Genomics Revolution Creating Fundamental Changes in Drug Discovery

In an environment where costs are under constant pressure, the pharmaceutical industry is under increasing strain to develop drugs that add real value.

This is an important driver for the evolution of the drug discovery procedure and for the introduction of processes that are efficient as well as quicker in delivering a higher per cent of pipeline molecules to the market.

Moreover, the genomics revolution is fast bringing about fundamental changes in drug discovery and clinical genomics solutions are targeting the needs of medical as well as pharmaceutical research, thus enabling the development of better and safer drugs.

Consequently, with experimental demands as well as goals becoming more aggressive, researchers are turning to instruments and procedures that promise a higher throughput.

Pharmaceutical R&D laboratories are reaching the point where existing products can no longer solve new bottlenecks.

While the main cause for this relates to the liquid-handling capabilities of most automation products, an increasing number of laboratories are expected to consider introducing microfluidics technology.

"At present, target validation is a major bottleneck for the pharmaceutical industry and it is for this reason that RNA Interference (RNAi) is likely to play a major role in target validation," notes Frost & Sullivan Healthcare Analyst Dr. Amarpreet Dhiman.

"The potency of RNAi and the range it works for as well as the fact that yield determination is easier with RNAi when compared to other technologies are added factors driving its acceptance."

Among challenges impacting the Asia Pacific drug discovery market, regulatory hurdles are likely to be a major impediment to the drug discovery process.

With concerns over drug efficacy and safety, regulatory agencies are extremely cautious while implementing new regulations and in the coming years, this challenge is likely to have a high impact on the Asia Pacific drug discovery market.

India's pharmaceutical industry, for example, is one of the most regulated in the world and price controls are affecting the profitability of the industry. In addition, weak patent protection is also proving a long-term threat to foreign investment in India's drug market.

Nevertheless, pressure from the World Trade Organisation is speeding up discussions within the Indian Government to improve patent protection.

Further, the regulatory environment related to drug administration in China has also undergone significant changes in the last decade.

These improvements, as contemplated in the three newly adopted laws or regulations, include modification of new drug definitions, abolishment of administrative protection mechanisms, simplification of regulatory filing procedures, promotion of commercialisation and standardisation of the manufacturing process.

The drug discovery market in Asia Pacific was worth US$5.62 billion in 2004 and is likely to reach US$18.55 billion in 2011.

In revenue terms, the market shows a strong bias towards the segment for basic research, which by itself was worth around US$3.14 billion in 2004.

Regionally, Singapore is fast becoming the hub in Asia Pacific for drug discovery R&D. This is mainly due to the Government's effort to diversify the country's economic portfolio and three agencies are directly linked to the task of implementing favourable initiatives.

While the Biomedical Sciences Group of the Economic Development Board's (EDB) is responsible for formulating industry development plans and attracting international companies to set up operations in Singapore, BioOne Capital makes strategic investments in companies with the aim of generating small spin-offs.

Further, the Biomedical Research Council (BMRC) is taking the lead in coordinating and funding the public sector as well as academic research and training of scientists.

Equally, India is fast gaining proficiency and expertise, which is assisting its move from generic as well as specialty contract manufacturing to innovative drug discovery and development.

"As pharmaceutical research and manufacturing capabilities grow in Asia Pacific, opportunities will emerge for global pharmaceutical and biotechnology companies that are looking for new markets for their products and services," says Dr. Dhiman.

"Understanding the challenges and being aware of the opportunities is the first step in being prepared to capitalise on the explosive growth that is being seen in drug discovery and development research in all Asia Pacific countries."