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市场调查报告书
商品编码
1883044
化学指示剂市场规模、占有率、成长及全球产业分析:依类型、应用和地区划分的洞察与预测(2024-2032 年)Chemical Indicators Market Size, Share, Growth and Global Industry Analysis By Type & Application, Regional Insights and Forecast to 2024-2032 |
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随着全球医疗机构日益重视灭菌品质和感染预防,全球化学指示剂市场持续扩张。产业数据显示,受外科手术量、住院人数以及製药和医疗器材产业灭菌需求成长的推动,2024 年市场规模预计将达到 4.2 亿美元。预计到 2025 年,在对无菌保证产品持续需求的推动下,市场规模将达到 4.357 亿美元。到 2032 年,受产品创新、技术进步以及全球医疗机构对灭菌监测系统日益普及的推动,化学指示剂市场预计将显着增长至 5.809 亿美元。
市场成长推动因素
市场成长的关键推动因素之一是医院获得性感染 (HAI) 的增加。随着住院患者人数的增加,医疗保健系统中与感染相关的风险也随之上升。根据澳洲健康与福利研究所的数据,预计住院患者人数将从 2019 年的 1,110 万增加到 2024 年的 1,260 万,这意味着需要安全医疗环境的患者人数将显着增加。在加拿大,艰难梭菌感染病例数预计将从 2021 年的 3,643 例增加到 2022 年的 3846 例,这凸显了对严格的灭菌控制方法日益增长的需求。
另一个主要的成长推动因素是对生物製剂和生物相似药的需求不断增长,这些产品需要严格的灭菌流程。 2024年,FDA批准了16种生物製剂(2021年批准了14种),这直接推动了製药生产中对高性能灭菌验证工具的需求。
市场限制因子
儘管有成长机遇,但发展中地区仍面临挑战。中低收入国家对灭菌规程的遵守情况不佳、监管执法不力以及缺乏标准化监测,限制了化学指示剂的应用。例如,根据NCBI 2023年的报告,印度每100名住院患者中就有15人感染医院获得性感染,凸显了灭菌管理实践中的不足。许多医疗机构为了节省成本而限制灭菌耗材的使用,这对市场成长产生了负面影响。
市场机会
发展中地区製药和医疗器材製造业的显着成长创造了巨大的机会。各公司正在扩建其设施,以满足全球灭菌标准。 2024年2月,泰尔茂株式会社在波多黎各开设了一家新的医疗器材製造厂,以满足日益增长的全球医疗保健需求。这些扩张需要强大的灭菌监测流程,从而支持对化学指示剂日益增长的需求。
此外,医疗保健专业人员对灭菌标准和安全措施的认识不断提高,为泰尔茂在亚太地区、拉丁美洲和部分欧洲地区的市场渗透提供了新的机会。
市场挑战
替代方法(例如生物指示剂)的出现可能会限制化学指示剂的应用。生物指示剂被认为是灭菌验证的黄金标准,它确认微生物已被杀,而化学指示剂则验证暴露条件。像STERIS这样的公司不断投资于生物验证系统,这在某些市场对化学指示剂市场构成了压力。
主要市场趋势
市场参与者正致力于推出新产品,以提高灭菌工作流程的效率。Solventum 的 Attest 超快速 VH2O2 挑战套件将于 2025 年推出,它整合了化学和生物指示剂,反映了市场对快速灭菌验证技术日益增长的需求。
北美
北美将在 2024 年引领全球市场,达到 1.488 亿美元(占 35.42% 的市占率)。该地区的领先地位归功于其先进的医疗保健体系、高手术量和健全的监管框架。预计美国在 2024 年每年将报告 30,100 例中心静脉导管相关血流感染 (CLABSI) 病例,这将增加对灭菌监测的需求。
欧洲
欧洲将在 2024 年占第二大市场占有率,这主要得益于积极参与医疗会议的企业。在 2024 年 ACHEMA 展会上,Getinge 展示了其化学指示剂解决方案,提高了人们对该技术的认知度和应用率。
亚太地区
预计到2032年,亚太地区将维持最高的成长率。像STERIS这样的公司正在持续扩建其灭菌设施,包括2024年在中国苏州建成的X光片处理中心,以支持该地区的成长。
拉丁美洲与中东/非洲
预计这些地区将稳定成长,这主要得益于医疗保健能力的提升、新灭菌中心的建立以及製造商更多地参与诸如2025年阿拉伯国际医疗器械展览会(Arab Health 2025)等展会。 Lister Biomedical在展会上展示了其灭菌耗材。
The global chemical indicators market continues to expand as healthcare facilities worldwide increase emphasis on sterilization quality and infection prevention. According to industry data, the market was valued at USD 420.0 million in 2024, driven by the rising volume of surgical procedures, higher hospital admissions, and growing sterilization requirements in pharmaceutical and medical device sectors. In 2025, the market value is projected to reach USD 435.7 million, supported by continued demand for sterility assurance products. By 2032, the chemical indicators market is expected to grow substantially to USD 580.9 million, supported by product innovation, technological advancements, and greater adoption of sterility monitoring systems across healthcare facilities globally.
