Today the Indian pharmaceutical industry is valued at $12 billion with annual CAGR of 10-11 per cent and spends around 18 per cent of its revenue on R & D. In India the clinical research industry is $ 2.2 billion with a healthy CAGR of 23 per cent.
The Indian diagnostic industry and pharmaceutical industry have several synergies in various areas starting from Phase I studies through post marketing surveillance projects. Most of the international CROs have established their offices in India directly or through the affiliates to offer cost - effective solutions to their sponsors. India is ranked the third largest emerging market and is growing fastest in conducting number of trials.
The major central labs have heavily invested in high end technologies and instruments to offer esoteric testing, biomarkers, genomic testing, molecular diagnostics & DNA extraction techniques.
The central laboratories actively contribute in drug development process by bringing these technologies at their doorstep and thus cutting back time for drug development.
Current trends
The Indian pharmaceutical industry is growing multifold today which has resulted in huge increment in number of studies done in India as well as internationally. Some of the Indian CROs are taking lead roles to support global trials. With this trend, the Indian central labs like Metropolis has expanded operations globally either through direct presence or through alliance with global central laboratories. The Indian central laboratories have developed global affiliates. The decentralized central lab concept thereby offers global standards at regional cost.
Challenges
India is a preferred destination for clinical research for various reasons. The top two reasons are availability of patient pool in various therapeutic segment and cost. It is believed that the sponsors would save around 30 per cent cost if they conduct studies in India. Unfortunately, this may not be applicable when it comes to central laboratory services. Though central laboratories make best efforts to offer solutions at optimum cost, there are certain limitations. The laboratories use global testing standards, internationally accepted automated testing instruments and maintaining the global QA standards all of which come at 30 per cent reduced cost. The fixed cost of running and managing instruments are globally the same. However best possible efforts are made to keep pricing at optimum level with no compromise in quality.
Opportunities
The labs have set up in-house R & D to develop new assays as per the protocol specific requirements. Indian clinical research industry has seen increasing trend in complex therapeutic areas like oncology, vaccines, anti-infective studies and which has kept us in pace to develop new biomarkers, microbiology testing.
With new molecules and new combinations of drugs entering in the Indian market, Phase IV trials offer bigger opportunities to Indian diagnostic industry. There is an increasing demand for safety tests and specialized panels for Phase IV projects.
With growing competition among the pharmaceutical companies, it becomes difficult for them to retain patients on long-term therapies. Areas like liver transplantation, diabetes, oncology, HIV, cardiovascular diseases are chronic therapies and the patient needs prolonged and at times life long medication.
Many pharmaceutical companies are seen offering personalized assistance like maintaining patient diaries, therapy follow up, medicine delivery through direct channels and taking help from diagnostic laboratories to monitor the drug levels as well as well- being of their patients. Pharmaceutical companies are seen taking a step forward to offer their patients set of diagnostic tests either free or at discounted rates. Metropolis is a preferred service provider for most of the pharmaceutical companies due to its extensive network of laboratories. This arrangement benefits patients as they get diagnostic tests at minimal prices and thus pharma companies get benefited by retaining these patients on their drug therapies.
Key drivers
There was a time when accreditations like CAP, ISO 15189 were with only few central laboratories in India. However, with increase in awareness about quality and patient safety, many laboratories in India are opting for these accreditations. However, having only accreditation is not the only qualification for a central laboratory. The major driving forces are IT capabilities and logistics network.
Geographically India is a very complex country which signifies the need for robust logistics network for qualification as a central laboratory. Internationally,laboratories use specialized couriers for transportation of samples but in India this does not work as the cost of transportation may be four - fold for lab analysis and thus is not justified. Very few laboratories have been able to develop the logistics network for quicker turn around time, Metropolis being one of the fore runners.
All in all, the current scenario presents ample of opportunities for diagnostic industry to collaborate with pharmaceutical industry so as to offer attractive package deal to the patients. This will not only benefit both the industries but will also help the well-being of the end customer- the patient.
The author is MD & CEO, Metropolis Healthcare Ltd