市場調查報告書
商品編碼
1453952
到 2030 年的真實世界證據解決方案市場預測:按組件、部署、應用程式、最終用戶和地區進行的全球分析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 |
根據 Stratistics MRC 的數據,2023 年全球現實世界證據解決方案市場規模將達到 184 億美元,預計到 2030 年將達到 612 億美元,預測期內年複合成長率為 18.7%。
來自各種非傳統臨床研究環境的醫療資料,電子健康記錄(EMR)、申請和投訴資料、產品和疾病登記以及行動裝置和健康應用程式上收集的資料,通常被稱為真實世界證據解決方案是的。 RWE 解決方案利用電子健康記錄、申請資料庫和病患登記等來源的資料來深入了解臨床試驗受控環境之外的醫療干涉措施的安全性、有效性和成本效益。
《世界老化人口報告》顯示,2020 年全球 65 歲以上人口約 7.27 億,預計到 2050 年將達到 15 億。
越來越關注以病人為中心的醫療保健
在傳統的臨床試驗中,患者的經驗和結果可能無法完全反映現實世界的情況。隨著向以患者為中心的護理的轉變,人們越來越認知到了解患者日常生活中治療如何發生的重要性。 RWE 解決方案透過利用電子健康記錄、病患登記和穿戴式裝置等來源的真實資料,在這項範例中發揮關鍵作用。此外,透過分析這些資料,醫療保健相關人員可以深入了解患者偏好、治療依從性和介入措施的實際有效性。
實施成本高
建立強大的萊茵集團能力需要在基礎設施、技術、人才取得和持續維護方面進行大量投資。需要大量的財政資源來開發收集、整合和分析不同的現實世界資料來源所需的資料基礎設施。然而,實施機器學習和自然語言處理等先進的分析工具和技術需要大量的軟體授權、客製化和培訓成本。建立由資料科學家、生物統計學家和領域專家組成的多學科團隊會增加 RWE舉措的整體成本。
資料分析的進展
隨著醫療保健資料的數量和複雜性持續呈指數級成長,資料分析的創新使利益相關人員能夠從大型現實資料集集中獲得有意義的見解。機器學習、人工智慧和自然語言處理等技術使得從電子健康記錄記錄、申請資料庫和患者登記等不同的現實世界資料來源中識別模式、相關性和趨勢成為可能。這種分析能力不僅有助於產生可靠的現實世界證據,而且還提高了資料分析過程的效率和準確性。
隱私和資料安全問題
隨著醫療保健決策越來越依賴真實世界資料(RWD),確保敏感患者資訊的隱私和安全已變得至關重要。遵守 GDPR 和 HIPAA 等嚴格的資料保護條例會增加 RWE 工作的複雜性和成本。相關人員必須考慮圍繞患者資料的使用、共用和保護的道德和法律考慮。資料外洩、未授權存取和濫用個人健康資訊的潛在風險進一步加劇了這些擔憂,並削弱了人們對 RWE 解決方案的信任和信心。
隨著醫療保健產業面臨前所未有的挑戰,對真實世界資料(RWD)的需求激增,RWE 解決方案以了解病毒的影響、評估治療效果並為公共衛生應對措施提供資訊而促進了招募。 RWE 在促進快速臨床決策和評估現有藥物的安全性和有效性方面發揮了關鍵作用,以便在大流行的緊急情況下重新利用。然而,疫情凸顯了資料存取、品質和基礎設施方面現有的差異,加劇了有效利用真實世界證據解決方案的挑戰。
預計醫療設備開發領域在預測期內將是最大的。
由於監管機構越來越需要可靠的真實資料來支援醫療設備核准和上市後監管,醫療設備開發領域預計將在預測期內佔據最大佔有率。 RWE 解決方案使製造商能夠產生有關設備安全性、有效性和實際性能的證據,以滿足監管期望並加速市場進入。此外,向基於價值的醫療保健的轉變和對患者結果的重視需要傳統臨床試驗之外的全面證據。
預計資料集領域在預測期內的年複合成長率最高
資料集領域在整個預測期內佔據了最大的市場佔有率,因為它在為獲得可行的見解提供基礎方面發揮著至關重要的作用。隨著電子健康記錄(EHR)、申請資料庫、病患登記、穿戴式裝置和健康社會決定因素等資訊來源提供多樣化和廣泛的資料集,RWE 產生的潛力正在急劇擴大。此外,這些豐富的資料集提供了現實世界中患者群體、治療途徑和醫療保健結果的全面視圖。
這是因為中國、印度、日本和韓國等國家的快速都市化、人口成長和醫療成本上升正在推動對循證醫療解決方案的需求。促進在醫療保健決策中使用現實世界證據解決方案的監管改革和舉措正在加速該地區的市場成長。此外,數位醫療基礎設施的區域擴張和電子健康記錄的採用正在產生大量的現實世界資料,為 RWE 的利用創造了機會。
由於實施了促進使用 RWE 進行藥物核准、市場准入和上市後監督的政策和舉措,預計亞太地區將在整個統治時期呈現盈利成長。中國的監管改革,包括接受國外臨床試驗資料和建立快速醫藥品認證過程,正在推動製藥公司採用 RWE 解決方案。此外,印度簡化監管流程和促進創新的努力正在為萊茵集團創造有利的環境。
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.