[시장보고서]생명과학 품질 관리 소프트웨어 시장 규모, 점유율, 동향 분석 보고서 : 용도별, 도입 형태별, 최종 용도별, 지역별, 부문별 예측(2025-2033년)

생명과학 품질 관리 소프트웨어 시장 규모, 점유율, 동향 분석 보고서 : 용도별, 도입 형태별, 최종 용도별, 지역별, 부문별 예측(2025-2033년)

Life Sciences Quality Management Software Market Size, Share & Trends Analysis Report By Deployment Mode (Web & Cloud-based, On-premise), By Application, By End-use, By Region, And Segment Forecasts, 2025 - 2033

상품코드 : 1888765

리서치사 : Grand View Research

발행일 : 2025년 11월

페이지 정보 : 영문 120 Pages

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한글목차

샘플 요청 목록에 추가

생명과학 품질 관리 소프트웨어 시장 요약

세계의 생명과학 품질 관리 소프트웨어 시장 규모는 2024년에 32억 7,000만 달러로 추정되며, 2033년까지 94억 7,000만 달러에 달할 것으로 예측됩니다.

2025년부터 2033년까지 CAGR 12.65%로 성장할 것으로 예상됩니다. 기술 발전과 규제 가이드라인 준수에 대한 요구가 증가하면서 시장 성장을 견인하는 요인으로 작용하고 있습니다.

또한, 스마트 기기의 보급과 사물인터넷(IoT) 활용 확대에 따라 시장 확대가 예상됩니다. 생명과학 품질 관리 소프트웨어(QMS)에 식스시그마 기법을 접목하면 산업 확장을 위한 새로운 기회가 열릴 것으로 예상됩니다.

규제 가이드라인 준수에 대한 요구가 높아지면서 생명과학 산업에서 QMS 도입이 크게 증가하고 있습니다. 이러한 변화는 제품의 안전성과 유효성 확보, 그리고 FDA 및 ISO 표준과 같은 당국의 엄격한 규제 준수가 필요하기 때문입니다. 생명과학 분야는 고도의 규제를 받고 있으며, 기업은 높은 품질과 안전 기준을 유지해야 합니다. 강력한 QMS는 조직이 이러한 규제 요건을 효율적으로 충족하고 제품이 대중이 사용하기에 안전하며 필요한 지침을 준수하도록 보장하는 데 도움이 됩니다.

또한, 기술 발전도 생명과학 산업에서 QMS 도입을 촉진하는 중요한 요소입니다. 이러한 변화는 고도로 규제된 환경에서 컴플라이언스, 효율성, 혁신에 대한 요구가 높아진 데 따른 것입니다. 생명과학 분야에서는 기존의 종이 기반 QMS에서 디지털화된 엔터프라이즈 품질 관리 소프트웨어(eQMS)로의 전환이 진행되고 있습니다. 이러한 전환을 통해 조직은 정책, 프로세스, 문서화를 통일하고 품질이 모든 업무 단계에 통합되도록 보장할 수 있습니다. 디지털 시스템은 실시간 데이터 접근을 가능하게 하여 의사결정과 업무 효율성 향상에 기여합니다.

세계의 생명과학 품질 관리 소프트웨어 시장 : 용도 변동 분석
세계의 생명과학 품질 관리 소프트웨어 시장 규모와 동향 분석, 용도별, 2021-2033년
데이터 관리
연수 관리
공급업체 관리
규제 및 컴플라이언스 관리
시정 시술·예방 시술(CAPA) 관리
감사 관리
변경 관리
부적합 관리
검사 관리
리스크 관리
기타

제5장 생명과학 품질 관리 소프트웨어 시장 : 도입 형태별 추정·동향 분석

세계의 생명과학 품질 관리 소프트웨어 시장 : 도입 형태 변동 분석
세계의 생명과학 품질 관리 소프트웨어 시장 규모와 동향 분석, 도입 형태별, 2021-2033년
클라우드 및 웹 기반
온프레미스

제6장 생명과학 품질 관리 소프트웨어 시장 : 최종 용도별 추정·동향 분석

세계의 생명과학 품질 관리 소프트웨어 시장 : 최종 용도 변동 분석
세계의 생명과학 품질 관리 소프트웨어 시장 규모와 동향 분석, 최종 용도별, 2021-2033년
제약 기업
바이오테크놀러지 기업
CRO/CDMO

