市場調查報告書
商品編碼
1260065
真實世界證據解決方案市場——增長、未來展望、競爭分析,2023 年至 2031 年Real World Evidence Solution Market - Growth, Future Prospects and Competitive Analysis, 2023 - 2031 |
在 2023 年至 2031 年的預測期內,全球真實證據解決方案市場預計將以 15% 的複合年增長率增長。 推動這一市場擴張的主要因素是臨床試驗的擴大以及療法從基於體積到基於價值的轉變。 RWE 和 RWD 可用於改進協議設計,減少代價高昂的協議更改次數,並創建合成控制臂以加快試驗執行並降低成本。 同樣,RWE 可以加快標籤擴展並降低歸檔所需文檔的總成本。 這些優勢增加了 RWE 系統在藥物和醫療設備研發中的採用。 監管機構對使用真實世界證據 (RWE) 解決方案的支持和增加研發支出預計將刺激市場增長。 從基於數量的護理轉向基於價值的護理預計也將有助於增加。 由於 COVID-19 大流行,許多市場進入者經歷了廣泛的業務中斷,擾亂了他們的日常運營。
擴大研發投入
大多數製藥、生物製藥和醫療器械企業繼續大力投資新藥和新技術的開發。 特別是,製藥企業正在積極投資於研發。 為了同時滿足藥物發現和開發的需求,不斷上升的研發成本正促使製藥和生物製藥公司從早期到後期的開發階段選擇完全集成或功能性的外包服務。 與所有其他行業相比,製藥行業用於研發的收入佔其收入的比例最高。 這種增加的研發支出預計將刺激藥物開發過程中對多種臨床前和臨床服務的需求,從而刺激 RWE 市場的擴張。
醫學專家和學者不願意依賴現實世界的證據解決方案
儘管 RWE 在應用程序中廣泛使用,但一些利益相關者仍然對依賴真實世界的證據猶豫不決。 例如,付款人已開始使用 RWE,並且更喜歡基於隨機臨床試驗 (RCT) 而不是外部觀察數據的藥物承保決定。 這種趨勢的主要原因是提供了許多標準和方法來考慮來自真實患者護理的臨床經驗證據。 此外,付款人在做出藥物申請決定時會使用範圍廣泛的程序和證據。 在製藥技術評估 (PTA) 程序中,這些差異會影響報銷、患者獲取和潛在的醫療保健結果。 因此,利益相關者不願在沒有標準化數據收集策略的情況下使用證據。
萊茵集團的端到端服務變得更加重要
隨著醫療保健行業參與者尋求創新解決方案來解決不可持續的成本負擔和相對較低的投資回報率,醫療保健生態系統正在轉型並專注於醫療保健支出。 為了展示價值,公司需要強大的證據生命週期管理能力。 其結果是一個端到端方法的機會,該方法利用生命科學組織的數據、證據和知識資產來打破傳統孤島,並實現從產品研發階段到商業化的洞察力驅動的決策。 這需要製定有效的治理計劃並利用雲和自助服務分析等技術。 他們還需要培養整合數據集的能力,並了解所需分析所需的相關資源(在數據訪問和質量方面也存在戰術挑戰)。
缺乏國際公認的研究方法標準和數據處理基礎設施
缺乏關於可用於設計、分析和報告 RWE 的標準和原則的全球協議是該領域的一個嚴重障礙。 由於缺乏一致性,RWE 的質量不足以包含在用於比較不同治療效果的證據體中。 這會降低所產生信息的潛在價值,從而降低產生信息的動力。 這進一步降低了關鍵利益相關者使用 RWE 解決方案的可能性。
到 2022 年,RWE 解決方案市場將由服務類別主導
將數據轉化為可操作證據的需求不斷增長,海量醫療保健數據的可用性是推動該領域市場擴張的主要原因。 客戶可以通過允許供應商根據他們的特定需求定制服務來節省時間和金錢,而不是獲取數據集並對其進行分析以獲得有價值的信息。 因此,對 RWE 服務的需求大於對 RWE 數據集的需求。 RWE 專家提供服務以建立智能 RWE 計劃(諮詢服務),同時與製藥和醫療設備公司的主題專家進行交流,並利用分析能力提供關鍵的統計見解。
2022 年,醫藥市場開發和審批板塊帶動了 RWE 解決方案市場
由於腫瘤和心血管領域臨床研究的增加,藥物研發和審批市場的細分成為最大的細分市場。 大流行後 COVID-19 的治療進展也有顯著增長。 該部門進一步細分為腫瘤學、心血管學、神經學、免疫學和其他治療領域。 由於癌症患病率上升以及專注於癌症治療和預防的臨床試驗和研究不斷增加,腫瘤學成為市場領導者。
預計製藥公司和醫療設備製造商將成為增長最快的最終用戶群體
製藥和醫療設備製造商的崛起是由於 RWE 研究在批准藥物、防止代價高昂的藥物召回以及評估現實世界中的療效方面越來越重要。 此外,RWE 在製藥行業的使用正在增加,因為它是一種滿足監管合規要求和與 HEOR 相關的付款人義務的應用程序。 製藥行業需要詳細說明已批准藥物的批准用途和醫學上可接受的替代用途的信息。 新藥有效推進臨床階段需要 RWE 數據。 因此,可靠的真實世界結果對於成功的相變至關重要。
北美仍然是世界領先者,亞太地區仍然是增長領先者
北美將佔據 RWE 解決方案市場的最大份額,而亞太地區有望在預測期內保持最高增長率。 亞太地區 RWE 解決方案市場的增長得益於臨床試驗數量的增加、政府加大力度引入 RWE 研究、慢性病發病率上升以及對更好的醫療服務需求的增長。這是一個因素,例如老年人口的增加。 此外,日本、中國等亞太國家臨床試驗基礎設施完善,醫療專業人才眾多,醫療功能發達,質量要求高,有助於
預測期內市場競爭加劇
全球市場高度分散且競爭激烈。 通過子公司和合作夥伴關係,市場進入者實施戰略計劃,例如產品開發和發布、分銷網絡擴展和全球運營。 除了投資組合多元化和併購,各大公司也進行投資組合多元化和併購。 例如,2021 年 8 月,Synos□□ Health 將與 Aetion 合作開發真實世界的、基於證據的解決方案,以提供分析驅動和監管級數據。 同樣,Thermo Fisher Scientific 於 2021 年 4 月宣布將以每股 47.50 美元的價格收購 PPD, Inc.。 市場上運營的主要公司包括 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。
本報告中回答的關鍵問題
影響現實世界證據解決方案市場增長的關鍵微觀和宏觀環境因素有哪些?
現在和預測期內,產品細分和地區的主要投資領域是什麼?
到 2031 年的估計和市場預測
在預測期內,哪些細分市場的複合年增長率最快?
哪個細分市場的市場份額更大,為什麼?
低收入和中等收入國家是否在投資現實世界的證據解決方案市場?
哪個地區的真實證據解決方案市場規模最大?
亞太、拉丁美洲、中東和非洲等新興市場的市場趨勢和動態如何?
推動現實世界證據解決方案市場增長的主要趨勢是什麼?
主要競爭對手及其在全球真實證據解決方案市場中的影響力的關鍵戰略是什麼?
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?