Originally Published IVD Technology April 2005
Anniversary Essays
10. The future
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Dick Aderman |
The editors of IVD Technology asked top executives at some of the leading IVD companies and other key industry figures to share their vision of what the future holds for the IVD industry. Here is what these people had to say on this topic:
The IVD industry has evolved dramatically during the last 10 years. At the rate the industry is growing and at the speed that new IVD technologies are being adopted, the next 10 years will see tremendous opportunities and advancements for laboratories, physicians, and patients. IVD manufacturers will continue to see breakthrough tests in the areas of molecular diagnostics and proteomics. But it is also imperative that manufacturers promote the value of the information that comes from these tests. Shifting the mind-set of the healthcare industry to better understand the value of diagnostics in the whole healthcare picture is a critical component. There are opportunities to show the significance of diagnostics to other markets within the healthcare continuum.
The biggest developments and advancements in the IVD industry will be through the wider proliferation of molecular diagnostic testing and proteomics. IVD manufacturers will be able to provide a much clearer picture in disease and disease progress. Manufacturers will become more closely linked with pharmaceutical companies because testing will be able to help decide the therapies of tomorrow. Molecular diagnostics will become more commonplace, and will continue to be a critical and important part of healthcare by providing laboratories with advanced testing options and innovative health information to physicians and patients.—Dick Aderman, senior vice president and general manager, Roche Diagnostics (Indianapolis)
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Steven I. Gutman |
From my perspective as a regulator, the IVD industry occupies a highly charged, creative, competitive, and incredibly talented niche in the world of medical devices. During the next 10 years, I see continued evolution in the science and technology supporting diagnostic testing. In spite of what will be significant fiscal concerns or constraints in healthcare spending, the aging population of baby boomers is likely to create great
demand for an increased menu of tests and increased volume in testing.
Of particular interest to me as a healthcare consumer as well as a regulator is watching what will be an emerging revolution in molecular diagnostics. Within 10 years, laboratories will be routinely exploiting knowledge from the human genome project. I certainly would be disappointed if in 10 years, new genomic and proteomic tests have not become part of the routine landscape for laboratories helping healthcare providers and patients to make better-informed personalized or individualized healthcare decisions.
However, new IVD technologies are likely to transcend molecular diagnostics and change the ability to diagnose and manage patients with all kinds of both common and uncommon diseases. Already at FDA we have seen progress in diagnostics for infectious, hematologic, metabolic, neoplastic, cardiovascular, and other diseases.—Steven I. Gutman, MD, director, Office of In Vitro Diagnostic Device Evaluation and Safety (Rockville, MD)
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Clifford E. Holland |
The IVD industry has seen great advancement in diagnostics during the past 10 years and expects to see even greater progress in the next decade when diagnostic information will become more central to patient care. These changes will result from three fundamental transformations: new technologies, automation, and the increased role of the laboratory in individualizing and monitoring disease therapy.
Many opportunities in diagnostics will come from new medical technologies, potentially creating a radical change on the diagnostics horizon. As new drugs and devices are developed, they will require corresponding diagnostic tests that tailor treatment. IVD companies will develop innovative diagnostic tests for many diseases for which no diagnostic tests are currently available. Bioinformatics, proteomics, and molecular diagnostics will drive much of this innovation.
The next decade will be an exciting era for diagnostics as IVD manufacturers have an opportunity to play an even more pivotal role in healthcare. Emerging IVD technologies will broaden the offering of information to the clinician and enhance the value of the laboratory to patient care. The laboratory will increasingly influence patient management and should evolve from being a cost center to a value generator. The key to success in the IVD industry during the next 10 years is providing physicians and patients with answers, not just test results.—Clifford E. Holland, worldwide president, Ortho-Clinical Diagnostics Inc. (Raritan, NJ)
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Attila T. Lörincz |
The IVD industry is growing at a modest pace overall with some segments growing much more quickly, especially molecular tests. This trend will continue, and IVDs will be a strong growth industry for at least the next 10 years. The IVD market should double or triple in size, and molecular tests will become the dominant part of the testing industry with the most valuable tests conducted being DNA, RNA, and newer proteomic tests.
