India today imports a large number of diagnostic medical devices. Despite the growth of the indigenous diagnostic industry, the imports in this sector have risen by nearly 41% in the last 2 years.
What is the reason for this rise?
Two parts of the growing rapid diagnostic industry are - the rapid card assays and their corresponding assay reading devices.
Rapid card assays are based on antigen–antibody reaction principles. This reaction produces colour, which indicates qualitative test results – positive or negative. For a long time diagnostics labs have used them (for a long time) as a preliminary test to see the presence of an analyte before the traditional testing method (Since traditional testing is expensive and time-consuming). Doing a card test helped diagnostic labs provide a quick (positive/ negative) response to doctors, who could start patient treatment earlier.
The innovation of assay readers has helped quantify the qualitative results obtained from rapid card tests. So the assay readers now give results on an analog scale instead of just a yes/no response. Their small size, portability, and functionality have made them popular as point-of-care devices.
The test assay OEMs (in India) however, are lagging. India’s dependency on imported rapid card assay has grown to an alarming level. China, UK, and USA markets appeal to manufacturers with their different customization services, product variety, and innovative technology. The Indian assay OEMs have not kept up with the needs of the companies making the card test reading devices.
An important market for device manufacturers is rural healthcare. In the diagnostic-deficient rural areas of India, these devices are the perfect choice for providing last-mile healthcare as they are inexpensive and require low technical skills.
Card assay OEMs, however, prefer to make card tests that are common or stated under the government's “Essential Diagnostics Scheme”. This ends up overlooking the need for the diagnostics tests required in rural areas (e.g. - infectious diseases tests). For device (card test reading) manufacturers this means looking for other sources to procure these tests or losing a market segment.
Device manufacturers also look at developing new biomarkers which allow them entry into new markets. A simple example of this would be tests required for neurodegenerative diseases or PCOS. To develop these tests, device manufacturers must look at sourcing reagents, sheets, and cards from different manufacturers in India – as Card Assay tests are not readily available. This makes the process long and inefficient for production for device manufacturers. This too pushes them to markets abroad providing collated services.
Another way that device manufacturers look at upgrading products is by changing the tested specimen. Most tests (card and otherwise) require the use of venous blood. Changing the specimen (to saliva or capillary blood) would make sample collection simpler and cheaper.
Shift to simpler specimens would involve customization or modifications to the available card tests. Indian card assay OEMs do not provide these and continue to make tests only for blood or urine specimens.
Some companies (e.g. - Inito) make card test readers that utilize personal mobile devices as assay readers for at-home tests. To make the testing more user-friendly they customize the card test for easy handling by the users.
But Indian card assay OEMs still focus only on diagnostic lab products and do not provide options in the growing market of at-home test kits.
Device manufacturers also struggle to find good quality reliable card tests. This is due to the presence of unstandardized OEM facilities, counterfeit products (like reagents or card tests), and lack of government regulation. Card tests (e.g. - Hb, HbA1c) show high error rates and variability on equivalence testing.
For device makers, it means running the risk of product recalls on sales made.
To quote PM Modi “Indian manufacturing needs an upgrade in its healthcare sector.”
The Indian assay OEMs are still unprepared to provide and change.
References http://www.biofootprintshealthcare.com/ https://www.inito.com/en-us/ https://www.vanguarddiagnostics.com/ https://www.sekbio.com/
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