Science and Medicine Group Inc. including Kalorama Information, SDi, BioInformatics, and IMV are marshaling our information and data resources to help those on the frontline in the fight against the COVID-19 virus. Science and Medicine Group Inc. is a market research and media company serving the life science, analytical instrument, diagnostic, medical imaging and dental industries. We also maintain four vibrant communities of more than 300,000 scientists and medical professionals including LabPulse.com, AuntMinnie.com, DrBicuspid.com, and The Science Advisory Board

Today we gave access to our Knowledge Center to employees of the Centers for Disease Control (CDC).   The Knowledge Center is an innovative information sharing platform that enables users to search almost 1,000 detailed reports on a wide variety of diagnostic and medical imaging technologies to understand the science behind the technologies as well as the capabilities and strategies of the market’s supplier base. The CDC will be able to use all the clinical diagnostics from Kalorama and diagnostic imaging from IMV to better coordinate a response among market participants from CT, Ultrasound, Molecular, and Point-of-Care diagnostics. We believe an “all diagnostics on deck” approach to COVID-19 detection would greatly accelerate the detection and also ease the strain on laboratory testing, some of which requires extensive PPE and often has time delays between sample collection and insight.

Kalorama Information, the most trusted name in healthcare and clinical diagnostics market research, has put a large database of diagnostic instruments in the U.S. online free of charge to start-ups, commercial entities developing COVID-19 solutions, and hospitals laboratories so they can locate sites that do testing in the US market. The entire Clinical Masterfile details the manufacturer and model of 39,628 clinical diagnostic instruments at 5,331 U.S. hospitals. Today we are making the COVID-19 instrument part of our Kalorama Clinical Masterfile available for commercial suppliers and local hospitals and labs.  These data will allow national and local hospitals and suppliers to find each other and get the necessary COVID-19 kits, reagents, and controls distributed through national supply chains or local swaps. The list has 1,787 FDA-EUA Approved Instruments or Instruments that can run EUA COVID-19 TaqMan ™ Assays.  We are also releasing 157 Instruments that are COVID-19 capable with Staff Training and Adjustment for Lab Developed Tests. Laboratory professions will be able to use the database to find each other and share reagents and kits needed to maintain their labs’ testing volume.

Bruce Carlson, Publisher of Kalorama Information said, “Market knowledge is essential for developers, potential investors and government agencies.  A crisis brings attention to many markets previously unconsidered, and new employees and agencies need to stay informed with foundational knowledge.  Market research exists for this purpose. Kalorama, IMV and other Science and Medicine Group Publications have available market assessment resources in molecular diagnostics, CT, next-generation sequencing, respiratory point-of-care testing, remote patient monitoring and immunoassays. These tools can provide companies with baseline market assessments to understand these markets which are more important than ever. We are tracking changes in these markets related to COVID-19 though various upcoming publications.”

Dentists and dental hygienists are currently only caring for critical patients but are generally on the frontlines of public health. We believe these practitioners, along with newly developed point-of-care swab tests, will be a key part of community outbreak monitoring once the virus outbreak is under control. To prepare, DrBicuspid.com has made articles and Continuing Education (CE) courses on infection control and PCR available at no charge for dentists and dental hygienists. Our editorial team, lead by Kevin Henry and Dr. David Rice, are prioritizing content to protect these practitioners and prepare them for serving patients once they are able to get back to work serving their patients.

“We know that dentists and dental team members have a lot of questions right now, including when dental practices might re-open on a full-time basis and be able to care for their full patient database,” said Kevin Henry, Editor-in-Chief of DrBicuspid.com. “Our job is to bring experts together from across the industry to answer these questions as well as providing advice on best business practices to help them overcome the financial hardships brought on by COVID-19.”

Science and Medicine Group will continue to look for opportunities to leverage our broad range of capabilities to assist industry and the scientific and medical communities in increasing testing and the development of therapies and vaccines.

