Biochemistry analyzers market is growing at a steady pace as advanced techniques are being implemented to obtain better outcomes. Also the growing demand for automated analyzers in public and private laboratories is resulting in the introduction of technological advancements to provide comprehensive testing solutions that facilitate efficient, accurate, and streamlined laboratory procedures.

Laboratories now desire complete solutions from a single provider, like closed system reagents with calibrators and controls, and viable software. This can help them in negotiation and also assure reliable service support. Leading brands are aware of the demand and are trying to come up with next-generation biochemistry automated integrated systems to suit the needs of high-end laboratories. There is a demand of leases and reagent rental contracts, which minimize maintenance requirements.

Additionally, the biochemistry 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. The market offers a healthy contribution in the in vitro diagnostic market and will grow in the upcoming years.

Indian Market

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The Indian market for biochemistry instruments and reagents in 2016 is estimated at Rs.1425.2 crore, with reagents dominating with an 81 percent market share. The Indian market is steadily shifting to reagents sold for open systems. 

The analyzer segment, which is estimated at Rs.275.2 crore, is steadily shifting in favor of the fully automated (FA) analyzers, which in 2016 are estimated to constitute 53 percent of the market in value terms. In volume terms, the semi-automated (SA) segment had an 88 percent share.

In the fully automated segment, the market is moving toward floor systems, which saw a growth of 6 percent as against bench-top models, which saw a 2 percent increase over 2015. In volume terms, in 2016, the floor systems are estimated to constitute 72 percent of the fully automated analyzers, with 28 percent being contributed by the bench-top models. However, in value terms, they both have a 50:50 share. 

2016 saw a geographical spread of the instruments, with Tier-III and IV markets also venturing into biochemistry analysis, albeit initially with semi-automated processes. This is expected to gain strength over the next couple of years. The Tier-I and II cities are gradually opting for the automated analyzers. A shift is being perceived in favor of mass spectrometry and immunoassays and molecular diagnostics finding favor. The clinical segment is expected to be a stagnant one, unless a policy change is seen from the government.  

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The government is gradually moving toward the PPP model, and procurement from the government is expected to ebb slowly. 2017 will perhaps be the year of consolidation. The market did have a negative impact from demonetization in the last 6 weeks of 2016, and this may continue for JFM 2017. Once GST sets in there may be renegotiation of contracts. On the positive side, the market may look upward, as orders are awaited from some tenders invited in 2016 and some funds may come in from companies interested in investing in this segment.

Global Market

The global market size of biochemistry analyzer is estimated at Rs.63,360 crore in 2016, forecast to surpass Rs.76,800 by 2021. This amounts to a CAGR between 5.1 and 5.5 percent during 2016–2021.

The key drivers would be rapid growth in diagnostics market, increased spending in healthcare, and augmented incidents in lifestyle diseases. Additionally, technological advancements and increased awareness of healthcare and diagnostic tests are likely to support growth. Rising numbers of point-of-care testing capabilities are also expected to provide the requisite impetus to demand. High cost of tests and shortage of highly qualified and trained personnel are some of the likely restraints.

Geographically, North America is the leading market and accounted for 60 percent of the market in 2016. Emerging markets such as BRIC countries are likely to grow at the fastest CAGR over the next 5 years.

Down the Road

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Under the emerging integrated health model, the clinical lab is but one strand in a complex web of healthcare partners. From the emergency department (ED), to physician’s offices, to the specialty clinics, patients are often treated at multiple points of care. Achieving reliable test results across the spectrum of healthcare settings, therefore, is not just desirable, but crucial.

Advances in clinical chemistry analyzers have enabled labs not just to meet ever-growing workloads, but even to improve turnaround times while achieving consistency in results and minimizing labor requirements. Additionally, the influx of integrated analyzers, which combine chemistry and immunoassay testing on a single platform, has provided labs with an opportunity to consolidate testing and streamline their workflow even further.

