용기 완전성 시험 시장 : 업계 동향과 세계 예측 - 검사 대상 용기 유형별, 검사 대상 용기 재료 유형별, 주요 지역별
Container Closure Integrity Testing Market: Industry Trends and Global Forecasts - Distribution by Type of Container Tested, Type of Container Material Tested and Key Geographical Regions
상품코드:1762545
리서치사:Roots Analysis
발행일:2025년 07월
페이지 정보:영문 212 Pages
라이선스 & 가격 (부가세 별도)
한글목차
용기 완전성 시험 시장 : 개요
세계의 용기 완전성 시험 시장 규모는 2035년까지의 예측 기간 중 7%의 CAGR로 확대하며, 현재 2억 3,600만 달러에서 2035년까지 5억 5,800만 달러로 성장할 것으로 예측됩니다.
시장 규모 및 기회 분석은 다음과 같은 매개 변수로 구분됩니다.
검사 대상 용기 유형
바이알
주사기
카트리지
검사 대상 용기 재질 유형
유리
플라스틱
주요 지역
북미
유럽
아시아태평양
라틴아메리카
중동 및 북아프리카
용기 무결성 테스트 시장 : 성장과 동향
용기 무결성 테스트는 잠재적 오염 물질에 대한 무균 장벽을 유지하는 데 중점을 두고 의약품을 포장하는 과정을 말합니다. 환자의 건강과 안전을 고려할 때, 의약품은 미생물 오염이 없어야 하며, 수명주기 동안 안전하게 사용할 수 있어야 합니다. 따라서 제품의 무균성과 안정성을 보장하기 위해 여러 가지 품질 검사가 이루어집니다. 품질 보증이 필요한 단계 중 하나는 의약품의 2차 포장입니다. 포장에 결함이 있으면 의약품이 열화되거나 불안정해져 치료가 제대로 이루어지지 않거나 환자에게 해를 끼칠 수 있는 등 심각한 결과를 초래할 수 있기 때문입니다. 실제로, 용기 폐쇄 시스템의 포장에 약간의 결함이 있어도 의약품의 무균성과 안정성에 악영향을 미치고 반응성 가스, 습도, 미생물의 침입으로 인한 오염을 유발할 수 있습니다. 따라서 의약품의 안전성을 보장하고 위험 가능성을 방지하기 위해 용기 무결성 시험을 실시합니다. 또한 제조부터 사용까지 의약품의 품질이 유지되도록 보장합니다. 실제로 이 기술을 사용하면 미크론 단위의 결함을 감지할 수 있으며, 제품 회수 사례를 최소화할 수 있습니다.
몇 가지 장점에도 불구하고 집중적인 전문 지식의 부족, 공간적 제약, 장비 설치에 대한 막대한 자본 투자는 제조 및 포장 기업에게 몇 가지 도전이 되고 있습니다. 따라서 이 분야의 일부 기업은 서비스 프로바이더에 도움을 요청하고 있습니다. 이는 신규 진출기업 및 기존 이해관계자들에게 서비스를 확장할 수 있는 좋은 기회를 창출하고 있습니다.
용기 무결성 테스트 시장 : 주요 인사이트
이 보고서는 용기 무결성 테스트 시장의 현황을 조사하고 업계의 잠재적인 성장 기회를 파악합니다. 주요 조사 결과는 다음과 같습니다.
현재 40개 이상의 서비스 프로바이더가 전 세계에서 용기 무결성 테스트 서비스를 제공합니다.
시장 상황의 특징으로, 용기 무결성 시험에는 신규 진출기업과 기존 기업 모두 존재합니다.
진출기업은 다양한 지역에 용기 무결성 테스트 시설을 설치하고 있으며, 이러한 시설을 결합하여 분산된 서비스 네트워크를 제공합니다.
경쟁 우위를 구축하기 위해, 진출기업은 신뢰할 수 있는 결과를 제공하는 첨단 기술을 통합하여 서비스 포트폴리오를 강화하고 있습니다.
용기 무결성 테스트용으로 개발된 장비는 85개 이상이며, 대부분 임상 및 상업용 규모에 대응하고 있습니다.
신뢰성 높고 정밀한 시험에 대한 요구가 높아짐에 따라 진화하는 시험 벤치마크에 부합하는 다양한 첨단 기술이 개발되고 있습니다.
장비의 상대적 경쟁력은 동종업계 그룹별로 다릅니다. 이는 제공되는 기능, 사용되는 분석 방법, 테스트되는 용기의 유형 등 여러 가지 매개변수에 따라 달라집니다.
용기 마개 무결성 테스트 서비스에 대한 수요는 향후 안정적인 속도로 성장할 것으로 예상되며, 아시아태평양이 전체 수요의 상당 부분을 차지할 것으로 보입니다.
