Contributed by Parthiban Vijayarangakannan, PhD, Co-founder and CEO at Cambridgene Limited.
Precision medicine based on the genetic profiles of patients is gaining importance in the US and Europe, despite the high associated costs of diagnostics, clinical trials and regulatory approvals. However, delivering precision medicine through healthcare systems in the highly populated countries of Asia can pose great challenges. India in particular has a complex healthcare system involving public and private players, inadequate regulatory frameworks, and restrictions on the transfer of biological samples for use in overseas research studies. This article takes a glimpse at current systems, challenges and future prospects for rolling out precision medicine in India.
Each person’s genetic profile is different, and this difference is even higher between various ethnic populations. Any diagnostic or drug trial that involves genome-based patient stratification needs to study each ethnic population separately and take into account not only the genetic differences but also environmental conditions and life style. While genomic or multi-omic research studies are more prevalent in Europe and US, they are limited in India. Routine genome-based diagnostics exist for a range of conditions but a lot of improvement is needed for future roll out of targeted therapy. Moreover, Indian regulations and frameworks are somewhat limited, posing further challenges for targeted or guided therapy.
Diagnosis and treatment of cancers and other diseases using guided therapy requires a deep understanding of each patient’s genetic makeup. As varying genetic profiles are known to contribute to many sub-types of a disease, the right drug at the right dose with early intervention is key to treatment success, particularly in potentially lethal targeted therapy in cancer patients. According to a study by Frost and Sullivan (May 2013), India had 2.8 million cancer cases in 2012, with an estimated 800,000 new cases every year. It is safe to expect that targeted therapy using advanced genetic profiling will soon catch up and grow proportionally with the future increase in size of the anti-cancer drug market in India.
Moreover, preventive treatment strategies based on genome-based diagnostics are also expected to gain market share in India. Early intervention in common diseases including heart and metabolic diseases such as statin therapy for hypercholestrolemia in young adults is also likely to gain importance in India in the context of genomic detection and analysis at early onset stages. This is likely to offer renewed market potential for existing drugs in new patient groups with novel diagnostic and treatment strategies.
Understanding patient demographics, including genetic variation, is useful for pharmaceutical companies seeking to address these market needs in future. An advantage for conducting large-scale studies for targeted therapy in India is the easy identification and evaluation of enough cases representing a sub population (e.g. cancer mutations in specific genes) in a disease group. It is often possible to bundle diagnostics of multiple diseases in a single study so that studies need not be repeated for related diseases.
Planning and development may include the analysis of patient populations and their genetic makeup for different types or sub-types of diseases, addressable sub populations, their current treatment strategies, affordability, costs, and benefits. This can then be utilized for developing studies that accelerate novel strategies for guided therapy in India in coming years. Moreover, these studies and approaches will prepare pharmaceutical and diagnostic companies to accelarate clinical trials and regultory approvals and to face the rapidly growing future demand in genetics-based precision medicine in India.