Human immunodeficiency virus (HIV) has been an ever-present feature of public health since its discovery in the 1980s. Though stigmatisation around the virus is certainly not as prevalent as it once was, unwelcome labels still permeate to this day. Not least on a global scale, where the virus transcends cultural divides. 

According to the World Health Organization (WHO), 38.4 million people globally were living with HIV in 2021. Despite 1.5 million people acquiring HIV in 2021, the overall trend of new infections is decreasing – there has been a 32% decrease annually since 2010.

Perhaps the most telling figure included in the WHO’s report is that there are 52% fewer deaths annually compared to 2010. The advancement of treatments such as anti-retroviral drugs and long-lasting therapies have been key to patients with HIV living largely normal lives. And, despite recent setbacks, the hope of an HIV vaccine still flickers on the pharmaceutical horizon.

However, a key determinant of patient health is the early diagnosis of HIV. Not only can early diagnosis lower possible transmission rates, but it also allows for early treatment and reduces the chances of developing Autoimmune Deficiency Syndrome (AIDS).

According to the UK Health Security Agency, the proportion of late diagnoses between 2020 and 2021 has risen from previous years. Although much of this has been attributed to testing disruption from the pandemic, there is still an overall trend of fewer tests being conducted – there were 266,746 fewer people tested in 2021 than in 2019.

HIV testing capability is key in being able to manage the virus, and consequently AIDS, in the public health sector. In a market model by Global Data, the global HIV testing market in 2022 was worth $1.8bn and is predicted to rise to $2.4bn in 2033, growing at a CAGR of 1.5.%.

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So what is fueling this growth if testing is still recovering from the Covid disruption hangover? The increased accessibility of, and favourable attitude towards, easy and quick HIV self-tests might provide the answer.

A preference for self-testing

Self-tests usually involve detecting HIV antibodies via conventional lateral flow technology from a sample of blood obtained by finger prick (though some tests can use saliva). These can be bought at a pharmacy or online and be conducted in the privacy of a home setting. The time for a result can vary between manufacturers but 15-40 minutes is the modal range. The window period of a self-test is long – it can detect HIV 18 to 90 days after exposure, so repeat testing is important.

Conventional testing technologies, however, currently dominate market segments.  Enzyme immunoassays and nucleic acid amplification were worth $1bn and $415m respectively in 2022. However, these tests require visiting a healthcare professional to obtain a sample and then a laboratory analysis. Their importance, however, is not, and will likely never be, in question – they are the tests required for further analysis in the case of a reactive self-test.

Nevertheless, self-tests conducted at home can be a key driver of the HIV testing market. Indeed, the HIV self-test market itself is predicted to reach nearly $500m by 2027.

Self-test kits remove the stigma – and taboo in some societies – that testing for HIV presents.

“Unfortunately, there’s still a lot of stigma around sexual health and testing,” says Helen Burkitt, Senior Sexual Health and Contraception Nurse at SH:24 (a free online sexual health service partnered with the NHS).

“People can feel very nervous and awkward about visiting a sexual health clinic. Often, there are lots of other people there in the waiting room and then you need to discuss with a nurse or doctor your sex life which again puts people off. Now they can test when they want, privately, without anybody else knowing.”

The pandemic shifts attitudes

The Covid-19 pandemic not only resulted in disruption to testing infrastructure, but it also challenged the public’s perception towards self-managing health – and indeed sexual health. Burkitt says that the closure of clinics helped to normalise online testing for the wider population

With access to medical services limited, patients were empowered to take charge of their health. An obvious example was the ability to easily test for Covid-19 itself with lateral flow tests.  The popularity of using self-testing kits to monitor personal health has extended to other viruses, including HIV.

The OraQuick HIV Self-Test is one such HIV self-test. Developed by OraSure Technologies, it received FDA approval in 2012 and is considered one of the leading rapid tests in the US. Partly because the test can be conducted with a saliva sample and does not require blood.

“A lot of consumers like the model of being in charge of your health that the pandemic brought on,” says Scott Gleason, Senior Vice President of Investor Relations and Corporate Communications at OraSure Technologies.

“How fast the rapid self-testing market develops depends on the regulatory environment. Reimbursement is critical. What partly drove Covid testing was that the tests were given away free by the government, or that they were reimbursed by commercial insures if you bought them at a pharmacy.”

Government schemes and public health initiatives will therefore be critical in the development of the rapid testing market.

Concerted funding on a global scale

“The frequency of rapid testing schemes is rising now as governments try to encourage HIV testing. The advent of therapies means more people realise it’s a manageable disease – unlike 20-30 years ago,” explains Selena Yu, Medical Analyst at GlobalData and author of the HIV testing market model.

