There are currently 76.1 billion in vitro diagnostics (IVD) procedures annually worldwide.  Global IVD procedure volumes are forecast to grow by several billion more through 2025, as revealed in IVD Procedure Volumes 2020-2025: Immunoassays, POC, Chemistry, Molecular, Microbiology and Other Tests, a recent report by Kalorama Information.

IVD procedures range from glucose to procedures including point-of-care and laboratory tests that are categorized according to the testing technology employed. Approximately 20 different technologies have been adapted to IVD applications. Clinical chemistry, hematology, and immunoassays comprise the top three disciplines based on number of tests performed worldwide. Molecular assays are expected to command the fastest growth in global procedural volume but will continue to make up only a small portion of total IVD activities. Among other IVD testing technologies, conventional microbiology, coagulation (hemostasis), histology, and cytology are the most widely employed.

IVD companies extending their reach in developing nations is among several notable growth factors reported by Kalorama Information’s recent report

Looking ahead, Kalorama Information anticipates the United States will account for the largest volume of IVD procedures implemented worldwide in 2025. The country will maintain a high, diverse level of tests based on its advanced medical delivery system, high healthcare spending intensity, and widespread health insurance coverage of the population. Moreover, its volume of IVD procedures will rise as patient care strategies place an increasing emphasis on early disease detection.

Kalorama Information highlights several areas of growth outside the U.S. and despite the maturation of IVD markets in developed countries. For one, the market’s aforementioned prominence in developed nations has IVD companies continuing to cast their nets in developing countries where rising incomes and standards of living are anticipated to spark a new health-conscious population with growing demands for quality medical care.  While once the focus was on the BRIC countries of Brazil, Russia, India and China, IVD companies now prefer to look at secondary markets of interest for IVD companies including Saudi Arabia, South Africa, Colombia and Vietnam.  But the primary focus is on the top seven emerging markets:

  • China
  • Brazil
  • Turkey
  • Korea
  • India
  • Russia
  • Mexico

Global sales are the source of growth for the industry, but not without considerations.  Outside of the U.S. and Europe, there are dramatic fluctuations in the stability of financial markets and economic systems and governments in global IVD markets, which has companies shifting resources every few years, finding the new fast-developing markets.

This begs the question, “where are the best markets?”  As a starting point – one of the major aspects of commercial potential is to look at available market, which Kalorama Information suggests is implied by the percent of the population that is urban, since urban populations usually have more access to healthcare in the way of physicians, hospitals, and clinics.  As the governments in developing countries increase the healthcare infrastructure to rural communities, there is expected to be a significant enlargement of the market for diagnostics.  These diagnostics would cover many of the primary care segments related to diabetes, anemia, hypertension, infectious diseases, sexually transmissible diseases and cancer screens.

Beyonds location, other notable growth trends for IVD procedures identified by Kalorama Information include, but are not limited to:

  • Steady population growth and aging, which will increase the number of individuals vulnerable to acute and chronic medical conditions.
  • Evolving epidemiological patterns, which will keep major diseases such as cancer, diabetes, heart failure, hepatitis, HIV/AIDS, influenza, malaria, and tuberculosis major threats to human health.
  • The expansion of healthcare cost containment initiatives, which will encourage medical providers to broaden the use of IVD tests to detect serious diseases in early stages when treatment is less costly and more likely to succeed.
  • The adaptation of new and existing IVD procedures to point of care (POC) sites in hospitals, outpatient facilities, retail clinics, nursing homes, and other near patient markets.
  • The COVID-19 pandemic.

Modern developments in cell and gene therapy products are transforming the treatment of cancers and genetic diseases, and in the process they have helped create a multi-billion dollar global industry that is poised to more than double over the next ten years, according to 2020 estimates by leading medical market research firm Kalorama Information as reported in Cell Therapy and Gene Therapy Markets. Therapies for cancer generate almost half of the cell and gene therapy market total, led by oncology drugs including Kymriah, Provenge, and Yescarta.  Now a new entrant into the market aims to join the ranks of these notable cell and gene therapy products for cancer.

