Biochemistry instruments are expanding system capabilities and introducing technological advancements to provide comprehensive testing solutions that facilitate efficient, accurate, and streamlined laboratory procedures. The factors contributing to the growth of biochemistry instruments and reagents market in India include the consolidation of diagnostic laboratory chains, major hospitals, and laboratory chains opening new centers in Tier-II and Tier-III cities, increasing government/private sector expenditure in healthcare, public healthcare awareness, and affordability.

In vitro diagnostics market has showcased several emerging trends over the past few years. Some of the most definitive of these trends have been the advent of decentralized testing, mounting automation in laboratories, increasing consolidation, and preference for early detection of diseases. Several pathological labs have resorted to invest heftily and have been adopting fully automated systems for diseases diagnosis. In light of this, the accuracy of test results has increased, while the turnaround times have been reduced significantly. Additionally, the growth of portable diagnostic devices has propelled the market for point-of-care (POC) testing in India.

Diagnostic laboratory testing is undergoing a complete transformation. With the focus on providing cost-effective, timely medical care for ambulatory patients, POC laboratory testing has become one of the fastest areas of growth in the medical field, with the number of tests increasing at an estimated 10 to 12 percent annually. The clinical chemistry and immunodiagnostic markets are undergoing significant transformation, caused by convergence of new and more stringent regulations; advances in diagnostic technologies, system engineering, automation, and IT; and intensifying competition. Some segments, like routine chemistry, already resemble commodity markets, where product positioning and cost per test are more critical than underlying technology. This evolving marketplace creates exciting opportunities for a variety of new instruments, reagent systems, and auxiliary products, such as specimen preparation, devices, controls, and calibrators.

Indian Market

The Indian market for biochemistry instruments and reagents in 2015 is estimated at Rs.1060 crore, with reagents dominating with a 75 percent market share. The Indian market is steadily shifting to reagents sold for open systems, their share having gone up from 50 percent in 2014 to 55 percent in 2015.

In the analyzer segment, the market is moving toward automated systems, which constituted 57 percent of the market in 2015. 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.

Bench-top lower throughput analyzers are seeing maximum growth. These analyzers have been developed without compromising on efficiency and accuracy of the system.

Adenosine deaminase activity (ADA) infection markers for TB diagnosis are increasingly being used on the biochemistry platform.

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.

The last couple of years have seen an increase not only in the number of hospital-attached laboratories but also an exponential growth in the diagnostic laboratories run by branded players in the Indian diagnostics market, including Super Religare Laboratories, Dr Lal Pathlabs, Quest Diagnostics, Thyrocare, and Metropolis. Entry of corporates into the pathology and laboratory segment with Tier-II and Tier-III expansions is leading to consolidation. The existing smaller labs are being taken over by corporate chains.

Global Market Trends

The global biochemistry instruments and reagents market was estimated at USD 9460 million in 2015. This market is expected to grow at a CAGR of 5.5 percent between 2015 and 2020, to reach USD 12,373 million in 2020.

New designs of biochemistry analyzers are being developed through refining the method of biochemical analysis. The method of multiplexing allows the analysis of multiple biochemical entities from a single sample. This is expected to fuel the development of new sensors for detection and analysis of biochemical entities with high sensitivity and selectivity.

Owing to the developments in electronics, there is an increase in the development of LED-based sensors, which have replaced the traditional halogen-based sensors. Development of software programs has allowed integration of various workflows of biochemistry analyzers for better control and operational efficiency. These innovations are expected to boost the growth of the global biochemistry instruments market.

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.

Technology Trends

Shifting toward automation from ELISA. The use of ELISAs for clinical testing within a laboratory is notably time- and personnel-consuming, with heavy resources used on manual interaction. Moving from ELISA technique to an automated biochemistry method for detection of the same analyte increases time- and personnel-efficiency considerably, and time and management efficiencies equal cost-effectiveness. The significance of ensuring quality in testing practices and thus confidence in clinical results is also a key consideration for running automated biochemistry tests over manual ELISA-testing techniques. The risk of error and contamination and, therefore, compromised clinical results, which is higher when running ELISA methods, will be greatly reduced through the alternative of biochemistry automation. By transitioning analytes historically only available on ELISA to automated biochemistry methods, laboratories are able to expand their test offerings to patients and clinicians. As an example, within key cardiovascular testing, analyses such as H-FABP, 11dhTxB2, adiponectin, and sPLA2 being available in an automated biochemistry format, allow laboratories to expand their testing and test menu with ease. Automated biochemistry analytes increase testing range, with little adjustment within the laboratory, allowing for detailed patient-testing profiles, without the manual restrictions placed by running ELISA techniques.

