세계의 의약품 무균 검사 시장 : 시장 규모, 점유율 및 동향 분석 - 유형별, 제품 유형별, 샘플별, 최종 용도별, 검사 유형별, 지역별 전망 및 예측(2023-2030년)
Global Pharmaceutical Sterility Testing Market Size, Share & Trends Analysis Report By Type, By Product Type, By Sample, By End-use, By Test Type, . By Regional Outlook and Forecast, 2023 - 2030
상품코드:1461690
리서치사:KBV Research
발행일:2024년 03월
페이지 정보:영문 314 Pages
라이선스 & 가격 (부가세 별도)
한글목차
세계 의약품 무균 검사 시장 규모는 예측 기간 동안 CAGR 10.7%로 성장하여 2030년까지 31억 달러에 달할 것으로 예상됩니다.
또한, 환자의 안전은 헬스케어의 최우선 과제이며, 의약품의 무균성이 조금이라도 손상되면 환자에게 심각한 위험을 초래할 수 있습니다. 오염된 의약품이나 의료기기로 인한 감염은 건강 상태의 악화와 의료 비용 증가로 이어질 수 있습니다. 따라서 이러한 요인들은 향후 몇 년동안 의약품에 대한 수요를 증가시킬 것입니다.
그러나 미국 약전(USP), 유럽 약전(EP) 등 규제 기관은 의약품의 안전성과 유효성을 보장하기 위해 무균 검사에 대한 엄격한 가이드라인을 시행하고 있으며, 이러한 요인으로 인해 의약품 시장 수요가 감소할 수 있습니다.
또한, 이러한 제품에 대한 수요 증가로 인해 안전성과 유효성을 보장하기 위한 엄격한 무균 검사 절차의 필요성이 강조되었습니다. 전염병으로 인해 백신을 포함한 의약품의 개발, 검사 및 승인 일정을 앞당겨야 했습니다. 따라서 코로나19는 의약품 시장에 긍정적인 영향을 미쳤습니다.
목차
제1장 시장 범위와 조사 방법
시장의 정의
목적
시장 범위
세분화
조사 방법
제2장 시장 요람
제3장 시장 개요
서론
개요
시장 구성과 시나리오
시장에 영향을 미치는 주요 요인
시장 성장 촉진요인
시장 성장 억제요인
시장 기회
시장이 해결해야 할 과제
Porter의 Five Forces 분석
제4장 세계 시장 : 유형별
세계의 아웃소싱 시장 : 지역별
세계의 인하우스 시장 : 지역별
제5장 세계 시장 : 제품 유형별
세계의 키트 및 시약 시장 : 지역별
세계의 기기 시장 : 지역별
세계의 서비스 시장 : 지역별
제6장 세계 시장 : 샘플별
세계의 의약품 시장 : 지역별
세계의 의료기기 시장 : 지역별
세계의 바이오의약품 시장 : 지역별
제7장 세계 시장 : 최종 용도별
세계의 제약 기업 시장 : 지역별
세계의 의료기기 기업 시장 : 지역별
세계의 조제 약국 시장 : 지역별
세계의 기타 시장 : 지역별
제8장 세계 시장 : 검사 유형별
세계의 바이오바덴 검사 시장 : 지역별
세계의 무균 검사 시장 : 지역별
세계의 세균내 독소 검사 시장 : 지역별
제9장 세계 시장 : 지역별
북미
북미 시장 : 국가별
미국
캐나다
멕시코
기타 북미
유럽
유럽 시장 : 국가별
독일
영국
프랑스
러시아
스페인
이탈리아
기타 유럽
아시아태평양
아시아태평양 시장 : 국가별
중국
일본
인도
한국
싱가포르
말레이시아
기타 아시아태평양
라틴아메리카/중동 및 아프리카
라틴아메리카/중동 및 아프리카 시장 : 국가별
브라질
아르헨티나
아랍에미리트(UAE)
사우디아라비아
남아프리카공화국
나이지리아
기타 라틴아메리카/중동 및 아프리카
제10장 기업 개요
Steris PLC
Charles River Laboratories International, Inc
Thermo Fisher Scientific, Inc
SGS SA
Sartorius AG
Sotera Health Company
Pacific Biolabs, Inc
Laboratory Corporation of America Holdings
Almac group
Pace Analytical Services, LLC
제11장 의약품 무균 검사 시장을 위한 성공 필수 조건
LSH
영문 목차
영문목차
The Global Pharmaceutical Sterility Testing Market size is expected to reach $3.1 billion by 2030, rising at a market growth of 10.7% CAGR during the forecast period.
Advances in medical technology have led to the development of increasingly complex medical devices. Consequently, the medical device companies by end-use would generate approximately 21.6% share in the market by 2030. The complexity of these devices may require more sophisticated sterility testing methodologies to ensure their safety and efficacy. This complexity can drive the demand for specialized sterility testing services tailored to the unique characteristics of medical devices.
Health authorities, including the FDA and EMA, maintain a global pharmaceutical quality and safety perspective. The regulatory frameworks established by these bodies set the benchmark for sterility testing requirements. As a result, pharmaceutical manufacturers must align their processes with these standards to navigate the complex landscape of international regulatory compliance. Hence, owing to these factors, there will be increased demand for pharmaceutical sterility testing.
