In recent years, technological advances have changed the face of drug discovery beyond imagination. Applications of new drug development technologies have changed the entire scenario of pharmaceutical field and indeed the human life in recent era. In the area of drug development, introduction of computer aided technologies for clinical trials and molecular synthesis is a milestone in the evolution of modem pharmaceutical sciences. In addition, the emergence of genomics and proteomics has changed the concept of drug discovery.
In today's changed scenario the drug discovery process starts at the gene level. It requires the knowledge of molecular biology to link the human disease with the functions of gene. It reflects that drug discovery has undergone a paradigm shift towards molecular biology, bio-informatics and genomic science. Today, genomics, proteomics, and combinatorial chemistry, are the buzzwords of research scholars. Technological advances have stimulated the growth of new drug entry in pharma market around the world. Indian IT companies are also contributing by offering required database solutions for major pharmaceutical and genome-based biotech companies, which is necessary for creating, storing and annotating genomic data for new drug development.
Nowadays, US$ 800 mn - $1.4 billion is the approximate cost to[bring a drug from the research lab to the market with its long gestation period of not less than 12 years. Only one of every 10,000 compounds will complete its successful journey from the arch lab to the retail shop. Patenting and other regulatory process in India may further delay its entry in the market.
Today, drugs in the segment of alimentary tract and metabolism treatment, systemic anti-infectives, cardiovascular system and respiratory system are in high demand. Pharmaceutical companies are exploring healthcare market in these lucrative segments. As lifestyle is changing and major population is prone to lifestyle related diseases including diabetes, hypertension, and excessive obesity, it is predicted that future pharmaceutical market will be concentrated to these segments. To survive in this cut-throat competition, pharmaceutical companies can concentrate their research and development efforts more to anti-diabetic, anti-hypertensive, and anti-obese market segment.
In developing countries like India, domestic as well as multinational companies cannot afford such investment for long duration because the returns from market in developing countries are not promising as the purchasing power of the people is very low. It reflects from the annual financial statement of many pharma companies, which shows just about 2% of its turn over for new drug discovery.
Scenario is also changing from pharmaceuticals to nutraceuticals and other health supplement products. Though these terminologies are very new to the healthcare market, but it is growing with the high annual growth rate, i.e., 25% in India. This growth rate indicates that nutraceutical companies are capturing major market segments with high speed than the pharmaceutical companies. Pharmaceutical giants like Morepen, Dabur, Ranbaxy, Lupin are targeting their efforts to nutraceutical market. Investment for the nutraceutical product development is much lesser than the investment for drug molecule. Absence of stringent regulatory guidelines for manufacturing and selling of nutraceutical product also encourage nutraceutical companies to try their fate in nutraceutical market. Ultimately this is resulting in overcrowding of market with adulterated and inferior quality nutraceutical products in healthcare market.
Challenges
The cost of bringing new molecule in the pharmaceutical market is estimated US $1.4 billion and drug gestation time with the help of modern technologies would be not less than 10 years. Pharmaceutical company after investing a lot of money and time for the development of one successful therapeutic molecule will get disappointed by delaying approval and regulatory process. Because of this scenario the pharmaceutical industries are under increasing pressure to improve their strength of drug discovery and development.
Though many pharmaceutical companies have their own patented molecules, still they are struggling to survive in the market. This is because they have ignored the unwritten rule of market, "Discovering right molecule at right time for right segment." Selection of a right drug for clinical trial studies may save time and money; it gives more chances of success. Pharmaceutical companies while selecting the molecule for clinical trials may consider their past experience, toxicological study of molecules, alteration of atomic arrangement and its applications and efficiency. For this purpose pharmaceutical companies can take help from computer aided drug designing and IT technologies.
From last few decades trend of drug discovery is changing to more molecular and oligopeptide level. Recombinant proteins, monoclonal antibodies, gene therapy, antisense, RNAi, and aptamers are considered as new and potential frontiers for drug discovery. Research in these area demands highly skilled personnel, highly sophisticated infrastructure and heavy monetary investment. Returns and success is not promising in this area. In developing countries, as per capital income is comparatively less than developing countries, it discourages research and development investment by pharmaceutical companies because it may take a long time to generate returns from market.
Emergence of new faculties of life sciences has the potential to influence the physician's prescription. Because of these reasons pharmaceutical companies are targeting their research and development efforts to explore the advance area of biotechnology, nanotechnology and nutraceuticals.
Indeed, it is difficult for a pharma company to take initiation for discovering new drug by exorbitant amount and waiting for 12 years where success is unpredictable. Various government and private institutes like NCL, CDRI, NARI, HSs, NTs, should work together in collaboration with pharmaceutical companies to fasten the new drug discovery and development process. Organizations can expect returns by giving marketing rights of newly developed drug to pharma companies. Such method can make use of best brains from academic institutes and the facilities available. The government should have to work in the direction to impulse the drug research in academic institutions by encouraging and providing them proper infrastructure and required funding.
However, India is contributing immensely in life sciences with capable scientific manpower, but the success and progress of the pharmaceutical sciences is only possible by the seamless integration of scientists from different areas like molecular biology, biophysics, biotechnology, biochemistry, chemistry, genetics, and other areas of life sciences.
(The authors are with department of Pharmacy Management, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal.)
--Courtesy:The Pharma Review October 2008