Pharmaceutical Isolator Market Size, Share, and Forecast 2031
预计到 2031 年,制药隔离器市场规模将从 2023 年的 70.2 亿美元增至 134.9 亿美元。预计 2023-2031 年期间,该市场的复合年增长率将达到 8.50%。制药隔离器采用自动化可能仍将是市场的主要趋势。
制药隔离器市场分析
制药和生物技术行业投资增加以及支持采用药物隔离器的监管框架等因素正在推动市场增长。生物技术和制药行业的增长最终将导致未来几年对药物隔离器的需求增加。预计市场将受到制药公司批准更多药物以满足不合规药物需求的趋势的推动。鉴于该地区仿制药行业的快速增长,预计亚太地区将在预测期内实现显着增长。
制药隔离器市场概览
众多大大小小的制药公司正在致力于研发新型分子,以治疗威胁人类生命的疾病。制药隔离器系统被视为寻找新药的重要设备。因此,越来越多的制药隔离器被用于保证无污染的产品处理和制造。制药隔离器可保护操作员免受潜在危险药物的接触,消除交叉污染的机会,并维持药品质量标准。在制药行业,生产新产品时必须极其谨慎。制药行业提供各种隔离器,可在产品制造过程中提供最高水平的无菌性——管理含有重要成分的药物,如激素和抗生素。使用生物药物时,预防措施更为重要。过去十年来,制药和生物技术公司对制药隔离器技术进行了大举投资。知名科技公司默克集团于 2017 年投资 3500 万欧元,在其位于意大利巴里的制造基地建造了一条隔离器下生物技术药物无菌灌装生产线。在巴里生物技术制造基地,该公司投资约 5000 万欧元建造了一个自动化仓库和一条隔离器下运行的全自动生产线。2020 年 12 月,总部位于英国的吸入剂合同开发制造公司 Vectura 的扩建基地又增加了六个密封隔离器和一个产品开发制造实验室。该设施使用强效活性药物成分 (HPAPI) 并开发新药物成分。
同样,2019 年 9 月,COMEDCO 与 Optima Pharma 和 Optima Life Science 联手提供广泛的无菌灌装和密封服务,包括冷冻干燥和隔离器技术。该联盟将能够利用 Optima 的隔离器技术迅速而有策略地推出新的口服分散膜 (ODF) 和透皮贴剂系统 (TPS)。因此,推动制药隔离器市场增长的主要因素是生物技术和制药公司不断增加的投资以及正在开发的用于治疗癌症、代谢、心血管、免疫和神经系统疾病等不同慢性疾病的长期药物管线。
定制研究以满足您的需求
我们可以优化和定制标准产品无法满足的分析和范围。这种灵活性将帮助您获得业务规划和决策所需的准确信息。
制药隔离器市场:
复合年增长率(2023 - 2031)8.50%- 2023 年市场规模
70.2 亿美元 - 2031年市场规模
134.9亿美元
市场动态
- 支持采用药物隔离器的监管框架有利于市场增长
- 制药隔离器自动化应用
- 新兴经济体中不断增长的制药和生物技术产业的市场机遇
关键人物
- 艾特科公司
- 示意图工程行业
- Nuaire 公司
- 科梅瑟
- 洁定公司
- 细川密克光集团
- Fedegari Autoclavi SpA
- 阿自倍尔泰星
- 新加坡
区域概况
- 北美
- 欧洲
- 亚太
- 南美洲和中美洲
- 中东和非洲
市场细分
- 开放式隔离器和封闭式隔离器
- 正压和负压
- 落地式
- 模块化的
- 移动的
- 袖珍的
- 桌面
- 便携的
- 无菌隔离器
- 隔离器
- 采样和称重隔离器
- 流体分配隔离器
- 示例 PDF 通过定性和定量分析展示了内容结构和信息的性质。
制药隔离器市场驱动因素和机遇
支持采用药物隔离器的监管框架有利于市场增长
与传统洁净室相比,制药隔离器可提供更无菌的环境。隔离室的内部压力(正压或负压)可防止操作员干扰造成的污染。遵守有关生产无菌药品的制药法规可确保持续无菌。此外,大多数专家一致认为,监管机构不再阻止制药隔离器等技术进步。关于隔离器与洁净室,美国食品药品管理局和欧洲药品管理局的指导方针在其采用中发挥了重要作用。FDA 在其最新的无菌环境制造指南中 55 次提到隔离器。与传统无菌处理相比,设计精良且具有充分维护、监控和控制协议的正压隔离器具有多种优势,包括降低处理过程中微生物污染的风险。
此外,FDA 指出,关键制药生产领域的操作员已被撤出,这预计将在未来几年加速制药隔离器的使用。根据趋势分析,美国使用隔离器技术的制药设施数量正在上升。1998 年,只有 84 家工厂采用隔离器无菌灌装。2000 年,有 174 家工厂;2002 年有 201 家;2004 年有 258 家。高效药物生产的增加与扩大提供无菌处理的设施有关。由于违反监管准则的成本很高,隔离器已成为制药行业必不可少的。制药隔离器对于在各种过程中维持无菌条件和密封是必不可少的。严格的无菌条件是确保质量控制、遵守其他监管要求和满足 FDA 现行良好生产规范 (cGMP) 准则(21 CFR 第 210 和 211 部分)所必需的。
