市场调查报告书
商品编码
1260065
真实世界证据解决方案市场——增长、未来展望、竞争分析,2023 年至 2031 年Real World Evidence Solution Market - Growth, Future Prospects and Competitive Analysis, 2023 - 2031 |
在 2023 年至 2031 年的预测期内,全球真实证据解决方案市场预计将以 15% 的复合年增长率增长。 推动这一市场扩张的主要因素是临床试验的扩大以及疗法从基于体积到基于价值的转变。 RWE 和 RWD 可用于改进协议设计,减少代价高昂的协议更改次数,并创建合成控制臂以加快试验执行并降低成本。 同样,RWE 可以加快标籤扩展并降低归檔所需文檔的总成本。 这些优势增加了 RWE 系统在药物和医疗设备研发中的采用。 监管机构对使用真实世界证据 (RWE) 解决方案的支持和增加研发支出预计将刺激市场增长。 从基于数量的护理转向基于价值的护理预计也将有助于增加。 由于 COVID-19 大流行,许多市场进入者经历了广泛的业务中断,扰乱了他们的日常运营。
扩大研发投入
大多数製药、生物製药和医疗器械企业继续大力投资新药和新技术的开发。 特别是,製药企业正在积极投资于研发。 为了同时满足药物发现和开发的需求,不断上升的研发成本正促使製药和生物製药公司从早期到后期的开发阶段选择完全集成或功能性的外包服务。 与所有其他行业相比,製药行业用于研发的收入占其收入的比例最高。 这种增加的研发支出预计将刺激药物开发过程中对多种临床前和临床服务的需求,从而刺激 RWE 市场的扩张。
医学专家和学者不愿意依赖现实世界的证据解决方案
儘管 RWE 在应用程序中广泛使用,但一些利益相关者仍然对依赖真实世界的证据犹豫不决。 例如,付款人已开始使用 RWE,并且更喜欢基于随机临床试验 (RCT) 而不是外部观察数据的药物承保决定。 这种趋势的主要原因是提供了许多标准和方法来考虑来自真实患者护理的临床经验证据。 此外,付款人在做出药物申请决定时会使用范围广泛的程序和证据。 在製药技术评估 (PTA) 程序中,这些差异会影响报销、患者获取和潜在的医疗保健结果。 因此,利益相关者不愿在没有标准化数据收集策略的情况下使用证据。
莱茵集团的端到端服务变得更加重要
随着医疗保健行业参与者寻求创新解决方案来解决不可持续的成本负担和相对较低的投资回报率,医疗保健生态系统正在转型并专注于医疗保健支出。 为了展示价值,公司需要强大的证据生命週期管理能力。 其结果是一个端到端方法的机会,该方法利用生命科学组织的数据、证据和知识资产来打破传统孤岛,并实现从产品研发阶段到商业化的洞察力驱动的决策。 这需要製定有效的治理计划并利用云和自助服务分析等技术。 他们还需要培养整合数据集的能力,并了解所需分析所需的相关资源(在数据访问和质量方面也存在战术挑战)。
缺乏国际公认的研究方法标准和数据处理基础设施
缺乏关于可用于设计、分析和报告 RWE 的标准和原则的全球协议是该领域的一个严重障碍。 由于缺乏一致性,RWE 的质量不足以包含在用于比较不同治疗效果的证据体中。 这会降低所产生信息的潜在价值,从而降低产生信息的动力。 这进一步降低了关键利益相关者使用 RWE 解决方案的可能性。
到 2022 年,RWE 解决方案市场将由服务类别主导
将数据转化为可操作证据的需求不断增长,海量医疗保健数据的可用性是推动该领域市场扩张的主要原因。 客户可以通过允许供应商根据他们的特定需求定制服务来节省时间和金钱,而不是获取数据集并对其进行分析以获得有价值的信息。 因此,对 RWE 服务的需求大于对 RWE 数据集的需求。 RWE 专家提供服务以建立智能 RWE 计划(咨询服务),同时与製药和医疗设备公司的主题专家进行交流,并利用分析能力提供关键的统计见解。
2022 年,医药市场开发和审批板块带动了 RWE 解决方案市场
由于肿瘤和心血管领域临床研究的增加,药物研发和审批市场的细分成为最大的细分市场。 大流行后 COVID-19 的治疗进展也有显着增长。 该部门进一步细分为肿瘤学、心血管学、神经学、免疫学和其他治疗领域。 由于癌症患病率上升以及专注于癌症治疗和预防的临床试验和研究不断增加,肿瘤学成为市场领导者。
预计製药公司和医疗设备製造商将成为增长最快的最终用户群体
製药和医疗设备製造商的崛起是由于 RWE 研究在批准药物、防止代价高昂的药物召回以及评估现实世界中的疗效方面越来越重要。 此外,RWE 在製药行业的使用正在增加,因为它是一种满足监管合规要求和与 HEOR 相关的付款人义务的应用程序。 製药行业需要详细说明已批准药物的批准用途和医学上可接受的替代用途的信息。 新药有效推进临床阶段需要 RWE 数据。 因此,可靠的真实世界结果对于成功的相变至关重要。
北美仍然是世界领先者,亚太地区仍然是增长领先者
北美将占据 RWE 解决方案市场的最大份额,而亚太地区有望在预测期内保持最高增长率。 亚太地区 RWE 解决方案市场的增长得益于临床试验数量的增加、政府加大力度引入 RWE 研究、慢性病发病率上升以及对更好的医疗服务需求的增长。这是一个因素,例如老年人口的增加。 此外,日本、中国等亚太国家临床试验基础设施完善,医疗专业人才众多,医疗功能发达,质量要求高,有助于
预测期内市场竞争加剧
全球市场高度分散且竞争激烈。 通过子公司和合作伙伴关係,市场进入者实施战略计划,例如产品开发和发布、分销网络扩展和全球运营。 除了投资组合多元化和併购,各大公司也进行投资组合多元化和併购。 例如,2021 年 8 月,Synos□□ Health 将与 Aetion 合作开发真实世界的、基于证据的解决方案,以提供分析驱动和监管级数据。 同样,Thermo Fisher Scientific 于 2021 年 4 月宣布将以每股 47.50 美元的价格收购 PPD, Inc.。 市场上运营的主要公司包括 IQVIA、IBM、ICON plc.、PAREXEL International Corporation、PPD、LLC、Optum, Inc.、Cognizant Technology Solutions Corporation、Oracle Corporation、SAS Institute Inc.、Synos□□ Health, Inc. Anthem、 Inc. Clinigen Group plc. Medpace Holdings Inc、Flatiron Health 和其他值得注意的公司。