Decentralized laboratory testing. There are three key drivers of decentralized lab testing: the increasing virulence of infectious diseases, the growth of companion diagnostics, and the need for better drug monitoring for diseases such as cancer. Additionally, in an effort to reduce costs and LOS, molecular testing for hospital-acquired infections has risen over the last several years. Currently, most molecular diagnostic tests are run in either large reference labs or in CLIA-accredited labs, but as more molecular diagnostic tests become available, particularly for conditions that benefit from a quick result, decentralized labs and near-patient settings are viewed as a viable and growing market. As personalized medicine continues to advance, bringing molecular diagnostic testing to POC in the physician's office will continue to be in demand. On one hand, the push toward decentralized testing can subsequently drive demand for POC technology. On the other hand, even with healthcare reforms' focus on cost control through preventive medicine in support of POC decentralized testing, higher direct costs for the performance of individual POC tests could deter some potential users. This is particularly applicable in cases where the reimbursements are not sufficient to justify the costs, and centralized testing resources are available.

Explosion of point-of-care technology. With emerging technological innovations in healthcare, including smartphone apps, biosensors, lab-on-a chip, and wearable devices, all of which offer a closer connection to the patient, point-of-care (POC) technologies are quickly becoming part of the transformation of the clinical chemistry laboratories. The driving concept in support of point-of-care testing (POCT) is to bring testing closer to the patient and results conveniently and quickly to the provider to expedite diagnosis and subsequent treatment. POCT allows for faster clinical decisions in hospitals, physicians' offices, ambulances, patient homes, and in the field. A number of factors, such as the increasing prevalence of infectious diseases in developing countries, the rising incidences of lifestyle diseases such as cardiac diseases and diabetes, the rising usage of home-based POC devices, and technological advancements with regard to development of advanced, faster, and easy-to-use devices are stimulating the demand for POCT. While POCT is one of the most active segments within the diagnostic industry, the technological capabilities far outnumber the rate of POCT adoption.

Role of exosomes as biomarkers in clinical diagnostics. Research on the biology, function, and potential application of exosomes has increased exponentially over the past decade. It has been clinically proven that one or perhaps the most important biomedical utility of exosomes is their potential application as biomarkers in clinical diagnostics. Compared with biomarkers detected in conventional specimens such as serum or urine, exosomal biomarkers provide comparable or higher specificity and sensitivity attributed to their excellent stability. Particularly, exosomal biomarkers from easily obtainable biofluids such as saliva would be quite suitable for clinical applications. Recent technical advances in exosome isolation not only facilitated exosome research but also made exosomal diagnostics more cost-efficient.

In addition to exosomal proteins and RNAs, exosomal lipids have also been shown to have diagnostic potential. The utility of exosomes may be further expanded, since they are found not only in mammalian cells but also in diverse pathological microorganisms such as gram-negative bacteria, eukaryotic parasites of the kinetoplast lineage, and opportunistic fungal pathogens. In general, exosomal biomarkers are still in 
the early discovery/development stage and their potential value in clinical diagnostics waits to be fully explored.

Challenges

The last decade has seen enormous progress in the exploration and understanding of the behavior of molecules in their natural cellular environments at increasingly high spatial and temporal resolution. Advances in microscopy, development of new fluorescent reagents, and genetic editing have enabled quantitative analyses of protein interactions, intracellular trafficking, metabolic changes, and signaling. Modern biochemistry now faces new and exciting challenges. The quality, price, and availability of high-throughput sequencing instruments have improved to the point that this technology may be close to becoming a routine tool in the diagnostic laboratory. Two groups of challenges, however, have to be resolved in order to move this powerful research technology into routine use in the clinical microbiology laboratory. The computational/bioinformatic challenges include data storage cost and privacy concerns, requiring analyses to be performed without access to cloud storage or expensive computational infrastructure. The logistical challenges include interpretation of complex results and acceptance and understanding of the advantages and limitations of this technology by the medical community.

Technological advancement is one of the major factors driving the growth of the biochemistry instruments market. Increase in automation for high-throughput analyses of biochemical entities has helped in saving time and generates results quickly. Developments of software programs have also allowed the integration of various workflows of biochemistry instruments for better control and operational efficiency. However, the negative impact of recession could pose a challenge to the growth of this market, restricting healthcare spending, especially in the developed regions.

