![]() |
市場調査レポート
商品コード
1504255
リアルワールドエビデンス(RWE)ソリューションの世界市場の評価:コンポーネント別、用途別、収益モデル別、展開方式別、エンドユーザー別、地域別、機会、予測(2017年~2031年)Real-World Evidence Solutions Market Assessment, By Component, By Application, By Revenue Model, By Mode of Deployment, By End-user, By Region, Opportunities and Forecast, 2017-2031F |
||||||
カスタマイズ可能
|
リアルワールドエビデンス(RWE)ソリューションの世界市場の評価:コンポーネント別、用途別、収益モデル別、展開方式別、エンドユーザー別、地域別、機会、予測(2017年~2031年) |
出版日: 2024年07月01日
発行: Market Xcel - Markets and Data
ページ情報: 英文 215 Pages
納期: 3~5営業日
|
世界のリアルワールドエビデンス(RWE)ソリューションの市場規模は、2023年の18億6,000万米ドルから2031年に44億8,000万米ドルに達すると予測され、2024年~2031年の予測期間にCAGRで11.57%の成長が見込まれます。市場は近年著しい成長を示しており、今後も力強い拡大ペースを維持すると予測されます。
リアルワールドエビデンス(RWE)ソリューション市場は、医療・ライフサイエンス部門の中でも活気があり、急速に拡大している市場です。RWEは、管理された臨床研究からのデータではなく、実際の患者の経験や医療処置からの情報や考察を指します。患者転帰を改善し、医薬品開発を促進し、医療の意思決定を導く可能性があるため、市場は近年ますます目立ってきています。市場は、複数の重要な側面の結果として成長しています。何よりもまず、リアルワールドエビデンスソリューションへのニーズは、エビデンスに基づく医療が重視されるようになり、医療システムのステークホルダーが十分な情報に基づいた意思決定を行うことが求められるようになったことによって促進されています。RWEは、さまざまな患者集団に対する薬剤や機器などの医療介入の安全性と有効性を評価するのに有用です。これにより、リアルワールドの文脈における患者転帰、疾病の発生、治療成果の理解が容易になります。さらに、電子カルテ(EHR)やデジタルヘルス技術の普及により、RWE分析に利用できるデータが多数提供されるようになっています。RWEソリューション市場は、医療産業におけるビッグデータアナリティクス、機械学習、AIの統合によって可能になったリアルワールドデータの効果的な収集、管理、分析の結果として成長してきました。RWEソリューションの主なエンドユーザーは製薬企業で、市場参入、市販後調査、医薬品開発の支援に活用されています。RWEは保険者、医療提供者、規制当局によって活用され、医薬品の承認、決済方針、治療ガイドラインについて十分な情報を得た上で意思決定を行っています。この幅広い用途は、市場の適応性と拡大の余地を示しています。例えば、第31回Conference on Retroviruses and Opportunistic Infections(CROI 2024)では、Gilead Sciences, Inc.が2024年2月、抗ウイルス研究開発プログラムのRWEと新たな臨床データを発表すると発表しました。4件の口頭発表と、HIV、COVID-19、ウイルス性肝炎に関する最新情報も、約80件の研究から得られたデータに含まれる見込みです。
エビデンスに基づく医療への注目の高まりが市場成長をもたらす
世界のリアルワールドエビデンス(RWE)ソリューション市場の拡大は、エビデンスに基づく医療が重視されていることによるものと考えられます。RWEは、医療産業においてデータ主導の意思決定がますます重要になっている時代において、医療行為、医薬品開発、医療政策に影響を与える強力な技術となっています。リアルワールドエビデンス(RWE)は、入手可能な最良の臨床データの選択に基づくエビデンスに基づく医療のプロセスにとって極めて重要です。リアルワールドエビデンス(RWE)は、医療サービスの有効性と質を向上させるために、保険者、製薬企業、規制当局、医師などの医療ステークホルダーによってますます評価されるようになってきています。その重要性にもかかわらず、臨床試験はしばしば、実世界の患者集団を正しく表現することに問題を抱えています。しかし、RWEはより広範な患者の属性と臨床シナリオを捉え、医療介入と治療がさまざまな実環境でどのように機能するかについての考察を提供します。
エビデンスに基づく医療に焦点を当て、RWEを適用することは、研究開発、特に製薬産業にとって非常に有益です。RWEは、製薬企業が実際の医療現場で患者からデータを収集し、薬や治療の有効性と安全性を明らかにするのに役立ちます。この情報は、ターゲットとなる患者集団の選択から、より効果的な臨床試験や市販後調査の計画まで、医薬品開発の複数の段階における意思決定に役立ちます。また、それは臨床試験という管理された環境だけにとどまりません。保険者と規制機関は、医薬品の承認、市場参入、償還方針に関して十分な情報に基づいた決定を下すためにRWEによる考察を活用しています。彼らは最善の治療法への公平なアクセスを保証し、医療介入の臨床的影響と現実の費用対効果を評価することにより、リソース配分を最適化します。
当レポートでは、世界のリアルワールドエビデンス(RWE)ソリューション市場について調査分析し、市場規模と予測、市場力学、主要企業の情勢と見通しなどを提供しています。
Global real-world evidence solutions market is projected to witness a CAGR of 11.57% during the forecast period 2024-2031F, growing from USD 1.86 billion in 2023 to USD 4.48 billion in 2031F. The market has experienced significant growth in recent years and is expected to maintain a strong pace of expansion in the coming years.
