市场调查报告书
商品编码
1540794
2024-2032 年药物警戒市场报告(按服务提供者、产品生命週期、类型、流程、治疗领域、最终用途和地区划分)Pharmacovigilance Market Report by Service Provider, Product Life Cycle, Type, Process Flow, Therapeutic Area, End Use, and Region 2024-2032 |
IMARC Group年全球药物警戒市场规模达79亿美元。药物不良反应(ADR)的日益普遍,加上政府机构推出有利政策以提高人们对正确使用药物的认识并进行临床试验,主要刺激了药物警戒市场的成长。
主要市场驱动因素:各种生活方式疾病(包括心臟病、高血压、糖尿病等)发病率的上升正在增加全球药物的使用。因此,对药物警戒(PV)的需求不断增加,以检测以前未知的不良反应,识别频率或严重程度的变化,评估药物的风险和益处以确定所需的行动等。的机会药物警戒市场前景。
主要市场趋势:药物警戒市场的主要趋势之一包括开发先进平台以确保自动报告药物不良反应 (ADR)。此外,由于竞争环境,主要参与者也专注于加强製造业务和简化研发活动。除此之外,临床试验数量的增加预计将在预测期内推动药物警戒市场的发展。
竞争格局:一些着名的药物警戒市场主要参与者包括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。
挑战与机会:根据药物警戒市场分析,一些挑战包括政府机构严格的监管要求、管理和从大量资料中获取有意义的见解的复杂性不断增加,以及平衡全面药物安全监测的需求日益增加控製成本的压力正在阻碍全球药物警戒产业的成长。然而,促进策略合作以确保药品安全和维护公众健康预计将在未来几年推动药物警戒市场份额的成长。
技术不断进步的发展
机器学习 (ML)、自然语言处理 (NLP)、人工智慧 (AI)、巨量资料分析等新技术的日益整合正在增强药物警戒流程。与此一致,这些技术正在获得广泛的关注,因为它们有助于识别不良事件、风险评估、实现有效的讯号检测等,预计这将在预测期内推动市场成长。例如,赛诺菲和德勤合作开发了ConvergeHEALTH Safety,这是下一代人工智慧(AI) 软体即服务不良事件案例受理平台,该平台改变了药物警戒(PV) 流程并解决了行业中一些最紧迫的操作安全问题。为此,ArisGlobal 推出了 USFDA 不良事件报告系统 (FAERS II),这是一个由 LifeSphere MultiVigilance 提供支援的电子安全报告平台,推动了市场成长。此外,Saama Technologies Inc. 开发了新的製药主动安全分析 (ASAP) 产品。 ASAP 是首批经过验证的药物警戒解决方案之一,利用 TreeScan 方法和美国食品药物管理局 (FDA) 的哨兵通用资料模型来检测安全讯号。
政府机关实施严格的法规
全球各地的政府当局正在临床试验中实施严格的规则,并提高人们对正确使用药物的认识,这正在刺激药物警戒服务的使用。例如,根据《药物安全与监管前沿》发表的一项研究,上市后药物评估的重要性对于描述现实环境中的药物安全状况非常重要。此类研究进一步提高了药物警戒的重要性,从而刺激了市场成长。此外,由于存在 N-亚硝基喹那普利和亚硝胺药物相关杂质 (NDSRI),Aurobindo Pharma USA 重新配製了喹那普利和氢氯噻嗪片 USP 20mg/12.5mg。因此,监管机构对医疗资讯日益增长的需求预计将推动预测期内的市场成长。
製药公司越来越多地采用药物警戒服务
药物警戒服务因其优势(例如在更短的时间内获得更好的结果以及提高内部资源灵活性)而被全球主要製药公司广泛采用。例如,根据疫苗不良事件通报系统的数据,在註射了 4,041,396 剂 Moderna COVID-19 疫苗后,发现了 10 例过敏反应病例(每百万剂中有 2.5 例)。因此,对药物警戒服务不断增长的需求也刺激了市场的成长。除此之外,主要产业参与者也正在进行策略合作,这将在预测期内继续推动药物警戒市场的发展。例如,IQVIA 与 NRx Pharmaceuticals 达成策略合作,提供医疗资讯和药物警戒服务,为潜在的监管行动做好准备。
高级临床试验阶段的数量不断增加
为了提高临床试验的功效,主要参与者正在开发先进的临床试验,这正在刺激全球药物警戒市场。例如,Cognizant 与 Medable Inc. 建立合作关係,共同提供基于 Medable 的软体即服务平台的临床研究解决方案,用于分散式临床试验。据此,根据药物警戒市场概况,Viedoc 与 LINK Medical 建立了 Viedoc 建立的合作关係。此次合作旨在提高 LINK Medical 及其客户的试验效率。这种伙伴关係允许交流需求、经验、想法等,并测试新功能。
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.