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市场调查报告书
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1495977

全球药物安全检测市场－2024年至2029年预测

Global Pharmacovigilance Market - Forecasts from 2024 to 2029
出版日期: | 出版商: Knowledge Sourcing Intelligence | 英文 123 Pages | 商品交期: 最快1-2个工作天内

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简介目录

预计药物安全检测市场在预测期内将以 10.54% 的年复合成长率成长，市场规模将从 2022 年的 57.98 亿美元增至 2029 年的 116.88 亿美元。

药物安全检测，也称为药物安全，是涉及检测、评估、理解和预防副作用以及与药物和疫苗相关的其他问题的科学和活动。所有药物和疫苗在批准使用之前都经过严格的临床试验安全性和有效性测试。

该市场的关键驱动因素包括药物消费量和药物开发率的上升、副作用和药物毒性发生率的上升以及药物安全检测服务外包趋势的上升。由于久坐的生活方式、缺乏体力活动、生活方式的改变和饮食习惯紊乱，糖尿病、高血压和心血管疾病（CVD）等与文明病患病率不断上升，导致药物消费量增加。显示对药物监测的高需求，推动了市场成长。

根据世界卫生组织（WHO）统计，2019年有1,790万人死于心血管疾病，占全球死亡人数的32%。其中约 85% 的死亡是由于心臟病或中风所致。在全球整体，估计有 12.8 亿年龄在 30 岁至 79 岁之间的人患有高血压，其中大多数（2/3）居住在低收入和中等收入国家。此外，预计 2019 年糖尿病将导致 150 万人死亡。

另一方面，资料安全风险高、缺乏全球监管协调以及缺乏不利事件收集资料标准等因素预计将对药物安全检测市场构成挑战。

市场驱动因素：

  • ADR 的上升预计将推动药物安全检测市场的发展。

由于药物不良反应（ADR）的增加，药物安全检测市场预计将成长。促成这一增长的因素包括药物使用增加、患者群体多样化、严格的监管要求、药物安全问题、先进的监测技术、临床试验的全球化、以患者为中心的方法以及新兴市场的市场成长，其中包括药物安全检测公司之间的开拓和服务供应商。世界各地的监管机构都需要强有力的药物安全检测工作来确保药品安全，而资料分析和人工智慧等先进监测技术可以更有效地检测和监测 ADR。

根据美国疾病管制与预防美国的数据，约6.7%的住院患者出现严重的ADR，死亡率为0.32%。假设这些数字属实，每年住院病患中约有 2,216,000 起严重ADR，导致超过 106,000 人死亡。假设这些统计数据属实，药品不良反应是继肺病、糖尿病、爱滋病、肺炎、事故和车祸后的第四大死因。因此，全球 ADR 流行率的上升预计将增加对药物安全检测市场的需求。

市场限制因素：

  • 不良反应报告的不一致可能会阻碍药物安全检测市场的发展。

药物安全检测涉及影响大量患者群体并进而影响医疗保健系统的药物品质、剂量错误和药物不良反应。就诊期间不一定会出现副作用。它可能会在服药后几个小时内发生。患者未能报告副作用可能会导致诊断和调查不一致，从而危及生命。此外，长期对大量人群给药可能会产生先前科学研究中未发现的副作用。

例如，费森尤斯卡比美国公司于2020年因Lidocaine交叉污染召回盐酸右Dexmedetomidine咪定0.9%氯化钠注射液。 2021 年，由于亚硝胺和 N-亚硝基Varenicline超过FDA 临时可接受的摄入量，辉瑞公司自愿召回所有批次的Chantix 0.5mg 和1mg 片剂至患者（消费者/用户）水平。长期使用 N-亚硝基Varenicline可能会增加人类罹患癌症的风险，但使用这种药物的个人不会立即面临风险。

北美地区预计将大幅成长

北美地区预计将成为药物安全检测市场的主导市场。在美国，药物滥用和相关药物不良反应显着增加。据美国卫生与公众服务部称，ADR 估计占医院不利事件的三分之一，每年影响约 200 万名住院患者。住院时间从 1.7 天增加到 4.6 天。

每年，门诊 ADE 影响约 350 万人次就诊、估计 100 万人次急诊就诊以及超过 125,000 人次住院。由于将内部药物安全检测业务委託给委託研究组织的高成本，美国的药物安全检测系统正在从医疗保健系统中的被动角色转变为主动角色。

