Biochemistry analyzers continue to evolve

The evolution of automation in clinical biochemistry laboratories is unparalleled. No longer is it simply being used to assist the laboratory technologist in test performance, it now includes processing and transport of specimens, loading of  specimens into automated analyzers, assessment of the results of the tests performed,  and storage of specimens.

Clinical biochemistry testing is an integral part of laboratory analysis and often marks the first line of tests among a battery of examinations. The clinical biochemistry laboratory is generally with the largest volume of samples and different tests to be carried out. Therefore, this sector proves extremely important, regarding both financial matters, and quality and safety of the presented diagnosis, seen that the reported results are essential to indicate a patient’s state, helping medical decision-making, and therapeutic conduct. Considering the relevance of the obtained results, it is increasingly necessary to have timely and good-quality analysis performed and released in the laboratory reports. Continuously improved processes must be the main focus of any organization, as those initiatives ultimately aim at offering better products or services to their clients, fully meeting their needs and thus preserving and, if possible, improving the level of competitiveness of the enterprise in the market. In the field of medicine, more than trying to satisfy clients’ desires, one tries unceasingly to optimize processes, aiming at minimizing risks to patients’ lives. This attitude is materialized in the provision of consistent and reliable diagnostic information in the exact moments they are more necessary. Technological advances in the area of laboratory biochemistry allowed the evolution of several types of analysis equipment that conduct tests with diverse methods, being able to analyze a great deal of samples in a short period of time.

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. The advent of computer- or microprocessor-based technology and software programming ushered in a new era for diagnostic testing—one that eventually led to automated environments enabling clinical biochemistry laboratories to perform fast, high-quality testing, and gain workflow efficiencies. A number of technological advancements have been introduced so far, including instruments dedicated to a single or dual test menu, such as the flame photometer, and the chloride/CO2 and glucose analyzers. 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. Emerging technological innovations in biosensors, lab-on-a-chip, and wearable devices are transforming the point-of-care (PoC) diagnostic market. As systems are becoming 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.

The biochemistry sector is one of the fastest moving sectors in Indian IVD industry. Currently, the biochemistry auto-analyzers are the backbone of major diagnostic chains in the country. Biochemistry analyzers are used in all types of laboratories, from small PoC to high-throughput clinical labs, to test for analytes such as proteins, enzymes, and electrolytes. Benchtop analyzers are the most common type, but compact bedside models, usually with fewer test options, and high-throughput floor-based units are also available. The biochemistry market in India is dominated by few major multinational companies. Manufacturers are developing analyzers with low volume reagent consumption. The new instruments are able to automate repetitive sample analysis steps that would have otherwise been done manually. Manufacturers are customizing analyzers for use in smaller laboratories, use in very high volume situations such as in a large hospital, or in the field. As software capabilities continue to develop, clinical biochemistry analyzers will be able to offer increased testing speed and degree of automation. Moreover, as a result of the convergence of system engineering, automation, and IT technology, a significant change has been brought in the market. Advances in clinical biochemistry analyzers will be concurrent with the development of new assays, further improving patient care. The need of the hour is to validate multiple biomarkers in the field of cancer diagnostics in order to bring the molecular testing in the ambit of biochemistry analyzers.

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 Rs 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. Number of tests conducted is 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.

Major Vendors in Indian Fully Automatic Biochemistry Instruments Market – 2018*
Tier I	Tier II	Tier III	Others
Transasia	Roche and Siemens	Beckman, Abbott, Mindray, OCD, and CPC	Trivitron, Sysmex, Tulip, BioSystems, and Accurex (Dirui)
*Vendors are placed in different tiers on the basis of contribution of estimated value of total instruments installed-sold and placed to the overall revenues of the Indian fully automatic biochemistry instruments market.

Indian Semi-Automatic Biochemistry Instruments Market – 2018*
Tier I	Tier II	Others
Transasia	Mindray, Robonik, and CPC	Agappe, Accurex, Tulip, Microlab, Beacon, regional brands in North and West India
*Vendors are placed in different tiers on the basis of their sales contribution to the overall revenues of the Indian semi-automatic biochemistry instruments market.