시장은 향후 10년간 CAGR 7%를 보일 것으로 예측되며, 그 기회는 다양한 유형의 용기 폐쇄 시스템별, 용기 재료별, 지역별로 잘 분산될 것으로 보입니다.
용기 마개 무결성 검사 시장 : 주요 부문
검사 대상 용기 유형에 따라 시장은 바이알, 주사기, 카트리지로 구분됩니다. 현재 바이알이 제약 산업에서 가장 일반적으로 사용되는 용기 유형이기 때문에 바이알 부문이 전 세계 용기 무결성 테스트 시장에서 가장 큰 점유율을 차지하고 있습니다. 이러한 추세는 향후 수년간 변하지 않을 것으로 예측됩니다.
검사 대상 용기 재료 유형에 따라 시장은 유리와 플라스틱으로 구분됩니다. 현재 유리계는 화학적 안정성이 높고 품질 등급이 규제 당국에 의해 인정받고 있으며, 전 세계 용기 무결성 검사 시장에서 가장 높은 비중을 차지하고 있습니다.
주요 지역별로 시장은 북미, 유럽, 아시아태평양, 라틴아메리카, 중동 및 북아프리카로 구분됩니다. 현재 아시아태평양은 폐쇄 무결성 테스트 시장에서 가장 큰 매출 점유율을 차지하고 있습니다. 이는 이 지역의 제약 산업이 성장하고 의약품 생산이 증가하고 있기 때문입니다. 또한 라틴아메리카 시장은 향후 더 높은 CAGR로 성장할 가능성이 높습니다.
As per Roots Analysis, the global container closure integrity testing market is estimated to grow from USD 236 million in the current year to USD 558 million by 2035, at a CAGR of 7% during the forecast period, till 2035.
The market sizing and opportunity analysis has been segmented across the following parameters:
Type of Container Tested
Vials
Syringes
Cartridges
Type of Container Material Tested
Glass
Plastic
Key Geographical Regions
North America
Europe
Asia Pacific
Latin America
Middle East and North Africa
CONTAINER CLOSURE INTEGRITY TESTING MARKET: GROWTH AND TRENDS
Container closure integrity testing refers to the process of packaging a drug product while focusing on maintaining the sterile barrier against potential contaminants. Considering patients' health and safety, the drug products are expected to be free from microbial contamination and safe for use throughout its life cycle. Therefore, several quality checks are performed in order to ensure the product's sterility and stability. One of the stages that require quality assurance is secondary packaging of the drug product, as compromised packaging could have serious consequences, such as drugs may degrade or become unstable, leading to ineffective treatments and potential harm to patients. In fact, even minor defects in the packaging of container closure system could adversely affect the sterility and stability of the drug, allowing contamination via reactive gases, humidity and microbial ingress. Thus, to ensure the safety of drug and prevent any chance of risk, container closure integrity testing is performed. It also ensures that the quality of a drug product is maintained from manufacturing to its use. In fact, by using this technique, detection of micron defects is possible which facilitates minimum cases of product recalls.
Despite several advantages, lack of focused expertise, spatial limitation and huge capital investment in the installation of equipment poses a few challenges for the manufacturing and packaging companies. Therefore, several companies in this area are seeking assistance from service providers. This has created lucrative opportunities for upcoming and existing stakeholders to expand their offerings.
The report delves into the current state of the container closure integrity testing market and identifies potential growth opportunities within industry. Some key findings from the report include:
Presently, over 40 service providers provide container closure integrity testing services across the globe; majority of the service providers use deterministic methods for testing purposes.
The market landscape features the presence of both new entrants and well-established players for testing integrity of container closure systems.
Players have established their container closure integrity testing facilities in various geographical locations; these facilities, combined, offer a well distributed services network.
In pursuit of building a competitive edge, players are enhancing their service portfolio by integrating advanced technologies that offer reliable results.
Over 85 pieces of equipment have been developed for container closure integrity testing; majority of the equipment is designed for both clinical / commercial scale operations.
Given the increasing demand for reliable and precise testing, various advanced techniques have been developed to comply to the evolving testing benchmarks.
The relative competitiveness of equipment varies across different peer groups; this is driven by several parameters, such as features offered, the analytical methods used, and type of container tested.
The demand for container closure integrity testing services is expected to grow at a steady pace in the foreseen future; Asia-Pacific will drive a significant proportion of the overall demand.
The market is expected to grow at a CAGR of 7% in the coming decade; the opportunity is likely to be well distributed across various types of container closure systems, container materials and geographical regions.