主要发展

  • 2023 年 3 月 - LEO Pharma 和 ICON 联手加速医学皮肤病学临床试验的进行，旨在透过提供创新的临床试验和新药物来改善患者的生活。该合作伙伴关係包括专注于临床开发的精益可扩展性的混合采购模式、分散临床试验的共同投资、存取 ICON 的内部辅助服务、范围和规模经济、外部资料等等。
  • 2023 年 2 月 - 临床研究组织 Parexel推出了名为“New Medicines, Novel Insights”的系列，为生物製药行业提供有关药物开发趋势的全球见解和证据驱动的指导。第一份报告《罕见疾病治疗发展进展》探讨了罕见疾病治疗开发中的挑战并提出了最佳实践。本系列重点关注以患者为中心的药物开发、监管导航、适应性测试和患者访问。
  • 2023 年 1 月 - 全球分析与临床研究服务供应商 IQVIA 与中国阿里云建立首次合作伙伴关係。该公司使用阿里云上的 Salesforce 在中国当地提供託管解决方案，让客户可以利用平台并扩大投资。 IQVIA 列出了丰富的临床到商业产品，包括符合中国资料驻留法规的精心策划的客户参与套件。此次合作将使 IQVIA 能够加速并扩大针对中国在地化需求的解决方案的开发。

目录

第一章简介

  • 市场概况
  • 市场定义
  • 调查范围
  • 市场区隔
  • 货币
  • 先决条件
  • 基准年和预测年时间表
  • 相关利益者的主要利益

第二章调查方法

  • 研究设计
  • 调查过程

第三章执行概述

  • 主要发现

第四章市场动态

  • 市场驱动因素
  • 市场限制因素
  • 波特五力分析
  • 产业价值链分析
  • 分析师观点

第五章全球药物安全检测市场：依临床试验阶段划分

  • 介绍
  • 临床前
  • 第一阶段
  • 第二阶段
  • 第三阶段
  • 第四阶段

第六章全球药物安全检测市场：依服务供应商

  • 介绍
  • 合约外包
  • 公司内部

第七章 全球药物安全检测市场：依最终使用者分类

  • 介绍
  • 药品
  • 生技公司
  • 医疗设备製造商
  • 其他的

第八章全球药物安全检测市场：按地区

  • 介绍
  • 北美洲
  • 南美洲
  • 欧洲
  • 中东/非洲
  • 亚太地区

第九章竞争环境及分析

  • 主要企业及策略分析
  • 市场占有率分析
  • 合併、收购、协议和合作
  • 有竞争力的仪表板

第十章 公司简介

  • Cognizant
  • Sciformix（Covance）
  • IQVIA
  • APCER Life Sciences, Inc.
  • Navitas Life Sciences
  • BioClinica
  • Accenture
  • ArisGlobal
  • Capgemini
  • FMD K&L Inc.
简介目录
Product Code: KSI061612099

The global pharmacovigilance market is expected to grow at a compound annual growth rate of 10.54% over the forecast period to reach a market size of US$11.688 billion in 2029 from US$5.798 billion in 2022.

Pharmacovigilance, also known as drug safety, is the science and activities involved with the detection, evaluation, comprehension, and prevention of adverse effects or other medicine or vaccine-related problems. All medicines and vaccines are submitted to rigorous testing for safety and efficacy in clinical trials before they are licenced for use.

The major driving factors of this market include rising drug consumption and drug development rates, rising rates of adverse drug reactions and drug toxicity, and an increasing tendency to outsource pharmacovigilance services. The rising prevalence of lifestyle-related diseases, such as diabetes, hypertension, and cardiovascular diseases (CVDs), as a result of sedentary lifestyles, a lack of physical activity, changing lifestyle patterns, and poor diets, leading to increased drug consumption, indicating a high demand for drug monitoring and fuelling the market growth.

According to the World Health Organization (WHO), 17.9 million people died from CVDs in 2019, accounting for 32% of all global deaths. About 85 % of these fatalities were caused by a heart attack or a stroke. Globally, an estimated 1.28 billion individuals aged 30-79 years have hypertension, with the majority(2/3rd) residing in low- and middle-income nations. Furthermore, diabetes is directly responsible for an anticipated 1.5 million fatalities in 2019.

On the other hand, factors such as high data security risk, a lack of global regulatory harmonization, and a lack of data standards for adverse event collection are expected to pose challenges to the global pharmacovigilance market.

Market Drivers:

  • An increased prevalence of ADRs is anticipated to drive the global pharmacovigilance market.

