의약품 품질 관리 시장 규모 조사 : 제품별, 분석 유형별, 대상 제품별 및 지역별 예측(2022-2032년)

Global Pharmaceutical Quality Control Market is valued at approximately USD 4.71 billion in 2023 and is anticipated to grow with a healthy growth rate of more than 12.21% over the forecast period 2024-2032. The rising costs of drug manufacturing and the increasing need to comply with stringent regulatory requirements are driving the market's growth. In the pharmaceutical sector, manufacturing expenses constitute a significant portion of a company's total costs, and the development costs of new drugs have consistently risen, with investments required for bringing lab-conceived ideas to successful commercialization projected to be around USD 2 billion. Moreover, Pharmaceutical companies are heavily regulated to ensure consumer health and safety, necessitating adherence to numerous quality standards. Small and mid-sized pharmaceutical businesses are particularly focusing on regulatory compliance to produce high-quality products and remain competitive.

The primary factors driving the pharmaceutical quality control market include the increasing number of accredited clinical laboratories, growing acceptance of third-party quality controls, and a rising preference for external quality assessment assistance. The surge in the prevalence of various diseases worldwide has led to an increased number of laboratory tests, prompting both public and private sectors to expand the number of laboratories. Clinical laboratories need to obtain accreditation from regulatory organizations to conduct diagnostic tests, which assesses their competency and quality systems against established standards, thereby driving market growth. Furthermore, regulatory bodies like the U.S. Food and Drug Administration (FDA) and the International Organisation for Standardisation (ISO) enforce stringent manufacturing practices, further propelling the demand for advanced quality control systems.

The key regions considered for the Global Pharmaceutical Quality Control Market study include North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa. In 2023, North America dominated the market due to its advanced technological infrastructure, stringent regulatory standards, and significant investment in research and development. The region's robust healthcare system and the presence of major pharmaceutical companies drive the adoption of cutting-edge quality control measures. High standards for drug safety and efficacy, along with a focus on innovation and compliance, contribute to North America's leadership. Additionally, the integration of sophisticated analytical technologies and a strong emphasis on quality assurance practices further enhance its position as a key player in the global Pharmaceutical Quality Control market. Europe holds a healthy market share, driven by significant investments in R&D for the pharmaceutical industry. Furthermore, the Asia-Pacific region is expected to register fastest growth due to the expansion of pharmaceutical businesses, especially in countries like China and India.

Major market players included in this report are:

• BioMerieux SA
• SGS S.A.
• Charles River Laboratories International Inc.
• WiXi AppTec
• Merck KGaA
• Thermo Fisher Scientific Inc.
• Toxikon Corporation
• Sartorius AG
• REMI Group
• Perkin Elmer

The detailed segments and sub-segment of the market are explained below:

By Product:

• Consumables
• Instruments
• Services

By Analysis Type:

• Sterility Testing
• Bioburden Testing
• Endotoxin Testing
• Stability Testing
• Extractable & Leachable Testing
• Raw Material Testing
• Others

By Products Tested:

• Vaccines
• Plasma Products
• Drugs

By Region:

• North America
• U.S.
• Canada
• Europe
• UK
• Germany
• France
• Spain
• Italy
• Rest of Europe
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• Rest of Asia Pacific
• Latin America
• Brazil
• Mexico
• Rest of Latin America
• Middle East & Africa
• Saudi Arabia
• South Africa
• Rest of Middle East & Africa

Years considered for the study are as follows:

• Historical year - 2022
• Base year - 2023
• Forecast period - 2024 to 2032

Key Takeaways:

• Market Estimates & Forecast for 10 years from 2022 to 2032.
• Annualized revenues and regional level analysis for each market segment.
• Detailed analysis of geographical landscape with Country level analysis of major regions.
• Competitive landscape with information on major players in the market.
• Analysis of key business strategies and recommendations on future market approach.
• Analysis of competitive structure of the market.
• Demand side and supply side analysis of the market.

Table of Contents

Chapter 1. Global Pharmaceutical Quality Control Market Executive Summary

• 1.1. Global Pharmaceutical Quality Control Market Size & Forecast (2022- 2032)
• 1.2. Regional Summary
• 1.3. Segmental Summary
  • 1.3.1. By Product
  • 1.3.2. By Analysis Type
  • 1.3.3. By Products Tested
• 1.4. Key Trends
• 1.5. Recession Impact
• 1.6. Analyst Recommendation & Conclusion

Chapter 2. Global Pharmaceutical Quality Control Market Definition and Research Assumptions

• 2.1. Research Objective
• 2.2. Market Definition
• 2.3. Research Assumptions
  • 2.3.1. Inclusion & Exclusion
  • 2.3.2. Limitations
  • 2.3.3. Supply Side Analysis
    • 2.3.3.1. Availability
    • 2.3.3.2. Infrastructure
    • 2.3.3.3. Regulatory Environment
    • 2.3.3.4. Market Competition
    • 2.3.3.5. Economic Viability (Consumer's Perspective)
  • 2.3.4. Demand Side Analysis
    • 2.3.4.1. Regulatory frameworks
    • 2.3.4.2. Technological Advancements
    • 2.3.4.3. Environmental Considerations
    • 2.3.4.4. Consumer Awareness & Acceptance
• 2.4. Estimation Methodology
• 2.5. Years Considered for the Study
• 2.6. Currency Conversion Rates

Chapter 3. Global Pharmaceutical Quality Control Market Dynamics

• 3.1. Market Drivers
  • 3.1.1. Increasing cost of drug manufacturing
  • 3.1.2. Need for regulatory compliance
• 3.2. Market Challenges
  • 3.2.1. High costs of quality control systems
  • 3.2.2. Complexity of regulatory requirements
• 3.3. Market Opportunities
  • 3.3.1. Expansion of pharmaceutical industries in emerging markets
  • 3.3.2. Technological advancements in quality control systems

