August 2014

A Truly Indian Growth Story

The Indian IVD industry has ably delivered on its promise, growing at an admirable rate. It is now a sector that has both Indian and foreign players competing to provide diagnostic tools to an ever hungry medical sector. As the industry looks to grow beyond the urban centers and grow into rural sectors, ENNs Rajesh K Sharma takes a critical look at the industry.

Truly-IndianA s Indian healthcare industry grows, the associated industries that assist it get an opportunity to grow as well. The IVD industry in India was, till very recently, a largely unorganized sector, populated by local players as well as multinationals, but with little to no interaction between them. While the local players were mostly involved in the servicing segment by making the reagents, the multinationals devoted themselves to building the IVD machines. But now, things are hanged, and Indian manufacturers have also entered the equipment side of the business.
The Indian IVD industry has seen double digit growth in the past few years. It is expected to grow at a CAGR of 20 percent and will be valued at $1.5 billion by 2018 according to Others like Carl McEvoy are more optimistic, pegging it at $760 million in2014 itself. The optimistic outlook cast by them is a clear indicator of the tremendous of the IVD sector in India.
The IVD sector, which encapsulates both, the equipments and the reagents, is vast in scope. It includes segments like immunochemistry, biochemistry, haematology, microbiology, blood gas and electrolyte, molecular diagnostics, urinalysis and coagula tion analysis. This tends to be confusing to most people, as the breadth of the sector seems to cover all aspects of diagnostics, having a footstep in multiple medical disciplines. In India, biochemistry has the largest share among all the diagnostics, but this too is changing as competition among the players rises. Another reason for other streams getting more attention is the changing lifestyles that have brought forward newer medical conditions that require diagnosis.
The changing fortunes of the IVD industry have been duly noted, and the industry is now raring to go. More multinational companies have entered the Indian marketplace and even the Indian companies have expanded their portfolios. They are now producing more types of reagent as well as equipments. This frenzy in the IVD space is producing companies that are pushing Indian manufacturing further. To compete with foreign manufacturers, they are stressing on quality. The multinationals, in turn, have to price their devices lower to match the price advantages that the Indian manufacturers enjoy. This is ultimately benefitting the patient, who can now get affordable treatment at a fraction of the cost. The technological advancements and higher efficiency systems are taking the market to new heights. Use of advanced and cutting-edge technologies in understanding a disease prognosis has further strengthened the sophistication level of participants in the sector.
Rapidly rising automation needs along with the rising incidence of diseases are consistently driving the growth of the Indian diagnostics market. The increasing number and complexity of tests, coupled with a shortage in laboratory staff, is leading to a greater level of automation in laboratories. Labour accounts for around 65 percent of operating expenses in a typical laboratory, and automating a laboratory can expand its capabilities while achieving significant savings.
Till now, most of the growth driving the IVD industry has been in the metro cities. But manufacturers are now looking at Tier II and Tier III cities to grow. India is the home to over 100 cities with enough population size to generate demands for diagnostics centres catering to a wide range of requirements. Several healthcare giants are seeking to tap into this market. Lifestyle and communicable diseases are no longer restricted to urban centres and are spreading to rural areas as well. As a large portion of rural areas do not have even the basic healthcare facilities, several cases remain undiagnosed. The changing disease patterns, rising incidence of diseases, higher healthcare spending, and untapped markets create abundant opportunities for IVD manufacturers in rural and semi-urban areas.

“More multinational IVD manufacturers have entered the Indian marketplace and even the Indian companies have expanded their portfolios”

But despite this positive outlook, the industry has some roadblocks to overcome if it has to live up to its reputation. Due to low entry barriers, the IVD industry still remains fragmented. There is not standardization among the players. Also, a well-defined regulatory pathway for diagnostics industry is missing. Due to lack of regulatory framework, there is no clarity on the classification and requirements for approval of diagnostics products and novel medical devices in India. If the industry is to venture into smaller towns and villages, then there have to be some common standards to be adhered to, so that the sector does not become a confusing mess of competing standards that are often in contrast to each other.

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