市場調查報告書
商品編碼
1540794
2024-2032 年藥物警戒市場報告(按服務提供者、產品生命週期、類型、流程、治療領域、最終用途和地區分類)Pharmacovigilance Market Report by Service Provider, Product Life Cycle, Type, Process Flow, Therapeutic Area, End Use, and Region 2024-2032 |
IMARC Group年全球藥物警戒市場規模達79億美元。藥物不良反應(ADR)的日益普遍,加上政府機構推出有利政策以提高人們對正確使用藥物的認知並進行臨床試驗,主要刺激了藥物警戒市場的成長。
主要市場促進因素:各種生活方式疾病(包括心臟病、高血壓、糖尿病等)發病率的上升正在增加全球藥物的使用。因此,對藥物警戒(PV)的需求不斷增加,以檢測以前未知的不良反應,識別頻率或嚴重程度的變化,評估藥物的風險和益處以確定所需的行動等。的機會藥物警戒市場前景。
主要市場趨勢:藥物警戒市場的主要趨勢之一包括開發先進平台以確保自動報告藥物不良反應 (ADR)。此外,由於競爭環境,主要參與者也專注於加強製造業務和簡化研發活動。除此之外,臨床試驗數量的增加預計將在預測期內推動藥物警戒市場的發展。
競爭格局:一些著名的藥物警戒市場主要參與者包括Accenture plc、ArisGlobal LLC、BioClinica Inc. (Cinven Partners LLP)、Capgemini、Cognizant、International Business Machines Corporation、ICON plc.、IQVIA Inc.、ITClinical、Parexel International Corporation 、及 Wipro Limited 等。
挑戰與機會:根據藥物警戒市場分析,一些挑戰包括政府機構嚴格的監管要求、管理和從大量資料中獲取有意義的見解的複雜性不斷增加,以及平衡全面藥物安全監測的需求日益增加控制成本的壓力正在阻礙全球藥物警戒產業的成長。然而,促進策略合作以確保藥品安全和維護公眾健康預計將在未來幾年推動藥物警戒市場佔有率的成長。
技術不斷進步的發展
機器學習 (ML)、自然語言處理 (NLP)、人工智慧 (AI)、巨量資料分析等新技術的日益整合正在增強藥物警戒流程。與此一致,這些技術正在獲得廣泛的關注,因為它們有助於識別不良事件、風險評估、實現有效的訊號檢測等,預計這將在預測期內推動市場成長。例如,賽諾菲和德勤合作開發了ConvergeHEALTH Safety,這是下一代人工智慧(AI) 軟體即服務不良事件案例受理平台,該平台改變了藥物警戒(PV) 流程並解決了行業中一些最緊迫的操作安全問題。為此,ArisGlobal 推出了 USFDA 不良事件報告系統 (FAERS II),這是一個由 LifeSphere MultiVigilance 提供支援的電子安全報告平台,推動了市場成長。此外,Saama Technologies Inc. 開發了新的製藥主動安全分析 (ASAP) 產品。 ASAP 是首批經過驗證的藥物警戒解決方案之一,利用 TreeScan 方法和美國食品藥物管理局 (FDA) 的哨兵通用資料模型來檢測安全訊號。
政府機關實施嚴格的法規
全球各地的政府當局正在臨床試驗中實施嚴格的規則,並提高人們對正確使用藥物的認知,這正在刺激藥物警戒服務的使用。例如,根據《藥物安全與監管前沿》發表的一項研究,上市後藥物評估的重要性對於描述現實環境中的藥物安全狀況非常重要。此類研究進一步提高了藥物警戒的重要性,從而刺激了市場成長。此外,由於存在 N-亞硝基喹那普利和亞硝胺藥物相關雜質 (NDSRI),Aurobindo Pharma USA 重新配製了喹那普利和氫氯噻嗪片 USP 20mg/12.5mg。因此,監管機構對醫療資訊日益成長的需求預計將推動預測期內的市場成長。
製藥公司擴大採用藥物警戒服務
藥物警戒服務因其優勢(例如在更短的時間內獲得更好的結果以及提高內部資源靈活性)而被全球主要製藥公司廣泛採用。例如,根據疫苗不良事件通報系統的數據,在注射了 4,041,396 劑 Moderna COVID-19 疫苗後,發現了 10 例過敏反應病例(每百萬劑中有 2.5 例)。因此,對藥物警戒服務不斷成長的需求也刺激了市場的成長。除此之外,主要產業參與者也正在進行策略合作,這將在預測期內繼續推動藥物警戒市場的發展。例如,IQVIA 與 NRx Pharmaceuticals 達成策略合作,提供醫療資訊和藥物警戒服務,為潛在的監管行動做好準備。
高級臨床試驗階段的數量不斷增加
為了提高臨床試驗的功效,主要參與者正在開發先進的臨床試驗,這正在刺激全球藥物警戒市場。例如,Cognizant 與 Medable Inc. 建立合作關係,共同提供基於 Medable 的軟體即服務平台的臨床研究解決方案,用於分散式臨床試驗。據此,根據藥物警戒市場概況,Viedoc 與 LINK Medical 建立了 Viedoc 建立的合作關係。此次合作旨在提高 LINK Medical 及其客戶的試驗效率。這種夥伴關係允許交流需求、經驗、想法等,並測試新功能。
The global pharmacovigilance market size reached US$ 7.9 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 15.9 Billion by 2032, exhibiting a growth rate (CAGR) of 7.8% during 2024-2032. The increasing prevalence of adverse drug reactions (ADRs), coupled with the launch of favorable policies by government bodies to generate awareness about the proper usage of medicines and conduct clinical trials, is primarily stimulating the pharmacovigilance market growth.