同样,制药行业的隔离器必须符合欧盟 GMP 洁净室分类中规定的 A 级标准。欧盟 (EU) 良好生产规范 (GMP) 附件 1 的最终版本预计将于 2021 年发布。例如,更新草案已于 2020 年 2 月发布。这些 GMP 指南涵盖了隔离器设计和使用的几个重要主题,包括无菌设备设计、自动化和数字化、隔离器的无菌性和 H202 表面消毒。世卫组织无菌药品良好生产规范指南附件 6 第 8 节也提到了使用隔离器技术减少加工区域的人为干预。所有这些监管指南都推动了市场对制药隔离器的采用。
新兴经济体中不断增长的制药和生物技术产业的市场机遇
制药隔离器市场中的大多数公司都位于北美和欧洲。亚太地区、中东和拉丁美洲等具有巨大增长潜力地区的几个国家已被市场领先供应商边缘化。尽管如此,中国和印度等国家的制药研究资金正在增加。此外,上述地区的几个国家可以实施无菌隔离器等尖端技术。他们还努力通过创建高性能且价格合理的系统成为世界上最先进的药物开发商。例如,对于激素产品的生产,上海玛雅制药提供了无菌负压隔离器。可以使用此隔离器执行称重、包装、取样和其他高活性生产过程。由于中国、印度和巴西等新兴国家的医疗保健市场多样化、劳动力和原材料成本低廉、生命科学研究增加、政府支持、CRO 和制药行业蓬勃发展以及技术进步和整合,预计制药隔离器市场将大幅扩张。
这些发展中国家的政府也投入大量资金来支持制药业的研究。由于对更好药物的需求不断增长、药物渠道受限以及研发费用不断上升,制药公司对外包药物研发的兴趣日益浓厚,无菌隔离器在新兴市场的需求也日益增加。巴西、中国和印度的许多 CRO 为制药和生物技术公司提供药物研发服务。此外,全球生物制药生产商发现亚洲国家是极具吸引力的外包目的地。推动亚洲制药隔离器增长的主要原因之一是中国和印度等国家制造和运营成本低廉。
此外,基于中国和印度生物制药领域的最新进展,市场潜力巨大。生物制剂和生物仿制药产品线的不断扩大为亚太地区的合同制造商带来了新的机遇。根据国际制药工程学会的数据,2016 年约有 200 种新的生物药品在中国食品药品监督管理局 (CFDA) 注册进行临床试验。在未来几年,合同制造预计将支持整个国家生物制药行业的扩张。此外,由于其运营成本较低,因此主要帮助早期药物创新者。为了满足不断增长的需求,许多 CMO 正在扩大其制造业务的范围。例如,韩国生物仿制药制造商 Optima Korea 和 Aprogen 于 2020 年启动了一个独特的隔离器项目。Aprogen 是韩国首批将隔离器技术应用于高速注射器系统的两家企业之一。在预测期内,新兴经济体的制药隔离器市场将因上述因素而出现盈利机会。
制药隔离器市场报告细分分析
有助于得出医药隔离器市场分析的关键部分是类型、压力、配置、应用和最终用户。
- 根据类型,制药隔离器市场分为开放式隔离器和封闭式隔离器。开放式隔离器部分在 2023 年占据了最大的市场份额。
- 根据压力指示,市场分为正压和负压。正压部分在 2023 年占据了最大的市场份额。
- 根据配置,市场分为落地式、模块化、移动式、紧凑式、桌面式和便携式。落地式在 2023 年占据了相当大的市场份额。
- 根据应用,制药隔离器市场细分为无菌隔离器、密闭隔离器、取样和称重隔离器、流体分配隔离器等。无菌隔离器细分市场在 2023 年占据了最大的市场份额。
- 根据最终用户,市场分为医院、制药和生物技术公司、研究和学术实验室等。制药和生物技术公司在 2023 年占据了相当大的市场份额。
医药隔离器市场份额(按地区)分析
制药隔离器市场报告的地理范围主要分为五个区域:北美、亚太、欧洲、中东和非洲、南美和中美。
北美制药隔离器市场分为美国、加拿大和墨西哥。2021 年,美国占据了北美最大的制药隔离器市场份额。市场增长的驱动因素包括美国制药隔离器的采用率不断提高、公共卫生意识不断增强、政府战略活动不断增加以及领先企业的存在。灭菌方法的使用率不断提高、不合规成本不断增加、研究实验室不断增加以及隔离器效率不断提高,这些因素正在刺激全球制药隔离器市场的增长。此外,制药隔离器可以有效地处理危险材料,再加上新产品的推出,也有助于实现增长。一些制造商正在采用创新的商业战略来多样化其产品组合并扩大其在全球范围内的影响力。通过研发活动进行产品开发是帮助市场参与者提高市场份额的关键战略之一。例如,2017 年 4 月,领先的串行设备网络硬件供应商 Perle Systems 宣布推出新产品 RS232 串行接口隔离器,可用于工厂、实验室以及工业和零售行业。市场参与者中流行的另一个重要趋势是隔离器的定制和个性化,以避免污染风险、保护人员并提供无缝产品。
