Laboratory automation is set to alter the fate of the clinical chemistry analyser market
Innovative clinical diagnostics tests and technologies are the foundation for evidence-based medicine, allowing for early intervention that improves patients’ health outcomes, often lowering costs for the broader health system. It was during the first decades of the century that blood and urine were first measured using quantitative analysis and instrumentation, and the results applied to human disease and health. What might be called the golden age of clinical chemistry began during the years after World War II. Between 1948 and 1960, such products as radioimmunoassay and the auto analyzer were introduced.
Several years later, the advent of computer- or microprocessor-based technology and software programming ushered in a new era for diagnostic testing—one that would eventually lead to automated environments that would enable laboratories to perform fast, high-quality testing, and gain workflow efficiencies. Mid-decade, a number of technological advancements were introduced; these included instruments dedicated to a single or dual test menu, such as the flame photometer, and the chloride/CO2 and glucose analyzers.
In the succeeding decades, the industry has witnessed a fast-evolving series of technological advancements in clinical chemistry instrumentation. With each new system generation, novel features have been introduced – such as closed tube sampling, automated maintenance processes, streamlined calibration, and internet-based remote diagnostics – all of which are intended to help laboratories better meet the needs of physicians and patients, while creating efficiencies, driving quality, lowering costs, and addressing fluctuations in the workforce.
The global clinical chemistry market is expected to reach USD 10 billion in terms of value by the end of 2026, with an average year-on-year growth rate pegged at 5 percent through 2026, estimates Persistence Market Research. The increasing prevalence of lifestyle-related diseases, such as obesity and cardiovascular diseases, has immensely contributed to the growth of the clinical chemistry market. The increase in laboratory automation is also expected to be one of the most important factors leading to the growth of the clinical chemistry market.
Clinical chemistry is one of the most explored and reliable branches of clinical diagnostics and pathology. Conventional clinical chemistry analysis involves use of various substrates and enzymes or catalysts to detect and quantify the presence of analytes in a given sample based on principles of colorimetry involving light absorption and refraction phenomenon of specific substance at specific wavelength. It includes use of wet reagents, large set-ups, and requires large volume of samples. Dry chemistry analysis, on the other hand, is based on the reflectance measurement of specific substance at specific wavelength and its comparative study with the standards.
Dry chemistry analyzers comprise highly sensitive multilayered reagent coated slides instead of wet reagents. It requires only 10 ml to 50 ml of sample. The results of dry chemistry analyzers are comparable to conventional wet chemistry analyzers. However, results differ for certain parameters among dry and conventional chemistry analyzers. Dry chemistry analyzers are compact and easy to operate, as these do not require storage space for reagents, there is no need for pipetting of reagents, these are semi to fully automatic, and require small volume of sample. These factors have contributed to high adoption of dry chemistry analyzers in acute care settings, physician offices, etc. Dry chemistry analyzers such as blood glucose analyzers, blood cholesterol analyzers, and blood electrolyte analyzers have been widely used across the globe. There are large number of dry chemistry analyzer manufacturers in the market. Major concern among the users is high cost of test cartridges or slides compared to conventional chemistry analyzer reagents. Moreover, most of the analyzers work on closed system principle, with compatibility with own reagent slides or cartridges.
The US has high adoption of technically advanced diagnostic devices and preference for point-of-care testing devices. These factors have led to high uptake of dry chemistry analyzers in the US. Europe is projected to account for the second largest share of the this market owing to well-established healthcare infrastructure and demand for preventive and quality healthcare. Large population, high unmet needs, and increase in healthcare expenditure are anticipated to contribute to the growth of the dry chemistry analyzers market in Asia-Pacific over the next 6 years.
A large number of suppliers of dry chemistry analyzers compete in the market in terms of extension of test parameters, lowering of test cost, and efficacy of analyzers. Key players include Fujifilm Corporation, Ortho Clinical Diagnostics, Arkray, Diatest GmbH, Acon Laboratories, Inc., MedTest, Abbott, F. Hoffmann-La Roche Ltd., SD Biosensor, and Kontrolab.
Developments in automation
Improvements in analyzer design and performance continue to be driven by a number of factors: technological breakthroughs, enhanced manufacturing practices, the integration of software into the lab environment, and medical discovery. In addition, changes in the reimbursement landscape and user needs have spurred the development of systems that feature flexibility and performance that far surpass their predecessors.
Clinical chemistry automation is a relatively new field in the combination of chemistry and medicine. The discipline was once documented as pathological chemistry or chemical pathology with the dedicated purpose of the analysis of bodily fluids for diagnostic and therapeutic purposes. It was not until the early 1900’s that the American Association for Clinical Chemistry (AACC) and the International Federation for Clinical Chemistry (IFCC) introduced the term clinical chemistry, which today has become one of the most accepted terms in IVDs.
Clinical chemistry structures a discipline combined of chemistry, immunochemistry, biochemistry, endocrinology, toxicology, engineering, and informatics with the sole purpose of providing the support to clinicians to improve the diagnosis and treatment of patients across a wide variety of diagnostic disciplines. Over the last few decades there has been a significant decrease in the number of analytical errors in clinical laboratories much to the fact that laboratories are required to meet very high standards. The technological developments and scientific innovations in the field of clinical chemistry from the early 1950s to date have been vast, enhancing laboratory capabilities, and providing the necessary support to clinicians and laboratories to improve patient diagnosis and treatment.
