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ファーマコビジランス・ソフトウェアの世界市場 (2025年～2033年)

Global Pharmacovigilance Software Market - 2025-2033

出版日
ページ情報
英文 176 Pages
納期
即日から翌営業日
カスタマイズ可能
適宜更新あり
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=144.06円
ファーマコビジランス・ソフトウェアの世界市場 (2025年～2033年)
出版日: 2025年03月11日
発行: DataM Intelligence
ページ情報: 英文 176 Pages
納期: 即日から翌営業日
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  • 目次
概要

ファーマコビジランス・ソフトウェアの世界市場は、2024年に2億1,895万米ドルに達し、2033年には4億1,542万米ドルに達すると予測され、2025年～2033年の予測期間中にCAGR 7.4％で成長する見込みです。

ファーマコビジランス・ソフトウェアは、医療産業において必要不可欠なツールであり、市場に投入された後の医薬品の安全性を監視するために設計されています。その主な機能は、医薬品が一般に販売された後に発生する可能性のある潜在的な安全性の懸念を特定し、管理することです。このソフトウェアは、有害事象の報告を促進し、安全性シグナルを検出し、継続的な患者の安全性を確保するためにデータを分析します。

ファーマコビジランス・ソフトウェアは、医薬品の安全性に関するプロセスを合理化することで、製薬会社、医療提供者、規制機関は、必要な規制要件を満たしながら、患者の幸福に集中することができます。主な機能には、有害事象報告、さまざまなソースからのデータ統合、動向を特定するためのリアルタイム分析、国際規制へのコンプライアンスの確保などがあります。

市場力学：

促進要因と抑制要因

製薬・バイオ産業の成長

製薬業界とバイオテクノロジー業界の成長は、ファーマコビジランス・ソフトウェア市場の重要な促進要因です。これは主に、規制上の要求の高まり、副作用（ADR）の発生件数の増加、技術の進歩によるものです。クラウドコンピューティング、自然言語処理、予測分析などの技術革新は、ファーマコビジランスの状況を再構築し、スケーラブルで俊敏な安全監視ソリューションを提供しています。人工知能（AI）のような技術の統合は、シグナル検出、リスク評価、報告能力を強化します。

製薬業界の拡大に伴い、医薬品の安全性を効果的に監視・管理するための堅牢なファーマコビジランス・システムの必要性が高まっています。このような拡大はデータ量の増加と複雑化につながり、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なります。2022年に米国食品医薬品局（FDA）によって37の新薬が承認され、これらの新薬のかなりの割合（65％）が迅速化パスウェイを通じて審査・承認され、半数以上（54％）が希少疾患を対象としていることは、ファーマコビジランス・ソフトウェア市場の成長に直接影響します。このような新薬、特に希少疾患治療薬が市場に導入されるにつれ、実社会における安全性プロファイルを監視するための強固で効率的なファーマコビジランスの必要性が高まっています。承認プロセスが迅速化されることで、医薬品の上市が早まることが多いですが、そのために市販前の安全性データが制限されることがあり、市販後調査の重要性が高まります。したがって、上記の要因が市場の成長を促進すると予想されます。

高い導入コストが市場成長を抑制する可能性。

先進的なファーマコビジランス・システムは、効率性の向上や患者の安全性の強化といったメリットをもたらしますが、こうしたメリットは、小規模な医療提供者が直面する財政的制約と天秤にかける必要があります。ファーマコビジランス・ソフトウェア、特に高度なシステムの導入コストは高額になる可能性があります。中小規模の病院や診療所では、ソフトウェアのライセンス料、統合コスト、ハードウェアの要件を賄うことが難しいかもしれません。

目次

第1章 分析手法と分析範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

  • 影響要因
    • 促進要因
      • 製薬・バイオテクノロジー産業の成長
      • 薬物有害反応の発生率の上昇
    • 抑制要因
      • 高い導入コスト
      • 規制上のハードル
    • 機会
      • 技術進歩
  • 影響分析

