The United States is the largest IVD market in the world, with $24.1 billion in annual revenues. Although it’s a strong market, growth in the United States has been slower than in other parts of the world due to financial restrictions, limited reimbursements, uncertainty regarding healthcare reform, healthcare budget cuts, and market saturation (in some segments).
Even with such headwinds, IVD’s future remains bright. In a 2014 industry report, “The United States Market for In Vitro Diagnostic Tests,” healthcare market research firm Kalorama Information reviewed multiple diagnostics segments and analyzed them in terms of their forecasted compound annual growth rate.
“The five sectors that we determined will have the highest growth rates for the U.S. through 2018 are histology, point-of-care, molecular assays, and microbiology and virology,” Bruce Carlson, publisher of Rockville, Md.-based Kalorama Information, told Medical Product Outsourcing. “Where most U.S. IVD market segments maintain a growth rate of one to three percent annually, we’re seeing these market segments reaching five percent growth or higher.”
The five sectors Carlson outlined are histology, point of care, molecular assays (non-infectious disease), molecular assays (infectious), as well as microbiology and virology.
Technologies in the histology market segment are used to characterize cells and biopsied tissues and distinguish tumor attributes.
“Growth in this segment primarily represents cancer testing,” Carlson explained. “Since testing leads to early detection and better outcomes, it’s more of a priority in cancer —probably seconded only by infectious disease. As a result, institutions (government-funded, healthcare insurance companies, etc.) are willing to spend money on the test portion because it leads to better detection, treatment and recovery. Plus, when it comes to cancer testing, it’s not uncommon for three or four different tests to be performed in order to better understand the progression of the cancer, the type of cancer, what areas of the body it’s affecting, etc.”
Revenue growth also is expected in this segment as labs and manufacturers prioritize and innovate lower-cost tests. In addition, the Centers for Medicare and Medicaid Services (CMS) is expected to readjust their reimbursement rates for histology testing in response to protest from pathology groups, reference laboratories, and specialized IVD companies when the 2012-2013 rate adjustments fell below what tests and procedures cost.
Point of Care
Point-of-care (POC) diagnostics is the largest IVD segment in the United States, according to Kalorama’s report, generating $3.6 billion in annual revenues. Growth in POC testing also reflects patients’ preference for getting tested in a doctor’s office, a medical clinic, or even at their workplace or home rather than in a hospital or central laboratory. With the easing of Clinical Laboratory Improvement Amendments (commonly called CLIA) test product waivers in the United States, a wide range of personnel now can purchase and perform diagnostic tests with minimal certification or training, making POC testing more prominent.
“In post-Affordable Care Act U.S., healthcare, where operational flexibility, ease of use and rapid results are highly valued, POC’s efficient and cost-effective application is a primary reason why we expect this segment to marginally exceed overall U.S. IVD market growth,” said Carlson.
A specific area of POC that is experiencing increased interest and investment is molecular diagnostics platform.
“We’re noticing a high number of manufacturers focusing on infectious disease applications for POC,” Peter Gyorda, senior Consultant with Waltham, Mass.-based Boston Biomedical Consultants Inc., told MPO. “Molecular POC diagnostics can offer improved test quality results in comparison to existing POC methods, such as rapid tests. However, there are still significant regulatory hurdles that must be overcome before widespread adoption.”
Compact molecular diagnostic systems also are being introduced into the market in increasing numbers.
“Not only have fluidics cartridges become more affordable, with better functionality and zero molecule carryover, but detectors are also getting miniaturized,” said Marius Balger, CEO of BIT Group, which provides services in the field of contract development and manufacturing as well as after-sales service for customers in the fields of medical, diagnostics, life-science, and biotechnology.
“Combine that with advances in isothermal amplification chemistries and microfluidics, compact molecular diagnostic systems are solidifying their role as a go-to technology for facilitating better, faster patient treatment and finding the right personalized therapy.”
Molecular Assays (Non-Infectious Disease)
As organized by Kalorama Information, non-infectious molecular assays are used for neonatal and prenatal screening; hereditary disease screening; tissue typing for transplantation (organ and marrow); detecting cancer markers in blood; circulating tumor cell testing, and pharmacodiagnostics (PGx), also referred to as companion diagnostics.
In addition to the development of cancer therapies and hereditary disease screening (notably the BRCA gene that raises a patient’s risk of breast cancer), an area that is expected to contribute to stronger U.S. molecular assays market growth in 2014 and beyond is pharmacodiagnostics.
“The idea behind PGx is to test first in order to avoid a therapy that might be costly and ineffective, or even harmful to a patient, as well as identify patient populations that will most likely benefit from a therapy,” said Carlson. “Because this process helps prevent testing waste and redundancies, CMS and private insurers are more willing to pay for them.”