제7장 생명과학 품질 관리 소프트웨어 시장 : 지역별 추정·동향 분석

지역별 시장 점유율 분석(2024년 및 2033년)
지역별 시장 대시보드
시장 규모 및 예측 동향 분석, 2021-2033년
북미
- 미국
- 캐나다
- 멕시코
유럽
- 영국
- 독일
- 프랑스
- 이탈리아
- 스페인
- 노르웨이
- 스웨덴
- 덴마크
아시아태평양
- 일본
- 중국
- 인도
- 호주
- 한국
- 태국
라틴아메리카
- 브라질
- 아르헨티나
중동 및 아프리카
- 남아프리카공화국
- 사우디아라비아
- 아랍에미리트
- 쿠웨이트

제8장 경쟁 구도

기업/경쟁 분류
전략 매핑
2024년의 기업 시장 상황 분석
기업 개요/리스트
- Dassault Systemes
- IQVIA(Pilgrim)
- MasterControl Solutions, Inc.
- AmpleLogic
- Qualio-QMS for Life Sciences
- QT9 Software
- Sparta Systems-TrackWise(Honeywell International Inc.)
- AssurX, Inc
- ETQ, LLC(Hexagon)
- Veeva Systems
- Qualityze
- Ideagen

KSM

영문 목차

영문목차

Life Sciences Quality Management Software Market Summary

The global life sciences quality management software market size was estimated at USD 3.27 billion in 2024 and is projected to reach USD 9.47 billion by 2033, growing at a CAGR of 12.65% from 2025 to 2033. Technological advancements and the growing need to comply with regulatory guidelines are factors driving market growth.

In addition, the market is expected to expand due to the growing use of smart devices and the internet of things (IoT). The incorporation of the Six Sigma approach into life sciences Quality Management Software (QMS) is anticipated to open new opportunities for industrial expansion.

The increasing demand for compliance with regulatory guidelines significantly drives the adoption of QMS in the life sciences industry. This shift is influenced by the need to ensure product safety, efficacy, and adherence to stringent regulations imposed by authorities, such as the FDA and ISO standards. The life sciences sector is highly regulated, requiring companies to maintain high-quality and safety standards. A robust QMS helps organizations meet these regulatory demands efficiently, ensuring that products are safe for public use and comply with necessary guidelines.

In addition, technological advancements are also a significant factor in harnessing the adoption of QMS in the life sciences industry. This transformation is largely due to the increasing need for compliance, efficiency, and innovation within a highly regulated environment. The life sciences sector is transitioning from traditional, paper-based QMS to digital Enterprise Quality Management Software (eQMS). This shift allows organizations to harmonize policies, processes, and documentation, ensuring that quality is integrated into every operational step. Digital systems facilitate real-time data access, enhancing decision-making and operational efficiency.

Global Life Sciences Quality Management Software Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global life sciences quality management software market report based on application, deployment method, end use, and region:

Application Outlook (Revenue, USD Million, 2021 - 2033)
Data Management
Training management
Supplier management
Regulatory and Compliance Management
Corrective Action Preventive Action (CAPA) Management
Audit Management
Change Management
Non-Conformances Management
Inspection Management
Risk Management
Others
Deployment Mode Outlook (Revenue, USD Million, 2021 - 2033)
Cloud & Web based
On-premises
End Use Outlook (Revenue, USD Million, 2021 - 2033)
Pharmaceutical Firms
Biotech Firms
CROs/CDMOs
Regional Outlook (Revenue, USD Million, 2021 - 2033)
North America
- U.S.
- Canada
- Mexico
Europe
- Germany
- UK
- France
- Italy
- Spain
- Denmark
- Sweden
- Norway
Asia Pacific
- China
- Japan
- India
- South Korea
- Australia
- Thailand
Latin America
- Brazil
- Argentina
MEA
- South Africa
- Saudi Arabia
- UAE
- Kuwait

