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市场调查报告书
商品编码
1755938
2032 年霉浆菌检测市场预测:按产品、技术、应用、最终用户和地区进行的全球分析Mycoplasma Testing Market Forecasts to 2032 - Global Analysis By Product, Technique, Application, End User and By Geography |
根据 Stratistics MRC 的数据,全球霉浆菌检测市场预计在 2025 年达到 11.9807 亿美元,预计到 2032 年将达到 25.993 亿美元,预测期内的复合年增长率为 11.7%。
霉浆菌检测是製药和生物技术生产中重要的品管方法,用于确定细胞培养物、疫苗和生物製药是否受到霉浆菌污染。霉浆菌是一种难以用传统微生物学方法鑑定的细菌,因为它没有细胞壁,并且对许多常见抗生素具有抗药性。霉浆菌污染会改变细胞的代谢方式,导致其停止生长,进而影响产品安全和实验结果。此外,各种检测技术,包括酵素连结免疫吸附测定、培养方法和PCR,可以确保生物製品和研究材料的真实性和安全性。
据 ATCC 称,连续细胞培养中的霉浆菌污染率为 15-35%,而原代细胞培养中的支原体污染率至少为 1%。
基于细胞的研究的兴起
由于哺乳动物细胞培养在药物研发、癌症研究、毒理学、疫苗开发、个人化医疗等领域的广泛应用,霉浆菌检测已成为学术和商业性实验室的必需环节。错误的结论、扭曲的实验数据、改变的基因表现以及降低的可重复性都可能由受污染的细胞株造成。这种高频率凸显了常规筛检程序对于维持研究结果完整性的重要性。为了保持实验系统的准确性和可靠性,霉浆菌检测已成为大多数分子生物学和生物医学实验室的常规检测。
昂贵的先进测试技术
数位PCR、即时PCR和新一代定序(NGS)等先进检测技术高成本,是限制霉浆菌检测市场发展的主要因素之一。儘管这些技术速度更快、灵敏度更高,但它们需要在专用工具、化学品和技术人员方面投入大量的初始资金。开发中国家的中小型生物製药公司、学术机构和低预算实验室无法负担这些系统,从而限制了常规霉浆菌检测的普及。此外,这些先进仪器的频繁维护、校准和验证也增加了营运成本。
高性能係统建置与自动化
建构高性能自动化霉浆菌检测平台,为解决生物製造中的可扩展性和效率问题带来巨大机会。随着批次数量的增加、严格的放行计画和检测频率的提高,生物製药公司正在寻求能够减少手动任务和周转时间,同时提高可重复性的解决方案。此外,大型合约生产与製造组织 (CDMO) 和生技药品製造商将对能够提供与其製造执行系统 (MES) 和品管系统 (QMS) 相容的整合霉浆菌检测模组的公司抱有浓厚的兴趣。
其他污染检测技术的激烈竞争
具有多重检测能力和广泛覆盖范围的替代性微生物污染检测技术正给市场带来越来越大的压力。近期,使用新一代定序 (NGS) 和元基因组分析的平台可以在一次检测中同时检测多种细菌、病毒、真菌和霉浆菌。儘管这些综合技术尚处于起步阶段,但它们正受到寻求全面污染监测系统的主要生物製造商的青睐。此外,如果传统的单标靶霉浆菌检测套组无法跟上整合式多参数解决方案的步伐,它们可能会失去市场占有率。
COVID-19 疫情以多种方式影响了霉浆菌检测市场。一方面,全球供应链中断和实验室进入受限导致常规检测业务暂时停滞,尤其是在学术机构和小型生物技术公司。许多与 COVID-19 无关的临床试验和生技药品生产被推迟,因此污染检测的紧迫性有所降低。然而,疫情也凸显了生技药品和疫苗生产中强有力的品管的重要性,促使人们增加了对品质保证和生技药品基础设施(包括霉浆菌检测)的投资。
预计聚合酵素链锁反应(PCR)部分在预测期内将占据最大份额。
聚合酵素链锁反应(PCR) 因其卓越的灵敏度、特异性、快速的周转时间以及识别多种霉浆菌的能力,预计将在预测期内占据最大的市场占有率。在生技药品生产和细胞治疗程序中,PCR 被认为是污染检测的黄金标准。然而,PCR 比酵素结合免疫吸附试验 (ELISA) 更灵敏,后者因其经济实惠和易于使用而广受好评。研究中通常采用直接法和间接法。
预计细胞株测试部分将在预测期内达到最高复合年增长率
预计细胞株测试领域将在预测期内达到最高成长率。这一增长源于哺乳动物细胞株在疫苗、单株抗体和生技药品生产中日益广泛的应用,而这些生产过程都需要严格的污染筛检。病毒检测虽然对生物安全至关重要,但由于对病原体的关注度不断提高以及对先进疗法的监管需求,其应用也在稳步增长。生产终端细胞测试虽然不如上游细胞株测试常见,但对于确认批次无菌性仍然至关重要。由于细胞株测试已被整合到生物生产的早期阶段,它将继续成为成长最快的应用。
预计北美将在预测期内占据最大的市场占有率。这得益于强劲的研发支出、成熟的生物製药产业以及FDA等组织支持的严格监管标准。该地区的许多CRO、CDMO和生技药品製造商都要求在生产的每个阶段定期进行污染筛检。完善的法律规范、对细胞和基因治疗的持续投资以及先进分子诊断技术的广泛应用,都有助于巩固市场主导地位。此外,关键参与企业的存在和强大的学术研究支持早期采用尖端测试解决方案和技术进步,从而确保北美在全球市场占据主导地位。
预计亚太地区将在预测期内实现最高的复合年增长率。生技药品需求的不断增长、中国、印度和日本等国生产能力的提升以及製药和生物技术研究投资的不断增加是推动这一快速增长的关键因素。由于监管更加严格以及对污染控制意识的不断增强,霉浆菌检测服务和产品在这些国家也变得越来越普及。此外,该地区新兴国家提供的成本优势也推动了市场扩张,使其成为受託製造厂商(CMO) 和委外研发机构(CRO) 的理想之地。
According to Stratistics MRC, the Global Mycoplasma Testing Market is accounted for $1198.07 million in 2025 and is expected to reach $2599.30 million by 2032 growing at a CAGR of 11.7% during the forecast period. Mycoplasma testing is a crucial quality control method used in pharmaceutical and biotechnology production to find out whether cell cultures, vaccines, and biopharmaceutical products are contaminated with Mycoplasma. Because they lack a cell wall, mycoplasmas