IVD in 2019: 8 out-of-the-box predictions

2019 01 04 21 54 7555 Eight Number 400

What's in store for the in vitro diagnostics (IVD) market in 2019? Based on our 2018 research, here are eight little-discussed trends that we expect to unfold this year.

1. Another year of 'prove to play' for tests

Bruce Carlson of Kalorama Information.Bruce Carlson of Kalorama Information.

Yes, your new 2019 diagnostic test product will be effective, logical, and popular with users. But even the most logically useful tests -- such as tests that avoid high-cost treatments on patients -- will still need to address scientific proof.

"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," said Melissa Elder, a pharmaceutical and IVD analyst for Kalorama Information. "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 a test is performed prior to initiating treatment, is there a significant improvement in clinical response and outcomes over tests that do not have pretreatment diagnostics?

2. Watch liquid biopsy and imaging pair-ups in 2019

Liquid biopsy will see gains in acceptance, but there are challenges. A recent article in Nature sums up some of them. Difficulty in collecting enough relevant samples from patients, and enough circulating tumor cells (CTCs) or circulating cell-free DNA (cfDNA) in samples, is an issue. Also, there is IT difficulty and cost, the need for better error correction, and the magnitude of interpretation.

To varying degrees, progress will be made on these fronts, because the promise of noninvasive technologies is a winner. But we think that in 2019 liquid biopsy's most interesting use will be as a complementary tool, assisting other tests. For instance, liquid biopsy has been shown to reduce false negatives when used in conjunction with 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-epidermal growth factor receptor (EGFR) monoclonal antibody (mAb) therapy, as well as emerging RAS mutations during therapy with anti-EGFR mAb indicating resistance.

3. Hungary, Romania, and Eastern Europe will shine in 2019

Both clinical diagnostics and analytical instrument companies 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 spending. Hungary made tremendous gains in R&D spending in 2017, according to figures released in 2018 by the Central Statistical Office. Hungary's 2017 R&D spending grew 21.1% to HUF 517.258 million.

From 2016 to 2017, the country's R&D as a percentage of gross domestic product (GDP) rose from 1.20% to an estimated 1.35%. Meanwhile, Kalorama Information noted in its recent IVD study that Hungary continues to expand its private health market, which currently represents about 38% of spending. Hungary's health spending represents about 7.5% of GDP, or $21 billion annually. Of particular note is histology spending, which we estimate will grow 8% each year in the next five years as Hungary addresses lung and breast cancer patient populations.

Romania is another growth country for clinical diagnostics, with growth rates of 10% in histology testing and nearly 5% in overall IVD spending. Both countries are dealing with rates of breast and lung cancer that are higher than rates in Eastern Europe and in the continent generally. Romania is continuing to develop an action plan for diabetes that intends to bring prevalence rates down from the current 12.4%.

4. If you want to sell a laboratorian in 2019, you'll 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, according to IMV's "2019 Trends in Marketing to Clinical Diagnostic Labs." The report cites credibility factors and buying habits among laboratorians, what influences them, what sites they use, and how best to approach them.

5. Revenue decreases at labs, lab consolidation, and pushback on vendors

The impact of the Protecting Access to Medicare Act (PAMA) and resulting Medicare Part B cuts on testing is being felt. 2019 will bring more pressure on spending and consolidation for lab customers, and that means downstream effects on IVD vendors.

A survey from IMV indicated that most labs have seen an impact: 55% of a panel of 110 labs indicated they had experienced revenue decreases -- from single digits to double digits -- as a result of Medicare Part B cuts, and more than 60% will "review agreements with vendors for instruments and reagents."

6. Clinical sequencing gains crucial popular support

More than any other diagnostic tool, the sequencer is set up for popular recognition and eventually demand.

Sequencing scored some wins in 2018: An October 2018 study of participants in a recent Clinical Sequencing Evidence-Generating Research (CSER) consortium program found that reporting incidental sequencing results generally did not cause undue distress or other adverse impacts on patients. It also found that reporting these results lead to only modest costs for medical follow-up, at least within the first year.

Other good news comes from the BabySeq Project, where testing on a population of newborns has revealed the possible utility of broad sequencing of populations. One anecdote that has gained traction is the story of a baby who was discovered to have a BRCA2 mutation, meaning she would be at high risk for developing breast or ovarian cancer as an adult. The knowledge of that mutation was not actionable for the baby at that moment, which raised the question of whether it should be reported. However, as a consequence, the mother was tested and discovered that she, too, has the BRCA2 mutation. If the mother now has a better chance of avoiding or surviving cancer, it benefits the whole family.

One of the fastest-growing areas of clinical sequencing has been in cancer diagnostics, which has only intensified since the March 2018 decision by the U.S. Centers for Medicare and Medicaid Services (CMS) to offer national coverage for next-generation sequencing (NGS) in advanced cancer patients. Research presented at the American Society of Human Genetics meeting in October 2018 suggested that clinical sequencing could also be helpful for pediatric cancer patients. Although the researchers didn't examine survival outcomes, they reported that in a sample of 253 pediatric cancer patients who had whole-genome or exome sequencing at St. Jude Children's Research Hospital, 79% had at least one finding that could help guide care. We expect more of a foundation for clinical sequencing demand due to stories like these.

7. Direct-to-consumer testing -- floodgates open, flood must wait

Patients can now access diagnostic testing without their doctor. Quest Diagnostics 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.

In addition, Walgreens and LabCorp announced a large-scale expansion of their LabCorp at Walgreens collaboration. The two companies have agreed to open at least 600 LabCorp patient service centers at Walgreens stores across the U.S. over the next four years, inclusive of the 17 locations that have opened since they first announced their consumer-focused initiative in June 2017. LabCorp at Walgreens locations are currently open in Florida, Colorado, North Carolina, and Deerfield, IL, serving as an important part of LabCorp's network of nearly 2,000 patient service centers across the U.S. This is in addition to 23andMe's offering of DNA testing for select BRCA variants without a doctor's order.

2019 is the first full year the gate is open for customers to test themselves. We think eventually consumers will warm to self-testing, but some prodding, advertising, apps, and social media will be needed.

8. AI will be seen as a team player, not a job replacer

We believe that talk of artificial intelligence (AI) replacing doctors (or other workers) will be less of the discussion surrounding AI by at least the end of 2019. Instead, more attention will be on the positive, supporting role that AI can play as algorithms analyze myriad data points that a human cannot always process.

The demand is there for AI: The National Academies of Sciences, Engineering, and Medicine reports that "diagnostic errors contribute to approximately 10% of patient deaths" and also account for 6% to 17% of hospital complications.

The systems are proving their worth: Babylon Health claims its system performed 10% better than the average general practitioner entrant examinee for induction into the Royal College of General Practitioners. And then there are apps: Prevencio recently announced that its Hart PAD test diagnosed peripheral artery disease (PAD) in diabetes mellitus patients at high positive predictive value and negative sensitivity levels in a Massachusetts General Hospital study. These are just a few of the recent developments.

Disclosure: LabPulse.com is a sister company of Kalorama Information.