In the ever-evolving landscape of digitization in the pharmaceutical and healthcare industry, digital biomarkers emerge as a viable solution for early disease diagnosing and screening. Digital biomarker is an analytical tool analyzed in silico using advanced algorithms, ensuring real-time data analysis. Biomarkers play a significant role in regular disease monitoring in patients and developing tailored therapies based on genetic information. During drug development, digital biomarkers help identify undetected biological events that conventional processes fail to capture. The data collected from digital biomarkers has been processed by transferring it into medical devices and computational software for detailed analysis. Real-time analysis allows researchers to generate actionable insight and modify drug formulation, significantly reducing the time needed to develop the drug and improving accuracy. In the healthcare industry, digital biomarkers help in early screening, saving time for diagnosing disease and providing precise treatment to improve patient outcomes. Owing to its significance, several regulatory bodies across the globe have begun to evaluate software as a potential medical device. As the trend continues, digital biomarkers market players continue exploring advanced digital solutions that improve disease diagnostic and treatment protocols. Let’s take a deep dive into the future trends of digital biomarkers that will be followed in the upcoming years to facilitate treatment protocols.
What Are Digital Biomarkers?
A digital biological (biomarker) is an objective measure derived from digital devices such as wearable smartwatches to measure heart rate, blood pressure, sleep activity, and blood flow. These biomarkers are helpful in clinical research, disease diagnosis, patient care, and therapeutic development. Examples of digital biomarker categories include diagnostics, susceptibility, monitoring, predictive, prognostic, and safety biomarkers. Digital biomarkers have also been used in various therapeutic areas, such as cardiovascular disorders, neurological disorders, movements, and respiratory conditions.
What is the Importance of Digital Biomarkers in Clinical Studies?
Drug development is a time-consuming endeavor, and it may take around 10-15 years to develop a drug for therapeutic usage successfully. Most of the drugs under clinical trials failed to reach the development stage due to invalid data and lack of evidential proof of safety. The integration of digital technologies, such as digital twins and digital biomarkers, has paved the way for clinical studies with real-time tracking. With digital biomarkers, researchers can study the therapeutic effects of drugs with high precision —ultimately reducing the time of clinical trials and helping to save plenty of investment waste due to drug failure. Here are a few more benefits of using digital biomarkers in clinical studies.
▪ Continuous Monitoring
Digital biomarkers facilitate clinical studies with real-time data prediction. It helps to monitor physiological and behavioral changes continuously during drug trials. The continuous tracking of health data provides a comprehensive representation of individual health, allowing researchers to modify drugs and change formulation precisely using the collected data.
▪ Early Detection and Screening
Early detection prevents disease progression and patient complications during drug trials. With digital biomarkers, researchers can detect subtle changes in volunteers’ health parameters and take necessary preventive steps to safeguard patients from the effects of drugs. Moreover, early detection is also helpful in modifying drug formulation based on the data recorded by digital biomarkers.
▪ Enable the Development of Precision Medicine
Digital biomarkers help researchers and healthcare professionals tailor drugs or interventions based on specific patient characteristics. These digital biomarkers play a crucial role in compiling data through digital sources such as mobile applications, wearable devices and other digital tools. For instance, digital biomarkers help to monitor changes in the heart rate, sleep pattern, activity level and physiological behavior metrics. The information collected using digital biomarkers enables clinicians to advance their research for the development of drug formulation according to unique patient requirements that further helps to improve positive outcomes.
What is the Current Digital Biomarkers Market Landscape?
The current market landscape features over 30 players, which are actively engaged in developing digital health solutions and digital biomarkers that can be analyzed in silico for the study of diseases and clinical conditions. The ongoing digitization efforts that have contributed to the pharmaceutical industry have led to the development of advanced biologics that help to treat a broad range of diseases, including cancer.
Currently, several industrial start-ups and market players are trying to develop advanced digital biomarker solutions that revolutionize clinical trials, disease diagnosis, and patient monitoring. When digital biomarkers are integrated with specific phenotypic signatures, they show great potential to generate data insights associated with esoteric medical fields such as neurology and psychiatry. Experts believe that in the future, diagnostic / treatment protocols for different medical indications, such as how biochemical biomarkers manage hypertension and diabetes, are likely to be determined by digital biomarkers.