Road Ahead

The future of biochemistry lies in a patient-centered laboratory. Biochemistry laboratories need to focus in the five areas: improved utilization of existing and new tests; definition of new roles for laboratory professionals that are focused on optimizing patient outcomes by adding value at all points of the diagnostic brain-to-brain cycle; development of standardized protocols for prospective patient-centered studies of biomarker clinical effectiveness or extra-analytical process effectiveness; benchmarking of existing and new tests in specified situations with commonly accepted measures of effectiveness; and agreed definition and validation of effectiveness measures and use of checklists for articles submitted for publication.

Progress in these areas is essential in order to enhance the value of laboratory tests and prevent valuable information from being lost in meaningless data. This requires effective collaboration with clinicians, and a determination to accept patient outcome and patient experience as the primary measure of laboratory effectiveness.

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. Companies are launching their next-gen biochemistry automated integrated systems to suit need of high-end laboratories. There is a demand for leases and reagent rental contracts, which minimize maintenance requirements. Additionally, the biochemistry analyzer 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.Industry SpeakImproved Patient Care through 
Excellent Laboratory Performance

Sunil Dhadkar

Sr. Manager - Business 
Developmen ,
Transasia Bio-Medicals Ltd.

Quality control is the most efficient tool to cross check laboratory's performance. Quality control programs focus on accuracy and precision of each parameter at micro level. Presently, laboratories are heading towards external quality assurance (EQA) program followed by performing traditional internal QC checks.{mosimage}

Clinical Laboratory's quality management is based on quality efforts taken for improvement. With the expected boom in advanced technologies (from clinical tests methodologies to highly sophisticated instruments in IVD industry), maintaining quality standards is now more important than ever.

To stay on the top, laboratories should follow stringent quality standards by performing EQA program along with parallel QC. Ultimately, now EQA is considered as a new industry standard for Quality Control.

Bearing this in mind Transasia Bio-Medicals Ltd. offers EQA program - EMQAS (Erba Mannheim Quality Assurance System) which provides inter-laboratory comparison and peer group statistics. It enables the laboratory to monitor analytes performance by method and instrument specific peer group comparison.

Key highlights are exclusive program for routine clinical biochemistry parameters, conducted bi- annually, with cycle of six months, 26 clinical biochemistry parameters providing flexibility of selection from analytes, report pattern is based on Z Score and multi-guard rule of QC, Certificate of Participation and Certificate of Excellence are issued.

Key features of the program includes human serum controls (Lyophilized), method and instrument wise report with most advanced histograms and Levy Jennings charts, technical support from strong R&D team, easy access to online EMQAS portal and monthly evaluation report with analyte specific report and summary report, online.

Industry Speak

Biomarkers for Early-Stage Alzheimer's Disease

Dr Jacqueline Gosink

Product Manager,

EUROIMMUN AG

Alzheimer's disease is a major global challenge of our times, with prevalence predicted to rise dramatically as populations age. No cure is available, and early diagnosis is crucial for managing the disease. Since clinical diagnosis is difficult, especially in the initial stages, analysis of biomarkers in patient's cerebrospinal fluid (CSF) is increasingly used as a diagnostic support tool.

{mosimage}Analysis of the beta-amyloid (Aβ) peptides 1-42 and 1-40 together with total tau can significantly aid early diagnosis of Alzheimer's disease. These neurochemical biomarkers can be measured precisely, reproducibly, and independently of matrix effects using a new generation of ELISAs based on well-characterised capture antibodies.

Alzheimer's disease was first described in 1906, and is 60-70 percent the most common cause of dementia in old age. The risk for developing Alzheimer's disease doubles for around every five years after age 65, with 30 percent of persons over 90 suffering from the disease. In contrast to the age-dependent, sporadic form of Alzheimer's disease, the familial, genetically caused form can also occur in young adults from 30 years of age.

The diagnosis of Alzheimer's disease in the early and pre-symptomatic stages requires reliable, quantifiable CSF biomarkers like soluble Aβ 1-42 and tau proteins. The concentration of these analytes in the CSF reflects the neuropathogloical changes in the brain. There are currently no blood markers available that show the same clinical value as the CSF markers.

Patients with Alzheimer's disease show a significantly decreased level of Aβ 1-42, which is detectable 5-10 years before the start of cognitive changes. The concentrations of total tau on the other hand, increase when patients show advanced neurodegeneration and cognitive impairment. It is thus possible to discriminate Alzheimer's patients from healthy persons by means of CSF markers.

