市場調査レポート

商品コード

1722477

ファーマコビジランスおよび医薬品安全性ソフトウェア市場レポート：機能、提供モード、エンドユーザー、地域別、2025年～2033年

Pharmacovigilance and Drug Safety Software Market Report by Functionality, Delivery Mode, End User, and Region 2025-2033

出版日: 2025年05月01日
発行: IMARC
ページ情報: 英文 134 Pages
納期: 2～3営業日

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価格

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全表示
概要
図表
目次

概要

サンプル依頼リストに入れる

ファーマコビジランスおよび医薬品安全性ソフトウェアの世界市場規模は2024年に2億1,420万米ドルに達しました。今後、IMARC Groupは、市場は2033年までに3億5,080万米ドルに達し、2025年から2033年にかけて5.63%の成長率（CAGR）を示すと予測しています。大衆の間で慢性疾患が蔓延していること、医薬品の商業化に関する厳しい規制が実施されていること、ソフトウェア機能とユーザーフレンドリーなインターフェイスの継続的な進歩が市場を推進している主な要因の一部です。

ファーマコビジランスおよび医薬品安全性ソフトウェアのとは、医薬品副作用（ADR）やその他の医薬品関連の安全性に関する懸念事項のモニタリング、分析、報告を合理化し、強化するために設計された専門的なコンピュータ・プログラムのことです。これらのソフトウェアシステムは、医薬品の安全かつ効果的な使用を保証するファーマコビジランスの分野で重要な役割を果たしています。これらのソフトウェア・ソリューションにより、製薬会社、規制当局、ヘルスケア専門家は、医薬品の安全性に関する大量のデータを効率的に収集、管理、分析できるようになります。また、潜在的なリスクやパターンの検出を容易にし、タイムリーな介入やリスク軽減戦略を可能にします。

このようなソフトウェアソリューションは、臨床研究企業やアウトソーシング企業による採用が増加していることが、この市場を牽引しています。これらの企業は、開発中の医薬品の安全性と有効性を確保し、市販後調査を実施するための強固なファーマコビジランス・システムの重要性を認識しています。さらに、慢性疾患の有病率の増加も市場の成長に寄与しています。長期投薬が必要な患者の増加に伴い、効果的な医薬品安全性監視・管理の必要性も高まっています。これとは別に、世界各国の政府が医薬品の商業化に厳しい規制を課しているため、医薬品安全性規制が複雑化し、需要をさらに押し上げています。さらに、最先端技術の利用がファーマコビジランスおよび医薬品安全性ソフトウェアの容易な導入を促進しています。さらに、ソフトウェア機能とユーザーフレンドリーなインターフェイスの継続的な進歩により、組織はこれらのソリューションを既存のワークフローに実装し統合することが容易になり、市場に好影響を与えています。

ファーマコビジランスおよび医薬品安全性ソフトウェアの市場動向と促進要因：

製薬産業の拡大

製薬業界の開拓は、世界のファーマコビジランス（PV）および医薬品安全性ソフトウェア市場に大きな影響を与えています。製薬業界の拡大に伴い、新薬や治療法の開発が増加しています。このため、有害事象を監視、分析、管理するためのPVおよび医薬品安全性ソフトウェアの必要性が高まり、同ソフトウェアの需要増につながっています。さらに、製薬業界の拡大によりデータ量と複雑性が増大し、データを管理・分析するための高度なソフトウェアが必要とされています。このため、このような複雑なデータセットを効果的に処理するために、PVや医薬品安全性ソフトウェアにAIや機械学習の開発・導入が進んでいます。また、ファーマコビジランスおよび医薬品安全性ソフトウェアのはこれらのリスク管理に役立ち、リスク管理ニーズの高まりが同市場の需要を牽引しています。

医薬品副作用の発生率の増加

副作用（ADR）の発生率の増加は、世界のファーマコビジランスおよび医薬品安全性ソフトウェアの市場に大きな影響を与えています。ADRの報告件数の増加により、市場における医薬品の安全性と有効性を確保するための強固なファーマコビジランス・システムとソフトウェア・ソリューションに対するニーズが高まっています。副作用は患者の健康や福祉に深刻な影響を及ぼし、入院や追加医療費、さらには死亡事故につながる可能性があります。そのため、世界中の規制当局は、製薬会社がADRを効果的に監視・報告するための厳しいガイドラインや規制を実施しています。これに伴い、ソフトウェア・ソリューションを提供する企業は、大量の有害事象データを効率的に処理できる高度なツールや機能を提供するために継続的に技術革新を行っているため、世界のファーマコビジランスおよび医薬品安全性ソフトウェアの市場は、ADRの発生率の上昇に直接対応する形で大きな成長を遂げています。

