市场调查报告书
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1453952
到 2030 年的真实世界证据解决方案市场预测:按组件、部署、应用程式、最终用户和地区进行的全球分析Real World Evidence Solutions Market Forecasts to 2030 - Global Analysis By Component (Services, Data Sets and Other Components), Deployment (Cloud-based and On-premise), Application, End User and By Geography |
根据 Stratistics MRC 的数据,2023 年全球现实世界证据解决方案市场规模将达到 184 亿美元,预计到 2030 年将达到 612 亿美元,预测期内复合年增长率为 18.7%。
来自各种非传统临床研究环境的医疗资料,电子健康记录(EMR)、申请和投诉资料、产品和疾病登记以及行动装置和健康应用程式上收集的资料,通常被称为真实世界证据解决方案是的。 RWE 解决方案利用电子健康记录、申请资料库和病患登记等来源的资料来深入了解临床试验受控环境之外的医疗干预措施的安全性、有效性和成本效益。
《世界老化人口报告》显示,2020 年全球 65 岁以上人口约 7.27 亿,预计到 2050 年将达到 15 亿。
越来越关注以病人为中心的医疗保健
在传统的临床试验中,患者的经验和结果可能无法完全反映现实世界的情况。随着向以患者为中心的护理的转变,人们越来越认识到了解患者日常生活中治疗如何发生的重要性。 RWE 解决方案透过利用电子健康记录、病患登记和穿戴式装置等来源的真实资料,在这项范例中发挥关键作用。此外,透过分析这些资料,医疗保健相关人员可以深入了解患者偏好、治疗依从性和介入措施的实际有效性。
实施成本高
建立强大的莱茵集团能力需要在基础设施、技术、人才取得和持续维护方面进行大量投资。需要大量的财政资源来开发收集、整合和分析不同的现实世界资料来源所需的资料基础设施。然而,实施机器学习和自然语言处理等先进的分析工具和技术需要大量的软体授权、客製化和培训成本。建立由资料科学家、生物统计学家和领域专家组成的多学科团队会增加 RWE倡议的整体成本。
资料分析的进展
随着医疗保健资料的数量和复杂性持续呈指数级增长,资料分析的创新使利益相关人员能够从大型现实资料集集中获得有意义的见解。机器学习、人工智慧和自然语言处理等技术使得从电子健康记录记录、申请资料库和患者登记等不同的现实世界资料来源中识别模式、相关性和趋势成为可能。这种分析能力不仅有助于产生可靠的现实世界证据,而且还提高了资料分析过程的效率和准确性。
隐私和资料安全问题
随着医疗保健决策越来越依赖真实世界资料(RWD),确保敏感患者资讯的隐私和安全已变得至关重要。遵守 GDPR 和 HIPAA 等严格的资料保护条例会增加 RWE 工作的复杂性和成本。相关人员必须考虑围绕患者资料的使用、共用和保护的道德和法律考虑。资料外洩、未授权存取和滥用个人健康资讯的潜在风险进一步加剧了这些担忧,并削弱了人们对 RWE 解决方案的信任和信心。
随着医疗保健产业面临前所未有的挑战,对真实世界资料(RWD)的需求激增,RWE 解决方案以了解病毒的影响、评估治疗效果并为公共卫生应对措施提供资讯而促进了招募。 RWE 在促进快速临床决策和评估现有药物的安全性和有效性方面发挥了关键作用,以便在大流行的紧急情况下重新利用。然而,疫情凸显了资料存取、品质和基础设施方面现有的差异,加剧了有效利用真实世界证据解决方案的挑战。
预计医疗设备开发领域在预测期内将是最大的。
由于监管机构越来越需要可靠的真实资料来支援医疗设备核准和上市后监管,医疗设备开发领域预计将在预测期内占据最大份额。 RWE 解决方案使製造商能够产生有关设备安全性、有效性和实际性能的证据,以满足监管期望并加速市场进入。此外,向基于价值的医疗保健的转变和对患者结果的重视需要传统临床试验之外的全面证据。
预计资料集领域在预测期内的复合年增长率最高
资料集领域在整个预测期内占据了最大的市场份额,因为它在为获得可行的见解提供基础方面发挥着至关重要的作用。随着电子健康记录(EHR)、申请资料库、病患登记、穿戴式装置和健康社会决定因素等资讯来源提供多样化和广泛的资料集,RWE 产生的潜力正在急剧扩大。此外,这些丰富的资料集提供了现实世界中患者群体、治疗途径和医疗保健结果的全面视图。
这是因为中国、印度、日本和韩国等国家的快速都市化、人口增长和医疗成本上升正在推动对循证医疗解决方案的需求。促进在医疗保健决策中使用现实世界证据解决方案的监管改革和倡议正在加速该地区的市场成长。此外,数位医疗基础设施的区域扩张和电子健康记录的采用正在产生大量的现实世界资料,为 RWE 的利用创造了机会。
由于实施了促进使用 RWE 进行药物核准、市场准入和上市后监督的政策和倡议,预计亚太地区将在整个统治时期呈现盈利成长。中国的监管改革,包括接受国外临床试验资料和建立快速医药品认证过程,正在推动製药公司采用 RWE 解决方案。此外,印度简化监管流程和促进创新的努力正在为莱茵集团创造有利的环境。
According to Stratistics MRC, the Global Real World Evidence Solutions Market is accounted for $18.4 billion in 2023 and is expected to reach $61.2 billion by 2030 growing at a CAGR of 18.7% during the forecast period. Healthcare data from a range of non-traditional clinical research settings, including electronic medical records (EMRs), billing and claim data, product and disease registries, and data gathered by mobile devices and health apps, are referred to as real-world evidence solutions. RWE solutions encompass a range of tools and methodologies that harness data from sources such as electronic health records, claims databases, and patient registries to generate insights into the safety, efficacy, and cost-effectiveness of medical interventions outside the controlled environment of clinical trials.
According to the World Ageing Population report, in 2020 highlights, approximately 727 million people living worldwide were aged 65 years and above, and the number is expected to reach 1.5 billion by 2050.
