Molecular systems that can test at the point of care was always expected to be a factor in COVID-19.   Last year, when our report published, the novel coronavrius was limited in most news accounts to a disease affecting Wuhan, China, we said this: “As presented, the revenues for this segment are forecast to increase from $360 million to $852 million between 2019 and 2024, with a compound annual growth (CAGR) of 18.8%.”  

The spread of the disease in the United States and developed world would prove us wrong.  Molecular point of care systems were in great demand, and eclipsed our projected market size estimate for 2024 was already exceeded by the end of 2020. 

In our latest report, The Market and Potential for Molecular Point of Care (https://kaloramainformation.com/product/2021-molecular-point-of-care/) Kalorama estimates a market of $900 million dollars, with the lion’s share of that instruments and consumables purchased for COVID-19 testing purposes.

It’s not a surprise.  Molecular point-of-care (mPOC) diagnostic solutions offer improvements in the sensitivity and specificity of existing near-patient and rapid tests while expanding the diagnostic capabilities at points of care such as hospital critical care units, physician offices, outpatient clinics, and community health posts in the developing world, and are used to assess conditions or admit patients. The concept of molecular point of care is to mix the accessibility of POC testing with the accuracy of molecular technology.

Molecular point-of-care (mPOC) diagnostic solutions offer improvements in the sensitivity and specificity of existing near-patient and rapid tests while expanding the diagnostic capabilities at points of care such as hospital critical care units, physician offices, outpatient clinics, and community health posts in the developing world, and are used to assess conditions or admit patients. The concept of molecular point of care is to mix the accessibility of POC testing with the accuracy of molecular technology. Kalorama has covered molecular point-of-care on a yearly or biyearly basis since 2013.

We projected 18% growth each year in molecular POC systems and consumables revenues.  The spread of the disease in the United States and developed world would prove us wrong.

We  define molecular point of care as near-patient PCR, sequencing or other NAT systems that offer small instrument size, near patient placement as well as fast turnaround of tests and that offer tests that are CLIA-waived or tests that require a lower threshold of operational training so that they may be in the next five years.

Cepheid’s GeneXpert, Abbot’s IDNOW, Roche’s Cobas Liat and bioMerieux’s BioFire are examples of mPOC systems.
COVID-19 has resulted in a huge acceleration in both system installations and spending on consumables per system. Cepheid’s installed base increased by around 30% in 2020 and bioMerieux’ systems sales increased from around 600 per quarter to around 2,000. Spend per system was reported by many companies to have increased around 50%-60%.

The molecular point-of-care market is overwhelmingly in the respiratory category, with most of that dedicated to influenza testing. Other tests include HAIs and STIs, among other diseases.

From Lab Pulse , a sister publication to Kalorama Information – www.labpulse.com

Experience with COVID-19 has cast a bright light on the state of healthcare and the great need for change, which has already begun, said panelist Rahul Dhanda, co-founder and CEO of Sherlock Biosciences, a pioneer in diagnostics based on CRISPR gene editing technology. At the start of the pandemic, tests were not widely available and had to be rationed; diagnosis and treatment were focused on symptoms, which is not atypical in the healthcare space, Dhanda noted.

But as time went on, there was a shift in thinking about the distribution of diagnostics outside standard structures — both in terms of how samples are accessed and how results are delivered, he said. Sherlock’s CRISPR SARS-CoV-2 lab-based test kit received emergency use authorization (EUA) from the U.S. Food and Drug Administration in May. Designed for use in CLIA-certified laboratories, the molecular testing product delivers results in about one hour.

Sherlock, which is based in Cambridge, MA, is also developing products based on its internal splint-pairing expression cassette translation reaction (INSPECTR) platform. The firm’s synthetic biology technology supports instrument-free handheld testing, including paper-strip diagnostics and over-the-counter disposable rapid molecular tests for COVID, much like the well-accepted home-based pregnancy tests, according to the company. In December, the company announced that it received a $5 million grant from the Bill & Melinda Gates Foundation to advance development.

What’s needed now is appropriate management of a new set of tools, in Dhanda’s view.

“We are seeing a trend toward self-testing that pre-COVID was a great dream of anybody who had spent their career in diagnostics and now is a reality that we all want to see happen and are developing technologies to get there,” the executive said.

The goal of bringing molecular diagnostics anywhere and everywhere becomes easier with the variety of applications now available, Dhanda added. Sherlock plans to make point-of-care diagnostics products available, with the ability to deliver results in developing as well as well-developed countries.

“If we are going to make these strides forward and we are committed to healthcare, we have to be committed to the equitable distribution of those healthcare solutions,” Dhanda said.

We are now seeing a surge of technologies get to the market that enable point-of-care testing in less resource-intensive environments, including at home, said Jeff Hawkins, CEO at San Diego-based Truvian Sciences. That’s a trend that contrasts with the lack of rapid testing at the start of the pandemic; the change was made possible by public and private investments, Hawkins noted.

Don’t mess with Mr. In Between

Truvian has developed a blood-based point-of-care platform with the aim of introducing “something as disruptive as humanly possible.” Point-of-care diagnostics should offer the quality of a central lab, yet be easy to run sitting on a countertop, Hawkins suggested.

Truvian’s EasyCheck immunoglobulin M and G (IgM/IgG) COVID-19 antibody test received an EUA in July. The company is looking to partner with global healthcare players to take the platform into regions across the world, including areas where people don’t have access to healthcare unless they live near a major city center and where — if diagnostics are available — they are typically of very low quality.

Infectious disease diagnostics is a key area of investment focus at Artiman Ventures, said panelist Ajit Singh, PhD, a partner with the firm. Furthermore, the company values the ability to diagnose infections quickly, at low cost, and with no need for a high level of expertise in administration — all achieved without sacrificing accuracy.

One of the companies in Artiman’s portfolio attracting attention in the last year is Visby Medical (formerly called Click Diagnostics). Visby, which was founded by Stanford University professor Adam de la Zerda, PhD, developed a handheld disposable polymerase chain reaction (PCR) test for COVID-19 that it said requires only two minutes of hands-on time for testing and delivers results within 30 minutes.

