Forming new connections

Beyond new and improved assays, innovation is underway in how clinical chemistry connects through automation to other areas of clinical laboratories.

Several major changes in the clinical chemistry market have been brought about as a result of the convergence of system automation, engineering, and IT technology. Technological advancements in the clinical chemistry market have created numerous opportunities for various new reagents, instruments, calibrators, and several other related clinical chemistry products.Constant developments in clinical chemistry devices have resulted in enhancing the product portfolio of manufacturers as well as improving the efficacy of test results. Advancements in the expansion of clinical chemistry testing menus and instrument capabilities, immunoassay instruments and reagent adaptable to core laboratory workstations is also projected to contribute to the growth of the clinical chemistry market in coming years.

In the present scenario, healthcare settings, majorly hospitals are significantly inclined toward owning fully-automated clinical chemistry systems that have built-in quality-assurance capabilities. These clinical chemistry systems possess the ability to process a larger number of samples at a time.

These fully-automated clinical chemistry systems are capable of performing functions such as tube sampling, the recognition of a sample and reagent bottles, cap piercing, dilution, and automatic re-run.

There is also an increase in the number of government initiatives that aim at promoting better healthcare diagnostic facilities to provide quicker results, which has further contributed to the shift toward these automated devices. This shift is one of the major factors contributing to the growth of clinical chemistry market.

Point-of-care (PoC) testing is important for the rapid detection of the analytes close to the patient for better diagnosis, management, and monitoring. It enables the detection of diseases at an early stage. A wide range of PoC assays for the quantitative determination of biomarkers is being developed with the use of easy-to-use and portable PoC biochemical and clinical analyzers.

The role of laboratory-based physicians or clinical pathologists is consistently being challenged on various fronts, like, increasing the patient autonomy exercised for direct testing, exponential advancements in clinical chemistry technology, and the usage of non-medical specialists as substitutes.

Clinical chemistry is typically the largest volume category of a laboratory and is expected to remain so in the future. While novel menu launches in clinical chemistry may not be developing at the same pace as heterogeneous immunoassay, molecular, or next-generation sequencing, companies continue to invest material research and development funds into product line enhancements, such as more scalable and automated solutions, enhanced connectivity with other platforms, and improved [information technology] offerings.

When it comes to test menus for clinical chemistry and related areas, several new assays and new biomarkers are in development.

Certainly, there are new tests that are always innovating in terms of the core laboratory. New biomarkers may soon be available for diagnosing and monitoring traumatic brain injury, and encouraging research is emerging for tests for Alzheimer’s disease.

Beyond new and improved assays, innovation is underway in how clinical chemistry connects through automation to other areas of clinical laboratories. This is a continuation of a trend that has been happening over the past few decades, as core laboratories have grown to encompass disciplines spanning chemistry, immunoassay, hematology, and hemostasis, among other categories. Going forward, more novel technologies once reserved for specialized settings, such as molecular/virology, may increasingly migrate into the core laboratory.

Efforts are underway to connect both mass spectrometry and molecular diagnostics instruments to clinical chemistry systems. If mass spectrometry could be connected to chemistry and immunoassay analyzers on the same platform, drugs of abuse testing could be done in real time, with samples moving directly from immunoassay screening to confirmatory testing. Likewise, if molecular diagnostics instruments were to connect to core laboratories, chemistry and immunoassay testing could be combined for diagnosing and monitoring infectious diseases, with follow-up molecular confirmation using the same sample on the same track. The risk of contamination for molecular diagnostics tests has been a barrier in the past, but companies are coming up with new ways to manage this risk.

Psychological dependence on automation
There has been a long debate regarding human psychological dependence on automation. Basically, replacement of manual activities with automation has some major consequences, i.e. locus-of-control in the staff, rapid deterioration of skills and inefficient resuming of manual functioning when automation should fail. These last two aspects are especially important in clinical laboratories, as the transfer of technical skills to the operational environment would then make it challenging, both technically and psychologically, to resume manual abilities. It may even seem paradoxical but replacing many manual activities with automation would make the staff feel like being sent into the middle of nowhere when facing automation failures.

The human response to automation failure was shown to often be dramatic, and this might be attributable to – at least – two major causes. The first, is the almost irreversible loss of confidence in manual skills, whilst the second, even more challenging, is the lack of manual power (consequent to staff reduction) needed for resuming all those activities that have been conveyed to automation (sorting, centrifugation, decapping, aliquoting or recapping, sample loading, and unloading). This challenge is magnified for young or new staff, who may have little experience with manual laboratory work, thus paralyzing the laboratory, being unable to provide data to the clinicians and ultimately jeopardizing patients’ health. There is no easy way to come out of this situation other than by implementing an expensive back-up system, as previously discussed, or delivering samples to another neighboring laboratory.

Additional staff-related problems can then be highlighted, including anxiety, uncertainty, and even resistance to the changes. Hence, the laboratory management should be engaged in emphasizing the exciting aspects of the changes, highlighting the many possible favorable consequences and opportunities that may be generated by the new organization.

