Highly advanced software are available for robotic operations with high throughput and to support various automated operations like auto dilution, auto-rerun with dilution, reflex testing, and sample transport management.
Science has enabled an increasingly rich understanding of the human body and the diseases and disorders to which it is subjected – and of biomarkers that offer objective evidence of those diseases and disorders. For clinical biochemistry, that means that new and novel assays for use in the diagnosis and management of various disease states are being constantly discovered and developed. As highly specialized assays continue to become a part of the standard of care, analyzer designs have also kept pace with the accompanying workload demands. The clinical biochemistry analyzer can now be found in a wide variety of venues, from physicians’ offices and other point-of-care (PoC) settings to commercial, research, and high-throughput hospital laboratories.
The modern biochemistry laboratories have evolved rapidly since the 1990s, driven mainly by technological advances that focus on automation. 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. New analyzers deliver high throughput in lesser time and provide high efficacy. Similarly, PoC testing has gained momentum in the past years as the need for quick turnaround time and reliable results has accelerated.
Today technology is evolving from a hardware-based approach to a software-based approach. Highly advanced software are available for robotic operations with high throughput and support various automated operations like auto dilution, auto-rerun with dilution, reflex testing, sample transport management, and effective handling of samples and reagents, while maintaining the accuracy in volume measurement. The advent of computer- or microprocessor-based technology and software programming ushered biochemistry laboratories into a new era for diagnostic testing enabling laboratories to operate with greater efficiency than ever before. Computers and microprocessor technology have also 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.
The growth of global biochemistry analyzers market is majorly driven by increasing adoption of automation in laboratories for quicker and reliable results, increasing healthcare expenditure, and increasing need for immediate diagnosis of various diseases. Various other factors responsible for the market growth include development of technologically advanced analyzers as well as low cost of analyzers. However, calibration difference among different instruments resulting in varied test results and requirement of high capital investments are expected to hinder the growth of the market to a certain extent. On the other hand, marginal distribution of these analyzers in the emerging economies can provide significant opportunities to investors and manufacturers in terms of monetary benefits and geographic network expansion.
Indian market dynamics
In 2017, the Indian biochemistry instruments and reagents market is estimated at `1540 crore, with reagents continuing to dominate at an 81 percent market share. The Indian market is steadily shifting to reagents sold for open systems; however, system pack reagents continue to hold sway on the market with a 41 percent market share. In the analyzer segment, the market is moving toward fully automated (FA) analyzers, which constituted 53 percent of the market in value terms. In volume terms, the semi-automated (SA) segment had an 88 percent share in 2017.
The large labs are moving toward modular systems, so that the same instrument can be used for biochemistry and immunochemistry, and major upgrading is taking place from standalone systems to modular ones. As soon as the labs need to conduct more than 300 tests per day, they upgrade to floor models. Benchtop analyzers are seeing traction. These analyzers have been developed without compromising on efficiency and accuracy of the system. Many smaller labs in smaller towns are moving from manual tests to automation, and replacing their equipment with benchtop analyzers.
The year 2017 saw procurement for floor analyzers primarily for government facilities. Consolidation is being done among the private chain of laboratories. Currently, except for a handful of domestic manufacturers, the lab reagents and equipment meant for conducting various diagnostic tests are imported. Under the Make in India initiative, Agappe has partnered with Hitachi Chemical Company Ltd. through technology licensing for manufacturing their most advanced fully automatic specific protein and clinical chemistry analyzers in India. This initiative, once it becomes functional, would also mark the beginning of clinical laboratories all over India embracing the automation mode, thereby enhancing the quality of tests and accuracy of results.
Affordable pricing would help rural penetration with medium and smaller labs also entering the platform of advanced testing. The instrument provides ease of operation and fast and highly specific results at a reduced cost estimated at roughly one-third of the cost per test compared to the conventional method analyzers. The aim is to provide everyone across the nation the right result at the right time for proper diagnosis and avail treatment on time.
In an effort to reduce the price burden for people who spend a hefty amount of money on medical tests, 45 diagnostic laboratories in Bangalore city have come under one umbrella. This massive collaboration will reduce the price of many diagnostics tests by 40 percent on an average. The Association of Diagnostic Centers – Bengaluru has till now published a list of 26 tests comparing the current test prices with the reduced prices. However, in this city, only 50 of the 1000 odd laboratories possess high-end equipment. Currently, there is no mechanism in place to check prices that laboratories charge and this new initiative may be able to bridge the gap in the prices that are prevalent in different laboratories.
Recent systems are built to deliver maximum productivity for laboratories enabling them to thrive in today’s environment. Plus, the systems are designed to minimize workflow interruptions and maximize user-friendliness, and deliver a faster, reliable turnaround time.
Positive identification with shorter turnaround time. Manufacturers are developing biochemistry analyzers with multiplexing capabilities. Such type of analyzers possess the feature of positive identification that reduces the process of repeated pathogen testing. This becomes a critical feature in cases of samples that have low volume such as neonatal units. This type of system with shorter turnaround time gives advantages of high clarity and result accuracy. The feature of positive identification helps acquire accurate results in shorter run time by avoiding the inclusion of too many targets. On the other hand, besides pathogen testing, biochemistry analyzers are used for drug monitoring, drug abuse detection, and many more applications. Due to such technological advancements in the field of professional diagnostics, the applications of biochemistry analyzers that were initially restricted to the detection of infectious diseases are now finding use in other areas as well. As a result of this technological evolution, diagnostics tests are now witnessing a boost in demand.
Analyzers with low volume reagent consumption. Initially, biochemistry analyzers were used for repetitive analysis that consumed a lot of reagents. This has now changed and due to the replacement by discrete working systems, low volume reagents are now being used. The new instruments are able to automate repetitive sample analysis steps that would have otherwise been done manually by a lab technician. Moreover, as a result of the convergence of system engineering, automation, and IT technology, a significant change has been brought in the biochemistry analyzers market. The use of ELISAs (enzyme-linked immunosorbent assays) for clinical testing within a laboratory is time consuming and demands more personnel and resources. However, moving from ELISA technique to an automated biochemistry method increases time and personnel efficiency considerably, and this leads to cost-effectiveness as well.
Cryo-EM technology. A trio of scientists, Jacques Dubochet, Joachim Frank, and Richard Henderson, shared the 2017 Nobel Prize for Chemistry for their work on the cryo-electron microscopy (cryo-EM) technique that has allowed scientists to study biological molecules in unprecedented sharpness, not least the Zika virus and proteins thought to be involved in Alzheimer’s disease. The technology has opened up the molecular world of the cell to direct observation. The future is also exciting, with scientists using the technique to probe the structure of drug targets, as well as components within cells involved in sensing pain, temperature, and pressure. Further improvements in resolution are also afoot. According to the Nobel Committee for Chemistry, the cryo-EM has moved biochemistry into a new era where it is now facing an explosive development and is all set for an exciting future.
Computers, microprocessors, and robotics have 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 produce thousands of tests per hour with sophisticated information management systems. 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. 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. Taking into consideration current and future trends is essential in maximizing the lifespan of any analyzer. The continuing emergence of new, clinically significant biomarkers and technological advancements has a significant impact on such assay development. Biochemistry analyzers will thus become faster and more efficient as technology and software is developed and enhanced.