Rising tech in the IVD market

The IVD market is poised for growth with aging population and advancements in testing methods. However, which areas will grow the fastest will depend on the potential future pandemics, lifestyle trends that might have an impact on chronic diseases, and consumer demand.

IVDs form a significant and indispensable part of the patient journey in the current healthcare systems. Over the last two decades, they have significantly advanced from being just screening tools. They are not only enabling better healthcare efficiency but better economics of treatment as well. This has become possible by them being part of screening, diagnosis, determining prognosis, stratification of patients, as well as monitoring during the treatment cycles.

The demand for testing and movement of current and new technologies has continued to demonstrate gains in most areas of the IVD market. New products, changes in global health spending, regulatory changes in major markets, and disease trends are among the factors that produce a constantly evolving market picture. There are some growing segments in the market that have attracted industry attention. Among these are next-generation sequencing (NGS), personalized medicine, and mass spectrometry. Immunochemistry, point-of-care (POC) testing, and molecular diagnostics are also segments of great market interest, anticipated to be a core part of the future of IVD. The IVD market remains dynamic, demonstrating constant innovations.

In coming years, many Indian players will emerge and contribute toward overall market development of this unorganized sector to organized. Industry has already seen big pharma companies and chains of hospitals entering into laboratory testing as an important business vertical. This transformation is critical and will continue to bring more and more technological advancements, such as incorporation of data analytics, artificial intelligence (AI), and machine learning (ML) in laboratory testing to advance the science of diagnostics.

In addition, the application of machine learning, deep neural networks, and multimodal biomedical AI is poised to reinvigorate clinical research from all angles, including drug discovery, image interpretation, streamlining electronic health records, improving workflow and, over time, advancing public health. In addition, innovations in wearables, sensor technology, and Internet of Medical Things (IoMT) architectures offer many opportunities (and challenges) to acquire data.

Technology trends
POCT and microfluidics. A major trend in the in-vitro diagnostics world is the rise of point-of-care testing (POCT) performed at or near the site of the patient, such as the doctor’s office or the patient’s own home. POCT provides significantly faster turnaround times than central or satellite laboratory testing, and is associated with much lower costs.

Recent years have emphasized the need for faster, accurate, more affordable, and less invasive diagnostic tests. During the height of the Covid-19 pandemic, rapid at-home testing kits were indispensable tools. As the prevalence of diseases continues to rise, POCT will only become more important, particularly in remote and low-income settings.

POC technology is becoming increasingly crucial in response to the expanding need for rapid identification of both chronic and infectious diseases. The incorporation of smart devices into POC diagnostics has increased the safety, accuracy, and user-friendliness of this technology. Biosensors are another example of newer POC testing technology that is gaining increased sensitivity as research advances. A common example of biosensors used in POC diagnostics is a commercially available blood glucose monitor.

Further trends in the IVD market include the high demand for low-volume sample analysis and high-throughput screening methodologies. One emerging technology with the potential to answer these challenges is known as microfluidics – miniaturized devices that manipulate the behavior of a fluid through a series of reagents. Microfluidics devices are sometimes referred to as lab-on-a-chipBiomarkers. due to the technology’s ability to integrate several laboratory functions on a single integrated circuit.

The potential for microfluidics is only just emerging, with advantages including low-volume sample analysis, high-throughput analysis, automation, and rapid analysis times, plus a small footprint, low cost, portability, and disposability.

As the industry continues moving to POCT, lab-on-a-chip devices are the ideal way to get there, and a large number of medical devices companies are currently innovating in this space.

One company, for example, has commercialized a POCT blood analysis system that can perform up to 14 different tests using just 0.1 ml of blood on a single disc. Results are provided in as little as 12 minutes. Meanwhile, another company has marketed a device that enables clinicians to quickly test for 22 different pathogens associated with a range of respiratory infections. The single test requires one nasopharyngeal swab and delivers a diagnosis in 45 minutes.

Silicone elastomers (PDMS) have emerged as a key material in microfluidic chip fabrication due to a range of advantages and unique properties. Silicone’s chemical inertness, optical transparency, and flow properties make it highly suitable for microfluidics. In addition, its ease of processing, rapid manufacturing, flexibility, and lower cost has made silicone an easy choice for many companies.