此外,技术进步和全球实验室隔离器市场领导者推出的创新设备可能会在未来几年刺激市场增长。例如,美国的 Geneva Scientific LLC 目前提供用于负压和正压再循环的医院药房隔离器。与生物安全柜和层流洁净工作台等开放式洁净空气系统相比,该设备可提供卓越的产品无菌性。Class Biologically Clean, Ltd. 提供带有聚丙烯储存箱的育种隔离器。该设备用于利用公司的柔性薄膜材料培育无菌啮齿动物的选择性群落。类似的推出将为全球实验室隔离器市场带来积极影响,为新产品的开发提供健康的竞争平台
制药隔离器市场报告范围
报告属性 | 细节 |
---|---|
2023 年的市场规模 | 70.2亿美元 |
2031 年市场规模 | 134.9亿美元 |
全球复合年增长率(2023 - 2031) | 8.50% |
史料 | 2021-2022 |
预测期 | 2024-2031 |
涵盖的领域 | 按类型
|
覆盖地区和国家 | 北美
|
市场领导者和主要公司简介 |
|
- 示例 PDF 通过定性和定量分析展示了内容结构和信息的性质。
制药隔离器市场新闻和最新发展
制药隔离器市场通过收集一级和二级研究后的定性和定量数据进行评估,其中包括重要的公司出版物、协会数据和数据库。下面列出了制药隔离器市场的一些发展情况:
- Getinge 推出 ISOPRIME;一款具有全面连接和可追溯性功能的隔离器。对于寻求兼具高品质、多功能性和连续操作且价格具有竞争力的刚性壁隔离器的客户来说,它是理想的解决方案。(来源:Getinge,新闻稿,2023 年 6 月)
- Comecer 与 G-CON 合作,加快实施细胞和基因治疗 cGMP 制造设施。G-CON 的新无菌设施集成了 Comecer 的上游加工和下游灌装技术,提供交钥匙无菌设施解决方案,包括隔离技术。(来源:Comecer,新闻稿,2021 年 6 月)
制药隔离器市场报告覆盖范围和交付成果
“制药隔离器市场规模和预测(2021-2031)”报告对以下领域进行了详细的市场分析:
- 范围内涵盖的所有主要细分市场的全球、区域和国家层面的制药隔离器市场规模和预测
- 制药隔离器市场趋势以及市场动态,如驱动因素、限制因素和关键机遇
- 详细的 PEST/波特五力分析和 SWOT 分析
- 制药隔离器市场分析涵盖主要市场趋势、全球和区域框架、主要参与者、法规和最新的市场发展。
- 行业格局和竞争分析,涵盖市场集中度、热图分析、知名参与者以及医药隔离器市场的最新发展
- 详细的公司简介
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
This text is related
to segments covered.
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
This text is related
to country scope.
Frequently Asked Questions
The market is expected to register a CAGR of 8.50% during 2023–2031.
ITECO SRL, Schematic Engineering Industries, Nuaire Inc., Comecer, Getinge AB, Hosokawa Micron Group, Fedegari Autoclavi S.p.A., Azbil Telstar, Gelman Singapore
Adopting automation in pharmaceutical isolators will likely remain a key trend in the market.
Key factors driving the market are an Increase in pharmaceutical and biotechnology industry investments and a regulatory framework to support the adoption of pharmaceutical isolators.
North America dominated the pharmaceutical isolator market in 2023
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published and advised several client across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organization are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.