Chapter 1. Methodology and Scope

1.1. Market Segmentation & Scope
1.2. Market Definitions
- 1.2.1. Application Segment
- 1.2.2. Deployment Mode
- 1.2.3. End Use Segment
1.3. Information analysis
- 1.3.1. Market formulation & data visualization
1.4. Data validation & publishing
1.5. Information Procurement
- 1.5.1. Primary Research
1.6. Information or Data Analysis
1.7. Market Formulation & Validation
1.8. Market Model
1.9. Total Market: CAGR Calculation
1.10. Objectives
- 1.10.1. Objective 1
- 1.10.2. Objective 2

Chapter 2. Executive Summary

2.1. Market Outlook
2.2. Segment Snapshot
2.3. Competitive Insights Landscape

Chapter 3. Life Sciences Quality Management Software Market Variables, Trends & Scope

3.1. Market Lineage Outlook
- 3.1.1. Parent market outlook
- 3.1.2. Related/ancillary market outlook.
3.2. Market Dynamics
- 3.2.1. Market driver analysis
  - 3.2.1.1. Technological advancements in the life science industry
  - 3.2.1.2. Growing need to comply with regulatory guidelines
  - 3.2.1.3. Increasing use of quality management software (QMS) in the life sciences supply chain to ensure product quality and safety
- 3.2.2. Market restraint analysis
  - 3.2.2.1. Security concerns with cloud deployment
  - 3.2.2.2. A shortage of skilled professionals
3.3. Life Sciences Quality Management Software Market Analysis Tools
- 3.3.1. Industry Analysis - Porter's
  - 3.3.1.1. Supplier power
  - 3.3.1.2. Buyer power
  - 3.3.1.3. Substitution threat
  - 3.3.1.4. Threat of new entrant
  - 3.3.1.5. Competitive rivalry
- 3.3.2. PESTEL Analysis
  - 3.3.2.1. Political landscape
  - 3.3.2.2. Technological landscape
  - 3.3.2.3. Economic landscape
  - 3.3.2.4. Environmental Landscape
  - 3.3.2.5. Legal Landscape
  - 3.3.2.6. Social Landscape

Chapter 4. Life Sciences Quality Management Software Market: Application Estimates & Trend Analysis

4.1. Segment Dashboard
4.2. Global Life Sciences Quality Management Software Market Application Movement Analysis
4.3. Global Life Sciences Quality Management Software Market Size & Trend Analysis, by Application, 2021 to 2033 (USD Million)
4.4. Data Management
- 4.4.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
4.5. Training Management
- 4.5.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
4.6. Supplier Management
- 4.6.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
4.7. Regulatory and Compliance Management
- 4.7.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
4.8. Corrective Action Preventive Action (CAPA) Management
- 4.8.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
4.9. Audit Management
- 4.9.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
4.10. Change Management
- 4.10.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
4.11. Non-conformances Management
- 4.11.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
4.12. Inspection Management
- 4.12.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
4.13. Risk Management
- 4.13.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
4.14. Others
- 4.14.1. Market estimates and forecasts, 2021 - 2033 (USD Million)

Chapter 5. Life Sciences Quality Management Software Market: Deployment Mode Estimates & Trend Analysis

5.1. Segment Dashboard
5.2. Global Life Sciences Quality Management Software Market Deployment Mode Movement Analysis
5.3. Global Life Sciences Quality Management Software Market Size & Trend Analysis, by Deployment Mode, 2021 to 2033 (USD Million)
5.4. Cloud & Web-based
- 5.4.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
5.5. On-premises
- 5.5.1. Market estimates and forecasts, 2021 - 2033 (USD Million)

Chapter 6. Life Sciences Quality Management Software Market: End Use Estimates & Trend Analysis

6.1. Segment Dashboard
6.2. Global Life Sciences Quality Management Software Market End Use Movement Analysis
6.3. Global Life Sciences Quality Management Software Market Size & Trend Analysis, by End Use, 2021 to 2033 (USD Million)
6.4. Pharmaceutical Firms
- 6.4.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
6.5. Biotech Firms
- 6.5.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
6.6. CROs/CDMOs
- 6.6.1. Market estimates and forecasts, 2021 - 2033 (USD Million)

Chapter 7. Life Sciences Quality Management Software Market: Regional Estimates & Trend Analysis