As more and more testing is being driven to the core lab from across the healthcare network, capabilities such as reliability, scalability, and turnaround time – especially for stat assays – are no longer regarded as merely nice to have. These are critical fundamental capabilities that drive the metrics by which labs are measured.

Manufacturers of clinical chemistry analyzers have designed their devices to offer a growing number of automated features, all to enable their users to achieve optimal productivity. As they consider equipment for purchase, customers can select from systems that offer everything from intelligent sample management and remote system diagnostics to automated dilution, calibration, and quality control (QC) – and a host of other advanced features.

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With more esoteric and specialty testing now being performed at smaller laboratories, lab professionals are increasingly considering integrated analyzers – systems capable of processing both clinical chemistry tests and immunoassays.

Integrated platforms offer a number of benefits: a vast menu of assays, avoidance of maintenance costs associated with operating separate systems, elimination of multiple quality-control protocols, and streamlined record-keeping. Still, several companies cited their wariness of the consolidated technology.

What does the future hold for the market in clinical chemistry and integrated analyzers? To meet the shifting needs of clinical laboratories in a variety of settings, manufacturers anticipate that the trend toward greater platform consolidation will continue.

Manufacturers will continue to expand the immunoassay menus of their integrated systems to match the menus offered by standalone clinical chemistry systems combined with standalone immunoassay systems. But while additional assays may migrate from immunoassay systems to integrated systems, an increasing prevalence of proprietary reagent formats may negatively affect customers by limiting open-channel flexibility.

There will likely be a rapid advance in the number of immunoassays available on the market, which will put pressure on IVD manufacturers to deliver integrated analyzers that can accommodate the growth. Applications for unique tests may find their way onto integrated platforms, especially those with high-throughput capabilities. Laboratory consolidation is the challenge of the day, hence a need for larger platforms.

Laboratories are looking for a total solution that involves a suite of products and services beyond just chemistry and integrated systems. 

Diagnostic companies that are positioned to offer the broadest suite of advanced diagnostic instrumentation, automation, and advanced information technology will best meet the needs of the future.

Mohammed Suhail Hussain, Senior Product Manager, CPC Diagnostics
Industry Speak
A Complete Profiling Solution

This is the era of innovation for introduction of new tests and automation in the laboratory segment. As days and years progress, we see new trends in testing methodology and automation of these tests, including both regular and niche tests.

The laboratories are looking for automation with each and every new parameter they perform for reducing manual errors as well as the turnaround time (TAT). There is also need for multi-parametric testing to improve the TAT and also to reduce the wastage/cost. For example, in the field of autoimmune/infectious/allergy testing, where vast numbers of auto antibodies or infectious parameters or allergy parameters are to be screened and subsequently to be confirmed for diagnosis of various diseases, there is need for introducing the multi-parametric, disease-specific approach to the diagnosis of the above said parameters to reduce the TAT and also to give clear inputs to clinicians. 

Euroimmun offers the above range of parameters in the field of autoimmune, infectious, and allergy testing in the form of EUROLine assays, where multiple parameters are coated in individual nitro-cellulose membrane strips. After processing these samples on the strips, the results are interpreted using EUROLinescan software, where one can report these assays in both quantitative and semi-quantitative formats. This multi parametric test system for confirmation assists the laboratory as well as the clinician to rule in or rule out various disease conditions as well as the activity at one go in a short span of time. 

The automation of these multi-parametric Line Immunoassays can be achieved by the introduction of an automated processor. This assists in reducing manual errors and providing highly precise and reliable results in a shorter TAT. Plexmat 4 system manufactured by CPC Diagnostics is a multi-tasker in profiling. It helps the laboratories to automate the EUROLine immunoassays and helps in reducing manual errors which might occur during the process, and ensuring highly precise and reliable results.

This approach will help the laboratories to provide a complete profiling solution, as well as clinician community for better diagnosis and timely intervention in various disease conditions.