Silicone materials lend themselves to use in injection-molding processes, meaning small-scale components can be produced at very high volumes. This often gives silicone the edge over other polymer materials, such as thermoplastics, from early-stage manufacturing right up to the way to commercialization.

To successfully run biochemical tests in a confined environment, advanced materials are required for gaskets and adhesives. Silicone elastomer technologies can once again be used in these applications, creating strong bonds between substrates, and preventing fluid leakage.

Biomarkers. Predictive and prognostic biomarkers are driving this revolution. An early example is the prostate-specific antigen (PSA) blood test, which contributed to a 40-percent decline in the prostate cancer mortality rate when it became widespread in the US in the 1990s.

Biomarkers are also used to inform treatment decisions, helping physicians predict a patient’s response to a drug, avoid adverse side effects, and optimize treatment plans. The discovery of the HER2 gene as a predictor of a metastatic breast cancer patient’s response to Herceptin is a well-known example.

With other biomarkers being identified all the time, scientists are well on their way to a new model of medical care known as precision medicine, where the right treatment can be selected for the right patient the first time around.

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

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

Molecular diagnostics. In the last five years, molecular diagnostics has emerged as one of the largest and fastest growing segment within the IVD industry, primarily due to significant advances in the PCR, especially RTPCR (real-time polymerase chain reaction) and next-generation sequencing (NGS). These advances are allowing amplification and decoding of genetic and epigenetic information. Molecular diagnostics/testing development spreads across genetic disorders, infectious diseases, as well as oncology.

Global molecular diagnostics market outlook has witnessed several advancements over the years, owing to robust efforts from the industry players to develop innovative products and achieve commendable market share. Research studies pertaining to molecular diagnostics solutions have offered a deep insight of molecular attributes to the healthcare industry to facilitate a better understanding of human health and develop care standards for diagnoses of diseases.

The introduction of NAAT (nucleic acid amplification test) devices has given healthcare professionals access to more advanced diagnostic tools. Since these tools possess high specificity, sensitivity, and offer superior-quality results, the CDC or Centers for Disease Control and Prevention has certified NAAT as the gold standard for the diagnosis and detection of various ailments, such as influenza, malaria, and trichomonas. This, in turn, is likely to present lucrative growth prospects for the global market outlook in the forthcoming years.

Similarly, technologies relating to multiplex assays has emerged, which has obviated the need for drawing large amount of patient blood samples.

Another technology, which has come to prominence, has been the new improved versions of lateral flow assays, offering cost advantages and higher specificity and sensitivity as compared to predecessor versions. This is an important enabler for both emerging countries as well as POCT.

Digital PCR. Digital PCR transforms exponential and analog polychromase chain reactions into a linear, digital signal. The technology has been shown to be better than other methods at detecting subtle differences between samples with similar genomic structures. This is especially important in determining drug targets for pharmaco-diagnostic testing and stratifying disease.

At this time, no digital PCR systems have been cleared for clinical diagnostics, but they are used in cancer research. Billerica, MA-based RainDance Technologies’s microdroplet-based RainStorm technology enables researchers to perform fully automated biological analysis in disease areas, including cancer, infectious disease, immunology, and genetic screening. In 2012, Carlsbad, CA-based Life Technologies (acquired by Thermo Fisher Scientific early this year) introduced its QuantStudio 3-D digital PCR system, a scalable, chip-based instrument that the company says is offered at a bench-top price, potentially democratizing this technology for the rapidly growing market. The QuantStudio is used for cancer research only, though an FDA-cleared version can be used with Quidel flu assays.

Digital clinical diagnostics. Software technologies being developed on the back of significant advancements in the medical data storage, integration and interpretation capabilities, and aided by AI/ML are helping in the development and commercialization of digital diagnostics. These would be approved by US FDA and other regulatory bodies as screening tools aiming at freeing up specialist healthcare provider time. These advancements would, therefore, allow wider reach of diagnostic technologies for better patient care.