The company’s single-use personal PCR test received an EUA from the FDA in September 2020, paving the way for use in moderate complexity lab environments. Per the EUA, swabs may be taken by a healthcare professional or self-collected by a patient under supervision.

Founded in 2012, Visby had originally developed the technology platform for use in diagnosis of sexually transmitted diseases, but switched gears quickly in 2020 to apply it to the development of a viral RNA test for COVID-19. While the turnaround time from the start of the pandemic and EUA was fast, the concept for a simple test for infection was originally envisioned in 2010-2011 and development took several years.

The company has been producing about 50,000 devices per month, according to Singh. Funding granted by the U.S. National Institutes of Health and the Biomedical Advanced Research and Development Authority in October 2020 will be used to scale up manufacturing. While currently authorized for use in labs, the product is being positioned for over-the-counter use.

Addressing collateral damage

When considering the effect of the pandemic on diagnostics development, it’s important to see beyond the coronavirus itself and to take stock of collateral damage worldwide, suggested Madeline Repollet, PhD, head of clinical laboratories at Angle, which has offices in the U.K. and the U.S. Research suggests that as many as 20% of coronavirus cases in U.K. hospital patients were actually transmitted in the hospital setting.

Consequently, patients fear going to the hospital, and procedures deemed to be unnecessary have been scaled back, Repollet noted. This is driving a need for liquid biopsies in oncology, with blood drawn at home by a visiting professional or at a collection center, as an alternative to invasive tissue biopsies, she said.

Angle’s research-use-only (RUO) Parsortix technology is used for genetic testing of circulating tumor cells, using a 10-mL blood sample in an ethylenediaminetetraacetic acid (EDTA) vacutainer tube. The company is focusing on how to make this available to patients who have not received treatment during the pandemic, Repollet said.

The unpredictable events of 2020 might cause one forswear all prediction-making.  Yet for Science and Medicine Group, the publishing brands we offer (Strategic Directions International, Bioinformatics, Kalorama Information, IMV, Instrument Business Outlook) are in the business of prediction-making.  Thus once again, we offer our top ten predictions for 2021 based on our market research publications:

  1. Recovery in Academic and Lab Markets:2020 was obviously an atypical year, and in analytical and life science instrumentation markets (chromatography, spectroscopy, mass spectrometry and other fields) 2021 will also be atypical as a year of recovery.  Academic and government lab budgets are expected to take more than one year to recover, since public funding has been so impacted by lower tax revenues and important spending to directly address the crisis.      This from Strategic Directions International, authors of the The 2020 Global Assessment Report: The Laboratory Analytical & Life Science Instrumentation Industry  https://strategic-directions.com/global-assessment-report-2/
  2. That Growth Will Be Weighted Toward Asia: The current resurgence of the pandemic in the US and Europe will delay the recovery of these markets in 2021, while many Asia Pacific countries that were more successful in suppressing the disease are already seeing increased demand for lab instrumentation and equipment.
  3. Boost in the M&A Market for Instrument Companies: Instrument Business Outlook, the premier newsletter for instrument executives, expects M&A activity to increase in 2021.  Although the COVID-19 outbreak may have slowed M&A activity across many industries earlier this year, that changed late in the year.   The largest deals for the cell-based instrument market came from 10x Genomics and Bio-Rad Laboratories and were focused on single-cell analysis. 10x Genomics purchased two companies in the spatial analysis space, including its  $350 million acquisition of ReadCoo), while Bio-Rad had its $100 million deal for Celsee.
  4. Radiation Therapy Capital Purchases Up in 2021: Although the COVID-19 pandemic has impacted this year’s capital budgets for radiation therapy equipment, it is likely that investments are being shifted to 2021-2022. This according to IMV Info’s RT Market Outlook – https://imvinfo.com/product/2020-radiation-therapy-benchmark-report/  Going forward, a higher 25% of the sites are planning to have capital budgets of $1 million or more in 2021 and 2022, compared to the current 18% of 2020 budgets. 10.
  5. Urgent Cares Provide Perfect Outlet for COVID-19 Vaccines: Urgent care locations have grown over the past decade, Kalorama estimates the urgent care locations in the United States to be 9,900, growing from nearly 7,000 in 2013.  That’s spectacular growth, driven by a need for more healthcare services, improved insured populations and resistance to physician office waiting times.  Now there’s opportunity with new COVID-19 vaccines.  “There is no better front-line for distribution of a widely utilized vaccine among a healthy population,” said Bruce Carlson, Publisher of Kalorama Information.  “of course supplemented by traditional vaccine outlets such as governments and physician offices.  But urgent cares offer walk-in, no previous relationship service, which is ideal for a vaccine.”   The market research firm’s report The U.S. Urgent Care Center Market, says that what distinguishes urgent care centers is that they are a walk in clinic offering extended hour access for acute illness and injury care that is either beyond the scope or availability of the typical primary care practice but offer less services than an emergency room would.
  6. Customized Retargeted Ads Will Help Instrument Companies Advertise Their Products:If they use it correctly that is.  According to The 2020 Best Practices for Advertising to Life Scientists: Online and in Print  https://bioinfoinc.com/product/advertising-life-scientists-2020/ a report conducted by Bioinformatics, part of Science and Medicine Group.  Watch age and demographic preferences, and keep ads simple and benefit messages concise.  They also will respond to retargeted ads, if they are done well.  There is also generational differences in how they will respond to ads.  This is one of the many insights in the report, which essentially asks life scientists how they prefer to learn about new products.      
  7. Antibody testing for COVID-19:will be on the increase, brought about by vaccine effectiveness.  This means both the official studies of vaccine effectiveness and the informal checking by concerned individuals.  Antibody testing was talked about last year in the midst of the heaviest part of the COVID-19 crisis as a test used to ‘return to work.’  That did not work out in great numbers, but expect resurgence.
  8. Growth in Applied Markets for Lab Instrumentation:Uses such as food and environmental testing are forecast to increase spending by 7%-8% in 2021 on average.
  9. New Instrument Entrants in Diagnostics “Stay In:”Expect more diagnostics investments by instrument companies as their COVID-19 solutions opened the door to clinical labs and partners they may not have worked with before.    Bruker, Perkin-Elmer, Fluidigm are among the makers also in diagnostics.  QIAGEN recently discussed in their investors day how the huge increase in instrument placements this year for COVID 19 testing will pay dividends for consumables sales in years to come.
  10. 10.   High Sensitivity Troponin POC Approval:Troponin can be a predictor of heart attack and a  marker of coronary disease status.  hsTn assays are able to accurately measure 10-fold lower concentrations of cardiac troponin than contemporary assays.   The use of high sensitivity troponin in point of care settings, particularly the ER has been showing promise, and it’s been used with COVID-19 patients to detect severity, but there are no FDA approvals.   A product from Quidel has CE Mark, and Abbott i-Stat’s test has shown high sensitivity levels, though there is no predicting which brand or test would be the first POC hsTN nor do we make one.

