Rajendran Anuciya, Kella Alekhya, Narayanasamy Damodharan
Department of Pharmaceutical Quality Assurance, SRM College of Pharmacy, Faculty of Medicine and Health Science, SRM Institute of Science and Technology, Chengalpattu, IND.
Cureus. 2024 Aug 13;16(8):e66792. doi: 10.7759/cureus.66792. eCollection 2024 Aug.
An increasing number of developments and trends are driving the expansion of the digital therapeutics (DTx) market in the pharmaceutical industry. Digital therapeutics are therapies intended to treat, diagnose, and prevent diseases by using patient-directed clinically assessed software applications, which can optimize the effectiveness and delivery of healthcare. These digital innovations became important as the world changed, particularly during the coronavirus pandemic. Nowadays pharma companies are getting more comfortable with the idea of digital therapies. The majority of pharmaceutical companies are examining how to incorporate pharmaceuticals and digital therapies into their treatment regimens, leveraging digital tools to enhance patient outcomes and streamline healthcare delivery. A thorough overview of the most recent technological advancements in the creation of digital therapies shows particular technologies that are essential to the market's future growth. Moreover, the evaluation of digital therapeutics by clinical trial and real-world data is outlined. The critical quality attributes of DTx products and the challenges, including data management issues and regulatory obstacles, which make the creation, approval, and marketing of customized medicines more difficult, are covered in this review article. Overall, pharma companies are venturing into the world of digital therapeutics while acknowledging the limitations of the emerging field.
越来越多的发展和趋势推动着制药行业数字疗法（DTx）市场的扩张。数字疗法是指通过使用经临床评估的、面向患者的软件应用程序来治疗、诊断和预防疾病的疗法，这些应用程序可以优化医疗保健的效果和提供方式。随着世界的变化，尤其是在新冠疫情期间，这些数字创新变得至关重要。如今，制药公司对数字疗法的理念越来越认同。大多数制药公司正在研究如何将药物和数字疗法纳入其治疗方案，利用数字工具来改善患者治疗效果并简化医疗服务的提供。对数字疗法创建过程中最新技术进展的全面概述展示了对市场未来增长至关重要的特定技术。此外，还概述了通过临床试验和真实世界数据对数字疗法进行的评估。这篇综述文章涵盖了DTx产品的关键质量属性以及那些使定制药物的创建、批准和营销更加困难的挑战，包括数据管理问题和监管障碍。总体而言，制药公司在认识到这个新兴领域局限性的同时，正涉足数字疗法领域。