A recent report from Dallas, Texas-based research firm MarketsandMarkets also supports this outlook, projecting that the global PGx/companion diagnostics market will grow to $8.7 billion by 2019.
Many cancer-focused companion diagnostics already are being successfully marketed, with several becoming part of a routine diagnostic and treatment plan.
Molecular Assays (Infectious)
Whereas non-infectious molecular assay diagnostics primarily focuses on prenatal and hereditary testing, the infectious molecular assay segment focuses on detecting bacterial and viral pathogens and infections.
While overall growth in this segment has slowed, Kalorama Information projects higher than average growth in product introductions as well as increased testing for the following infections and pathogens:
• Hospital- or healthcare-acquired infections (HAIs)
• Respiratory viruses
• Emerging infectious diseases
• Urinary tract infections
Through 2018, sales growth in the United States is expected to be above 10 percent on average for these molecular testing segments. Notably, support for molecular testing for healthcare-acquired infections (HAIs) recently has increased.
“HAIs are major contributors to rates of sepsis, one of the top ten leading causes of death for most age groups. This has led to industry and government-backed campaigns to mitigate the incidence and prevalence of these types of infections,” said Carlson.
Microbiology and Virology
Traditional and automated microbial identification and antibiotic susceptibility testing (ID/AST) also represent one of the faster growing IVD segments in the United States. Clinical samples that are run on ID/AST systems originate from urine, sputum, the respiratory system, urogenital system, wounds, blood, stool, cerebrospinal fluid, and post-surgical dressings and sutures.
Bolstering traditional microbiology’s role in clinical testing and driving sales is larger labs’ steady adoption of automated ID/AST, culturing and other pre-analytical systems that will streamline and standardize specimen processing across all sample types.
Kalorama also identifies chromogenic media as a high-growth area within traditional microbiology. Through the use of metabolized fluorescence or coloring on the culture medium, chromogenic media is able to quickly and cost-effectively identify and qualify the presence of pathogens such as salmonella, shigella, E. coli, strep B, staph, candida, and HAIs (methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus).
Effect of Emerging Markets
A discussion about IVD wouldn’t be complete without mentioning global growth.
While the United States holds its position as the largest IVD market, demand for diagnostic testing in emerging markets continues to outpace that of the United States. According to Frost & Sullivan’s “Analysis of the Global In Vitro Diagnostics Market,” the global IVD market is expected to reach $62.6 billion by 2017.
“The Asia-Pacific region is one of the fastest growing markets,” said Frost & Sullivan’s Life Sciences Senior Industry Analyst Divyaa Ravishankar. “As countries within this region continue to invest in healthcare infrastructure and expand healthcare services to their citizens, their need for more testing products and services increases.”
China in particular has proven to be a key catalyst of revenue growth.
“Increasingly affluent populations in China’s cities are creating strong demand for quality healthcare, so the Chinese government is actively encouraging—both financially and through regulation—their hospitals and clinics to expand service and testing capabilities,” said Balger. “They are also ramping up efforts to develop, manufacture, and promote their own diagnostic goods. Taking all this into consideration, we estimate China’s growth rate to be around 15 percent over the next 10 to 15 years.”
In addition to China, test volume growth is expected to remain robust across many other emerging markets, including Latin America, parts of Eastern Europe, Middle East and Africa.
“Given their favorable market dynamics, including increased government investments in healthcare, enhanced awareness of disease management and prevention, and greater focus by both multinational and domestic companies across these regions, these emerging markets are forecast to represent close to 40 percent of the worldwide IVD market by 2018,” said Gyorda.
With increasing international initiatives, IVD resources and infectious disease treatment programs have become more accessible to these countries, resulting in rising market demand for diagnostic testing and monitoring devices.
“Global customers will start upgrading from lower-cost, manual/semi-automated platforms, to higher-cost, more sophisticated automated solutions, which tend to offer improved assay quality,” said Gyorda.
In order to fulfill the IVD demands of various emerging markets, Balger reasons that OEMs will best be served to enter into these markets not only with their own reagents and consumable supply chains, but also with instrumentation as an essential part of the system solution.
Notable trends shaping the future of the IVD market include:
• Healthcare reform. “In 2011, there were about 46 million U.S. residents without health insurance. In 2014, the U.S. now has about 15 million people who have gained more access to healthcare and healthcare testing,” said Divyaa. “In addition, under the Affordable Care Act, preventative services for women—such as mammograms, screenings for cervical cancer, etc.—generally must be covered by health plans at no cost to the patient. This will all increase the future volume of IVD testing.”