What about last year’s predictions?  https://www.prweb.com/releases/top_10_life_science_and_healthcare_market_predictions_for_2020/prweb16824913.htm)  COVID-19 certainly threw predictions for a loop – those about Asian markets, rising imaging volumes in the U.S. multiphotonics and sequencing prep sales were affected;  (we extend those predictions to 2021) others held, more or less, to be true:   CART-T therapy sales should near a billion with final results still out, AI remains most useful in imaging applications, mass spectrometry is being brought to bear even in COVID-19 detection.  Hematology handhelds, while limited by COVID-19, continued to grow within the category of hematology tests.

The distribution of COVID-19 vaccines has focused testmakers on how they can continue to contribute when vaccines are released. For Roche Diagnostics, vaccines and tests and their alignment are key to 2021 growth. Roche held its session “Entitled COVID-19: The critical role of Diagnostics,” on the first day of The American Association of Clinical Chemistry, Monday December 14th.  The briefing focused on lessons learned from the global healthcare crisis, including challenges, solutions and future outlook. Thomas Schinecker, CEO Roche Diagnostics Division, Matt Sause, President and CEO of Roche Diagnostics North America, and William Morice, MD, PhD, President, Mayo Clinic Laboratories, a customer of Roche, participated in the discussion.

“Testing together with vaccines is key to stopping the pandemic,” Sause said.

Roche recently announced that its Elecsys® Anti-SARS-CoV-2 S antibody test has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The semi-quantitative serology (blood) test can be used to measure the level of antibodies in people who have been exposed to the SARS-CoV-2 virus.   The new test targets antibodies that are directed against the region of the COVID-19 spike protein, specifically the area that enables the virus cell to bind to the host cell receptor, which is required for the virus to enter the host cell.

The test provides a numerical result from 0.40-250 U/mL reflecting the concentration of antibodies, as well as a qualitative result.

“Not all patients react the same way,” said Schinecker at the briefing. “What you can do with antbody tests is find out who has antibodies and to what level, and to test the effectiveness of a vaccine after they are vaccinated.”

Any potential vaccine for SARS-CoV-2 would work (amongst other mechanisms) by triggering the immune response to develop neutralizing antibodies in the person receiving the vaccine. In doing so, the vaccine trains the body’s immune system to recognize and fight an exposure to SARS-CoV-2, in a controlled way, without being exposed to the actual virus. The company says there would be a benefit in knowing the starting levels of antibodies a person has, prior to vaccination, in order to evaluate any change in antibody levels that the vaccine induces.

Roche is partnering with Moderna to include a Covid-19 antibody test in the company’s ongoing vaccine trials for baselining and assessing natural infection in trial participants.

In other news, Roche confirmed it would apply for an EUA for its rapid POC antigen test, now in trials, in the early part of 2021. They also emphasized other areas, such as their transplantation test products, and cardiac markers.

 

Although virtual this year, this years meeting of the American Association for Clinical Chemistry (AACC) is probably more important than ever.  The industry is at the forefront of worldwide efforts to combat the COVID-19 disease.   In the United States, national focus is on laboratorians in an unprecedented way.  In vitro diagnostic vendors are under pressure to deliver instruments and reagents as never before.

As usual, AACC is the largest gathering of lab professionals and the IVD vendors that service them.  This year to keep their interest and participation, virtual happy hours and even ugly sweater parties are part of the meeting, along with the usual complement of scientific sessions and posters.  In this article, Kalorama outlines what areas to watch out for will be.

Laboratorians have been busy all year and this year especially have been a focus of national attention.   Now it is their time to be heard from.

Kalorama Information analysts will be viewing events and vendor announcements.  Kalorama’s market report on the IVD industry can be found at: https://kaloramainformation.com/product/the-worldwide-market-for-in-vitro-diagnostics-13th-edition/

What We’ll Be Watching

In particular, analysts are keeping their eye on the following:

 

Time to Hear from Labs

 Laboratorians have been busy all year and have been a focus of national attention.   Now it is their time to speak.  Expect to hear what various labs across the country and the world are experiencing in terms of the COVID-19 disease, and associated workloads, staff issues, stress and supply problems.  In particular, Kalorama analysts are on the lookout to hear if supply issues have continued even this many months out.  Recent surveys from AACC and AMP reflected this.


One session,  Just The Facts on SARS-COV-2 should provide some of this story.  https://www.aacc.org/cln/cln-daily/2020/just-the-facts-on-sars-cov-2?  Giuseppe Lippi, MD, and John Hackett, PhD, offer insight into the mechanisms of infection, viral kinetics, and human-to-human transmission of SARS-CoV-2. Additional details on the characteristics of COVID-19 disease progression, including viral incubation, respiratory involvement, inflammatory responses, thrombotic response, and death (or remission) also are addressed.

