In 2022, testing for SARS-CoV-2 is expected to add almost $33 billion to the in vitro diagnostic (IVD) market, according to Kalorama Information, which recently published the 15th edition of “The Worldwide Market for In Vitro Diagnostic Tests.” Thereafter, SARS-CoV-2 testing is projected to decline about 6% per year to about $23 billion in 2027.
“The SARS-CoV-2 virus has shown that it can adapt, and there are enough variants that it has staying power. At this point, it’s endemic,” said Bruce Carlson, senior vice president of Kalorama, which is published by the Science and Medicine Group. “We do think that COVID testing will decline, but it won’t go away. COVID testing still will be a significant dollar contributor to the market.”
Donna Hochberg, PhD, a partner with Health Advances, a healthcare consulting firm in Newton, Massachusetts, agrees. “We are out of the pandemic phase, so there is less surveillance, but COVID testing is still pretty high volume, especially over-the-counter antigen testing.”
Hochberg predicts that the SARS-CoV-2 testing market, combined with testing for influenza, will end up being two to three times the traditional flu testing market. Mini-panels, which include testing for SARS-CoV-2, flu, and respiratory syncytial virus (RSV), will help drive growth in this market.
“Patients have a lower threshold for what drives them to get tested now,” she said. “Before COVID, if you had a cold, you wouldn’t get tested or you wouldn’t go to the doctor, but now people are more likely to get tested for any cold- or flu-like illness.”
GLOBAL IVD MARKET TO REACH $127.4 BILLION AS CONSOLIDATION CONTINUES
Overall, the worldwide IVD market is projected to reach $127.4 billion by the end of this year, with $94.8 billion originating from non-SARS-CoV-2 tests and $32.6 billion from SARS-CoV-2 tests, according to Kalorama. By 2027, the market is expected to top $140 billion. Not surprisingly, cancer testing is among one of the fastest growing segments, with in situ hybridization, molecular cancer markers, immunohistochemistry, and HPV molecular testing among the strongest growth areas.
Molecular diagnostics (MDx) is continuing its upward trajectory, said Hochberg, who notes laboratories that adopted platforms for SARS-CoV-2 PCR testing can now use those platforms for other types of molecular testing. She predicts that non-SARS-CoV-2 MDx will grow by the mid to high single digits annually over the next few years.
COVID-19 reinforced rather than broke the consolidation trend in IVD companies, noted Carlson.
“The pandemic brought a host of new, smaller companies—yet larger companies had the distribution and production capacity, as well as credibility with labs,” he said.
In 2022, the top IVD companies account for about $101 billion of IVD product sales, compared to $97 billion in 2021 and $47 billion in 2016. This represents an approximately 13.7% increase in top-tier revenues for 2016−2022.
For the first time, Abbott Diagnostics now leads the IVD market, according to Kalorama. In the last edition of the report, the top position was tied between Roche and Abbott. The reason, said Carlson, is Abbott’s position in point-of-care testing (POCT) from its Alere acquisition, the pandemic, and glucose test sales.
Other growth areas include drugs of abuse, immunoassays, cardiac markers, fecal occult blood, HbA1c POCT, tests for inherited diseases, and molecular testing for organ transplants.
Mass spectrometry, which can offer higher accuracy than immunoassays, continues to be an important part of the market—and not just for microbiology. Kalorama estimates that mass spectrometry will have a compound annual growth rate (CAGR) of 14% over the next 5 years and exceed a billion dollars by 2027. Drivers in this area include HbA1c testing, vitamin D testing, and companion diagnostics.
Automation also is helping drive growth in mass spectrometry, said Hochberg, who notes that Thermo Fisher Scientific’s Cascadion analyzer gives labs more ability to perform testing. “There are a lot of benefits to mass spectrometry, such as specificity and multiplexing, that will override some of the technical challenges, particularly when you have automation in place,” she said.
Hochberg sees mass spectrometry being used to test difficult-to-measure analytes, such as estradiol, which is a complex molecule not measured well by immunoassay, and in therapeutic drug monitoring.