Major Vendors in Indian Biochemistry Reagents Market – 2018*
Tier I	Tier II	Tier III
Transasia, Roche, Siemens, OCD, and Abbott	Randox, Accurex, Agappe, DiaSys, and CPC	BioSystems, Fuji, and local brands
*Vendors are placed in different tiers on the basis of their sales contribution to the overall revenues of the Indian biochemistry reagents market.
ADI Media Research

Vendor update
Roche showcases how labs are driving change across health networks at AACC 2018. Roche has launched the cobas c 513 analyzer at the American Association for Clinical Chemistry (AACC) Clinical Lab Expo held from July 29 to August 2, 2018 by showcasing how laboratories are driving change at integrated health networks by optimizing both lab operations and clinical decision-making processes. The cobas c 513 analyzer is a fully automated chemistry platform that raises the standard in HbA1c testing throughput. Today’s laboratories are faced with tremendous pressure to increase productivity and reduce costs, while striving to achieve accurate and reliable results to help improve patient outcomes and quality of care. Choosing the right partner to help overcome these challenges is vital to a lab’s success. No matter the size of the lab, or lab network, Roche offers a solution to ensure the clinical chemistry needs are met. Enabling the personalization and standardization of lab’s processes, Roche cobas c 513 analyzer helps to achieve consistent results quickly. In addition, the company provides an extensive and expanding test menu so the laboratories can help provide patients with the results they need, now and in the future.

Beckman Coulter launches DxC 700 AU to help streamline laboratory workflow with a 30 percent reduction of test-processing steps. Beckman Coulter in October 2018 launched its new DxC 700 AU chemistry analyzer that brings together the advanced capabilities of two successful Beckman Coulter products-the simple intuitive design of the DxC analyzer and the robust throughput, workhorse capabilities and proven uptime of the AU analyzer-into one standardized platform designed to meet the needs of mid- to high-volume clinical laboratories. The DxC 700 AU chemistry analyzer reduces the number of test-processing steps by 30 percent, streamlining workflow for laboratory professionals. The reduction in steps is the result of powerful operating software, an all-new design, and an intuitive user-interface that allow operators to spend less time on daily tasks and more time producing the quality results that empower better decision-making for better patient care. Along with its efficiency, the DxC 700 AU analyzer reduces total cost of ownership by using longer lasting and fewer consumables compared to other industry same-class systems. The system is further designed for time- and cost-savings superior uptime through the unique Beckman Coulter 3&60 concept that gives laboratory staff the ability to change out replacement parts in three steps, within 60 seconds, with no tools.

Global market
The global biochemistry analyzers market size was valued at USD 3.3 billion in 2018 and is expected to witness a robust CAGR of 5.4 percent from 2019–2026, according to Coherent Market Insight. Biochemistry analyzers market is expected to gain significant traction due to increasing usage of biochemistry analyzers in laboratories for diagnosis of increasing infectious diseases and rising prevalence of lifestyle diseases, such as, diabetes and cardiovascular disorders. According to the International Diabetes Federation, more than 10 percent of the world’s adult population or around 642 million people will have diabetes by 2040; such high prevalence is projected to be a key driver of the market. Furthermore, growth in aging population is boosting the market as elderly people are generally prone to infectious diseases and other disorders. High preference for automated analyzers among medical professionals and healthcare initiatives from government is further augmenting the growth of the global market.

PoC testing is a major trend in the biochemistry analyzers and in vitro diagnostics markets, as it supports patient-centered approaches and provides faster results. PoC testing enables rapid analysis of blood samples, with devices designed to address the challenges faced in the treatment and diagnosis of various chronic diseases. Moreover, the high cost of clinical diagnostic devices has increased the demand and adoption rate of PoC testing devices. The specimens can be studied using a unique barcode number when automated biochemistry analyzers are used. The results obtained can be automatically viewed in the laboratory information system. The systems provide good quality results and avoid pre and post analytical errors, thereby generating accurate results. It generates quicker reports, which helps in better disease management and patient outcomes, especially in critical cases. In vitro diagnostic manufacturers are developing analyzers with new capabilities and feature sets, including greater use of automation, increases from low- or medium-volume to high-volume devices, and upgraded technology to offer a wider array of tests and provide faster and more accurate results.

Manufacturers are developing biochemistry analyzers with multiplexing analyzers that include the feature of positive identification, which reduces the process of repeated pathogen testing. The industry is highly competitive in nature due to the presence of various local and international manufacturers. 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.