ヘルスケア支出の増加

ヘルスケアへの支出が世界的に増加し続ける中、患者の安全性を最適化し、ヘルスケア提供の全体的な質を向上させることが重視されるようになっています。ファーマコビジランスおよび医薬品安全性ソフトウェアのは、副作用（ADR）やその他の薬剤関連の問題を効果的にモニタリング、評価、管理することで、これらの目標を達成する上で重要な役割を果たします。ヘルスケア支出の増加に伴い、患者の安全性への注目が高まっています。ファーマコビジランス・ソフトウェアは、ヘルスケア組織や規制当局にADRを監視・予防するためのツールを提供し、薬害に関連する経済的負担を軽減します。さらに、ヘルスケア支出の増加により、リソースの最適化が必要となっています。さらに、ファーマコビジランス・ソフトウェアは有害事象データの効率的な管理を可能にし、報告および分析プロセスを合理化します。

北米
- 米国
- カナダ
アジア太平洋地域
- 中国
- 日本
- インド
- 韓国
- オーストラリア
- インドネシア
- その他
欧州
- ドイツ
- フランス
- 英国
- イタリア
- スペイン
- ロシア
- その他
ラテンアメリカ
- ブラジル
- メキシコ
- その他
中東・アフリカ
- 市場内訳：国別

第10章 SWOT分析

概要
強み
弱み
機会
脅威

第11章バリューチェーン分析

第12章ポーターのファイブフォース分析

概要
買い手の交渉力
供給企業の交渉力
競合の程度
新規参入業者の脅威
代替品の脅威

第13章価格分析

第14章競合情勢

市場構造
主要企業
主要企業のプロファイル
- Ab Cube
- Anju Software Inc.
- ArisGlobal LLC
- Cognizant
- Ennov Solutions Inc.
- Extedo GmbH
- Max Application
- Oracle Corporation
- Sarjen Systems Pvt Ltd
- Sparta Systems Inc.（Honeywell International Inc.）
- Tata Consultancy Services Limited
- United BioSource LLC
- Wipro Limited

