It is estimated that around 60 percent of all medical decisions are made with the support of in vitro diagnostic (IVD) testing. In vitro diagnostics are used to diagnose illness and disease by evaluating biologic specimens taken directly from the human body. IVD market segments include instruments, reagents, and software that is used in diagnostics. Due to the increased aging population, the need for IVD products is growing. The global market for these products reached $61 million in 2016 and is expected to generate $84 million in revenue by the year 2023.
In the past, in vitro diagnostics were only available in the clinical setting. Advances in technology have made it possible for many tests to be undertaken at home, often with nearly instant results. Home tests are no less accurate, more convenient, and can be easily performed by the end user. Point-of-care systems are generally membrane-based test strips that are enclosed inside a plastic cassette. These patient self-tests can detect changes in disease pathophysiology at the earliest onset; empowering patients to take better control of their illnesses. More advanced diagnostics have also been developed. Tests that require only a single drop of blood, urine, or saliva can be performed and interpreted within minutes. The point-of-care market has made way for a robust and thriving retail segment of the industry.
Furthering this growth trend is the global evolution of the Internet of Things (IoT). It is estimated that by the year 2020 there will be over 30 billion connected devices. While the specific IVD segment of IoT connected devices is unknown, the software and IT community are stepping up to improve efficiencies, increase security, and drive revenue opportunities. Three main areas for the IVD market to capitalize on the increasingly connected world are:
There are corporate, practical, and technological challenges within the IVD industry. We will discuss a few of the most notable yet surmountable difficulties here.
As far back as 1997, it was noted that the market for IVD was becoming crowded. In the intervening years, regulatory and compliance matters have thinned the market considerably. However, it remains one of the most competitive in the broader biomedical materials industry. Today every aspect of the IVD industry including core lab, POC, hematology, molecular testing, blood banking, histology and cytology, microbiology, and coagulation are heavily regulated.
Furthermore, the strict quality control standards each company must employ are often self-limiting —though necessary. Quality assurance measures must be present in every step of the IVD manufacturing process. With the changing regulatory landscape, evolving customer needs, and industry consolidation, quality is even more critical. QA plays a crucial role in ensuring that IVD tests are accurate, reproducible.
In the IVD industry, there are literally no "one-size-fits-all" solutions. Every device and each test are required to meet different and specific criteria. From particular reagent solution to the filtration and membraneous collection materials, each must be produced according to the testing device to achieve the best performance and most accurate and reliable results. The degree of customization needed in the supply chain to meet industry standards can be challenging. The supply chain plays a significant role in ensuring that the manufacturing of IVD products is conducted with no interruption. Companies like Sartorius whose expertise in the production of specific, varied, and custom microporous membranes are positioned for continued growth due to their agility.
With these factors in mind, we expect to see explosive growth in the following:
Non-invasive Prenatal Testing: NIPT only requires a simple blood test to analyze the circulating DNA of a fetus and will pinpoint a baby’s risk for many genetic disorders. This test is currently elective for many patients of low to moderate risk. However, it is preferred over more invasive tests that elicit more significant risks to the mother and baby.
Next Generation Sequencing: NGS is the catch-all term for modern DNA and RNA high-throughput sequencing. It includes the following:
All of these technologies allow for a less expensive application of genomics and precision medicine than previously possible.
Liquid Biopsy: This is a simple blood test that can look for cancer cells circulating in the blood. It isolates pieces of DNA from any tumor cells. The liquid biopsy can be used to help discover cancer at its earliest stage. It may also be helpful in planning treatments or in determining how well a treatment is working. It can be diagnostic of recurrent cancer.
In vitro diagnostics are already prevalent in aiding in diagnosis and decision making throughout the healthcare industry. The IVD market is expected to continue to grow in order to keep up with the aging population. In conjunction, the technology to better remotely monitor patients is improving, opening additional opportunities for more advanced at-home testing.