Growth Opportunities for Digital Biomarkers in Drug Development

Growth Opportunities for Digital Biomarkers in Drug Development

Transformational Growth for Clinical Trials via Enhancements to Patient Recruitment, Stratification, Monitoring, and Drug Response Comprehension

RELEASE DATE
13-Jul-2022
REGION
Global
Research Code: DA5C-01-00-00-00
SKU: HC03559-GL-TR_26702
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Description

Pharmaceutical companies spend billions of dollars in drug development because of expensive and time-consuming clinical trials, with a meager success rate. Frequent clinical visits, manual data processing, and a lack of consistent data on the effectiveness of the investigation of medical products contribute to their low success rate.

Digital biomarkers derived from wearable sensors and advanced algorithms offer an opportunity to analyze the response of investigational medical products in clinical trials continuously and remotely. Digital biomarkers eliminate the need for frequent clinic visits to monitor the patient's health status.

The halting of clinical trials because of the COVID-19 pandemic has fueled digital biomarker adoption for remote patient monitoring in clinical practices and clinical trials. Remote patient monitoring is imperative for pharmaceutical companies to conduct efficient clinical trials, save costs, and decide on proceeding with or discontinuing an investigational drug. Efforts are underway by market participants to transform digital biomarkers into digital measurements or endpoints in clinical trials. Digital biomarkers are instrumental in assessing the efficacy and safety of the therapy in DCTs and timely patient recruitment.

Digital biomarkers offer an opportunity for pharmaceutical companies to advance research in complex diseases, such as AD and PD, and to find novel biomarkers that demonstrate the effectiveness of an investigational drug on a patient’s disease condition in clinical trials. The study focuses on 3 major therapy areas, neurology, oncology, and cardiology, which digital biomarkers impact.

Table of Contents

Why Is It Increasingly Difficult to Grow?The Strategic Imperative 8™: Factors Creating Pressure on Growth

The Strategic Imperative 8™

The Impact of the Top 3 Strategic Imperatives on Digital Biomarkers for the Drug Development Industry

Growth Opportunities Fuel the Growth Pipeline Engine™

Research Methodology

Amidst the Ambiguity among Researchers, Regulatory Bodies Have Provided a Digital Biomarker Definition for Clear Expectations

Digital Biomarkers Can Explain a Health Variability in Humans

Digital Biomarkers Are Inexpensive, Non-invasive, and Comparatively New in Clinical Practice

The Role of Digital Biomarkers in Expediting the Drug Development Process Will Grow Significantly

Digital Biomarkers Can Revolutionize Pharmaceutical Clinical Trials by Solving Major Challenges

The Development of Digital Biomarkers Improves Healthcare Delivery and Patients' Outcomes

Several Literatures Present Digital Biomarker Utilization for Measuring Health Parameters or Monitoring Disease Conditions

Digital Biomarkers Enable the Shift from Product-based to Service-based Model in the Pharmaceutical Industry

Growth Drivers

Growth Restraints

Scope of Analysis

Application Segmentation (Non-exhaustive)

Complexity of Neurological Disorders and Slow Drug Development Pose Significant Burdens on the Healthcare System

Digital Biomarkers Can Accelerate Clinical Trials through Remote Patient Recruitment and Understanding Disease Mechanisms

Activity and Vocal Biomarkers are the Emerging Digital Biomarkers in Neurology Clinical Trials

Gait, Speech, and Sleep Are the Main Biomarkers Digital Health Devices Collect in Clinical Trials

Pharmaceutical Companies and Universities Collaborate to Pursue Neurology Clinical Trials with Digital Biomarkers

Smartphone App for Data Collection to Provide Digital Biomarkers and Continuous Monitoring of Trial Participants

Cancer Results in Significant Unmet Needs Because of Limited Treatment Options and Disease Understanding

Digital Biomarkers Enable Quality-of-life Assessments in Cancer Patients, Which Have Importance in Oncology Clinical Trials

Digital Biomarkers for Oncology Are in the Nascent Stage of Adoption for Disease Management and Clinical Trials

Digital Imaging Data Is the Main Digital Biomarker That Oncology Clinical Trials Collect

Major Companies Involved in Clinical Trials Utilizing Digital Biomarkers

AI Technology for Identifying Digital Biomarkers for Precise Skin Cancer Diagnosis and Improved Treatment Selection

Cardiology Complications Lead to Millions of Deaths Every Year, Costing Significant Economic and Healthcare Losses

Digital Biomarkers Enable Remote Data Collection, Enhancing Safety Signal Accuracy and Eliminating Patient Inconvenience