The majority of tests will still be performed at the central labs of hospitals and reference testing entities. While esoteric testing will not increase proportionally by much, the big winners will be the point-of-care molecular tests. These tests will come on strong somewhat later, in the 7–10-year time frame.
The IVD industry will provide a diverse offering of tests and platforms. There will be a wide range of equipment, from full random-access analyzers for molecular testing similar to the clinical chemistry analyzers of today to specialized tests and equipment for low-volume esoteric uses. Some IVD manufacturers may incorporate chemistry, immunology, and molecular testing in one high-throughput, multiplex, random-access black-box platform. The industry will be stronger in 10 years as it becomes clearer to the public that good outcomes in medicine are tied to quality IVD tests.—Attila T. Lörincz, PhD, senior vice president of research and development and chief scientific officer, Digene Corp. (Gaithersburg, MD)
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Edward J. Ludwig |
An imperative for the IVD industry is to provide dependable, easy-to-use, and cost-effective products for the early detection and treatment of potentially devastating diseases. IVD manufacturers must continue to develop effective diagnostics that help transform these once life-threatening diseases into manageable chronic conditions. The next 10 years will be a very exciting period for medicine in general and for the IVD industry specifically, as manufacturers apply much of the groundbreaking biological research that has been taking place in recent years.
An additional challenge for the IVD industry is to better educate the public, policymakers, and healthcare providers around the world on the value that new diagnostic technologies provide. The efficient use of cost-effective diagnostics can save billions of dollars in healthcare costs and help governments around the world to more efficiently deploy their limited healthcare resources.
I believe there will be increased growth and demand for diagnostics. People around the world will welcome the development of new IVD technologies to meet their pressing needs. The new technologies that IVD manufacturers develop must enable earlier, more-specific, and more-effective treatment of disease. By successfully doing so, human suffering can be reduced and manufacturers can help more people live healthy and complete lives.—Edward J. Ludwig, chairman, president, and chief executive officer, Becton, Dickinson and Co. (Franklin Lakes, NJ)
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Alain Mérieux |
Diagnostics will be more important for the healthcare industry, and its added value will be even more recognized than ever. It will be a tool that will play a significant role in improving the quality of healthcare.
The demand for diagnostic tests will significantly increase not only in the field of cancer but also in cardiac diseases, along with the discovery of new biomarkers. IVDs will also become more critical in detecting and fighting infectious diseases.
Strong growth will also be experienced in industrial diagnostics, along with the growing public concern regarding the traceability of raw materials and the contamination risks associated with food (e.g., bovine spongiform encephalopathy) and the environment (e.g., Legionella).
Over the medium term, pathologies such as cardiovascular diseases and cancers will be significant growth areas for the IVD industry. Such growth will be due to technological developments that increase the potential role of diagnostics in the analysis and management of treatments, as well as to the increasing frequency of these pathologies as a result of changing life-styles and the aging population.
The growth in the IVD industry will also be driven by the development of new technologies such as molecular biology, human genetics, and nanotechnologies that will provide new applications and address unmet medical needs.—Alain Mérieux, chairman, president, and chief executive officer, bioMérieux Inc. (Marcy l’Etoile, France)
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Hank Nordhoff |
During the next decade, IVDs will become more important to increasing both the quality and cost-effectiveness of healthcare delivery. At the same time, molecular diagnostics will be the fastest-growing segment of the IVD industry, based on its potential to provide vital, actionable information to drive appropriate healthcare decisions.
In this context, broader use of IVDs can make healthcare delivery safer, more precise, and more efficient. Rather than simply confirming the presence of disease, IVD companies in the future can play a much larger role in healthcare delivery by helping physicians and other caregivers individualize treatment, predict disease risks, and monitor patient responses to therapy.