Vials Occupy the Largest Share of the Global Container Closure Integrity Testing Market
Based on the type of container tested, the market is segmented into vials, syringes and cartridges. At present, the vials segment holds the maximum share of the global container closure integrity testing market owing to the fact that vials are the most commonly used type of container in the pharmaceutical industry. This trend is likely to remain the same in the coming years.
By Type of Container Material Tested, Glass System Accounts for the largest share of the Global Container Closure Integrity Testing Market
Based on the type of container material tested, the market is segmented into glass and plastic materials. Currently, the glass segment captures the highest proportion of the global container closure integrity testing market due to its higher chemical stability and regulatory acceptance in terms of its quality grade.
Asia-Pacific Accounts for the Largest Share of the Market
Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa. Currently, Asia-Pacific dominates the closure integrity testing market and accounts for the largest revenue share. This can be attributed to the growing pharmaceutical industry and increasing production of pharmaceutical products in this region. Further, the market in Latin America is likely to grow at a higher CAGR in the coming future.
Example Players in the Container Closure Integrity Testing Market
Berkshire Sterile Manufacturing
Confarma
Curia
DDL and Nelson Labs
Eurofins
SGS
Stevanato
Wilco
CONTAINER CLOSURE INTEGRITY TESTING MARKET: RESEARCH COVERAGE
Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the global container closure integrity testing market, focusing on key market segments, including [A] type of container tested, [B] type of container material tested and [C] key geographical regions.
Market Landscape: A comprehensive evaluation of container closure integrity testing service providers, based on several relevant parameters, such as [A] year of establishment, [B] company size, [C] location of headquarters, [D] location of analytical facilities, [E] type(s) of analytical method(s) offered, [F] type(s) of probabilistic method(s), [F] type(s) of deterministic method(s) offered, [G] leakage susceptibility, [H] type(s) of container(s) tested and [I] accreditations.
Company Competitiveness Analysis: A comprehensive competitive analysis of container closure integrity testing service providers, examining factors, such as [A] supplier power and [B] service strength.
Company Profiles: In-depth profiles of key players providing container closure integrity testing, focusing on [A] overview of the company, [B] financial information (if available), [C] service portfolio, [D] location of analytical facilities, [E] type(s) of analytical method(s) used, [F] types(s) of container(s) tested and [G] recent developments and an informed future outlook.
Case Study: A detailed assessment of equipment used by various manufacturers to test container closure integrity, focusing on key features, such as [A] type(s) of analytical method(s) offered, [B] type(s) of container(s) tested and [C] container material(s) of container closure integrity testing technologies.
Product Competitiveness Analysis: A comprehensive competitive analysis of container closure integrity testing equipment, examining factors, such as [A] product strength and [B] product applicability.
Regional Capability Assessment: A detailed assessment of container closure integrity testing capability across key geographies, based on a number of parameters, such as [A] number of container closure integrity testing service providers, [B] number of analytical testing facilities, [C] number of container closure integrity technology manufacturers, [D] number of container closure integrity testing technologies, [E] number of patents and [F] demand of container closure integrity testing service.
Benchmarking Analysis: An insightful analysis of the various container closure integrity testing analytical techniques, based on various parameters, such as [A] the number of service providers offering analytical technique for testing purpose, [B] equipment providers developing equipment for particular technique, [C] number of equipment, [D] number of container closure systems tested and [E] benchmarking of analytical techniques.
Demand Analysis: An in-depth analysis of the current and future demand of container closure integrity testing service, based on various relevant parameters, such as [A] type of container closure system tested and [B] type of material used, across different regions
SWOT Analysis: An analysis of industry affiliated trends, opportunities and challenges, which are likely to impact the evolution of container closure integrity testing market; it includes a Harvey ball analysis, assessing the relative impact of each SWOT parameter on industry dynamics.
KEY QUESTIONS ANSWERED IN THIS REPORT
How many companies are currently engaged in this market?
Which are the leading companies in this market?
What factors are likely to influence the evolution of this market?
What is the current and future market size?
What is the CAGR of this market?
How is the current and future market opportunity likely to be distributed across key market segments?
REASONS TO BUY THIS REPORT
The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.
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TABLE OF CONTENTS
1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.2.1. Research Assumptions
1.2.2. Project Methodology
1.2.3. Forecast Methodology
1.2.4. Robust Quality Control
1.2.5. Key Considerations
1.2.5.1. Demographics
1.2.5.2. Economic Factors
1.2.5.3. Government Regulations
1.2.5.4. Supply Chain
1.2.5.5. COVID Impact / Related Factors
1.2.5.6. Market Access
1.2.5.7. Healthcare Policies
1.2.5.8. Industry Consolidation
1.3 Key Questions Answered
1.4. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Chapter Overview
3.2. Primary Packaging: Container Closure Systems
3.3. Types of Container Closure Systems
3.4. Problems Related to Container Closure Systems
