The editors of asked top executives at some of the leading IVD companies and other key industry figures to share their vision on what the future holds for the IVD industry. Here is what these people had to say on this topic:

Diagnostics have always played a pivotal role for medical progress and better healthcare. I believe this has never been more true than today, with information becoming a key asset in healthcare. This trend is fed by novel technologies providing added information with a high clinical value, which enhance the utility of IVD systems beyond the detection and diagnosis of specific conditions toward efficient management of diseases and patients.

I believe that the continuous growth of the IVD industry reflects the rising importance of corresponding technologies. This is particularly true for molecular tests, currently the fastest growing IVD segment with a compound annual growth rate of 16%, which enable new insights into the emergence and course of diseases and pave the way to personalized healthcare approaches based on genetic information. In the United States alone, molecular tests are available for more than 2,000 diseases.

The progress achieved in molecular diagnostics during the past 10-15 years is truly impressive, and it is still in an early stage of development. Fueled by scientific research, the next 15 years will see the development of novel molecular biomarkers and the dissemination of molecular testing technologies into routine clinical practice in both developed and developing countries, aided by the development of convenient and affordable testing systems.
The opportunities for the IVD industry are abundant, and it is up to IVD manufacturers to deliver on this promise to achieve yet another milestone for patients, healthcare professionals, and the healthcare system as a whole.—Bob Barret, vice president, global marketing, molecular diagnostics, Qiagen GmbH (Hilden, Germany)
 

Today, IVDs account for less than 3% of healthcare costs. Yet, it provides nearly 80% of information used for therapy selection. The acceleration of technology and automation, coupled with informatics and middleware, will enable the retrieval of patient diagnostics from anywhere in the hospital, dramatically increasing the value of IVDs.
With an aging population, multi-drug resistant organisms, and lab consolidation, there is an increasing need for rapid results. The decline in skilled resources is driving the transformation to full automation and fueling the lean lab movement. While there will be strong attraction to new technologies, these solutions will need the appropriate regulatory clearances and financial compatibility with the hospitals’ budgets.

Challenges to the IVD industry include financial pressures, laboratory consolidation, and managing the capacity to offer real medical value in compressed time frames. In addition, the IVD industry’s challenge is to take an active role in debating the balance between reimbursement and high-value medical tests, while possibly decreasing reimbursement rates for lower-value tests.

The global need to get more value from healthcare expenditures will drive innovations such as theranostics, the fusion of medicine and diagnostics. This is the cornerstone for preventive care and personalized medicine, which is becoming more pervasive, particularly with cancer biomarkers.—Thierry Bernard, corporate vice president, commercial operations, bioMérieux SA (Marcy l’Etoile, France)
 

Increasing demand for diagnostic testing from legions of newly insured patients will fuel significant growth in the United States for IVD companies through 2025. However, brutal customer cost pressures will be the norm. More tests than ever will be ordered, but reimbursements will be squeezed by cash-strapped public payers. As the newly insured patients get regular check ups, they will need blood chemistry panels and follow-up tests for diabetes, cancer, and other conditions. The push toward personalized medicine will accelerate, and doctors will be ordering precise, patient-specific cancer monitoring tests, for example. New biomarkers will increase and succeed if they detect serious diseases sooner and cheaper.

Burgeoning workloads and dwindling customer resources will keep the IVD industry focused on automation and data management to help laboratories do even more with even less. Long-term success for many IVD companies may occur as much if not more from technological advancements in software and communications technologies than from new systems and assays. So IVD companies in the future will be challenged to transform into successful information companies as well as diagnostic product suppliers. They will be valued for the quality and speed of information they generate, interpret, and communicate, especially if plans for universal automated medical records become a reality.—John Coulter, divisional vice president, U.S. commercial operations, Abbott Diagnostics (Abbott Park, IL)

Reimbursement will likely be the biggest driver of the IVD industry in the next 15 years. As with past automation for clinical chemistry panels, more of the advanced tests such as amplified molecular testing are being automated. When government policymakers catch up with this innovation trend, procedural payment codes for automation will no longer be appropriate.

From a submission/compliance perspective, the IVD industry will feel greater regulatory burdens as the increased conservatism of FDA programs slow the introduction of costly technologies and increase the penalties for error. To counter this government conservatism, the IVD industry will need to become more effective as a lobby group, forcing new considerations of the regulatory cost/benefit ratio. This can and should be accomplished by carefully measuring regulatory risk, cost, and benefit between the U.S. system and foreign systems, and making a case for less regulation. If the regulatory burden cannot be reduced, Americans will suffer. However, such suffering may remain poorly expressed and understood because those not treated and those not diagnosed have no way to measure and express the problem.

