의약품 규제 관리 시스템 시장 - 세계 산업 규모, 점유율, 동향, 기회, 예측, 경쟁별, 전개 형태별, 최종사용자별, 지역별, 경쟁별(2020-2030년)

Pharma Regulatory Management Systems Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Component, By Deployment, By End User, By Region & Competition, 2020-2030F

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한글목차

의약품 규제 관리 시스템 세계 시장 규모는 2024년 99억 8,000만 달러로 평가되었고, 2030년까지 예측 기간 동안 9.95%의 연평균 복합 성장률(CAGR)로 괄목할 만한 성장이 예상됩니다.

의약품 규제 관리 시스템 세계 시장은 제약 및 생명과학 분야의 규제 준수 및 규제 프로세스 간소화를 촉진하기 위해 설계된 전문 소프트웨어 솔루션 및 기술의 개발 및 채택을 포함하는 산업을 의미합니다. 이러한 배경에는 암 환자 증가, 심혈관 질환 증가, 인구 고령화 등이 있습니다. 예를 들어, GLOBOCAN 2022 데이터에 따르면 전 세계 암 발병 건수는 1,990만 건을 넘어섰습니다. 아시아가 980만 명 이상으로 가장 많았고, 유럽이 440만 명, 북미가 260만 명으로 그 뒤를 이었습니다. 이 데이터는 암 발병률의 지역적 격차를 강조하며, 전 세계적으로 의료비 부담이 증가하고 있음을 강조합니다. 따라서 이러한 문제를 관리하기 위해 의약품 규제 위원회는 빠르게 확대되고 있습니다.

시장 개요
예측 기간	2026-2030년
시장 규모(2024년)	99억 8,000만 달러
시장 규모(2030년)	174억 9,000만 달러
CAGR(2025-2030년)	9.95%
급성장 부문	온프레미스
최대 시장	북미

시장 성장 촉진요인

규제 복잡화

주요 시장 이슈

빠르게 진화하는 규제

주요 시장 동향

클라우드 기반 솔루션을 통한 유연성

목차

제1장 개요

제2장 조사 방법

제3장 주요 요약

제4장 고객의 소리

제5장 세계의 의약품 규제 관리 시스템 시장 전망

• 시장 규모와 예측
  • 금액별
• 시장 점유율과 예측
  • 컴포넌트별(서비스, 솔루션)
  • 전개 형태별(클라우드, 온프레미스)
  • 최종사용자별(정부기관, 병원 및 요양기관, 제약 및 바이오테크놀러지 기업)
  • 지역별
  • 기업별(2024년)
• 제품 시장 맵
  • 컴포넌트별
  • 전개 형태별
  • 최종사용자별
  • 지역별

제6장 북미의 의약품 규제 관리 시스템 시장 전망

• 시장 규모와 예측
• 시장 점유율과 예측
• 북미 : 국가별 분석
  • 미국
  • 캐나다
  • 멕시코

제7장 유럽의 의약품 규제 관리 시스템 시장 전망

• 시장 규모와 예측
• 시장 점유율과 예측
• 유럽 : 국가별 분석
  • 독일
  • 영국
  • 프랑스
  • 이탈리아
  • 스페인

제8장 아시아태평양의 의약품 규제 관리 시스템 시장 전망

• 시장 규모와 예측
• 시장 점유율과 예측
• 아시아태평양 : 국가별 분석
  • 중국
  • 일본
  • 인도
  • 호주
  • 한국

제9장 남미의 의약품 규제 관리 시스템 시장 전망

• 시장 규모와 예측
• 시장 점유율과 예측
• 남미 : 국가별 분석
  • 브라질
  • 아르헨티나
  • 콜롬비아

제10장 중동 및 아프리카의 의약품 규제 관리 시스템 시장 전망

• 시장 규모와 예측
• 시장 점유율과 예측
• 중동 및 아프리카 : 국가별 분석
  • 남아프리카공화국
  • 사우디아라비아
  • 아랍에미리트(UAE)
  • 쿠웨이트

