitoring diseases and wellness; providing prognosis; predicting treatment response; assessing the potential risk of developing a disease or disorder; guiding patient management; and mitigating or preventing future disease.

In India, the Central Drugs Standard Control Organization (CDSCO) regulates in vitro diagnostic (IVD) devices. The IVD industry operates within the framework of stringent regulatory oversight, designed to ensure the safety and efficacy of medical devices and diagnostic tools.

A landmark event in IVD was declaration of the first EDL (essential diagnostic list) by WHO in May 2018. It was an official acknowledgement of a highly important role of IVD in healthcare.

Following that, ICMR has compiled a detailed, informative and purposeful document on national essential diagnostic list in the year 2019. It states that diagnostics serve a key role in improving health and quality of life; equitable accessibility, affordability, and appropriate use of good-quality diagnostics are integral to high-quality healthcare.

ICMR document on NEDL highlights that accurate diagnostics are indispensable for effective management of diseases, leading to better patient care and clinical outcomes, increase affordability by reducing overall therapy cost, and also reduce antimicrobial resistance.

I feel ICMR on NEDL is timely and will contribute in a big way in improving healthcare of the nation.

Regulations are quintessential in clinical labs; the two important regulations are NMC Act and CEA Act 2010. Clinical Establishments (Registration and Regulation) Act, 2010 or the CEA provides for the registration of state-run and private health facilities, including medical laboratories, However CEA is not implemented in many states including Delhi. We do not have registry of labs in Delhi. There are many illegal labs, sample collection facilities, and lab aggregators giving inaccurate lab reports with huge damage to the health of people. This needs to be corrected immediately. Good news is that the Delhi health minister has given an undertaking to implement the CEA 2010 in Delhi High Court in response to a civil writ petition on April 4, 2024. This will definitely improve the quality of lab services in Delhi.

We also need to discuss risk assessment of laboratory services, good laboratory practices, and judicious use of laboratory tests, newer molecular and genomic testing, etc.

The author is MBBS from AFMC and MD-Pathology from AIIMS.