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市場調查報告書
商品編碼
1525320

全球藥品品質控制市場規模研究，依產品、分析類型、測試產品及區域預測 2022-2032

Global Pharmaceutical Quality Control Market Size Study, by Product, by Analysis Type, by Products Tested and Regional Forecasts 2022-2032
出版日期: | 出版商: Bizwit Research & Consulting LLP | 英文 285 Pages | 商品交期: 2-3個工作天內

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簡介目錄

2023年全球藥品品質管制市場價值約47.1億美元，預計在2024-2032年預測期內將以超過12.21%的健康成長率成長。藥品製造成本的上升以及遵守嚴格監管要求的需求日益增加正在推動市場的成長。在製藥業，製造費用占公司總成本的很大一部分，而新藥的開發成本持續上升，將實驗室構思成功商業化所需的投資預計約為20億美元。此外，為了確保消費者的健康和安全，製藥公司受到嚴格監管，因此必須遵守眾多品質標準。中小型製藥企業特別注重監管合規性，以生產高品質的產品並保持競爭力。

推動藥品品質控制市場的主要因素包括獲得認可的臨床實驗室數量的增加、對第三方品質控制的接受程度不斷提高以及對外部品質評估援助的偏好不斷增加。全球各種疾病盛行率的激增導致實驗室檢測數量增加，促使公共和私營部門擴大實驗室數量。臨床實驗室需要獲得監管組織的認可才能進行診斷測試，根據既定標準評估其能力和品質體系，從而推動市場成長。此外，美國食品藥物管理局 (FDA) 和國際標準化組織 (ISO) 等監管機構強制執行嚴格的製造實踐，進一步推動了對先進品質控制系統的需求。

全球藥品品質控制市場研究考量的關鍵區域包括北美、歐洲、亞太地區、拉丁美洲以及中東和非洲。 2023年，北美憑藉其先進的技術基礎設施、嚴格的監管標準以及大量的研發投資而佔據市場主導地位。該地區強大的醫療保健系統和大型製藥公司的存在推動了尖端品質控制措施的採用。藥品安全性和有效性的高標準，以及對創新和合規性的關注，有助於北美的領先地位。此外，先進分析技術的整合和對品質保證實踐的高度重視進一步增強了其作為全球藥品品質控制市場關鍵參與者的地位。在製藥業研發的大量投資的推動下，歐洲擁有健康的市場佔有率。此外，由於製藥業務的擴張，預計亞太地區將實現最快的成長，特別是在中國和印度等國家。

目錄

第 1 章：全球藥品品質管制市場執行摘要

  • 全球藥品品質管制市場規模及預測（2022-2032）
  • 區域概要
  • 分部摘要
    • 按產品分類
    • 按分析類型
    • 按測試產品
  • 主要趨勢
  • 經濟衰退的影響
  • 分析師推薦與結論

第 2 章：全球藥品品質管制市場定義與研究假設

  • 研究目的
  • 市場定義
  • 研究假設
    • 包含與排除
    • 限制
    • 供給側分析
      • 可用性
      • 基礎設施
      • 監管環境
      • 市場競爭
      • 經濟可行性（消費者的角度）
    • 需求面分析
      • 監理框架
      • 技術進步
      • 環境考慮
      • 消費者意識和接受度
  • 估算方法
  • 研究涵蓋的年份
  • 貨幣兌換率

第 3 章：全球藥品品質管制市場動態

  • 市場促進因素
    • 藥品生產成本增加
    • 合規性需求
  • 市場挑戰
    • 品質控制系統成本高
    • 監理要求的複雜性
  • 市場機會
    • 新興市場製藥業的擴張
    • 品質控制系統的技術進步

第 4 章：全球藥品品質控制市場產業分析

  • 波特的五力模型
    • 供應商的議價能力
    • 買家的議價能力
    • 新進入者的威脅
    • 替代品的威脅
    • 競爭競爭
    • 波特五力模型的未來方法
    • 波特的五力影響分析
  • PESTEL分析
    • 政治的
    • 經濟
    • 社會的
    • 技術性
    • 環境的
    • 合法的
  • 頂級投資機會
  • 最佳制勝策略
  • 顛覆性趨勢
  • 產業專家視角
  • 分析師推薦與結論

第 5 章：全球藥品品質控制市場規模與預測：依產品分類 - 2022-2032

  • 細分儀表板
  • 全球藥品品質控制市場：2022 年和 2032 年產品收入趨勢分析
    • 耗材
    • 儀器
    • 服務

第 6 章：全球藥品品質控制市場規模與預測：按分析類型 - 2022-2032

  • 細分儀表板
  • 全球藥品品質控制市場：分析類型收入趨勢分析，2022 年和 2032 年
    • 無菌檢測
    • 生物負載測試
    • 內毒素檢測
    • 穩定性測試
    • 可萃取和可浸出測試
    • 原料檢測
    • 其他

第 7 章：全球藥品品質控制市場規模與預測：按測試產品分類 - 2022-2032

  • 細分儀表板
  • 全球藥品品質控制市場：2022 年和 2032 年測試產品收入趨勢分析
    • 疫苗
    • 血漿產品
    • 藥品

第 8 章：全球藥品品質控制市場規模與預測：按地區 - 2022-2032

  • 北美洲
    • 美國
    • 加拿大
  • 歐洲
    • 英國
    • 德國
    • 法國
    • 西班牙
    • 義大利
    • 歐洲其他地區
  • 亞太
    • 中國
    • 印度
    • 日本
    • 澳洲
    • 韓國
    • 亞太地區其他地區
  • 拉丁美洲
    • 巴西
    • 墨西哥
    • 拉丁美洲其他地區
  • 中東和非洲
    • 沙烏地阿拉伯
    • 南非
    • 中東和非洲其他地區

第 9 章：競爭情報

  • 重點企業SWOT分析
  • 頂級市場策略
  • 公司簡介
    • WiXi AppTec
      • 關鍵訊息
      • 概述
      • 財務（視數據可用性而定）
      • 產品概要
      • 市場策略
    • Merck KGaA
    • Thermo Fisher Scientific Inc.
    • Toxikon Corporation
    • Sartorius AG
    • REMI Group
    • Perkin Elmer
    • BioMerieux SA
    • SGS SA
    • Charles River Laboratories International Inc.

第 10 章：研究過程

  • 研究過程
    • 資料探勘
    • 分析
    • 市場預測
    • 驗證
    • 出版
  • 研究屬性
簡介目錄

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