The real-world evidence (RWE) solutions market is a vibrant and fast-expanding market within the healthcare and life sciences sector. Rather than data from controlled clinical studies, RWE refers to information and insights from actual patient experiences and healthcare procedures. Due to its potential to improve patient outcomes, increase medication development, and guide healthcare decisions, this market has become increasingly prominent in recent years. The global RWE solutions market is growing as a result of several important aspects. First and foremost, the need for real-world evidence solutions is driven by the growing emphasis on evidence-based medicine and the healthcare system's stakeholders' requirement to make informed decisions. RWE is useful for assessing the safety and efficacy of medical interventions, such as drugs and devices, on a variety of patient groups. This facilitates comprehension of patient outcomes in real-world contexts, illness development, and therapy outcomes. Moreover, a multitude of data that may be utilised for RWE analysis has been made possible by the widespread use of electronic health records (EHRS) and digital health technology. The market for RWE solutions has grown as a result of the effective gathering, management, and analysis of real-world data made possible by the integration of big data analytics, machine learning, and artificial intelligence in the healthcare industry. Among the main end-users of RWE solutions are pharmaceutical businesses, which utilize them to assist market entry, post-market surveillance, and drug development. RWE is utilized by payers, healthcare providers, and regulatory authorities to make well-informed decisions about drug approvals, payment policies, and treatment guidelines. This wide range of applications demonstrates the market's adaptability and room for expansion. For instance, at the 31st Conference on Retroviruses and Opportunistic Infections (CROI 2024), Gilead Sciences, Inc. announced in February 2024 that it would present RWE and new clinical data from its antiviral research and development programs. Four oral presentations and the latest information on HIV, COVID-19, and viral hepatitis were also expected to be included in the data, which comes from nearly 80 studies.
Growing Emphasis on Evidence-Based Medicine Leads to Market Growth
The expansion of the global real-world evidence (RWE) solutions market can be attributed to the emphasis on evidence-based medicine. RWE has become a potent technology that influences medical practices, pharmaceutical development, and healthcare policy in an era where data-driven decision-making is becoming increasingly important in the healthcare industry. Real-world evidence is crucial to the process of evidence-based medicine, which is based on choices of the best available clinical data. Real-world evidence is becoming more and more valued by healthcare stakeholders, such as payers, pharmaceutical firms, regulators, and physicians, to improve the effectiveness and quality of healthcare services. Despite its importance, clinical trials frequently have problems while correctly representing the patient population in the actual world. However, RWE captures a wider range of patient demographics and clinical scenarios and offers insights into how healthcare interventions and therapies function in various real-world settings.
