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 smaller analyzers 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.

Indian Market

 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.

Global Market

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.

Emerging Trends

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.

Technological Advancements

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.

Outlook

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.

Industry Speak

Technology Updating Determine the Future

 The Indian IVD Market has registered a prolific growth over the span of last 8–10 years. The revenues of India in-vitro diagnostics market have grown at a CAGR of 20 percent. Increasing automation, mounting health awareness, growing consolidations, higher penetration of insurance cover, rapid urbanization, increasing number of laboratories, and the overall improvement in the medical infrastructure are some of the major factors responsible for the growth showcased over the last 8–10 years.

Automation and robotics are increasingly freeing life scientists from the need to baby-sit their experiments leads to increased productivity and lower costs for laboratories and more creative time for individual researchers. New analyzers that deliver high throughput in lesser time and provide high efficacy. Similarly, Point- of-Care (PoC) testing has gained momentum in the past years as need for quick turnaround time and reliable results have accelerated. The fast access to results is particularly useful in critical situations when testing needs to be carried out frequent intervals.

Today the technology is evolved from hardware based approach to software based approach. 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, sample transport management, effective handling of samples and reagent while maintaining the accuracy in volume measurement.

Taking into consideration current and future trends is essential in maximizing the lifespan of any analyzer. As systems become more sophisticated, integration, convenience, and application specificity are key. The continuing emergence of new, clinically significant biomarkers, and technological advancements have a significant impact on such assay development. Biochemistry analyzer will also become faster and more efficient as technology and software is developed and enhanced.

BioSystems offers a broad, extensive portfolio of clinical diagnostics products to streamline the work flow, enhance operational efficiency and improve patient treatment. The various product line includes a wide range of reliable instruments and reagents for clinical chemistry, focused on R&D and invested in analytical systems innovation for clinical analysis laboratories, develops a new generation of semi-automatic and automatic analyzers based on LED (Light- Emitting Diode) technology, optimized for biochemistry ad turbidimetric assays, paving a new path for automated analyzer performance.

Chandramohan K
Product Manager,
BioSystems Diagnostics, India

 

Industry Speak

Clinical Chemistry Market Growing At a Steady Pace

 On market trends

Clinical chemistry testing is an integral part of laboratory analysis and often marks the first line of tests among a battery of examinations. The clinical chemistry market is growing at a steady pace of around 8–10 percent.

Laboratories are trying to differentiate themselves by offering specialized tests such as drug screenings, extended lipid profile, therapeutic drug monitoring and entering into quality accreditations like NABL. Emerging technological innovations in biosensors, lab-on-a-chip, and wearable devices are transforming the point-of-care diagnostic market.

On growth drivers

Increased health awareness and demand for preventive and therapeutic diagnosis are the key growth drivers from the consumers’ side. From the industry perspective, technological innovations and penetration of chain laboratories in Tier II, III, and IV cities and towns have contributed to the growth.

The government’s Public Private Partnership (PPP) is also boosting the growth of this segment by making available affordable tests.

On technology trends

This is the era of innovation for introduction of new tests. Additionally, the influx of integrated analyzers which combine chemistry and immunoassay testing on a single platform has provided laboratories with an opportunity to consolidate testing and streamline both regular and niche tests.

On buyers perspective

The need for high performance, cost-effectiveness in terms of reusable hard glass cuvettes and reduced disposable plastic usage, on-board cooling, less reagent consumption, integration to LIS, and minimum downtime with good service support are some of the factors that are considered for purchase.

Laboratories prefer a total solutions provider offering products and services beyond just chemistry and integrated systems. 

On future outlook

As systems become more sophisticated, integration, convenience, and application specificity have become critical factors. Analyzers now offer a growing number of automated features, to enable their users to achieve optimal productivity. A buyer can choose from a wide array of systems that offer everything from intelligent sample management and remote system diagnostics to advanced features.

Transasasia Bio-Medicals Ltd. is one of the India’s first diagnostic companies to manufacture and export state-of-the-art blood analyzers and reagents. It offers a complete product range of advanced semi and fully automated clinical chemistry analyzers and reagents, complete with a round the clock after-sales and service support.

Shreedhar Shanbhag
Product Manager- Biochemistry,
Transasia Bio-Medicals Ltd.

 

Industry Speak

Automation in Biochemistry is No More a Luxury

 

 Automation in biochemistry is no more a luxury; rather it has become an integral part of all laboratories, regardless of their size. However, the reasons for automation are different in different workload segments. In the smaller lab segment, aspiration to move from semi-automated system is a factor, coupled by desire to have more accurate result delivery system. In higher customer segment, improving the turnaround times (TAT) and workflow is more important. And in order to achieve that, integration of routine biochemistry with CLIA based immunoassay systems is major demand currently.