The global pharmacovigilance market is expected to grow due to the rise in Adverse Drug Reactions (ADRs). Factors contributing to this growth include rising drug utilization, diverse patient populations, stringent regulatory requirements, drug safety concerns, advanced monitoring technologies, globalization of clinical trials, patient-centric approach, market expansion in developing regions, collaboration between pharmaceutical companies and pharmacovigilance service providers, and post-marketing surveillance activities. Regulatory authorities worldwide require robust pharmacovigilance activities to ensure drug safety, and advanced monitoring technologies like data analytics and artificial intelligence are enhancing the ability to detect and monitor ADRs more effectively.

According to the Centers for Disease Control and Prevention, about 6.7 percent of hospitalized patients experience a severe ADR, with a mortality rate of 0.32 percent. If these figures are assumed to be true, then there are about 2,216,000 severe ADRs in hospitalized patients per year, which results in over 106,000 deaths. If these statistics are assumed to be true, then ADRs are the fourth-largest cause of death, followed by pulmonary illness, diabetes, AIDS, pneumonia, accidents, and automobile accidents. Therefore, the rising global prevalence of ADRs will increase demand in the pharmacovigilance market.

Market Restraints:

  • Inconsistent reporting of adverse reactions could hinder the global pharmacovigilance market

Pharmacovigilance is concerned with drug quality, dosage mistakes, and adverse drug responses that influence the healthcare system by impacting a large patient population. An adverse reaction does not necessarily occur during a visit to the healthcare center. It may occur several hours after the medication has been administered. Patients failing to report adverse reactions leads to inconsistency in diagnosis and research, which can be life-threatening. Furthermore, administering medicines for extended periods to a large population might result in adverse reactions that have not previously been detected in scientific studies.

For instance, Fresenius Kabi USA recalled Dexmedetomidine HCL in 0.9 % Sodium Chloride Injection in 2020 owing to lidocaine cross-contamination, which could have resulted in a potentially fatal allergic reaction. In 2021, due to the presence of nitrosamine and N-nitroso-varenicline at or above the FDA's interim permissible consumption limit, Pfizer voluntarily recalled all batches of its Chantix 0.5 mg and 1 mg Tablets to the patient (consumer/user) level. Long-term use of N-nitroso-varenicline may be linked to elevated cancer risk in humans, although there is no immediate danger to individuals using this drug.

North America region is expected to grow significantly.

The global pharmacovigilance market is expected to be dominated by the North American region. The number of drug abuse and associated adverse drug reactions in the United States has increased significantly. According to the U.S. Department of Health and Human Services, ADRs account for an estimated one-third of all hospital adverse events and affect about 2 million hospital stays each year in inpatient settings. Increasing hospital stays from 1.7 to 4.6 days.

ADEs in outpatient settings account for about 3.5 million doctor visits each year, as well as an estimated 1 million emergency room visits and over 125,000 hospitalizations. The pharmacovigilance system in the United States is transitioning from a passive to a proactive role in the healthcare system as a result of the high costs of in-house pharmacovigilance operations being outsourced to contract research organizations.

Key Developments:

  • March 2023- LEO Pharma and ICON partnered to expedite clinical trial execution in medical dermatology, aiming to enhance patients' lives by providing access to innovative trials and new medicines. The partnership includes a hybrid sourcing model, focusing on lean scalability in clinical development, co-investment in decentralized trials, access to ICON's in-house ancillary services, economies of scope and scale, and external data. The partnership will support LEO Pharma's 2030 strategy, bringing innovative treatments to patients faster and supporting a more sustainable business.
  • February 2023- Parexel, a clinical research organization, launched a series called New Medicines, Novel Insights, providing global insights into drug development trends and evidence-based guidance to the biopharmaceutical industry. The first report, Advancing Rare Disease Drug Development, explores challenges in rare disease drug development and shares best practices. The series emphasizes patient-focused drug development, regulatory navigation, adaptive trials, and patient access. It aims to make clinical development faster, more efficient, and patient-friendly.
  • January 2023- IQVIA, a global provider of analytics and clinical research services, partnered with Alibaba Cloud in China for its first collaboration. The company provides solutions hosted in Mainland China using Salesforce on Alibaba Cloud, allowing customers to use or extend their investments on the platform. IQVIA offer rich clinical to commercial products, including its Orchestrated Customer Engagement suite, compliant with Chinese data residency regulations. The partnership enables IQVIA to accelerate and expand the development of solutions tailored to China's localized needs.

