한글목차

세계 약물 감시 소프트웨어 시장은 2024년에 2억 1,895만 달러에 달했습니다. 2033년에는 4억 1,542만 달러에 달할 것으로 예측되며, 2025-2033년의 예측 기간 동안 7.4%의 연평균 복합 성장률(CAGR)을 보일 것으로 예상됩니다.

약물 감시 소프트웨어는 의약품이 시장에 출시된 후 의약품의 안전성을 모니터링하기 위해 고안된 의료 산업에서 필수적인 도구입니다. 주요 기능은 의약품이 시판된 후 발생할 수 있는 잠재적 안전성 문제를 식별하고 관리하는 것입니다. 이 소프트웨어는 부작용 보고를 촉진하고, 안전성 신호를 감지하고, 데이터를 분석하여 지속적인 환자 안전을 보장합니다.

Pharmacovigilance 소프트웨어는 의약품 안전 프로세스를 간소화하여 제약사, 의료 서비스 제공업체 및 규제 기관이 필요한 규제 요건을 충족시키면서 환자의 복지에 집중할 수 있도록 지원합니다. 주요 기능으로는 부작용 보고, 다양한 출처의 데이터 통합, 동향 파악을 위한 실시간 분석, 국제 규정 준수 보장 등이 있습니다.

시장 역학:

성장 촉진요인과 억제요인

제약-바이오 산업의 성장

제약 및 생명공학 산업의 성장은 약물 감시 소프트웨어 시장의 중요한 촉진제입니다. 이는 주로 규제 요구 사항 증가, 부작용(ADR) 발생 건수 증가, 기술 발전으로 인한 것입니다. 클라우드 컴퓨팅, 자연어 처리, 예측 분석과 같은 기술 혁신은 약물감시의 상황을 재구성하고 확장 가능하고 민첩한 안전 모니터링 솔루션을 제공합니다. 인공지능(AI)과 같은 기술의 통합은 신호 감지, 위험 평가 및 보고 능력을 강화합니다.

제약 산업이 확대됨에 따라 의약품의 안전성을 효과적으로 모니터링하고 관리할 수 있는 강력한 약물감시 시스템의 필요성이 증가하고 있습니다. 2022년 미국 식품의약국(FDA)은 37개의 신약을 승인할 것으로 예상되며, 이 중 상당수(65%)가 신속 심사 경로를 통해 심사 및 승인될 것이며, 절반 이상(54%)이 희귀질환을 대상으로할 것으로 예상됩니다. 절반 이상(54%)이 희귀질환을 대상으로 한다는 점은 약물 감시 소프트웨어 시장의 성장에 직접적인 영향을 미칠 것으로 보입니다. 이러한 신약, 특히 희귀질환 치료제가 시장에 출시됨에 따라 실제 임상에서 안전성 프로파일을 모니터링하기 위한 견고하고 효율적인 약물감시의 필요성이 증가하고 있습니다. 승인 절차가 빨라짐에 따라 의약품의 출시가 빨라지는 경우가 많지만, 이로 인해 시판 전 안전성 데이터가 제한될 수 있어 시판 후 조사의 중요성이 높아집니다. 따라서 위의 요인들이 시장 성장을 가속할 것으로 예상됩니다.

높은 도입 비용이 시장 성장을 억제할 가능성.

첨단 약물감시 시스템은 효율성 향상과 환자 안전 강화와 같은 이점을 제공하지만, 이러한 이점은 소규모 의료 서비스 제공업체가 직면한 재정적 제약과 균형을 이루어야 합니다. 약물 감시 소프트웨어, 특히 고급 시스템의 경우 도입 비용이 매우 높을 수 있습니다. 중소규모의 병원이나 클리닉에서는 소프트웨어 라이선스 비용, 통합 비용, 하드웨어 요구사항을 감당하기 어려울 수 있습니다.

목차

제1장 분석 방법이및 분석 범위

제2장 정의와 개요

제3장 주요 요약

제4장 시장 역학

• 영향요인
  • 성장 촉진요인
  • 성장 억제요인
  • 기회
• 영향 분석

제5장 전략적 인사이트와 업계 전망

• 시장 리더와 선구자
  • 새로운 선구자와 주요 기업
  • 최대 판매를 자랑하는 브랜드를 확립한 리더
  • 확립된 제품을 보유한 시장 리더
• CXO 시점
• 최신 개발과 Break through
• 사례 연구/진행 중인 연구
• 규제와 상환 상황
  • 북미
  • 유럽
  • 아시아태평양
  • 라틴아메리카
  • 중동 및 아프리카
• Porter의 Five Forces 분석
• 공급망 분석
• 특허 분석
• SWOT 분석
• 미충족 요구와 갭
• 시장 진입 및 확장을 위한 추천 전략
• 시나리오 분석 : 베스트 케이스/베이스 케이스/워스트 케이스 예측
• 가격 분석과 가격 시장 역학
• KOL(Key Opinion Leader)

제6장 기능별

• 유해사례 보고 소프트웨어
• 의약품 안전성 감사 소프트웨어
• 문제 추적 소프트웨어
• 완전 통합형 소프트웨어

제7장 제공 방법별

• 온프레미스 제공 방법
• 온디맨드/클라우드 기반(SaaS) 제공 방법

제8장 최종사용자별

• 제약 기업 및 바이오테크놀러지 기업
• CRO(의약품 임상시험수탁기관)
• 병원 및 의료기관
• 기타

제9장 지역별

• 북미
  • 미국
  • 캐나다
  • 멕시코
• 유럽
  • 독일
  • 영국
  • 프랑스
  • 스페인
  • 이탈리아
  • 기타 유럽
• 남미
  • 브라질
  • 아르헨티나
  • 기타 남미
• 아시아태평양
  • 중국
  • 인도
  • 일본
  • 한국
  • 기타 아시아태평양
• 중동 및 아프리카

제10장 경쟁 구도

• 경쟁 시나리오
• 시장 현황 및 점유율 분석
• 인수합병(M&A) 분석

제11장 기업 개요

• Ennov
  • 기업 개요
  • 제품 포트폴리오
    • 제품 설명
    • 제품 핵심성과지표(KPI)
    • 제품 판매 실적과 예측
  • 재무 개요
    • 기업 매출
    • 매출 점유율 : 지역별
    • 매출 예측
  • 주요 발전
    • 인수합병(M&A)
    • 주요 제품 개발 활동
    • 규제기관 승인 등
  • SWOT 분석
• Oracle
• ArisGlobal
• EXTEDO
• Clinevo Technologies
• IQVIA
• Quanticate
• Cloudbyz
• Accenture
• Flex Databases
• 각 기업에 관한 같은 데이터가 제공됩니다.

제12장 부록

영문목차

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