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By Monica Heger

One major hurdle in bringing next-generation sequencing into the clinic is how it will be received by payors and hospitals.

In a webinar hosted by Illumina this week, Trisha Brown, vice president of clinical affairs at Medco subsidiary DNA Direct, said that demonstrating the technology's cost effectiveness will be key to gaining reimbursement and encouraging hospital uptake.

Currently though, there is broad variability among payors and hospitals in both their general knowledge about genomics and their readiness to incorporate the technology into health care, Brown said.

Cost-Effectiveness Data

With regards to health plans, it is the "wild, wild West," Brown said, and there is a broad spectrum of plans from those that will not deal with genetic or genomic information at all, to plans that mention whole-genome or whole-exome sequencing — although none that state specifically that those tests will be covered. There are even some plans that say they don't cover genetic tests, said Brown, but actually do without realizing that the tests they are covering are genetic.

Brown said that a study conducted by DNA Direct found that of 200 publicly available health plans, about one-third have coverage policies on genetics or genomics tests, with policies naming up to 150 specific tests. Additionally, three plans specifically mention whole-genome sequencing, but "all state that it's experimental and not covered."

Nevertheless, she said, there have been cases where whole-genome sequencing has been covered. For instance, Howard Jacob, director of the Human and Molecular Genetics Center at the Medical College of Wisconsin, has said that two insurance companies have agreed to reimburse for whole-genome sequencing of pediatric patients with rare, undiagnosed diseases (CSN 8/24/2011).

As of June, Illumina had also received reimbursement for two cases that used genome sequencing to diagnose disease (CSN 6/15/2011).

"Sometimes it doesn't matter what the policies are" of the specific health plans, said Brown. "If you're able to make a good case for why whole-genome sequencing is going to benefit this member and potentially improve outcomes, there's a good chance they're going to cover it," she said.

The more that whole-genome sequencing proves to be cost-effective, the more likely that health insurance companies will reimburse for it, she said.

Health insurance plans are "ready to embrace genomics as soon as the return on investment is there," she said.

However, not everyone agrees. For instance, in November, a Medicare official indicated that the Centers for Medicare and Medicaid Services had no plans to consider reimbursement for whole-genome sequencing-based tests any time soon because it would be difficult to convince CMS that whole-genome sequencing has value in helping physicians make patient decisions (CSN 11/9/2011).

Employers may help accelerate the reimbursement of genomic tests, said Brown. Because employers' goals are to keep their employees healthy and productive, they have a different return on investment than health plans, said Brown. And individual employers can negotiate with providers to cover genetic tests for their employees that wouldn't otherwise be covered.

Driving Hospital Revenue

While the main driver for payors to reimburse for genomic tests will be cost-effectiveness demonstrations, for hospitals, genomic tests have the potential to increase revenues.

While spending for esoteric testing currently represents only about 2 percent of all health care spending, in 2012 molecular genetic testing is estimated to be about a $4 billion market, said Brown, with next-gen sequencing poised to potentially capture half that.

As reported by Clinical Sequencing News sister publication PCR Insider, consulting firm DeciBio has estimated that the global molecular diagnostics market, which is currently valued at $5.9 billion, is expected to hit nearly $11 billion by 2015, with next-generation sequencing-based testing experiencing the highest rate of growth over the next four years, at around 100 percent growth per annum.

While next-gen sequencing is currently a very small portion of the molecular diagnostic market, by 2015 it is expected to be between $700 million and $1.1 billion.

Hospitals, which are looking for new ways to drive revenue, stand to benefit, said Brown. The model for hospitals has changed such that they no longer make the bulk of their money from "heads on beds," said Brown. Rather, hospitals are making money from outpatient services such as colonoscopies and mammograms, and genomic tests are another outpatient service that hospitals could bring on board.

While many genomic tests currently in use at hospitals are based on PCR, arrays, or other technology, a number of hospitals are developing next-gen sequencing-based tests.

The Mayo Clinic, for instance, is working on sequencing-based hereditary colon cancer and mitochondrial disease tests, and is studying how to integrate whole-genome sequencing into patient care (CSN 2/15/2012).

Mount Sinai Hospital in New York is developing a sequencing-based pharmacogenomic test that it wants to make accessible via patients' electronic medical records (CSN 12/14/2011).

Pharmacogenomics will perhaps be how most hospitals make their first entrance into genomics testing, said Brown, because it is appealing to payors, employers, and physicians alike since it has already demonstrated that it is cost-effective, will reduce employee sick time, and the data can be readily used by physicians in patient care.

From her survey of 200 health plans, she said that 40 pharmacogenomic tests are already mentioned in health plans.

For clinical applications of next-gen sequencing, "pharmacogenomics is at the top of the list," said Brown. While whole-genome sequencing to diagnose rare disease and to help guide treatment of cancer has recently made headlines, using next-gen sequencing in pharmacogenomics is applicable to a larger number of people. "There's a lot of potential for pharmacogenomics," she said.

Going forward, the adoption of next-gen sequencing in the clinic still has a number of hurdles, she said. Analysis is still expensive and complicated, particularly for whole-genome sequencing, and acceptance by the US Food and Drug Administration is a "hurdle that has to be overcome."