What Are The Top Trends in Digital Biomarkers?
Digital biomarkers provide a deep insight into vital health parameters and potential healthcare problems. The ongoing innovations in bioinformatics, genomics, metabolomics, and proteomics have accelerated the demand for advanced biomarkers that led to precise diagnostics and treatment. Currently, digital biomarker providers are focusing on the top trends of digital technologies that benefit the biopharmaceutical and healthcare industry by simplifying drug development and disease management.
1. Vitality Biomarkers
Reactive approaches to managing diseases and personal health are the main emphasis of healthcare systems. Several industrial stakeholders are creating digital biomarkers that monitor or gauge an individual’s vitality.
Vitality biomarkers allow doctors to assess a patient’s health before symptoms appear. This makes it possible to intervene early and may possibly stop health issues from getting worse. Furthermore, wearable and Internet of Things (IoT) devices are democratizing these improvements by recording important health data in real time. The data collected from these devices significantly contributed to disease diagnosis and early screening.
2. Microbiome-Based Risk Analysis
Developing a single medication that works for all patients is challenging due to the complexity and variety of illnesses. Furthermore, the main reason for this lack of personalization is that traditional diagnostic techniques must consider the microbiome effect. Considering the reasons above, digital biomarker-developing companies are now focused on developing AI-based solutions for identifying biomarkers within the human microbiomes.
For instance, a microbiome artificial intelligence drug enabler is a cloud-based solution that utilizes comprehensive microbiome datasets. It facilitates the discovery of therapeutic molecules and integrates computational biology to enhance the development of personalized medicines.
3. Advance Imaging Biomarkers
The traditional diagnosing approach consumes significant time to generate definitive results. Moreover, patients may undergo different ineffective treatments that enhance the cost and may lead to potential side effects. The development of advanced imaging biomarkers enables healthcare professionals to track change at the cellular level in real time—providing enormous metrics of disease progression.
For instance, diffusion-weighted imaging solutions analyze the treatment effect on tumors by tracking water molecule movement. The functional imaging biomarker helps to measure metabolic responses to different therapies in conditions such as heart disease. Advances in imaging biomarkers enable clinicians to extract vast amounts of information using data characterization algorithms that aid in precisely characterizing disease and predicting treatment outcomes.
4. Non-Invasive Biomarkers
Painful, invasive diagnostic procedures reduce patient compliance and result in less frequent monitoring. The invasive monitoring approach poses a risk of infection and complications. Due to which many patients avoid early detection or regular monitoring, resulting in an increasing risk of diseases and treatment failure. Hence, non-invasive biomarkers such as breath, feces, saliva, and urine can be used to detect diseases or health information.
For example, medical practitioners can detect conditions like diabetes and lung cancer by examining the volatile organic compounds (VOCs) in a patient’s breath. Furthermore, salivary biomarkers have the potential to accurately and consistently monitor viral illnesses and hormonal abnormalities. The optimistic outlook of non-invasive biomarkers is further enhanced by advancements in wearable technology, allowing for ongoing health monitoring.
5. Cognitive Biomarkers
Several digital biomarkers market players are developing cognitive biomarkers for diagnosing neurodegenerative disorders and progressing cognitive disorders. For instance, neuroimaging biomarkers such as volumetric MRI help in the detection of brain atrophy interlinked with Alzheimer’s disease.
Concluding Remarks
The demand for digital healthcare products in clinical trials has increased over the past few decades. The advances in AI-powered analytical tools and next-generation sequencing enable researchers to do in-depth analyses of diseases and provide precise treatment. In the future, pharmaceutical companies may observe advances in digital biomarkers, remarking on using biomarkers and biosensors for detailed analysis during drug development. The data-driven technology is further fueled by increasing investments by key digital biomarkers market players to develop novel solutions that help improve patient experience. As the demand for digital health solutions increases, the market is anticipated to grow steadily.
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