are a class of bacteria that are difficult to identify using conventional microbiological techniques and resistant to many common antibiotics. Mycoplasma contamination can change how cells metabolize, stop them from growing, and affect the safety of products or the outcomes of experiments. Moreover, the dependability and security of biological products and research materials are guaranteed by a variety of testing techniques, including enzymatic assays, culture methods, and PCR.
According to ATCC, Mycoplasma contamination of continuous cell cultures ranges from 15-35%, with primary cell cultures exhibiting a minimum 1% contamination rate, and emphasizes routine testing throughout production to ensure both safety and experimental reliability.
Growing use of research based on cells
Mycoplasma testing is now essential in both academic and commercial labs due to the extensive use of mammalian cell cultures in drug discovery, cancer research, toxicology, vaccine development, and personalized medicine. Erroneous conclusions, distorted experimental data, changed gene expression, and impaired reproducibility can all result from contaminated cell lines. This high frequency emphasizes how crucial routine screening procedures are to maintaining the integrity of research findings. To preserve the caliber and dependability of experimental systems, Mycoplasma testing has become commonplace in the majority of molecular biology and biomedical labs.
Expensive advanced testing techniques
The high cost of sophisticated detection technologies like digital PCR, real-time PCR, and next-generation sequencing (NGS) is one of the main factors limiting the market for Mycoplasma testing. Despite having higher speed and sensitivity, these techniques necessitate a large initial investment in specialized tools, chemicals, and skilled workers. The adoption of routine Mycoplasma testing is often limited by the inability of small and medium-sized biopharmaceutical companies, academic institutions, and low-budget laboratories in developing nations to afford these systems. Moreover, frequent maintenance, calibration, and validation of these sophisticated instruments raise operating costs.
Creation of high-throughput systems and automation
The creation of high-throughput, automated Mycoplasma testing platforms offers a significant chance to solve issues with biomanufacturing's scalability and efficiency. Biopharma firms are looking for solutions that decrease manual handling and turnaround time while enhancing reproducibility due to rising batch volumes, strict release schedules, and an increase in testing frequency. Additionally, large-scale CDMOs and biologics manufacturers will be very interested in companies that can provide integrated Mycoplasma detection modules that are compatible with manufacturing execution systems (MES) and quality management systems (QMS).
