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市场调查报告书
商品编码
1525320

全球药品品质控制市场规模研究，依产品、分析类型、测试产品及区域预测 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个工作天内

价格
简介目录

2023年全球药品品质管制市场价值约47.1亿美元，预计在2024-2032年预测期内将以超过12.21%的健康成长率成长。药品製造成本的上升以及遵守严格监管要求的需求日益增加正在推动市场的成长。在製药业，製造费用占公司总成本的很大一部分，而新药的开发成本持续上升，将实验室构思成功商业化所需的投资预计约为20亿美元。此外，为了确保消费者的健康和安全，製药公司受到严格监管，因此必须遵守众多品质标准。中小型製药企业特别注重监管合规性，以生产高品质的产品并保持竞争力。

推动药品品质控制市场的主要因素包括获得认可的临床实验室数量的增加、对第三方品质控制的接受程度不断提高以及对外部品质评估援助的偏好不断增加。全球各种疾病盛行率的激增导致实验室检测数量增加，促使公共和私营部门扩大实验室数量。临床实验室需要获得监管组织的认可才能进行诊断测试，根据既定标准评估其能力和品质体系，从而推动市场成长。此外，美国食品药物管理局 (FDA) 和国际标准化组织 (ISO) 等监管机构强制执行严格的製造实践，进一步推动了对先进品质控制系统的需求。

全球药品品质控制市场研究考量的关键区域包括北美、欧洲、亚太地区、拉丁美洲以及中东和非洲。 2023年，北美凭藉其先进的技术基础设施、严格的监管标准以及大量的研发投资而占据市场主导地位。该地区强大的医疗保健系统和大型製药公司的存在推动了尖端品质控制措施的采用。药品安全性和有效性的高标准，以及对创新和合规性的关注，有助于北美的领先地位。此外，先进分析技术的整合和对品质保证实践的高度重视进一步增强了其作为全球药品品质控制市场关键参与者的地位。在製药业研发的大量投资的推动下，欧洲拥有健康的市场份额。此外，由于製药业务的扩张，预计亚太地区将实现最快的成长，特别是在中国和印度等国家。

目录

第 1 章：全球药品品质管制市场执行摘要

  • 全球药品品质管制市场规模及预测（2022-2032）
  • 区域概要
  • 分部摘要
    • 按产品分类
    • 按分析类型
    • 按测试产品
  • 主要趋势
  • 经济衰退的影响
  • 分析师推荐与结论

第 2 章：全球药品品质管制市场定义与研究假设

  • 研究目的
  • 市场定义
  • 研究假设
    • 包含与排除
    • 限制
    • 供给侧分析
      • 可用性
      • 基础设施
      • 监管环境
      • 市场竞争
      • 经济可行性（消费者的角度）
    • 需求面分析
      • 监理框架
      • 技术进步
      • 环境考虑
      • 消费者意识和接受度
  • 估算方法
  • 研究考虑的年份
  • 货币兑换率

第 3 章：全球药品品质管制市场动态

  • 市场驱动因素
    • 药品生产成本增加
    • 合规性需求
  • 市场挑战
    • 品质控制系统成本高
    • 监理要求的复杂性
  • 市场机会
    • 新兴市场製药业的扩张
    • 品质控制系统的技术进步

第 4 章：全球药品品质控制市场产业分析

  • 波特的五力模型
    • 供应商的议价能力
    • 买家的议价能力
    • 新进入者的威胁
    • 替代品的威胁
    • 竞争竞争
    • 波特五力模型的未来方法
    • 波特的五力影响分析
  • PESTEL分析
    • 政治的
    • 经济
    • 社会的
    • 技术性
    • 环境的
    • 合法的
  • 顶级投资机会
  • 最佳制胜策略
  • 颠覆性趋势
  • 产业专家视角
  • 分析师推荐与结论

第 5 章：全球药品品质控制市场规模与预测：依产品分类 - 2022-2032

  • 细分仪表板
  • 全球药品品质控制市场：2022 年和 2032 年产品收入趋势分析
    • 耗材
    • 仪器
    • 服务

第 6 章：全球药品品质控制市场规模与预测：按分析类型 - 2022-2032

  • 细分仪表板
  • 全球药品品质控制市场：分析类型收入趋势分析，2022 年和 2032 年
    • 无菌检测
    • 生物负载测试
    • 内毒素检测
    • 稳定性测试
    • 可萃取和可浸出测试
    • 原料检测
    • 其他的

第 7 章：全球药品品质控制市场规模与预测：按测试产品分类 - 2022-2032

  • 细分仪表板
  • 全球药品品质控制市场：2022 年和 2032 年测试产品收入趋势分析
    • 疫苗
    • 血浆产品
    • 药品

第 8 章：全球药品品质控制市场规模与预测：按地区 - 2022-2032

  • 北美洲
    • 我们
    • 加拿大
  • 欧洲
    • 英国
    • 德国
    • 法国
    • 西班牙
    • 义大利
    • 欧洲其他地区
  • 亚太
    • 中国
    • 印度
    • 日本
    • 澳洲
    • 韩国
    • 亚太地区其他地区
  • 拉丁美洲
    • 巴西
    • 墨西哥
    • 拉丁美洲其他地区
  • 中东和非洲
    • 沙乌地阿拉伯
    • 南非
    • 中东和非洲其他地区

第 9 章：竞争情报

  • 重点企业SWOT分析
  • 顶级市场策略
  • 公司简介
    • WiXi AppTec
      • 关键讯息
      • 概述
      • 财务（视数据可用性而定）
      • 产品概要
      • 市场策略
    • 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：研究过程

  • 研究过程
    • 资料探勘
    • 分析
    • 市场预测
    • 验证
    • 出版
  • 研究属性
简介目录

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