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市場調查報告書
商品編碼
1883044
化學指示劑市場規模、佔有率、成長及全球產業分析:依類型、應用和地區劃分的洞察與預測(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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隨著全球醫療機構日益重視滅菌品質和感染預防,全球化學指示劑市場持續擴張。產業數據顯示,受外科手術量、住院人數以及製藥和醫療器材產業滅菌需求成長的推動,2024 年市場規模預計將達到 4.2 億美元。預計到 2025 年,在對無菌保證產品持續需求的推動下,市場規模將達到 4.357 億美元。到 2032 年,受產品創新、技術進步以及全球醫療機構對滅菌監測系統日益普及的推動,化學指示劑市場預計將顯著增長至 5.809 億美元。
市場成長推動因素
市場成長的關鍵推動因素之一是醫院獲得性感染 (HAI) 的增加。隨著住院患者人數的增加,醫療保健系統中與感染相關的風險也隨之上升。根據澳洲健康與福利研究所的數據,預計住院患者人數將從 2019 年的 1,110 萬增加到 2024 年的 1,260 萬,這意味著需要安全醫療環境的患者人數將顯著增加。在加拿大,艱難梭菌感染病例數預計將從 2021 年的 3,643 例增加到 2022 年的 3846 例,這凸顯了對嚴格的滅菌控制方法日益增長的需求。
另一個主要的成長推動因素是對生物製劑和生物相似藥的需求不斷增長,這些產品需要嚴格的滅菌流程。 2024年,FDA批准了16種生物製劑(2021年批准了14種),這直接推動了製藥生產中對高性能滅菌驗證工具的需求。
市場限制因子
儘管有成長機遇,但發展中地區仍面臨挑戰。中低收入國家對滅菌規程的遵守情況不佳、監管執法不力以及缺乏標準化監測,限制了化學指示劑的應用。例如,根據NCBI 2023年的報告,印度每100名住院患者中就有15人感染醫院獲得性感染,凸顯了滅菌管理實踐中的不足。許多醫療機構為了節省成本而限制滅菌耗材的使用,這對市場成長產生了負面影響。
市場機會
發展中地區製藥和醫療器材製造業的顯著成長創造了巨大的機會。各公司正在擴建其設施,以滿足全球滅菌標準。 2024年2月,泰爾茂株式會社在波多黎各開設了一家新的醫療器材製造廠,以滿足日益增長的全球醫療保健需求。這些擴張需要強大的滅菌監測流程,從而支持對化學指示劑日益增長的需求。
此外,醫療保健專業人員對滅菌標準和安全措施的認識不斷提高,為泰爾茂在亞太地區、拉丁美洲和部分歐洲地區的市場滲透提供了新的機會。
市場挑戰
替代方法(例如生物指示劑)的出現可能會限制化學指示劑的應用。生物指示劑被認為是滅菌驗證的黃金標準,它確認微生物已被殺,而化學指示劑則驗證暴露條件。像STERIS這樣的公司不斷投資於生物驗證系統,這在某些市場對化學指示劑市場構成了壓力。
主要市場趨勢
市場參與者正致力於推出新產品,以提高滅菌工作流程的效率。Solventum 的 Attest 超快速 VH2O2 挑戰套件將於 2025 年推出,它整合了化學和生物指示劑,反映了市場對快速滅菌驗證技術日益增長的需求。
北美
北美將在 2024 年引領全球市場,達到 1.488 億美元(佔 35.42% 的市佔率)。該地區的領先地位歸功於其先進的醫療保健體系、高手術量和健全的監管框架。預計美國在 2024 年每年將報告 30,100 例中心靜脈導管相關血流感染 (CLABSI) 病例,這將增加對滅菌監測的需求。
歐洲
歐洲將在 2024 年佔第二大市場佔有率,這主要得益於積極參與醫療會議的企業。在 2024 年 ACHEMA 展會上,Getinge 展示了其化學指示劑解決方案,提高了人們對該技術的認知度和應用率。
亞太地區
預計到2032年,亞太地區將維持最高的成長率。像STERIS這樣的公司正在持續擴建其滅菌設施,包括2024年在中國蘇州建成的X光片處理中心,以支持該地區的成長。
拉丁美洲與中東/非洲
預計這些地區將穩定成長,這主要得益於醫療保健能力的提升、新滅菌中心的建立以及製造商更多地參與諸如2025年阿拉伯國際醫療器械展覽會(Arab Health 2025)等展會。 Lister Biomedical在展會上展示了其滅菌耗材。
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