Biosensors Market Size, Share & Trends Report 2030

Glucose biosensors are normally used to detect concentrations of glucose in individuals with diabetes. These biosensors use bioelements—such as proteins, including enzymes and nucleic acids—to analyze the concentration of glucose in individuals. The glucose biosensors market is expected to witness high growth owing to the increasing number of people suffering from diabetes. The World Health Organization (WHO) estimates diabetes as the seventh-leading cause of death by 2030. This has significantly contributed to the increasing use of glucose monitoring devices that use biosensors. Glucose monitoring devices are gaining traction due to increasing incidences and prevalence of lifestyle diseases, such as diabetes, that require regular monitoring. Moreover, the proven efficacy of such testing kits has resulted in their growing adoption by doctors. According to the International Diabetes Federation, the number of people suffering from diabetes is expected to grow by 853 million by 2040 worldwide. Glucose monitoring devices are used to detect and monitor diabetes. Presently, it is estimated that glucose-detecting biosensors account for a major share of the biosensors market.

Biosensors technology has witnessed a slow rate of adoption in the recent years due to the high price of biosensors and the demand emanating only from the healthcare industry. Adoption of biosensors for nonmedical applications, such as military, biodefense, fermentation control, and environment monitoring is a challenge for industry players due to limited R&D and positive outcomes. However, there is also a potential market for non-biomedical applications, which need to be identified by players and promoted to end users. Another reason for slow adoption is enzyme-based transducers used in biosensors. Enzyme-based transducers are expensive as the cost of sourcing, extraction, isolation, and purification is high. Biosensors also have certain disadvantages, such as heat sterilization not being possible because of denaturalization of biological material, stability of biological material (e.g., enzyme, cell, antibody, and tissue) dependent on natural properties of the molecule that can be denaturalized under environmental conditions (pH, temperature, or ions), and cells in biosensors becoming affected by other molecules that are capable of diffusing through the membrane. These factors have led to a slow rate of adoption.

Wearable biosensors find increasing opportunities for the continuous monitoring of vital signs of patients, premature infants, children, athletes or fitness buffs, and individuals in remote areas far from medical and health services. Wearable and connected biosensors enable remote monitoring to allow patients to avoid hospitalization or leave earlier. By enabling telemedicine (monitoring and transmitting physiological data from outside the hospital), wearable biosensors can ease the burden on healthcare personnel and free up hospital space for more responsive care. Smart textiles with sensors in the fabric can provide a simple, more convenient system to monitor vital signs. Biosensor patches or tattoos, leverage conformal, printed electronics, can better enable physicians to collect data on a patient for long periods. Such sensors dovetail with the quantified self-trend to track one’s biological data to optimize one’s health. Moreover, disposable patches can allow analyzing key biomarkers such as sodium, potassium, and glucose, in sweat or other substances.

Despite the high demand for biosensors for medical applications, manufacturers are facing several regulatory barriers due to multilayered regulations mandated by the FDA and the laboratory regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) (for the premarket approval of POC testing kits). For the approval of any new POC device in the US, manufacturers are required to submit performance data to the FDA. This data should demonstrate that healthcare professionals and patients can use devices and can obtain results like clinical laboratory tests. Standards and guidelines developed for point-of-care testing (POCT) using evidence-based procedures are designed to assist with the implementation, management, operation, and on-going quality assessment of the selected technology. With adherence to appropriate standards and guidelines, POCT provides significant benefits for both patients and healthcare providers. Though it helps end users, the standards and guidelines are stringent and time-consuming for the approval of new POC devices and pose a key challenge for market players.