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의약품 무균성 시험 시장 규모, 점유율, 성장 분석 : 유형별, 시험 제품별, 시험 유형별, 샘플별, 최종 용도별, 지역별 - 산업 예측(2025-2032년)
Pharmaceutical Sterility Testing Market Size, Share, and Growth Analysis, By Type (In-House, Outsourcing), By Test Product (Kits and Reagents, Instruments), By Testing Type, By Sample, By End Use, By Region - Industry Forecast 2025-2032
상품코드 : 1673613
리서치사 : SkyQuest
발행일 : 2025년 03월
페이지 정보 : 영문 157 Pages
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한글목차

세계의 의약품 무균성 시험 시장 규모는 2023년에 22억 달러로 평가되며, 2024년 24억 8,000만 달러에서 2032년에는 63억 5,000만 달러로 성장하며, 예측 기간(2025-2032년)의 CAGR은 12.5%로 성장할 전망입니다.

세계의 의약품 무균성 시험 시장은 엄격한 규제 요건, 고품질 의약품에 대한 수요 증가, 의약품의 안전성과 유효성에 대한 높은 관심에 힘입어 강력한 성장세를 보이고 있습니다. 미국 FDA 및 EMA와 같은 규제기관은 의약품에 유해한 미생물 오염이 없는지 확인하기 위해 무균 시험을 의무화하여 환자의 건강을 보호하고 있습니다. 그러나 시험 절차 및 의약품 제제의 복잡성에 따른 높은 비용으로 인해 시장은 어려움에 직면해 있습니다. 그럼에도 불구하고 많은 기업이 무균 시험 아웃소싱을 위해 시험 위탁 기관을 이용하고 전문적인 전문 지식과 리소스의 혜택을 누리고 있으므로 기회가 생기고 있습니다. 또한 맞춤형 의료 및 생물제제에 대한 수요 증가는 이 필수적인 시장의 성장을 더욱 촉진할 것으로 보입니다.

목차

서론

조사 방법

개요

시장 역학과 전망

주요 시장 인사이트

의약품 무균성 시험 시장 규모 : 유형별 & CAGR(2025-2032)

의약품 무균성 시험 시장 규모 : 시험 제품별 & CAGR(2025-2032)

의약품 무균성 시험 시장 규모 : 시험 유형별 & CAGR(2025-2032)

의약품 무균성 시험 시장 규모 : 샘플 & CAGR(2025-2032)

의약품 무균성 시험 시장 규모 : 최종 용도별 & CAGR(2025-2032)

의약품 무균성 시험 시장 규모 : 지역별 & CAGR(2025-2032)

경쟁 정보

주요 기업 개요

결론과 제안

KSA
영문 목차

영문목차

Global Pharmaceutical Sterility Testing Market size was valued at USD 2.2 billion in 2023 and is poised to grow from USD 2.48 billion in 2024 to USD 6.35 billion by 2032, growing at a CAGR of 12.5% during the forecast period (2025-2032).

The global pharmaceutical sterility testing market is experiencing robust growth, propelled by stringent regulatory requirements, heightened demand for high-quality pharmaceutical products, and a strong focus on drug safety and efficacy. Regulatory bodies like the US FDA and EMA mandate sterility testing to ensure that medications are free from harmful microbial contamination, thus safeguarding patient health. However, the market faces challenges due to the high costs associated with testing procedures and the increasing complexity of pharmaceutical formulations. Nevertheless, opportunities are emerging as many companies turn to contract testing organizations for outsourcing sterility testing, benefiting from specialized expertise and resources. Additionally, the rising demand for personalized medicine and biologics is poised to further drive growth in this essential market.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Pharmaceutical Sterility Testing market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Pharmaceutical Sterility Testing Market Segments Analysis

Global Pharmaceutical Sterility Testing Market is segmented by Type, Test Product, Testing Type, Sample, End Use and region. Based on Type, the market is segmented into In-House and Outsourcing. Based on Test Product, the market is segmented into Kits and Reagents, Instruments and Services. Based on Testing Type, the market is segmented into Sterility Testing, Bioburden Testing, Bacterial Endotoxin Testing and Rapid Microbial Method. Based on Sample, the market is segmented into Pharmaceuticals, Medical Devices and Biopharmaceuticals. Based on End Use, the market is segmented into Compounding Pharmacies, Medical Device Companies, Pharmaceutical Companies and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Pharmaceutical Sterility Testing Market

The global pharmaceutical sterility testing market is being significantly propelled by the rising demand for biologics and biosimilar drugs, which have proven effective in managing severe health conditions, including cancer, neurological disorders, and various infectious diseases. As the need for these innovative therapies grows, so does the necessity for rigorous pharmaceutical sterility testing to guarantee the safety and efficacy of such products. The recent approval of multiple biosimilars, including Trastuzumab, Rituximab, and Adalimumab, has further enhanced the market growth, reflecting a broader industry trend towards ensuring high-quality and safe therapeutic options for patients worldwide.

Restraints in the Global Pharmaceutical Sterility Testing Market

The Global Pharmaceutical Sterility Testing market faces a notable restraint due to the high costs associated with sterility testing services, which can create significant challenges for a wide range of customers, particularly in emerging markets or resource-limited environments. Small and medium-sized pharmaceutical and medical device companies often struggle with the necessary infrastructure to perform reliable sterility testing in-house. As a result, these companies are more inclined to outsource such testing services to ensure compliance with FDA regulations, further highlighting the financial constraints that can hinder their ability to utilize essential sterility testing services effectively.

Market Trends of the Global Pharmaceutical Sterility Testing Market

The Global Pharmaceutical Sterility Testing market is experiencing a notable shift toward the adoption of rapid microbial detection technologies, driven by the industry's need for efficiency and compliance. These advanced technologies significantly reduce testing timelines, enabling faster results while ensuring the sterility of pharmaceutical products. As regulatory bodies emphasize stringent quality control measures, manufacturers are increasingly investing in rapid testing solutions to streamline operations and maintain competitiveness. This trend is projected to continue in the coming years, with the market expanding as companies prioritize innovation to enhance their sterility testing processes, thereby meeting the evolving demands of the pharmaceutical landscape.

Table of Contents

Introduction

Research Methodology

Executive Summary

Market Dynamics & Outlook

Key Market Insights

Global Pharmaceutical Sterility Testing Market Size by Type & CAGR (2025-2032)

Global Pharmaceutical Sterility Testing Market Size by Test Product & CAGR (2025-2032)

Global Pharmaceutical Sterility Testing Market Size by Testing Type & CAGR (2025-2032)

Global Pharmaceutical Sterility Testing Market Size by Sample & CAGR (2025-2032)

Global Pharmaceutical Sterility Testing Market Size by End Use & CAGR (2025-2032)

Global Pharmaceutical Sterility Testing Market Size & CAGR (2025-2032)

Competitive Intelligence

Key Company Profiles

Conclusion & Recommendations

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