The focus on evidence-based medicine and the application of RWE has been extremely beneficial for research and development, particularly for the pharmaceutical industry. It helps pharmaceutical corporations collect data from patients in actual healthcare settings, highlighting their medications' and treatments' efficacy and safety. This information helps with decision-making at several stages of drug development, from selecting target patient populations to planning more effective clinical trials and post-market surveillance. It also goes beyond the controlled setting of clinical trials. Payers and regulatory bodies utilize the insights by RWE to make well-informed decisions concerning medicinal approvals, market access, and reimbursement policies. They guarantee fair access to the best therapies and optimize resource allocation by assessing the clinical impact and real-world cost-effectiveness of healthcare interventions.
For example, in February 2024, Datavant, Inc. and PINC AI Applied Sciences (PAS), which is a division of Premier, Inc., extended their cooperation to advance trial diversity and equity, improve clinical trial operations, and advance healthcare research. The goal of this partnership is to accelerate the creation of novel treatments and solutions that will improve patient outcomes. To link clinical trial data with PAS's real-world data (RWD) and produce RWE that spurs innovation in clinical research, PAS will make use of Datavant, Inc.'s trial tokenization technology and data connectivity platform. This program provides deeper understanding of the efficacy and safety of medical interventions in real-world settings beyond the controlled environments of clinical trials.
Patient-Centric Healthcare Leading to Market Expansion
In addition to revolutionizing healthcare delivery, the idea of patient-centric healthcare is also driving growth in the global market for real-world evidence (RWE) solutions. Patient-centric healthcare prioritizes the experiences, preferences, and results of the patient at the center of the decision-making process. This philosophical change in healthcare directly and significantly impacts the acceptance and growth of RWE solutions. Patient-centric healthcare places a strong emphasis on the value of understanding the patient's viewpoint and life experiences. Data on treatment choices, quality of life after the treatment, outcomes reported by patients, and therapy adherence are all part of this process. This patient-generated data, which offers a thorough picture of the patient's journey and their reactions to medical procedures, is essential for RWE analysis. Furthermore, a constant flow of patient-generated data is produced by patients actively participating in self-care, which is made possible by digital health technologies and patient engagement tools. Patients can track their health and communicate in real time about their experiences with wearable technology, smartphone apps, and telemedicine platforms. To further enhance the real-world data utilized in healthcare decision-making, RWE solutions have the possibility to access a multitude of information directly from patients in this data-rich environment.
The need for RWE solutions that can integrate a wider range of real-world data sources, such as electronic health records, claims data, and social determinants of health, is driven by patient-centric healthcare in addition to patient-generated data. Healthcare stakeholders are encouraged to consider a wide range of elements that impact patients' well-being, from socioeconomic conditions to lifestyle choices, by emphasizing holistic patient care. Additionally, collaborative decision-making-in which patients actively engage in conversations regarding the advantages, disadvantages, and possible courses of treatment-is encouraged by patient-centric healthcare. By giving patients and medical professionals evidence-based insights into the efficacy and safety of different treatment options in the real world, RWE solutions facilitate shared decision-making. For example, the TSX Implant was first presented in Japan in February 2024 by ZimVie, Inc., a global player in the life sciences sector with a focus on the dentistry and spine sectors. With the goal of delivering advantages such as peri-implant health, sustained osseointegration, crestal bone preservation, and prosthetic stability, this implant incorporates design elements supported by more than two decades of clinical and RWD experience, hence improving patient experience and giving them better quality results.
Increasing Dominance of Drug Development Segment Fuels Market Growth
The global real-world evidence (RWE) solutions market has grown significantly, and one of the main drivers of this growth has been pharmaceutical research and development (R&D). The way the pharmaceutical business conducts research has been changing, and it now relies more and more on real-world evidence to guide and expedite the medication development process. This change has been a major factor behind the increasing demand for RWE solutions since they provide pharmaceutical organizations with useful information and efficiency-boosting chances at different phases of the drug development process. RWE contributes significantly to pharmaceutical R&D by offering important insights regarding the efficacy and safety of medications and treatments in real-world settings. Traditional clinical trials are carried out in carefully regulated settings with stringent inclusion and exclusion criteria, which may not accurately reflect the wide range of patient groups and clinical circumstances seen in everyday practice. RWE fills this void by providing an abundance of information gathered from actual patients in typical healthcare environments. Pharmaceutical companies can utilize this data to target patients more precisely, conduct clinical trials that are more successful and economical, and even look into new therapeutic indications according to their current medications.
