The COVID-19 pandemic was a defining moment for diagnostic testing, reshaping how we engage with healthcare. At the height of the pandemic, at-home PCR tests became a lifeline, enabling people to screen and monitor their health without leaving the safety of their homes. The widespread acceptance of these tests was solidified in 2022 when the U.S. government's free at-home COVID-19 test kit program saw one-third of American households utilizing the tests.3
As the world transitions to a post-pandemic era, the development of at-home diagnostic testing and applications beyond COVID-19 screening shows no signs of slowing down. With about 70% of medical decisions reliant on lab results and 14 billion tests ordered annually,4 the potential of convenient, remote access to other laboratory testing is undeniable. Several long-term trends, including rising healthcare costs, accessibility concerns, population changes and technological advancements, are shaping the future of at-home diagnostics.
The evolution of diagnostic testing
At-home diagnostic tests have been used for decades; the first home pregnancy test entered the American market in the late 1970s and was soon followed by other popular assessments, like blood glucose meters.5 The far-reaching potential of at-home testing, however, was not widely appreciated until the early 2000s when Elizabeth Holmes introduced the ill-fated Theranos.
Unfortunately, the dramatic downfall and fraudulent reality of Theranos, a company that promised to revolutionize home lab testing, cast a long shadow over the industry. The resulting public mistrust stalled progress in home diagnostics development until the COVID-19 pandemic hit in 2020, and at-home PCR tests became a global necessity. imaware, having successfully launched scientifically-validated at-home blood tests the previous year, was able to quickly produce one of the first FDA-approved at-home coronavirus antibody tests. Critical for essential travel and, once restrictions eased, social gatherings, the widespread and rapid acceptance of home COVID screening tests gave at-home diagnostics a second wind.
With this "re-launch," the at-home diagnostics testing market finally had the chance to flourish. The global at-home test industry reached a value of $7.3 billion in 2023 and, growing at a compound annual growth rate (CAGR) of 5.9%, is expected to reach $12.3 billion by 2034.6
Factors shaping the future
In order to capture their share of the fast-growing home diagnostics market, big players and hungry newcomers are exploring expanded test applications, from patient-centric kits that enable remote patient-provider interactions to consumer-geared kits that support performance optimization solutions.
As industry development and adoption continues, here are five key trends shaping the long-term trajectory of at-home diagnostic testing:
1. Climbing healthcare costs
With healthcare expenses continuing to climb — projected to increase by almost 9% in 20247 — patients and providers are searching for cost-reduction strategies that won't compromise the quality of care.
Chronic conditions, which account for approximately 90% of annual healthcare spend, are a clear target for cost reduction.8 Though many chronic conditions are preventable, it is estimated that only 8% of Americans undergo preventive screenings regularly.9 More accessible, convenient and affordable than many traditional screening methods, at-home diagnostic tests offer a critical solution to this problematic statistic.
Putting it to the test, a study by the National Cancer Institute found that enabling patients to collect and mail in stool samples rather than having to undergo the entire rigamarole of a diagnostic colonoscopy procedure led to a significant increase in the number of up-to-date colorectal screenings.10 In these cases, at-home testing can help reduce healthcare costs by preventing more considerable long-term expenses and providing a less resource-heavy alternative while relieving the overall burden on the healthcare system. Speaking of which…
2. Rising physician shortages
According to the Association of American Medical Colleges (AAMC), the U.S. is projected to experience a shortage of up to 124,000 physicians by 2034.11 This looming crisis will not only make it more challenging for patients to access timely care but also contribute to greater practitioner burnout, further fueling the shortage issues. Not to mention the added pressure of an aging population; by 2030, approximately one in five Americans will be of retirement age,12 a demographic requiring ever-increasing levels of care. Also working against the growing need for healthcare professionals is that more than two out of every five current practitioners will be 65 or older within the next decade.13
At-home kits can offer some reprieve by enabling individuals to monitor aspects of their health themselves, reducing the personnel and resource expenditures of in-person doctor's visits without letting important check-ups fall by the wayside. The remote nature of these tests also helps by extending practitioner reach to rural locations, providing flexibility for mobility issues and enabling more frequent touchpoints with high-risk individuals. As the overworked system faces rising pressure, at-home testing will become integral to the standard care process.