“As the world comes together as friends and neighbors to fight the pandemic, we are proud to provide our MasterFile database to researchers and clinicians,” said Jonathan West, Vice President of Business Development. “They are the true “Superheroes” of our time and the entire Science and Medicine Group team is humbled by the opportunity to support them. “

Demand for testing has gone from a healthcare industry topic to a national crusade in weeks with the onset of COVID-19. High-throughput tests have been approved by the U.S. Food and Drug Administration (FDA) for use in the U.S. for the detection of SARS-CoV-2, the virus behind the disease. But for true intervention in doctors offices — or even airports, many see so-called “point-of-care” (POC) IVD tests as the ideal solution.  A new report on worldwide point-of-care markets from IVD market researcher Kalorama Information has been released amid the coronavirus outbreak. The report has markets for all kinds of near-patient testing — everything from self testing for glucose to rapid HIV tests to cardiac marker tests. Yet the focus in recent weeks has been on tests for COVID-19. Point-of-care tests are tests designed to be portable enough and fast enough to be useful during an one visit or in a decentralized location within a hospital or clinic.

To break a transmission chain, fast access is needed. These tools offer fast access, rather than waiting on texts or doctor’s office staff for restults. Kalorama publishes a report each year on POC markets and has just released its 2020 version: https://kaloramainformation.com/product/the-worldwide-market-for-point-of-care-poc-diagnostics-7th-edition/.

In terms of actual tests for coronavirus tests, there are no U.S. approvals at the time of writing, but products are in development. Molecular POC (mPOC) tests make the most sense because the threat is a virus and can be identified using the gold standard of reverse transcription polymerase chain reaction (RT-PCR). Point-of-care tests are currently used for flu and step tests, including systems by Abbott (ID NOW), Roche (Liat), and Cepheid (Xpert Xpress) mPOC-maker Cepheid says it is developing an automated molecular test for the qualitative detection of SARS-CoV-2. And Cepheid says it will try to utilize its tens of thousands of existing instrument placements. “By leveraging the design principles of our current Xpert Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted to provide rapid detection of current and future pandemic coronavirus strains, we are developing a test that can be applied in multiple settings where actionable patient management information is needed quickly,” the company said.

Singapore POC maker Credo Diagnostics Biomedical announced this week that it has obtained the CE mark in Europe for an assay to detect SARS-CoV-2. The test runs on the firm’s platform, called VitaPCR, and the company said it uses PCR and runs the test in 20 minutes. The system needs minimal operator training to run and involves no additional equipment, according to Credo.

The company says the VitaPCR SARS-CoV-2 Assay is now also pending Emergency Use Authorization from the FDA and Emergency Use Listing from the World Health Organization.  While not as fast as immunoassays, the mPOC systems typically use isothermal amplification to achieve much faster turnaround than the regular lab-based RT-PCR tests. This is one of their biggest strengths, along with low. The following are some additional examples of molecular diagnostic systems and assays including POC and other technologies which are available or under development:

  • Aldatu Biosciences – PANDAA qDx SARS-CoV-2
  • Becton Dickinson (BD) – BD and BioGX submitted for EUAs on BD Max platform
  • BGI/ Pathomics Health – Fluorescent RT-PCR kit (CE marked); 2019-nCoV PMseq Kit
  • Bio-Rad – standards – synthetic COVID-19 RNA transcripts and human genomic DNA
  • bioMerieux/ BioFire Defense – FilmArray, BioFire COVID-19 Test
  • Biomeme – Go Strips for  COVID-19
  • BIONEER Corporation – AccuPower 2019-nCoV
  • Caspr Biotech – Phantom 1.0 Dx, disposable test usingCRISPR
  • Cepheid – Test in development for Xpert Xpress system announced; partnership for Sherlock Biosciences’ CRISPR-based SHERLOCK (Specific High-sensitivity Enzymatic Reporter unLOCKing) engineering biology platform, to design tests to run on Cepheid’s GeneXpert systems
  • CerTest Biotec – VIASURE 2019-nCoV Real Time PCR Kit (CE mark for BD Max platform)
  • Co-Diagnostics – Logix Smart Coronavirus Disease 2019 (COVID-19) Test; single step rRT-PCR (CE mark)
  • Coyote Bioscience – Mini8 Portable Molecular Diagnostic QPCR Station (CFDA approved)
  • Credo Diagnostics Biomedical – VitaPCR platform, COVID-19 assay (CE mark)
  • Curetis/ OpGen/ BGI – RTPCR test kit for SARS-CoV2 (CE mark)
  • Diagnostics for the Real World Ltd – SAMBA II COVID-19 Test
  • GenMark – ePlex SARS-CoV-2 test; sample-to-answer system based on competitive DNA hybridization and electrochemical detection technology (RUO, with EUA submitted)
  • HiberGene – HG Swift, can use battery power, pursuing Fast Track Emergency Use in China
  • Integrated DNA Technologies (Danaher) – 2019-nCoV CDC EUA Kit
  • Jiangsu Qitian Gene Biotechnology Co., Ltd. – Fluorescent RAA Detection for 2019-nCoV
  • LabCorp – COVID-19 reverse transcription polymerase chain reaction (RT-PCR) test (EUA issued)
  • LGC Biosearch – primer and probe kits for CDC Real-Time RT-PCR Diagnostic Panel
  • MiCo Biomed Co. Ltd – VERI-QTM PCR 316 COVID-19 detection system
  • Mobidiag – Novodiag COVID-19 + InfA/B – multiplex test for coronavirus and influenza
  • Molbio – TrueLab, Truenat SARS CoV-2 – TruePrep and TrueNAT instruments
  • Mologic – battery powered point-of-need diagnostic test
  • Novacyt – qPCR (CE mark)
  • OnSiteGene – Peak V
  • Pinpoint Science – SARS-Cov-2 test in partnership with Analog Devices
  • Qiagen – QIAstat-Dx, Respiratory Panel 2019-nCoV
  • QuantuMDx – Q-POC
  • RainSure Bio – DropX-2000 Digital PCR System, RainSure COVID-19 dPCR Detection Kit
  • Randox Laboratories Ltd – Extended Coronavirus Array
  • Seegene – Allplex 2019-nCoV assay (CE mark)
  • Sentinel Diagnostics – Stat-NAT COVID-19 assay
  • SolGent – DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit (CE mark)
  • Twist Bioscience – NGS-based target capture for SARS-CoV-2 detection and screening
  • Ubiquitome – Liberty16, open mobile real time PCR system with 2-3 hour battery life

 

In addition to direct tests for SARS-CoV-2, Kalorama expects demand for flu tests to increase due to “rule-out” testing.

Right now, molecular is the focus for the current pandemic, but immunoassays also are in development. Molecular tests generally analyze the viral RNA in patient throat/nasal swabs, but there are other POC testing methods that use immunoassays to detect the patient’s COVID-19 antibodies in blood or serum. It appears there are roles for both mPOC and immunoassay POC tests as there are trade-offs between the two. Immunoassays generally suffer from a high rate of false negatives (low sensitivity), with some rare exceptions. Nonetheless, immunoassays can have comparable speci􀂦city and a varying combination of lower cost, faster turnaround, greater portability, and, thus, advantages in the context of larger-scale population surveillance, screening, and triaging of patients in outbreak situations.

About Kalorama Information

Not since the Swine Flu epidemic of 2009 has there been this amount of emphasis on vaccines and vaccine development.  This new infectious disease threat with no anti-viral, nor vaccine is causing significant concern among healthcare providers, governments and the public.  Last-resort measures such as school closings and curfews in place in the United States has only increased focus on a vaccine solution that could provide enough protections to individuals.

Kalorama covers vaccines markets from 2018 to projected 2024 markets in its market research study: https://kaloramainformation.com/product/vaccines-2018-world-market-analysis-key-players-trends-pediatric-and-adult-segments-influenza-cervical-cancer-combinations-hepatitis-pneumococcal-mmr-varicella-poliovirus-hib-others/
A new report will be out in July 2020.

Some diseases have proven extremely difficult to address through vaccines – HIV, for example. However, although much is unknown about COVID-19, it is nonetheless a respiratory disease that belongs to a class of diseases – corona viruses – that is well understood.  This provides more confidence

We talked with our vaccine analysts to get their sense of the landscape with novel coronavirus.