Chapter 4. Global Pharmaceutical Quality Control Market Industry Analysis

• 4.1. Porter's 5 Force Model
  • 4.1.1. Bargaining Power of Suppliers
  • 4.1.2. Bargaining Power of Buyers
  • 4.1.3. Threat of New Entrants
  • 4.1.4. Threat of Substitutes
  • 4.1.5. Competitive Rivalry
  • 4.1.6. Futuristic Approach to Porter's 5 Force Model
  • 4.1.7. Porter's 5 Force Impact Analysis
• 4.2. PESTEL Analysis
  • 4.2.1. Political
  • 4.2.2. Economical
  • 4.2.3. Social
  • 4.2.4. Technological
  • 4.2.5. Environmental
  • 4.2.6. Legal
• 4.3. Top investment opportunity
• 4.4. Top winning strategies
• 4.5. Disruptive Trends
• 4.6. Industry Expert Perspective
• 4.7. Analyst Recommendation & Conclusion

Chapter 5. Global Pharmaceutical Quality Control Market Size & Forecasts by Product 2022-2032

• 5.1. Segment Dashboard
• 5.2. Global Pharmaceutical Quality Control Market: Product Revenue Trend Analysis, 2022 & 2032 (USD Billion)
  • 5.2.1. Consumables
  • 5.2.2. Instruments
  • 5.2.3. Services

Chapter 6. Global Pharmaceutical Quality Control Market Size & Forecasts by Analysis Type 2022-2032

• 6.1. Segment Dashboard
• 6.2. Global Pharmaceutical Quality Control Market: Analysis Type Revenue Trend Analysis, 2022 & 2032 (USD Billion)
  • 6.2.1. Sterility Testing
  • 6.2.2. Bioburden Testing
  • 6.2.3. Endotoxin Testing
  • 6.2.4. Stability Testing
  • 6.2.5. Extractable & Leachable Testing
  • 6.2.6. Raw Material Testing
  • 6.2.7. Others

Chapter 7. Global Pharmaceutical Quality Control Market Size & Forecasts by Products Tested 2022-2032

• 7.1. Segment Dashboard
• 7.2. Global Pharmaceutical Quality Control Market: Products Tested Revenue Trend Analysis, 2022 & 2032 (USD Billion)
  • 7.2.1. Vaccines
  • 7.2.2. Plasma Products
  • 7.2.3. Drugs

Chapter 8. Global Pharmaceutical Quality Control Market Size & Forecasts by Region 2022-2032

• 8.1. North America Pharmaceutical Quality Control Market
  • 8.1.1. U.S. Pharmaceutical Quality Control Market
    • 8.1.1.1. Product breakdown size & forecasts, 2022-2032
    • 8.1.1.2. Analysis Type breakdown size & forecasts, 2022-2032
    • 8.1.1.3. Products Tested breakdown size & forecasts, 2022-2032
  • 8.1.2. Canada Pharmaceutical Quality Control Market
• 8.2. Europe Pharmaceutical Quality Control Market
  • 8.2.1. U.K. Pharmaceutical Quality Control Market
  • 8.2.2. Germany Pharmaceutical Quality Control Market
  • 8.2.3. France Pharmaceutical Quality Control Market
  • 8.2.4. Spain Pharmaceutical Quality Control Market
  • 8.2.5. Italy Pharmaceutical Quality Control Market
  • 8.2.6. Rest of Europe Pharmaceutical Quality Control Market
• 8.3. Asia-Pacific Pharmaceutical Quality Control Market
  • 8.3.1. China Pharmaceutical Quality Control Market
  • 8.3.2. India Pharmaceutical Quality Control Market
  • 8.3.3. Japan Pharmaceutical Quality Control Market
  • 8.3.4. Australia Pharmaceutical Quality Control Market
  • 8.3.5. South Korea Pharmaceutical Quality Control Market
  • 8.3.6. Rest of Asia Pacific Pharmaceutical Quality Control Market
• 8.4. Latin America Pharmaceutical Quality Control Market
  • 8.4.1. Brazil Pharmaceutical Quality Control Market
  • 8.4.2. Mexico Pharmaceutical Quality Control Market
  • 8.4.3. Rest of Latin America Pharmaceutical Quality Control Market
• 8.5. Middle East & Africa Pharmaceutical Quality Control Market
  • 8.5.1. Saudi Arabia Pharmaceutical Quality Control Market
  • 8.5.2. South Africa Pharmaceutical Quality Control Market
  • 8.5.3. Rest of Middle East & Africa Pharmaceutical Quality Control Market

Chapter 9. Competitive Intelligence

• 9.1. Key Company SWOT Analysis
• 9.2. Top Market Strategies
• 9.3. Company Profiles
  • 9.3.1. WiXi AppTec
    • 9.3.1.1. Key Information
    • 9.3.1.2. Overview
    • 9.3.1.3. Financial (Subject to Data Availability)
    • 9.3.1.4. Product Summary
    • 9.3.1.5. Market Strategies
  • 9.3.2. Merck KGaA
  • 9.3.3. Thermo Fisher Scientific Inc.
  • 9.3.4. Toxikon Corporation
  • 9.3.5. Sartorius AG
  • 9.3.6. REMI Group
  • 9.3.7. Perkin Elmer
  • 9.3.8. BioMerieux SA
  • 9.3.9. SGS S.A.
  • 9.3.10. Charles River Laboratories International Inc.

Chapter 10. Research Process

• 10.1. Research Process
  • 10.1.1. Data Mining
  • 10.1.2. Analysis
  • 10.1.3. Market Estimation
  • 10.1.4. Validation
  • 10.1.5. Publishing
• 10.2. Research Attributes