本报告中回答的关键问题
影响现实世界证据解决方案市场增长的关键微观和宏观环境因素有哪些?
现在和预测期内,产品细分和地区的主要投资领域是什么?
到 2031 年的估计和市场预测
在预测期内,哪些细分市场的复合年增长率最快?
哪个细分市场的市场份额更大,为什么?
低收入和中等收入国家是否在投资现实世界的证据解决方案市场?
哪个地区的真实证据解决方案市场规模最大?
亚太、拉丁美洲、中东和非洲等新兴市场的市场趋势和动态如何?
推动现实世界证据解决方案市场增长的主要趋势是什么?
主要竞争对手及其在全球真实证据解决方案市场中的影响力的关键战略是什么?
The global market for real-world evidence solutions is expected to grow at a CAGR of 15% during the forecast period of 2023 to 2031. This market's expansion is primarily driven by the primary factors driving the growth of this market are the expansion of clinical trials and the change from volume-based to value-based treatment. Utilizing RWE and RWD can improve protocol design, hence reducing the number of costly protocol changes, and enabling the creation of synthetic control arms to speed up trial execution and save expenses. Similarly, RWE can expedite label expansion and reduce the overall cost of filing-required documentation. Due to these benefits, the adoption of RWE systems in drug and medical device research and development is increasing. Support from regulatory bodies for the use of Real-World Evidence (RWE) solutions and a rise in R&D expenditures are expected to stimulate market growth. In addition, the shift from volume-based to value-based care is anticipated to contribute to the rise. As a result of the COVID-19 pandemic, numerous market participants began to experience widespread business disruptions, which hindered routine corporate operations.
Increased Investment in Research and Development
The majority of pharmaceutical, biopharmaceutical, and medical device businesses continue to make substantial investments in the development of novel medications and technologies. Particularly, the pharmaceutical business is heavily invested in R&D. To meet the demands of both drug discovery and development, pharmaceutical and biopharmaceutical businesses are opting for fully integrated or functional outsourcing services, from the early development phase to the late-stage development phase, due to increased R&D expenditures. The pharmaceutical industry spends the highest proportion of its income on research and development compared to all other industries. This increase in R&D spending, spurred by the requirement for multiple preclinical and clinical services during the drug development process, is anticipated to fuel the expansion of the RWE market.