7.1. Regional Market Share Analysis, 2024 & 2033
7.2. Regional Market Dashboard
7.3. Market Size, & Forecasts Trend Analysis, 2021 to 2033:
7.4. North America
- 7.4.1. U.S.
  - 7.4.1.1. Key country dynamics
  - 7.4.1.2. Regulatory framework
  - 7.4.1.3. Competitive scenario
  - 7.4.1.4. U.S. market estimates and forecasts 2021 - 2033 (USD Million)
- 7.4.2. Canada
  - 7.4.2.1. Key country dynamics
  - 7.4.2.2. Regulatory framework
  - 7.4.2.3. Competitive scenario
  - 7.4.2.4. Canada market estimates and forecasts 2021 - 2033 (USD Million)
- 7.4.3. Mexico
  - 7.4.3.1. Key country dynamics
  - 7.4.3.2. Regulatory framework
  - 7.4.3.3. Competitive scenario
  - 7.4.3.4. Mexico market estimates and forecasts 2021 - 2033 (USD Million)
7.5. Europe
- 7.5.1. UK
  - 7.5.1.1. Key country dynamics
  - 7.5.1.2. Regulatory framework
  - 7.5.1.3. Competitive scenario
  - 7.5.1.4. UK market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.5.2. Germany
  - 7.5.2.1. Key country dynamics
  - 7.5.2.2. Regulatory framework
  - 7.5.2.3. Competitive scenario
  - 7.5.2.4. Germany market estimates and forecasts 2021 - 2033 (USD Million)
- 7.5.3. France
  - 7.5.3.1. Key country dynamics
  - 7.5.3.2. Regulatory framework
  - 7.5.3.3. Competitive scenario
  - 7.5.3.4. France market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.5.4. Italy
  - 7.5.4.1. Key country dynamics
  - 7.5.4.2. Regulatory framework
  - 7.5.4.3. Competitive scenario
  - 7.5.4.4. Italy market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.5.5. Spain
  - 7.5.5.1. Key country dynamics
  - 7.5.5.2. Regulatory framework
  - 7.5.5.3. Competitive scenario
  - 7.5.5.4. Spain market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.5.6. Norway
  - 7.5.6.1. Key country dynamics
  - 7.5.6.2. Regulatory framework
  - 7.5.6.3. Competitive scenario
  - 7.5.6.4. Norway market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.5.7. Sweden
  - 7.5.7.1. Key country dynamics
  - 7.5.7.2. Regulatory framework
  - 7.5.7.3. Competitive scenario
  - 7.5.7.4. Sweden market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.5.8. Denmark
  - 7.5.8.1. Key country dynamics
  - 7.5.8.2. Regulatory framework
  - 7.5.8.3. Competitive scenario
  - 7.5.8.4. Denmark market estimates and forecasts, 2021 - 2033 (USD Million)
7.6. Asia Pacific
- 7.6.1. Japan
  - 7.6.1.1. Key country dynamics
  - 7.6.1.2. Regulatory framework
  - 7.6.1.3. Competitive scenario
  - 7.6.1.4. Japan market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.6.2. China
  - 7.6.2.1. Key country dynamics
  - 7.6.2.2. Regulatory framework
  - 7.6.2.3. Competitive scenario
  - 7.6.2.4. China market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.6.3. India
  - 7.6.3.1. Key country dynamics
  - 7.6.3.2. Regulatory framework
  - 7.6.3.3. Competitive scenario
  - 7.6.3.4. India market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.6.4. Australia
  - 7.6.4.1. Key country dynamics
  - 7.6.4.2. Regulatory framework
  - 7.6.4.3. Competitive scenario
  - 7.6.4.4. Australia market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.6.5. South Korea
  - 7.6.5.1. Key country dynamics
  - 7.6.5.2. Regulatory framework
  - 7.6.5.3. Competitive scenario
  - 7.6.5.4. South Korea market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.6.6. Thailand
  - 7.6.6.1. Key country dynamics
  - 7.6.6.2. Regulatory framework
  - 7.6.6.3. Competitive scenario
  - 7.6.6.4. Thailand market estimates and forecasts, 2021 - 2033 (USD Million)
7.7. Latin America
- 7.7.1. Brazil
  - 7.7.1.1. Key country dynamics
  - 7.7.1.2. Regulatory framework
  - 7.7.1.3. Competitive scenario
  - 7.7.1.4. Brazil market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.7.2. Argentina
  - 7.7.2.1. Key country dynamics
  - 7.7.2.2. Regulatory framework
  - 7.7.2.3. Competitive scenario
  - 7.7.2.4. Argentina market estimates and forecasts, 2021 - 2033 (USD Million)
7.8. MEA
- 7.8.1. South Africa
  - 7.8.1.1. Key country dynamics
  - 7.8.1.2. Regulatory framework
  - 7.8.1.3. Competitive scenario
  - 7.8.1.4. South Africa market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.8.2. Saudi Arabia
  - 7.8.2.1. Key country dynamics
  - 7.8.2.2. Regulatory framework
  - 7.8.2.3. Competitive scenario
  - 7.8.2.4. Saudi Arabia market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.8.3. UAE
  - 7.8.3.1. Key country dynamics
  - 7.8.3.2. Regulatory framework
  - 7.8.3.3. Competitive scenario
  - 7.8.3.4. UAE market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.8.4. Kuwait
  - 7.8.4.1. Key country dynamics
  - 7.8.4.2. Regulatory framework
  - 7.8.4.3. Competitive scenario
  - 7.8.4.4. Kuwait market estimates and forecasts, 2021 - 2033 (USD Million)