 

Home Collection

The unexpected and unprecedented demand for testing given the COVID-19 crisis has lead to a parallel demand for new sampling methods, including home testing.  What are vendors developing and what will scientific sessions say about the experience and performance of these methods in 2020?

Vaccine Connections

Analysts will be on the look out for tests, like antibody tests or specific collection devices, related biomarkers for preexisting conditions, any developments that might pair up well with vaccines, now that COVID-19 vaccines will be available.  Already some of these products have been announced.    And any related sessions.

 How Robust is R&D and New Products

AACC is a particularly important time for vendors to launch new products and to announce partnerships and mergers.  Perhaps this year, COVID-19 may have impacted these activities, but we suspect not.  We’ll be watching to see if new products of a variety of tests are launch or if the primary focus is COVID-19.  Of note: Siemens announced its new epoc Blood Analysis System with new epoc NXS Host, which the company says provides critical test results at the point of care in less than a minute to promptly diagnose and monitor patients in acute care settings.    Roche announced a high-volume laboratory SARS-CoV-2 antigen test

Respiratory Combo Panels

Roche, Quest labs and Quidel are among the companies that have announced tests for a combination of Flu and COVID-19.  Will there be more announcements in this promising area.

AI in Diagnostics

With the lab industry in what many described as a ‘war’  this year, did artificial intelligence technologies provide any assistance?  We’ll be looking at sessions, vendor press releases and posters to see if there’s any positive statistics to match some of the AI-based approaches announced in the past few years; or promising new efforts that might help improve diagnosis using in vitro diagnostics.

Attendance and participation

Tens of thousands attend AACC.  Kalorama has noted over the years how many a city has been surprised at the size of the industry it is hosting when the convention comes to town.  This year, will virtual sessions lead to a decline or perhaps even an increase in participation?, since more laboratorians can access than may have been able to attend in previous years.

Key Laboratory Supply Vendors at AACC

Of note – AACC has announced its Vendor Support Awards, which are a good indication of the significant companies in the industry supplying laboratorians.  This year, AACC recognizes 45 different companies and organizations that generously support the association through sponsorships, advertising, and exhibiting. These significant contributions make it possible for AACC to improve patient care by fostering research, innovation, and professional excellence in the field of laboratory medicine.

The AACC 2020 Corporate Supporter Award recipients include:
  • Siemens Healthineers
  • Abbott Diagnostics
  • Roche Diagnostics
  • Beckman Coulter, Inc.
  • Sysmex
  • BD
  • Ortho Clinical Diagnostics
  • Instrumentation Laboratory (IL)
  • Bio-Rad Laboratories
  • Randox Laboratories
  • Diagnostica Stago, Inc.
  • Thermo Fisher Scientific
  • Fujirebio
  • HORIBA Medical
  • DiaSorin Inc.
  • BioFire Diagnostics, LLC
  • Nova Biomedical Corporation
  • EUROIMMUN US
  • SARSTEDT
  • Grifols
  • Sebia
  • Binding Site, Inc.
  • Sekisui Diagnostics LLC
  • SCIEX
  • BioMerieux Inc.
  • MilliporeSigma
  • IDS Co, LTD
  • Hemosure / WHPM
  • Orchard Software Corp.
  • Hologic, Inc.
  • Diazyme Laboratories, Inc.
  • Tosoh Bioscience
  • Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
  • Waters Corporation
  • DiagnostikNet-BB e.V.
  • ARK Diagnostics, Inc.
  • Kamiya Biomedical Company
  • Luminex Corporation
  • Tecan
  • Hamilton Company
  • Streck, Inc.
  • Zeus Scientific
  • Quest Diagnostics
  • Wallonia Export-Investment Agency

Urgent care locations have grown over the past decade, Kalorama estimates the urgent care locations in the United States to be 9,900, growing from nearly 7,000 in 2013.  That’s spectacular growth, driven by a need for more healthcare services, improved insured populations and resistance to physician office waiting times.  Because of these undisputable positives, it’s common to see the urgent care industry presented only with rose-colored glasses.  Thus it should be stated that market growth is not without limits, in fact, a report from Kalorama Information suggests the “period of extensive location growth” for these centers may have passed.  This is according to a recent report U.S. Urgent Care Center Market: https://kaloramainformation.com/product/the-u-s-market-for-urgent-care-centers/ 

What distinguishes urgent care centers is that they are a walk in clinic offering extended hour access for acute illness and injury care that is either beyond the scope or availability of the typical primary care practice but offer less services than an emergency room would.   Estimates of locations vary as there are varying definitions of what an urgent care center is.

Growth cannot be without limits.  In fact, a report from Kalorama Information suggests  the “period of extensive location growth” for these centers may have passed.

The urgent care business model involves providing a full range of services of nonemergency acute care. UCCs differ from traditional physicians’ offices with procedure rooms for lacerations and fractures, a radiology department for x-ray services, and a laboratory.  There is a need for these locations, but the industry will not be a “boom mode” forever.  There are limiters to growth as well as drivers, and there is increasing visibility on those limiters.   The fastest growth, Kalorama estimates, happened in the early part of this decade, between 2011 and 2017.

The Beginnings of Market Crowding

“There are certainly areas of the country where an urgent care center has popped up on almost every intersection,” says the Journal of Urgent Care in a recent article.  Indeed, there is a growth trend but also visible limits to urgent care center growth. There are enough U.S. potential patients for each urgent care to have patient population of 30,000, Kalorama estimates,  where many industry experts suggest a 50,000 patient area is optimal for a successful urgent care practice.  This will be a limiter on the growth of urgent care center locations. It might be said that the current urgent care industry is satisfactory for meeting the needs of the U.S. population, but Kalorama does believe that there’s room to grow in rural areas and for more efficient operators to expand.  No market operates at such a perfected level of supply and demand and, in some markets, say with a greater income level or where hospitals have closed, urgent care has worked beyond these estimates.