Market Segmentation:

By Clinical Trial Phase

  • Preclinical
  • Phase I
  • Phase II
  • Phase III
  • Phase IV

By Service Provider

  • Contract Outsourcing
  • In-house

By End-User

  • Pharmaceuticals
  • Biotechnology Companies
  • Medical Device Manufacturers
  • Others

By Geography

  • North America
  • USA
  • Canada
  • Mexico
  • South America
  • Brazil
  • Argentina
  • Others
  • Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Others
  • Middle East and Africa
  • Saudi Arabia
  • UAE
  • South Africa
  • Others
  • Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Taiwan
  • Thailand
  • Indonesia
  • Others

TABLE OF CONTENTS

1. INTRODUCTION

  • 1.1. Market Overview
  • 1.2. Market Definition
  • 1.3. Scope of the Study
  • 1.4. Market Segmentation
  • 1.5. Currency
  • 1.6. Assumptions
  • 1.7. Base and Forecast Years Timeline
  • 1.8. Key Benefits to the Stakeholder

2. RESEARCH METHODOLOGY

  • 2.1. Research Design
  • 2.2. Research Processes

3. EXECUTIVE SUMMARY

  • 3.1. Key Findings

4. MARKET DYNAMICS

  • 4.1. Market Drivers
  • 4.2. Market Restraints
  • 4.3. Porter's Five Forces Analysis
    • 4.3.1. Bargaining Power of Suppliers
    • 4.3.2. Bargaining Power of Buyers
    • 4.3.3. Threat of New Entrants
    • 4.3.4. Threat of Substitutes
    • 4.3.5. Competitive Rivalry in the Industry
  • 4.4. Industry Value Chain Analysis
  • 4.5. Analyst View

5. GLOBAL PHARMACOVIGILANCE MARKET BY CLINICAL TRIAL PHASE

  • 5.1. Introduction
  • 5.2. Preclinical
    • 5.2.1. Market Opportunities and Trends
    • 5.2.2. Growth Prospects
    • 5.2.3. Geographic Lucrativeness
  • 5.3. Phase I
    • 5.3.1. Market Opportunities and Trends
    • 5.3.2. Growth Prospects
    • 5.3.3. Geographic Lucrativeness
  • 5.4. Phase II
    • 5.4.1. Market Opportunities and Trends
    • 5.4.2. Growth Prospects
    • 5.4.3. Geographic Lucrativeness
  • 5.5. Phase III
    • 5.5.1. Market Opportunities and Trends
    • 5.5.2. Growth Prospects
    • 5.5.3. Geographic Lucrativeness
  • 5.6. Phase IV
    • 5.6.1. Market Opportunities and Trends
    • 5.6.2. Growth Prospects
    • 5.6.3. Geographic Lucrativeness

6. GLOBAL PHARMACOVIGILANCE MARKET BY SERVICE PROVIDER

  • 6.1. Introduction
  • 6.2. Contract Outsourcing
    • 6.2.1. Market Opportunities and Trends
    • 6.2.2. Growth Prospects
    • 6.2.3. Geographic Lucrativeness
  • 6.3. In-house
    • 6.3.1. Market Opportunities and Trends
    • 6.3.2. Growth Prospects
    • 6.3.3. Geographic Lucrativeness

7. GLOBAL PHARMACOVIGILANCE MARKET BY END-USER

  • 7.1. Introduction
  • 7.2. Pharmaceuticals
    • 7.2.1. Market Opportunities and Trends
    • 7.2.2. Growth Prospects
    • 7.2.3. Geographic Lucrativeness
  • 7.3. Biotechnology Companies
    • 7.3.1. Market Opportunities and Trends
    • 7.3.2. Growth Prospects
    • 7.3.3. Geographic Lucrativeness
  • 7.4. Medical Device Manufacturers
    • 7.4.1. Market Opportunities and Trends
    • 7.4.2. Growth Prospects
    • 7.4.3. Geographic Lucrativeness
  • 7.5. Others
    • 7.5.1. Market Opportunities and Trends
    • 7.5.2. Growth Prospects
    • 7.5.3. Geographic Lucrativeness

