The in-home testing market that largely began with pregnancy tests back in the 70’s has been exploding for several years. New tests for health conditions we would have never imagined now serve as tools to empower consumers. Thus, companies that position products to leverage the in-home diagnostics boom drive revenue growth while improving consumer health.
Many companies large and small sell diagnostic tests and monitoring devices to healthcare professionals that could also be sold directly to consumers or over the counter (OTC). Likewise, other firms possess the technical expertise to develop ground-breaking technologies with the potential to capture a significant portion of the healthcare testing and monitoring market.
They lack only the marketing expertise to evaluate the market and position the test offering for success. Here’s the bottom line:
The medical device market is $156B and expected to grow to $210B by 2023, of which the OTC diagnostics and monitoring market is estimated at $20 billion and is projected to grow at double digit rates for years to come.
Additionally, the types of health conditions that can be diagnosed and monitored at home are steadily increasing. Not to mention that many disease states have yet to enter the in-home testing market, presenting additional attractive growth opportunities.
Customers utilize the affordable, highly accurate and easy to use, home tests of today to diagnosis the onset of disease as well as to monitor chronic health conditions. Indeed, in-home tests make a great choice for consumers looking to proactively manage their health.
Consider this sample of the many types of tests available in the market today. Not an all-inclusive list, however I suspect that some of these tests will nevertheless surprise you. Costs range from $10 to $100 depending on the type of test.
Pregnancy, HIV, STD’s, Illegal Drugs, HPV, Menopause, Testosterone, Fertility, Ovulation, Cancer’s including colon, Food sensitivities, Lyme, Stress, Sleep, EKG, Flu, and YES, now even COVID-19
Several factors are driving the rapid growth of this market, including new technologies and consumer preference. I led the launch of the first in-home self-test for HIV in 2012. This experience crystalized my belief that many consumers would prefer testing in the privacy of their own home.
In-home tests eliminate the need to make an appointment and travel to a doctor’s office, take time off from work or personal matters, and usually cost much less. Convenience and Privacy reign supreme here!
The accessibility of healthcare also affects demand. Many people within the U.S. and around the world either do not have healthcare coverage or find it difficult to travel to a provider given the distance or lack of access to transportation. Plus, the increasing prevalence of chronic diseases is furthering driving the need.
Another factor driving growth is the aging population. Now at the time in life where more healthcare issues arise, the Baby Boom generation grew up with pregnancy and other early tests, so their level of familiarity and trust is well established.
Overall, in-home tests serve as a convenient, private, and low cost means to manage consumer health earlier and with greater frequently. Although these tests can diagnosis diseases early or monitor various conditions, results should be considered preliminary. They should not replace regular doctor visits and testing.
Clearly, the 1st step towards revenue growth from in-home testing is to assess your organization’s interest and capability to enter the market. The required subsequent effort includes navigating the regulatory landscape, refining or developing the product and packaging, and developing a sales and marketing launch plan.
If your organization already sells medical devices to healthcare professionals, be sure to assess the market opportunity with focus on a few key research-based insights:
For the HIV self-test, we had been selling the product to healthcare professionals for years, but several modifications to packaging and labeling were needed to make it “consumer friendly”. We also had to learn and perform the regulatory requirements while building the launch plan, which included both ecommerce and major U.S. retailers.
If you do not have a previously developed medical device, then first assess the market and technical capability required. Of course, you could also acquire a device.
Market Assessment and Concept Test
A market assessment includes a look at the size of the market or affected population, competitors, pricing, and other factors. The goal is to determine if there is sufficient demand for the technology you envision to become a profitable in-home test.
Once that is determined, the product is defined, and technical feasibility is assured, then devote your efforts to product concept testing with your intended audience. Concept tests determine product acceptability and the likelihood of purchase at a given price. They also identify important insights that drive product development as well as elements of the marketing plan.
Companies seeking to launch an in-home test must explore the regulatory requirements very early in the process. Not all devices require FDA approval, but many need clinical studies to demonstrate the safety and efficacy of the product.
FDA approval takes time and adds cost. But the risks can be reduced by thorough product concept testing to validate the consumer need and appeal of the offering prior to these investments.
In-home testing provides an exciting path for revenue growth. If you would like to explore the opportunities you may have further, please reach out with the contact information below. As a medical industry expert I will conduct a preliminary assessment to quickly determine the ideal growth opportunity and path for your organization.