“In Charleston, SC, for example, there are over 45 urgent care centers serving a population of 127,000. There are more than 120 urgent care centers serving the 1.6 million people of Phoenix, AZ. This begs the question: are markets too saturated? ”  – The Journal of Urgent Care

This trend has been seen with bank branches – explosive growth followed by retrenchment.  Between 2010 and 2019, the number of full-service bank branches fell from almost 95,000 to just over 83,000, according to a Quartz analysis of data from the Federal Deposit Insurance Corp. (FDIC). That is a loss of 12%.

The fastest source of pure growth for urgent care locations will be in rural areas lacking urgent care, rather than in urban areas. In urban areas, clinic growth by specific chains or successful upstarts will tend to come at the expense of another chain.

Furthermore, patient traffic is often seasonal, being higher in urban areas and in winter months. Such patient droughts favor larger operators who can keep afloat during a slow season to await a busier one.

Variance in Quality and Performance

As we’ve indicated, some of the growth in urgent cares is coming from centers located nearby an existing urgent care.  Even if both centers survive, metrics will drop in one or both.   In the next five years, those competition battles will play out across the nation.  Some urgent care locations and many urgent care chains are highly successful.  But not all are.    Patient volumes, revenue per patient, total clinic revenue, services offered, as well as testing capabilities and pharmacy services will all vary between urgent care centers.  As to who will win out, utilization of the best techniques will go a long way to determine which center in a market wins out.

Qualities of a High-Growth Urgent Care Center

Not on this list, but important, is the role of urgent care consultants.  Guidance from urgent care consultants, physicians with previous experience in urgent care or a national chain is a likely indicator of performance.

What does this variance in performance has to do with growth?  Simply said, it means not all centers will be here in a few years.  This will be a limiter on the growth of locations in the market. An exact estimate of successful and poor performing urgent care centers is difficult. It is possible that at least one-fourth of U.S. urgent care locations are operating at poor performance levels with under-average patient visits and per-clinic revenues.  The competition could eliminate poor performers.

A Senior Problem?

Urgent care may have an issue with seniors, and if that is the case, it is a trend the industry will need to reckon with for future growth potential.  A PNC Healthcare consumer survey found that 85 percent of seniors choose to see primary care physicians first. Only 11 percent of that population goes first to an urgent care center. A report by FAIR Health, a nonprofit that studies insurance claims, found that 60% of patient visits come from those 50 years old or younger.

Currently, Urgent care demographics lean towards younger and middle-aged customers, who to some degree are escaping physicians that older patients prefer.   This isn’t to say that education programs and outreach couldn’t change this current trend, but so far urgent care is an option to avoid clogged waiting rooms and utilized by young and middle-aged, usually working persons and their children.

A report by FAIR Health found that 60% of patient visits come from those 50 years old or younger.

Why is this an issue? Care for seniors is where the largest dollars in healthcare are. Seniors are the growth area of healthcare spending. Urgent care centers will need to compete for that aging democratic to capture greater dollars per patient and accelerate growth to the most optimistic projections.  This trend is troubling for the long term growth of urgent care centers, since spending is more likely to come from senior care than any other group.  For instance, Information from the Department of Health and Human Services indicates that seniors spend $11,000 per year on healthcare vs. $1,900-7,000 from those under 65.

Competition from Retail Clinics and Other Venues

Just as urgent cares could fact their growing pain era, there are new forms of competition.  Starting with retail clinics, but also from patient-friendly policies at doctor’s offices that can accommodate off-business hours.   As for retail clinics, there are at least 2,000 locations across the U.S., mostly at drug stores and each one pulls to a degree from existing or potential urgent care.  Some confuse these in-store health service locations, usually staffed by a nurse practitioner with urgent cares but they are not, they are competition, taking some of the high-volume visits away from urgent care.   For retail clinics, according to Kalorama’s reporting on that industry –  Total revenues are expected to continue to rise, driven by growth of each of the key metrics used to derive these estimates (patients treated, treatment fees, as well as clinic locations). Additionally, while the first clinics priced services extremely competitively to build business, as the clinics become more accepted, prices have gradually risen.

Growth in Retail Clinics

Although in most cases, this price increase will be smaller than the double-digit annual increases of healthcare service products and prices offered by other providers, it will nonetheless be necessary as retail clinics increasingly optimize their business models to maximize profitability and keep pace with ongoing increases in their own operating costs. For instance, the salaries for nurse practitioners continue to rise as demand for their services grows.

On the Bright Side…

Of course there are positives for urgent care:  Growth is fueled by the need for alternatives for patients and healthcare providers. For patients, traditional physician office hours and crowded waiting rooms are not meeting needs. The time it takes to schedule a new patient physician appointment in 15 major metropolitan areas has increased by 30 percent since 2014, according to a new survey conducted by Merritt Hawkins, a national physician search firm and a company of AMN Healthcare.

The result is confirmed by other studies.  The supply of doctors is also limited and the U.S. is feeling the pinch. Across the U.S., shortages of both general practice and specialist physicians are resulting in delays to treatment and long waiting times.  And COVID-19 vaccines will be a likely boon for urgent care being front-line, accessible and able to serve those:

Kalorama Information’s Report: The Market for U.S. Urgent Care Centers

Kalorama Information has a detailed report on urgent care center markets. The report is available at: https://kaloramainformation.com/product/the-u-s-market-for-urgent-care-centers/

Siemens Healthineers yesterday announced its SARS-CoV-2 IgG Antibody Test (sCOVG)1 has proven to measure neutralizing antibodies and has achieved CE Mark. The test is an enhanced version of the assay which became available globally this summer, including in the U.S. It demonstrates the ability to detect neutralizing antibodies and reports quantitative results measuring the amount of neutralizing antibodies present in a patient’s blood sample. The company has submitted an application to FDA under Emergency Use Authorization.

To measure a vaccine’s effectiveness, it is critical to identify both the presence of these neutralizing antibodies as well as quantitatively assess the likely level needed to protect against future encounters with the virus.