Mohammed Suhail Hussain
Senior Product Manager,
CPC Diagnostics

Pavan Kumar M, Chief Operating Officer, Bhat Bio-Tech India (P) Ltd.

In the very early days, clinical chemistry labs were equipped with a regular simple candle to heat the samples like blood or urine to analyze the parameters like protein, urea, etc.; later centrifugation and spectrophotometry/colorimetry concepts arrived, wherein one can measure the concentration of the sample by measuring its absorbance of a specific wavelength of light.

At present, semi-auto and fully automated biochemistry analyzers are ruling the market and have replaced the earlier traditional methods of testing. The method of multiplexing allows the analysis of multiple parameters for a single sample in a shorter time, and also allows lesser manual intervention and thus one can avoid the human errors and can achieve better results. Huge development in the electronics sector has contributed for the development of new sensors for detection and analysis of patient samples with higher sensitivity and specificity. The traditional halogen-based sensors are being replaced by new LED-based sensors. The advancement in the software 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 increase in the automation of biochemistry analyzers is a key advancement in technology for high-throughput analysis of biochemistry parameters. High-throughput analysis consumes less time and results can be generated very quickly.

Pavan Kumar M
Chief Operating Officer,
Bhat Bio-Tech India (P) Ltd.

Alex Xu, Overseas Technical Director, Snibe
Industry Speak
Homocysteine as a Biomarker

Cardiovascular disease (CVD) is a class of diseases, which has become the leading cause of death globally. Though CVD is estimated to be highly preventable through improving risk factors like healthy eating, exercise, and avoidance of smoking, it has still attracted worldwide concern for its striking mortality risk.

Homocysteine (Hcy), a sulfur-containing amino acid, is an important intermediate metabolite of methionine, which contributes to atherosclerosis. And increase of Hcy is claimed to be a significant risk factor for the development of many diseases. In addition, Hcy can be precisely measured via HPLC or FPLA, and biochemistry method is also widely applied as reported. Thus evaluation of Hcy level to indicate risk of cardiovascular disease becomes possible as a diagnostic support tool. 

It was first proposed in 1969 that increase of Hcy could be associated with vascular occlusive disease among the general population. And numerous experimental studies have revealed the relevance between Hcy level with the pathogenesis of vascular disease since 1990s. Besides, plasma Hcy also correlates positively with various clinical traits, including dyslipidemia, increased blood pressure, and impaired renal function. 

A recent research reported that the elevation of Hcy level is associated with the severity as well as the presence of coronary artery disease (CAD). And the study suggested an independent role of Hcy in prediction of CAD risk even after correction for baseline differences. Moreover, Hcy was reported to have strong association with the genesis of coronary heart disease (CHD).

Some limitations may still exist in the application of Hcy, and more researches remain to be performed. However, under the situation of high incidence of cardiovascular disease nowadays, the evaluation of Hcy, followed up with targeted treatment, will turn out to acquire a very important clinical significance.

Alex Xu
Overseas Technical Director,
Snibe

Varun Kumar Sharma, Deputy Application Manager (IVD), Mindray
Industry Speak
Chemistry Analyzers – A Growing System

Clinical chemistry analysis is one of the integral parts of laboratory analysis. And it makes the first line of tests among a battery of examinations tests, which are ordered immediately upon admission in hospitals, and preventive health checkups. Awareness of health checkups and significance of blood testing is increasing amongst the people. At the same time, greater coverage under medical insurance has given major impetus to volume of testing. Clinical chemistry is a combination of biochemistry, immunochemistry, endocrinology, and toxicology. Clinical chemistry analyzers are becoming increasingly sophisticated. Laboratories are recognizing greater value in them for improvement of disease management and patient care. 