Early Efforts and a First Trial Dose

COVID-19 vaccine candidates are now heading into trials. Companies in various stages of development include Gilead, GlaxoSmithKline, Pfizer, Moderna, Medicago and others.

Pfizer chairman and CEO Dr Albert Bourla said: “Many companies, including Pfizer, are working to develop antiviral therapies to help infected patients fight this emerging virus as well as new vaccines…Pfizer is working to advance our own potential antiviral therapies and is engaged with BioNTech on a potential mRNA coronavirus vaccine.”

Cambridge, MA-based Moderna announced first participant dose in a Phase 1 trial for mRNA-1273 against the novel coronavirus.  Moderna’s mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein. The company’s Phase 1 study is evaluating the safety and immunogenicity of three dose levels of mRNA-1273 (25, 100, 250 μg) administered on a two-dose vaccination schedule, given 28 days apart. A total of 45 healthy adults will be enrolled in the study. Participants will be followed through 12 months after the second vaccination. The primary objective is to evaluate the safety and reactogenicity of a two-dose vaccination schedule of mRNA-1273. The secondary objective is to evaluate the immunogenicity to the SARS-CoV-2 S protein.

This is a major opportunity for vaccine developers, so it is likely that if a developer has a vaccine  that could be even partially effective, they will do everything possible to move it thru trials quickly.   At the same time, governments are looking for more tools to contain the spread. It’s clear that steps taken to date have not been sufficient.   So they are highly motivated to support vaccine development efforts.

Technology 

Demand is not the issue, according to Kalorama’s vaccine analysts.  The market pull will be there, but in vaccine markets, where customers are generally governments, it comes down to the technology – the products.

Some diseases have proven extremely difficult to address through vaccines – HIV, for example. However, although much is unknown about COVID-19, it is nonetheless a respiratory disease that belongs to a class of diseases – corona viruses – that is well understood.  This provides more confidence that it is possible to create a vaccine that would protect some portion of the population.

Since other countries do have significant vaccine development resources – China, India, Japan, etc. – it is certainly possible that a vaccine could be developed overseas before one is developed in the U.S. In fact, I would guess that Chinese vaccine developers began working on this weeks before U.S. vaccine developers.

The Gaurdian reported that about 35 companies and academic institutions are racing to create such a vaccine, at least four of which already have candidates they have been testing in animals.

Stat News reported about an interesting synthetic mRNA solution that is being developed.   https://www.statnews.com/2020/03/11/researchers-rush-to-start-moderna-coronavirus-vaccine-trial-without-usual-animal-testing/ that would be “programmed with the goal of getting our inner machinery to produce certain coronavirus-like proteins — the very proteins that the pathogen uses to gain entry into our cells. Researchers at Moderna and the NIH think that once those homemade dummy virus particles are there, the thinking goes, our bodies will learn to recognize and clobber the real thing.”

Production

Of course, developing a vaccine is only part of the problem. Any vaccine would have to be effectively manufactured and distributed. That could create significant roles for many other players.

Most inactivated influenza vaccines are produced by growing influenza viruses in eggs.  This requires a staggering amount of them. For the H1N1 flu vaccine, a million eggs are required for 3 million doses, more or less.

Egg-based production process begins with candidate vaccine viruses (CVVs) grown in eggs provided by the CDC or approved partner per current FDA regulatory requirements. These CVVs are then injected into fertilized hen’s eggs and incubated for several days to allow the viruses to replicate. The fluid containing virus is harvested from the eggs.

Cell-based flu vaccine has been developed as an alternative to the egg-based manufacturing process. On August 31, 2016, FDA issued an approval for Seqirus, the sole FDA-approved cell-based flu vaccine manufacturer in the United States, to begin using cell-grown CVVs.  Cell culture technology is potentially more flexible than the traditional technology, which relies upon adequate supply of eggs. Recombinant DNA manufacturing is another option. This method does not require an egg-grown vaccine virus and does not use chicken eggs at all in the production process. Instead, manufacturers isolate a certain protein from a flu virus. This proteins are then combined with portions of another virus that grows well in insect cells and allowed to replicate. A protein is harvested from this mix that is used to make the vaccine.

