查看购物车
  • Traditional Chinese
  • English
  • Japanese
  • Korean
封面
市场调查报告书
商品编码
1403405

到 2030 年药品无菌检测市场预测：按产品、检测类型、服务、应用、最终用户和地区进行的全球分析

Pharmaceutical Sterility Testing Market Forecasts to 2030 - Global Analysis By Product, Test Type, Service, Application, End User and By Geography
出版日期: | 出版商: Stratistics Market Research Consulting | 英文 200+ Pages | 商品交期: 2-3个工作天内

价格

根据 Stratistics MRC 的数据，2023 年全球药品无菌检测市场规模为 16.1 亿美元，预计在预测期内将以 13.4% 的复合年增长率增长，到 2030 年达到 38.8 亿美元。

药品的无菌测试是一个重要的品管过程，可确保药品和医疗产品中不存在活微生物。它在严格的无菌条件下进行，检验批次无菌性并防止可能危及患者安全的污染。此测试通常使用薄膜过滤或直接接种方法进行，符合 USP 和 EP 等监管标准。

根据2021-2022年美国联邦预算，印度科技部向DBT（生物技术部）拨款4.3亿美元，较2020-2021年预算增加25%。

成长动力：医药供应链全球化

药品供应链的全球化显着增加了原材料和製造流程的国际采购，增加了严格的无菌测试协议以确保产品安全和监管合规性的重要性。随着供应链的相互连结日益紧密，对强大的无菌检测解决方案的需求不断增加，推动了药品无菌检测市场的成长，成为在全球范围内保持药品完整性的关键要素。

成长抑制因素：时间和经济限制

由于测试过程的复杂性，药品无菌测试公司面临时间和财务限制。严格的程序对于确保产品符合监管标准至关重要。时间限制是由于需要在有限的生产计划内获得准确的结果而产生的，并影响整体效率。经济压力来自于维持无菌环境、专业设备和僱用熟练人员的高成本。因此，这方面阻碍了市场的扩大。

机会：外包检验服务

随着製药公司寻求成本效率、法规遵循和缩短时间，外包无菌检测使他们能够利用专业知识、先进技术和专用设施。这一趋势使公司能够简化业务、减轻内部测试负担并确保严格的品质标准。随着对无菌保证的日益重视，检测服务外包已成为製药公司的策略解决方案，推动市场成长和创新。

威胁：快速演化的病原体

药品的无菌检测面临快速进化的病原体的威胁，其性能优于传统的检测方法。随着病原体的进化，它们对现有灭菌方法的抵抗力更强，可能会损害药物安全。快速突变率、水平基因转移和新出现的菌株增加了未检测到污染物的风险。传统的无菌检测无法跟上这些病原体的动态特性，这可能对确保药物功效构成挑战。

COVID-19 的影响

COVID-19大流行对药品无菌检测市场产生了重大影响。对药品（包括疫苗和治疗药物）的需求增加，增加了对严格无菌测试的需求。这促使企业专注于确保其产品的安全性和有效性，市场迅速成长。此外，这场大流行凸显了在药品製造过程中保持无菌的重要性，导致人们更加重视先进的无菌测试技术和方法，以满足监管标准并应对新的医疗保健挑战。

快速微测试产业预计在预测期内规模最大

与传统方法相比，快速微测试领域由于其快速的结果预计将出现良好的成长。这些测试采用聚合酶连锁反应 (PCR) 或萤光技术等先进技术，可快速检测药品中的微生物污染。快速微量测试的实施提高了效率，减少了测试时间，确保无菌产品快速上市，并最终有助于改善药品製造流程和法规遵循。

预计无菌製药业在预测期内复合年增长率最高

由于其品质保证和长期成本降低，无菌製药行业预计在预测期内将出现最高的复合年增长率。药品的无菌测试对于确保无菌药品不含有害微生物非常重要。这个严格的製程评估产品批次是否有细菌、真菌和病毒。这个过程提高了製药公司的声誉，降低了产品召回的可能性，并最终有助于无菌药物生产的整体完整性和可靠性。