The growing demand for automated analyzers in public and private laboratories is resulting in introduction of technological advancements to provide comprehensive testing solutions that facilitate efficient, accurate outputs. The growth factors for clinical chemistry instruments and reagent market in India are merging of single or local diagnostics laboratories with laboratory chains and opening of new centers in smaller cities.

Clinical chemistry is an established and stable market due to high levels of automation in laboratories. Biochemistry instruments are segmented into fully automated and semi-automated analyzers, closed, and open systems. Laboratories now desire complete solutions from a single provider, for example, closed system reagents with calibrators and controls. Closed systems also ensure better-quality results and improved compatibility in terms of QC and calibrators. There is an increasing demand for leases and reagent rental contracts, which minimize maintenance requirements. It also minimizes capital investment from the user. 

Mindray is one of the leading global providers of medical devices and solutions. Firmly committed to our mission of sharing medical technologies with the world, we are dedicated to innovation in the fields of in vitro diagnostics, patient monitoring and life support, and medical imaging. By virtue of this, we are able to offer complete solutions. We adopt advanced technologies and transform them into accessible innovations, bringing healthcare within reach. The company develops, manufactures, and markets products that innovate complex biomedical testing, and delivering a wide range of automated instruments and IT solutions, keeping in mind the need of a laboratory.

Varun Kumar Sharma
Deputy Application Manager (IVD),
Mindray

Sachin Singh, Head-Strategic & Operational Marketing, DiaSys Diagnostics India Pvt. Ltd.
Industry Speak
Next Gold Standard in HbA1c Measurement

The diagnostic market has showcased several emerging trends over the past few years. Some of most definitive trends have been advent of unique parameters in light of accuracy of test results compared to standard technologies. The clinical chemistry and immunodiagnostic market is undergoing significant transformation, meeting customer requirement of workflow solutions and parameters available with unique advances in diagnostic technologies, moving from immunology to chemistry platform using immunoturbidimetry principle. This evolving market place creates existing opportunities for new instruments and reagent parameters. Companies are launching different parameters of biochemistry reagents in closed systems, which will create demand with expanding capabilities, thereby securing the future of next-generation laboratory for unique tests.

Our product portfolio comprises more than 90 plus clinical chemistry and immunoturbidimetric reagents for routine and special diagnostics including suitable calibrators and controls. The DiaSys instrumentation product range covers automated clinical chemistry analyzers, semi-automated analyzers, and POC instruments for patient-near testing. We also provide complete hematology solutions instruments, immunological reagents of advanced technology reagents along with controls, and calibrators and Ecoline, which are manufactured by the manufacturing unit of DiaSys Diagnostics India Pvt. Ltd.

Technology Update. Diabetes constitutes a major health problem since incidences are increasing rapidly worldwide and particularly in India. To initiate intervention strategies and to overcome late diabetic complications, early diagnosis of diabetes is crucial. In the past, glycated hemoglobin A1 (HbA1c) was used for monitoring diabetes only, but since 2011, HbA1c is also recommended by international organizations as WHO and ADA as a suitable marker for the diagnosis of diabetes. Our new enzymatic HbA1c assay – HbA1cNETFS – reveals outstanding specificity and precision. Moreover, this test highly correlates to HPLC and also to IFCC reference material, and is unaffected by interferences from Hb variants. By application of HbA1cNETFS to the fully automated DiaSys system response910, workflow is optimized, due to the implemented on-board hemolysis, thus eliminating error-prone and time-consuming manual preparation.

Sachin Singh
Head-Strategic & Operational Marketing,
DiaSys Diagnostics India Pvt. Ltd.

Sudhir Nair, Associate VP-Sales, Agappe Diagnostics
Industry Speak
New Trend in Clinical Chemistry Automation

Biochemistry segment in the Indian IVD has shown major growth in all directions. This includes the increase in the number of parameters performed and the addition of new technology systems to perform the tests with ease.