Additional challenges for IVD manufacturers during the next 15 years will include the expansion of laboratory-developed tests (LDT) outside the FDA paradigm. While FDA has claimed jurisdiction, there has been no evidence of high-level discussions that would resolve the CLIA vs. FDA discrepancies in providing diagnostic information to physicians and patients. Neither the resources nor motivation are there, but as more LDTs are offered and more innovative companies move into the market via their own CLIA specialty lab rather than the FDA route, the marketplace for traditional IVD manufacturing and kit distribution will change.

With the advent of sensitive nucleic acid technologies and databases to identify genes, gene interactions, and gene impacts and prognoses, highly likely breakthroughs will include more targeted therapies. With such targeting, the cohort of patients to test is reduced further, allowing the CLIA approach to succeed. There will always be room for the high throughput common tests, but for many of these, tests the sensitivity achieved is quite adequate. Where greater test sensitivity is needed, such as with glucose monitoring, technology improvements will continue. Hopefully in 15 years, advances in stem cell treatment will allow that particular product line to wind down for the previously insulin dependent population.—Glen P. Freiberg, president, RCQ Consulting (San Diego)

The IVD industry will increase in importance and value during the next 15 years through continued demonstration of how diagnostics can improve patient care by delivery of the right treatments to the right patients at the right time. Data from the European Diagnostic Manufacturers Association demonstrates that IVD tests comprise less than 2% of healthcare spending worldwide and yet they influence more than 60% of healthcare decisions.

For many years, physicians have relied on molecular viral load testing of HIV and hepatitis to determine whether a patient is responding to treatment, and as new therapies are developed, the role of diagnostic testing will remain critical. In the ensuing era of personalized healthcare, it is likely that therapies will have even greater reliance on companion diagnostic tests to identify patients who will show the greatest response to treatments. One exciting example is the BRAFV600E Mutation Test (investigational use only) that is being used to inform the selection of melanoma patients for clinical trials and treatment with an investigational drug.

As treatment regimes and therapeutics continue to advance, the role of IVDs becomes more critical to ensure that all patients have the opportunity for optimal treatment, and consequently the value of the IVD industry will continue to grow.—Neil Gunn, vice president, global business, Roche Molecular Diagnostics (Pleasanton, CA)

Demographic changes are driving significant changes in the delivery of healthcare. The number of people over the age of 65 in the United States is expected to double by 2030, and one in three may be diagnosed with cancer. The solution to these tough challenges will be in the form of integrated diagnostics.

The future of diagnostics is moving toward the integration of laboratory diagnostics, medical imaging, and information technology solutions. This new model will help physicians integrate diagnostic information for the patient across the entire continuum of care— from prevention to early detection, monitoring, treatment, and after care. Integrated diagnostics will enable a significant shift from the current focus on acute diagnosis and treatment toward a broader focus on the full cycle of diagnostic care. The potential of integrated diagnostics is powerful. Healthcare providers will be positioned to streamline workflows, improve clinical outcomes, and provide more affordable care to the patients they serve.—David Hickey, executive vice president, central laboratory, global research and development, Siemens Healthcare Diagnostics (Malvern, PA)
 

As the molecular diagnostics industry continues to mature and becomes an increasingly important part of the global IVD market during the next 15 years, more will be expected of the technologies and their providers.

Although molecular tests comprise only about 10% of the IVD market today, this percentage will increase steadily. Growth will be driven by the ongoing discovery of clinically relevant genes and genetic pathways, and increased adoption of new and existing tests for infectious disease, oncology, and pharmacogenomic applications.

As molecular testing becomes more commonplace globally, providers will need to deliver effective automated systems to run increasingly complex assays. In fields such as cancer, technologies that deliver multiplex results will become increasingly important in the future. Sequencing could ultimately play a significant role here as costs decline and if formidable technical and bioinformatics challenges can be overcome.

For molecular diagnostics to thrive during the next 15 years, regulatory and reimbursement systems around the world must keep pace with rapid product improvements, and elected officials must prioritize more cost-effective patient care over political expediency, providing a supportive environment for the innovation that produces continued scientific and commercial progress.—Carl Hull, president and chief executive officer, Gen-Probe Inc. (San Diego)

From the point-of-view of a regulator, I believe that during the next 5 years, the IVD industry will attract more interest as diagnostics become more critical and visible in providing better quality healthcare. Smaller companies may emerge to fill unmet diagnostic needs through single site testing or with business models that are very focused on niche testing.

In the next 15 years, it seems likely that the IVD industry will take advantage of the huge amount of human genome information now being generated to create tests that can detect ever more fine disease classifications and predict more accurately whether a patient will respond to a given therapy. In addition, epigenetic information will probably be more used in diagnostics as more is discovered about how the genome is regulated. Thus the IVD industry may be divided by the various technologies available. It is possible that what were once tool providers will see the value of entering the diagnostic market with their own tests.