Market Growth Drivers
One of the key factors driving market growth is the rising number of hospital-acquired infections (HAIs). With hospitalizations increasing, healthcare systems are witnessing a parallel rise in infection-related risks. According to the Australian Institute of Health and Welfare, hospitalizations increased from 11.1 million in 2019 to 12.6 million in 2024, representing a substantial rise in patients requiring safe care environments. In Canada, cases of Clostridioides difficile infections increased from 3,643 in 2021 to 3,846 in 2022, reinforcing the growing need for robust sterilization monitoring practices.
Another major growth contributor is the expanding demand for biologics and biosimilars, which require stringent sterile processing. With the FDA approving 16 biologics in 2024, compared with 14 in 2021, pharmaceutical manufacturing now demands high-performance sterilization validation tools, directly boosting the demand for chemical indicators.
Market Restraints
Despite growth opportunities, the market faces challenges in developing regions. Limited adherence to sterilization protocols, inconsistent regulatory enforcement, and lack of standardized monitoring in low- and middle-income countries restrict the adoption of chemical indicators. For example, NCBI reported in 2023 that 15 out of every 100 hospitalized patients in India acquire a hospital-acquired infection, highlighting gaps in sterilization practices. Many facilities use limited sterility consumables as cost-saving measures, negatively affecting market growth.
Market Opportunities
Strong growth in pharmaceutical and medical device manufacturing in developing regions is generating significant opportunities. Companies are expanding facilities to meet global sterilization standards. In February 2024, Terumo Corporation opened a new device manufacturing plant in Puerto Rico to support rising global healthcare demand. These expansions require robust sterilization monitoring processes, supporting rising demand for chemical indicators.
In addition, increasing awareness among healthcare professionals about sterilization norms and safety practices provides new opportunities for market penetration in Asia Pacific, Latin America, and parts of Europe.
Market Challenges
The availability of alternatives such as biological indicators may limit chemical indicator adoption. Biological indicators, considered the gold standard for sterilization validation, confirm microbial destruction, whereas chemical indicators verify exposure conditions. Companies like STERIS continue to invest in biological validation systems, putting pressure on the chemical indicator segment in certain markets.
Key Market Trends
Market players are focusing heavily on new product launches to strengthen sterilization workflow efficiency. Solventum's 2025 launch of the Attest Super Rapid VH2O2 Challenge Pack, integrating both chemical and biological indicators, reflects the rising demand for rapid sterilization verification technology.
North America
North America led the global market in 2024, valued at USD 148.8 million with a 35.42% share. The region's leadership is attributed to advanced healthcare systems, high surgical volume, and strong regulatory frameworks. The U.S. reported 30,100 annual CLABSI cases in 2024, increasing the need for sterilization monitoring.
Europe
Europe held the second-largest market share in 2024, driven by companies actively participating in medical conferences. At ACHEMA 2024, Getinge showcased its chemical indicator solutions, strengthening awareness and adoption.
Asia Pacific
Asia Pacific is expected to grow at the highest rate through 2032. Companies such as STERIS continue expanding sterilization facilities, including the Suzhou, China X-ray processing expansion in 2024, supporting regional growth.
Latin America & Middle East/Africa
These regions show steady growth due to emerging healthcare capabilities, new sterilization centers, and increased presence of manufacturers at events like Arab Health 2025, where LISTER BIOMEDICAL showcased sterilization consumables.
Conclusion
With market value increasing from USD 420.0 million in 2024 to an estimated USD 580.9 million by 2032, the chemical indicators market is underpinned by rising sterilization needs, growth in biologics manufacturing, and rising global healthcare workloads. Product innovation, new manufacturing facilities, and strong regulatory initiatives will continue to fuel market expansion.
Segmentation
By Product
By Parameter
By Sterilization Method
By End-user
By Region