図表

List of Figures

Figure 1: Global: Pharmacovigilance and Drug Safety Software Market: Major Drivers and Challenges
Figure 2: Global: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million USD), 2019-2024
Figure 3: Global: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 4: Global: Pharmacovigilance and Drug Safety Software Market: Breakup by Functionality (in %), 2024
Figure 5: Global: Pharmacovigilance and Drug Safety Software Market: Breakup by Delivery Mode (in %), 2024
Figure 6: Global: Pharmacovigilance and Drug Safety Software Market: Breakup by End User (in %), 2024
Figure 7: Global: Pharmacovigilance and Drug Safety Software Market: Breakup by Region (in %), 2024
Figure 8: Global: Pharmacovigilance and Drug Safety Software (Adverse Event Reporting Software) Market: Sales Value (in Million USD), 2019 & 2024
Figure 9: Global: Pharmacovigilance and Drug Safety Software (Adverse Event Reporting Software) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 10: Global: Pharmacovigilance and Drug Safety Software (Drug Safety Audits Software) Market: Sales Value (in Million USD), 2019 & 2024
Figure 11: Global: Pharmacovigilance and Drug Safety Software (Drug Safety Audits Software) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 12: Global: Pharmacovigilance and Drug Safety Software (Issue Tracking Software) Market: Sales Value (in Million USD), 2019 & 2024
Figure 13: Global: Pharmacovigilance and Drug Safety Software (Issue Tracking Software) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 14: Global: Pharmacovigilance and Drug Safety Software (Fully Integrated Software) Market: Sales Value (in Million USD), 2019 & 2024
Figure 15: Global: Pharmacovigilance and Drug Safety Software (Fully Integrated Software) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 16: Global: Pharmacovigilance and Drug Safety Software (On-premises) Market: Sales Value (in Million USD), 2019 & 2024
Figure 17: Global: Pharmacovigilance and Drug Safety Software (On-premises) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 18: Global: Pharmacovigilance and Drug Safety Software (Cloud-based) Market: Sales Value (in Million USD), 2019 & 2024
Figure 19: Global: Pharmacovigilance and Drug Safety Software (Cloud-based) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 20: Global: Pharmacovigilance and Drug Safety Software (Pharmaceutical and Biotechnology Companies) Market: Sales Value (in Million USD), 2019 & 2024
Figure 21: Global: Pharmacovigilance and Drug Safety Software (Pharmaceutical and Biotechnology Companies) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 22: Global: Pharmacovigilance and Drug Safety Software (Contract Research Organizations) Market: Sales Value (in Million USD), 2019 & 2024
Figure 23: Global: Pharmacovigilance and Drug Safety Software (Contract Research Organizations) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 24: Global: Pharmacovigilance and Drug Safety Software (Business Process Outsourcing Firms) Market: Sales Value (in Million USD), 2019 & 2024
Figure 25: Global: Pharmacovigilance and Drug Safety Software (Business Process Outsourcing Firms) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 26: Global: Pharmacovigilance and Drug Safety Software (Other End Users) Market: Sales Value (in Million USD), 2019 & 2024
Figure 27: Global: Pharmacovigilance and Drug Safety Software (Other End Users) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 28: North America: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million USD), 2019 & 2024
Figure 29: North America: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 30: United States: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million USD), 2019 & 2024
Figure 31: United States: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 32: Canada: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million USD), 2019 & 2024
Figure 33: Canada: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 34: Asia-Pacific: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million USD), 2019 & 2024
Figure 35: Asia-Pacific: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 36: China: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million USD), 2019 & 2024
Figure 37: China: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 38: Japan: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million USD), 2019 & 2024
Figure 39: Japan: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 40: India: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million USD), 2019 & 2024
Figure 41: India: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 42: South Korea: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million USD), 2019 & 2024
Figure 43: South Korea: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 44: Australia: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million USD), 2019 & 2024
Figure 45: Australia: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 46: Indonesia: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million USD), 2019 & 2024
Figure 47: Indonesia: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 48: Others: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million USD), 2019 & 2024
Figure 49: Others: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 50: Europe: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million USD), 2019 & 2024
Figure 51: Europe: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 52: Germany: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million USD), 2019 & 2024
Figure 53: Germany: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 54: France: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million USD), 2019 & 2024
Figure 55: France: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 56: United Kingdom: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million USD), 2019 & 2024
Figure 57: United Kingdom: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 58: Italy: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million USD), 2019 & 2024
Figure 59: Italy: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 60: Spain: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million USD), 2019 & 2024
Figure 61: Spain: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 62: Russia: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million USD), 2019 & 2024
Figure 63: Russia: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 64: Others: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million USD), 2019 & 2024
Figure 65: Others: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 66: Latin America: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million USD), 2019 & 2024
Figure 67: Latin America: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 68: Brazil: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million USD), 2019 & 2024
Figure 69: Brazil: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 70: Mexico: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million USD), 2019 & 2024
Figure 71: Mexico: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 72: Others: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million USD), 2019 & 2024
Figure 73: Others: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 74: Middle East and Africa: Pharmacovigilance and Drug Safety Software Market: Sales Value (in Million USD), 2019 & 2024
Figure 75: Middle East and Africa: Pharmacovigilance and Drug Safety Software Market: Breakup by Country (in %), 2024
Figure 76: Middle East and Africa: Pharmacovigilance and Drug Safety Software Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 77: Global: Pharmacovigilance and Drug Safety Software Industry: SWOT Analysis
Figure 78: Global: Pharmacovigilance and Drug Safety Software Industry: Value Chain Analysis
Figure 79: Global: Pharmacovigilance and Drug Safety Software Industry: Porter's Five Forces Analysis

List of Tables

Table 1: Global: Pharmacovigilance and Drug Safety Software Market: Key Industry Highlights, 2024 and 2033
Table 2: Global: Pharmacovigilance and Drug Safety Software Market Forecast: Breakup by Functionality (in Million USD), 2025-2033
Table 3: Global: Pharmacovigilance and Drug Safety Software Market Forecast: Breakup by Delivery Mode (in Million USD), 2025-2033
Table 4: Global: Pharmacovigilance and Drug Safety Software Market Forecast: Breakup by End User (in Million USD), 2025-2033
Table 5: Global: Pharmacovigilance and Drug Safety Software Market Forecast: Breakup by Region (in Million USD), 2025-2033
Table 6: Global: Pharmacovigilance and Drug Safety Software Market: Competitive Structure
Table 7: Global: Pharmacovigilance and Drug Safety Software Market: Key Players

Product Code: SR112025A5030

The global pharmacovigilance and drug safety software market size reached USD 214.2 Million in 2024. Looking forward, IMARC Group expects the market to reach USD 350.8 Million by 2033, exhibiting a growth rate (CAGR) of 5.63% during 2025-2033. The growing prevalence of chronic diseases among the masses, the implementation of strict regulations on the commercialization of drugs, and continual advancements in software capabilities and user-friendly interfaces are some of the major factors propelling the market.