Moreover, RWE is essential for post-market surveillance, which helps to keep an eye on the efficacy and safety of medications and medical devices after they are made available to the general public. RWE is used by pharmaceutical businesses and regulatory bodies, including the U.S. Food and Drug Administration (FDA), to identify adverse events, evaluate the long-term efficacy of medications, and make well-informed judgments about safety alerts. The prompt and thorough monitoring contributes to the preservation of pharmaceutical products' reliability and safety in the marketplace. Additionally, RWE makes comparative effectiveness research easier, giving pharmaceutical companies insight into how their products perform in real-world patient populations relative to competitors. They can use this knowledge to better distinguish between their products, find areas of development, and overcome obstacles for easier market entry. For example, Thermo Fisher Scientific Inc. acquired CorEvitas LLC in July 2023 for a total of USD 912.5 million with the intention of bolstering its real-world, regulatory-grade evidence for licensed medical treatments and therapies to enhance its drug development segment.
North America to Dominate the Real-World Evidence Solutions Market
With the biggest market share in the world, the real-world evidence solutions market, North America emerged as the leading participant. The use of real-world evidence in healthcare decision-making has been supported by regulations more and more throughout North America, especially in the United States. Real-world data is valuable, and regulatory bodies like the United States Food and Drug Administration (FDA) have begun incorporating it into their decision-making procedures, such as post-market surveillance and drug approvals. There is a sizable pharmaceutical and life sciences sector in North America. These sectors have a significant stake in the global real-world evidence solutions market because they depend on real-world data to guide drug research, prove drug efficacy, and facilitate access to markets. For example, in the Federal Food, Drug, & Cosmetic Act (FD&C Act) of North America, Section 505-F (b) defines RWE as "data concerning the use, or potential benefits or challenges, of a drug obtained from sources apart from traditional clinical trials." The presence of numerous pharmaceutical companies in North America drives the demand for real-world evidence solutions.
For example, the FDA announced the launch of the Advancing Real World Evidence Program in October 2022. Enhancing the quality and acceptability of RWE-based approaches to support new labeling claims, such as accepting new applications for already-approved medical products or fulfilling post-approval research requirements, is the goal of this program. This program is a component of the FDA's commitment as stated in the FDA User Fee Reauthorization Act of 2022, which includes the Prescription Drug User Fee Act VII.
Future Market Scenario (2024-2031F)
The main factors contributing to the anticipated growth of the real-world evidence solutions market are the increasing prevalence of chronic disorders, increasing emphasis on evidence-based medicine and increasing demand for patient-centric healthcare services. Rising awareness in people and the need are also factors that will always propel the market growth in the future. Given that technology is advancing, cutting-edge technology in the area can also be expected. Players in this market are expanding at an unparalleled rate, introducing cost-effective and efficient technologies. For instance, the FDA released draft guidance in December 2023 on how it evaluates real-world data (RWD) when determining whether to approve or clear a medical device by providing anonymized examples of its RWE utilization.
Key Players Landscape and Outlook
Several companies such as IQVIA Inc., Kaia Health Software, Inc., Thermo Fisher Scientific Inc., Merative L.P., Optum, Inc., ICON plc, Parexel International (MA) Corporation, Syneos Health, PerkinElmer, Inc., Datavant, Inc., etc., are expanding business by planning and adopting new strategies. They are complying with new strategic initiatives regarding the launches of newly developed RWE solutions to help researchers and to bring up their presence in the market. New product launches, agreements based on contracts, acquisitions and mergers, investments and partnerships are a few ways through which they are trying to achieve the same.
Palantir Technologies Inc. and Parexel International (MA) Corporation collaborated in April 2024 to use AI to speed up and improve the delivery of efficient and secure clinical trials for clients in the global biopharmaceutical industry. Through this collaboration, Paraxel International (MA) Corporation is able to further develop its skills in advanced analytics, RWE, and health outcomes, as well as improve its clinical trial processes.
All segments will be provided for all regions and countries covered
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.