In Vitro Diagnostics Trends: Faster, Smarter, and More Personalized

According to a 2016 report in PLoS One, between 60 and 70% of medical decisions are made based on the results of in-vitro diagnostics (IVD) testing. Using the evaluation of specimens taken directly from the human body, in-vitro diagnostics are utilized to diagnose illness and disease, and many other tests including pregnancy tests, cholesterol tests, and more. Market segments for the in-vitro diagnostics market include instruments, diagnostic reagents, and software related to diagnostics.

The global IVD market is projected to reach a market value of US$77 billion by 2022, showing a projected growth of over 54% as compared to a market value of $50 billion in 2011. The rapid market growth of IVD technologies, as well as certain trends, has spurred medical device makers to continue expanding their portfolio of innovative clinical solutions. These solutions include clinical laboratory tests, molecular diagnostic tests, and other point-of-care tests. 

Trends Currently Driving IVD Technologies

Since the 1990s, genomic research has been a major driver that has benefited the in vitro diagnostics industry. But more recently, the industry is responding to several widespread developments, which have triggered innovations and expansion in IVD technologies. These large-scale trends include:

• Aging global population People around the world are living longer. In 2017, the United Nations estimated that 962 million people or 13% of the world's population are aged 60 years or older. Their numbers are expected to double by 2050. Key consumers of cardiovascular, diabetes, and other chronic disease tests are found in this population segment. 
• Prevalence of chronic diseases While the growing segment of older people is more vulnerable to chronic diseases such as diabetes, cardiovascular disease, and cancer, they negatively affect patients of all ages. Factors such as sedentary lifestyle, poor eating habits, smoking, and high alcohol consumption among large swaths of the population have contributed to the increase in these conditions.
• Increase in the occurrence of infectious diseases HIV, Methicillin-resistant Staphylococcus aureus (MRSA), streptococcal infections, influenza, hepatitis, Zika virus, and other diseases have created a high disease burden worldwide. Early detection of infectious diseases can make the difference between life and death in many cases.
• Influence of big tech innovators Google, Apple, IBM, Dell, and other movers and shakers in information technology are finding ways to transform raw IVD data into actionable medical knowledge.
• Acceptance of personalized care and desire for ease-of-use  Consumers have warmed to the idea of DNA testing in health care. They also want to be able to track their conditions more closely and to take control of when and where they receive diagnostic testing. 

IVD Technologies Riding the Wave of Surging Trends

Industry trends that are grounded in rapid disease identification, ease of use and personalized care for patients, and the advanced use of analytics. These trends are pushing medical device manufacturers to expand the current base of IVD technologies as well as to pursue work on developing new ones. The technologies that are most heavily influenced by these trends are point-of-care (POC), liquid biopsy, molecular diagnostics, and artificial intelligence (AI), and the Internet of Things (IoT) used in conjunction with in-vitro diagnostics.

Point-of-Care

Medical testing performed outside of the laboratory setting, or POC testing provides rapid results. Patients and health care providers can use these tests ad hoc. A popular submarket in POC testing is direct-to-consumer (DTC) testing, which gives access to medical test results to patients-consumers directly, allowing a high level of privacy and personalization.

Most POC testing devices are handheld electronics or molecular collection tools that use the lateral flow immunoassay (LFIA) platform. 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 in at-home pregnancy tests, one of the earlier forms of POC testing.

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.

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.

Watch our video series about biomedical innovation. 

Molecular Diagnostics

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

AI and IoT in Support of IVD Technologies

Artificial intelligence and the Internet of Things have both been readily incorporated into in vitro diagnostics 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.

Conclusion

An informed public and increased demand for rapid disease identification have helped the in vitro diagnostics industry to flourish in recent years. IVD technology is boosted both by the continued advancement of molecular diagnostics and the connection to smart devices at the intersection of AI and IoT. Despite slightly slower progress in IVD technologies such as liquid biopsy due to regulatory hurdles and still evolving research techniques, medical device makers are anticipating additional opportunities to create more innovative products in this industry.