Strong competition from other techniques for contamination detection
Alternative microbial contamination detection technologies with multiplexing capabilities or wider coverage are putting more and more pressure on the market. Many bacteria, viruses, fungi, and mycoplasma can all be detected simultaneously in a single assay by more recent platforms that use next-generation sequencing (NGS) or metagenomic analysis. Despite their infancy, these all-encompassing techniques are gaining traction with major biomanufacturers looking for comprehensive contamination monitoring systems. Furthermore, the failure of conventional and single-target Mycoplasma testing kits to keep up with integrated and multiparametric solutions could result in a loss of market share.
The COVID-19 pandemic affected the mycoplasma testing market in a variety of ways. On the one hand, routine testing operations were momentarily slowed, particularly in academic and small biotech settings, by the disruption of global supply chains and limitations on lab access. There was less of an urgent need for contamination testing because many clinical trials and the production of biologics unrelated to COVID-19 were postponed. But the pandemic also brought to light the significance of strong quality control in the manufacturing of biologics and vaccines, which led to a rise in investments in quality assurance, including mycoplasma testing, and biologics infrastructure.
The polymerase chain reaction (PCR) segment is expected to be the largest during the forecast period
The polymerase chain reaction (PCR) segment is expected to account for the largest market share during the forecast period because of its great sensitivity, specificity, quick turnaround time, and capacity to identify a variety of Mycoplasma species. In the production of biologics and cell therapy procedures, PCR is regarded as the gold standard for contamination detection. However, PCR is more sensitive than enzyme-linked immunosorbent assay (ELISA), which is praised for its affordability and ease of use. In research contexts, both direct and indirect assays are commonly employed.
The cell line testing segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the cell line testing segment is predicted to witness the highest growth rate. The growing use of mammalian cell lines in the production of vaccines, monoclonal antibodies, and biologics-all of which need stringent contamination screening-is what is causing this growth. Despite being crucial for biosafety, virus testing is steadily increasing because of its wider focus on pathogens and the regulatory need for advanced therapies. Although end-of-production cell testing is less common than upstream cell line testing, it is still essential for verifying batch sterility. Because cell line testing is integrated into early stages of bioproduction, it continues to be the application with the fastest rate of growth.
During the forecast period, the North America region is expected to hold the largest market share, driven by its strong R&D expenditures, established biopharmaceutical sector, and strict regulatory standards upheld by organizations such as the FDA. Many CROs, CDMOs, and biologics manufacturers in the area need regular contamination screening at every stage of production. A developed regulatory framework, growing investments in cell and gene therapies, and the widespread use of sophisticated molecular diagnostics all contribute to market dominance. Furthermore, the presence of important players and strong academic research supports early adoption of cutting-edge testing solutions and technological advancement, securing North America's dominant position in the global market.
Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR. The growing demand for biologics, growing manufacturing capacities in nations like China, India, and Japan, and growing investments in pharmaceutical and biotechnology research are the main drivers of this quick growth. Mycoplasma testing services and products are also becoming more popular in these nations due to stricter regulations and increased awareness of contamination control. Additionally, propelling market expansion are the cost advantages that the region's emerging economies provide, which make it a favored location for contract manufacturing organizations (CMOs) and contract research organizations (CROs).
Key players in the market
Some of the key players in Mycoplasma Testing Market include Thermo Fisher Scientific, Inc., Becton, Dickinson, and Company (BD), Eurofins Scientific, Agilent Technologies, F. Hoffmann-La Roche Ltd., Clongen Laboratories, LLC, Bionique Testing Laboratories, Inc., Lonza Group Ltd., Merck KGaA, Charles River Laboratories International, Inc., Bio-Rad Laboratories, Inc, PromoCell GmbH, Norgen Biotek Corp., Sartorius AG and Minerva Biolabs GmbH.
In February 2025, Thermo Fisher Scientific Inc. has announced a 10-year virtual power purchasing agreement (VPPA) with renewable energy developer, X-ELIO. The agreement aims to increase the access to renewable electricity across the healthcare and pharmaceutical supply chains. Expected to be operational in early 2026, the project will include a cohort of three partners across both sectors.
In October 2024, BD (Becton, Dickinson and Company) announced it has reached an agreement to resolve the vast majority of its existing hernia litigation. Terms of the settlement agreement, which are confidential, include cases in both the Rhode Island consolidated litigation and the federal multidistrict litigation in Ohio.
In October 2024, Eurofins Scientific has reached an agreement with SYNLAB to acquire its clinical diagnostics operations in Spain. The transaction is subject to customary conditions, including regulatory approvals, and is expected to close in 2025. SYNLAB's clinical diagnostics operations in Spain provide clinical diagnostics testing, including genetics and anatomical pathology services, throughout the country, achieving revenues of approximately €140m in 2023.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.