Major Market Drivers: The elevating incidences of various lifestyle diseases, including cardiac disorders, hypertension, diabetes, etc., are augmenting the usage of drugs across the globe. Consequently, there is an elevating need for pharmacovigilance (PV) to detect previously unknown adverse effects, recognize changes in the frequency or severity, assess the risks and benefits of drugs to determine required actions, etc. This, in turn, is providing significant opportunities in the pharmacovigilance market outlook.
Key Market Trends: One of the key pharmacovigilance market trends includes the development of advanced platforms to ensure automated adverse drug reactions (ADR) reporting. Furthermore, key players are also focusing on enhancing manufacturing operations and streamlining R&D activities, owing to the competitive environment. Besides this, the rising number of clinical trials is expected to fuel the pharmacovigilance market in the forecasted period.
Competitive Landscape: Some of the prominent pharmacovigilance market key players are Accenture plc, ArisGlobal LLC, BioClinica Inc. (Cinven Partners LLP), Capgemini, Cognizant, International Business Machines Corporation, ICON plc., IQVIA Inc., ITClinical, Parexel International Corporation, and Wipro Limited, among many others.
Challenges and Opportunities: According to the pharmacovigilance market analysis, some of the challenges, including stringent regulatory requirements by government bodies, the rising complexities in managing and deriving meaningful insights from a vast amount of data, and the increasing need for balancing comprehensive drug safety monitoring with the pressure to control costs, are hindering the growth of the pharmacovigilance industry across the globe. However, fostering strategic collaborations to ensure the safety of drugs and safeguard public health is expected to propel the pharmacovigilance market share in the coming years.
The Development of Continuous Technological Advancements
The increasing integration of novel technologies, such as machine learning (ML), natural language processing (NLP), artificial intelligence (AI), big data analytics, etc., is enhancing the pharmacovigilance processes. In line with this, these technologies are gaining extensive traction, as they help in identifying adverse events, risk assessments, enabling efficient signal detection, etc., which is expected to fuel the market growth over the forecasted period. For instance, Sanofi and Deloitte collaborated on ConvergeHEALTH Safety, a next-generation artificial intelligence (AI) software-as-a-service adverse events case intake platform that transformed pharmacovigilance (PV) processes and addressed some of the industry's most pressing operational safety issues. In line with this, ArisGlobal introduced the go-live of the USFDA Adverse Event Reporting System (FAERS II), an electronic safety reporting platform powered by LifeSphere MultiVigilance, which propelled the market growth. Furthermore, Saama Technologies Inc. developed the new Active Safety Analytics for Pharma (ASAP) products. ASAP is one of the first validated pharmacovigilance solutions to leverage the TreeScan methodology and the United States Food and Drug Administration's (FDA) Sentinel Common Data Model for detecting safety signals.
Stringent Regulations Implemented by Government Bodies
Government authorities across the globe are implementing strict rules in clinical trials and generating awareness regarding the proper utilization of medicines, which is stimulating the usage of pharmacovigilance services. For example, according to a study published in Frontiers in Drug Safety and Regulation, the significance of post-marketing medication evaluation is important for characterizing drug safety profiles in real-world settings. Such studies are further increasing the importance of pharmacovigilance, thereby stimulating the market growth. Moreover, Aurobindo Pharma USA reformulated Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, owing to the presence of N-Nitroso-Quinapril and Nitrosamine Drug Substance Related Impurity (NDSRI). Consequently, the inflating need for medical information among regulatory authorities is expected to fuel the market growth over the forecasted period.