According to a recent article in the Los Angeles times, there are many different vaccine-making platforms, each with its own set of advantages and disadvantages. https://www.latimes.com/science/story/2020-03-12/why-does-it-take-so-long-to-make-a-coronavirus-vaccine “For example, a vaccine based on the virus’ genome can be made quickly, in perhaps a month or two, but it may be harder to manufacture in giant quantities. Another option is to take the virus’ genetic snapshot and put it into a different virus for transport. These vaccines take longer to make — say, six to eight months — but they can be scaled up more readily.”

” almost 33% of readers believe it will take over a year, while slightly more 28% are optimistic there could be a vaccine available within three months.” -Pharmaceutical Technology

An article in Pharmaceutical Technology  said that “Readers of Pharmaceutical Technology have been voting on how long they think it will take for a vaccine to be available to patients. With over 164,000 votes cast, the results show than almost 33% of readers believe it will take over a year, while slightly more 28% are optimistic there could be a vaccine available within three months.”

In general,  this is a very major opportunity for the vaccine industry to shine.  We would expect it to rise to the occasion with at least one, if not several, potential products.  Kalorama will of course report on updates in our biennial vaccine market research study.

 

[by Christina Chew]  It is increasingly common to test in panels to gain clarity on disease while treatment will be most effective.  Numerous multiplex products are on the market, and their effectiveness has been shown in studies, but there are challenges with reimbursement.   In this article, we will look at the current status of syndromic testing.   Syndromic and other microbiology diagnostic markets are covered in our report The Worldwide Microbiology Market (Traditional Microbiology, Microbiology/Infectious Disease Immunoassays, Molecular Microbiology, Mass Spectrometry in Microbiology)

“With these FDA clearances and new tests being introduced over the last decade, companies are placing bets on syndromic testing taking off. Siemens Healthineers, for example, is betting that syndromic testing will boost its diagnostics franchise by acquiring Luxembourg-based Fast Track Diagnostics in 2018.”

Since the discovery of duplex DNA in 1953 by Watson and Crick, the diagnostics area has witnessed tremendous growth in the field of molecular diagnostics, particularly in areas such as improved sensitivity, versatility of technology and automation. In the past decade, molecular diagnostics has resulted in a paradigm shift in clinical practice by enabling rapid detection of pathogens in blood cultures, respiratory specimens, stool, etc. During this time, we have also witnessed the launch of a single molecular test, such as the Abbott ID NOW (formerly Alere i) to a multiplex molecular panels with more than five targets, such as the FilmArray Blood Culture Identification (BCID) panel by BioFire Diagnostics, LLC (a Biomerieux company). This revolutionary multiplex tests enable rapid diagnosis of certain infections thus allowing healthcare providers make clinical management decisions in a timely manner.

The word syndromic comes from the root syndrome meaning a set of medical signs and symptoms that are correlated with each other or with a specific health-related cause. Often, patients can present with symptoms that are non-specific, but a combination of them can suggest certain diagnoses.

There have been a number of multiplex respiratory panels that can detect 5 or more pathogens simultaneously that have been FDA cleared. Upper respiratory infection is very common and afflicts millions of people in the US each year. It is the most cited reason for doctors’ visits. The first multiplex panel to receive FDA clearance was the Luminex xTAG RVP v1, which received clearance in 2008. This was followed by the Luminex xTAG-RVP Fast clearance three years later. They test 12 and 8 targets, respectively, with turnaround time of 8 and 6 hours. The NxTAG RPP (Luminex), which was cleared in 2015 can detect 20 pathogens at once with a turnaround time of 4 hours. GenMark Diagnostics’ eSensor RVP assay is performed on the XT-8 system and targets 14 pathogens with a turnaround time of 8 hours. Of all the commercialized respiratory multiplex tests, BioFire’s FilmArray respiratory panel (FA-RP) provides results in an hour, the fastest among its competitors.

