首頁 > 市場調查報告書 > 製藥

醫藥品法規環境

市場調查報告書

商品編碼

1495977

全球藥物安全檢測市場－2024年至2029年預測

Global Pharmacovigilance Market - Forecasts from 2024 to 2029

出版日期: 2024年04月16日 | 出版商:

Knowledge Sourcing Intelligence | 英文 123 Pages | 商品交期: 最快1-2個工作天內

價格

簡介目錄

預計藥物安全檢測市場在預測期內將以 10.54% 的年複合成長率成長，市場規模將從 2022 年的 57.98 億美元增至 2029 年的 116.88 億美元。

藥物安全檢測，也稱為藥物安全，是涉及檢測、評估、理解和預防副作用以及與藥物和疫苗相關的其他問題的科學和活動。所有藥物和疫苗在批准使用之前都經過嚴格的臨床試驗安全性和有效性測試。

該市場的關鍵促進因素包括藥物消費量和藥物開發率的上升、副作用和藥物毒性發生率的上升以及藥物安全檢測服務外包趨勢的上升。由於久坐的生活方式、缺乏體力活動、生活方式的改變和飲食習慣紊亂，糖尿病、高血壓和心血管疾病（CVD）等與文明病患病率不斷上升，導致藥物消費量增加。顯示對藥物監測的高需求，推動了市場成長。

根據世界衛生組織（WHO）統計，2019年有1,790萬人死於心血管疾病，佔全球死亡人數的32%。其中約 85% 的死亡是由於心臟病或中風所致。在全球整體，估計有 12.8 億年齡在 30 歲至 79 歲之間的人患有高血壓，其中大多數（2/3）居住在低收入和中等收入國家。此外，預計 2019 年糖尿病將導致 150 萬人死亡。

另一方面，資料安全風險高、缺乏全球監管協調以及缺乏不利事件收集資料標準等因素預計將對藥物安全檢測市場構成挑戰。

市場促進因素：

ADR 的上升預計將推動藥物安全檢測市場的發展。

由於藥物不良反應（ADR）的增加，藥物安全檢測市場預計將成長。促成這一成長的因素包括藥物使用增加、患者群體多樣化、嚴格的監管要求、藥物安全問題、先進的監測技術、臨床試驗的全球化、以患者為中心的方法以及新興市場的市場成長，其中包括藥物安全檢測公司之間的開拓和服務供應商。世界各地的監管機構都需要強力的藥物安全檢測工作來確保藥品安全，而資料分析和人工智慧等先進監測技術可以更有效地檢測和監測 ADR。

根據美國疾病管制與預防美國的數據，約6.7%的住院患者出現嚴重的ADR，死亡率為0.32%。假設這些數字屬實，每年住院病患中約有 2,216,000 起嚴重ADR，導致超過 106,000 人死亡。假設這些統計數據屬實，藥品不良反應是繼肺病、糖尿病、愛滋病、肺炎、事故和車禍後的第四大死因。因此，全球 ADR 流行率的上升預計將增加對藥物安全檢測市場的需求。

市場限制因素：

不良反應報告的不一致可能會阻礙藥物安全檢測市場的發展。

藥物安全檢測涉及影響大量患者群體並進而影響醫療保健系統的藥物品質、劑量錯誤和藥物不良反應。就診期間不一定會出現副作用。它可能會在服藥後幾個小時內發生。患者未能報告副作用可能會導致診斷和調查不一致，從而危及生命。此外，長期對大量人群給藥可能會產生先前科學研究中未發現的副作用。

例如，費森尤斯卡比美國公司於2020年因Lidocaine交叉污染召回鹽酸右Dexmedetomidine咪定0.9%氯化鈉注射液。 2021 年，由於亞硝胺和 N-亞硝基Varenicline超過FDA 臨時可接受的攝入量，輝瑞公司自願召回所有批次的Chantix 0.5mg 和1mg 片劑至患者（消費者/用戶）水平。長期使用 N-亞硝基Varenicline可能會增加人類罹患癌症的風險，但使用這種藥物的個人不會立即面臨風險。

北美地區預計將大幅成長

北美地區預計將成為藥物安全檢測市場的主導市場。在美國，藥物濫用和相關藥物不良反應顯著增加。據美國衛生與公眾服務部稱，ADR 估計佔醫院不利事件的三分之一，每年影響約 200 萬名住院患者。住院時間從 1.7 天增加到 4.6 天。

每年，門診 ADE 影響約 350 萬人次就診、估計 100 萬人次急診就診以及超過 125,000 人次住院。由於將內部藥物安全檢測業務委託給委託研究組織的高成本，美國的藥物安全檢測系統正在從醫療保健系統中的被動角色轉變為主動角色。

主要發展

2023 年 3 月 - LEO Pharma 和 ICON 聯手加速醫學皮膚病學臨床試驗的進行，旨在透過提供創新的臨床試驗和新藥物來改善患者的生活。該合作夥伴關係包括專注於臨床開發的精益可擴展性的混合採購模式、分散臨床試驗的共同投資、存取 ICON 的內部輔助服務、範圍和規模經濟、外部資料等等。
2023 年 2 月 - 臨床研究組織 Parexel推出了名為“New Medicines, Novel Insights”的系列，為生物製藥行業提供有關藥物開發趨勢的全球見解和證據驅動的指導。第一份報告《罕見疾病治療發展進展》探討了罕見疾病治療開發中的挑戰並提出了最佳實踐。本系列重點關注以患者為中心的藥物開發、監管導航、適應性測試和患者訪問。
2023 年 1 月 - 全球分析與臨床研究服務供應商 IQVIA 與中國阿里雲建立首次合作夥伴關係。該公司使用阿里雲上的 Salesforce 在中國當地提供託管解決方案，讓客戶可以利用平台並擴大投資。 IQVIA 列出了豐富的臨床到商業產品，包括符合中國資料駐留法規的精心策劃的客戶參與套件。此次合作將使 IQVIA 能夠加速並擴大針對中國在地化需求的解決方案的開發。

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

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