第5章 戦略的洞察と業界展望

  • 市場のリーダーと先駆者
    • 新たな先駆者と主要企業
    • 最大の売上を誇るブランドを確立したリーダー
    • 確立された製品を持つ市場リーダー
  • CXOの視点
  • 最新の開発とブレークスルー
  • ケーススタディ/進行中の研究
  • 規制と償還の情勢
    • 北米
    • 欧州
    • アジア太平洋地域
    • ラテンアメリカ
    • 中東・アフリカ
  • ポーターのファイブフォース分析
  • サプライチェーン分析
  • 特許分析
  • SWOT分析
  • アンメットニーズとギャップ
  • 市場参入と拡大のための推奨戦略
  • シナリオ分析：ベストケース・ベースケース・ワーストケースの予測
  • 価格分析と価格市場力学
  • キーオピニオンリーダー (KOL)

第6章 機能別

  • 有害事象報告ソフトウェア
  • 医薬品安全性監査ソフトウェア
  • 問題追跡ソフトウェア
  • 完全統合型ソフトウェア

第7章 提供方法別

  • オンプレミス提供方法
  • オンデマンド/クラウドベース（SaaS）提供方法

第8章 エンドユーザー別

  • 製薬・バイオテクノロジー企業
  • CRO (医薬品開発業務受託機関)
  • 病院・医療機関
  • その他

第9章 地域別

  • 北米
    • 米国
    • カナダ
    • メキシコ
  • 欧州
    • ドイツ
    • 英国
    • フランス
    • スペイン
    • イタリア
    • その他欧州地域
  • 南米
    • ブラジル
    • アルゼンチン
    • その他南米
  • アジア太平洋
    • 中国
    • インド
    • 日本
    • 韓国
    • その他アジア太平洋地域
  • 中東・アフリカ

第10章 競合情勢

  • 競合シナリオ
  • 市況・シェア分析
  • M&A分析

第11章 企業プロファイル

  • Ennov
    • 企業概要
    • 製品ポートフォリオ
      • 製品説明
      • 製品の主要業績評価指標（KPI）
      • 製品販売の実績・予測
    • 財務概要
      • 企業の収益
      • 収益シェア：地域別
      • 収益予測
    • 主な発展
      • 合併と買収
      • 主な製品開発活動
      • 規制当局の承認等
    • SWOT分析
  • Oracle
  • ArisGlobal
  • EXTEDO
  • Clinevo Technologies
  • IQVIA
  • Quanticate
  • Cloudbyz
  • Accenture
  • Flex Databases
  • 各企業についての同様のデータが提供されます。

第12章 付録

目次
Product Code: HCIT9207

The global pharmacovigilance software market reached US$ 218.95 million in 2024 and is expected to reach US$ 415.42 million by 2033, growing at a CAGR of 7.4% during the forecast period of 2025-2033.

Pharmacovigilance software is an essential tool in the healthcare industry, designed to monitor the safety of medications after they are released to the market. Its primary function is to identify and manage potential safety concerns that may arise once a drug is available for public use. This software facilitates the reporting of adverse events, detects safety signals, and analyzes data to ensure ongoing patient safety.

By streamlining processes related to drug safety, pharmacovigilance software enables pharmaceutical companies, healthcare providers, and regulatory bodies to focus on patient well-being while meeting necessary regulatory requirements. Key features include adverse event reporting, data integration from various sources, real-time analytics for identifying trends, and ensuring compliance with international regulations.

Market Dynamics: Drivers & Restraints

Growth of the Pharmaceutical and Biotechnology Industries

The growth of the pharmaceutical and biotechnology industries is a significant driver for the pharmacovigilance software market, largely due to increasing regulatory demands, rising incidences of adverse drug reactions (ADRs), and technological advancements. Technological innovations, such as cloud computing, natural language processing, and predictive analytics, are reshaping the pharmacovigilance landscape, offering scalable and agile safety monitoring solutions. The integration of technologies like artificial intelligence (AI) enhances signal detection, risk assessment, and reporting capabilities.

