Time to Upgrade Biochemistry Technology

Manufacturers are developing multiplexing analyzers offering shorter turnaround time with high clarity and result accuracy.

The clinical biochemistry technology is reaching a new level, differing from where it was a decade ago, due to the aggressive development of instrument speed and precision. In addition to this, accuracy of biochemistry analyzers in analyzing blood and urine samples has benefited pathology labs and diagnostic centers in the recent past.

The latest trend gaining momentum is the modular design of biochemistry analyzers. The fully automatic biochemistry analyzer is used to analyze many biochemical parameters of a blood sample like blood glucose, urea, protein, etc., to detect various diseases related to kidney, liver, and other metabolic disorders. It is a high performance-based micro-controller inbuilt with the photometric technology.

Manufacturers have now designed their instruments to offer a growing number of automated features, all to enable their users to achieve optimal productivity since fully-automated analyzers will remain in great demand in the years to come. Some of the leading manufacturers are also developing multiplexing analyzers – a cost-effective upgrade to the existing product line.

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
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 FA 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 FA analyzers, with 28 percent being contributed by the bench-top models. However, in value terms, they both have a Rs. 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 SA 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.

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 analyzers is estimated at Rs. 63,360 crore in 2016, forecast to surpass 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 (POCT) 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.

One of the major factors hindering the growth of this market is limitation of closed system that uses reagents and consumables from the same vendor from which the product was provided for efficient performance to reduce the risks of carrying contamination and increasing sample detection sensitivity. Compatibility issues are observed when consumables and instruments from different companies are used in the same instruments.

The clinical diagnostics application segment has dominated theglobal marketin revenue terms and is projected to continue to do so over the years. The drug development applications segment is expected to be the second most lucrative segment in the global biochemistry analyzers market, while the bioreactor byproduct detection segment is anticipated to be the least attractive segment in the global market.

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.

Technology Trends
In 1978, the industry was changed with the introduction of an automated system that allowed a number of critical routine chemistry tests to be performed using one consolidated unit. This 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.

Automation in clinical chemistry labs reduces errors and delivers properly checked results in reduced turnaround time. This is crucial in the clinical test process as it determines diagnosis and treatment. The use of automated analyzers with the ability to incorporate different tests, assay types, reagents, software, and accessories provides a comprehensive package for improving clinical effectiveness and outcomes. Washing and rinsing is also a mundane and tedious task. To overcome this issue, advanced automated systems are designed to wash automatically.

Adoption of POCT is currently a popular trend in the market since it provides faster results and supports patient-centered approaches to health care 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 their adoption rate.

Manufacturers are developing biochemistry analyzers with multiplexing analyzers. 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.These types of systems with shorter turnaround time give advantages of high clarity and result in 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.

Initially, biochemistry analyzers were used for repetitive analysis that consumed a lot of reagents. This has now changed, and due to 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. Moreover, as a result of the convergence of system engineering, automation, and IT technology, a significant change has been brought in the market. The shift from enzyme-linked immunosorbent assay (ELISA) technique to an automated biochemistry method increases time and personnel efficiency considerably, and leads to cost effectiveness as well.

Road Ahead
Today, clinical diagnosis needs could be fulfilled with the use of a biochemical analyzer, which is expected to detect a number of disorders that cannot be detected with the help of traditional biochemical methods. Considering the development of biochemical tests being highly related to a nation’s healthcare improvement, biochemical detection could be a critical part of clinical testing in the future enabling manufacturers to develop a broad suite of advanced instrumentation.