The IVD industry, globally and within India has observed phenomenal changes in the way it supported the diagnosis of COVID-19 samples. From logistics capabilities, to testing capacities, to reporting, all activities observed a turnaround in the way they used to function before COVID-19. India alone has registered 400 percent growth in the number of new labs which started molecular testing during the pandemic. By mid-March 2021, India had 2400 molecular laboratories performing COVID-19 PCR testing. This is a huge step toward making India Atmanirbhar for complex disease testing, where molecular techniques are proven to be the gold standard. While the disease remains uncontained, such demand is likely to keep growing.
Demand for IVD products of all kinds—reagents, instruments, and systems used to diagnose and monitor COVID-19, heart disease, diabetes, and other conditions— is surging. Prominent players, including 3B Blackbio Biotech, HiMedia, Trivitron Healthcare, Mylab are expanding in the market very quickly. And they are meeting an increasingly supportive regulatory landscape for product development and commercialization.
The IVD market has been propelled by the COVID-19 pandemic for much of this year, and the global response to the crisis is expected to continue to drive diagnostics growth. But it is not the only driver.
Also pushing the market for IVDs will be a number of factors. First, as diagnostics laboratories increasingly use fully automated instruments, they will decrease hands-on time, reduce batch testing, and provide doctors with quicker tests compared to non-automated instruments. Second, the integration of biomarkers and the availability of biomolecular tools are predicted to help in the development of a new set of condition-specific tests, thus creating new opportunities for the growth of IVD market size. And finally, the IVD market will be driven by the use of personalized medicine products in treating cancer and other chronic diseases, along with increasing technological advances related to artificial intelligence and machine learning, which makes it possible to achieve higher levels of diagnostic precision.
The IVD market in India is growing at a phenomenal pace and the country has the potential to emerge as a global manufacturing hub in the medical devices space. India is the fourth largest market for IVD devices in Asia after China, Japan, and South Korea. Demand for personalized medicines, innovation in diagnostic techniques, increasing preference for point-of-care testing among the general population, a growing geriatric population base and increasing disposable incomes are driving the growth of the IVD sector in India.
Increasing proliferation of lifestyle ailments like heart disease and rising awareness of minimally invasive and non-invasive diagnostic techniques have emerged as positive triggers for positioning India as a rapidly rising market for IVD devices. The demand for clinical chemistry products is anticipated to be vastly bolstered by advances in self-monitoring methods for diabetes and patient screening techniques along with the increasing use of point-of-care systems which offer greater diagnostic accuracy. The molecular diagnostics products market is expanding rapidly as they possess higher precision and allow for speedy detection of infectious diseases and genetic disorders at an early stage of development.
To ensure the availability and supply of oxygen for medical use during COVID-19, premises having facility to manufacture industrial oxygen for medical use should be granted manufacturing license to manufacture oxygen for medical use within 24 hours of receiving application, fees, etc.
The novel coronavirus disease (COVID-19) has raged into a second wave which has become more testing in April: More than 273,000 news cases and 1,620 deaths were recorded till April 19, 2021.
This more deadly phase has stressed out India’s health infrastructure and the improvements made in the last year. Scarcity of testing kits, vaccines, hospital beds, and medical oxygen have been reported from several states.
Accelerated development and adoption of new technologies
As the COVID-19 pandemic gathered force, demand grew for not only faster testing but also testing in much higher volumes. That demand was a struggle to meet when it came to RT-PCR testing, as a result of laboratories’ turnaround times and shortage of reagents.
The response to that struggle has been the accelerated development of new diagnostic technologies, such as next-generation sequencing (NGS) and CRISPR. Those technologies could come to challenge the leading position of the current RT-PCR systems for viral COVID-19 tests, particularly if regulators further facilitate their fast introduction.