In July 2022, the WHO released its strategic report on tackling HIV, emphasising the importance of self-testing as a method for tackling transmission and gaining earlier diagnoses. The Joint United Nations Programme on HIV/AIDS (UNAIDS) aims to eliminate AIDS as a public health problem by 2030. Between 2017 and 2020 alone, three times as many countries globally implemented HIV self-testing policies.

Another example is the recent programme by NHS England, which offered free HIV rapid tests to the public as part of National HIV Testing Week in early February 2023.

In the US, OraSure Technologies itself is working in partnership with the Centers for Disease Control and Prevention (CDC) to provide up to a million rapid home tests to communities with high HIV prevalence rates. Called the “Together Take Me Home Program”,  the CDC will fund the initiative with $41.5m. Such global and country-specific policies will encourage market growth.

The US is the largest market for HIV tests and Yu’s model predicts that it will be worth nearly $1bn alone by 2033. Whilst funding was diverted to Covid-19 during the pandemic, Yu says HIV resources are being restored. Indeed, in the UK, the NHS conducted an opt-out testing scheme at hospital emergency departments – funding £20m ($24m) for the programme. Self-testing is an area seen by the WHO and government organisations as being a significant driver in lowering HIV transmission.

“There is a lot of funding going towards self-testing initiatives,” says Professor Jamie Vera, Chair in HIV Medicine at Brighton and Sussex Medical School. 

“The opt-out programme by the NHS is an example of a government financially backing the aim of eliminating HIV.”

Resources are not just restricted to Western countries, either. Despite the high prevalence rate in Africa, strategies are being implemented there too, he says.

“There’s been lots of research going into accessibility in different settings, particularly Sub-Saharan Africa. The self-tests are convenient and empower people to take charge of their health.”

Professor Vera adds that there is a push towards distribution capabilities – this includes vending machines that distribute HIV self-test kits. Not only have these been set up in public spaces in the UK, but they have also been deployed in Zambia, he says.

Self-testing becomes self-monitoring

A further trend that Yu predicts is that HIV self-tests might become a regular monitoring method rather than a test that is taken solely when an individual believes they have been exposed to the virus – similar to the trend that developed during the pandemic when many people tested daily. For those who test positive for HIV, further confirmatory analysis tests should be sought, but for those who test negative, and especially those who are in higher-risk demographic categories, there is a possibility that home rapid HIV tests will provide an accessible monitoring solution with privacy and little stigma.

Professor Vera agrees: “Just like you monitor cholesterol and blood pressure, this is just another aspect of your health. Covid has facilitated self-testing of infectious diseases more generally.”

“Not only do self-tests lead to an uptake in HIV testing, but it also minimises the attached stigma,” he adds.

Challenges ahead

This is not to say that the future acceptance of self-tests will be without its challenges. Though the tests have high sensitivity when conducted by healthcare professionals, it can be lowered when used by patients. Written instructions are sometimes not clear enough and clarifying in-person demonstrations are needed for patients to complete the test successfully. Education and outreach programmes are needed if the tests are to be adopted as a mainstream method of HIV detection.

Though global initiatives to increase distribution of self-test kits are plentiful, there still exists a necessary amount of funding if the demand for kits is to be met, especially in low and middle-income countries. Unitaid predicts demand for 29 million tests in these countries by 2025, with a projected funding gap of $105m. There also needs to be further funding and resources for healthcare steps after a positive test.  Professor Vera says issues with the pathway of care are challenges faced by many countries.

If HIV self-tests are to become a viable, long-term healthcare strategy, this will need to be addressed.

“Pathway of care is one of the difficulties, but self-testing remains an important intervention in terms of eventual HIV elimination,” he adds.

Digital frameworks are also inherently key to the future of the HIV self-testing landscape. A study by The Lancet demonstrated that websites, social media, mobile applications and digital vending machines all increased uptake, engaged first-time testers and helped reach hard-to-reach populations. The acceleration in technological advancement and accessibility of digital healthcare (a Global Data report predicts that nearly 7 billion people will be internet users by 2023) have been key in the success of patients using self-test HIV kits. According to the UK Health Security Agency, online testing accounted for 98% of the rise in the number of tests taken between 2020 and 2021 – this has been a key factor in driving the market to its current size.

“With the availability of online testing services, you don’t need to go into a clinic to get tested, you can do it from the comfort and privacy of your own home,” says Helen Burkitt.

“This means many people are now accessing STI testing who may not have done so before due to their discomfort around attending a clinic.”

If self-testing is to become a viable, central method of HIV diagnosis and management, it will need to overcome these challenges. But based on current trends catalysed by attitude changes towards self-management of health and by policy implementation from global initiatives, HIV self-test kits are no doubt already playing an integral role in the future landscape of the HIV testing market.