In Vitro Diagnostics (IVD): A Closer look

Upgrading the diagnosis is an indispensable aspect in the era of developing medical facilities. Diagnosis helps to understand and interpret the human body’s reactions to infections or to various bacteria which cause disease. In addition to clinical services, the global healthcare industry is also driven by the In-Vitro Diagnostic (IVD) sector. The oligopoly is guided by better testing methods, enhanced control of the treatment and increased availability of over-the-counter tests, which has contributed to the industry’s rapid growth. Large number of medical decisions are made on the basis of In-vitro diagnostic (IVD) test results.

In vitro diagnostics are used to diagnose illness and disease using the evaluation of specimens taken directly from the human body. In vitro diagnostics market segments include diagnostic-related instruments, reagents, and software.

The Market Segments

It is segmented as per the Product type, Technique, Application, End-user and Region.

·         The market is classified into reagents, instruments and software & services, depending on the Product type.

·         The market is segmented into immunodiagnostics, haematology, molecular diagnostics, tissue diagnosis, clinical chemistry, next generation sequencing  and other IVD techniques, based on Techniques.

·         The market is divided into classes of infectious diseases, cancer, heart diseases, immune system disorders, nephrological diseases, gastrointestinal diseases, based on Application.

·         Whereas, depending on the End-user, it is divided into hospitals, academic & medical schools, point of care testing and others.

In 2019, the global IVD market covered a huge size worth US $71.2 billion. It is now estimated that the compound annual growth rate (CAGR) of 4.75% will be recorded and a market value of US$ 78 billion is projected to be reached by 2022. Rapid market growth of IVD technologies, as well as some trends, has spurred manufacturers of medical devices to continue to expand their portfolio of innovative clinical solutions.

Also the COVID-19 outbreak has resulted in the emergence in the demand for screening and diagnostics test kits. The market has experienced a rise over the weeks, which may continue over the next few months. This is mainly due to the augmented and emergency launches and approvals for SARs-nCOV-2 screening and diagnostic kits and rapid ongoing developments. This pandemic has affected the regions of Northern America and Europe the most, leading to major shortage of diagnostic kits for virus testing. The market is experiencing an upsurge in demand for in vitro testing kits in this period and is anticipated to grow significantly in the future.

With major technological advances such as molecular diagnostics and next-generation sequencing, the IVD sector has reached new heights, making a whole range of genetic, genomic and proteomic testing possible. These large-scale trends are pushing manufacturers of medical devices to expand the existing IVD technology base as well as pursue work on developing new ones. The most highly influenced technologies include:

Point-of-Care

Medical testing conducted outside the laboratory setting and much closer to the patient’s location, or POC testing, yields quick results. Those tests can be used ad hoc by patients and health care providers. Direct-to-consumer (DTC) testing is a common submarket of POC testing, which allows patient-consumers direct access to medical test results, allowing a high degree of privacy and personalization.

Most POC testing devices are handheld electronics or molecular collection tools which use the immunoassay (LFIA) platform for lateral flow. Often manufactured in the form of membrane-based test strips enclosed inside a plastic cassette, the LFIA platform has a strong track record of accuracy and effectiveness due to its use for at-home pregnancy tests, one of the earliest forms of POC testing.

In response to the rising need for fast detection of both chronic and infectious diseases, POC technology is becoming increasingly crucial. The incorporation of smart devices into POC diagnostics has made this technology safer, more accurate and more user-friendly. Biosensors are another example of the newer POC testing technology that is becoming more sensitive as research progresses. A common example of biosensors used in POC diagnostics is a blood glucose monitor which is commercially available.

Liquid Biopsy

Liquid biopsy detects biomarkers of the disease in biological fluids like blood or cerebrospinal fluid. Since most patients would prefer to avoid the pain of having tissue or cells removed for laboratory analysis, the healthcare industry has drawn considerable attention to this still-emerging IVD technology.

To date, liquid biopsy has been shown to be effective in detecting non-small cell lung and pancreatic cancer among a few others, and its improvement in sensitivity and specificity levels shows promise for early detection of cancer as well as detection of other cancers. However, standardized techniques and regulatory approval are lagging behind the research for this technology.

Molecular Diagnostics

With the increasing acceptance of more personalized diagnostics by patients and the improved turnaround time for the results of DNA testing, the technology used to analyze biomarkers in the genome and the proteome has moved to the fore in recent years. Molecular diagnostics has a wide range of applications: from infectious disease identification to oncology to immune function predictions, and which drugs work best for a given disease.

AI and IoT in Support of IVD Technologies

Artificial intelligence and the Internet of Things were both readily incorporated into the technology for in vitro diagnostics. AI brings advanced data analytics to IVD applications, and reduces errors. AI-backed IoT technology assists in remote control and equipment and system capacity management during downtime. Patients are connected to the medical data gathered from in vitro diagnostic tests via their smart devices.

From the dependency on Laboratory Developed Tests to using In-Vitro Diagnostic technologies, the medical market has grown manifolds. Results achieved from IVD tests are crucial for routine patients. These investigations help achieve a perspective on a patient’s health condition providing a gateway to know if an early intervention is necessary. This in turn not only benefits the patient from a better health perspective but also reduces a major cost from the late stage healthcare expenditures. Since the development of IVDs, the large array of markers and reagents have proven their effectiveness in testing not just for an individual for a certain healthcare issue but also served a major hand in pupulation studies. Considering the acceptance for this technology and it’s undoubted quality in terms of both results and speed, it could be easily put to picture that IVD technologies are going to have a full blown reign on the medical market with an increasing need to handle more and more patient data.