Pharmacovigilance and drug safety software refers to specialized computer programs designed to streamline and enhance the monitoring, analysis, and reporting of adverse drug reactions (ADRs) and other drug-related safety concerns. These software systems play a crucial role in the field of pharmacovigilance, which is dedicated to ensuring the safe and effective use of medications. These software solutions enable pharmaceutical companies, regulatory authorities, and healthcare professionals to efficiently collect, manage, and analyze large volumes of data pertaining to drug safety. They also facilitate the detection of potential risks and patterns, allowing for timely intervention and risk mitigation strategies.

The pharmacovigilance and drug safety software market is driven by the increasing adoption of these software solutions by clinical research and outsourcing companies. These organizations recognize the importance of robust pharmacovigilance systems to ensure the safety and efficacy of drugs in development and post-marketing surveillance. Moreover, the growing prevalence of chronic diseases is also contributing to the growth of the market. As the number of patients requiring long-term medication increases, so does the need for effective drug safety monitoring and management. Apart from this, governments worldwide are imposing strict regulations on the commercialization of drugs, leading to increased complexity in drug safety regulations, further impelling the demand. Besides, the availability of cutting-edge technology is facilitating the easy adoption of pharmacovigilance and drug safety software. Furthermore, continual advancements in software capabilities and user-friendly interfaces make it easier for organizations to implement and integrate these solutions into their existing workflows, thus impacting the market favorably.

Pharmacovigilance and Drug Safety Software Market Trends/Drivers:

Expansion of the Pharmaceutical Industry

The development of the pharmaceutical industry is having a significant influence on the global pharmacovigilance (PV) and drug safety software market. As the pharmaceutical industry expands, there has been an increase in the development of new drugs and therapies. This leads to a greater need for PV and drug safety software to monitor, analyze, and manage adverse events, leading to an increase in demand for this software. Moreover, the pharmaceutical industry's expansion has led to a rise in data volume and complexity, requiring sophisticated software for managing and analyzing data. This is driving the development and adoption of AI and machine learning within PV and drug safety software to handle, such complex datasets effectively. Also, pharmacovigilance and drug safety software help manage these risks, and the growing need for risk management is driving demand in this market.

Growing Incidence of Adverse Drug Reactions

The increasing incidence of adverse drug reactions (ADRs) is significantly influencing the global pharmacovigilance and drug safety software market. The raising number of reported ADRs has created a greater need for robust pharmacovigilance systems and software solutions to ensure the safety and efficacy of drugs in the market. Adverse drug reactions can have serious consequences on patient health and well-being, leading to hospitalizations, additional medical costs, and even fatalities. Therefore, regulatory authorities worldwide have implemented stringent guidelines and regulations for pharmaceutical companies to monitor and report ADRs effectively. Along with this, the global pharmacovigilance and drug safety software market has experienced significant growth as a direct response to the rising incidence of ADRs since companies offering these software solutions are continuously innovating to provide advanced tools and functionalities that can handle large volumes of adverse event data efficiently.

The Increasing Healthcare Expenditure

As healthcare expenditure continues to rise globally, there is a growing emphasis on optimizing patient safety and improving the overall quality of healthcare delivery. Pharmacovigilance and drug safety software play a crucial role in achieving these objectives by ensuring the effective monitoring, assessment, and management of adverse drug reactions (ADRs) and other drug-related problems. With higher healthcare spending, there has been a growing focus on patient safety. Pharmacovigilance software provides healthcare organizations and regulatory authorities with the tools to monitor and prevent ADRs, thereby reducing the economic burden associated with medication-related harm. Moreover, healthcare expenditure growth necessitates the optimization of resources. Furthermore, pharmacovigilance software enables the efficient management of adverse event data, streamlining the reporting and analysis processes.