Additionally, Patient safety is a top priority in healthcare, and any compromise in the sterility of pharmaceutical products can pose serious risks to patients. Infections resulting from contaminated drugs or medical devices can lead to adverse health outcomes and increased healthcare costs. Thus, these factors will fuel the demand for pharmaceuticals in the upcoming years.
However, Regulatory bodies, such as the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP), enforce stringent guidelines for sterility testing to ensure the safety and efficacy of pharmaceutical products. Hence, these factors can lead to reduced demand in the pharmaceutical market.
Furthermore, the increased demand for these products emphasized the need for rigorous sterility testing procedures to guarantee their safety and effectiveness. The pandemic necessitated expedited timelines for developing, testing, and approving pharmaceutical products, including vaccines. Hence, the COVID-19 pandemic positively impacted the pharmaceutical market.
By Type Analysis
Based on type, the market is segmented into in-house and outsourcing. In 2022, the outsourcing segment held 59% revenue share in the market. Outsourcing sterility testing offers cost-efficiency benefits. Establishing and maintaining an in-house sterility testing facility involves substantial capital investment, ongoing operational costs, and the need for skilled personnel. Hence, these factors will help in the expansion of the segment.
By Product Type Analysis
On the basis of product, the market is divided into kits & reagents, instruments, and services. In 2022, the instruments segment witnessed a 25% revenue share in the market. Technological advances have led to the development of sophisticated instruments that offer improved capabilities for sterility testing. Automated systems, robotics, and advanced analytical instruments contribute to the overall efficiency of testing processes, allowing for faster and more accurate detection of microbial contaminants. Therefore, these factors can drive the expansion of the segment.
By Sample Analysis
Based on sample, the market is segmented into pharmaceuticals, medical devices, and biopharmaceuticals. The pharmaceuticals segment held the 46% revenue share in the market in 2022. Many pharmaceutical companies increasingly outsource manufacturing and testing activities to contract service providers. This trend can contribute to the growth of the market, with contract testing laboratories playing a key role in providing sterility testing services. Therefore, these factors can lead to enhanced demand in the segment.
By End Use Analysis
On the basis of end-use, the market is divided into compounding pharmacies, medical device companies, pharmaceutical companies, and others. The compounding pharmacies segment recorded an 11% revenue share in the market in 2022. Compounding pharmacies customize medications to meet the unique needs of individual patients. They are crucial in providing tailored solutions for patients requiring specific formulations, dosages, or delivery methods not readily available in commercially manufactured medications. Hence, these factors will pose lucrative growth prospects for the segment.
By Test Type Analysis
Based on test type, the market is divided into sterility testing, bioburden Testing, and bacterial endotoxin testing. In 2022, the bioburden testing segment recorded 42.5% revenue share in the market. Bioburden testing plays a key role in meeting regulatory requirements and ensuring compliance with quality standards. Regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have strict guidelines for controlling microbial contamination in pharmaceutical products. Thus, these factors can assist in the expansion of the segment.
By Regional Analysis
By region, the market is segmented into North America, Europe, Asia Pacific, and LAMEA. In 2022, the Europe segment acquired a 26.17% revenue share in the market. Europe has a well-established pharmaceutical industry with a diverse range of products. The continuous growth of the pharmaceutical sector, including the development of new drugs and biologics, contributes to the demand for sterility testing to ensure product safety and efficacy. Therefore, these factors will pose lucrative growth prospects for the segment.
Recent Strategies Deployed in the Market
Feb-2024: Thermo Fisher Scientific, Inc. expanded its footprints in Asia-Pacific with the inauguration of a sterile drug facility in Singapore. Through this expansion, Thermo Fisher will facilitate end-to-end vaccine manufacturing in Singapore, thereby fortifying its vaccine supply chain resilience and enhancing future pandemic preparedness for the region.
Feb-2024: Charles River Laboratories International, Inc. launched the Endosafe Trillium rCR cartridge, an animal-free testing solution, to expand its robust bacterial endotoxin testing (BET) portfolio. The endosafe trillium rCR will enhance testing efficiency and accelerate manufacturing.
May-2023: Charles River Laboratories International, Inc. unveiled Accugenix Next Generation Sequencing (Accugenix NGS) for bacterial and fungal identification. Accugenix NGS will enable the company to deliver swift and precise results while fostering stronger technical collaboration with biotech and pharma customers.
Mar-2023: Pace Analytical Services, LLC, completed the acquisition of Alpha Analytical, LLC, a full-service environmental laboratory services company. Through this acquisition, Pace will broaden its presence and bring essential services closer to businesses and communities in the Northeastern United States.
Sep-2019: Charles River Laboratories International, Inc. expanded its microbial solutions suite by launching the EndoScan-V software platform and the Celsis automated detection solution. EndoScan-V is a validation software for detecting and measuring endotoxins that generates and reports quantitative test data. Celsis will provide automated sterility results within 6 days, enabling manufacturers to promptly confirm the presence or absence of microbial contamination.