比最大的地区

预计亚太地区在预测期内将占据最大的市场占有率。中国可望在药品无菌检测领域占有重要地位。该地区的新兴国家正采取各种措施扩大国内医药市场，吸引跨国公司在本国开展业务。此外，印度对药品的高额投资使其能够製造医疗设备并进行广泛的无菌测试。此外，预算增加、生物技术研发增加以及该地区工业和创业发展等因素正在推动市场成长。

复合年增长率最高的地区

预计北美在预测期内的复合年增长率最高。该地区的製药业有大有小，检测需求多样。快速发展的技术和对创新的重视正在影响产业的无菌检测方法，带来机会和挑战。北美各地的地理和监管多样性正在进一步影响製药公司的测试实践和合规策略。此外，该地区许多主要市场相关人员的存在预计将为市场成长做出重大贡献。

免费客製化服务：

订阅此报告的客户可以利用以下免费自订选项之一：

  • 公司简介
    • 其他市场公司的综合分析（最多 3 家公司）
    • 主要企业SWOT分析（最多3家企业）
  • 区域分割
    • 根据客户兴趣对主要国家的市场估计、预测和复合年增长率（註：基于可行性检查）
  • 竞争基准化分析
    • 根据产品系列、地理分布和策略联盟对主要企业基准化分析

目录

第一章执行摘要

第二章 前言

  • 概述
  • 相关利益者
  • 调查范围
  • 调查方法
    • 资料探勘
    • 资料分析
    • 资料检验
    • 研究途径
  • 调查来源
    • 主要调查来源
    • 二次调查来源
    • 先决条件

第三章市场趋势分析

  • 促进因素
  • 抑制因素
  • 机会
  • 威胁
  • 产品分析
  • 应用分析
  • 最终用户分析
  • 新兴市场
  • 新型冠状病毒感染疾病（COVID-19）的影响

第4章波特五力分析

  • 供应商的议价能力
  • 买方议价能力
  • 替代品的威胁
  • 新进入者的威胁
  • 公司之间的竞争关係

第五章全球药品无菌检测市场：依产品

  • 用具
  • 套件和试剂

第六章全球药品无菌检测市场：依测试类型

  • 容器密闭完整性测试
  • 无菌测试
    • 薄膜过滤
    • 直接接种
  • 细菌内毒素检查
  • 萤光标记
  • 快速微量测试
    • 生物负载测试
    • ATP生物发光
    • 电阻
  • 其他测试类型

第七章全球药品无菌检测市场：依服务分类

  • 公司内部
  • 委託

第八章全球药品无菌检测市场：依应用分类

  • 无菌药物
  • 生技药品和治疗学
  • 医疗设备

第九章全球药品无菌检测市场：依最终用户分类

  • 配药房
  • 医疗设备公司
  • 製药公司
  • 其他最终用户

第十章全球药品无菌检测市场：按地区

  • 北美洲
    • 美国
    • 加拿大
    • 墨西哥
  • 欧洲
    • 德国
    • 英国
    • 义大利
    • 法国
    • 西班牙
    • 其他欧洲国家
  • 亚太地区
    • 日本
    • 中国
    • 印度
    • 澳洲
    • 纽西兰
    • 韩国
    • 其他亚太地区
  • 南美洲
    • 阿根廷
    • 巴西
    • 智利
    • 南美洲其他地区
  • 中东和非洲
    • 沙乌地阿拉伯
    • 阿拉伯聯合大公国
    • 卡达
    • 南非
    • 其他中东和非洲

第十一章 主要进展

  • 合约、伙伴关係、协作和合资企业
  • 收购和合併
  • 新产品发布
  • 业务扩展
  • 其他关键策略

第十二章 公司简介

  • Nelson Laboratories LLC
  • Laboratory Corporation of America Holding
  • Pacific BioLabs
  • Pace Analytical
  • Charles River Laboratories
  • Thermo Fisher Scientific Inc
  • STEMart
  • Boston Analytical
  • Almac Group
  • Solvias AG
  • Redberry-Rapid Microbiology
  • Rapid Micro Biosystems
  • Sartorius AG
  • Intertek
  • BioScreen Testing Services Inc.
  • WuXi AppTec
  • Microbac Laboratories
  • NSF International
  • Eurofins Scientific
Product Code: SMRC24630

According to Stratistics MRC, the Global Pharmaceutical Sterility Testing Market is accounted for $1.61 billion in 2023 and is expected to reach $3.88 billion by 2030 growing at a CAGR of 13.4% during the forecast period. Pharmaceutical sterility testing is a crucial quality control process ensuring the absence of viable microorganisms in drugs and medical products. Conducted under strict aseptic conditions, it verifies the sterility of batches, preventing contamination that could compromise patient safety. Commonly performed using membrane filtration or direct inoculation methods, this testing adheres to regulatory standards such as USP or EP.

