Top Infectious Diseases in the IVD Market - HIV

The following analysis is derived from Kalorama Information’s recently released global market research report:The Worldwide Market for Infectious Disease Diagnostic Tests.

This is the second in a series of five posts outlining the leading infectious diseases or disease groups in terms of IVD market sales.

At over $2 billion in IVD market revenue, diagnostic tests for human immunodeficiency virus (HIV) infections are found across segments, including immunoassays, molecular assays, and blood screening assays. Treatment of chronic HIV infection using antiretroviral (ART) drugs has added significant value to the HIV test market and has driven demand for more sophisticated and higher value assays. The viral pathogen has influenced the reformulation of clinical and public health approaches to infectious diseases that treat them as chronic disease burdens rather than individual health episodes. Although a comparatively mature market segment of infectious disease diagnostics, HIV diagnostics is finding growth through the expansion of disease control programs in the developing world and more sophisticated assays used in conjunction with treatment.

Infectious diseases represent a significantly greater share of the total disease burden in developing countries than in the developed world. For HIV specifically, the case is much the same. The WHO has estimated that 75% of the global HIV disease burden - measured in disability-adjusted life years (DALY; combining years lost to disability and premature mortality) - is found in low-income countries. Granted significant gaps in funding exist between active HIV screening campaigns and the United Nations’ Millennium Development Goals (MDGs), foreign investment has still expanded dramatically over the past 15 years in support of public health in low-income countries.

HIV diagnosis in the developing world is predominately accomplished using rapid immunoassays procured by global aid organizations such as the Clinton Foundation HIV/AIDS Initiative, Roll Back Malaria, UNAIDS, United States President’s Emergency Plan for Aids Relief (PEPFAR), the Global Fund to Fight AIDS, and Tuberculosis and Malaria, and World Health Organization. Diverse vendors from throughout the world are used under these programs, but few are smaller than mid-sized IVD companies.

Marginal opportunity exists in the remaining market for rapid HIV tests. A handful of IVD players similarly dominate sales of rapid HIV tests in major markets such as the United States. Market expansion has been negligible from the introduction of an in-home or over-the counter (OTC) rapid HIV test or OraSure Technologies’ OraQuick In-Home HIV Test in 2012. Product innovation has otherwise largely mirrored the laboratory HIV test space with the introduction of antigen-antibody (Ag-Ab) combo rapid assays, such as the Alere Determine HIV-1/2 Ag/Ab Combo assay. Combo assays provide improved diagnostic accuracy through the acute and chronic stages of HIV infection.

HIV was at the forefront of clinical molecular diagnostics in the 1990s and subsequently developed HIV assays have seized upon the strengths of real-time PCR in accurate quantitation and target specificity. Quantitative HIV testing or viral load monitoring is associated with periodic testing of chronic HIV patients as part of antiretroviral therapy. Preliminary HIV diagnosis on the other hand is rarely accomplished using molecular assays; HIV combo immunoassays provide adequate sensitivity at a significantly lower price. Leveraging immunodiagnostics to perform viral load testing is not common, but has been developed by Cavidi with its near-patient ELISA-format ExaVir system. The ExaVir system and several portable molecular systems introduced in recent years are intended to address HIV therapy in the developing world. Diagnostic platforms for HIV testing in the developing world are still largely in the development stage; ruggedness, low-cost reagents (including non-PCR) and non-molecular methodologies remain preferred features in such markets where improved testing platform performance needs to be achieved at significantly reduced costs.

Dynamic areas of molecular HIV testing include viral tropism and viral resistance testing. Studies have indicated that anywhere from 5% to 20% of transmitted HIV infections are resistant to one or more drugs. Genotyping molecular assays can be used to characterize the resistance of an infection as well as its tropism or target immune cell type. Drug resistance and tropism assays are performed at lower volumes than screening tests and viral load tests, but are expected to see rising usage with the expansion of antiretroviral therapeutics and a healthcare emphasis on personalized medicine.

Donated blood is invariably screened for HIV wherever blood safety programs are active. Immunoassays are prevalently used to screen blood for HIV, though national blood programs and officiating organizations also commonly use nucleic acid tests (NATs) for HIV wherever NAT blood screening has been implemented, including in the United States, Canada, the United Kingdom, Germany, France, Italy, Australia, Japan, Hong Kong, Singapore, Thailand, Malaysia, Egypt, and Mexico. Countries such as China that are trialing blood screening transition to NAT are expected to introduce HIV NAT screening first alongside hepatitis B and C (HBV; HCV).