In March 2020, the U.S. Food and Drug Administration (FDA) approved a new cell-based gene therapy idecabtagene vicleucel, which will be sold as Abecma. The new therapy is for adult patients with relapsed myeloma (myeloma that returns after completion of treatment) or refractory myeloma (myeloma that does not respond to treatment) who have not responded to at least four different types of therapy. Abecma is the first cell-based gene therapy for the treatment of multiple myeloma that has been approved by the FDA. The safety and effectiveness of Abecma were established in a study of 127 patients with relapsed myeloma and refractory myeloma who received at least three prior antimyeloma lines of therapy.

Multiple myeloma is one of several areas in the oncology sector that Kalorama Information identified as having strong development pipelines, alongside hematologic cancers (leukemia, lymphoma), brain cancer, and ovarian cancer.

Though the exact cause is unknown, multiple myeloma is a cancer that forms in a type of white blood cell called a plasma cell. Plasma cells help people fight infections by making antibodies that recognize and attack germs. Multiple myeloma causes cancer cells to accumulate in the bone marrow, where they crowd out healthy blood cells. Rather than produce helpful antibodies, the cancer cells produce abnormal proteins that can cause complications, including damage to the bones, kidneys, and immune system.

Multiple myeloma is not curable but is treatable and patient outlook is often dependent on age and the stage of the condition when diagnosed. Myeloma accounted for approximately 1.8% (32,000) of all new cancer cases in the U.S. in 2020, according to the National Cancer Institute. For people with multiple myeloma who require treatment, several treatments are available to help control the disease—now including Abecma. Multiple myeloma is one of several areas in the oncology sector that Kalorama Information identifies as having strong development pipelines, alongside hematologic cancers (leukemia, lymphoma), brain cancer, and ovarian cancer.

In the case of Abecma as a treatment option, the therapy is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy. Abecma doses are customized treatments created using a patient’s own T-cells, which are a type of white blood cell, to help fight the myeloma. The T-cells are collected and genetically modified to include a new gene that facilitates targeting and killing myeloma cells. Once modified, the cells are infused back into the patient.

 

A recent deal in the news cements the viability of the respiratory segment and the use of small molecular systems to test for them.  First introduced in 2013, PCR and other NAAT-based molecular systems have become a central part of testing for ailments such as flu, strep, RSV and COVID-19.  They remain in competition with immunoassay systems which on the whole still field better installed base numbers.  It was though antibotic resistance would be the key issue to propel these systems, but COVID-19 has proved to be the situation where they were best suited, as we had predicted when COVID-19 was not yet present in the United States last year.

As Roche has inked a $1.8 billion acquisition agreement with GenMark Diagnostics, the case for mPOC has been moved forward.   The deal is expected to close in the second quarter of this year.  GenMark designs molecular diagnostic tests that identify multiple pathogens from a single patient sample, Roche said. Its syndromic panel testing portfolio will complement Roche’s molecular diagnostic portfolio, according to the firm.

Kalorama’s mPOC report can be found here: https://kaloramainformation.com/product/2021-molecular-point-of-care/

Once the transaction is complete, GenMark Diagnostics will continue to operate out of its current location in Carlsbad, CA.

What’s obvious about the deal is that it is not just about the company’s current business.  The deal is multiples of the company’s revenue.  But it’s about the future, and a future that was evident in the companies fourth quarter.   Just shy of 10 percent of the company’s new systems came from the last quarter of 2020.   For example, the company placed 70 net new ePlex analyzers in the quarter, which the company said was out of 792 total systems.
We think it’s the end year success and not so much the past business is what Roche is betting will continue.   Clearly you are seeing COVID-19 influence strategy, if not for this wide scale infection, then possibly to be in position for the attractive respiratory market, or for the next pandemic.
GenMark’s ePlex system also has a Blood Culture Identification (BCID) Panel product that can provides broad coverage of organisms that can lead to sepsis along with their resistance genes. This broad coverage means that about 95% of currently identified bloodstream infections can be detected early with the ePlex BCID Panels, compared to other panels that detect significantly fewer sepsis-causing bacteria and fungi.  The original goal of many of the molecular point of care systems were to get to a faster syndromic test.

