Global demand for clinical chemistry products is projected to increase 2.8 percent annually to $18 billion in 2018, according to Kalorama Information’s estimates. The most current estimates and forecasts can be found in its Global IVD Market Report.
Clinical chemistry procedures measure levels of naturally produced and externally consumed compounds (i.e., therapeutic and illicit drugs and toxicants) in the body to detect potential diseases and other medical conditions, assess general health status, and monitor therapies. Commonly tested compounds include carbohydrates, electrolytes, enzymes, lipids, minerals, and proteins, as well as therapeutic medicines. A related field, toxicology, involves the detection and analysis of toxic substances in the body, including poisons and drugs-of-abuse.
Advances in technology have led to the incorporation of various immunoassay procedures on clinical chemistry workstations. Immunoassay tests detect and measure analytes in the body by assessing antigen and antibody reactions in patient specimens.
These procedures can be used to identify any medical condition that triggers an in vivo immune response, including cancer, cardiovascular damage, drug abuse, infectious and viral diseases, infertility, pregnancy, and thyroid disorders. Immunoassay tests are also employed widely in therapeutic drug monitoring to evaluate the effectiveness of medicines against various tumors and pathogenic microorganisms. Compared to clinical chemistry, immunoassays techniques provide more disease-specific and definitive results.
Based on the advanced nature of medical delivery systems and the widespread health insurance coverage of residents, the major developed economies (United States, Canada, the West European countries, Australia, and Japan) combined will account for almost 60 percent of this total. However, demand in the developing countries as a whole will advance faster as medical delivery systems are expanded and upgraded and the availability and accessibility of basic patient testing services improves.
Of the three major groups of clinical chemistry products, reagents, supporting consumables, and instruments used in general chemistry, blood gas and electrolyte measurement, and urinalysis procedures will command the largest share of global revenues over the long term, reaching $8.9 billion in 2021. Applications in regular patient physical examinations and pre- and post-hospital admission testing will account for the majority of demand. On the downside, this product group will generate below average sales growth due to the commodity, price-sensitive nature of most reagents and the maturing of instrument markets in major countries.
Spurred by advances in instrument capabilities and the expansion of testing menus, immunoassay reagents and instruments adaptable to core laboratory workstations will post the fastest sales growth among clinical chemistry-related products. Total global demand recorded by this product group is projected to increase 3.9 percent annually to nearly $7.4 billion in 2021. Rising applications in the diagnosis of cancer, heart disorders, infectious and viral diseases, infertility, and various other medical conditions will underlie gains.
The third group of clinical chemistry products consists reagents, supporting materials, and instruments indicated for professional point-of-care testing. This product group is forecast to post global demand of nearly $3.5 billion in 2021, up 2.5 percent annually from 2016. Growth will reflect the ongoing expansion of onsite IVD capabilities in physicians’ offices, clinics, pharmacies, and hospital departments. Tighter controls imposed by health insurance plans on patient testing benefits will moderate faster gains. Moreover, POC applications served by clinical chemistry products will remain relatively limited due to advances in dedicated immunoassays and other more definitive IVD technologies.
Based on purchasing frequency and number of products in use, reagents and supporting consumables will continue to account for more than 80 percent of global clinical chemistry product demand over the long term. Nonetheless, instruments will retain a sizable share of segment sales as improved performance and cost-saving advantages encourage laboratories to replace older equipment with new advanced systems, especially in the area of combination clinical chemistry/immunoassay workstations.
The global clinical chemistry market is led by large, multinational players, including Abbott Laboratories, Beckman Coulter (Danaher), Hitachi, Instrumentation Laboratory, Ortho-Clinical Diagnostics, Roche Diagnostics, and Siemens Healthineers. These competitors have access to vast operating resources and have sold thousands of instrument systems to hospitals, independent clinical laboratories, and point-of-care facilities. The top producers of clinical chemistry systems are seeking to maintain their leading positions through the development of integrated systems and by dominating the supply of complementary reagents and consumables. All of the leading producers, for example, have introduced equipment modules that add immunoassay capabilities to core clinical chemistry workstations. Most of them also compete actively in POC markets, especially in the supply of professional testing products.