List of Key Companies Profiled
Steris PLC
Charles River Laboratories International, Inc.
Thermo Fisher Scientific, Inc.
SGS S.A.
Sartorius AG
Sotera Health Company
Pacific Biolabs, Inc.
Laboratory Corporation of America Holdings
Almac Group
Pace Analytical Services, LLC
Global Pharmaceutical Sterility Testing Market Report Segmentation
By Type
Outsourcing
In-House
By Product Type
Kits & Reagents
Instruments
Services
By Sample
Pharmaceuticals
Medical Devices
Biopharmaceuticals
By End Use
Pharmaceutical Companies
Medical Device Companies
Compounding Pharmacies
Others
By Test Type
Bioburden Testing
Sterility Testing
Bacterial Endotoxin Testing
By Geography
North America
US
Canada
Mexico
Rest of North America
Europe
Germany
UK
France
Russia
Spain
Italy
Rest of Europe
Asia Pacific
China
Japan
India
South Korea
Singapore
Malaysia
Rest of Asia Pacific
LAMEA
Brazil
Argentina
UAE
Saudi Arabia
South Africa
Nigeria
Rest of LAMEA
Table of Contents
Chapter 1.Market Scope & Methodology
1.1Market Definition
1.2Objectives
1.3Market Scope
1.4Segmentation
1.4.1Global Pharmaceutical Sterility Testing Market, by Type
1.4.2Global Pharmaceutical Sterility Testing Market, by Product Type
1.4.3Global Pharmaceutical Sterility Testing Market, by Sample
1.4.4Global Pharmaceutical Sterility Testing Market, by End Use
1.4.5Global Pharmaceutical Sterility Testing Market, by Test Type
1.4.6Global Pharmaceutical Sterility Testing Market, by Geography
1.5Methodology for the research
Chapter 2.Market at a Glance
2.1Key Highlights
Chapter 3.Market Overview
3.1Introduction
3.1.1Overview
3.1.1.1Market Composition and Scenario
3.2Key Factors Impacting the Market
3.2.1Market Drivers
3.2.2Market Restraints
3.2.3Market Opportunities
3.2.4Market Challenges
3.3Porter's Five Forces Analysis
Chapter 4.Global Pharmaceutical Sterility Testing Market by Type
4.1Global Outsourcing Market by Region
4.2Global In-House Market by Region
Chapter 5.Global Pharmaceutical Sterility Testing Market by Product Type
5.1Global Kits & Reagents Market by Region
5.2Global Instruments Market by Region
5.3Global Services Market by Region
Chapter 6.Global Pharmaceutical Sterility Testing Market by Sample
6.1Global Pharmaceuticals Market by Region
6.2Global Medical Devices Market by Region
6.3Global Biopharmaceuticals Market by Region
Chapter 7.Global Pharmaceutical Sterility Testing Market by End-use
7.1Global Pharmaceutical Companies Market by Region
7.2Global Medical Device Companies Market by Region
7.3Global Compounding Pharmacies Market by Region
7.4Global Others Market by Region
Chapter 8.Global Pharmaceutical Sterility Testing Market by Test Type
8.1Global Bioburden Testing Market by Region
8.2Global Sterility Testing Market by Region
8.3Global Bacterial Endotoxin Testing Market by Region
Chapter 9.Global Pharmaceutical Sterility Testing Market by Region
9.1North America Pharmaceutical Sterility Testing Market
9.1.1North America Pharmaceutical Sterility Testing Market by Type
9.1.1.1North America Outsourcing Market by Region
9.1.1.2North America In-House Market by Region
9.1.2North America Pharmaceutical Sterility Testing Market by Product Type
9.1.2.1North America Kits & Reagents Market by Country
9.1.2.2North America Instruments Market by Country
9.1.2.3North America Services Market by Country
9.1.3North America Pharmaceutical Sterility Testing Market by Sample
9.1.3.1North America Pharmaceuticals Market by Country
9.1.3.2North America Medical Devices Market by Country
9.1.3.3North America Biopharmaceuticals Market by Country
9.1.4North America Pharmaceutical Sterility Testing Market by End-use
9.1.4.1North America Pharmaceutical Companies Market by Country
9.1.4.2North America Medical Device Companies Market by Country
9.1.4.3North America Compounding Pharmacies Market by Country
9.1.4.4North America Others Market by Country
9.1.5North America Pharmaceutical Sterility Testing Market by Test Type
9.1.5.1North America Bioburden Testing Market by Country
9.1.5.2North America Sterility Testing Market by Country
9.1.5.3North America Bacterial Endotoxin Testing Market by Country
9.1.6North America Pharmaceutical Sterility Testing Market by Country
9.1.6.1US Pharmaceutical Sterility Testing Market
9.1.6.1.1US Pharmaceutical Sterility Testing Market by Type
9.1.6.1.2US Pharmaceutical Sterility Testing Market by Product Type
9.1.6.1.3US Pharmaceutical Sterility Testing Market by Sample
9.1.6.1.4US Pharmaceutical Sterility Testing Market by End-use
9.1.6.1.5US Pharmaceutical Sterility Testing Market by Test Type