Another growing infectious disease multiplex molecular test is in the gastrointestinal (GI) area. Conventional test methods for GI pathogens, such as culture, antigen tests and microscopic exams are not only time consuming but also costly and have limited sensitivity. According to the World Gastroenterology Organization, there are 2 billion new cases annually, resulting in 1.9 billion deaths among children under 5 years old. And according to the Centers for Disease Control and Prevention (CDC), GI illnesses account for 76 million emergency department (ED) visits and hospitalizations in the US each year. The severity of foodborne illnesses makes the case for faster and more sensitive molecular tests.

There are three FDA cleared multiplex assays that can detest more than 5 stool pathogens – xTAG GI pathogen panel and Verigene Enteric Pathogens by Luminex and BioFire FilmArray GI panel from BioFire. A study conducted at the University of Texas Medical Branch found that the BioFire FilmArray GI panel improved patient care due to its ability to identify a broad range of pathogens in an hour, allowing for proper treatment while reducing the need for further diagnostic tests and hospitalization. The authors also found that overall health care cost could have been reduced by almost $300 per patient if the FilmArray GI panel was used. This study definitely makes a compelling case for the need of GI multiplex syndromic tests.

With these FDA clearances and new tests being introduced over the last decade, companies are placing bets on syndromic testing taking off. Siemens Healthineers, for example, is betting that syndromic testing will boost its diagnostics franchise by acquiring Luxembourg-based Fast Track Diagnostics in 2018. Siemens Healthineers currently does not have commercialized molecular tests for infectious diseases. Fast Track Diagnostics (FTD) offers a wide range of tests, such as respiratory, GI, STI, and touts its capability to distinguish between viral or bacterial infection in one test. So far, FTD has not received FDA clearances for its tests yet.

However, reimbursement remains a challenging topic with syndromic multiplex testing. Multiplex assays are assigned various billing codes related to the number of targets in the tests. However, in late 2018, Palmetto deemed the multiplex viral panels do not meet Medicare’s “reasonable and necessary” criteria. Palmetto also stated that there is a lack of clinical utility when it comes to rapid and sensitive nucleic acid testing in decreasing the use of antibiotics. Finally, the Medicare contractor determined that syndromic surveillance isn’t part of Medicare benefits. This is a set back for syndromic testing. It may take years of clinical studies to prove the clinical utility and ROI of syndromic tests to gain a reversal of this decision.

Syndromic multiplex testing is relatively new to the market and is performed in a clinical microbiology setting. It is anticipated that it will become increasingly common over time and can be used in point-of-care settings. Given that reimbursement is a challenge, it may not be adopted as readily as many had hoped. The long turnaround time, lack of flexibility in some panels and cost considerations may delay POC adoption. Kalorama’s prediction of growth in the molecular POC space hasn’t materialized. Until the reimbursement challenges is resolved, growth in syndromic molecular multiplex testing could be slowed.
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Christina Chew

Special Projects Analyst, Kalorama Information

Make sure to visit our In Vitro Diagnostics page, Kalorama’s all-in-one resource covering the IVD market. 

Infectious Disease Molecular IVD Market: Fastest Growth of Any Molecular Test Segment

Infectious Disease is the best-selling and fastest-growing part of molecular testing, as Kalorama notes in its report Infectious Disease Diagnostics.     Molecular diagnostics’ performance and applicability is unparalleled among IVD technologies in the market for infectious disease testing and the overall healthcare market. Microarray, next-generation sequencing and development-stage isothermal amplification methods represent promising contributions to the molecular diagnostics market.

Several trends make molecular diagnostics the most dynamic segment of the infectious disease diagnostics market:

  • Decentralization of testing to include hospital labs and near-patient points using sample-to-answer or integrated analyzers
  • Development of molecular assays as a first response for testing of emerging disease threats
  • Rising availability of antiviral therapies, both in commercial therapies introduced and worldwide public health campaigns
  • Aggressive healthcare response to nosocomial or hospital-acquired infections (HAIs)
  • Penetration of next-generation sequencing (NGS) into healthcare with potential for clinical sequencing in the area of critical infections

Regional Market Share in Molecular Diagnostics Used for Infectious Disease Detection

