Accutest Research Laboratories, one of the leading Indian CROs, is all set to grab a lion's share in Japanese contract research market. The Mumbai-based CRO is expected to soon sign deals with Japanese pharma companies to conduct clinical trials of the new molecules. Along with outsourcing clinical trials, Accutest plans to set up its own research centres and offices in regulated markets like the US and Europe.

Accutest, which had set up their office in Japan six months back to closely monitor the Japanese contract research market, signed pact with a leading Japanese CRO to outsource bio-studies to India. It is the first Indian CRO to set up an office in Japan.

Acknowledging the development, Dr. Satish V Sawant, director, Accutest Research Lab, told Pharmabiz, "Presently, talks are on with 4-5 Japanese pharma companies for conducting phase II and phase III studies in India. The molecules are mainly from cardiovascular segment. Once we get a nod from the Japanese government, the trials can be started by first quarter of 2006."

Sawant said, "Though the norms and regulations are stringent in Japanese pharma market, being an untapped market there is wider scope for contract research. The government is yet to approve the outsourcing of trials and bio-studies. On receiving an approval from the government we hope to double our revenue with a major share from the Japanese market."

"We expect to gain Rs 8-10 crore in the first year after we strike a deal with the Japanese companies," he further added without naming the companies and the value of the deal.

"The Japanese government demands the trials should be conducted in Mangolian race, which is too similar to the people in Japan. As we have tie-ups with around 60 hospitals in India, we hope there will be no hindrances in conducting trials in the specified race," he said

"We have entered into an agreement with a leading Japanese CRO to outsource their bio-studies and data management work to India. Many Japanese CROs are keen to outsource their work to India but the government is turning their deaf ear to their requests," stated Sawant

As the third largest pharma market, Japanese market is rapidly growing. So it is inevitable to outsource the research studies to maintain the speed of drug discovery, he opines.

Meanwhile, the company plans to set up offices and research centres in the US and Europe as part of widening its business to outside India. "We are on an expansion spree and the centres in the US and Europe will be opened at the end of next year. The centre in Europe will be situated either in Germany or in Spain," he informed.

The Ahmedabad centre of Accutest has started operations this month. Apart from this centre, it has two more centres in New Bombay and Pune. The company will expand its bed capacity from 48 to 100 in the New Bombay centre soon. Presently, Accutest has a total of 150 bed capacity in all the three centres. The company is also looking to set up its centres in South India. Among the 16 bio-studies submitted by Accutest for the US FDA approval three have received a positive opinion. Outside India, Accutest has submitted 70 bio-studies to various regulatory authorities like UK MHRA, South Africa MCC, Anvisa, for approval.

The CR market in India, which holds 1/3rd of the whole pharmaceutical market, has registered a growth of around 50 per cent last year and is expected to rise to a $3-billion market by 2010 although there is a shortage of trained investigators, opine experts.