Laboratories require systems that have a high accuracy, with ability to manage high growing volumes, and also offer remote data acquisition capabilities.
The field of immunology witnesses a period of extraordinary and unprecedented discovery and advancement in virtually every aspect of basic and clinical research. These progresses are in part the result of technological advances which enable quantitatively and comprehensively measuring the immune response to genetic or environmental perturbations. Immunochemistry analyzers are becoming more and more popular nowadays as these have proved to be very effective tools to diagnose cancer, hepatitis, illegal drugs, fertility problems, sodium levels, endocrine function, and the detection of blood clots.
The recent development of high-sensitivity immunoassays ushers in a new era for immunodiagnostics. Single molecule counting or detection technology, linked with traditional immunoassay technology, has made it possible to realize the holy grail of immunoassay development – specifically, improving the signal-to-noise ratio of an assay by up to a thousand-fold. The market is also witnessing the launch of innovative products such as compact and portable instruments with expanded feature sets often including pre-analytical automation, interoperability with clinical chemistry and other analyzers, automated reflex testing protocols, automated specimen storage, automated quality control, and flexible reporting methods.
Indian Market Dynamics
In 2016, the Indian immunochemistry market is estimated at Rs. 1914 crore. The ELISA kits market in 2016 is estimated at Rs. 306 crore and rapid tests at Rs. 225 crore, both seeing a decline every year. The immunochemistry instruments and reagents market is estimated at Rs. 1383 crore. Reagents continue to account for 90 percent of the market.
Chemiluminescence immunoassay (CLIA) systems have been steadily gaining momentum, especially in Tier-I cities where the installation base and replacement market is increasing, resulting in a decline in enzyme-linked immunosorbent assay (ELISA) tests. Rapid tests are also seeing a decline, particularly with blood banks, which are now being monitored more closely by the FDA (Food and Drug Administration). Facing stringent checks, they are gradually shifting to chemiluminescence.
The segment is receiving impetus with increasing awareness of tests for AMH (anti-Mullerian hormone) and vitamin D. The need for automation is now also being felt by laboratories in Tier-III and IV cities, perhaps being pushed by the opening of competitive labs by corporate chains.
Global Market Dynamics
The global immunochemistry instruments and reagents market is expected to reach USD 24.5 billion by 2019 from USD 19.8 billion in 2016, growing at a CAGR of 7.2 percent. North America dominates the market, with government funding being a major factor. Presence of advanced immunochemistry instruments is another major factor for the high share of the US market. The Asian market is poised to grow at the highest CAGR owing to increasing government investments in the life sciences sector and improving healthcare facilities in the region. The rising focus of prominent players on the Asian immunochemistry market is another factor driving its growth. Increasing number of baby boomers that require frequent health checkups is also a main driver for this market.
Automation and integration are driving the analyzers market. Offering a broad assay menu, including infectious diseases, is a central competitive factor for increasing installed base of analyzers. Consequently, market participants of this highly competitive market are expected to continue infectious disease immunoassay product development and menu expansion.
Reagent sales typically comprise approximately 85 percent of fiscal revenues from any single system. Instrument placement is necessary for reagent sales. Many competitive factors in the immunoassay testing market lie with the instrumentation platform. The installed base of an instrument allows for an increase in test sales. When deciding on a particular testing platform, central laboratories value integrated and automated solutions.
The number of tests offered by an instrument promotes the installed base and future reagent sales. A majority of testing platforms are closed systems in which the instrument does not facilitate tests of another provider. The competitive advantage in this market lies with companies that offer a broad testing menu on an integrated and automated system. Servicing the instruments installed in the laboratory is another significant part of the value proposition market participants should offer. Test performance is yet another competitive factor. However, it is becoming difficult for market participants to stand out on the basis of higher sensitivity or other testing characteristics.
As the market becomes highly competitive, it becomes essential for manufacturers to retain their installed base. This provides recurring reagent business, and hence, several market participants adopt various strategies with their customers.
