Molecular Diagnostics could be said to be the most important part of in vitro diagnostics.  This is especially true in the wake of COVID-19.  Kalorama Information has, for many years, estimated the size of and forecasted the growth of the worldwide market for these important in vitro diagnostic tests in all major segments, and does so in this edition as a pandemic has reached developed markets including the United States.

2020 was set to be a year of growth and innovations in molecular diagnostics under any circumstances. New products, higher growth than other in vitro diagnostic categories, continued acceptance of next-generation sequencing methods were driving. Liquid biopsy technologies and the increased use of predictive genetic tests were and still are areas of anticipated revenue growth. The sudden onset of SARS-CoV-2 and the resulting disease COVID-19 put the world’s focus on DNA-based testing in an unexpected way.

The Size of the Molecular Diagnostic Test Market

As it was MDx segment has been fastest growing segment within the global IVD market. The global market was estimated to be $8,760 million in 2019. Including  COVID-19 tests, Kalorama Information now projects that market to be $13.4 billion dollars. A multi-year forecast including COVID-19 cannot be made with accuracy given the unknowns of the virus threat, outside of COVID-19, other  test segments are expected to grow to 9,025 in 2025. Major segments that are expected to drive the growth are infectious diseases, cancer, and transplant diagnostics. A detailed analysis of each of these application segments is presented in the respective segment.

Infectious Disease Assays Drive Growth

Infectious disease testing segments are driven by the COVID-19 crisis (not only detection tests but related rule-out respiratory tests and HAIs). The demand will come from advanced markets such as North America and Europe, while blood screening, histology and inherited diseases testing are driven by additions to blood test protocols and emerging markets.

COVID-19 Impact

Kalorama estimates a 4.4 billion dollar market for COVID-19 testing by year’s end. Unique near-patient tests, sample collection methods such as saliva or self-test, NGS and mass spectrometry testing, multiple PCR test targets, improved antibody tests, high throughputs, extraction kit workarounds – these are all examples of areas that innovators can improve. The worldwide demand for COVID tests has materialized rapidly from zero and is on course to become a multi-billion dollar market in 2020.

Will this market continue into future years? Assuming, as estimated in our analysis, cancer tests are able to be completed in a surge of ‘make-up’ healthcare visits and procedures later in the year and into 2021 it presages a strong momentum for growth. It’s worthwhile noting that DNA-based testing technologies already represent nearly a 10 billion-dollar market without COVID-19. While it’s possible COVID-19 tests will be panelized and added to larger menus and may not have the emergency system sales of 2020, its influence should last in other ways. It already has boosted the respiratory and healthcare infection testing market segments.

For More Information: Kalorama Information’s Latest Market Research Study

For more information, Kalorama Information’s report on the worldwide  MDx market, Molecular Diagnostics Markets in the COVID-19 Era is available:

This report provides 2020 market sizing and expected growth to 2025 for the following segments:

• COVID-19 Molecular IVD Test Market (Full Year 2020 Projected and Market 2H 2020)
  • COVID-19 Molecular IVD Test Market North America
  • COVID-19 Molecular IVD Test Market Europe
  • COVID-19 Molecular IVD Test Market Asia Pacific
  • COVID-19 Molecular IVD Test Market Rest of World
• Infectious Disease Markets, including:
  • Hepatitis
  • HIV
  • Respiratory
  • HAIs and Sepsis Tests
  • TB
  • Sexually Transmitted Diseases
• NAT Blood Testing
• Molecular Histology
• Molecular Cancer Testing
• Molecular Transplantation Testing
• Inherited Disease Testing
  • NIPT
  • Inherited
  • Thrombophilia
  • Pharmacogenomics

There has also been a huge influx of product introductions from small, obscure companies. These have mostly targeted the low end of the price range and often had poor performance, while a small number of high-end automated systems are mostly limited to certain segments of the market, such as independent reference laboratories and centralized hospital laboratories. Low-quality products from fly-by-night companies are the predictable result of the shortages and the relatively basic resources needed to produce mediocre antibody test kits with a low level of quality control. A few major companies are seeing the most test runs, particularly in the United States.

COVID-19 testing has also been a bit of a double-edged sword for labs generally, for in vitro diagnostics and for molecular tests. Boosting volumes in infectious disease have been notably paired with drops due to social distancing measures and hospital surgical postponements. What is the result? Kalorama Information’s report helps to sort out the array of news and reports about the current state of molecular diagnostics, reasonable global estimates for COVID, and the impact of COVID-19 on the rest of molecular testing.

Kalorama covers the global markets. For All Markets, Kalorama Information provides the following:

• Impacts of COVID-19 on Market Segments
• Regional Market Distribution
• Profiles of Top Companies
• Major Companies with COVID-19 Tests
• Other Companies with COVID-19 Tests
• HIV Products on the Market
• Transplantation Products on the Market
• The Increasing Role of Next-Generation Sequencing
• Trends – Lab Automation and Molecular Diagnostics
• Trends – CRISPR
• Trends – Artificial Intelligence
• Company Profiles

Kalorama Information has monitored 2020 secondary sources, trade publications, medical journals, government websites and policy documents, as well as financial statements from vendors to assess the market impact of COVID-19. In addition, Kalorama has been tracking lab volumes with a survey since mid-April, and Kalorama’s U.S. MasterFile product was used to keep track of instrument trends.

Companies Profiled in the Report Include

• Abbott Diagnostics
• Agena Bioscience
• Agendia BV
• ARUP Laboratories
• Asuragen
• Advanced Cell Diagnostics
• Agilent
• Amoy Diagnostics
• Applied Spectral Imaging
• Becton, Dickinson & Co.
• Biocartis
• BGI
• Berry Genomics
• BioMerieux
• Bio-Rad
• Care DX
• Danaher
  • Cepheid
  • Beckman Coulter
  • Leica Biosystems
• Eiken Chemical
• Fluidigm
• GenMark
• Genotypic Technology PVT
• Greiner Bio-One GMBH
• Grifols
• Hologic
• Illumina
• Immucor
• Meridian
• Molbio
• Myriad Genetics
• Nanostring
• Neogenomics
• NeuromoDX
• Perkin Elmer
• Oxford Nanopore
• Promega
• Prescient Medicine
• Qiagen
• Quidel
• Roche
• Thermo
• Vela
• Veracyte