8. GLOBAL PHARMACOVIGILANCE MARKET BY GEOGRAPHY

  • 8.1. Introduction
  • 8.2. North America
    • 8.2.1. By Clinical Trial Phase
    • 8.2.2. By Service Provider
    • 8.2.3. By End-User
    • 8.2.4. By Country
      • 8.2.4.1. USA
        • 8.2.4.1.1. Market Opportunities and Trends
        • 8.2.4.1.2. Growth Prospects
      • 8.2.4.2. Canada
        • 8.2.4.2.1. Market Opportunities and Trends
        • 8.2.4.2.2. Growth Prospects
      • 8.2.4.3. Mexico
        • 8.2.4.3.1. Market Opportunities and Trends
        • 8.2.4.3.2. Growth Prospects
  • 8.3. South America
    • 8.3.1. By Clinical Trial Phase
    • 8.3.2. By Service Provider
    • 8.3.3. By End-User
    • 8.3.4. By Country
      • 8.3.4.1. Brazil
        • 8.3.4.1.1. Market Opportunities and Trends
        • 8.3.4.1.2. Growth Prospects
      • 8.3.4.2. Argentina
        • 8.3.4.2.1. Market Opportunities and Trends
        • 8.3.4.2.2. Growth Prospects
      • 8.3.4.3. Others
        • 8.3.4.3.1. Market Opportunities and Trends
        • 8.3.4.3.2. Growth Prospects
  • 8.4. Europe
    • 8.4.1. By Clinical Trial Phase
    • 8.4.2. By Service Provider
    • 8.4.3. By End-User
    • 8.4.4. By Country
      • 8.4.4.1. Germany
        • 8.4.4.1.1. Market Opportunities and Trends
        • 8.4.4.1.2. Growth Prospects
      • 8.4.4.2. France
        • 8.4.4.2.1. Market Opportunities and Trends
        • 8.4.4.2.2. Growth Prospects
      • 8.4.4.3. United Kingdom
        • 8.4.4.3.1. Market Opportunities and Trends
        • 8.4.4.3.2. Growth Prospects
      • 8.4.4.4. Italy
        • 8.4.4.4.1. Market Opportunities and Trends
        • 8.4.4.4.2. Growth Prospects
      • 8.4.4.5. Spain
        • 8.4.4.5.1. Market Opportunities and Trends
        • 8.4.4.5.2. Growth Prospects
      • 8.4.4.6. Others
        • 8.4.4.6.1. Market Opportunities and Trends
        • 8.4.4.6.2. Growth Prospects
  • 8.5. Middle East and Africa
    • 8.5.1. By Clinical Trial Phase
    • 8.5.2. By Service Provider
    • 8.5.3. By End-User
    • 8.5.4. By Country
      • 8.5.4.1. Saudi Arabia
        • 8.5.4.1.1. Market Opportunities and Trends
        • 8.5.4.1.2. Growth Prospects
      • 8.5.4.2. UAE
        • 8.5.4.2.1. Market Opportunities and Trends
        • 8.5.4.2.2. Growth Prospects
      • 8.5.4.3. South Africa
        • 8.5.4.3.1. Market Opportunities and Trends
        • 8.5.4.3.2. Growth Prospects
      • 8.5.4.4. Others
        • 8.5.4.4.1. Market Opportunities and Trends
        • 8.5.4.4.2. Growth Prospects
  • 8.6. Asia Pacific
    • 8.6.1. By Clinical Trial Phase
    • 8.6.2. By Service Provider
    • 8.6.3. By End-User
    • 8.6.4. By Country
      • 8.6.4.1. China
        • 8.6.4.1.1. Market Opportunities and Trends
        • 8.6.4.1.2. Growth Prospects
      • 8.6.4.2. India
        • 8.6.4.2.1. Market Opportunities and Trends
        • 8.6.4.2.2. Growth Prospects
      • 8.6.4.3. Japan
        • 8.6.4.3.1. Market Opportunities and Trends
        • 8.6.4.3.2. Growth Prospects
      • 8.6.4.4. South Korea
        • 8.6.4.4.1. Market Opportunities and Trends
        • 8.6.4.4.2. Growth Prospects
      • 8.6.4.5. Taiwan
        • 8.6.4.5.1. Market Opportunities and Trends
        • 8.6.4.5.2. Growth Prospects
      • 8.6.4.6. Thailand
        • 8.6.4.6.1. Market Opportunities and Trends
        • 8.6.4.6.2. Growth Prospects
      • 8.6.4.7. Indonesia
        • 8.6.4.7.1. Market Opportunities and Trends
        • 8.6.4.7.2. Growth Prospects
      • 8.6.4.8. Others
        • 8.6.4.8.1. Market Opportunities and Trends
        • 8.6.4.8.2. Growth Prospects

9. COMPETITIVE ENVIRONMENT AND ANALYSIS

  • 9.1. Major Players and Strategy Analysis
  • 9.2. Market Share Analysis
  • 9.3. Mergers, Acquisitions, Agreements, and Collaborations
  • 9.4. Competitive Dashboard

10. COMPANY PROFILES

  • 10.1. Cognizant
  • 10.2. Sciformix (Covance)
  • 10.3. IQVIA
  • 10.4. APCER Life Sciences, Inc.
  • 10.5. Navitas Life Sciences
  • 10.6. BioClinica
  • 10.7. Accenture
  • 10.8. ArisGlobal
  • 10.9. Capgemini
  • 10.10. FMD K&L Inc.