In contrast to Aβ 1-42, the level of Aβ 1-40 remains unchanged in Alzheimer's patients. Measuring Aβ 1-40 together with Aβ 1-42 enables calculation of the Aβ 1-42 to 1-40 ratio which helps to increase the efficiency of early diagnostics. A ratio of under 0.1 indicates amyloid pathology. This ratio might further help to discriminate Alzheimer's disease from other diseases such as vascular dementia.

Industry Speak

The Changing Trends in 
Biochemistry Instruments

{mosimage}Joe Baby Padayatty

National Sales Manager,

Mindray Medical India Pvt Ltd

Clinical chemistry analysis is one of the integral part of laboratory analysis. Awareness of health scans and significance of blood testing is increasing amongst the people. This awareness has paved the way for the establishment of quality patient care in laboratory. Clinical chemistry is a combination of biochemistry, immunochemistry, endocrinology, toxicology (abused and therapeutic drug testing), analytical chemistry, engineering, informatics, and other specialties, which includes many modern technologies. Clinical chemistry analyzers are a growing system and 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 are resulting in the introduction of technological advancements to provide comprehensive testing solutions that facilitate efficient, accurate, and streamlined laboratory procedures. The growth factors for clinical chemistry instrument and reagent market in India are merging of single or local diagnostics laboratories with laboratories 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. Automation is taking place in the clinical chemistry laboratory; reagent and consumable demand is also growing. Biochemistry instruments are segmented into fully automated and semi-automated analyzers, closed and open systems. 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. Many companies are launching their next-generation biochemistry automated integrated systems to suit need of high end laboratories. There is a demand of leases and reagent rental contracts which minimize maintenance requirements. Additionally, the biochemistry analyzer market is moving towards testing consolidation, which is creating demand for integrated systems with expanded capabilities, thereby securing the future for next-generation laboratory analyzers.

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 patient monitoring and life support, In vitro diagnostics, and medical imaging. Inspired by the needs of our customers, we adopt advanced technologies and transform them into accessible innovations, bringing healthcare within reach. Mindray develops, manufactures, and markets products that innovate complex biomedical testing and delivers the wide range of automated instrument and IT solution, keeping in mind the need of laboratory.

Second Opinion

Market Trends in Biochemistry Instruments and Reagents

Dr Charandeep Singh Sahni

Pathologist and Director,

Helix Pathlabs, Mohali

The biochemistry equipment and reagent industry is experiencing rapid technological developments. The need for a highly accurate and wider test menu has resulted in the introduction of new test parameters. Though the demand for these tests is high, laboratories remain subject to low profitability and intense competition. India's per capita healthcare expenditure is low due to its large billion-plus population and low per capita income. This scenario is not likely to improve because of rising healthcare costs and India's ever-growing population. According to estimates provided by industry sources, there are approximately 50,000-60,000 laboratories that service 2.5-3.5 million patients per day. This includes specialized laboratories, laboratory facilities in hospitals and nursing homes, and small testing centers with basic facilities. {mosimage}

The biochemistry equipment and reagent market is growing at an excellent rate. Contributing factors to the growth are increasing health awareness and demand for quality healthcare; changing demographics and prevalence of disease; increasing corporate presence in healthcare including establishing diagnostic laboratories; the expansion of pathology diagnostic market to towns and rural areas; the growing number of insured lives; changes in medical liability legislation; and a developing clinical research market. Though stratification exists in the laboratories, there are a growing number of corporate players. The high-end laboratories, which offer automated biochemistry systems, cater to approximately 30 percent of the national workload while the second tier regional laboratories cater to 40 percent of the patients. The manual laboratories account for the remaining 30 percent patients. The emerging trend of corporate players establishing diagnostic centers in small towns and rural areas will provide opportunities for the import of automated systems and imported reagents. The market for biochemistry equipment is highly competitive. Equipment is often leased or rented, and revenue is generated through consumables. The vendor is assured of the sales of reagents for a 5-7 year period while the hospital and laboratories do not have to incur major capital expenditure for equipment. Increasing competition pressures the laboratories to continuously improve quality and provide rapid results; this demand drives the need for equipment and reagents that perform multiple functions efficiently. There are opportunities for technologically superior products. With growing competition, laboratories are trying to distinguish themselves by using better reagents and instrumentation.


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