As drugmakers in Asian nations prepare to launch their first R&D-based products, the prices at which they will be available on their domestic markets will be very different from those charged to western nations. All nations must make their own evaluations of these medicines’ values, and some of them could be produced for export only, a London conference has heard.
In India, drug discovery initiatives by the leading locally-owned firms have got underway only within the last 10 years, but the leading nine companies combined currently have 36 New Chemical Entities in development, through their own internal R&D programmes, according to GV Prasad, Chief Executive of Dr Reddy’s, speaking at The Economist’s annual pharmaceutical conference.
These moves towards innovation have been spurred by the introduction of India’s product patent regime in 2005, which is also producing new partnerships between Indian firms and international innovator and biotechnology companies.
Leading Indian drugmakers will likely produce their first R&D-based drugs within the next 10-15 years and they will, for the first time, have to consider the ”huge” issue of pricing – in the past, the country’s lack of patents meant that this was never a consideration, said Mr Prasad. Therefore, dual pricing policies will have to be introduced to accommodate very different markets, he said.
75% of top-50 pharma undertaking trials in India
Dr Prasad also told the meeting that, currently, over 75% of the world’s top 50 pharmaceutical companies are conducting clinical development in India, largely in late-stage clinical trials. However, the next area to develop in the country will be preclinical and early-phase discovery, he said, and it is forecast that the value of outsourced contract research carried out in India will be close to $2 billion by 2010. Also, by that date, Asia is projected to account for up to 50% of all clinical trials carried out worldwide.
A major reason for conducting trials in India is the population size; every sixth patient in the world is Indian, and they suffer not only diseases of developing nations but also those of the industrialized world, he said, Recruitment of patients in 10 times faster than in the USA, with a trial taking an average of 14 weeks to set up, and fees for chemical investigators are half those of US levels.
Pricing not the only answer
Pricing is not the only answer to China’s drug market problems, said Rae Yuan, head of the Roche Pharma Development Center in the country. While 17 rounds of official drug price reductions in the last 10 years have led a number of multinational manufacturers to remove their products from the market, some drugs whose prices have not been reduced have been enjoying good growth, she said.
In China, the government has focused on life sciences as the pillar industry which will modernise the national economy from a manufacturing to a knowledge base, said Dr Yuan. Moves to encourage the industry have included a strong crackdown on corruption, improvements to intellectual property rights protection and major changes to the regulatory processes, with efforts by the State Food and Drug Administration to streamline the clinical trial and review process.
The country has more than 300 research institutes and 500 early-stage biotechnology companies in over 200 High-Tech Parks, said Dr Yuan. There are also more than 200 Good Clinical Practice (GCP)-approved trial centres in China, six drug screening centres, a number of Good Laboratory Practice (GLP)-standard laboratories and three GLP evaluation centres, she added,
Biomedical research hub
In Singapore, the government provides a very comprehensive system of basic healthcare and aims to strike a balance, so if you want a particular treatment, you pay for it. Therefore, in this market, domestically-produced drug innovations would simply have to compete, said Ting Wee Liang, regional director of Singapore’s Economic Development Board in London. Singapore’s biomedical industry has grown from a value of S$6.3 billion in 2005 to S$23.0 billion in 2006, and the government is aiming to build the sector into a world leader, through the development of the Biopolis biomedical research hub, which is shared by private research companies and five government research institutes, and the Tuas Biomedical Park for manufacturing, in which nine global biomedical companies are already present, Mr Liang told the meeting. By Lynne Taylor