examines global trends in the volume of IVD procedures conducted in clinical laboratories and at point-of-care sites. Aging population trends and a rising level of diseases and disorders will boost the volume of patient testing conducted in most countries. The adaptation of molecular and other advanced life science technologies to new and improved reagents and instruments will broaden IVD capabilities in detecting medical conditions. Medical providers throughout the world will rely increasingly on point-of-care (POC) and clinical laboratory tests to identify patient health problems in early stages and prescribe appropriate therapies.
The global in vitro diagnostic (IVD) industry includes approximately 500 participants, ranging in size from small, narrowly focused firms to large diversified multinational companies. Since IVD products serve healthcare applications, producers are subject to strict government regulations and serve highly price-sensitive markets. Overall success in the industry requires an effective balancing of research and development, productivity, manufacturing efficiencies, effective marketing and distribution, and responsive customer service. In general, the competitive structure of the global IVD industry is relatively concentrated at the top tier.
Ten large, multinational corporations, controlled almost 70 percent of the global market in 2016. Except for Alere which specializes in products for point-of-care (POC) markets, all of other industry leaders -- Roche, Abbott Laboratories, Siemens, Danaher, Thermo Fisher Scientific, Becton Dickinson, Sysmex, Ortho Clinical Diagnostics, and bioMerieux -- compete in multiple product segments and achieved their strong competitive positions by supplementing internal research and development activities with acquisitions and external collaborative agreements.
Because it is not possible in a report of this scope to include all market participants, the following profiles include the top producers and companies with extensive global IVD operations. These manufacturers profiled accounted for total world IVD product sales of almost $45 billion in 2014 and their products and systems are utilized in about three-fourths of all global IVD and clinical lab procedures. In addition to the top producers, profiles of selected clinical laboratory service companies are also presented in this report.
The selection of IVD procedures by medical providers depends on a number of factors. Among the key influences are the nature of the healthcare activity involved, the presence or absence of obvious patient symptoms, patient characteristics and history, and, increasingly, cost and third-party reimbursement eligibility. Based on broad detection capabilities, core laboratories generate the largest share of global IVD procedure volume, or 62 percent in 2016. These establishments apply clinical chemistry and immunoassays to the high throughput analysis of blood samples. Both techniques are able to detect or measure several target markers simultaneously. As a result, a single clinical chemistry or immunoassay test can involve multiple IVD procedures.
Increasing applications in the testing of hospital patients, patients undergoing physical examinations and periodic healthcare checkups, and patients suspected of ingesting toxic substances will boost the volume of core laboratory procedures implemented worldwide. However, growth in this activity will slow from historical levels as many countries see shorter hospital stays and tighter health insurance restrictions on outpatient testing. Moreover, increasing competition from point-of-care (POC), molecular, and histology/cytology diagnostics will eliminate the need for some core laboratory tests.
IVD Market Growth
Growth estimates in the IVD market range from 3 to 4%, but this number depends on the segment covered. Some segments will grow at half the rate, others at double or triple average. Most areas of the IVD market are competitive. New companies enter the IVD market on a consistent basis, and IVD market revenue growth exceeds device or average pharmaceutical markets.It is difficult to keep up with fast moving trends in the in vitro diagnostic market space, thus Kalorama Information has several reports addressing the IVD market. This report focuses on procedure volumes.
Through 2021, the fastest global growth in IVD procedure volume will emerge in molecular assays followed by histology/cytology processes, and non-glucose POC tests. Reflecting further advances in amplification technologies and the discovery of new genetic and protein markers, molecular assays will expand applications in cancer and infectious disease detection and characterization, transplant matching, donated blood screening, and pharmacodiagnostics. The increasing use of in situ hybridization in the diagnosis, analysis, and monitoring of hematopoietic neoplasms and solid tumors, along with the widening adaptation of immunohistochemistry techniques to the identification of cancerous cell- and tissue-based antigens, will underlie fast-paced growth in the combined worldwide volume of histology and cytology procedures. The continuing diversification of hospital ambulatory and emergency departments, outpatient clinics, and physicians’ offices into onsite patient testing will promote strong growth in the number of non-glucose POC procedures conducted on lower volume, desktop immunoassay systems.
Demand patterns and growth prospects for IVD procedures will vary widely by country and region. The fastest growth in volume will occur in developing countries that leverage increasing economic prosperity to achieve significant improvements in medical delivery systems and resident healthcare accessibility. By contrast, the impoverished nations of Africa, Asia, and Central and South America, are not expected to achieve a significant upgrading of diagnostic testing capabilities in the near term and will remain dependent on philanthropic organizations to detect and control epidemic threats such as HIV, Ebola, and Zika.
Due to maturing markets, the volume of IVD procedures implemented in the developed world will increase more slowly than the average pace of the developing economies. Moreover, in most developed countries, the strengthening of healthcare cost containment initiatives and price controls will result in tighter restrictions being imposed on patient services. This trend will increase pressure on medical providers to avoid prescribing or implementing unnecessary tests, which, in turn, will hold down growth in the volume of IVD procedures.
In spite of tighter cost containment measures and slower overall growth in the volume of IVD procedures, the developed countries will provide the best revenue opportunities for high value-added esoteric patient tests. By enabling the earlier detection and more definitive diagnosis of complex diseases and disorders, these tests hold significant potential to improve the quality and reduce the overall cost of patient care. Accordingly, they are expected to build up applications in the U.S. and other developed countries pursuing value-based healthcare strategies.
IVD Testing Venues
The performance of global IVD procedures is divided among hospitals, independent clinical laboratories, physicians’ offices, and other medical establishments. Through onsite clinical and satellite laboratories, hospitals account for the largest share of volume, or approximately 60 percent in 2016. Generally, these laboratories conduct routine IVD testing on samples extracted from institutionalized patients and patients who are treated by institutional ambulatory departments.
Independent clinical laboratories perform approximately one-third of the worldwide volume of IVD tests. These establishments dominate the implementation of esoteric procedures outsourced from hospitals. They also provide routine IVD testing for physicians’ offices, outpatient facilities, and various ancillary medical providers. An estimated 20,000 independent clinical laboratories are in operation globally.
Laboratories operated by physicians’ offices and other medical establishments conduct the remaining seven percent of the volume of world IVD procedures. This segment primarily performs POC tests for detecting or monitoring disease markers, such as glucose, electrolytes, infectious agents, and cardiac-related parameters. Physicians’ offices make up approximately half of the estimated 500,000 other IVD laboratories operating worldwide. The remaining half is divided among a broad assortment of medical concerns, including ambulatory surgery centers, community clinics, home healthcare agencies, nursing homes, and paramedic organizations.
Global Market Environment
The global volume of IVD procedures will rise with aging demographic patterns, an increasing incidence of acute medical conditions, an increasing prevalence of chronic health problems, and changing patient care approaches emphasizing disease prevention and early detection. Other factors contributing to growth will include the widening availability of medical providers, ongoing improvements in medical delivery systems, an expanding volume of patient activity, and heightened attention on reducing the incidence of healthcare-associated infections (HAI) in hospitals and other healthcare facilities. Technological advances will exert a mixed impact on the level of IVD procedures conducted worldwide. The development of new and upgraded detection capabilities, especially in the areas of molecular assays and cellular analysis, will broaden the availability of high value-added esoteric tests. Conversely, advances in automation and reagent sensitivity will reduce the number of procedures required to obtain definitive diagnostic results for many diseases and disorders.