Pharmacovigilance and Drug Safety Software Industry Segmentation:

Breakup by Functionality:

Adverse Event Reporting Software
Drug Safety Audits Software
Issue Tracking Software
Fully Integrated Software

Adverse event reporting software dominates the market

Adverse event reporting software dominates the market as it is a critical aspect of regulatory compliance in the healthcare and pharmaceutical industries. It offers robust data management capabilities, allowing efficient collection, organization, and analysis of adverse event data. It enables the identification of patterns, trends, and potential safety issues associated with specific products or interventions. This data-driven approach helps pharmaceutical companies, healthcare providers, and regulatory agencies make informed decisions regarding product safety and risk mitigation strategies. Additionally, it provides a systematic and standardized approach to capturing and reporting these events, ensuring compliance with regulatory requirements. It provides a centralized platform for healthcare professionals, drug safety experts, and other stakeholders involved in adverse event reporting. Additionally, the software can scale to handle large volumes of adverse event data, ensuring its effectiveness even for organizations with extensive reporting requirements.

Breakup by Delivery Mode:

On-premises
Cloud-based

On- premises delivery holds the largest share in the market

On-premises deployment holds the largest share of the market as it provides organizations with a higher level of control and security over their data. It offers greater flexibility for customization and integration with existing systems. Organizations can tailor the software to their specific requirements and integrate it seamlessly with other on-premises applications or infrastructure. This level of customization and integration is beneficial for organizations with complex IT environments or unique business processes. The deployment allows organizations to maintain data sovereignty by ensuring that sensitive data remains within the borders of their own country. Moreover, the widespread adoption of on-premises software help eliminate the potential performance issues related to network latency or dependence on internet connectivity. Also, it allows organizations to maintain compliance and meet regulatory standards more easily.

Breakup by End User:

Pharmaceutical and Biotechnology Companies
Contract Research Organizations
Business Process Outsourcing Firms
Others

Contract research organizations hold the largest share in the market

CROs hold a significant position and are the leading users of the market's products or services. They specialize in providing comprehensive research services, allowing pharmaceutical and biotech companies to outsource various aspects of their R&D activities. This outsourcing model offers numerous benefits, including access to specialized expertise, reduced operational costs, and increased efficiency in trial execution. They provide in-depth knowledge of industry best practices, regulatory requirements, and emerging trends which makes it an attractive choice for companies seeking reliable partners to navigate complex research processes and achieve successful outcomes. They also have the ability to scale their resources and infrastructure according to project requirements, enabling them to support both small-scale studies and large multinational trials. They can provide expertise in risk management, data integrity, and compliance, helping companies navigate the complex regulatory landscape and mitigate potential pitfalls.

Breakup by Region:

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

North America exhibits a clear dominance, accounting for the largest pharmacovigilance and drug safety software market share

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. According to the report, North America accounted for the largest market share.

North America has a robust and well-established pharmaceutical industry, with numerous companies involved in drug discovery, development, and commercialization. The region is at the forefront of technological innovation, including advancements in healthcare and information technology. The region has a robust IT infrastructure, a favorable investment climate for research and development, and a strong focus on adopting digital solutions. North American pharmaceutical companies and research institutions often collaborate with academic institutions, healthcare providers, and technology companies to drive innovation in pharmacovigilance and drug safety. These collaborations foster the development and adoption of state-of-the-art software solutions, further enhancing North America's dominance in the market. Additionally, the region has stringent regulatory requirements for drug safety and pharmacovigilance is another significant factor responsible for impelling the market across the North America region.

Competitive Landscape:

Top companies in the market are investing in research and development activities to create advanced pharmacovigilance and drug safety software solutions. These software platforms are designed to capture, process, analyze, and report adverse events, safety data, and other relevant information related to pharmaceutical products and medical interventions. Various companies offer flexible and scalable software platforms that can be tailored to meet the unique needs of pharmaceutical companies, CROs, and healthcare institutions. Additionally, companies leverage advanced data analytics techniques, such as artificial intelligence (AI) and machine learning (ML), to analyze large volumes of safety data and identify potential safety signals. These analytics capabilities help in the early detection of adverse events, signal management, risk assessment, and trend analysis.

The report has provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:

Ab Cube
Anju Software Inc.
ArisGlobal LLC
Cognizant
Ennov Solutions Inc.
Extedo GmbH
Max Application
Oracle Corporation
Sarjen Systems Pvt Ltd
Sparta Systems Inc. (Honeywell International Inc.)
Tata Consultancy Services Limited
United BioSource LLC
Wipro Limited.

