药物开发中数字生物标誌物的增长机会

本报告探讨数字生物标誌物，重点关註三个主要治疗领域：神经病学、肿瘤学和心脏病学，包括增长机会、监管格局、行业评估和分析以及专利格局。

内容

战略要务

增长机会分析

• 在研究人员之间存在歧义的情况下，监管机构提供了数字生物标誌物的定义以明确预期
• 数字生物标誌物解释了人类健康的变化
• 数字生物标誌物价格低廉、无创且在临床环境中相对较新
• 数字生物标誌物在促进药物开发过程中的作用将大大扩大
• 数字生物标誌物可以解决关键挑战，从而彻底改变药物临床试验
• 数字生物标誌物的发展将改善医疗保健服务和患者治疗效果
• 有几家出版物使用数字生物标誌物来衡量健康状况和监测疾病
• 数字生物标誌物使製药行业能够从基于产品的模式转变为基于服务的模式
• 增长驱动力
• 抑制增长的因素
• 分析范围
• 使用细分

增长机会分析 - 神经病学

• 神经系统疾病的复杂性和药物开发的延迟正在给医疗保健系统带来压力
• 数字生物标誌物通过远程招募患者和了解疾病机制来加速临床试验
• 活动和声音作为神经病学临床试验中的新数字生物标誌物
• 数字健康设备在临床试验中收集的关键生物标誌物是步态、言语和睡眠
• 製药公司和大学合作利用数字生物标誌物推进神经病学临床试验
• 通过数据收集智能手机应用提供数字生物标誌物，以持续监测临床试验参与者

增长机会分析 - 肿瘤学

• 由于治疗选择有限且对疾病的了解有限，癌症的需求尚未得到满足
• 数字生物标誌物可用于评估癌症患者的生活质量，这在癌症临床试验中非常重要
• 肿瘤学数字生物标誌物处于疾病管理和临床试验采用的早期阶段
• 数字影像数据是肿瘤临床试验中收集的关键数字生物标誌物
• 参与使用数字生物标誌物进行临床试验的主要公司
• AI 技术可识别数字生物标誌物，以准确诊断和改进皮肤癌的治疗选择

成长机会分析 - 心脏病学

• 心脏病并发症每年导致数百万人死亡，并造成重大经济和医疗保健损失
• 数字生物标誌物可实现远程数据收集、提高安全信号准确性并消除患者的不便
• 心脏病学中的数字生物标誌物可以提高疾病诊断的准确性
• 心率、血压和体力活动是心脏病临床试验中的关键数字生物标誌物
• 参与利用数字生物标誌物进行临床试验的领先公司
• 通过远程传感器技术减少基于住院的数字生物标誌物收集的治疗策略评估

监管状况

• FDA 指南提供了支持新型生物标誌物资格的证据框架
• 高质量的数据、药物开发的优势和证据的呈现是资格的主要要求
• FDA 监管计划侧重于数字健康技术开发并指导开发人员
• EMA 强调了成功认证数字生物标誌物以支持药物批准的关键考虑因素

行业评估与分析

• 大多数製药公司依靠技术开发合作伙伴在临床试验中实施数字生物标誌物
• 製药公司需要评估在临床试验中对技术开发人员和可穿戴设备的依赖程度
• NCI 和 NIA 是专注于肿瘤学和神经学的数字生物标誌物研究的领先资助机构
• 私人资金专注于开发新的数字生物标誌物以及整合患者解决方案和数字平台
• 公共资金侧重于评估用于早期疾病诊断的新数字生物标誌物，例如癌症和神经系统疾病
• 市场参与者通过建立伙伴关係和协作来加速数字生物标誌物的开发
• 老牌公司和新兴公司正在开发新的数字生物标誌物，以加强临床试验和推进研究
• 由于多家公司和增加的研究资金，北美成为数字生物标誌物的最大采用者
• 案例研究：中外药业有限公司 - 数字生物标誌物的方法
• 案例研究：赛诺菲 - 用于 CNS 临床试验的数字生物标誌物
• 数字生物标誌物在 DCT 的实施中发挥着重要作用

专利格局

• 数字生物标誌物创新专注于开发移动应用、软件和分析算法
• 神经病学和肿瘤学是与数字生物标誌物相关的领先专利申请人的重点领域
• 主要专利

增长机会宇宙

• 增长机会 1：用于临床试验患者招募的数字生物标誌物
• 增长机会 2：用于临床试验中远程、非接触式、连续、准确的患者监测的数字语音生物标誌物
• 增长机会 3：开发新的数字生物标誌物以准确分析患者的药物反应
• 增长机会 4：用于评估用于临床研究的数字生物标誌物的分析和临床验证

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)

Next Steps

• Your Next Steps
• Why Frost, Why Now?
• Legal Disclaimer