藥物開發中數字生物標誌物的增長機會

本報告探討數字生物標誌物，重點關註三個主要治療領域：神經病學、腫瘤學和心髒病學，包括增長機會、監管格局、行業評估和分析以及專利格局。

內容

戰略要務

增長機會分析

• 在研究人員之間存在歧義的情況下，監管機構提供了數字生物標誌物的定義以明確預期
• 數字生物標誌物解釋了人類健康的變化
• 數字生物標誌物價格低廉、無創且在臨床環境中相對較新
• 數字生物標誌物在促進藥物開發過程中的作用將大大擴大
• 數字生物標誌物可以解決關鍵挑戰，從而徹底改變藥物臨床試驗
• 數字生物標誌物的發展將改善醫療保健服務和患者治療效果
• 有幾家出版物使用數字生物標誌物來衡量健康狀況和監測疾病
• 數字生物標誌物使製藥行業能夠從基於產品的模式轉變為基於服務的模式
• 增長驅動力
• 抑制增長的因素
• 分析範圍
• 使用細分

增長機會分析 - 神經病學

• 神經系統疾病的複雜性和藥物開發的延遲正在給醫療保健系統帶來壓力
• 數字生物標誌物通過遠程招募患者和了解疾病機制來加速臨床試驗
• 活動和聲音作為神經病學臨床試驗中的新數字生物標誌物
• 數字健康設備在臨床試驗中收集的關鍵生物標誌物是步態、言語和睡眠
• 製藥公司和大學合作利用數字生物標誌物推進神經病學臨床試驗
• 通過數據收集智能手機應用提供數字生物標誌物，以持續監測臨床試驗參與者

增長機會分析 - 腫瘤學

• 由於治療選擇有限且對疾病的了解有限，癌症的需求尚未得到滿足
• 數字生物標誌物可用於評估癌症患者的生活質量，這在癌症臨床試驗中非常重要
• 腫瘤學數字生物標誌物處於疾病管理和臨床試驗採用的早期階段
• 數字影像數據是腫瘤臨床試驗中收集的關鍵數字生物標誌物
• 參與使用數字生物標誌物進行臨床試驗的主要公司
• AI 技術可識別數字生物標誌物，以準確診斷和改進皮膚癌的治療選擇

成長機會分析 - 心髒病學

• 心髒病並發症每年導致數百萬人死亡，並造成重大經濟和醫療保健損失
• 數字生物標誌物可實現遠程數據收集、提高安全信號准確性並消除患者的不便
• 心髒病學中的數字生物標誌物可以提高疾病診斷的準確性
• 心率、血壓和體力活動是心髒病臨床試驗中的關鍵數字生物標誌物
• 參與利用數字生物標誌物進行臨床試驗的領先公司
• 通過遠程傳感器技術減少基於住院的數字生物標誌物收集的治療策略評估

監管狀況

• FDA 指南提供了支持新型生物標誌物資格的證據框架
• 高質量的數據、藥物開發的優勢和證據的呈現是資格的主要要求
• FDA 監管計劃側重於數字健康技術開發並指導開發人員
• EMA 強調了成功認證數字生物標誌物以支持藥物批准的關鍵考慮因素

行業評估與分析

• 大多數製藥公司依靠技術開發合作夥伴在臨床試驗中實施數字生物標誌物
• 製藥公司需要評估在臨床試驗中對技術開發人員和可穿戴設備的依賴程度
• NCI 和 NIA 是專注於腫瘤學和神經學的數字生物標誌物研究的領先資助機構
• 私人資金專注於開發新的數字生物標誌物以及整合患者解決方案和數字平台
• 公共資金側重於評估用於早期疾病診斷的新數字生物標誌物，例如癌症和神經系統疾病
• 市場參與者通過建立夥伴關係和協作來加速數字生物標誌物的開發
• 老牌公司和新興公司正在開發新的數字生物標誌物，以加強臨床試驗和推進研究
• 由於多家公司和增加的研究資金，北美成為數字生物標誌物的最大採用者
• 案例研究：中外藥業有限公司 - 數字生物標誌物的方法
• 案例研究：賽諾菲 - 用於 CNS 臨床試驗的數字生物標誌物
• 數字生物標誌物在 DCT 的實施中發揮著重要作用

專利格局

• 數字生物標誌物創新專注於開發移動應用、軟件和分析算法
• 神經病學和腫瘤學是與數字生物標誌物相關的領先專利申請人的重點領域
• 主要專利

增長機會宇宙

• 增長機會 1：用於臨床試驗患者招募的數字生物標誌物
• 增長機會 2：用於臨床試驗中遠程、非接觸式、連續、準確的患者監測的數字語音生物標誌物
• 增長機會 3：開發新的數字生物標誌物以準確分析患者的藥物反應
• 增長機會 4：用於評估用於臨床研究的數字生物標誌物的分析和臨床驗證

下一步

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

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

Strategic Imperatives

• 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

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)

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

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

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

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

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
• Key Patents (continued)

Growth Opportunity Universe

• 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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