But with these great opportunities come great challenges for the IVD industry. IVD manufacturers must build the expertise to master and nurture new technologies, from microarrays to real-time genetic amplification and detection. Manufacturers must do a better job of communicating the value of these technologies to healthcare regulators, payers, providers, and even patients. IVD manufacturers must also find creative ways to partner with pharmaceutical firms, some of which will be threatened by the potential of theranostics to fragment their target markets. In addition, manufacturers must help implement privacy safeguards that protect against discrimination based on genetic information.—Hank Nordhoff, chairman, president, and chief executive officer, Gen-Probe Inc. (San Diego)
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David Okrongly |
The IVD industry is facing an enviable challenge that other industries could only hope for: managing the remarkable fruits of healthcare’s progress during the last decade. Mapping of the human genome and advances in molecular testing will continue to create powerful insights into predicting, preventing, and treating disease. The challenge for the IVD industry is to make these scientific advances accessible, accurate, efficient, and fully integrated into clinical care, and at a price the healthcare system not only can afford to pay but also is willing to pay because of diagnostics’ value in improving clinical outcomes.
IVD manufacturers can only fully reap the rewards of healthcare’s scientific advances if talent and determination can transform the laboratory in two fundamental ways: leveraging automated technology and building more-powerful information management systems. These are the keys to the IVD industry unlocking the true clinical potential of IVDs.
The IVD industry will find ways to engage diagnostic technologies efficiently and deliver the data to prove it. And considering the potential impact that IVDs can make on the entire healthcare system—from the bottom line to the ultimate top line, which is longer lives for healthy patients—the IVD industry has an obligation to do nothing less.—David Okrongly, PhD, senior vice president of research and development, Bayer Diagnostics (Tarrytown, NY)
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Leif E. Olsen |
Based on current trends, the IVD industry will experience significant growth during the next 10 years. The key to this growth will primarily be the increased demand for diagnostic testing in the emerging markets (e.g., India and China). In addition, new technologies (e.g., theranostic tests) for molecular-based diagnostic products will power the growth in developed markets (e.g., North America, Western Europe, and Japan). These tests will be developed primarily for predictive medicine and disease management. However, there are certain regulatory and reimbursement factors that could affect this growth.
One of the most significant challenges facing the IVD industry is how to become more profitable, especially with significant increases in healthcare costs. Competitive pricing will also drive IVD companies to find ways to cut costs, become more productive, and still maintain their regulatory compliance status with quality system regulations. In addition, new technologies will present challenges to the regulators when premarket submissions show up at FDA for product approval or clearance.
IVD companies will focus their product development strategies on developing theranostic tests for predictive medicine and disease management. These new diagnostic technologies (e.g., proteomics, genomics, and pharmacogenomics) will revolutionize diagnostic testing for cardiovascular disease, central nervous system disease, cancer, and aging.—Leif E. Olsen, regulatory affairs specialist, Hogan & Hartson LLP (Washington, DC)
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Donal Quinn |
Some powerful trends have the potential for driving change in the IVD industry. Some of these trends offer tremendous opportunity for IVD manufacturers that can seize and shape them. Other trends bear watching since they can present long-term challenges if manufacturers fail to address them appropriately. Those trends fall into two major categories: healthcare cost containment, and emerging scientific discoveries and developments in exciting new areas such as genomics and proteomics. IVD manufacturers should also be intensely aware of the place of the industry in the whole healthcare continuum and should work diligently to ensure that the role of IVDs is both recognized and acknowledged. The chance to play a critical and lifesaving role in the realm of predictive medicine is exciting. The IVD industry should seize this opportunity and make the best possible strategic decisions so that manufacturers help shape a very positive future for diagnostics and healthcare in general.
IVD manufacturers are poised on the brink of change and have every opportunity to take control of our own destiny in a way that benefits society as a whole. By seeing challenges as opportunities, manufacturers open new doors to the future and create a healthcare-delivery system based on prevention rather than cure. This is a world we can all identify with and aspire to build.—Donal Quinn, president, global customer management, Dade Behring Inc. (Deerfield, IL)
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