Some of the challenges to be met in diagnostics are emerging now, including the difficulties of validating large multiplex test panels and finding sufficient patients and samples to validate ever smaller populations, as disease can be more finely differentiated. I hope to see some creative, perhaps informatics-based approaches that will alleviate these problems. In addition, regulators will likely need to define pathways so that diagnostic technologies can be kept as current as possible, without requiring wholesale revalidations, but I can’t predict what those pathways might look like.

Given the sequence race that is taking place now, I think that some of the major advances will be in informatics tools that allow large amounts of sequences to be assessed. With this, very good user interfaces will be needed, which allow physicians to easily understand results and apply them to their patients.—Elizabeth Mansfield, PhD, director, personalized medicine staff, Office of In Vitro Diagnostic Device Evaluation and Safety (Silver Spring, MD)

The IVD industry has a great value proposition. With the ever increasing cost of healthcare, only to be accelerated by healthcare reform as struggles to expand coverage continue, the healthcare system needs to seek out efficiencies as never before. To achieve that, the healthcare system needs to improve decision-making, and reliable diagnostic information is one of the keys. The hope of personalized medicine I suspect will become a reality, allowing the healthcare system to treat patients more effectively with what they need and only what they need.

Getting there, though, will not be easy. Among other things, it will require a coherent federal policy to support the development of these new diagnostic tools. The confluence of reimbursement policy, CLIA regulation, and FDA oversight will need to produce a regulatory environment that encourages innovation. Many issues have to be sorted out, including the regulatory pathways for companion diagnostics developed in parallel but perhaps out of sync with drugs, payment policies that support rather than discourages new products, appropriate standards at FDA for clearing new diagnostic tests in which the clinical utility is still being explored, and the appropriate role for and oversight of clinical laboratories in developing new tests.

In the end, I suspect those issues will be resolved in favor of greater access to potentially life-saving information. But as anyone who works in Washington knows, the road will be long and bumpy.—Bradley M. Thompson, JD, attorney, Epstein Becker Green (Washington, DC)
 

The IVD industry is one of the most dynamic and innovative parts of the healthcare system, providing physicians and their patients with valuable information needed to make smarter, customized healthcare decisions. During the next 15 years, the IVD industry will continue to grow as the value of these tests to more accurately and promptly diagnose disease is realized.

The IVD industry stands on the threshold of an exciting new era of personalized medicine and testing using advanced diagnostic technologies. Many gene-based, molecular, and other advanced diagnostics are emerging that enable identification of susceptibility to disease long before symptoms occur, giving the ability to custom tailor treatments for individual patients to achieve maximum effectiveness. This means better outcomes for not only patients but also the healthcare system as a whole, as diseases will be detected earlier when they are less expensive to treat and when there is a greater chance for complete recovery.

In order to provide patients with timely access to these valuable tests, the IVD industry must work with policymakers to establish a modernized risk-based approach to the regulation of IVDs and focus on reforming the antiquated Medicare payment system to fully recognize the value of new tests. These key reforms would encourage the continued innovation of tests that provide physicians and their patients with information to make smarter, customized healthcare decisions, and that help to prevent deaths, adverse events, and costs associated with many of the nation’s most burdensome diseases or other conditions.—Stephen J. Ubl, president and chief executive officer, AdvaMed (Washington, DC)
 

To understand where the IVD industry is going, it is helpful to think about where it been as an industry. For the past 15 years, the industry has focused primarily on efficiency: how to offer efficient, high-volume systems with the healthcare system’s desire for streamlined services. This has created a model that leverages large, centralized lab facilities to maximize the speed and volume of tests.

Today, the technological advancements in areas such as cellular and molecular diagnostics are making IVDs more complex. While there is still a need to accommodate large volumes of standard tests in centralized facilities, the IVD industry is seeing a growing need for specialized testing at different sites of care than it is used to. Proprietary lab facilities are starting to grow as the demand for unique skills to perform and interpret new IVD tests grows. In addition, the prevalence of chronic diseases and conditions, such as heart disease and diabetes, are requiring ongoing treatment, which includes ongoing monitoring through diagnostic testing. The need for rapid results in a convenient setting is driving a change in the way that some IVDs are delivered. Point-of-care and near patient testing models that produce results in the office while patients wait, and even home testing kits, are not only changing consumer expectations of the role IVDs play in their healthcare but also helping healthcare providers make faster and better decisions about the course of care for their patients.

Where I think the IVD industry is going in the next 15 years is toward a more patient-centric model in which technology enables a more personalized testing experience, one that happens at the most appropriate site of care, is conducted through the least invasive means, and offers a wealth of unique information about a patient’s health status, risk factors, and future progression. Essentially, IVDs will increase their importance as the catalyst for clinical decision-making and an enabler of a more effective and efficient healthcare system.—Michael Yang, general manager, Veridex LLC (Raritan, NJ)