Development of technologically advanced analyzers
The evolution of automation in clinical biochemistry laboratories has paralleled that in the manufacturing industry, progressing from fixed automation, whereby an instrument performs a repetitive task by itself, to programmable automation, which allows the instrument to perform a variety of different tasks. Intelligent automation also has been introduced into some individual instruments to allow them to self-monitor and respond appropriately to changing conditions. The improved reproducibility gained by automation has led to a significant improvement in the quality of laboratory tests. Many small laboratories now have consolidated into larger, more efficient entities in response to market trends involving cost reduction. The drive to automate these mega-laboratories has led to new avenues in laboratory automation. No longer is automation simply being used to assist the laboratory technologist in test performance, it now includes processing and  transport  of  specimens,  loading of  specimens into automated analyzers, assessment of the results of the tests performed,  and  storage  of  specimens.

Fully automated biochemistry analyzers can perform functions such as recognition of sample and reagent bottles, cap piercing, tube sampling, dilution, and automatic re-run, which reduces human effort and time, and require lesser volumes of reagent and sample. These analyzers aid scientists in measuring the concentration of any substance in a reaction mixture. Therefore, the implementation of automation in the analyzers is expected to contribute to reduced turnaround time (TAT) and increased throughput. Conventional biochemistry analyzers that are used for repetitive analysis require large amounts of reagents and time. However, technologically advanced analyzers are now capable of automating the process of repetitive sample analysis that were earlier done by lab technicians. Industry players are developing analyzers with feature of positive identification that decreases the process of repeated pathogen testing. This feature is important for samples with low volume such as neonatal units. Furthermore, integrated systems that combine immunochemistry and biochemistry tests are gaining huge attention as they increase the workflow efficiency by delivering fast TAT and high throughput. They also help in achieving increased instrument capacity by connecting different analyzer units with a single sample presentation mechanism.

Clinical biochemistry laboratories are under pressure to produce faster results and manage resources more efficiently. Increasing number of samples to be analyzed is increasing the demand for faster analytical methods that are capable of providing better information for decision-making. The need for automated analyzers for environmental and industrial samples has increased the research for new and cost-effective strategies of automation and control of analytical systems. The widespread availability of open-source hardware along with novel analytical methods have opened the possibility of implementing standalone automated analytical systems at low cost. 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. Evolutions in software have opened pathways for automation, which heightens consistency and reduces operator error, and for fast and accurate analysis, predictive analytics, and data interpretation, which help to ensure the highest quality of results. The advancement in the software also allows easy operation and interfaces of the instruments to various connecting devices like mobile/personal computers that allow minimum human interference and records the results as it is so that there will be very less chance of manipulating the obtained results, thus increasing the test/report quality.

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. 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 toward 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.

For conventional systems with turnaround 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. Latex enhanced immunoturbidimetry based testing (LEIT) is becoming popular in the industry because of its 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.

Road ahead
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. Clinical chemistry tests form a very important set of tests in a pathology laboratory; a tool that clinicians and patients alike depend on to pin down the symptoms for treatment and relief. However, it is this very set of tests that have come in question. First, what is the normal and acceptable range (upper and lower limits) of different biomarkers in a particular population has been debated in different scientific fora. A second problem which the doctors and technicians have to grapple with is the variability of test-results in itself; even a broadly similar set of instruments and methods can provide variable results. It is then a real challenge to the physician to decide whether the patient is suffering from a disease or something else, since other factors can also cause changes in test levels. Standardization and harmonization of clinical chemistry testing are therefore still a formidable challenge, due to the lack of proper reference intervals and sometimes due to standardized measurement procedures. Laboratory medicine community the world over has realized that variability in test results in different platforms can create a lot of confusion to clinicians and the general population; harmonization of procedures is therefore the need of the hour.

In today’s changing healthcare climate, laboratories around the world are challenged to elevate patient care and reduce operating costs at the same time. The low cost of ownership of analyzers helps laboratories to achieve their goals and manage resources effectively without compromising quality. While choosing the right instrument is important in 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. The road map for laboratory medicine, therefore will involve strategies for harmonizing, communicating, and integrating with all stakeholders, like clinicians, diagnosticians, and IVD industry, in order to formulate guidelines for assisting in correct measurement, diagnosis, and management of diseases.

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. 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, manufacturers will continue the trend of downsizing units to reduce footprint, allowing more testing capabilities with smaller-sized machines. 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.

Industry Speak

Industry Speak

Industry Speak

Industry Speak

Industry Speak