According to the Union Budget for the years 2021 to 2022, the Indian Ministry of Science and Technology allocated US$ 430 million, a 25% increase from the budget for the years 2020 to 2021, for the DBT (Department of Biotechnology).

Market Dynamics:

Driver:

Globalization of pharmaceutical supply chains

The globalization of pharmaceutical supply chains has significantly increased international sourcing of raw materials and manufacturing processes which has heightened the importance of stringent sterility testing protocols to ensure product safety and regulatory compliance. As supply chains become more interconnected, the demand for robust sterility testing solutions has risen, driving the growth of the pharmaceutical sterility testing market as a critical component in maintaining the integrity of pharmaceutical products on a global scale.

Restraint:

Time & financial constraints

Pharmaceutical sterility testing companies face time and financial constraints due to the intricate nature of the testing process. Rigorous procedures are essential to ensure products meet regulatory standards. Time constraints arise from the need for accurate results within limited production timelines, affecting overall efficiency. Financial pressures stem from the high costs associated with maintaining sterile environments, specialized equipment, and employing skilled personnel. Thereby, this aspect impedes the market from expansion.

Opportunity:

Outsourcing of testing services

As pharmaceutical companies strive for cost efficiency, regulatory compliance, and faster time-to-market, outsourcing sterile testing allows them to leverage specialized expertise, advanced technologies, and dedicated facilities. This trend enables businesses to streamline operations, reduce in-house testing burdens, and ensure stringent quality standards. With the increasing emphasis on sterility assurance, outsourcing testing services emerges as a strategic solution for pharmaceutical companies, fostering growth and innovation in the market.

Threat:

Rapidly evolving pathogens

Pharmaceutical sterility testing faces a threat from rapidly evolving pathogens due to their ability to outpace traditional testing methodologies. As pathogens evolve, their resistance to existing sterilization methods increases, potentially compromising drug safety. Rapid mutation rates, horizontal gene transfer, and emerging strains heighten the risk of undetected contaminants. Conventional sterility tests may struggle to keep pace with the dynamic nature of these pathogens, posing challenges in ensuring the efficacy of pharmaceutical products.

COVID-19 Impact

The COVID-19 pandemic has significantly impacted the pharmaceutical sterility testing market. The increased demand for pharmaceutical products, including vaccines and therapeutics, has driven the need for rigorous sterility testing. This has led to a surge in market growth as companies focus on ensuring the safety and efficacy of their products. Additionally, the pandemic has highlighted the importance of maintaining sterility in pharmaceutical manufacturing processes, resulting in greater emphasis on advanced sterility testing technologies and methods to meet regulatory standards and address emerging healthcare challenges.

The rapid micro test segment is expected to be the largest during the forecast period

The rapid micro test segment is estimated to have a lucrative growth, due to its quicker results compared to traditional methods. These tests employ advanced technologies, such as polymerase chain reaction (PCR) or fluorescence-based techniques, enabling swift detection of microbial contamination in pharmaceutical products. The implementation of Rapid Micro Tests enhances efficiency, reduces testing time, and ensures faster release of sterile products to the market, ultimately contributing to improved pharmaceutical manufacturing processes and regulatory compliance.

The sterile drugs segment is expected to have the highest CAGR during the forecast period

The sterile drugs segment is anticipated to witness the highest CAGR growth during the forecast period, due to its quality assurance and long term cost savings. Pharmaceutical Sterility Testing is critical for sterile drugs to ensure they are free from harmful microorganisms. This rigorous process involves assessing product batches for bacterial, fungal, or viral contamination. This process enhances pharmaceutical companies' reputation, reduces the likelihood of product recalls, and ultimately contributes to the overall integrity and reliability of sterile drug manufacturing.