AI and IoT in support of IVD technologies. AI and IoT have both been readily incorporated into IVD technology. AI brings advanced data analytics and reduction of errors to IVD devices. IoT technology backed by AI assists in remote monitoring and management of devices and device efficiency during downtime. Through their smart devices, patients are connected to the medical data gathered from in vitro diagnostics tests.

Needless and less invasive blood sample collection devices. Needle-stick injuries to healthcare providers as well as patient distress caused due to multiple needle punctures have been major unaddressed problems primarily in the in-patient diagnostics. Innovators are working on devices, which allow blood collection from the indwelling catheter line as well as needless blood collection devices, which can help less painful blood collection and improve patient experience.

Smartphone-based biosensors as a diagnostic tool. Certain companies and researchers are working to ensure utilization of advancement of sensors being used in smartphones. Ixensor, is developing a smartphone-based diagnostic platform – a software algorithm, which turns immunodiagnostic strip data using color and image sensors in the smartphone.

Market trends
Over the next decade, Kalorama predicts a number of trends that will shape the IVD market, from increased participation by non-US countries to increased collaboration between companies and evolution of sampling methods. Some of the trends include:

Regions of market influence. Korea and China are slated for higher overall growth in IVD. The Chinese market for IVDs is estimated at nearly USD 6.6 billion and is expected to show annual growth of 3.8 percent to reach USD 7.9 billion in 2027. Glucose monitoring is a major focus area for the Chinese IVD market, representing roughly 25 percent of the market’s value. South Korea, which in 2020 initiated a fast-track procedure for international patients with severe illness, has shown tremendous growth in medical tourism. The IVD market in South Korea is considered favorable for its regulatory process and foreign investment opportunities. The IVD market in Korea was estimated at USD 545 million in 2022 with 5.8 percent annual growth, reaching nearly USD 721 million by 2027.

Collaborations, acquisitions. The future of the industry lies in the development of more sensitive, faster, user-friendly, information technology-capable devices for a host of new protein and molecular markers. No company owns all the technology needed to develop these new tests and systems. Thus, many companies are acquiring other IVD manufacturers to shore up their research and development. For example, in February 2022, BD, looking to broaden its flow cytometry segment for hematologic cancer and blood diseases, acquired Cytognos. In April 2022, bioMérieux acquired Specific Diagnostics to add to its critical infection sepsis line, and in June 2022, Fujirebio acquired ADx NeuroSciences and Qiagen acquired Blirt for additional growth in reagents.

New sample methods. Tests using blood, nasal fluid, and tissue dominate the IVD market, but the search for easier-to-collect samples continues. The pandemic and the need for rapid, reliable testing has heightened interest in saliva as a convenient medium for infectious diseases. Recent studies have shown that saliva is just as effective as a nasopharyngeal swab for traditional SARS-CoV-2 PCR tests and useful in at-home rapid antigen tests. The Food and Drug Administration has issued more than 30 emergency-use authorizations for saliva-based SARS-CoV-2 tests. Saliva is also increasingly being used to diagnose diseases affecting the mouth, esophagus, stomach, large and small intestines, kidney, and liver.

There is also work being done in using breath and capillary blood for diagnostic testing. Patient-focused testing services, such as Everlywell, Everly Health, and LetsGetChecked, are driving the market for finger-prick sample collection.

Patient-focused testing services want to make sample collection as easy as possible. POCT is also pushing sample collection in that direction.

Outlook
Overall, it is clear that there is more innovation in the IVD ecosystem, as increasing technological advancements continue to play a key role in diagnosis, supporting both physicians and patients.

As the global population ages and new testing methods are developed, the worldwide IVD market will continue to grow. But which areas will grow the fastest will depend on a number of key factors, including potential future pandemics, lifestyle trends that might have an impact on chronic diseases, and consumer demand.

A consumer-oriented democratization of testing is sure to play a key role in growth of in vitro diagnostics, especially as consumers have become more knowledgeable about testing during the Covid-19 pandemic. Automation also will help to drive growth in the IVD market.

The pandemic really exacerbated the labor shortage in labs, which has made automation even more important. With more automation comes the ability to perform more tests, which will lead to an increase in development of new assays. Automation is a big growth driver.