제11장 시장 역학

• 성장 촉진요인
• 과제

제12장 시장 동향과 발전

• 최근 동향
• 인수합병(M&A)
• 제품 출시

제13장 Porter의 Five Forces 분석

• 업계내 경쟁
• 신규 참여 가능성
• 공급업체의 힘
• 고객의 힘
• 대체품의 위협

제14장 경쟁 구도

• Instem PLC
• NNIT A/S
• EXTEDO
• Amplexor USA Inc
• MasterControl Inc
• Charles River Laboratories International Inc.
• Parexel International Corporation
• IQVIA Inc.
• ICON Inc.
• Pharmalex GmbH

제15장 전략적 제안

16 리서치사에 대해·면책사항

LSH

영문 목차

영문목차

Global Pharma Regulatory Management Systems Market was valued at USD 9.98 billion in 2024 and is anticipated to project impressive growth in the forecast period with a CAGR of 9.95% through 2030. The Global Pharma Regulatory Management Systems Market refers to the industry that encompasses the development and adoption of specialized software solutions and technologies designed to facilitate regulatory compliance and streamline regulatory processes within the pharmaceutical and life sciences sector. This is ascribed due to rising cancer cases, growing cardiovascular diseases, aging popultion, etc. For instance, according to GLOBOCAN 2022 data, global cancer incidence surpassed 19.9 million cases. The highest number of cases was reported in Asia, with over 9.8 million, followed by Europe with 4.4 million and North America with 2.6 million. This data highlights regional disparities in cancer prevalence, emphasizing the growing healthcare burden worldwide. Therefore, in order to manage these issues, the regulatory committee of pharmaceutical is growing rapidly.

Market Overview
Forecast Period	2026-2030
Market Size 2024	USD 9.98 Billion
Market Size 2030	USD 17.49 Billion
CAGR 2025-2030	9.95%
Fastest Growing Segment	On-Premises
Largest Market	North America

Key Market Drivers

Rising Regulatory Complexity

The pharmaceutical industry operates in a highly regulated environment, where adherence to stringent regulatory standards is paramount to ensure the safety, efficacy, and quality of pharmaceutical products. Over the years, the regulatory landscape governing this industry has become increasingly complex, with a growing number of guidelines, requirements, and compliance standards imposed by regulatory authorities worldwide. This rising regulatory complexity has emerged as a significant driving force behind the rapid growth of the Global Pharma Regulatory Management Systems (PRMS) Market. For instance, Japan's Central Social Insurance Medical Council approved a drug repricing system expected to lead to an average price reduction of approximately 4.38%. This system covers nearly 17 top-selling drugs, including Vyndaqel, Samsca, Revlimid, Lynparza, Stelara, and Dupixent. In April 2023, the prices of over 2,000 drugs in Japan saw an average reduction of 9.4%. These developments are likely to impact pharmaceutical regulatory managemnet systems market in the near future.

Key Market Challenges

Rapidly Evolving Regulations

One of the foremost challenges is the ever-changing regulatory landscape in the pharmaceutical industry. Regulatory bodies like the U.S. FDA and the EMA continually update and revise guidelines, making it challenging for PRMS providers to keep their systems aligned with the latest requirements. Pharmaceutical companies require agile solutions that can adapt to evolving standards.

Key Market Trends

Cloud-Based Solutions for Flexibility

Cloud computing is becoming increasingly prevalent in the pharmaceutical industry. Cloud-based PRMS solutions offer scalability, flexibility, and the ability to access data and tools from anywhere. This trend will enable smaller pharmaceutical companies to adopt PRMS without significant upfront infrastructure costs.

