India's diagnostic industry headed for a major boom

The USD 500 million domestic pathology industry growing over the last five years at an estimated Compound Annual Growth Rate (CAGR) of 20 per cent per annum is on the verge of a major boom, Falaknaaz Syed reports.

Industry experts cite emergence of the country as a preferred global R&D hub, expansion of the clinical trials market, opening up of the health insurance industry for privatisation, consolidation amongst organised players, increased health awareness and quality consciousness in urban India resulting in an increased test prescription rate and Public-Private Partnerships (PPP) as the major reasons for the boom.

The pathology market is currently 2.5 per cent of the overall healthcare delivery market. There are 40,000 independent path labs in the country and the industry is highly competitive and price-driven with kickbacks and business referral payments in the absence of a regulatory body. Around 70 per cent of treatment decisions in the country are based on lab results.

Speaking about India as a preferred destination for outsourcing clinical trials, Dr Arvind Lal, Chairman and Managing Director of Dr Lal PathLabs, New Delhi, said, "India offers a diverse population and therefore a varied gene pool. Also patient recruitment and retention is easier, better and faster than in the Western countries. International drug companies save 50 per cent in clinical trials cost in India and so prefer outsourcing clinical trials to the country. A major evidence is that the number of Contract Research Organisations (CROs) based in India have increased four-fold between 2001 and 2003. By 2010, two million patients are expected for clinical trials in India; translating into 20 million tests."

Also 100 of the Fortune 500 companies have set up R&D facilities in the country, 70 MNCs including Delphi, Eli Lilly, GE, HP, Heinz and DaimlerChrysler have R&D facilities in the country.

In January 2005, Ministry of Health and Family Welfare passed the Drugs and Cosmetics Amendment Rules, permitting foreign and domestic companies to conduct clinical trials for pharmaceuticals in India and other countries simultaneously. Thus phase II and III clinical trials can now occur in India and abroad simultaneously. Experts feel that the Product Patent Protection will encourage MNCs to import technology into India to develop new products thereby boosting the clinical trials market and are optimistic that the medical device trials will soon follow suit.

Besides, molecular diagnostics and pharmacogenomic testing too are touted as the future drivers of the diagnostic industry provided the government brings in relaxation on customs duty and service tax. Molecular diagnostics is the fastest growing segment of the in-vitro diagnostics (IVD) market with a projected growth of 25 per cent per annum. Viral diagnostics, immune system disease diagnostics, bacterial, parasitic and fungal identification, cancer diagnosis and monitoring are the segments where molecular technologies enjoy significant cost-benefit advantage. Similarly, pharmacogenomic testing too is believed to usher in an era of personalised medicine where diagnostic tests that will help in selecting the best of the several therapies will be a prerequisite for prescribing a therapy, say experts.

Speaking about outsourcing opportunities in India, Janak Singh Bajwa, Group Director, SRL Ranbaxy Ltd, New Delhi opines, "The outsourcing opportunity from UK alone is about 450 million pounds or Rs 3600 crore and outsourcing to India has just started."

"Clinicians require a comprehensive range of tests to arrive at the correct diagnosis. Lab testing not being a hospital's core business, they don't develop the capability to conduct the full range of tests. Infact, nor do most labs. They find it more convenient to outsource. This strategy is more cost effective for them. So, world-wide hospitals and labs outsource some of the more Esoteric Tests. The question before hospitals in developed countries like UK is not whether to outsource these tests, but whether to send them to India or not. This constitutes a major risk for them as any incorrect diagnosis, any delayed reports or if critical tests are not performed, pose a major risk to their reputation and in fact open them up to litigation. They are therefore risk averse and require a lot of reassurance before changing."

"The scene is similar to what the IT industry was when it started 15 years back. I'm sure in another five years we would be looking at a similar success story," he added.

Dr Sushil Shah, Chairman, Metropolis Health Services, Mumbai, a chain of diagnostic centres, feels that entry of foreign health insurance companies in India will be an important driver of the domestic diagnostic industry as coverage of pathology services will be inevitable in the policy.

Says Dr Shah, "Today there are 800 private labs in the US of which the top 10 laboratories carry out 85 percent of the pathological workload. Earlier like in India, the US too had standalone labs but the scenario changed when health insurance entered the US healthcare market. Insurance companies tied up with labs that had quality control, uniform systems of billing and services. This consolidation came about and the

functioning changed. Since in India, the public healthcare system is falling apart and there is around 20 per cent inflation in private sector each year. International health insurance companies when enter India, will tie up with chain of labs thereby changing the face of the diagnostic industry."

"By 2010, two million patients are expected for clinical trials in India; translating into 20 million tests" - Dr Arvind Lal, Chairman and Managing Director of Dr Lal PathLabs	"Entry of foreign health insurance companies in India will be the key drivers of the Indian diagnostic industry" - Dr Sushil Shah, Chairman of Metropolis Health Services

Expansion plans of major path labs

Most renowned path labs are expanding regionally and foraying into the international markets as well. For instance, SRL Ranbaxy Ltd has signed outsourcing contracts with several UK hospitals to provide pathological services. The Group with 17 labs, 550 collection centres distributed in 350 towns across the country and seven franchise labs is looking for both Franchisee's and acquisitions in all the major cities of the country.

Says Bajwa, "Franchisees are expected to invest 50 lakh. When we go for a franchise, we look for knowledge of local markets and entrepreneurship in our partner, while SRL Ranbaxy brings in the ability to run the lab."

Metropolis Health Services too plans to increase its collection centres and franchise systems. "We have full fledged labs performing around 1500 different kinds of tests, proper logistics and billing services and our systems are in place. We plan to have chains across India with a central billing system. We currently have 13 labs in India and plan to open two labs by end of this year and another seven labs by next year. When foreign health insurance companies come to India, they will prefer to tie-up with us," informed Dr Shah.

Similarly, Dr Lal PathLabs plans to build South Asia's biggest lab in Rohini in Delhi besides expanding in the country. Says Dr Lal, "We currently have 13 labs in the country and by next five years will have 50 labs. From 250 sample collection centres, we plan to double it to 500 in next five years. These collection centres would be in addition to the 500 pick-up points like major hospitals, nursing homes, other pathology labs, doctor's offices etc. Our current test menu, which is the largest in the country, of more than 1500 tests and panels would be expanded further."

falak@expresshealthcaremgmt.com