Medical Practitioners and Academics' Reluctance to Rely on Real-World Evidence Solutions
Despite the widespread use of RWE across applications, certain stakeholders continue to be hesitant to rely on real-world evidence. For instance, although payers have begun using RWE, they prefer to base drug coverage decisions on randomized clinical trials (RCTs) rather than external observational data. The primary reason for this preference is the provision of numerous standards and methodologies for examining clinical experience evidence derived from actual patient care. In addition, payers utilize a wide range of procedures and evidence when determining pharmaceutical coverage. During the pharmaceutical technology assessment (PTA) procedure, these differences can impact reimbursement, patient access, and potential healthcare outcomes. Therefore, stakeholders are hesitant to use evidence without a standardized data-gathering strategy.
Increased Emphasis on RWE's End-To-End Services
As players in the healthcare business seek innovative solutions to address the unsustainable cost burden and relatively low return on investment, the healthcare ecosystem is transforming, and there is a growing focus on healthcare costs. To demonstrate value, businesses require robust capabilities in evidence lifecycle management. Consequently, an opportunity for an end-to-end approach to leverage the data, evidence, and knowledge assets of a life sciences organization has been created, which is aiding in the dismantling of conventional silos and enabling insight-driven decision-making from the product R&D phase to its commercialization. This entails creating an effective governance plan and using technologies like cloud and self-service analytics, as well as acquiring the capacity to integrate data sets and comprehend the relevant resources for the required analytics (and tactical issues around data access and quality).
Absence Of Globally Acknowledged Methodology Standards and Data Processing Infrastructure
In this sector, the lack of globally agreed standards or principles that may be used in the design, analysis, and reporting of RWE has become a serious obstacle. This lack of unanimity has resulted in RWE not being of sufficient quality to be included in the body of evidence used to compare the efficacy of various treatment approaches. This has decreased the potential value of the produced information, hence decreasing the incentive to produce it. This further diminishes the likelihood that significant stakeholders will use RWE solutions.
In 2022, The Services Category Dominated the RWE Solutions Market
The rising requirement to translate data into actionable evidence and the availability of a vast quantity of healthcare data are the primary reasons driving the expansion of this market sector. Clients can save time and money by relying on vendors to tailor their services to their specific needs, as opposed to acquiring data sets and analyzing them to generate valuable information. Consequently, the demand for RWE services is greater than that for RWE data sets. Experts in RWE communicate and work with the subject matter expert of pharmaceutical and medical device firms to provide services to establish intelligent RWE plans (consulting services) and employ analytical capabilities to provide significant statistical insights.
In 2022, The Drug Development and Approvals Segment Led the RWE Solutions Market
Due to the increasing number of clinical studies in oncology and cardiovascular medicines, the drug development and approvals market segment is the most significant. In addition, post-pandemic treatment advancements for the COVID-19 infection had a substantial increase. This division is further subdivided into oncology, cardiovascular disease, neurology, immunology, and other therapeutic fields. Due to the rising incidence of cancer and the growing number of clinical trials and research focusing on cancer treatment and prevention, the oncology segment leads the market.
Pharmaceutical And Medical Device Firms Are Anticipated to be The Fastest Growing End Users Segment
The rapid rise of pharmaceutical and medical device firms is attributable to the growing significance of RWE studies in medication approvals, the prevention of costly drug recalls, and the evaluation of therapeutic performance in real-world contexts. In addition, the pharmaceutical industry's use of RWE continues to rise due to its application in addressing regulatory compliance requirements and payer obligations connected to HEOR. Pharmaceutical businesses demand information detailing both the approved and medically acknowledged alternative uses for previously approved medications. For novel medications to effectively progress through clinical phases, RWE data is required. Therefore, the successful phase transition is contingent upon robust real-world results.
North America remains the Global Leader, and APAC is the Growth Leader
North America held the greatest share of the RWE solutions market, while Asia-Pacific is anticipated to maintain the highest growth rate over the forecast period. Supporting the growth of the RWE solutions market in the Asia Pacific region are factors such as the rising number of clinical trials, increasing government initiatives for the adoption of RWE studies, the rising incidence of chronic diseases, the rising demand for better healthcare services, and the rising geriatric population. Moreover, nations such as Japan and China in the region have a well-established clinical trial infrastructure, a strong medical workforce, solid healthcare capabilities, and high-quality requirements, all of which contribute to the growth of the market in the Asia Pacific.