Key Market Players

• Instem PLC
• NNIT A/S
• EXTEDO
• Amplexor USA Inc
• MasterControl Inc
• Charles River Laboratories International Inc.
• Parexel International Corporation
• IQVIA Inc.
• ICON Inc.
• Pharmalex GmbH

Report Scope:

In this report, the Global Pharma Regulatory Management Systems Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Pharma Regulatory Management Systems Market, By Component:

• Services
• Solutions

Pharma Regulatory Management Systems Market, By Deployment:

• On-Cloud
• On-Premises

Pharma Regulatory Management Systems Market, By End User:

• Government Agencies
• Hospitals & Care Providers
• Pharmaceutical & Biotechnology Companies

Pharma Regulatory Management Systems Market, By Region:

• North America
  • United States
  • Canada
  • Mexico
• Europe
  • Germany
  • United Kingdom
  • France
  • Italy
  • Spain
• Asia-Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Kuwait

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Pharma Regulatory Management Systems Market.

Available Customizations:

Global Pharma Regulatory Management Systems market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Pharma Regulatory Management Systems Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Component (Services, Solutions)
  • 5.2.2. By Deployment (On-Cloud, On-Premises)
  • 5.2.3. By End User (Government Agencies, Hospitals & Care Providers, Pharmaceutical & Biotechnology Companies)
  • 5.2.4. By Region
  • 5.2.5. By Company (2024)
• 5.3. Product Market Map
  • 5.3.1. By Component
  • 5.3.2. By Deployment
  • 5.3.3. By End User
  • 5.3.4. By Region

6. North America Pharma Regulatory Management Systems Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Component (Services, Solutions)
  • 6.2.2. By Deployment (On-Cloud, On-Premises)
  • 6.2.3. By End User (Government Agencies, Hospitals & Care Providers, Pharmaceutical & Biotechnology Companies)
  • 6.2.4. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Pharma Regulatory Management Systems Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Component
      • 6.3.1.2.2. By Deployment
      • 6.3.1.2.3. By End User
  • 6.3.2. Canada Pharma Regulatory Management Systems Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Component
      • 6.3.2.2.2. By Deployment
      • 6.3.2.2.3. By End User
  • 6.3.3. Mexico Pharma Regulatory Management Systems Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Component
      • 6.3.3.2.2. By Deployment
      • 6.3.3.2.3. By End User

7. Europe Pharma Regulatory Management Systems Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Component (Services, Solutions)
  • 7.2.2. By Deployment (On-Cloud, On-Premises)
  • 7.2.3. By End User (Government Agencies, Hospitals & Care Providers, Pharmaceutical & Biotechnology Companies)
  • 7.2.4. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. Germany Pharma Regulatory Management Systems Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Component
      • 7.3.1.2.2. By Deployment
      • 7.3.1.2.3. By End User
  • 7.3.2. United Kingdom Pharma Regulatory Management Systems Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Component
      • 7.3.2.2.2. By Deployment
      • 7.3.2.2.3. By End User
  • 7.3.3. France Pharma Regulatory Management Systems Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Component
      • 7.3.3.2.2. By Deployment
      • 7.3.3.2.3. By End User
  • 7.3.4. Italy Pharma Regulatory Management Systems Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Component
      • 7.3.4.2.2. By Deployment
      • 7.3.4.2.3. By End User
  • 7.3.5. Spain Pharma Regulatory Management Systems Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Component
      • 7.3.5.2.2. By Deployment
      • 7.3.5.2.3. By End User

