ARLINGTON, VA., The world market for diagnostics is estimated at $69.2 billion in 2019 and is expected to grow a little more than 4% annually to reach $85.2 billion by 2024. This is according to an upcoming report by market researcher Kalorama Information, part of Science and Medicine Group. This estimate includes all laboratory and hospital-based in vitro diagnostic tests instruments and reagents, and OTC product sales.
Kalorama Information released the 12th edition of its 2,000-page Worldwide Market for In Vitro Diagnostic Tests and has made a special offer available exclusively on its site.
Kalorama cited companion testing and demand for personalized medicine, demand for improved infectious disease testing, and sales to China and other nations as reasons for increasing sales. There are limits to growth however; such as the actions of developed-nation governments to reduce reimbursements and the severe drop in the glucose market recently due to cheaper meter competition. Consolidation of labs continues to be a market limiter as well. The market is also boosted by the aging world population and the stream of new test innovations – this is a field where double-digit percentages of sales invested back in R&D is not uncommon – and the market is offset by reimbursement cuts worldwide and slower buying in mature sectors. Mass spectrometry has arrived, the report said. Once an instrument in research it is now an essential part of microorganism identification, drug testing and other applications. For the second time, we include reporting on mass spectrometry clinical testing in the report. and it makes a contribution to the market and to growth.
The firm includes hundreds of firms in in its report but said that Roche, Abbott Diagnostics, Siemens Healthcare, Danaher, Thermo Fisher Scientiic, bioMerieux and Ortho Clinical Diagnostics are among top tier competitors.
Some other findings of the report:
- Roche leads, Abbott is 2nd. But no company, not even these large IVD companies, owns all the technology to compete in an increasingly complex world. Chapter 2 of the report lists over 60 recent mergers and acquisitions related to IVD. Significant recent deals. Last year Abbott brought POC leader Alere into its operations, completing an acquisition finalized in 2017. Recently, Meridian Biosciences purchased GenePOC.
- Major chemistry vendors are developing improved models selling their existing customers on staying with them – to preserve and expand revenue, as well as create barrier entry against other vendors in a shrinking lab environment. Footprint improvements, IT enhancements, EMR, automation and expanded menus are part of this change.
- Mass spectrometry has gone from a research tool to a significant category in the market, especially in developed markets, for the identification of bacteria, fungi and mycobacteria. The MALDI-TOF market has exploded in recent years in microbiology labs, thanks largely to the IVD regulatory approval of the VITEK MS and MALDI Biotyper. There are limitations, throughput and operator experience among them.|
- A clear majority of the market is outside the United States. All of the major IVD companies reported double-digit increases in their sales in China with growth in the other top emerging markets: Brazil, Turkey, Korea, India, Saudi Arabia and Mexico. Other emerging markets of interest for IVD vendors were Colombia, UAE, South Africa and the Eastern Europe region. These countries continue to invest in healthcare infrastructure and insurance coverage for a growing more affluent middle class.
- The market continues to grow, but what the dollars represent is changing. Twenty years ago, clinical chemistry and immunoassays were most of testing. Still today, the traditional core lab test segments – chemistry/immunoassay, hematology and coagulation – make up 34% of the dollar value of the IVD market in 2019, while they are over sixty percent of tests run. As molecular, infectious disease, and cancer tests increase in importance, the market share of these core tests will decrease to 29% in 2024.
- Sepsis is a growing problem and early detection is crucial for patients. Approximately 1.7 million individuals in the US develop sepsis each year and there is currently no gold standard for diagnosis in the clinical setting. Procalcitonin (PCT) and lactate are two established biomarkers for sepsis, but there are limitations. Several European studies have reported reduction in antibiotic usage with PCT-guided decision making, but a large multi-center US discussion did not show results. A novel marker, Human Neutrophil Lipocalin (HNL), a glycoprotein released from activated neutrophils during bacterial infections, has attracted some attention.