Neutralizing antibodies are critical in the fight against COVID-19 because they defend cells from infection by the virus. A virus typically produces an immune response of many antibodies that act as an army to help fight off the virus; however, only a small subset of those antibodies are capable of neutralization—blocking the virus from infecting additional cells. Those neutralizing antibodies develop either in response to natural infection or to vaccination, then subsequently bind to the virus and block infection. To measure a vaccine’s effectiveness, it is critical to identify both the presence of these neutralizing antibodies as well as quantitatively assess the likely level needed to protect against future encounters with the virus.   Siemens Healthineers says its antibody test will make learning this information possible as vaccines are rolled out and exposure to COVID-19 is tested against immunization and the level of immunity a vaccine provides.

The Siemens Healthineers said its SARS-CoV-2 IgG antibody tests are available on one of the largest installed bases of automated immunoassay analyzers worldwide, and the largest in the U.S. This includes the Atellica® Solution and ADVIA Centaur® XP and XPT families of analyzers and the Dimension Vista® and Dimension® EXL™ systems.

Kalorama Information has recently produced a report on COVID-19 testing.  The report is available at: https://kaloramainformation.com/product/covid-19-update-clinical-testing-telehealth-vaccines-and-other-markets/

Surprising effectiveness levels for COVID-19 vaccine candidates have been reported in the news lately, with Pfizer and Moderna releasing company data.   This rightly gives many hope, and also may lead to a question as to whether the PCR and immunoassay testing for the disease we are seeing in 2020 will continue much longer.  It may be natural to suspect that if a vaccine is available, there will be less cases thus less reasons to test. But this isn’t normally the interplay between vaccines and diseases.

In its COVID-19 update report, Kalorama Information estimated that test volume was up in labs and among IVD vendors, and new technologies are becoming available. The firm, a sister company to LabPulse.com, projects a $10.5 billion market for COVID-19-related tests. This is an increase of over $1 billion dollars from the firm’s August update with much of the increase based on the production and usage of antigen tests.

It is possible a vaccine solution will be developed, and it may be widely funded and distributed. Many candidates from major pharmaceuticals are in advanced phases.  Unless the disease “goes away” or is or heading there, the need for testing remains. Patients will present with symptoms, and they will need testing.  We’d also note the following:

  • Despite the presence of one of the most widely-used adult vaccines, hundreds of millions are earned by IVD companies selling flu tests.  Kalorama details this market each year in its global IVD market report.
  • This question of vaccines eliminating testing was raised with cervical cancer vaccines in relation to histology stains and HPV testing, which has only grown since the launch of Gardasil and other vaccines.
  • Vaccine use will not be universal: a recent online survey of adults residing in the U.S. found that close to 70% of those surveyed would accept a COVID-19 vaccine if one were widely available. Results of the study were published in the journal Vaccine on August 20. Nor is the problem unique to the US: German daily Süddeutsche Zeitung newspaper reported just over 60% of people in Germany would be willing to get vaccinated against COVID-19.
  • As Kalorama analyst Justin Saeks indicates “It is also possible that as the case with many novel viruses, the virus passes through the population, on a very large scale or there may be mutations. So far, journal literature is leading the other direction, that mutations are not as likely because of error correction systems in the viral DNA.”  yet the point remains -for market modelers and diagnostic industry watchers, it is still possible that COVID-19 might form strains and variants or co-infect with RSV and influenza in typical ways.
  • Antibody tests have been developed and are in a sense ready and waiting.  Labs will likely see higher demand for antibody tests after a vaccine is available to test effectiveness post-vaccination and to test for how long immunity lasts.
  • Patients presenting with symptoms will still need testing, at minimum COVID-19 remains a major testing application for 2021 and likely into 2022.
  • Combination tests such as those offered by Quidel, Quest, Lab Corp, Cepheid and other makers group  COVID-19 among other tests.  This will be useful to rule-out COVID-19 even after a period of wide vaccine usage.  The ability to run COVID-19 as a panel as opposed to a single test will facilitate more testing.

It is fair to say that a a vaccine may reduce the great expansion of testing, especially testing that extends to asymptomatic populations.   Reopening plans in the United States and developed companies will drive markets, and that create additional unknowns beyond the medical concerns.  Right now though, all indications are in the opposite direction, that broad testing is gaining popularity.    This is facilitated by rapid antigen tests, most of which are performed at the point of care, detect viral particles rather than antibodies in the patient.  They are seeing usage, though perhaps not to the level advocated by some proponents.  In some models, everyone would be tested or every school student or worker.

One enterprising plan was recently detailed in The Atlantic Monthly, based on Harvard epidemiology professor Michael Mina (https://www.theatlantic.com/health/archive/2020/08/how-to-test-every-american-for-covid-19-every-day/615217/) The plan involves extensive use of low cost/ high volume rapid tests in schools and workplaces. Test in this scenario would be used in great numbers and performed daily.

Likely a more moderate practice continues – some schools, some workplaces engage in this kind of testing, with industry-based and regional variances.

The attractiveness is seen in the South Korea example.  The nation is a different governmental system than the United States, but also a model for a testing protocol that would involve test volume increases. A new study indicates that point-of-care testing played an important role in reducing the spread of SARS-CoV-2 there compared to the U.S., which has experienced 47 times the number of cases and almost 80 times the number of deaths. South Korea’s response to the COVID-19 pandemic has been widely lauded — and is becoming heavily studied.

If vaccines do provide some decline in the overwhelming demand for testing, perhaps the laboratory industry could use it.  Even in the fall of 2020, there are capacity limitations, questions about testing accuracy, and challenges with sample collection. But creative solutions have been emerging at labs to help ease the load during a difficult time.

 

 

In 2020, the global market for preventive vaccines is valued at $37.4 billion, up overall from $30.7 billion in 2015.  The finding was made in Kalorama Information’s report, Vaccines 2020 (https://kaloramainformation.com/product/vaccines-2020-world-market-analysis-players-trends/).  Strong continued growth in the global vaccines market is expected through 2025, specifically:

  •  Growth at high double-digit rates.
  •  Sales of adult vaccines are expected to increase revenues at a faster pace than pediatric vaccines.
  • The United States comprises the single largest market for vaccines

More details are available in Kalorama’s report, including regional breakouts, disease-based market breakouts and forecasts, trends and other information.  COVID-19 vaccines are not part of this market number, though Kalorama does forecast these in its report.