Growing focus on patient-centric healthcare
In traditional clinical trials, patients' experiences and outcomes may not fully reflect real-world scenarios. With the shift towards patient-centric care, there's an increasing recognition of the importance of understanding how treatments perform in the everyday lives of patients. RWE solutions play a crucial role in this paradigm by harnessing real-world data from sources such as electronic health records, patient registries, and wearable devices. Additionally, by analyzing this data, healthcare stakeholders gain insights into patient preferences, treatment adherence, and real-world effectiveness of interventions.
High implementation costs
Establishing robust RWE capabilities necessitates substantial investments in infrastructure, technology, talent acquisition, and ongoing maintenance. Developing the necessary data infrastructure to collect, integrate, and analyze diverse sources of real-world data requires significant financial resources. However, implementing advanced analytics tools and methodologies, such as machine learning and natural language processing, incurs considerable expenses in software licensing, customization, and training. Building multidisciplinary teams comprising data scientists, biostatisticians, and domain experts adds to the overall cost of RWE initiatives.
Advancements in data analytics
As the volume and complexity of healthcare data continue to increase exponentially, innovations in data analytics empower stakeholders to extract meaningful insights from large-scale real-world datasets. Techniques such as machine learning, artificial intelligence, and natural language processing enable the identification of patterns, correlations, and trends within diverse sources of real-world data, including electronic health records, claims databases, and patient registries. These analytical capabilities not only facilitate the generation of robust real-world evidence but also enhance the efficiency and accuracy of data analysis processes.
Privacy and data security concerns
With the increasing reliance on real-world data (RWD) for healthcare decision-making, ensuring the privacy and security of sensitive patient information becomes paramount. Compliance with stringent data protection regulations, such as GDPR and HIPAA, adds complexity and cost to RWE initiatives. Stakeholders must navigate ethical and legal considerations surrounding patient data usage, sharing, and protection. The potential risks of data breaches, unauthorized access, and misuse of personal health information further exacerbate these concerns, eroding trust and confidence in RWE solutions.
As the healthcare industry faced unprecedented challenges, the demand for real-world data (RWD) surged, driving the adoption of RWE solutions for understanding the impact of the virus, assessing treatment effectiveness, and informing public health responses. RWE played a crucial role in evaluating the safety and efficacy of existing drugs for repurposing, facilitating rapid clinical decision-making amidst the urgency of the pandemic. However, the pandemic also highlighted existing disparities in data access, quality, and infrastructure, exacerbating challenges in leveraging Real World Evidence Solutions effectively.