The regional market picture is important in consideration of molecular diagnostics.  Kalorama Information estimates that developed markets of the United States, Europe and Japan account for roughly 90% of the global molecular infectious disease test market.  The U.S. market is expected to significantly outperform the European and Japanese markets based on its unique growth factors including strong demand for hepatitis testing and care among retirees and younger at-risk populations; molecular respiratory infection screening including multiplex ID panels and rapid near-patient assays; development of the molecular POC market; and the continued penetration of stand-alone HPV screens. Macroeconomic and demographic conditions in Japan and Western Europe have also inhibited demand for new molecular diagnostic technologies in infectious disease.

Outside of the success of vendors such as Cepheid with its HBDC program, the developing world is relatively limited as a market for molecular infectious disease tests. Middle-income countries such as China, Brazil and others in East Asia and Latin America are leading targets for market development. National priorities in the improvement of healthcare systems and healthcare availability could lift testing markets relating to antiviral therapy, molecular screening, and inpatient care. The low relative weight of these regions in the global market has been the result of low reliance on molecular testing methods and the prevalence of “homebrew” testing to meet limited demand concentrated among reference labs and medical hubs.

The rest of the world (ROW) – outside of the largest developed markets, China and Latin America – currently represents only 2% of the global market for molecular infectious disease diagnostics. However, low-income developing countries have potential as markets for molecular POC platforms, especially those incorporating isothermal or alternative amplification methods and other low-cost detection components. To successfully penetrate developing world markets, molecular POC platforms will need to make significant reductions in reagent and instrument component costs and be distributed with concessional pricing for public health programs. The over market projected for molecular infectious disease diagnostics in ROW countries by 2021 will feature a heavy mix of molecular POC products for HIV, TB, malaria, HPV, hepatitis C, and other tropical and neglected diseases.

Molecular Diagnostic Technologies in Infectious Disease Testing

In the healthcare market the pace of technological development in clinical molecular diagnostics has kept clinicians, payers, and regulars struggling to keep up. Because of an explosion of clinical molecular tests into the U.S. marketplace an overhaul in billing codes was instated to provide payers greater transparency into what is being ordered for which patients.   Confronted with major healthcare cost drivers in demographic aging and the introduction of medical technologies, payers often subject molecular diagnostic tests to a great deal of scrutiny, temporarily halting payments, or ending coverage for whole groups of tests. Payments continue where definitive clinical utility has been found, particularly for prognostic and companion assays in oncology. Proponents in the industry argue for an expanded definition of clinical utility used to make coverage decisions and are working to succeed with tests that offer accurate predictive capacities. Labs and other test develops hope to overcome regulatory hurdles for innovative molecular testing by introducing tests as services or “lab developed tests” rather than test kits or medical devices.

Molecular Infectious Disease Testing: Both a Revolutionary Technology and an Established One

Despite its prospects as an evolving and performance-leading field, with a fair amount of potential in many areas, molecular testing holds several established positions in developed healthcare systems:

  • Molecular assays play a crucial role in antiviral therapy monitoring because of their unmatched quantitative performance of real-time PCR in viral load testing. The value of antiviral therapy is still being realized in emerging markets and the developing world, providing continued market growth.
  • Other major application markets for molecular diagnostics and infectious disease testing include HAI/AMR testing and HPV. The decoupling of routine HPV testing from the traditional Pap smear as well as improved clinician and payer reception to the preventive health benefits o HPV screening have been breakthroughs for the molecular HPV market, and the commercialization of high-throughput molecular screening assays for HPV have supplanted prior FISH HPV assays and contributed significant market value.
  • Respiratory tract infections represent the newest major application market for molecular diagnostics used in infectious disease testing. The market for rapid respiratory assays at outpatient points of care and hospitals is currently served primarily by immunoassays.

The introduction of CLIA-waived molecular assays for the most market-significant respiratory infections – influenza and strep A – qualifies molecular diagnostics in rapid testing markets, but higher test costs remain a deterrent to client conversion to rapid molecular methods, and currently targeting the molecular conversion of the entire rapid respiratory test market is too ambitious when using current products.