The Rising Adoption of Pharmacovigilance Services by Pharmaceutical Companies
Pharmacovigilance services are extensively adopted by key pharmaceutical companies across the globe, owing to benefits, such as better outcomes over shorter periods and increasing internal resource flexibility. For example, according to the Vaccine Adverse Event Reporting System, 10 cases of anaphylaxis were detected after the administration of a reported 4,041,396 first doses of the Moderna COVID-19 vaccine (2.5 cases per million doses). Consequently, the growing need for pharmacovigilance services is also stimulating the market growth. In addition to this, key industry players are also entering into strategic collaborations, which will continue to propel the pharmacovigilance market over the forecasted period. For example, IQVIA entered into a strategic collaboration with NRx Pharmaceuticals to offer medical information and pharmacovigilance services in preparation for potential regulatory actions.
The Growing Number of Advanced Clinical Trial Phases
To enhance the efficacy of clinical trials, major prominent players are developing advanced clinical trials, which are stimulating the global market for pharmacovigilance. For example, Cognizant entered into a partnership with Medable Inc. to jointly deliver clinical research solutions based on Medable's software-as-a-service platform for decentralized clinical trials. In line with this, according to the pharmacovigilance market overview, Viedoc and LINK Medical entered into a partnership established by Viedoc. The collaboration was designed to enhance trial efficiency for LINK Medical and its clients. The partnership allowed for the exchange of needs, experience, ideas, etc., and the testing of new features.
IMARC Group provides an analysis of the key trends in each segment of the global pharmacovigilance market report, along with forecasts at the global, regional, and country levels from 2024-2032. Our report has categorized the market based on service provider, product life cycle, type, process flow, therapeutic area, and end use.
In-house
Contract Outsourcing
The report has provided a detailed breakup and analysis of the market based on the service provider. This includes in-house and contract outsourcing.
Pre-clinical
Phase I
Phase II
Phase III
Phase IV
A detailed breakup and analysis of the market based on the product life cycle has also been provided in the report. This includes pre-clinical, Phase I, Phase II, Phase III, and Phase IV.
Spontaneous Reporting
Intensified ADR Reporting
Targeted Spontaneous Reporting
Cohort Event Monitoring
EHR Mining
The report has provided a detailed breakup and analysis of the market based on the type. This includes spontaneous reporting, intensified ADR reporting, targeted spontaneous reporting, cohort event monitoring, and EHR Mining.
Case Data Management
Case Logging
Case Data Analysis
Medical Reviewing and Reporting
Signal Detection
Adverse Event Logging
Adverse Event Analysis
Adverse Event Review and Reporting
Risk Management System
Risk Evaluation System
Risk Mitigation System
The report has provided a detailed breakup and analysis of the market based on the process flow. This includes case data management (case logging, case data analysis, medical reviewing and reporting), signal detection (adverse event logging, adverse event analysis, and adverse event review and reporting, and risk management system (risk evaluation system and risk mitigation system).
Oncology
Neurology
Cardiology
Respiratory Systems
Others
The report has provided a detailed breakup and analysis of the market based on the therapeutic area. This includes oncology, neurology, cardiology, respiratory systems, and others.
Pharmaceuticals Companies
Biotechnology Companies
Medical Device Companies
Others
The report has provided a detailed breakup and analysis of the market based on the end-use. This includes pharmaceuticals companies, biotechnology companies, medical device companies, and others.
North America
United States
Canada
Asia-Pacific
China
Japan
India
South Korea
Australia
Indonesia
Others
Europe
Germany
France
United Kingdom
Italy
Spain
Russia
Others
Latin America
Brazil
Mexico
Others
Middle East and Africa
The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa.
Accenture plc
ArisGlobal LLC
BioClinica Inc. (Cinven Partners LLP)
Capgemini
Cognizant
International Business Machines Corporation
ICON plc.
IQVIA Inc.
ITClinical
Parexel International Corporation
Wipro Limited
(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)
March 2024: The American Society of Pharmacovigilance (ASP), along with several partners, is focused on advancing drug safety via minimizing ADEs, the fourth leading cause of death in the United States.
February 2024: The Indian Pharmacopoeia Commission (IPC) released the Draft Pharmacovigilance Guidance Document for pharmaceutical products for its latest Version 2.0. The Commission also offered suggestions from Marketing Authorization Holders (MAHs) on the draft document.
February 2024: The US Food and Drug Administration (FDA) Office of Surveillance and Epidemiology (OSE) launched the standardization of Risk Evaluation and Mitigation Strategies (REMS) data to facilitate its use.