The Medical Device Development segment is expected to be the largest during the forecast period
Medical Device Development segment is expected to hold the largest share during the forecast period as regulatory agencies increasingly require robust real-world data to support the approval and post-market surveillance of medical devices. RWE solutions enable manufacturers to generate evidence on device safety, effectiveness, and real-world performance, aligning with regulatory expectations and expediting market access. Additionally, the shift towards value-based healthcare and the emphasis on patient outcomes necessitate comprehensive evidence beyond traditional clinical trials.
The Data Sets segment is expected to have the highest CAGR during the forecast period
Data Sets segment dominated the largest share of the market throughout the extrapolated period, due to its crucial role in providing the foundation for generating actionable insights. With the increasing availability of diverse and expansive data sets from sources such as electronic health records (EHRs), claims databases, patient registries, wearables, and social determinants of health, the potential for RWE generation has expanded dramatically. Furthermore, these rich data sets offer a comprehensive view of patient populations, treatment pathways and healthcare outcomes in real-world settings.
Asia Pacific region commanded the largest market share over the projection period, as rapid urbanization, population growth, and increasing healthcare expenditure in countries like China, India, Japan, and South Korea have heightened the demand for evidence-based healthcare solutions. Regulatory reforms and initiatives promoting the use of Real World Evidence Solutions in healthcare decision-making have accelerated market growth in the region. Moreover, the regional expansion of digital health infrastructure and adoption of electronic health records are generating vast amounts of real-world data, creating opportunities for RWE utilization.
Asia Pacific region is projected to witness profitable growth throughout the domination period, due to implementing policies and initiatives that promote the use of RWE for drug approval, market access and post-market surveillance. Regulatory reforms in China, including the acceptance of foreign clinical trial data and the establishment of a faster drug approval process, have encouraged the adoption of RWE solutions by pharmaceutical companies. Additionally, initiatives in India aimed at streamlining regulatory processes and promoting innovation are creating a conducive environment for RWE utilization.
Key players in the market
Some of the key players in Real World Evidence Solutions market include Cegedim Health Data, Clinigen Group plc, Flatiron Health Inc, IBM Corporation, IQVIA Holdings Inc, Medpace Holdings Inc, Parexel International Corporation, PerkinElmer Inc, PPD Inc and Syneos Health.
In August 2023, Targe RWE launched an innovative line of cutting-edge analytical solutions that utilize advanced epidemiological techniques and reliable statistical principles to visualize and analyze data, addressing unmet needs and strategic concerns throughout the pharmaceutical product life cycle.
In June 2023, Thermo Fisher Scientific announced a definitive agreement to acquire CorEvitas, LLC, valued at USD 912.5 million in cash, from Audax Private Equity.
In November 2022, Castor, a provider of hybrid and decentralized clinical trial technology solutions, launched a new offering to simplify post-marketing clinical trials.
In September 2022, Lumanity, Inc. announced the creation of a new global practice composed of the U.S. and Europe-based experts in real world evidence. The aim was to help clients identify the correct real world data (RWD) and methodologies.
In September 2022, Verantos announced the launch of the Verantos Evidence Platform. This system has allowed pharmaceutical companies to generate real world evidence solutions with highly defined standards, which are approved by the U.S. FDA.
In June 2022, Dubai Health Authority (DHA) and its health insurance regulatory body launched a "first-of-its-kind" digital-led program to adopt value-based healthcare in the state.
In May 2022, Pfizer Inc. presented positive real world evidence for its combination therapy to treat metastatic breast cancer at ESMO Breast Cancer 2022. The combination therapy includes IBRANCE (palbociclib) and an aromatase inhibitor.
In March 2022, ISPOR-The Professional Society for Health Economics and Outcomes Research (HEOR), in partnership with the Bristol Myers Squibb-Pfizer Alliance, announced the launch of a new "About Real World Evidence" microsite.
In March 2022, the collaboration between Thermo Fisher and Symphogen has been expanded to include improved data workflow, which aids in the discovery and development of innovative cancer treatments.
In January 2022, IQVIA partnered with Argenex SE for accelerating the clinical development of new indications for VYVGART. Furthermore, it will leverage its scientific advice and technology in supporting clinical development by Argenx.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.