As the pharmaceutical sector expands, there's a greater need for robust pharmacovigilance systems to effectively monitor and manage drug safety. This expansion leads to a rise in data volume and complexity, necessitating sophisticated software for managing and analyzing data. The approval of 37 novel drugs by the US Food and Drug Administration (FDA) in 2022, with a significant proportion of these drugs (65%) being reviewed and approved through expedited pathways and over half (54%) targeting rare diseases, directly impacts the growth of the pharmacovigilance software market. As these novel drugs, particularly those for rare diseases, are introduced into the market, there is an increased need for robust and efficient pharmacovigilance to monitor their safety profiles in real-world settings. Expedited approval processes often mean that the drugs are brought to market faster, but this can sometimes limit the amount of pre-market safety data available, heightening the importance of post-marketing surveillance. Thus, the above factors are expected to drive market growth.

High Implementation Costs May Restrain the Market Growth.

Advanced pharmacovigilance systems offer benefits such as improved efficiency and enhanced patient safety, but these advantages must be weighed against the financial constraints faced by smaller healthcare providers. The cost of implementing pharmacovigilance software, especially advanced systems, can be high. Small and medium-sized hospitals and clinics may find it difficult to afford the software's licensing fees, integration costs, and hardware requirements.

Segment Analysis

The global pharmacovigilance software market is segmented based on functionality, delivery mode, end-user, and region.

Delivery Mode:

The cloud-based (SaaS) delivery model segment is expected to dominate the global pharmacovigilance software market share.

The cloud-based (SaaS) delivery model is poised to dominate the pharmacovigilance software market due to its numerous advantages, including cost-efficiency, scalability, and ease of access. By offering lower upfront costs through subscription-based pricing, this model allows pharmaceutical companies of all sizes, including small and medium enterprises, to utilize advanced safety monitoring tools without the burden of heavy investments in infrastructure.

Cloud-based solutions offer real-time data updates and enable seamless integration with other systems, ensuring faster decision-making and compliance with regulatory requirements. Companies are creating advanced cloud-based software solutions to optimize pharmacovigilance processing and safety data management. For instance, in December 2023, Thermo Fisher Scientific Inc. launched CorEvidence, a cloud-based data lake platform designed to enhance pharmacovigilance processes. This platform improves CorEvitas clinical research registries by streamlining workflow and deliverable management for pharmacovigilance. It effectively manages multiple data sources, simplifying the coding, classification, and reporting of adverse events for post-authorization safety studies.

Additionally, they enhance global collaboration among teams, improve data security through robust encryption, and ensure business continuity with disaster recovery features. These attributes make cloud-based pharmacovigilance solutions a highly attractive and practical choice for organizations aiming to streamline their operations and enhance patient safety effectively.

Geographical Analysis

North America is expected to hold a significant position in the global pharmacovigilance software market share

North America is expected to dominate the pharmacovigilance software market due to several key factors, including stringent regulatory requirements, a strong focus on patient safety, and the presence of major pharmaceutical and biotechnology companies. The region is projected to experience significant growth, driven by the increasing need for compliance with regulations set by authorities such as the FDA and Health Canada, which enforce rigorous safety monitoring and adverse event reporting standards.

Moreover, North America is at the forefront of technological advancements in pharmacovigilance, with companies adopting innovative solutions like artificial intelligence and machine learning to enhance signal detection and improve adverse event reporting accuracy. With this, the companies are developing innovative solutions. For instance, in December 2023, Thermo Fisher Scientific Inc. launched CorEvidence, a proprietary cloud-based data lake platform optimizing pharmacovigilance case processing and safety data management processes. The new platform enhances CorEvitas clinical research registries offered by Thermo Fisher's PPD clinical research business.

