Europe to Benefit from U.S. Consumer Demand for Home-Use Diagnostic Testing

The market for home-use diagnostics is set to take off as a result of the continuing trend toward consumer-driven healthcare. This new growth is expected to rival the size of the existing $7 billion global market in home-use diagnostics, which is currently dominated by pregnancy tests and glucose monitors.

The conclusion of a two-part report by Cambridge Consultants (Cambridge, MA, and Cambridge, UK) indicates that Europe may be the first to benefit from the consumer diagnostics revolution—even though key drivers for the explosion of the market will come predominantly from the United States.^1,2 In developing the report, Cambridge Consultants polled the opinions of 32 pharmaceutical and diagnostic experts in the United States and Europe during the course of two workshops. The European workshop, attended by 15 industry representatives, was held in late June 2007. Its U.S. counterpart, attended by 15 industry representatives, was held in October 2007.

In European countries with state-run healthcare systems, the growth of the home-use diagnostics industry will be driven by its potential to reduce pressure on health services, according to European workshop attendees. On the other hand, experts in the United States say the driver for growth in their market will come from a combination of two factors: the nation's healthcare reimbursement practices and an increasingly informed and health-savvy population, particularly among the Internet generation.

The traditional processes and structures that make up the U.S. healthcare insurance and reimbursement system have been slow to adopt new tests, often resulting in late diagnosis of preventable diseases and dramatically increasing the costs of patient care. But now, operating on the premise that earlier diagnosis can bring about significant cost savings, government agencies and other third-party payers are becoming eager to get home-use diagnostics onto the U.S. market as quickly as possible. However, market growth in the United States may be slowed considerably by the FDA approval process, which takes manufacturers of new diagnostic products an estimated three to five years to navigate.

Given such regulatory hurdles, manufacturers are beginning to seek softer markets in an effort to gain early acceptance for new test kits. However, it remains to be seen which geographic market the new generation of tests will enter first. India, for example, has few regulations in place for medical devices. Yet the country has a growing upper-middle class that offers an attractive target for home-use diagnostics.

On both sides of the Atlantic, conference delegates viewed the future of the industry in terms of the ways that new technologies will be deployed. Pharmacists and their currently underused expertise, for example, could become critical for administering and interpreting certain qualitative tests, thereby easing pressure on physician resources. In Europe, some governments are already increasing the power given to pharmacists to conduct diagnostic testing and screening, in an effort to reduce the burden on socialized healthcare systems. In the United States, physicians have limited time for patient consultations. As a result—given the proper regulatory framework—large U.S. pharmacy chains may decide to develop on-site diagnostic-testing facilities as a means of enticing customers into their stores.

Although pharmacy-based diagnostics may be an attractive model for the United States, Italy and the United Kingdom offer even more-fertile ground for such a development to occur. Each country has a pharmacy network that is supported by highly trained and underutilized pharmacy staff. In the UK, the move toward further utilization of these resources is expected to be accelerated by a recent revision of its independent dispensing legislation. The results of the revision are about to go into effect and should give pharmacies more control and power over diagnostics.

In both the United States and Europe, the types of home-use tests most likely to emerge are targeted at four main areas: screening, disease identification, disease monitoring, and prognostics. The roll-out of over-the-counter testing in pharmacies is expected to increase consumers' awareness and acceptance of home-use diagnostics.

Unlike pregnancy tests, most home-use diagnostics will not be considered sufficient unless they can supply users with more than a simple yes or no answer. Moreover, giving the consumer a number representing a cardiac-marker level or a cholesterol level would be useless, because such numbers are generally meaningless to untrained users. In all cases, said the conference delegates, test results should be presented in a way that will allow for easy interpretation, and accompanied by appropriate recommendations for action. What's necessary is advice, education, and support, so that the test results can be made actionable.

“For commercial success, diagnostic firms will have to understand consumer needs,” said Chris Price, a visiting professor in clinical biochemistry at Oxford University and delegate at the European workshop. “This will most likely happen through collaboration with consumer companies. Furthermore, evidence of the test's analytical performance and effectiveness will be needed, along with robust guidance and recommended actions to establish the sound reputation of this new market.”

Small companies that are developing home-use diagnostic tests offer examples of the need for such collaborations. Such companies are unlikely to achieve market penetration unless they work with larger, consumer-oriented companies that have access to distribution channels and brand marketing. Diagnostic companies need to realize that their tests are only one element of the product, said the conference delegates. Companies must also think about the consumer, who needs an actionable outcome.

Following this approach, for example, an emerging diagnostic company might partner with a large pharmaceutical company, thereby making better use of its test, giving consumers actionable outcomes and, as a result, increasing consumer compliance.

One aspect of the diagnostic marketplace identified as an important driver in both Europe and the United States is the dominance of reactive medicine. Generally speaking, only people who are ill go to visit their doctors. Conversely, people who are not ill typically do not go to the doctor. But emerging tests applied as prognostics could change this practice. Such tests open the possibility of performing predisposition testing to determine what sorts of medical conditions an individual might be prone to encounter at some point in the future. Such knowledge could enable individuals to delay or even prevent the onset of disease.

Another potential market driver is sample collection and processing, which is not only critical for test accuracy, but also related to user compliance. According to the Cambridge report, all consumers exhibit a clear preference for noninvasive sampling (e.g., imaging, oximetry, blood pressure, temperature, weight, body fat, transcutaneous measurement), followed by minimally invasive sampling (e.g., tears, sweat, urine, stool, hair, skin, saliva, breath), over invasive sampling (e.g., blood, tissue). By considering alternative methods for obtaining a sample, companies can dramatically increase compliance—and therefore also the utility of their tests.

Worldwide, the diagnostics industry hasn't fundamentally changed since the late 1980s. Now, as then, most of the market emphasis remains on blood-glucose and pregnancy tests. With advances in technology and increased consumer demand for information, however, the IVD industry is on the verge of an explosive new market in consumer-based diagnostic products.

New diagnostic technologies are decreasing costs, improving ease-of-use and reliability, and ensuring that home-use tests are fool-proof. According to conference delegates in both Europe and the United States, the market will soon be hit by a wave of home-use diagnostics for diseases such as asthma and allergies, as well as for genetic predisposition to conditions and diseases.

In the future, commented the conference delegates, advances in diagnostic technologies will make it as simple for individuals to check their health as it is to monitor their investments.

Reference

1. The Future of Diagnostics: A Consumer-Driven World? The U.S. Perspective (Cambridge, MA: Cambridge Consultants, 2007); available from Internet: www.cambridgeconsultants.com/fm_diagnostics_07.shtml.

2. The Future of Diagnostics: A Consumer-Driven World? (Cambridge, UK: Cambridge Consultants, 2007); available from Internet: www.cambridgeconsultants.com/fm_diagnostics_07.shtml.

Simon Burnell is head of the diagnostics group at Cambridge Consultants (Cambridge, UK). He can be reached via e-mail at [email protected].

© 2008 Canon Communications LLC

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