Key Questions Answered in This Report

1.What was the size of the global pharmacovigilance and drug safety software market in 2024?
2.What is the expected growth rate of the global pharmacovigilance and drug safety software market during 2025-2033?
3.What has been the impact of COVID-19 on the global pharmacovigilance and drug safety software market?
4.What are the key factors driving the global pharmacovigilance and drug safety software market?
5.What is the breakup of the global pharmacovigilance and drug safety software market based on the functionality?
6.What is the breakup of the global pharmacovigilance and drug safety software market based on the delivery mode?
7.What is the breakup of the global pharmacovigilance and drug safety software market based on the end user?
8.What are the key regions in the global pharmacovigilance and drug safety software market?
9.Who are the key players/companies in the global pharmacovigilance and drug safety software market?

1 Preface

2 Scope and Methodology

2.1 Objectives of the Study
2.2 Stakeholders
2.3 Data Sources
- 2.3.1 Primary Sources
- 2.3.2 Secondary Sources
2.4 Market Estimation
- 2.4.1 Bottom-Up Approach
- 2.4.2 Top-Down Approach
2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

4.1 Overview
4.2 Key Industry Trends

5 Global Pharmacovigilance and Drug Safety Software Market

5.1 Market Overview
5.2 Market Performance
5.3 Impact of COVID-19
5.4 Market Forecast

6 Market Breakup by Functionality

6.1 Adverse Event Reporting Software
- 6.1.1 Market Trends
- 6.1.2 Market Forecast
6.2 Drug Safety Audits Software
- 6.2.1 Market Trends
- 6.2.2 Market Forecast
6.3 Issue Tracking Software
- 6.3.1 Market Trends
- 6.3.2 Market Forecast
6.4 Fully Integrated Software
- 6.4.1 Market Trends
- 6.4.2 Market Forecast

7 Market Breakup by Delivery Mode

7.1 On-premises
- 7.1.1 Market Trends
- 7.1.2 Market Forecast
7.2 Cloud-based
- 7.2.1 Market Trends
- 7.2.2 Market Forecast

8 Market Breakup by End User

8.1 Pharmaceutical and Biotechnology Companies
- 8.1.1 Market Trends
- 8.1.2 Market Forecast
8.2 Contract Research Organizations
- 8.2.1 Market Trends
- 8.2.2 Market Forecast
8.3 Business Process Outsourcing Firms
- 8.3.1 Market Trends
- 8.3.2 Market Forecast
8.4 Others
- 8.4.1 Market Trends
- 8.4.2 Market Forecast

9 Market Breakup by Region

9.1 North America
- 9.1.1 United States
  - 9.1.1.1 Market Trends
  - 9.1.1.2 Market Forecast
- 9.1.2 Canada
  - 9.1.2.1 Market Trends
  - 9.1.2.2 Market Forecast
9.2 Asia-Pacific
- 9.2.1 China
  - 9.2.1.1 Market Trends
  - 9.2.1.2 Market Forecast
- 9.2.2 Japan
  - 9.2.2.1 Market Trends
  - 9.2.2.2 Market Forecast
- 9.2.3 India
  - 9.2.3.1 Market Trends
  - 9.2.3.2 Market Forecast
- 9.2.4 South Korea
  - 9.2.4.1 Market Trends
  - 9.2.4.2 Market Forecast
- 9.2.5 Australia
  - 9.2.5.1 Market Trends
  - 9.2.5.2 Market Forecast
- 9.2.6 Indonesia
  - 9.2.6.1 Market Trends
  - 9.2.6.2 Market Forecast
- 9.2.7 Others
  - 9.2.7.1 Market Trends
  - 9.2.7.2 Market Forecast
9.3 Europe
- 9.3.1 Germany
  - 9.3.1.1 Market Trends
  - 9.3.1.2 Market Forecast
- 9.3.2 France
  - 9.3.2.1 Market Trends
  - 9.3.2.2 Market Forecast
- 9.3.3 United Kingdom
  - 9.3.3.1 Market Trends
  - 9.3.3.2 Market Forecast
- 9.3.4 Italy
  - 9.3.4.1 Market Trends
  - 9.3.4.2 Market Forecast
- 9.3.5 Spain
  - 9.3.5.1 Market Trends
  - 9.3.5.2 Market Forecast
- 9.3.6 Russia
  - 9.3.6.1 Market Trends
  - 9.3.6.2 Market Forecast
- 9.3.7 Others
  - 9.3.7.1 Market Trends
  - 9.3.7.2 Market Forecast
9.4 Latin America
- 9.4.1 Brazil
  - 9.4.1.1 Market Trends
  - 9.4.1.2 Market Forecast
- 9.4.2 Mexico
  - 9.4.2.1 Market Trends
  - 9.4.2.2 Market Forecast
- 9.4.3 Others
  - 9.4.3.1 Market Trends
  - 9.4.3.2 Market Forecast
9.5 Middle East and Africa
- 9.5.1 Market Trends
- 9.5.2 Market Breakup by Country
- 9.5.3 Market Forecast