8. Asia-Pacific Pharma Regulatory Management Systems Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Component (Services, Solutions)
  • 8.2.2. By Deployment (On-Cloud, On-Premises)
  • 8.2.3. By End User (Government Agencies, Hospitals & Care Providers, Pharmaceutical & Biotechnology Companies)
  • 8.2.4. By Country
• 8.3. Asia-Pacific: Country Analysis
  • 8.3.1. China Pharma Regulatory Management Systems Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Component
      • 8.3.1.2.2. By Deployment
      • 8.3.1.2.3. By End User
  • 8.3.2. Japan Pharma Regulatory Management Systems Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Component
      • 8.3.2.2.2. By Deployment
      • 8.3.2.2.3. By End User
  • 8.3.3. India Pharma Regulatory Management Systems Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Component
      • 8.3.3.2.2. By Deployment
      • 8.3.3.2.3. By End User
  • 8.3.4. Australia Pharma Regulatory Management Systems Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Component
      • 8.3.4.2.2. By Deployment
      • 8.3.4.2.3. By End User
  • 8.3.5. South Korea Pharma Regulatory Management Systems Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Component
      • 8.3.5.2.2. By Deployment
      • 8.3.5.2.3. By End User

9. South America Pharma Regulatory Management Systems Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Component (Services, Solutions)
  • 9.2.2. By Deployment (On-Cloud, On-Premises)
  • 9.2.3. By End User (Government Agencies, Hospitals & Care Providers, Pharmaceutical & Biotechnology Companies)
  • 9.2.4. By Country
• 9.3. South America: Country Analysis
  • 9.3.1. Brazil Pharma Regulatory Management Systems Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Component
      • 9.3.1.2.2. By Deployment
      • 9.3.1.2.3. By End User
  • 9.3.2. Argentina Pharma Regulatory Management Systems Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Component
      • 9.3.2.2.2. By Deployment
      • 9.3.2.2.3. By End User
  • 9.3.3. Colombia Pharma Regulatory Management Systems Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Component
      • 9.3.3.2.2. By Deployment
      • 9.3.3.2.3. By End User

10. Middle East and Africa Pharma Regulatory Management Systems Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Component (Services, Solutions)
  • 10.2.2. By Deployment (On-Cloud, On-Premises)
  • 10.2.3. By End User (Government Agencies, Hospitals & Care Providers, Pharmaceutical & Biotechnology Companies)
  • 10.2.4. By Country
• 10.3. MEA: Country Analysis
  • 10.3.1. South Africa Pharma Regulatory Management Systems Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Component
      • 10.3.1.2.2. By Deployment
      • 10.3.1.2.3. By End User
  • 10.3.2. Saudi Arabia Pharma Regulatory Management Systems Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Component
      • 10.3.2.2.2. By Deployment
      • 10.3.2.2.3. By End User
  • 10.3.3. UAE Pharma Regulatory Management Systems Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Component
      • 10.3.3.2.2. By Deployment
      • 10.3.3.2.3. By End User
  • 10.3.4. Kuwait Pharma Regulatory Management Systems Market Outlook
    • 10.3.4.1. Market Size & Forecast
      • 10.3.4.1.1. By Value
    • 10.3.4.2. Market Share & Forecast
      • 10.3.4.2.1. By Component
      • 10.3.4.2.2. By Deployment
      • 10.3.4.2.3. By End User

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Recent Development
• 12.2. Mergers & Acquisitions
• 12.3. Product Launches

13. Porter's Five Forces Analysis

• 13.1. Competition in the Industry
• 13.2. Potential of New Entrants
• 13.3. Power of Suppliers
• 13.4. Power of Customers
• 13.5. Threat of Substitute Products

14. Competitive Landscape

• 14.1. Instem PLC
  • 14.1.1. Business Overview
  • 14.1.2. Product Offerings
  • 14.1.3. Recent Developments
  • 14.1.4. Financials (As Reported)
  • 14.1.5. Key Personnel
  • 14.1.6. SWOT Analysis
• 14.2. NNIT A/S
• 14.3. EXTEDO
• 14.4. Amplexor USA Inc
• 14.5. MasterControl Inc
• 14.6. Charles River Laboratories International Inc.
• 14.7. Parexel International Corporation
• 14.8. IQVIA Inc.
• 14.9. ICON Inc.
• 14.10. Pharmalex GmbH

15. Strategic Recommendations

16 About Us & Disclaimer

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