NGS has benefited from regulatory support. After decades of development in precision medicine, NGS could potentially become a platform for large-scale diagnostics, meaning that it would be suitable for testing entire communities or for conducting epidemiology studies. Authorities in China and the United States have already approved some NGS-based COVID-19 diagnostics for emergency use.6 Others are in development, with throughput as high as 100,000 samples per run.7 The companies pioneering such diagnostic techniques could well remain in the market in the future thanks to their technological expertise, manufacturing capabilities, and market acceptance established during the pandemic.
As the COVID-19 pandemic gathered force, demand grew for not only faster testing but also testing in much higher volumes.
Manufacturing-Capacity expansion in Asia and shift of supply
As demand for components used in molecular assays has soared, leading manufacturers, particularly those in China, have hurried to increase capacity for them. As a result, China now accounts for between 70 and 90 percent of global capacity for major molecular-assay components. That could eventually make China the leading global supplier for the diagnostics, too.
A laboratory organization whose activities span more than one field of testing or program, or which operate at multiple sites within a field, or involve a combination of multiple sites and fields/programs under a single Approved Pathology Authority, with a single quality management system, is regarded as a Laboratory Network. Tests that are manufactured and distributed only within such a network are considered, for regulatory purposes to be manufactured in-house.
Such a laboratory network must have a quality policy common to all sites manufacturing and using the in-house tests.
The quality system must be centrally managed and uniformly applied across all work locations manufacturing and using the in-house tests. Some local work instructions may be necessary due to location requirements etc. As a minimum requirement, the following elements of the quality system must be centrally managed: Management review; Internal quality audits; Corrective and preventive action; Complaints; Changes to the quality system documentation for key elements; and the network must have procedures for the control of site calibration and/or testing.
The organisation must have appointed a management representative with responsibility for maintenance and application of the quality system across all sites, fields of testing and/or accreditation programs.
Laboratory organisations with appropriate NATA Corporate Accreditation can be considered as a laboratory network, and may manufacture and distribute within their network as manufacturers of in-house tests. Distribution of a laboratory manufactured test in a multi-site organization that does not fulfil this definition will be considered as commercial supply, and these tests will be regulated as such.
The laboratory network must operate under a single Approved Pathology Authority (APA).
More than ever, IVD tools are needed to expand our options in detecting and diagnosing viral-mediated diseases. With the spread of SARS-CoV-2 it became indispensable to track and predict the hotspots of the outbreak, and to monitor the virus and the mutants thereof. It is THE time for IVDs to demonstrate their benefits in diagnostic testing by providing essential information on the scale, location, and trajectory of the disease.
It is paramount to be able to evaluate the infection status of whole populations, including symptomatic patients and asymptomatic carriers, and to assess potential immunity of individuals who were at risk or exposed to the virus. While IVD advantages include quick results, simultaneous multiple testing, ease of data recording, or scalability, the main reason for superiority is the test reliability and repeatability.
Accurate testing is a prerequisite for coping with COVID-19, however, the development of IVDs against viruses is not a trivial endeavor.
Up to date, the development of COVID-19 tests has ramped up massively. The rapidness of disease spreading and the urge to carry out large-scale testing, has led to the commitment of the diagnostic industry to concentrate its production and development capacities on one common goal. Despite the pace and urgent need, it remains critical to ensure a test’s reliability. Therefore, despite the high number of tests required to be readily available, developers need to ensure an in-depth quality control and quality assurance infrastructure to maintain accuracy and comparability.
To respond effectively to the outbreak, several test formats are currently available or in development: Molecular diagnostic tests useful for the detection of the virus, disease diagnosis and monitoring; IgG- or IgM-based tests to assess potential immunity, or tests to assess the viral load. Such tests would enable rapid, point-of-care testing, however, largely depend on validated specific antibodies, which extends their development time.
The reliability of all these test options is anchored in the reliability of their single components. Upon failure of one, virus-shedding carriers may be erroneously identified as virus-free. Therefore, both the IVD analytical and clinical performance needs to be defined through an appropriate validation strategy, batch release controls, and verification measures to ensure the reliability of the tests.