The in-vitro diagnostics (IVD) market is expected to reach USD 96.07 billion by 2025. According to primary and secondary research, the development of condition-specific markers and tests, growing significance of companion diagnostics, and point-of-care (POC) tests with multiplexing capabilities are the factors that are expected to provide significant growth opportunities in the coming years.

The Markets and Markets In Vitro Diagnostics Crystal Ball Event was a global virtual event that took place on February 28, 2022. Dr. Kumar PBS Pabbisetty, Associate Director, IQVIA MedTech, was among the four expert panelists that delved into discussions about the most promising opportunities in the IVD ecosystem, emerging technologies and approaches, and the key factors and considerations that IVD companies should focus on for the next decade. This blog covers four key questions that were answered throughout the event and highlights Kumar’s expert insights.

1. “What are the top 10 revenue growth opportunities for IVD ecosystem participants over the next 5 years? Which markets, technologies, customer segments are the most attractive to place bets on?”
   
   All four panelists highlighted many technological advancements in the IVD space, with Dr.Sudhakar S. Marla, Senior Director, Oncology Research and Development, Cepheid, emphasizing that we have barely scratched the surface of the IVD ecosystem.
   
   Kumar shared insights on the growing sectors of biosensors, software as medical devices, and microarrays as an opportunity for IVD companies. For example, he highlighted the advancements for the last two decades using microfluidic technologies, next generation sequencing, and microarrays, such as using one plate to analyze all of a person’s genes with limited effort and time. He also explained the increasing focus on precision medicine as companion diagnostics in monitoring and to identify therapeutic response of drug, and how the industry is now at a stage where we can predict future outcomes and prognosis of cancer and genetic disorders.
   
   Overall, technological advancements are enabling the industry to move beyond just the diagnosis stage. The IVD space now plays a key role in not only identifying symptoms and diagnosis, but in patient monitoring, personalized medicine, hospital management, and supporting physicians, clinicians and patients.


2. Which technologies and/or approaches are likely to result in the improvement or optimization of turnaround time, sensitivity and throughput of infectious diseases and cancer diagnosis?
   
   When it comes to sensitivity and specificity improvement, there is no one-size-fits-all approach — some tests may have low sensitivity, whereas others may have low specificity. While latest technologies such as molecular diagnostics have a high specificity and sensitivity, for other types of rapid tests there is scope for improvement especially tests used it for confirmatory purpose. For example, in many countries, POC tests are recommended to be used for disease identification and not for disease confirmation. However, if they have high sensitivity and specificity, it may be recommended for confirmatory and no follow-up is required.
   
   According to research, most of the errors occur at either the pre-analytical stage or the post-analytical stage. However, Kumar explained that there are some pre-analytical factors already being addressed by some manufacturers, such as avoiding misplacement of sample tubes by barcoding the tubes and ensuring the preservation of specimen stability during sample transportation by following guidelines.
   
   Overall, there is no complete standardized approach in improving specificity and sensitivity, and a lot of effort is being put into research and development for analytical validation and verifications followed by international standards, such as the International Organization for Standardization(ISO)/Clinical and Laboratory Standards Institute(CLSI) to bring good products to the market.


3. What are the key factors and considerations that IVD companies should focus on to make molecular diagnostics more affordable?
   
   Currently, laboratory identification tests come at a high price compared with routine diagnostics, and there is a need to balance the cost of the tests and producing accurate results for the patient. Kumar highlighted that there are several steps that can be taken by manufacturers and laboratories to make molecular diagnostics more affordable. For example, manufacturers can consider:
   • Provision of multiplexing capabilities, and high throughput of samples.
   • Process optimization through the automation and lean manufacturing.
   • Utilization of open systems that allow the customer and laboratory to select their choice of reagents and kit to reduce test cost.
   
   On the other hand, laboratories can also help to reduce costs by:
   • Optimizing the capital equipment costs by taking higher sample volume load of an equipment (e.g., selecting a 384 well plate instead of a 94 well plate in a polymerase chain reaction test or other tests).
   • Being aware of the timeframe for holding the samples and adding this into their standard operating procedures.
   • Considering a POC molecular diagnostic test for a better turnaround time.


4. Can mass spectrometry/liquid chromatography–mass spectrometry systems gain significant traction in clinical diagnostics in the next 5–10 years?
   
   Kumar shared his expert knowledge that matrix-assisted laser desorption/ionization (MALDI) is popular due to its limited amount of sample requirement for testing, ease of preparation, large database, and wide applications in clinical diagnostics. He also suggested that MALDI-time of flight (MALDI-TOF) play a key role in the early identification of microorganisms, highlighting that less sample is required for fastidious microorganisms and that it provides fast and accurate test results. He also highlighted that prescribing the right antibiotic is essential in identifying bacteria at species level. However, it is limited to its usage in clinical laboratories, especially in developing countries, due to high capital equipment cost.

The future of IVD is promising

Overall, it’s 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. Throughout the Markets and Markets event, the panelists provided their perspectives on the areas where there is scope for improvement, as well as key opportunities that will become available with research and development investment.

To listen in more detail about the most promising opportunities in the composites market, as seen through the lens of eminent chief experience officers in this space, reach out to the Markets and Markets team to watch the full event on demand.

IQVIA MedTech offer years of experience and expertise in the medical device and diagnostics space. If you’d like to learn more about how we can support you in this ever-changing environment, contact our team today.