• Aging populations. According to U.S. census projections, the population of those aged 65 and older is expected to more than double between 2012 and 2060, from 43.1 million to 92 million. “Conditions and diseases such as cancer, diabetes, hypertension, heart disease, and arthritis are more common as the American population ages,” said Carlson. “Tests for these conditions are frequently preceded by routine tests or screening tests, and also tend to require specialized tests for diagnosis and during treatment.”While the demand for testing is likely to increase, Gyorda reports that new biomarkers are currently being discovered that will help ease the volume of tests, particularly in oncology.
• Lab on a chip. Lab-on-a-chip platforms make it possible to analyze bodily fluid samples on a small, disposable plastic chip. While lab on a chip often is associated with point-of-care diagnostic testing, it also is likely to play a larger role in the traditional laboratory setting.“In order to meet the growing capacity and maintain their revenue flows, labs will need to develop more innovative, lab-on-a-chip technology and better connectivity solutions that will require less materials, less reagent, fewer sample volumes, less labor, less time, and less cost,” said Divyaa. “In other words provision of access to higher technology at a low cost.”
• Direct-to-consumer testing. “Retail healthcare is positioned to become very big business,” said Divyaa. “For example, [grocery store chain] Kroger has taken a significant step in this direction by installing self-use health screening kiosks in all its pharmacy locations. These kiosks give patients the ability to upload blood glucose numbers and other biometric data. The IVD industry will likely be impacted as these types of self-directed testing locations evolve and grow.”
• Next-generation sequencing. With the cost of genome sequencing dropping significantly over the past decade, new technologies were developed that have made it more affordable to study DNA, identify mutations, and understand and manage data.“In 2012, there were only about four predominant companies that championed the next-gen sequencing technology. By 2013, there were at least 12 new companies who had it,” Divyaa explained. “As associated costs continue to fall, more companies and industries are likely to collaborate and make IVD testing much more cost-effective, efficient, and accurate.”
Gyorda also projects that next-generation sequencing will move from the research laboratory into the clinical laboratory over the next five years. “There’s a parallel need for more biostatisticians and easy-to-use bioinformatics tools that can handle big data and convert them into actionable clinical decisions,” said Gyorda.
* Mobile diagnostics. “The use of mobile technology to better manage chronic diseases, diabetes in particular, is likely to increase in the coming years for two key reasons. First, financial incentives have been put in place under U.S. healthcare reform to encourage accountable care organizations to control long-term costs of chronic disease,” said Gyorda. “Second, pressure from payers to improve outcomes with self monitoring of blood glucose has led to the development of mobile health technology for data analysis and feedback.”
Also in development are portable smart phone-driven diagnostic devices that can quickly diagnose time-sensitive health conditions, like heart attacks or strokes, and mobile apps that make it easier for patients to gain access to test results.
“Large consumer market companies, like Apple and Google, will have an increasing interest in the medical and diagnostics market for systems such as self-testing/self-monitoring. For example, Apple’s wearable devices with related-health monitoring features. We’re already seeing the first entry steps of health monitoring into the realm of personalized medicine,” said Balger. “Now there is the opportunity to connect an app’s result with a diagnostic answer provided by software intelligence which will lead one towards an appropriate treatment—with the help of a doctor.”
* Collaborations and acquisitions. In the coming years, the most successful IVD companies are likely to be those that move into niche areas and partner with other companies who have the technologies and capabilities that they do not. For example, a company that leads the market in sequencers might look to enhance their value by collaborating with a company that investigates novel biomarkers. Acquisitions also are likely to increase as diagnostic companies look to boost their portfolio.
“Currently, at least 80 percent of clinical molecular testing is concentrated in North America and Western Europe,” said Carlson. “However, we’re now seeing more and more molecular testing companies and laboratories establishing partnerships in Brazil, Russia, India, China, South Korea, Mexico and Turkey. So we can expect these new collaborations to increase growth for that sector of the market.”
Based on the emergence of new, more user-friendly tests and technologies, increasing access to healthcare, and the prevalence of several chronic and infectious diseases, the IVD market in the United States and around the globe is likely to remain vigorous.
“Even though the overall IVD market has been slower in developed countries, there are multiple trends that are expected to accelerate growth—especially as companies learn to better promote the value of their tests for improved patient care that will save the healthcare system money,” said Carlson.
Divyaa agrees. “As diagnostic testing moves towards process simplicity and decentralization, demand will rise. Not only will this encourage entry into the molecular diagnostic market through acquisitions, but it will also increase penetration of biomarkers that can be tested at a point of care level.”
Although the regulatory environment remains complex, somewhat uncertain, and not globally harmonized, IVD’s significance in even the most basic healthcare services will drive the industry’s continued progress and growth.
Lenox Powell is a full-time freelance business and marketing copywriter based in Colorado Springs, Colo. She can be reached at firstname.lastname@example.org.