Clinical biochemistry is reaching a new level, differing from where it was a decade ago, due to the aggressive development of instrument speed and precision. In the realm of diagnostics, clinical chemistry has been at the forefront of the technological revolution to create an automated environment that enables fast, cost-efficient, and high-quality testing. The industry has changed with the introduction of an automated system that allows a number of critical routine chemistry tests to be performed using one consolidated unit. The initial system made it possible to complete these tests, commonly ordered as a STAT, in less than one minute using a single small sample. This technology became a foundation for the future of automated chemistry testing.
Current instruments consist of large multifunctional workstations capable of conducting multiple procedures simultaneously as well as smalleranalyzers dedicated to narrower, more specific applications. Advances in technology have also led to the incorporation of various immunoassay procedures on clinical chemistry workstations that can detect and measure analytes in the body by assessing antigen and antibody reactions in patient specimens. The new system’s chemistry and immunoassay integration allows simultaneous processing to provide fast and accurate results while offering a broad tests menu.
Today’s technologically advanced and sophisticated devices are highly accurate as well as time efficient. Currently, clinical chemistry analyzers are used for the analysis of several conditions such as diabetes, hyperlipidemia, and arteriosclerosis along with other regular health check-ups. Diabetes is one of the common non-communicable diseases (NCD) in India. Indian Council of Medical Research (ICMR) has informed that according to the International Diabetes Federation (IDF) Diabetes Atlas, 7th Edition, the prevalence of diabetes in India is 69.2 million in 2015 and is expected to further increase in the future. While health is a state subject, the Central Government supplements the efforts of State/UT governments to create awareness and provide healthcare facilities. Endocrinology is one of the major focus areas for newly set up AIIMS and many other institutions upgraded under Pradhan Mantri Swasthya Suraksha Yojna.
In 2017, the Indian biochemistry instruments and reagents market is estimated at `Rs. 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. Bench-top analyzers too 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 bench top analyzers.
2017 saw procurement for floor analyzers primarily for the government facilities. Consolidation is being done among the private chain of laboratories. Tests are being outsourced to referral labs by the smaller testing centers and an increase in the number of collection centers by the larger ones rather than investment in procurement of equipment. This is especially true of northern and western parts of the country.
Currently, except for a handful of domestic manufacturers, the lab reagents and equipment meant for conducting various diagnostic tests are currently 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, 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.
The global biochemistry instruments and reagents market is expected to grow at a CAGR of 6.02 percent during 2017–2021, predicts Research and Markets. Growing aged population, increasing healthcare expenditure, rising prevalence of lifestyle diseases, increasing use of point-of-care testing devices, and stringent regulatory policies for medical devices are some of the factors driving the market.
Increase in laboratory automation is the other major growth factor for this market. Laboratory automation results in greater improvement in productivity with safer working conditions, reduced operational cost, and reduction in labor force. Additionally, automation enables the effectiveness in the identification of samples, easy storage of data, less component consumption and sample volume, reduction, less occupied laboratory space, and reduction in turnaround time. However, one of the main factors hindering the growth of this market is limitation of a closed system that is specific to a reagent and performs better with specific consumables. Compatibility issues are observed when consumables and instruments from different companies are used in the same instruments.
Reagents and instruments utilize the latest formulations and technologies for quantitative determination of substrates, enzymes, and electrolytes in human serum, plasma, or urine. The reagents and kits market is expected to grow at the highest CAGR of the market in the coming years. Growth in this segment is driven by advancements, such as automation and high-throughput technologies in instruments.
Hospitals and diagnostic laboratories lead the revenue generation in the global market, where these products are required for disease diagnosis, treatment, treatment monitoring, disease surveillance, and clinical research. Factors such as the early diagnosis of diseases, allowing apt and swift intervention, thereby reducing the overall disease burden will contribute to the growth of this industry segment in the coming years.
According to Technavio, there are top three emerging trends that will drive the global market over the years.