There are currently 76.1 billion in vitro diagnostics procedures annually. Procedure volumes will grow to 111.3 billion in 2025.The chart below depicts the current global estimate and forecast of IVD procedures, including glucose and excluding COVID-19. Population, aging, insurance levels and new test development are factors in the growth of procedures.

 

Global volumes of various IVD procedures are presented in millions and reflect the evaluation of a single analyte, marker, or other variable of interest. It should be noted that some IVD tests involve more than one procedure as they provide for the analysis of multiple analytes.


Global sales of IVD products are expressed in current United States dollars and reflect sales for the year 2020 and forecasts for each year in the 2021 to 2025 period. A table that measures the total amount of IVD product sales against the total volume of IVD procedures is presented for each major testing category. The report also includes estimates of average fees paid to clinical laboratories and medical establishments for specific groups of IVD procedures.    The global volume of IVD procedures is forecast to increase 7.9% annually to 111.3 billion in 2025.

Procedure Volumes by Type Are Covered in Detail in Kalorama’s
Latest
IVD Procedures Volume Report
https://kaloramainformation.com/product/ivd-procedure-volumes-2020-2025/

The IVD landscape in 2020 has shifted due to the impact of the COVID-19 pandemic. The pandemic is impacting the world economy and creating uncertainty in the stock market and affecting supply chains all over the world. However, the IVD testing market is center stage for the fight against the Coronavirus. In vitro diagnostic (IVD) products continue to see positive sales growth in many categories, although several categories have experienced a temporary drop due to the uptick of COVID-19 testing. New products, changes in global health spending, regulatory changes in major markets and disease trends are among the factors that produce a constantly changing market picture. There are some growing segments in the market that have attracted industry attention. Among these are next-generation sequencing (NGS), cancer testing, and companion diagnostics technologies. Immunochemistry, point-of-care (POC) testing, and molecular diagnostics are also segments of great market interest, anticipated to be a big part of the future of IVD.

Several trends and factors will underlie growth including:

Steady population growth and aging, which will increase the number of individuals vulnerable to acute and chronic medical conditions.

• Evolving epidemiological patterns, which will keep major diseases such as cancer, diabetes, heart failure, hepatitis, HIV/AIDS, influenza, malaria, and tuberculosis major threats to human health.

• The expansion of healthcare cost containment initiatives, which will encourage medical providers to broaden the use of IVD
tests to detect serious diseases in early stages when treatment is less costly and more likely to succeed.

• The continuing widespread coverage of most developed world residents for basic and essential diagnostic procedures.

• Gradual improvements in the availability, accessibility, and diagnostic capabilities of developing world medical delivery systems.

• The periodic emergence of new infectious and viral disease threats, which will create a need for related IVD tests.

• Widening acceptance of routine health screening procedures in basic inpatient and outpatient care.

• Stepped up efforts by hospitals and other medical facilities to reduce the incidence and mortality of healthcare-associated infections (HAIs) and other inpatient complications.

• Advances in novel molecular and other advanced IVD technologies, which will increase disease detection capabilities.

• The adaptation of new and existing IVD procedures to point of care (POC) sites in hospitals, outpatient facilities, retail clinics, nursing homes, and other near patient markets.

• COVID-19 pandemic

IVD tests include well-established and newer, emerging technologies. Over the next several years, traditional tests based on clinical chemistry, immunoassays, hematology and conventional microbiology will account for the largest share of global procedural volume, or more than 83.3% of non-glucose tests in 2025. These older technologies will continue to build up patient volume based on low cost, broad applications, improving methods, and increasing availability in POC laboratories.

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/