The challenges faced by today’s laboratories are multiple – high false positive ratio, the ongoing pressure for faster TAT, a sudden spike in the number of samples to be processed, and the list does not stop there.

Biochemistry manufacturer across the globe are working hard, to meet dynamic needs to all segments of users. In small workload set ups accuracy and precision are paramount reason of choice; at the same time cost effectiveness also play a big role in buying cycle. Committed to the Voice Of the Customer (VOC) approach, Mindray not only listens to all these pain points of lab technicians and delivers the right laboratory solution, but it stays one step ahead of their needs by adding extra value to the products and services it provides. The newly launched BS 240pro/BS 360E Series Auto Biochemistry Analyzers are proof of that. They come with not only intuitive software but also loads of new function in the segment, like reflex testing & on board hemolysate preparation for HbA1c.

As the economy is growing bigger labs are getting more and more samples. And major driver for the growth are preventive health checks and medical insurance. Hence in high workload labs, integration and wide menu of parameters, both in routine chemistry and immunoassay is in major factor in choosing the best suitable system.

Keeping in sync with market dynamics, Mindray also has high throughput system like BS 600/BS 800 and in Immunoassay we have CL 1000i/1200i and 2000I. Our Sal 6000/8000 system offer seamless integration of high biochemistry and Immunoassay.

Varun Kumar Sharma
Sr. Area Sales Manager North (IVD),
Mindray Medical India Pvt. Ltd.

 

Industry Speak

Biochemistry Instrument and Reagent’s New Trends

 

 Automation industry in clinical chemistry is growing faster in India. With advancement in technologies, the entry level automation segment is moving ahead with a faster pace. With advancement in the IT, most of the new generation systems are equipped with reagent and sample barcodes having HIS/LIS connectivity. By integrating the systems to the HIS/LIS interface, the analytical errors are reduced drastically.

One of the new trends is remote diagnosis where the hardware is connected to the cloud based server and is checked for errors periodically. This new initiative from the hardware manufacturers is one of the key reasons for the minimal down time. Integration is playing an important role in IVD and the manufacturers are moving towards integrated systems to give complete solution to the customers. Usage of smart card based technology is another trend in the industry. Now more systems are coming up with smart card based calibration/programming where the cost of calibration is eluded.

From conventional systems with turn around table for samples, new generation systems are coming up with rack sampling technology for ease of use. These systems allow the customer continuous loading of sample without any interruption of the process and thus helps to reduce the TAT of testing. Fluidics mechanisms and photometry modules are evolving to a new era with the ability to handle very low volume liquids. There is a huge reduction in the reagent volume requirement and now there are systems which can perform the tests with 80uL reagent, reducing the cost of testing drastically.

The advancements in the robotic mechanisms made it possible to have compact systems with higher throughput. Latex enhanced immunoturbidimetry based testing is becoming popular in the industry because of the specificity, sensitivity, and accuracy. These parameters are easily adaptable to the new generation clinical chemistry platforms and witnessed an exponential growth over the last three years. It is expected that more parameters are going to be introduced in the LEIT platform which can be performed in the clinical chemistry systems to make the diagnosis easy and affordable.

Sanjaymon KR
General Manager - Business Development,
Agappe

Industry Speak

Accurate Diagnosis – A Key to Health

 

 Malaria is a mosquito borne disease transmitted by the infected anopheline mosquitoes. Malaria is a life-threatening disease caused by parasites known as Plasmodium (P) falciparum, P. vivax, P. malariae, and P. ovale.

Malaria is a global challenge that is responsible for substantial morbidity, mortality, and economic loss to the society. In India malaria is more prevalent in Odisha, Meghalaya, Mizoram, Maharashtra, Rajasthan, Gujarat, Karnataka, Goa, Southern Madhya Pradesh, Chhattisgarh, and Jharkhand.

Early and accurate diagnosis of malaria is very instrumental in reducing morbidity and mortality. Malaria is diagnosed using different techniques for example, conventional microscopy, QBC method, and rapid diagnostic tests (RDT). Over a period of time RDT has been developed and established as one of the most commonly used laboratory diagnostic method for malaria diagnosis. This is based on the principles of detection of antigen released from parasitized RBCs. The result is a colored test line obtained in 5–20 minutes. RDTs incorporate antibodies against Histidine rich protien2 (HRP2) specific for P. falciparum, Plasmosium specific LDH (pLDH) for all malaria species. Several studies are available to compare sensitivity and specificity of malaria RDTs.

Alere is one of the global leaders in PoCT tests for different infectious diseases. Alere is one of the largest providers of wide range of malaria RDT kits for early and accurate diagnosis.

Along with a good quality product with proven performance history, it is very important to follow recommended guidelines for diagnosis of malaria.

Shobhit Jain
Marketing Manager, Infectious Diseases,
Alere


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