Chapter 8. Competitive Landscape

8.1. Company/Competition Categorization
8.2. Strategy Mapping
8.3. Company Market Position Analysis, 2024
8.4. Company Profiles/Listing
- 8.4.1. Dassault Systemes
  - 8.4.1.1. Company overview
  - 8.4.1.2. Financial performance
  - 8.4.1.3. Product benchmarking
  - 8.4.1.4. Strategic initiatives
- 8.4.2. IQVIA (Pilgrim)
  - 8.4.2.1. Company overview
  - 8.4.2.2. Financial performance
  - 8.4.2.3. Product benchmarking
  - 8.4.2.4. Strategic initiatives
- 8.4.3. MasterControl Solutions, Inc.
  - 8.4.3.1. Company overview
  - 8.4.3.2. Financial performance
  - 8.4.3.3. Product benchmarking
  - 8.4.3.4. Strategic initiatives
- 8.4.4. AmpleLogic
  - 8.4.4.1. Company overview
  - 8.4.4.2. Financial performance
  - 8.4.4.3. Product benchmarking
  - 8.4.4.4. Strategic initiatives
- 8.4.5. Qualio - QMS for Life Sciences
  - 8.4.5.1. Company overview
  - 8.4.5.2. Financial performance
  - 8.4.5.3. Product benchmarking
  - 8.4.5.4. Strategic initiatives
- 8.4.6. QT9 Software
  - 8.4.6.1. Company overview
  - 8.4.6.2. Financial performance
  - 8.4.6.3. Product benchmarking
  - 8.4.6.4. Strategic initiatives
- 8.4.7. Sparta Systems- TrackWise (Honeywell International Inc.)
  - 8.4.7.1. Company overview
  - 8.4.7.2. Financial performance
  - 8.4.7.3. Product benchmarking
  - 8.4.7.4. Strategic initiatives
- 8.4.8. AssurX, Inc
  - 8.4.8.1. Company overview
  - 8.4.8.2. Financial performance
  - 8.4.8.3. Product benchmarking
  - 8.4.8.4. Strategic initiatives
- 8.4.9. ETQ, LLC (Hexagon)
  - 8.4.9.1. Company overview
  - 8.4.9.2. Financial performance
  - 8.4.9.3. Product benchmarking
  - 8.4.9.4. Strategic initiatives
- 8.4.10. Veeva Systems
  - 8.4.10.1. Company overview
  - 8.4.10.2. Financial performance
  - 8.4.10.3. Product benchmarking
  - 8.4.10.4. Strategic initiatives
- 8.4.11. Qualityze
  - 8.4.11.1. Company overview
  - 8.4.11.2. Financial performance
  - 8.4.11.3. Product benchmarking
  - 8.4.11.4. Strategic initiatives
- 8.4.12. Ideagen
  - 8.4.12.1. Company overview
  - 8.4.12.2. Financial performance
  - 8.4.12.3. Product benchmarking
  - 8.4.12.4. Strategic initiatives