Today presents a new world of automation—a complex integration of robotics, liquid handling, and numerous other technologies with the fundamental purpose of saving time and improving performance through the elimination of human error and reduced risk of cross-contamination. Today, laboratories operate with greater efficiency than ever before. Processes that were, in the past, performed manually, now are performed via instrumentation. Full automation of pre-analytical, analytical, and post-analytical tasks enables laboratories to perform more work using less labor and fewer resources. Similarly, computers and microprocessor technology have enabled the creation of smaller-footprint units that accommodate higher test volumes. Today’s consolidated systems typically perform hundreds of tests on one platform, whereas preceding systems required a number of dedicated instruments, each performing only a few selected tests.
With today’s clinical advancements, current technologies include a vast variety of colorimetry/ spectrophotometry, nephelometry, turbidimetry, photometry, ion specific electrodes testing (ISE), and a range of chromatographic and ligand assay methodologies such as chemiluminescence techniques.
An example of today’s advancements in technology and science can be identified with ELISA based techniques, which are notoriously inefficient and are particularly draining on time and personnel due to the manual intervention required. The manual nature of the method also means there is greater potential for human error, ultimately resulting in lack of sensitivity and potential for cross-reactivity.
In today’s laboratory, the transitions from traditional ELISA techniques to an automated method for the detection of the same analyte will significantly improve both cost and time. However, despite the abundant advancements in automation, many clinical laboratories continue to utilize manual methods such as ELISA for some specialized chemistries. The move to laboratory automation is still a premise of development, particularly in developing countries where the use of manual techniques is still in use and the availability of resources and high-quality diagnostics are reduced due to detrimental socio-economic factors.
Based on meeting the specific needs of the clinical chemistry laboratory, significant innovations involve manufacturers focusing heavily on developments on the introduction of multichannel systems, non-selective batch analyzers, and continuous flow analysis. The rise in continuous flow analysis enticed the movements in production and research on the use of discrete analysis with cuvettes and automatic mixing and pipetting of both samples and reagent, ultimately reducing the workflow of clinicians and increasing the accuracy, precision, and reliability of patient results. It was not until the 1980s, that truly sparked the move to laboratory automation where the introduction of simultaneous detection of multiple analytes at different wavelengths came into play, ultimately bestowing a new era for in vitro diagnostics.
In the early 1950s, to accompany laboratory automation and scientific innovation, ready-to-use reagent kits with instructions for use introduced a very significant innovation to the field of automation, eliminating the process of manually preparing reagent. Scientific research and development over the past few decades have increased laboratory testing capabilities and allow for laboratories to significantly reduce time and cost consolidating routine and specialized tests onto one single platform.
An example of how this has advanced clinical chemistry testing is the two main methods for the detection of proteins in patient samples: nephelometry and immunoturbidimetry. Nephelometry, although traditionally thought to be more sensitive, can be expensive due to higher consumable costs. In addition, nephelometers can be inefficient and are limited by their test menu. Immunoturbidimetry presents labs with the added advantage of consolidating a variety of chemistries on one system lowering laboratory costs as nephelometry requires the use of dedicated equipment and are much slower and require highly trained personnel.
Choosing a chemistry analyzer
Choosing a chemical analyzer will depend on the types of tests the laboratory wishes to run and the throughput required. Many other factors include: sample handling, degree of automation, footprint, operational costs, turnaround time (TAT), STAT capabilities, service dependency, and whether the analyzer can handle micro volume samples.
While choosing the right instrument is important to ensuring successful laboratory operations, it is only part of the equation. Laboratories today are looking for knowledgeable partners to help them apply proven continuous improvement strategies—borrowed from the manufacturing industry—to healthcare. A partner who is able to offer a total laboratory solution beyond instrumentation placement can help the laboratory to achieve its patient care and operational efficiency goals. This includes supporting the use of the instruments, identifying opportunities for automation, detecting workflow gaps, and helping to create efficiencies in managing resources.
Clinical chemistry has evolved greatly over time, driven by numerous factors—not the least being technological advancements in the world at large. Computers, microprocessors, and robotics paved the way for automation and cloud-based technology. With this, laboratories no longer consist of small standalone, manually operated units that performed a handful of tests; instead, they have transformed into bustling hubs featuring large integrated platforms that produced thousands of tests per hour with sophisticated information management systems. Future growth will build on this foundation, providing more capabilities in smaller-sized units. Instrumentation alone is only part of the equation. A strategic partnership can optimize laboratory performance, strengthening system advantages by integrating them into a total lab solution.
Chemistry analyzers have come a long way during the last few decades, and the fast pace of technological development will fuel further technological enhancements. The drivers that affect development today will catalyze change in the future, accompanied by new, as yet unforeseen, drivers. It is anticipated that growth will be most robust in the areas of automation and software. Manufacturers will work to meet the laboratory’s need to manage increasing workloads with decreasing resources, simplifying labor-intensive tasks that are still performed manually today. Areas targeted for higher levels of automation will include instrument maintenance, system troubleshooting, and consumables management.
Software development initiatives will target workflow inefficiencies and results processing. Cloud-based systems and integrated networks will enable patient histories to be recorded and recalled, regardless of where testing is performed.
In addition to this, designers will continue the trend of downsizing units to reduce footprint, allowing more testing capabilities with smaller-sized machines. This will help laboratories save valuable space while still meeting the demands of physicians and patients. This will also pave the way for new technology in the area of point-of-care devices, reducing, for example, the need for large sample volumes.