Considerations for purchasing a clinical chemistry analyzer
When choosing a clinical analyzer, research the instrument’s throughput capability (which can reach up to 10,000 combined ISE and colorimetric tests per hour), testing speed, and test menu to be sure it is a good fit for your laboratory. Will a STAT mode or random-access capability be required? Is batch, random, or continuous analysis preferred? Consider if additional testing will be offered by the lab in the future to ensure the system offers the required capabilities. Remember that a higher-end instrument that uses less expensive reagents may prove to be more cost-effective over its lifetime. Additional factors include sample handling, the unit’s footprint, and its ability to work with micro volumes, a valuable parameter in neonatal units. Laboratories handling thousands of tests per hour will require bar-code handling and data management software.

Generation of potential bottlenecks
The optimal management of stat testing is a critical issue in laboratories using TLA. The larger the volume of routine testing, the higher the risk of creating bottlenecks, which may then reduce system productivity and TAT. This circumstance may be especially concerning for stat testing, with the risk that urgent patient samples will wait for long before being centrifuged and analyzed. This would actually impose a detailed analysis of workflows within the system, with the development of rules and criteria enabling stat samples to by-pass routine specimens. On the other hand, priority criteria will need to be accurately balanced, thus avoiding that routine samples will be subjected to interminable delays within a fully-integrated system prioritizing stat testing. In this scenario, the flexibility of the automation system is foremost, as it would enable the laboratory to introduce changes (i.e. external centrifugation, manual loading of stat samples) even once the system has already been implemented.

Risk of transition toward a manufacturer’s-driven laboratory
A highly automated clinical laboratory strongly depends on efficient software programs and constructive partnership with manufacturers. The establishment of a strategic relationship with suppliers is thus essential for achieving the goal of an efficient TLA. Importantly, the manufacturers of some laboratory automation systems can integrate analyzers from many different companies, whilst this option is still under development for other companies. This implies that tenders should be more accurately defined according to the expected laboratory layout. Full commitment to a single vendor may be an additional risk, as this may pave the way to a manufacturer’s-driven laboratory. Hence, this may substantially limit, or even avert, laboratory professionals from organizing and managing their own laboratories.

Global market
The global clinical chemistry analyzers market size is projected to reach USD 15.2 billion by 2026 from USD 12.3 billion in 2021, at a CAGR of 4.3 percent, estimates MarketsandMarkets. The reagents segment accounted for the largest share of the market in 2020. The recurrent requirement of reagents in large numbers compared to analyzers is the major factor driving this segments growth. Based on test type, the lipid profile tests segment accounted for the highest growth rate in 2020. This can be attributed to the rapid growth in obesity rates and the increasing incidence of obesity-related diseases.

The growing prevalence of chronic diseases is anticipated to be responsible for the high urgency to adopt clinical chemistry analyzers, which thereby widens the scope for growth during 2021–2026. In addition, growing base of geriatric and bariatric population, which is highly susceptible to chronic diseases, is presumed to impel the demand further. Consequently, the resultant high sample volume requiring high capability analyzing devices is driving the market growth.

Moreover, increasing awareness pertaining to benefits associated with these devices is also a high impact rendering driver for clinical chemistry analyzers market. Advent of advanced chemistry analyzers has resulted in improved point-of-care testing capabilities, and thus created high potential growth opportunities for the market.

In addition, technological advancements in pre-analytical, analytical, and post analytical stages due to analyzing devices and reagents improved their diagnostic capabilities and overall efficiency, which is predicted to propel the growth further. These advancements include advent of microchips, sensors, chemometrics, and robotics. For instance, in February 2020, Ortho Clinical Diagnostics launched a clinical chemistry system that completed its integrated Vitros XT line which is designed to cover most typical lab tests. The company estimated its maximum throughput at 755 tests per hour with single-test slides and 1130 tests per hour with dual-test slides. Moreover, the company’s XT 3400 system received CE marking and is available in the US, Canada, Europe, India, Japan, and a few countries in the Middle East and Africa.

Furthermore, consistent efforts by public as well private healthcare organizations to increase the reliability of data have rapidly engendered the integration of automated chemistry analyzers and immunoassay systems, thereby resulting in overall reduction of workload in laboratories, thus propelling the demand.

In 2020, North America accounted for the largest share of the market. The large share of this region can be attributed to the increasing geriatric population, increasing prevalence of chronic and lifestyle conditions, implementation of favorable government initiatives, increasing healthcare expenditure, improved healthcare infrastructure, and the availability of technologically advanced instruments.

The major players operating in this market are HORIBA Ltd., Thermo Fisher Scientific, Trivitron Healthcare Pvt. Ltd., F. Hoffmann-La Roche Ltd., Danaher Corporation, Abbott Laboratories, Siemens AG, Sysmex Corporation, Hitachi, EKF Diagnostics, Ortho Clinical Diagnostics, ELITech Group, Mindray Medical International Ltd., Biobase Group, SFRI Medical Diagnostics, Randox Laboratories Ltd., Medica Corporation, Meril Life Sciences Pvt. Ltd., Erba Mannheim, Genrui Biotech Inc., Dirui Industrial Co. Ltd., Teco Diagnostics, Balio Diagnostics, Snibe Co. Ltd., and AMS Alliance.

Clinical chemistry analyzers shall continue to show promise
Advances in clinical chemistry analyzers will be concurrent with the development of new assays, further improving patient care. Manufacturers are customizing analyzers for use in smaller laboratories, use in very high volume situations such as in a large hospital, or in the field. As software capabilities continue to develop, clinical chemistry analyzers will be able to offer increased testing speed and degree of automation.