di , 16/08/2022

DUBLIN–(BUSINESS WIRE)–The “Growth Opportunities for Digital Biomarkers in Drug Development” report has been added to ResearchAndMarkets.com’s offering.

The study focuses on 3 major therapy areas, neurology, oncology, and cardiology, which digital biomarkers impact.

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.

Key Topics Covered:

1. Strategic Imperatives

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

2. Growth Opportunity Analysis

  • 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)

3. Growth Opportunity Analysis – Neurology

  • 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

4. Growth Opportunity Analysis – Oncology

  • 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
  • Growth Opportunity Analysis – Cardiology
  • 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

5. Regulatory Landscape

  • 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

6. Industry Assessment and Analysis

  • 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

7. Patent Landscape

  • 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

8. Growth Opportunity Universe

  • Growth Opportunity 1: Digital Biomarkers for Patient Recruitment in Clinical Trials
  • Growth Opportunity 2: Digital Vocal Biomarkers for Remote, Contactless, Continuous, and Accurate Patient Monitoring in Clinical Trials
  • Growth Opportunity 3: Novel Digital Biomarker Development to Accurately Analyze the Patient’s Drug Response
  • Growth Opportunity 4: Analytical and Clinical Validation to Evaluate Digital Biomarkers for Use in Clinical Research

For more information about this report visit https://www.researchandmarkets.com/r/izovqq



Laura Wood, Senior Press Manager


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