Offering large discounts on the list price of the analyzer. As the market for immunoassay and clinical assay systems is enormously shrinking and eroding, companies are now adding immunoassay components or clinical chemistry systems to existing analyzers in order to make it an integrated analyzer. As a result, customers receive large discounts. This works in their favor when laboratories have stringent budgets.
Bundle reagent rental contracts. The tendency toward opting for reagent rentals varies from region to region. For example, laboratories in emerging markets opt for multiple reagent vendors, while established markets in the United States and Europe prefer to select the instrument and the reagent from the same vendor, ensuring compliance and accreditation standards.
Offering upgrades and add-on analyzers and components. In order to retain their installed base, many vendors offer upgrades to existing analyzers at a very low cost to increase capabilities of existing outdated analyzers.
Drivers and Challenges
Under the strong rules and regulations, laboratories find it difficult to have good revenues. Thus it is very important to find ways to sustain in such a cost-crunched environment. Due to cost cutting in clinical lab fees, profitability per test is decreasing, which makes it necessary for the laboratories to focus on the volume rather than the value. There is also heavy pressure for quality, error-free results to ensure patient satisfaction. This forces labs to lean toward more automated systems with effective workflow solutions.
Globally, laboratories are encouraged to go in for automation due to the heavy influx of patients with insurance coverage. But with limited workforce in the clinical lab, it is difficult to manage the huge inflow of patients. On the other hand, patients need prompt and error-free results. Thus this scenario demands laboratories to seek the help of systems that have a high accuracy when managing high growing volumes and also offer remote data acquisition capabilities. Implementing informatics is critical, and the automated analyzers built today offer a full suite for barcode readers, rack detection systems, and sample/plate identification modules to avoid plate or sample switch.
It is expected that point-of-care instruments will facilitate patient-centered care, allow for more rapid turnaround times and immediate decision-making, and result in less fragmented healthcare in the future. Commercialization of technologically innovative products is also expected to increase considerably in the years to come. Immunoassays fundamentally changed clinical practice, and with the advancement of ultrasensitive immunoassays, the next disruption in healthcare will follow.
POCT – Evolving Trends in Diagnostics
Dr Aparna Jairam
Founder and Director,
Dr Aparna’s Pathology Laboratory,Mumbai,Centre of Excellence of Autoimmunity and Infertility,Indore
Point of care testing (POCT) was once considered as a very nonpathology kind of testing in a laboratory. I am convinced that with more and more multinationals and Indian diagnostic companies coming forward with good sensitivity, specificity, and traceability the methodology is in for diagnostics. ISO 15189:2012’s new edition also mentions POCT in the standard and the QSP and SOP to be maintained for the tests done by POCT in the scope of the respective pathology laboratory, thus opening the era of POCT and accreditation.
POC tests are simple medical tests, however, till some time back simplicity was not achievable until technology developed and better kits with better traceability were available. POCT is widely used in blood sugar tests; hemoglobin estimation; PT/INR; glycohemoglobin; arterial blood gases; cardiac markers like CKMB, troponins, BNP; infection makers like procalcitonin, urine pregnancy tests; infectious disease markers for HIV, HBsAg, HCV, drugs of abuse in urine, fecal occult blood, lipid makers; and will include many more tests in the future. Rheumatology, hormonal, tumor markers are now picking up in the field of POCT.
Standard, rapidly widely used parameters can be used by POCT; these can be used for mass screening of population, for making rapid decisions particularly in casualties for cardiac emergencies, reducing the burden on the healthcare, easy reportability, and thus use of the professional skills in the best way. POCT is a boon also in Tier-II and Tier-III cities, where access to best diagnostic labs is very rare.
The challenge in POCT is lack of availability of kits with specificity and traceability. POCT is the best way forward for our country, where there are challenges for the skilled manpower in areas like Tier-II and Tier-III cities, and there also exists a challenge in immediate access to some critical parameters like troponin. POCT will reduce the unnecessary admission in hospital, screening of major healthcare disease, and monitoring of diabetes, blood pressure.