‘Regulatory plays a major role in shaping up the market for infectious disease diagnostics in developing world’

Which countries are the biggest markets for infectious diseases in a descending order: developing versus developed? Which diseases worldwide have a huge market? Why? Where does India figure here?

Jayant Singh

India and China are the biggest markets for infectious disease diagnostics from a volume perspective. However, from a value perspective the US and Europe lead the pack. This is primarily on account of the difference in technologies used, the primary technology used in India and China are the first generation ELISA (enzyme-linked immunosorbent assay) and rapid card tests which are low-priced, whereas the developed world has migrated to the latest advancement in ELISA and nucleic acid testing, that is gradually becoming a norm rather than a reference test.

Big markets exist for infectious diseases diagnosis in the western world for diseases like HIV, Hepatitis B and C and hospital acquired infection (HAIs). However, the testing is primarily done on very high end platforms like NAT and Chemiluminescence. In addition to the diseases mentioned above there is the additional burden of diseases like cholera, TB, pneumonia, Kala Azar, malaria, dengue, swineflu, bird flu, trypanosomiasis, etc. in the developing world. India has a similar disease profile as that of the developing countries from an infectious disease diagnosis perspective.

How are governments in developing economies of Asia, Africa and Latin America tackling and further driving demand through the measures being taken. Explain.

Similar to the cases in India, other geographic regions like, Africa and Latin America are all resource scarce countries facing similar challenges of huge disease burden. With the lack of affordability coupled with difficulty of accessing the latest technology either due to cost or complexity for operating the technology, these countries are also characterised by being majority out of pocket markets from a payment perspective. This limits the scope of a government driven demand for these tests, however regulatory measures like the banning of serology tests for TB by Government of India is playing a major role in shaping up the market for various technologies for infectious diseases testing.

Having said that the government interventions driving the growth of this market (be it Asia or Africa) have been mainly felt in two disease areas namely, TB and HIV. The spending from donor agencies coupled with government funding for these two diseases has been a primary growth driver for testing e.g. Culture and NAT based tests for TB and NAT based testing for HIV and CD4 counting for disease monitoring have been the primary beneficiary of this phenomenon.

A similar phenomenon has been observed in certain blood banks, where respective state governments through a decree have made it mandatory for blood banks to use NAT technology for testing. To conclude, it can be said that the regulatory plays a major role in shaping up the market for infectious disease diagnostics in the developing world.

TB is a case where new molecular technologies (new estimates by WHO) for the screening of drug-resistant TB are replacing culture-based tests. Which other infectious diseases have seen the introduction of improved devices and technologies?

This phenomenon has been observed in multiple areas and there is nothing new about the same, testing for extra pulmonary TB through NAT has been there for quite some time in the market. A similar phenomenon has been observed in areas of HIV, Hepatitis B & C testing where, we have seen the markets moving from a rapid card test to a NAT based platform for organism identification and treatment monitoring.

NCD’s (cancer, diabetes, heart diseases) have taken precedence over infectious diseases when it comes to policy, health initiatives, and even pharma R&D. Do you then think that infectious diseases and their diagnostics have taken a backseat?

From a policy perspective, the government’s focus area is still on infectious diseases, however, off-late the government have also started focusing on the NCDs which makes it seem that the government focus has shifted to NCDs. The impact of communicable diseases in form of death, disability, morbidity is much early visible than NCDs (polio and leprosy being a case in point), it has only been due to the government effort coupled with efforts from NGOs and society that we have been able to eliminate diseases like polio and leprosy. However having said that the government of the day has taken a long way in terms of infectious diseases like TB, swine flu, cholera, malaria etc.

Pharma companies will be purely guided by commercial interests. Investing in a molecule for a disease of third world countries is considered a not so attractive proposition both from an investment as well as the price point of view. However, the same can’t be said for diagnostics, where we are seeing R&D efforts in making more sensitive and accurate tests for diseases like TB, HIV, Toxoplasma etc. This difference in behaviour can be primarily attributed to the low investments, higher success ratio, and lesser complexity in the areas of diagnostics compared to pharmaceuticals.

Malaria is one infectious disease which has remained where it was if one takes a look at the Lancet study. What diagnostic tests if any could help improve the situation? Similarly for Hepatitis C?

It can be as trying to kill a mosquito by a sword, effective tests like HRP, which are very specific to malaria tests like, PF & PV combined which can diagnose both strains of malaria are already available in the market at quite affordable prices. The failure is of the delivery mechanism to ensure that these tests reach the needy people, so the investment is required in strengthening the delivery system than investing in discovery of a new and more sensitive and accurate test for malaria or Hepatitis C.

Point of care tests could be the ultimate game changer when it comes to infectious disease diagnostics. How many infectious diseases have simple, cost effective point of care tests? How does the future look like?

Almost all the tests are available as point of care tests, however, they suffer from a common problem of false positives and negatives, unless this aspect of the technology is worked upon, these tests will be used as, ‘something is better than nothing’ option and doctors will have a lack of confidence on the results delivered by these tests.

However companies like Alere have done good work in making CD4 tests as point of care without a loss of sensitivity and accuracy, if companies are able to do so in all other disease areas then the future of POC testing will be very bright, else it will be primarily used in resource scarce countries where something is better than nothing.

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