10 SWOT Analysis

10.1 Overview
10.2 Strengths
10.3 Weaknesses
10.4 Opportunities
10.5 Threats

11 Value Chain Analysis

12 Porters Five Forces Analysis

12.1 Overview
12.2 Bargaining Power of Buyers
12.3 Bargaining Power of Suppliers
12.4 Degree of Competition
12.5 Threat of New Entrants
12.6 Threat of Substitutes

13 Price Analysis

14 Competitive Landscape

14.1 Market Structure
14.2 Key Players
14.3 Profiles of Key Players
- 14.3.1 Ab Cube
  - 14.3.1.1 Company Overview
  - 14.3.1.2 Product Portfolio
- 14.3.2 Anju Software Inc.
  - 14.3.2.1 Company Overview
  - 14.3.2.2 Product Portfolio
- 14.3.3 ArisGlobal LLC
  - 14.3.3.1 Company Overview
  - 14.3.3.2 Product Portfolio
- 14.3.4 Cognizant
  - 14.3.4.1 Company Overview
  - 14.3.4.2 Product Portfolio
  - 14.3.4.3 Financials
  - 14.3.4.4 SWOT Analysis
- 14.3.5 Ennov Solutions Inc.
  - 14.3.5.1 Company Overview
  - 14.3.5.2 Product Portfolio
- 14.3.6 Extedo GmbH
  - 14.3.6.1 Company Overview
  - 14.3.6.2 Product Portfolio
- 14.3.7 Max Application
  - 14.3.7.1 Company Overview
  - 14.3.7.2 Product Portfolio
- 14.3.8 Oracle Corporation
  - 14.3.8.1 Company Overview
  - 14.3.8.2 Product Portfolio
  - 14.3.8.3 Financials
  - 14.3.8.4 SWOT Analysis
- 14.3.9 Sarjen Systems Pvt Ltd
  - 14.3.9.1 Company Overview
  - 14.3.9.2 Product Portfolio
- 14.3.10 Sparta Systems Inc. (Honeywell International Inc.)
  - 14.3.10.1 Company Overview
  - 14.3.10.2 Product Portfolio
- 14.3.11 Tata Consultancy Services Limited
  - 14.3.11.1 Company Overview
  - 14.3.11.2 Product Portfolio
  - 14.3.11.3 Financials
  - 14.3.11.4 SWOT Analysis
- 14.3.12 United BioSource LLC
  - 14.3.12.1 Company Overview
  - 14.3.12.2 Product Portfolio
- 14.3.13 Wipro Limited
  - 14.3.13.1 Company Overview
  - 14.3.13.2 Product Portfolio
  - 14.3.13.3 Financials
  - 14.3.13.4 SWOT Analysis

ファーマコビジランスおよび医薬品安全性ソフトウェア市場レポート：機能、提供モード、エンドユーザー、地域別、2025年～2033年

Pharmacovigilance and Drug Safety Software Market Report by Functionality, Delivery Mode, End User, and Region 2025-2033

ファーマコビジランスおよび医薬品安全性ソフトウェアの市場動向と促進要因：

目次

第1章 序文

第2章 調査範囲と調査手法

第3章 エグゼクティブサマリー

第4章 イントロダクション

第5章 世界のファーマコビジランスおよび医薬品安全性ソフトウェア市場

第6章 市場内訳：機能別

第7章 市場内訳：提供モード別

第8章 市場内訳：エンドユーザー別

第9章 市場内訳：地域別

第10章 SWOT分析

第11章 バリューチェーン分析

第12章 ポーターのファイブフォース分析

第13章 価格分析

第14章 競合情勢