Among other things, it will require that researchers and clinicians "demonstrate that the information you're getting out of next-generation sequencing or any kind of genomic analysis is going to provide a benefit greater than the cost that you put into it."

"We have a lot of work to do to make that happen," she said

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Demonstrating Cost Effectiveness of Clinical NGS is Key to Payor Reimbursement, Hospital Uptake

U.S. Clinical Oncology Next Generation Sequencing (NGS)Market: Snapshot

With the advent of new technology, the potential that next generation sequencing (NGS) application holds in genetic counseling, disease management and treatment, and risk assessment is remarkable. From a clinical perspective, the technology can be applied to prenatal diagnosis, molecular diagnosis of genetic and infectious diseases, medical genetics and pharmacogenomics, carrier detection, cancer molecular diagnosis, and prognosis.

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In terms of technology, targeted sequencing and re-sequencing is a major contributor to the clinical oncology next generation sequencing market in the U.S. This technological segment will gain traction by enabling even higher throughput at reduced price per sample. Due to a decrease in the complexity of implementation, the use of whole genome sequencing (WGS) technology to make comparisons between tumor tissue and normal tissue is expected to witness a steep rise during the forecast period. In addition, researchers are of the opinion that through WSG everyone will be able to develop a personalized treatment plan. The segment is expected to grow further with the introduction of new tools such as NextSeq and MiniSeq platforms, which are likely to enhance the implement ability for a broad spectrum of research labs with varying sequencing needs.

Based on end user, the U.S. market for clinical oncology next generation sequencing is segmented into pharmaceutical and biotech entities, clinical research, academic research institutes, and hospitals and clinics. Owing to growing awareness regarding the benefits associated with the implementation of second-generation sequencing in academic and university-based research projects, academic institutes will hold a strong presence in the clinical oncology next generation sequencing market.

There are numerous players operating in the U.S. market. To hold their dominant position, many are banking on capitalizing data analysis requirements and need for more robust sequencing platforms through mergers and funding deals between major and minor players. A case in point would be Partek collaborating with Kennedy Krieger Institute. Together they have developed a commercial software for analyzing chromosomal abnormalities in diseases such as autism spectrum disorder, bipolar disorder, and schizophrenia.

U.S. Clinical Oncology Next Generation Sequencing (NGS)Market: Overview

With continued enhancement of new sequencing technology,next-generation sequencing(NGS) is being increasingly used in cancer genomics research. Also known as massively parallel sequencing, these days NGS is being leveraged in clinical oncology to provide improved tailored therapy for cancer. Next generation sequencing finds application in detecting rare forms of cancer mutations, uncovering familial cancer mutation carriers, and in providing molecular rationale for the exact targeted therapy. Hence, it is widely considered as a disruptive technology in the area of cancer treatment.

There have been many noteworthy achievements in the field of cancer genetics in the past couple of years on account of cutting-edge technologies and tanking costs of next-generation sequencing (NGS). The report by TMR Research offers key insights into the U.S. clinical oncology Next Generation Sequencing (NGS) market. It studies the degree of research and development in next generation sequencing for clinical oncology and furnishes crucial market figures from 2017 to 2025.

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U.S. Clinical Oncology Next Generation Sequencing (NGS) Market: Trends and Opportunities

Next generation sequencing has a number of advantages over traditional sequencing. First is its ability to completely sequence every kind of mutations for a large number of genes in one test cost-effectively. However, challenges exist in leveraging NGS, especially with respect to the need for simpler assays, more flexible throughput, reduced turnaround time, and most importantly in analyzing and interpreting the data. Overall, continued efforts to apply NGS in clinical oncology will take us one step closer to personalized medicine.

In the U.S., the clinical oncology next generation sequencing market has been buoyed by the astute initiatives of the government in the field of research and development in oncology. For example, loans and grants have been liberally disbursed by the U.S. government and various funding bodies to bring down the gap between genomic sequence analysis platforms development and their use in oncology research. In the near future, the substantial increase in spending related to cancer in the U.S. is slated to further drive up the demand for second generation sequencing platforms for diagnostic monitoring and theranostics applications.

A major challenge to the next generation sequencing is the time taken to uncover insights from the copious amount of data generated after the genome is sequenced. While this benefits the cancer patients as its aids in accurately studying many genes simultaneously that may be relevant to the patients tumor by using only a small amount of tissue at a reasonable cost, it also accords innumerable opportunities to commercial service providers to come up with proper solutions in much less time.

Companies Mentioned in Report

To present an in-depth assessment of the competition prevailing in the U.S. market for clinical oncology next generation sequencing, the report profiles companies such as Roche, llumina Inc., Pacific Bioscience, Agilent Technologies, GATC Biotech Ag, Macrogen Inc., Oxford Nanopore Technologies Ltd, Foundation Medicine, Life technologies Corp, Exosome Diagnostics, CLC Bio, Paradigm, Perkin Elmer, Inc, Inc, Partek, Inc, GnuBIO, and Caris Life Sciences.

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TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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US Clinical Oncology Next Generation Sequencing (NGS) Market Projected to be Resilient During 2025 - Cheshire Media