The major change in this segment happened in the clinical chemistry automation. Three decades ago, only MNCs represented this segment with heavy systems with vast space requirements, eluding the laboratories up to the middle segment. Introduction of bench-top systems in the late 90s revolutionized the testing in clinical chemistry laboratory. With more companies focusing in this segment, now systems are available with 100 tests/hour for the entry-level automation to 400 tests/hour for the upper segment. One of the limiting factors for the earlier automation system was the high cost of consumables and that of energy. This was well addressed by the instrument manufacturers and the new-generation systems are equipped with technology that consumes very less energy with low maintenance cost.

In clinical chemistry automation, the entry-level segment has shown the highest growth with more than 500 units installed annually in India. These new-generation systems are equipped with on-board cooling, on-board laundry, high-quality mixing, and excellent QC statistics to make sure that the quality of results is maintained at all levels. One of the breakthroughs in this segment is the reduction of size of the instrument which was one of the major concerns of customers in metro cities. Now systems are available in the market having a foot print of two semi-automated analyzers and a throughput of 100 tests/hour.

Another change that has happened in this segment is in modular automation. Till the last decade, the central laboratory concept was common in big hospitals and labs where all the different platforms are interconnected together with robotic platforms. Beginning of the current decade has shown a shift in the customer mind, where customers are shifting from modular systems to high-level independent platforms. 

With more and more parameters adding to the test portfolio and more laboratories entering into quality accreditations like NABL or QCI, we are expecting an exponential growth in the automation segment.

Sudhir Nair
Associate VP-Sales,
Agappe Diagnostics

Dr Nimmi Kansal, HOD-Biochemistry & Immunoassays, Dr Lal PathLabs
Second Opinion
Reference Laboratory Automation: Evaluation and Planning

Significant progress has been made in automating pre-analytical and post-analytical activities and integrating these operations with analytical systems. 

While the concept of lab automation is key to keep pace with rapid growth of specimen volumes and improved turnaround time to meet competitive demands, fundamentals to any decision to automate is an understanding of what processes are to be reengineered or automated and what efficiencies are to be realized. Some practical considerations that influence a laboratory’s decision to automate part or all of its operations are discussed here.

Evaluation of requirements. Any consideration of total or modular laboratory automation should start with an evaluation of requirements. A reference laboratory typically handles large volumes of routine tests, many exceptional tests, specimen containers, and handling situations. Nevertheless, if 80 percent of specimen containers and handling situations can be standardized and automated, the laboratory will achieve dramatic reduction in its labor usage and costs, which should be sufficient to justify the investment in automation. Such an evaluation begins with mapping of the current laboratory workflow, from the arrival of the patient specimens through completion of testing and reporting of results.

Workflow analysis. Potential workflow steps are mapped; the map may consist of a diagram of the movement of all entities (e.g., tubes, cups, bottles, racks, shipping containers, requisitions, reports, lists, and labels) in the building, and the people and sections who handled those entities. It includes all activities from arrival of work at the exterior door of the laboratory until the completion of testing, including archival storage of specimens for possible repeat or additional testing.

Timing study. The workflow map then is used to design a detailed timing study, in which all the steps in the process are timed from the arrival of shipments to the completion of specimen storage after test result verification. The purpose of this study is to determine the average elapsed times for various steps in the process to identify those steps that should be a focus of our reengineering and/or automation and, in particular, to identify bottlenecks.

Identify needs. The workflow analysis and timing study is directly related to process flow and will assist the lab to determine the process steps that are bottlenecks, waste labor, and are prone to error. Workflow analysis thus enables the lab to better identify what steps should be considered for automation.

Once the laboratory workflow has been mapped and its requirements have been identified, vendors are invited to make presentations and to host visits of laboratory management team to other laboratories where vendors have successful installations. It is important at this stage to focus on the requirements identified by workflow mapping and to not allow the vendor to try to sell equipment that may not be necessary.

Dr Nimmi Kansal
HOD-Biochemistry & Immunoassays,
Dr Lal PathLabs


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