The range of diagnostic tools available to the clinician has been steadily expanding since the advent of modern medicine. As a result, we are now at the threshold of seeing an exponential rise in this area, akin to the rapid developments in the field of digital technology that occurred over the last decade. The driving force behind the rapid expansion of the diagnostic market can be attributed to developments in biomolecular and genomic technologies.
The press regularly provides tantalising stories of how all disease diagnosis and therapy will soon become tailored to an individual's genetic makeup (often referred to as personalised medicine). Although the emerging field of pharmacogenomics (targeted drug therapy by taking account of an individual's genetic makeup) is expected to make rapid progress in the years to come, there have been some setbacks and disappointments.
Gene therapy is one of the fields, where the early enthusiasm has been tempered by difficulties in obtaining successful outcomes. Similarly, the discovery of the brca gene family and its putative link to breast cancer was followed by the realisation that genetic testing may not be highly predictive, especially for the Indian genetic makeup.
However, molecular diagnostics has been extremely successful in the area of infectious diseases, where viral and bacterial genotyping has made rapid progress. Similarly, cancer diagnostics through mutational analysis and gene expression profiling, though still at an embryonic stage, is likely to be the next major breakthrough area in clinical practice. Although clinicians require a large range and high efficacy of tests to undertake correct diagnosis, laboratory testing currently accounts for only 1 per cent of total health costs worldwide, according to the World Health Organization (WHO).
The current in vitro diagnostic segment is composed of various well established tests that clinicians have come to depend on, including clinical chemistry and immunoassay among others. Indeed, infectious disease and blood screening tests together are responsible for over 70 per cent of all diagnostic tests. The United States lead from the front, accounting for more than 50 per cent of sales. In this context, the overall market share of molecular diagnostics currently holds a modest position. The leading players in the industry are Roche Diagnostics, which currently holds close to 40 per cent market share, Abbot, Chiron and Bayer.
Although molecular diagnostics currently occupies only a modest share in comparison to other segments, given its astonishing growth rate molecular diagnostics can be considered as the future. Although estimates vary depending on the reporting methodology, there is a general consensus that the current growth rate is in excess of 25 per cent. These estimates do not take into account many cutting edge tests that are making their way into the marketplace, including esoteric tests. The rapid growth of this segment can be attributed to two factors. They are:
● A number of innovative companies are introducing early stage, often fledgling new technologies into clinical labs.
● The rapid development of automated systems and point-of-care platforms is adding to the throughput of molecular testing.
Together, these factors augur well for the future growth of molecular diagnostics with the accompanying prospect of greater affordability down the road.
Indian prospects
The emergence of ultra high-end tests is in general accompanied by consumer concerns of high cost. Therefore, the initial introduction of such tests must be targeted to the economic sector that can afford such tests. In this regard, there are three demographic factors in India that provide for an encouraging outlook in terms of market prospects. First of all, the economic boom in India has led to a striking increase in the purchasing power of middle to upper class people. Along with the increase in the purchasing power, there is also a more westernised attitude. Thus, although esoteric testing and disease screening programmes are largely at an embryonic stage compared to the West, the shift in economics and attitude provides for a more encouraging outlook in terms of the success of such efforts in the future.
The second encouraging demographic factor also relates to the economic boom. The arrival of multinational corporations in large numbers to India has been accompanied by a similar growth in indigenous corporate entities, especially those catering to information technology (IT), business process outsourcing (BPO) and other related sectors. As a result, a new corporate mentality is emerging in India, one in which employee health issues, especially those of managers and executives, get considerable attention.
A parallel development has been the progressive expansion of health insurance programmes that cover curative, diagnostic and health screening programmes. The continuing rapid expansion of the Indian economy suggests that this trend will only accelerate, and with it, the state-of-the-art diagnostic technologies would have a bright future. Also, the economic boom brings people from many different nationalities to India, who are accustomed to the westernized practice of routine medical checkups, early disease screening and application of the latest technologies for disease identification.
The third encouraging factor is the return of non-resident Indians (NRIs) to their domestic land in large numbers. This represents a significant market for high-end products and services. Throughout the country there is a boom in residential properties and services that are specifically tailored to meet the needs of NRIs. Medical services in particular have flourished with the establishment of NRI hospitals. Most of the NRIs are accustomed to having regular medical checkups as they are aware of the value of preventive medicine from their stay abroad.
Given the above demographic facts and trends, the future market potential for molecular diagnostics is extremely positive in terms of sales growth. The benefit of it to the overall medical community in India is that once market penetration has been achieved, financial return from investment coupled with advancing technology are likely to lead to cost reduction, allowing a large number of Indian population to afford these tests.
The current trends and future outlook for molecular diagnostics are excellent for the worldwide market. In terms of clinical importance, the rapid diagnosis of infectious disease in saving lives cannot be overstated in acute cases. The detection of predisposition to lifestyle disorders and underlying genetic factors that may contribute to eventual disease onset is important for the long term (chronic) health care management.
The initial market for emerging diagnostic technologies is the haves of economic group, as was the case with arrival of new technologies in the past. The provision of new and cutting-edge molecular tests in India will surely be followed by greater affordability as prices are expected to come down due to return on investment, competition and technology advancement. It is clear that India must now be ready to provide cutting-edge molecular diagnostic tests that are becoming available in other markets.
(The author is with PAC Med Biotech Pvt. Ltd.)