A mainstay of preventative medicine for over 70 years, a vaccine is a biological preparation used to trigger an immune response to a selected disease. The term derives from Edward Jenner’s use of cowpox (“vacca” means cow in Latin), which, when administered to humans, protected them against smallpox. Vaccines can be either prophylactic or therapeutic.

“Despite a small decline between 2019 and 2020 due to COVID-19 and lockdowns, the vaccine market has grown seven billion dollars in the last five years.”

Because of the large number of deadly diseases that have been virtually eliminated through the proliferation of effective vaccines, vaccination is generally viewed as one of the greatest public health achievements during the 20th century. As a result of widespread public vaccination, vaccine-preventable diseases and their resulting deaths are now rare in the developed nations and declining worldwide. Immunizations have eradicated smallpox; eliminated poliomyelitis in the Americas; and controlled measles, rubella, tetanus, diphtheria, Haemophilus influenzae type b, and other infectious diseases.

However, risks are associated with all immunobiologics. No vaccine is completely safe or 100% effective. Vaccination risks range from common, minor, and local adverse effects to rare, severe, and life-threatening conditions. For example, some autoimmune diseases like acute disseminated encephalomyelitis, Guillain-Barré syndrome, transverse myelitis and multiple sclerosis are known to be connected to vaccines. In addition, some studies have linked a significant rise in autism to certain vaccines, although there is no widespread agreement on this. Thus, recommendations for immunization practices balance scientific evidence of benefits for each person and to society against the potential costs and risks of vaccination programs. These risks, however, have led to a rising number of individuals declining vaccination for themselves and their children, which in turn is believed to have contributed to recent increases in several serious, highly infectious conditions including mumps.

The European market is presently the second largest global vaccine market, with nearly twenty percent of the market.    S

In 2020, the global market for human preventive vaccines experienced mixed performance in 2020 due to the impact of COVID-19. Sales overall declined from $38.4 billion in 2019 to $37.4 billion in 2020.

Despite the overall decreased market performance, in 2020, the report said some segments reported increases, including:
• Influenza vaccines
• Rotavirus vaccines
• Shingles vaccines

Through 2025, growth will be fueled by favorable demographics (population growth, rising life expectancy), continued new product introductions, indication expansions for some products and rising usage, particularly in India and China. However, mitigating against growth will be continuing concerns about vaccine safety and refusal to immunize. This report contains an expanded section on this topic.

In its COVID-19 Update report, Kalorama Information said that volume was up in labs and among IVD vendors, new technologies are available.  Kalorama projects a 10.5 billion-dollar market for COVID-19.  This is a 1 billion dollar increase from previous estimates.

For most aspects of the diagnostic testing process, there has still been a learning curve for all involved. Even in the fall of 2020, there are capacity limitations, questions about testing accuracy, and challenges with sample collection. But creative solutions have been emerging at labs to help ease the load during a difficult time.  With over a million deaths worldwide, the COVID-19 crisis has continued to unfold with great challenges for the healthcare system and its suppliers.

Although a sensitivity of roughly 80% seems striking as a low number, in fact the negative predictive value can still be sufficient if the disease prevalence is appropriately matched.

Rapid antigen tests are one of the factors driving growth; these tests can offer some major benefits in the effort to control the SARS-CoV-2 pandemic. The decision to apply antigen tests in certain situation as opposed to others is complicated and is still being completely sorted out. The decision to apply antigen testing depends on variables including:

  • Sensitivity and specificity of the test
  • Prevalence/ outbreak of COVID-19 in the given population
  • Remote location, availability of laboratories/ hospitals
  • Turnaround time of the test
  • Cost of the test
  • Ability to perform serial testing

The momentum of cases and tests, since our Kalorama’s COVID-19 Update in May has not slowed, sadly.  There are over 45 million cases worldwide; 9 million of them in the United States. The trend is troubling as well, and there are fears of increases as the U.S. influenza season has arrived. (perhaps mitigated, perhaps not by reports of a milder flu season based on the experience in the southern hemisphere).

The scarcity of various diagnostic test related products during the COVID-19 pandemic has further driven home the reality that different testing methods are best allocated for different situations. While antigen tests have been criticized for the lower performance characteristics compared to antibody and molecular tests, these metrics are not always the most significant. Antigen tests often can have sensitivity lower than 85% while the specificity needs to be fairly high, in the range of 98% or higher.   Although a sensitivity of roughly 80% seems striking as a low number, in fact the negative predictive value can still be sufficient if the disease prevalence is appropriately matched.

Marketed Tests

Marketed tests include:

  • Abbott Laboratories -BinaxNow COVID-19 Ag Card & Navica app
  • Access Bio -CareStart COVID-19 Antigen
  • BD-BD Veritor System for Rapid Detection of SARS-CoV-2
  • BIOHIT -HealthCare SARS-CoV-2 Antigen Rapid Test Kit
  • Confirm BioSciences -Verasure COVID-19 Antigen Rapid Swab Test
  • Dynamiker Biotechnology – Dynamiker SARS-CoV-2 Ag Rapid Test
  • Edinburgh Genetics – ActivXpress+ COVID-19 Antigen Complete Testing Kit
  • FenHe Technology -reOpenTest COVID-19 Rapid Antigen Test
  • JOYSBIO Biotechnology – COVID-19 Antigen Rapid Test Kit (Colloidal Gold)
  • LumiraDx – SARS-CoV-2 Ag Test
  • Menarini Diagnostica/ Boditech Med – iChroma COVID-19
  • OraSure Technologies – at-home test
  • Roche – SARS-CoV-2 Rapid Antigen Test
  • Sensitest – Corona Antigen Rapid Test
  • Sona Nanotech – Sona COVID-19 Rapid Antigen Test
  • Tigsun Diagnostics – COVID-19 Antigen Saliva Rapid Test