Competitive Landscape

The major global players in the pharmacovigilance software market include Ennov, Oracle, ArisGlobal, EXTEDO, Clinevo Technologies, IQVIA, Quanticate, Cloudbyz, Accenture, and Flex Databases, among others.

Key Developments

  • In March 2024, Qinecsa Solutions (Qinecsa) announced its acquisition of Insife ApS (Insife), a well-established Danish-based software, technology, and consultancy firm specializing in developing revolutionary pharmacovigilance platforms.
  • In October 2024, Ennov formed a strategic partnership with CognifAI to incorporate CognifAI's advanced AI-driven literature monitoring solution, CoVigilAI, into Ennov's comprehensive pharmacovigilance offering.

Why Purchase the Report?

  • Pipeline & Innovations: Reviews ongoing clinical trials and product pipelines and forecasts upcoming advancements in medical devices and pharmaceuticals.
  • Product Performance & Market Positioning: Analyze product performance, market positioning, and growth potential to optimize strategies.
  • Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
  • Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
  • Market Updates & Industry Changes: This covers recent regulatory changes, new policies, and emerging technologies.
  • Competitive Strategies: Analyze competitor strategies, market share, and emerging players.
  • Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
  • Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
  • Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
  • Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
  • Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
  • Post-market Surveillance: Uses post-market data to enhance product safety and access.
  • Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The Global Pharmacovigilance Software Market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2024

  • Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
  • Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
  • Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
  • Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
  • Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
  • Supply Chain: Distribution and Supply Chain Managers.
  • Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
  • Academic & Research: Academic Institutions.

Table of Contents

1. Methodology and Scope

  • 1.1. Research Methodology
  • 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

  • 3.1. Snippet by Functionality
  • 3.2. Snippet by Delivery Mode
  • 3.3. Snippet by End-User
  • 3.4. Snippet by Region

4. Dynamics

  • 4.1. Impacting Factors
    • 4.1.1. Drivers
      • 4.1.1.1. Growth of the Pharmaceutical and Biotechnology Industries
      • 4.1.1.2. Rising Prevalence of Adverse Drug Reactions
    • 4.1.2. Restraints
      • 4.1.2.1. High Implementation Costs
      • 4.1.2.2. Regulatory Hurdles
    • 4.1.3. Opportunity
      • 4.1.3.1. Advancement in Technology
  • 4.2. Impact Analysis

5. Strategic Insights and Industry Outlook

  • 5.1. Market Leaders and Pioneers
    • 5.1.1. Emerging Pioneers and Prominent Players
    • 5.1.2. Established leaders with largest-selling Brand
    • 5.1.3. Market leaders with established Product
  • 5.2. CXO Perspectives
  • 5.3. Latest Developments and Breakthroughs
  • 5.4. Case Studies/Ongoing Research
  • 5.5. Regulatory and Reimbursement Landscape
    • 5.5.1. North America
    • 5.5.2. Europe
    • 5.5.3. Asia Pacific
    • 5.5.4. Latin America
    • 5.5.5. Middle East & Africa
  • 5.6. Porter's Five Forces Analysis
  • 5.7. Supply Chain Analysis
  • 5.8. Patent Analysis
  • 5.9. SWOT Analysis
  • 5.10. Unmet Needs and Gaps
  • 5.11. Recommended Strategies for Market Entry and Expansion
  • 5.12. Scenario Analysis: Best-Case, Base-Case, and Worst-Case Forecasts
  • 5.13. Pricing Analysis and Price Dynamics
  • 5.14. Key Opinion Leaders

6. By Functionality

  • 6.1. Introduction
    • 6.1.1. Analysis and Y-o-Y Growth Analysis (%), By Functionality
    • 6.1.2. Market Attractiveness Index, By Functionality
  • 6.2. Adverse Event Reporting Software*
    • 6.2.1. Introduction
    • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 6.3. Drug Safety Audits Software
  • 6.4. Issue Tracking Software
  • 6.5. Fully Integrated Software