3. Evolving expectations
Out of all the user trends driving the evolution of at-home tests, growing demands for personalization are at the forefront.
Personalized medicine, for example, is a popular topic among patients and practitioners as we explore how tailored, individualized care plans can lead to better outcomes. Similarly, biometric data-generated solutions are gaining traction among consumers in the broader health and wellness market.14
Personalizing health products or services, however, requires health data that users often don't have readily available. Wearable health trackers are one convenient means of accessing individual metrics, but this data is limited to external readings. At-home test panels, on the other hand, can provide the internal biomarker analysis needed for deeper levels of personalization without sacrificing convenience. The resulting data can be used alone or combined with other mediums (like wearables) to deliver even more powerful insights.
As the concept of DIY health and personalization grows in popularity, healthcare providers and businesses alike will be better equipped to address consumer demands with targeted biomarker panels for at-home tests.
4. Groundbreaking technologies
Recent technological strides have had a transformative effect on home diagnostics as well as the health and wellness market as a whole. Wearables and apps, for example, play a significant role in the at-home diagnostic landscape by empowering Americans to take control of their health. In just the last year, 63.4% of U.S. adults have used an app for health-related purposes.15 Meanwhile, around 50% now use wearable devices to monitor their health, with 79% reporting improvements to their health.16
Artificial intelligence (AI) is another revolutionary advancement making waves, with 79% of leaders anticipating significant transformations within the next three years.17 The global AI market, valued at $196.63 billion in 2023, is expected to grow at a CAGR of 36.6% through 2030.18 AI's role in personalized medicine, in particular, is expected to further the importance of at-home diagnostic testing. For instance, AI's ability to identify patterns in at-home test results can assist with the early detection of potential health issues. This technology can also help consolidate home test results with other silos of personal health data, forming one concise and insightful source of information for patients and providers alike.
Integrating at-home testing with other digital health tools, like telemedicine, wearables, and AI, will ultimately enable the creation of more comprehensive health and wellness ecosystems for patients to utilize throughout their health journey.
5. Lingering concerns
Though the pandemic helped mitigate much of the apprehension around at-home diagnostic testing, patient concerns remain.
Accuracy and reliability are at the top of that list, for good reason: they are integral to the safe interpretation and application of the results. Education about at-home tests' inability to offer an official diagnosis is critical because, though certain conditions like sexually transmitted diseases can be confirmed and treated through remote means, other conditions may require further assessment. These limitations do not, however, negate the life-changing intel users can gain from home testing. For many, it may be their first step towards catching a potentially harmful condition or solving mysterious symptoms. As such, transparency and communication about the extent of test capabilities remain as important as ever.
By offering robust data analysis and personalized insights, intelligent platforms like imaware are stepping up to address patient concerns, ensuring that users can make informed decisions about their health. Physician reviews, end-to-end support and user-friendly results portals help bridge the gap between convenience, reliability and patient education. As the market continues to grow, it will be essential for companies to navigate these challenges carefully, ensuring their products meet the highest standards of quality and safety.
Summary
The COVID-19 pandemic accelerated the adoption of at-home diagnostic testing, which is now poised to play a critical role in the future of health. As the healthcare system faces mounting challenges, such as rising costs and workforce scarcity, at-home testing offers a viable solution for increasing accessibility, decreasing resources and empowering individuals to take control of their health. With ongoing technological advancements and consumer demand for more tailored and convenient health solutions, AI and personalized medicine will play a central role alongside digital diagnostics platforms in improving experiences and outcomes.
Businesses, healthcare professionals and decision-makers must anticipate and embrace these evolving trends, providing users with the tools they need to become their best selves from the comfort of home.