Market Competition to Intensify During the Forecast Period
The worldwide market is highly fragmented and competitive. Through subsidiaries and partnerships, market participants implement strategic initiatives such as product development and launch, distribution network expansion, and global footprint expansion. In addition to portfolio diversification and mergers & acquisitions, key players engage in portfolio diversification and mergers & acquisitions. For example, in August 2021, Syneos Health teamed with Aetion to develop a solution based on real-world evidence and to give analytically-driven data and regulatory-grade data. Similarly, Thermo Fisher Scientific announced in April 2021 that it will purchase PPD, Inc. for USD 47.50 per share. The key companies that are active in the market include IQVIA, IBM, ICON plc., PAREXEL International Corporation, PPD, LLC, Optum, Inc., Cognizant Technology Solutions Corporation, Oracle Corporation, SAS Institute Inc., Syneos Health, Inc., Anthem, Inc., Clinigen Group plc., Medpace Holdings Inc., Flatiron Health and Other notable players.
Historical & Forecast Period
This study report represents analysis of each segment from 2021 to 2031 considering 2022 as the base year. Compounded Annual Growth Rate (CAGR) for each of the respective segments estimated for the forecast period of 2022 to 2031.
The current report comprises of quantitative market estimations for each micro market for every geographical region and qualitative market analysis such as micro and macro environment analysis, market trends, competitive intelligence, segment analysis, porters five force model, top winning strategies, top investment markets, emerging trends and technological analysis, case studies, strategic conclusions and recommendations and other key market insights.
Research Methodology
The complete research study was conducted in three phases, namely: secondary research, primary research, and expert panel review. key data point that enables the estimation of Real World Evidence Solution market are as follows:
Research and development budgets of manufacturers and government spending
Revenues of key companies in the market segment
Number of end users and consumption volume, price and value.
Geographical revenues generate by countries considered in the report
Micro and macro environment factors that are currently influencing the Real World Evidence Solution market and their expected impact during the forecast period.
Market forecast was performed through proprietary software that analyzes various qualitative and quantitative factors. Growth rate and CAGR were estimated through intensive secondary and primary research. Data triangulation across various data points provides accuracy across various analyzed market segments in the report. Application of both top down and bottom-up approach for validation of market estimation assures logical, methodical and mathematical consistency of the quantitative data.
Market Segmentation
Component
Services
Data Sets
Disparate Data Sets
Clinical Settings Data
Claims Data
Pharmacy Data
Patient-Powered Data
Registry-Based Data Sets
Integrated Data Sets
Application
Drug Development And Approvals
Oncology
Neurology
Immunology
Cardiovascular Disease
Other Therapeutic Areas
Medical Device Development And Approvals
Post-Market Surveillance
Market Access Reimbursement/Coverage Decision Making
Clinical And Regulatory Decision-Making
End User
Pharmaceutical & Medical Device Companies
Healthcare Providers
Healthcare Payers
Other End Users
Region Segment (2021-2031; US$ Million)
North America
U.S.
Canada
Rest of North America
UK and European Union
UK
Germany
Spain
Italy
France
Rest of Europe
Asia Pacific
China
Japan
India
Australia
South Korea
Rest of Asia Pacific
Latin America
Brazil
Mexico
Rest of Latin America
Middle East and Africa
GCC
Africa
Rest of Middle East and Africa
Key questions answered in this report
What are the key micro and macro environmental factors that are impacting the growth of Real World Evidence Solution market?
What are the key investment pockets with respect to product segments and geographies currently and during the forecast period?
Estimated forecast and market projections up to 2031.
Which segment accounts for the fastest CAGR during the forecast period?
Which market segment holds a larger market share and why?
Are low and middle-income economies investing in the Real World Evidence Solution market?
Which is the largest regional market for Real World Evidence Solution market?
What are the market trends and dynamics in emerging markets such as Asia Pacific, Latin America, and Middle East & Africa?
Which are the key trends driving Real World Evidence Solution market growth?
Who are the key competitors and what are their key strategies to enhance their market presence in the Real World Evidence Solution market worldwide?