The IVD Industry As It May Unfold In 2019

Watch these 12 trends unfold in 2019.

Tests will still need to prove to play in 2019
Yes, new 2019 diagnostic test product will be effective, logical, and popular with providers and patients, but abstract cost-reduction is not enough. Even the most logically useful tests — such as tests that avoid high-cost treatments on patients — will still need to address scientific proof to survive in 2019, states Kalorama Information. While it would seem that companion and precision would be money well spent, in reality, there is a major breakdown of the system in too many cases. The decision for payor approval for diagnostic testing comes from strong, even overwhelming, scientific evidence that the testing will have a direct impact on outcomes and in many cases, this is difficult to show meaningful benefits. The question asked will be, if the test is performed prior to initiating treatment, is there a significant improvement in clinical response and outcomes over those that do not have pre-treatment diagnostics?

The sales rep will still be key to instrument sales
Sales representatives are perceived by some customers to be obsolete with the online availability of product information, but that perception is not the whole story. Customers still need their resourcefulness and their product knowledge as they push through purchases in their own organizations.

The cannabis testing equipment market grows
As the cannabis industry emerges from the black market to the grey market to the open market, it faces forces of standardization and regulation. Among other effects, this has stimulated the development of analytical testing methods for cannabis, and these new applications and methods are available not only in areas where the market is open but also in geographies where the industry remains clandestine. A variety of instruments and techniques, such as gas chromatography, HPLC, supercritical fluid chromatography, thin-layer liquid chromatography, GC/MS, LC/MS, ICP-OES, ICP-MS, X-ray diffraction spectroscopy, and qPCR, are all employed for a variety of testing uses — including potency testing, heavy metal testing, and safety testing. And although many cannabis suppliers prepare samples before sending them to be tested, there also exists a small but quickly growing market for sample preparation.

Revenue decreases at labs, lab consolidation and pushback on vendors
2019 will bring more pressure on spending and consolidation for lab customers. And that means a downstream impact on IVD vendors.

2019 sales of drug discovery instruments, reagents, and other technologies will be brisk

The total demand for technologies used in drug discovery reached approximately USD 5.2 billion in 2018. The market is projected to grow at a healthy annual rate of 6.4 percent over the next 5 years, driven by increasing demand for novel drugs as the global population ages.

Direct to consumer testing gates are open, flood to follow?
Patients can now access diagnostic testing without their doctor. Quest Laboratories has launched QuestDirect, an enhanced consumer-initiated testing service that empowers patients to manage and take control of their healthcare by ordering health and wellness lab testing from the convenience of their home. 2019 is the first full year the gate is open for the customer to test himself, will demand follow. They will, but some prodding, advertising, apps, social media will be needed.

Hungary, Romania and Eastern Europe shine in 2019
Clinical diagnostics and analytical instrument companies both are seeking emerging markets for growth. Eastern Europe is gaining attention as a reachable market with promise. Hungary has become interesting for the sale of analytical devices as it is increasing healthcare R&D spend. R&D spending is rising on a global basis. In 2016, estimated spending for the 34 countries that make up the OCED grew 2.3 percent to USD 1266 billion at current prices and purchase price parity (PPP). At well above this growth rate, Hungary made tremendous gains in R&D spending in 2017, according to figures released by the Central Statistical Office. Hungary’s 2017 R&D spending grew 21.1 percent to HUF 517.258 million (USD 1811 million). Between 2016 and 2017, the country’s R&D as a percentage of GDP rose from 1.20 percent to an estimated 1.35 percent.

Meanwhile, there is growth in practice too: Hungary continues to expand its private health market, which currently represents about 38 percent of spending. Hungary’s health spending represents about 7.5 percent of GDP or USD 21 billion annually. Of particular note is histology spending which is estimated to grow 8 percent each year in the next 5 years, as Hungary addresses lung and breast cancer patient populations. Romania is another growth country for clinical diagnostics, with growth rates of 10 percent in histology testing and nearly 5 percent in overall IVD spending. Both countries are dealing with higher than regional and European rates of breast and lung cancer. Romania, which continues to develop its action plan for diabetes and bring prevalence rates down from the current 12.4 percent.

Liquid biopsy – imaging pair ups in 2019
Liquid biopsy will see gains in acceptance, but there are challenges. The difficulty with collecting enough relevant sample from patients, error correction, and magnitude of interpretation are the main ones. Still, their usefulness in some cancers has been shown, and there is much development devoted to the non-invasive concept to make clinical routine closer to reality. One point of entry: in 2019, an interesting usage for CTCs and ctDNA-based testing will be in assisting other tests. For instance, imaging studies, liquid biopsy has been shown to reduce false negatives when used in conjunction with some imaging tests. A 2018 study published in Translational Oncology demonstrated that a combination of liquid biopsy and radiological imaging enabled visualization of the occurrence of clonal redistribution after discontinuation of anti-EGFR mAb therapy, as well as emerging RAS mutations during therapy with anti-EGFR mAb indicating resistance.

If anyone wants to sell a laboratorian in 2019, they will have to network
Laboratorians generally have a closer, in-person social network that they rely on for recommendations, advice or information about products and services. That is according to IMVI Research’s 2019 Trends in Marketing to Clinical Diagnostic Labs Report. The report cites credibility factors and buying habits among laboratorians, what influences them, what sites they use and how best to approach laboratorians.

AI will be seen as a team player, not a job replacer
Artificial intelligence was novel in the past few years, in 2019, the abstract concept fades and real products/software will be the focus. Talk of replacing doctors (or other workers) should, by at least the end of 2019 be less of the discussion surrounding artificial intelligence. Instead, more attention will be on the positive supporting role that AI can play as the systems think about myriad data points that a human cannot always process, AI as a supporting tool, a team player. The demand is there: diagnostic errors contribute to approximately 10 percent of patient deaths, and also account for 6 to 17 percent of hospital complications.