Innovation is underway in how clinical chemistry connects through automation to other areas of clinical laboratories.
Biochemistry analyzers have come a long way during the last few decades, and the fast pace of technological development will fuel further technological enhancements. Technological advancements in the biochemistry market have created numerous opportunities for various new reagents, instruments, calibrators, and several other related clinical chemistry products. Constant developments in devices have resulted in enhancing the product portfolio of manufacturers as well as improving the efficacy of test results. Advancements in the expansion of testing menus and instrument capabilities, immunoassay instruments, and reagent adaptables to core laboratory workstations are also projected to contribute to the growth of the biochemistry market in coming years.
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.
Indian market dynamics
In 2018, the Indian biochemistry instruments and reagents market is estimated at Rs 1742 crore, with reagents continuing to dominate at Rs 1450 crore, at an 83.24 percent market share.
The floor-standing analyzers are estimated at Rs 85 crore and 1610 units; benchtop analyzers at Rs 82 crore and 1580 units; and semi-automated analyzers at R 125 crore and 15,100 units.
In 2018, the outbreak of dengue, jaundice, and malaria were controlled. The effect of demonetization had faded. The MNCs found it challenging to maintain their respective shares and the segment saw growth in the vicinity of 12 percent as against some of its counterpart segments in the diagnostics industry, which saw a 20–25 percent growth.
The size of the segment in 2018 has been calculated on assigning a monetary value to all the instruments installed, whether placed or sold. The ratio of sold to placed instruments depends on the strength of the brand, and the type and price points of instruments. Over the last couple of years, the traditional ratio of 40 percent sold to 60 percent procured has transitioned to 25 percent sold and 75 percent placed.
As Ayushman Bharat gets implemented over the next couple of years, given the limited funds available with the government, it is anticipated that the government will take a page from the private sector and push for the operating-lease model, similar to the likes of Lal Pathlabs and Metropolis. Numbers of tests conducted are expected to be huge, and with the sample transport model already established, testing shall be done at centralized units. This consolidation will hurt the equipment industry. This will certainly be a change from the high-end integrated systems procured by the government currently.
The global clinical chemistry analyzers market, valued at USD 9140 million in 2018, is expected to reach USD 13,700 million by the end of 2025, growing at a CAGR of 5.2 percent, estimates The Market Report. Over the recent years, global market has been witnessing growth on account of rapid growing diagnostics market, increase in healthcare expenditure, increase in lifestyle diseases like diabetes, cardiovascular diseases, growth in aging population, and increasing demand for laboratory automation. Moreover, rapidly increasing number of hospitals and diagnostics laboratories due to surging prevalence of chronic diseases, cancer, vector-borne diseases, and blood disorders have been driving the market growth. However, high cost of clinical analyzing, dearth of qualified and trained professionals, and risk of result uncertainty restrain the market growth.
Major players are spending huge capital in product innovations, product/service extensions, and mergers and acquisitions, in order to dominate in the industry. Key players operating in the global biochemistry analyzers market include ELITechGroup, F. Hoffmann-La Roche, Beckman Coulter, Thermo Fisher Scientific, Alfa Wassermann, Ortho-Clinical Diagnostics, Randox Laboratories, Meril, Hologic, Abbott, Danaher Corporation, Accurex Biomedical, Siemens, and Horiba Medical. In order to gain competitive advantage in the industry, these players are adopting various growth strategies, such as, collaborations, agreements, partnerships, and new product launches.
When it comes to the latest innovations in diagnostic tests, new technologies, such as mass spectrometry and next-generation sequencing, get a lot of attention. Traditional clinical chemistry assays? Not so much. Many of the assays in core chemistry laboratories are fundamentally the same as they have been for decades.
Efforts are underway to connect both mass spectrometry and molecular diagnostics instruments to clinical chemistry system. 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. Meanwhile, advances in information technology and data analysis are impacting every area of clinical laboratories, including clinical chemistry. Diagnostics companies have improved the IT components of their products, incorporating dashboards and access to real-time analytics. With these tools, clinical chemists can use data to improve laboratory performance. For example, they can monitor turnaround time for STAT tests with color codes and alerts. They can review patient medians for drifts or shifts that might indicate a calibration issue. Clinical chemistry labs also are using laboratory-generated data in a research context, looking for patterns that may be predictive of health conditions or that might guide decisions on reflexive testing or add-on tests.
When it comes to test menus for clinical chemistry and related areas, several new assays and new biomarkers are under the development process. Beyond new and improved assays, innovation is underway in how clinical chemistry connects through automation to other areas of clinical laboratories. This is the 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. In the meantime, clinical chemistry innovation will remain largely in the realms of developing new biomarkers, improving existing technologies, and connecting clinical chemistry with other areas of clinical laboratories.
Dr Anjali Tewari
Director – Lab Sciences,
Regency Hospital Ltd.
Automation in clinical chemistry
Clinical chemistry has attained a different height, assisted by the technological revolution, especially the automated environment. Replacement of manual procedures with automation minimizes errors, requires minimal technical involvement, increases productivity, decreases TAT, and in turn reduces manpower requirement.
Various options of auto-analyzers available are:
- Benchtop models are best suited for small-sized labs. Their efficiency and accuracy are better than semi-automated analyzers. These usually have an option of using reagents of all manufacturers (open).
- Stand-alone floor models are available in separate units for clinical pathology and immunoassay (EIA/CLIA). A better analytic speed and a large test menu, with both open and closed systems, makes them best suited for mid-size labs.
- Modular systems have an improved throughput to perform both clinical chemistry and immunoassays. Most of these are closed but manufacturers may provide one or two open-position for reagents in case of unavailability of specific parameters. This is the best fit for large labs. Most of these analyzers use liquid reagents, either received as ready-to-use or to be reconstituted. The reconstitution has to be done manually and requires expertise.
- Dry chemistry analyzer is another option with an advantage of more stable reagents, less carryover, and minimal reagent wastage. These reagents are expensive and throughput is not as good as floor models, putting these at a disadvantage.
- The above description is for the analytic-phase automation.
The Integrated systems available now take care of pre-analytic phase, mainly identification, sorting, centrifugation, and post-analytic processes as storage and archiving, hence providing a total laboratory automation solution.
Automation is not complete even with these analytics; another component is informatics, which includes middle ware to interface the analyzer software with laboratory information system (LIS) or hospital information system (HIS). This maps the demographic and clinical data with the analytical result and also avoids typographic errors.
Analytics in the laboratory is no more a manual job; it is an integration of robotics and chemicals interfacing with technology.