7. By Delivery Mode

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Delivery Mode
    • 7.1.2. Market Attractiveness Index By Delivery Mode
  • 7.2. On-premise Delivery Mode*
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.3. On-demand/Cloud-based (SaaS) Delivery Mode

8. By End-User

  • 8.1. Introduction
    • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 8.1.2. Market Attractiveness Index By Age Group
  • 8.2. Pharma and Biotech Companies*
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.3. Contract Research Organizations (CROs)
  • 8.4. Hospitals & Health Institutions
  • 8.5. Others

9. By Region

  • 9.1. Introduction
    • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
    • 9.1.2. Market Attractiveness Index, By Region
  • 9.2. North America
    • 9.2.1. Introduction
    • 9.2.2. Key Region-Specific Dynamics
    • 9.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Functionality
    • 9.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Delivery Mode
    • 9.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 9.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.2.6.1. U.S.
      • 9.2.6.2. Canada
      • 9.2.6.3. Mexico
  • 9.3. Europe
    • 9.3.1. Introduction
    • 9.3.2. Key Region-Specific Dynamics
    • 9.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Functionality
    • 9.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Delivery Mode
    • 9.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 9.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.3.6.1. Germany
      • 9.3.6.2. U.K.
      • 9.3.6.3. France
      • 9.3.6.4. Spain
      • 9.3.6.5. Italy
      • 9.3.6.6. Rest of Europe
  • 9.4. South America
    • 9.4.1. Introduction
    • 9.4.2. Key Region-Specific Dynamics
    • 9.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Functionality
    • 9.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Delivery Mode
    • 9.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 9.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.4.6.1. Brazil
      • 9.4.6.2. Argentina
      • 9.4.6.3. Rest of South America
  • 9.5. Asia-Pacific
    • 9.5.1. Introduction
    • 9.5.2. Key Region-Specific Dynamics
    • 9.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Functionality
    • 9.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Delivery Mode
    • 9.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 9.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.5.6.1. China
      • 9.5.6.2. India
      • 9.5.6.3. Japan
      • 9.5.6.4. South Korea
      • 9.5.6.5. Rest of Asia-Pacific
  • 9.6. Middle East and Africa
    • 9.6.1. Introduction
    • 9.6.2. Key Region-Specific Dynamics
    • 9.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Functionality
    • 9.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Delivery Mode
    • 9.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User

10. Competitive Landscape

  • 10.1. Competitive Scenario
  • 10.2. Market Positioning/Share Analysis
  • 10.3. Mergers and Acquisitions Analysis

11. Company Profiles

Key Market Players

  • 11.1. Ennov*
    • 11.1.1. Company Overview
    • 11.1.2. Product Portfolio
      • 11.1.2.1. Product Description
      • 11.1.2.2. Product Key Performance Indicators (KPIs)
      • 11.1.2.3. Historic and Forecasted Product Sales
    • 11.1.3. Financial Overview
      • 11.1.3.1. Company Revenue's
      • 11.1.3.2. Geographical Revenue Shares
      • 11.1.3.3. Revenue Forecasts
    • 11.1.4. Key Developments
      • 11.1.4.1. Mergers & Acquisitions
      • 11.1.4.2. Key Product Development Activities
      • 11.1.4.3. Regulatory Approvals, etc.
    • 11.1.5. SWOT Analysis
  • 11.2. Oracle
  • 11.3. ArisGlobal
  • 11.4. EXTEDO
  • 11.5. Clinevo Technologies
  • 11.6. IQVIA
  • 11.7. Quanticate
  • 11.8. Cloudbyz
  • 11.9. Accenture
  • 11.10. Flex Databases
  • Similar data will be provided for each market player.

LIST NOT EXHAUSTIVE

12. Appendix

  • 12.1. About Us and Services
  • 12.2. Contact Us