Unique and Proprietary Technologies

In addition to the standard formats such as lateral flow and ELISA, there are also a number of unique technologies being applied for SARS-CoV-2 antigen testing. These include the following examples of companies and their products/ technologies that are either available or in development:

  • AmonMed Biotechnology – Rare Earth Nano Fluorescence Immunochromatography Avacta/ Adeptrix with Cytiva (Danaher) – working on rapid
  • POC saliva test for self-testing and large scale population screening
  • Celltrion – Magnetic Force-assisted Electrochemical Sandwich Immunoassay (MESIA) technology – CLIA high and medium complexity
  • E25Bio – paper based nasal swab test
  • Ellume – working with Qiagen on test cartridges for home use, POC, and high throughput system
  • Genspeed Biotech – micro-ELISA
  • Luminostics – antigen immunoassay that uses glow-in-the-dark nanomaterials
  • New Gene (Hangzhou) Bioengineering – novel ligand-receptor chromatography test kit

In October, the FDA provided a template to help test developers applying for EUA for SARS-CoV-2 antigen tests. The template provides a range of recommendations as well, for example in order to show the test suppliers how to handle their validation data. Many of these are suggested but not required.   The template recommends that antigen tests should have a sensitivity of at least 80%, but noted that serial testing could allow for results of lower-performing tests (e.g. 70% sensitivity) to be calculated cumulatively.

Vendor Moves

The shift to antigen testing introduces different vendors into the COVID-19 market than are present in PCR. BD and Quidel for instance, are players in antigen testing and have systems with significant placements worldwide.

The scarcity of various diagnostic test related products during the COVID-19 pandemic has further driven home the reality that different testing methods are best allocated for different situations. While antigen tests have been criticized for the lower performance characteristics compared to antibody and molecular tests, these metrics are not always the most significant. Antigen tests often can have sensitivity lower than 85% while the specificity needs to be fairly high, in the range of 98% or higher.   Although a sensitivity of roughly 80% seems striking as a low number, in fact the negative predictive value can still be sufficient if the disease prevalence is appropriately matched.

Becton Dickinson (BD) BD and Quidel, as well as Roche and Abbott are significant players in antigen testing; there are scores of others.  On July 6, 2020 BD announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for a rapid, point-of-care, SARS-CoV-2 diagnostic test for use with its broadly available BD Veritor™ Plus System. The launch of this new assay that delivers results in 15 minutes on a portable instrument. BD Veritor™ System, which is slightly larger than a cell phone, is currently in use at more than 25,000 hospitals, clinician offices, urgent care centers and retail pharmacies in all 50 U.S. states, per the company.

Earlier in the year, Quidel earned an EUA for The Sofia SARS Antigen Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral flow technology in a sandwich design for qualitative detection of nucleocapsid protein from SARS-CoV-2. Now the company has received a U.S. Food and Drug Administration emergency use authorization (EUA) for a rapid diagnostic that can simultaneously identify influenza A, influenza B, and the novel coronavirus. The ABC Test, also known as the Sofia 2 Flu + SARS Antigen FIA, is a cartridge-based, point-of-care diagnostic that works with both nasopharyngeal and nasal swab specimens. The test is designed for use in individuals with suspected respiratory viral infection within five days of symptom onset, according to the company. The three-way test works with the Sofia 2 Fluorescent Immunoassay Analyzer (FIA) and provides results within 15 minutes.

Abbott: On August, 26th, 2020, Abbott Launched its sixth COVID-19 test, the BinaxNOW™ COVID-19 Ag Card rapid antigen test – a fast, reliable, affordable and portable rapid test that Abbott will produce at mass scale to greatly expand access to testing to people who need it. The company said they would ship millions in September, ramping production to 50 million tests a month in October. This test offers results in 15 minutes and is available as an aid to diagnose the virus that causes COVID-19. The BinaxNOW test can be displayed on an optional app for iPhone and Android devices called NAVICA™. This first-of-its-kind app will allow people who test negative to have a temporary encrypted digital health pass that displays their results.

Roche Diagnostics has a rapid antigen test and recently announced that it intends to launch a high-volume SARS-CoV-2 Antigen test as an aid in the diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection. The test is planned to be made available at the end of 2020 for markets accepting the CE Mark. Roche also intends to file for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA). The Elecsys® SARS-CoV-2 Antigen test is a highly accurate laboratory immunoassay for the in vitro qualitative detection of the nucleocapsid antigen of SARS-CoV-2. The test is performed by healthcare professionals and uses nasopharyngeal or oropharyngeal swab samples from patients with signs and symptoms suggestive of COVID-19, or people with either known or suspected exposure to SARS-CoV-2.

On November 5th, Ortho Clinical Diagnostics announced that the FDA   accepted the company’s Emergency Use Notification (EUN) for the new VITROS® SARS-CoV-2 Antigen test, designed to detect active SARS-CoV-2 infection. The company has also submitted an Emergency Use Authorization (EUA).    The company said that with high sensitivity and specificity,ii Ortho’s SARS-CoV-2 antigen test offers exceptional utility for mass-scale testing where appropriate. The company is promoting it’s ability to detect infectious patients based on viral load. Per OrthoClinical Diagnostics, studies showed that samples with PCR cycle threshold (CT— a measure of viral load) levels at 30 – 33 or greater carry little to no live virus, suggesting these patients may no longer be infectious. Compared to PCR, the company says Ortho’s test may be better able to identify individuals with COVID-19 who are infectious because the test is offered with 100 percent sensitivity with samples with a CT count of less than 34.

Kalorama’s report says the jury is out on how much antigen tests like those by Quidel or Ortho are replacing and would replace molecular detection methods. They have different purposes for the most part. Right now the most likely path is that both methods would see usage into 2021, until the disease were to recede or significant and widely distributed pharmaceutical solutions were available.  Kalorama’s report is available at: https://kaloramainformation.com/product/covid-19-update-clinical-testing-telehealth-vaccines-and-other-markets/