The continuous glucose monitoring (CGM) market also is experiencing rapid growth, with a CAGR of 6.6% between 2021 and 2027, according to Research and Markets, a research firm based in Dublin. The spike in the senior population and the increasing prevalence of diabetes have been essential factors driving the CGM market’s expansion, said the company.
Currently, more than 537 million adults worldwide are living with diabetes, and this number is projected to balloon more than 37% to 783 million people by 2045. In the U.S. alone, diabetes is the most common chronic condition, with more than 133 million people living with diabetes or prediabetes. The CGM market is highly competitive, with only a few companies competing. Abbott, Roche, Tandem Diabetes Care, Dexcom, and Senseonics are among the biggest players.
WHAT TO WATCH:10-YEAR IVD TRENDS
Over the next decade, Kalorama is predicts a number of trends that will shape the IVD market, from increased participation by non-U.S. countries to increased collaboration between companies and evolution of sampling methods.
Among the trends discussed in the report:
Regions of market influence. Korea and China are slated for higher overall growth in IVD. The Chinese market for IVDs is estimated at nearly $6.6 billion and is expected to show annual growth of 3.8% to reach $7.9 billion in 2027. Glucose monitoring is a major focus area for the Chinese IVD market, representing roughly 25% of the market’s value. South Korea, which in 2020 initiated a fast-track procedure for international patients with severe illness, has shown tremendous growth in medical tourism. The IVD market in South Korea is considered favorable for its regulatory process and foreign investment opportunities. Kalorama estimates the IVD market in Korea to be $545 million in 2022 with 5.8% annual growth, reaching nearly $721 million by 2027.
Collaboration, acquisitions. The future of the industry lies in the development of more sensitive, faster, user-friendly, information technology-capable devices for a host of new protein and molecular markers. No company owns all the technology needed to develop these new tests and systems, said Carlson. Thus, many companies are acquiring other IVD manufacturers to shore up their research and development. For example, in February 2022, BD, looking to broaden its flow cytometry segment for hematologic cancer and blood diseases, acquired Cytognos. In April 2022, bioMérieux acquired Specific Diagnostics to add to its critical infection sepsis line, and in June 2022, Fujirebio acquired ADx NeuroSciences and Qiagen acquired Blirt for additional growth in reagents.
New sample methods. Tests using blood, nasal fluid, and tissue dominate the IVD market, but the search for easier-to-collect samples continues. The pandemic and the need for rapid, reliable testing has heightened interest in saliva as a convenient medium for infectious diseases. Recent studies have shown that saliva is just as effective as a nasopharyngeal swab for traditional SARS-CoV-2 PCR tests and useful in at-home rapid antigen tests. The Food and Drug Administration has issued more than 30 emergency use authorizations for saliva-based SARS-CoV-2 tests. Saliva is also increasingly being used to diagnose diseases affecting the mouth, esophagus, stomach, large and small intestines, kidney, and liver.
Hochberg noted that there is also work being done in using breath and capillary blood for diagnostic testing. Patient-focused testing services, such as Everlywell, Everly Health, and LetsGetChecked, are driving the market for finger-prick sample collection.
“Patient-focused testing services want to make sample collection as easy as possible,” she said. “Point-of-care testing is also pushing sample collection in that direction.”
As the global population ages and new testing methods are developed, the worldwide IVD market will continue to grow. But which areas will grow the fastest will depend on a number of key factors, including potential future pandemics, lifestyle trends that might have an impact on chronic diseases, and consumer demand.
A consumer-oriented “democratization” of testing is sure to play a key role in growth of in vitro diagnostics, Hochberg said, especially as consumers have become more knowledgeable about testing during the COVID-19 pandemic. Automation also will help to drive growth in the IVD market.
“The pandemic really exacerbated the labor shortage in labs, which has made automation even more important,” she said. “With more automation comes the ability to perform more tests, which will lead to an increase in development of new assays. Automation is a big growth driver.”
Kimberly Scott is a freelance writer who lives in Lewes, Delaware. +Email: [email protected]