Fully automated clinical chemistry analyzers. Clinical chemistry analyzers have been undergoing constant changes, with fully automated devices now available in the market. These analyzers can perform functions such as recognition of sample and reagent bottles, tube sampling, cap piercing, automatic re-run, and dilution. They not only save human time and effort but also require lesser volumes of sample and reagent.
Outsourcing from hospitals to reference laboratories. Value-based outsourcing is one of the major trends in the market, where the laboratory tests are outsourced to clinical reference laboratories. Small hospitals lacking basic infrastructure for clinical diagnosis have agreements with clinical laboratories. The hospitals outsource the patients to these labs for undergoing various diagnostic tests. In the past years, the market is moving from fee-for-service to value-based-care model to shift laboratory services to outsourcing diagnostic vendors. The shift from hospital outsourcing services to reference laboratories will be a major growth driver for the market.
Higher adoption rate of PoCT. Point-of-care testing (PoCT) is a popular trend in the clinical chemistry analyzers and in-vitro diagnostics markets since it provides faster results and supports patient-centered approaches to healthcare delivery. The sensory PoCT technology enables rapid analysis of blood samples, with devices designed to address the challenges faced in the diagnosis and treatment of cancer and stroke. The high cost of clinical diagnostic devices has triggered the adoption rate and increased the demand for PoCT devices.
Recent systems are built to deliver maximum productivity for laboratory 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, the 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 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.
Nobel Prize for Cryo-EM Technology
A trio of scientists Jacques Dubochet, Joachim Frank, and Richard Henderson shared the 2017 Nobel Prize for Chemistry 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.
A picture is key to understanding. Scientific breakthroughs often build upon the successful visualization of objects invisible to the human eye. However, biochemical maps have long been filled with blank spaces because the available technology has had difficulty generating images of much of life’s molecular machinery. Cryo-EM changes all of this. Researchers can now freeze biomolecules mid-movement and visualize processes they have never previously seen, which is decisive for both the basic understanding of life’s chemistry and for the development of pharmaceuticals.
The trio’s work and subsequent efforts have led to astonishing developments. The technology has opened up the molecular world of the cell to direct observation. Among the processes it has made clearer the mechanism by which DNA is copied into the single-stranded molecule RNA. 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-electron microscopy has moved biochemistry into a new era where it is now facing an explosive development and is all set for an exciting future.
Laboratory management in India is a super-specialized arena. The need of the hour is to make dedicated investments in terms of sophisticated analytical technologies, skilled human resources, instruments, and reagents; comply with stringent accreditation guidelines; and provide excellent customer service such as exhaustive test menu, along with short and accurate reporting times.
In order to overcome these challenges, the market is moving toward automated systems. Upgrading the laboratories to totally computerized fully automated systems has made a big difference in the bottom lines of many laboratories, by cutting down the cost of consumables and less requirement of qualified and trained technicians. These factors have prompted lab managers to go in for automation.
Customers are placing a lot of weightage on the quality of service backup they receive. The emphasis is on getting complete solutions from a single company.
High-end laboratories opt for automated integrated systems. Developments of software programs have also allowed the integration of various workflows of biochemistry analyzers for better control and operational efficiency.
One of the major factors driving the growth of the market is the advancement in technology. The increase in automation of biochemistry instruments is the key advancement in technology for high-throughput analyses of biochemical entities. High-throughput analyses consume less time and generate results quickly.
The use of automation in clinical labs has progressed significantly, from the first random-access analyzer to total lab automation (TLA). Laboratories now desire complete solutions from a single provider, like closed system reagents with calibrators and controls, and viable software.
Additionally, the fully automated analyzers market is moving toward testing consolidation, which is creating demand for integrated systems with expanded capabilities, thereby securing the future of next-generation laboratory analyzers. Given the trends being observed among biochemistry labs today, automation will play an even larger role in the future, going beyond operational effectiveness to also positively impact clinical effectiveness and ultimately help improve patient outcomes.