Digital Biomarkers in Cardiology Can Enhance Disease Diagnosis Accuracy

Heart Rate, Blood Pressure, and Physical Activity Are Crucial Digital Biomarkers in Cardiology Clinical Trials

Key Companies Involved in Clinical Trials Utilizing Digital Biomarkers

Treatment Strategy Evaluation to Reduce Hospitalization-based Digital Biomarker Collection Via Remote Sensor Technology

FDA Guidance Provides Evidentiary Framework to Support Novel Biomarker Qualification

Presenting High-quality Data, Benefits in Drug Development, and Evidence Are the Main Requirements for Qualification

FDA’s Regulatory Initiatives Focus on Digital Health Technology Development and Guide Developers

EMA Highlights Important Points to Consider for Successful Digital Biomarker Qualification that Support Approval of Medicinal Product

Most Pharmaceutical Companies Depend on Technology Development Partners to Implement Digital Biomarkers in Clinical Trials

Pharmaceutical Companies Should Evaluate Their Reliance on Technology Developers and the Wearable Devices for Clinical Trials

The NCI and NIA Are the Leading Institutes Offering Grants for Digital Biomarker Research Focusing on Oncology and Neurology

Private Funding Focuses on Novel Digital Biomarker Development and the Integration of Patient-facing Solutions with Digital Platforms

Public Funding Focuses on Evaluating Novel Digital Biomarkers for Early Disease Diagnoses, Such as Cancer and Neurological Diseases

Market Participants Adopt Partnerships and Collaborations to Accelerate Digital Biomarker Development

Established Companies and Start-ups Are Developing Novel Digital Biomarkers to Enhance Clinical Trials or Advance Research

North America Is the Largest Adopter of Digital Biomarkers due to Multiple Companies and Growing Research Funding

Case Study: Chugai Pharmaceutical Co., Ltd.—Digital Biomarker Initiatives

Case Study: Sanofi—Digital Biomarkers for CNS Clinical Trials

Digital Biomarkers Will Play a Significant Role in DCT Implementation

Digital Biomarker Innovations Focus on Mobile Application, Software, and Analysis Algorithm Development

Neurology and Oncology Are Focus Areas for the Top Patent Assignees Relating to Digital Biomarkers

Key Patents

Key Patents (continued)

Growth Opportunity 1: Digital Biomarkers for Patient Recruitment in Clinical Trials

Growth Opportunity 1: Digital Biomarkers for Patient Recruitment in Clinical Trials (continued)

Growth Opportunity 2: Digital Vocal Biomarkers for Remote, Contactless, Continuous, and Accurate Patient Monitoring in Clinical Trials

Growth Opportunity 2: Digital Vocal Biomarkers for Remote, Contactless, Continuous, and Accurate Patient Monitoring in Clinical Trials (continued)

Growth Opportunity 3: Novel Digital Biomarker Development to Accurately Analyze the Patient’s Drug Response

Growth Opportunity 3: Novel Digital Biomarker Development to Accurately Analyze the Patient’s Drug Response (continued)

Growth Opportunity 4: Analytical and Clinical Validation to Evaluate Digital Biomarkers for Use in Clinical Research

Growth Opportunity 4: Analytical and Clinical Validation to Evaluate Digital Biomarkers for Use in Clinical Research (continued)

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Related Research
Pharmaceutical companies spend billions of dollars in drug development because of expensive and time-consuming clinical trials, with a meager success rate. Frequent clinical visits, manual data processing, and a lack of consistent data on the effectiveness of the investigation of medical products contribute to their low success rate. Digital biomarkers derived from wearable sensors and advanced algorithms offer an opportunity to analyze the response of investigational medical products in clinical trials continuously and remotely. Digital biomarkers eliminate the need for frequent clinic visits to monitor the patient's health status. The halting of clinical trials because of the COVID-19 pandemic has fueled digital biomarker adoption for remote patient monitoring in clinical practices and clinical trials. Remote patient monitoring is imperative for pharmaceutical companies to conduct efficient clinical trials, save costs, and decide on proceeding with or discontinuing an investigational drug. Efforts are underway by market participants to transform digital biomarkers into digital measurements or endpoints in clinical trials. Digital biomarkers are instrumental in assessing the efficacy and safety of the therapy in DCTs and timely patient recruitment. Digital biomarkers offer an opportunity for pharmaceutical companies to advance research in complex diseases, such as AD and PD, and to find novel biomarkers that demonstrate the effectiveness of an investigational drug on a patient’s disease condition in clinical trials. The study focuses on 3 major therapy areas, neurology, oncology, and cardiology, which digital biomarkers impact.
More Information
Author Ashish Kaul
Industries Healthcare
No Index No
Is Prebook No
Podcast No
WIP Number DA5C-01-00-00-00