Region with largest share:

Asia Pacific is projected to hold the largest market share during the forecast period. China is anticipated to hold a significant rank in the pharmaceutical sterility testing sector. The region's emerging economies are taking diversed steps to expand their domestic pharmaceutical market and are enticing multinational corporations to establish operations in their nation. Additionally, India is prepared to manufacture medical devices and conduct extensive sterility testing due to its substantial pharmaceutical investment. Further, factors such as increase in budget, rise in biotechnology R&D, as well as industrial and entrepreneurship development in the region are boosting the market growth.

Region with highest CAGR:

North America is projected to have the highest CAGR over the forecast period. The region's diverse pharmaceutical landscape, encompassing large & small-scale manufacturers, contributes to varied testing needs. Rapidly evolving technologies and an emphasis on innovation present both opportunities and challenges, influencing the industry's approach to sterility testing. The geographic and regulatory diversity across North America further shapes testing methodologies and compliance strategies for pharmaceutical companies. Also, the presence of a large number of major market players in this region is expected to contribute significantly to the market growth.

Key players in the market:

Some of the key players profiled in the Pharmaceutical Sterility Testing Market include Nelson Laboratories LLC, Laboratory Corporation of America Holding, Pacific BioLabs, Pace Analytical, Charles River Laboratories, Thermo Fisher Scientific Inc, STEMart, Boston Analytical, Almac Group, Solvias AG, Redberry - Rapid Microbiology, Rapid Micro Biosystems, Sartorius AG, Intertek, BioScreen Testing Services Inc., WuXi AppTec, Microbac Laboratories, NSF International and Eurofins Scientific.

Key Developments:

In April 2023, STEMart, a U.S.-based provider of comprehensive services for all stages of medical device development, has introduced the Bioburden and Sterility Testing services for medical devices under the guidance of the ISO 11731 method. With extensive expertise in microbiology and sterility testing, STEMart can provide comprehensive services to support manufacturers in meeting regulatory goals and minimizing compliance risks.

In January 2023, Thermo Fisher Scientific, the world leader in serving science, is opening a new facility in Hangzhou, China, as part of its global effort to help companies provide therapies to patients more quickly. The site can address the needs of organizations in China, as well as those outside that country, for biologics and steriles development and manufacturing capabilities in the Asia-Pacific region.

Products Covered:

  • Instruments
  • Kits & Reagents

Test Types Covered:

  • Container Closure Integrity Testing
  • Sterility Testing
  • Bacterial Endotoxin Testing
  • Fluorescent Labeling
  • Rapid Micro Test
  • Other Test Types

Services Covered:

  • In-House
  • Outsourced

Applications Covered:

  • Sterile Drugs
  • Biologics & Therapeutics
  • Medical Devices

End Users Covered:

  • Compounding Pharmacies
  • Medical Devices Companies
  • Pharmaceutical Companies
  • Other End Users

Regions Covered:

  • North America
    • US
    • Canada
    • Mexico
  • Europe
    • Germany
    • UK
    • Italy
    • France
    • Spain
    • Rest of Europe
  • Asia Pacific
    • Japan
    • China
    • India
    • Australia
    • New Zealand
    • South Korea
    • Rest of Asia Pacific
  • South America
    • Argentina
    • Brazil
    • Chile
    • Rest of South America
  • Middle East & Africa
    • Saudi Arabia
    • UAE
    • Qatar
    • South Africa
    • Rest of Middle East & Africa

What our report offers:

  • Market share assessments for the regional and country-level segments
  • Strategic recommendations for the new entrants
  • Covers Market data for the years 2021, 2022, 2023, 2026, and 2030
  • Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
  • Strategic recommendations in key business segments based on the market estimations
  • Competitive landscaping mapping the key common trends
  • Company profiling with detailed strategies, financials, and recent developments
  • Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

  • Company Profiling
    • Comprehensive profiling of additional market players (up to 3)
    • SWOT Analysis of key players (up to 3)
  • Regional Segmentation
    • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
  • Competitive Benchmarking
    • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

  • 2.1 Abstract
  • 2.2 Stake Holders
  • 2.3 Research Scope
  • 2.4 Research Methodology
    • 2.4.1 Data Mining
    • 2.4.2 Data Analysis
    • 2.4.3 Data Validation
    • 2.4.4 Research Approach
  • 2.5 Research Sources
    • 2.5.1 Primary Research Sources
    • 2.5.2 Secondary Research Sources
    • 2.5.3 Assumptions

3 Market Trend Analysis

  • 3.1 Introduction
  • 3.2 Drivers
  • 3.3 Restraints
  • 3.4 Opportunities
  • 3.5 Threats
  • 3.6 Product Analysis
  • 3.7 Application Analysis
  • 3.8 End User Analysis
  • 3.9 Emerging Markets
  • 3.10 Impact of Covid-19

4 Porters Five Force Analysis

  • 4.1 Bargaining power of suppliers
  • 4.2 Bargaining power of buyers
  • 4.3 Threat of substitutes
  • 4.4 Threat of new entrants
  • 4.5 Competitive rivalry

5 Global Pharmaceutical Sterility Testing Market, By Product

  • 5.1 Introduction
  • 5.2 Instruments
  • 5.3 Kits & Reagents

6 Global Pharmaceutical Sterility Testing Market, By Test Type

  • 6.1 Introduction
  • 6.2 Container Closure Integrity Testing
  • 6.3 Sterility Testing
    • 6.3.1 Membrane Filtration
    • 6.3.2 Direct Inoculation
  • 6.4 Bacterial Endotoxin Testing
  • 6.5 Fluorescent Labeling
  • 6.6 Rapid Micro Test
    • 6.6.1 Bioburden Testing
    • 6.6.2 ATP Bioluminescence
    • 6.6.3 Electrical Resistance
  • 6.7 Other Test Types

7 Global Pharmaceutical Sterility Testing Market, By Service

  • 7.1 Introduction
  • 7.2 In-House
  • 7.3 Outsourced

8 Global Pharmaceutical Sterility Testing Market, By Application

  • 8.1 Introduction
  • 8.2 Sterile Drugs
  • 8.3 Biologics & Therapeutics
  • 8.4 Medical Devices

9 Global Pharmaceutical Sterility Testing Market, By End User

  • 9.1 Introduction
  • 9.2 Compounding Pharmacies
  • 9.3 Medical Devices Companies
  • 9.4 Pharmaceutical Companies
  • 9.5 Other End Users

10 Global Pharmaceutical Sterility Testing Market, By Geography

  • 10.1 Introduction
  • 10.2 North America
    • 10.2.1 US
    • 10.2.2 Canada
    • 10.2.3 Mexico
  • 10.3 Europe
    • 10.3.1 Germany
    • 10.3.2 UK
    • 10.3.3 Italy
    • 10.3.4 France
    • 10.3.5 Spain
    • 10.3.6 Rest of Europe
  • 10.4 Asia Pacific
    • 10.4.1 Japan
    • 10.4.2 China
    • 10.4.3 India
    • 10.4.4 Australia
    • 10.4.5 New Zealand
    • 10.4.6 South Korea
    • 10.4.7 Rest of Asia Pacific
  • 10.5 South America
    • 10.5.1 Argentina
    • 10.5.2 Brazil
    • 10.5.3 Chile
    • 10.5.4 Rest of South America
  • 10.6 Middle East & Africa
    • 10.6.1 Saudi Arabia
    • 10.6.2 UAE
    • 10.6.3 Qatar
    • 10.6.4 South Africa
    • 10.6.5 Rest of Middle East & Africa

11 Key Developments

  • 11.1 Agreements, Partnerships, Collaborations and Joint Ventures
  • 11.2 Acquisitions & Mergers
  • 11.3 New Product Launch
  • 11.4 Expansions
  • 11.5 Other Key Strategies

12 Company Profiling

  • 12.1 Nelson Laboratories LLC
  • 12.2 Laboratory Corporation of America Holding
  • 12.3 Pacific BioLabs
  • 12.4 Pace Analytical
  • 12.5 Charles River Laboratories
  • 12.6 Thermo Fisher Scientific Inc
  • 12.7 STEMart
  • 12.8 Boston Analytical
  • 12.9 Almac Group
  • 12.10 Solvias AG
  • 12.11 Redberry - Rapid Microbiology
  • 12.12 Rapid Micro Biosystems
  • 12.13 Sartorius AG
  • 12.14 Intertek
  • 12.15 BioScreen Testing Services Inc.
  • 12.16 WuXi AppTec
  • 12.17 Microbac Laboratories
  • 12.18 NSF International
  • 12.19 Eurofins Scientific

List of Tables

  • Table 1 Global Pharmaceutical Sterility Testing Market Outlook, By Region (2021-2030) ($MN)
  • Table 2 Global Pharmaceutical Sterility Testing Market Outlook, By Product (2021-2030) ($MN)
  • Table 3 Global Pharmaceutical Sterility Testing Market Outlook, By Instruments (2021-2030) ($MN)
  • Table 4 Global Pharmaceutical Sterility Testing Market Outlook, By Kits & Reagents (2021-2030) ($MN)
  • Table 5 Global Pharmaceutical Sterility Testing Market Outlook, By Test Type (2021-2030) ($MN)
  • Table 6 Global Pharmaceutical Sterility Testing Market Outlook, By Container Closure Integrity Testing (2021-2030) ($MN)
  • Table 7 Global Pharmaceutical Sterility Testing Market Outlook, By Sterility Testing (2021-2030) ($MN)
  • Table 8 Global Pharmaceutical Sterility Testing Market Outlook, By Membrane Filtration (2021-2030) ($MN)
  • Table 9 Global Pharmaceutical Sterility Testing Market Outlook, By Direct Inoculation (2021-2030) ($MN)
  • Table 10 Global Pharmaceutical Sterility Testing Market Outlook, By Bacterial Endotoxin Testing (2021-2030) ($MN)
  • Table 11 Global Pharmaceutical Sterility Testing Market Outlook, By Fluorescent Labeling (2021-2030) ($MN)
  • Table 12 Global Pharmaceutical Sterility Testing Market Outlook, By Rapid Micro Test (2021-2030) ($MN)
  • Table 13 Global Pharmaceutical Sterility Testing Market Outlook, By Bioburden Testing (2021-2030) ($MN)
  • Table 14 Global Pharmaceutical Sterility Testing Market Outlook, By ATP Bioluminescence (2021-2030) ($MN)
  • Table 15 Global Pharmaceutical Sterility Testing Market Outlook, By Electrical Resistance (2021-2030) ($MN)
  • Table 16 Global Pharmaceutical Sterility Testing Market Outlook, By Other Test Types (2021-2030) ($MN)
  • Table 17 Global Pharmaceutical Sterility Testing Market Outlook, By Service (2021-2030) ($MN)
  • Table 18 Global Pharmaceutical Sterility Testing Market Outlook, By In-House (2021-2030) ($MN)
  • Table 19 Global Pharmaceutical Sterility Testing Market Outlook, By Outsourced (2021-2030) ($MN)
  • Table 20 Global Pharmaceutical Sterility Testing Market Outlook, By Application (2021-2030) ($MN)
  • Table 21 Global Pharmaceutical Sterility Testing Market Outlook, By Sterile Drugs (2021-2030) ($MN)
  • Table 22 Global Pharmaceutical Sterility Testing Market Outlook, By Biologics & Therapeutics (2021-2030) ($MN)
  • Table 23 Global Pharmaceutical Sterility Testing Market Outlook, By Medical Devices (2021-2030) ($MN)
  • Table 24 Global Pharmaceutical Sterility Testing Market Outlook, By End User (2021-2030) ($MN)
  • Table 25 Global Pharmaceutical Sterility Testing Market Outlook, By Compounding Pharmacies (2021-2030) ($MN)
  • Table 26 Global Pharmaceutical Sterility Testing Market Outlook, By Medical Devices Companies (2021-2030) ($MN)
  • Table 27 Global Pharmaceutical Sterility Testing Market Outlook, By Pharmaceutical Companies (2021-2030) ($MN)
  • Table 28 Global Pharmaceutical Sterility Testing Market Outlook, By Other End Users (2021-2030) ($MN)

Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.