病毒过滤市场基于(关键地区、市场参与者、规模和份额)- 到 2031 年的预测

  • Report Code : TIPHE100001427
  • Category : Biotechnology
  • Status : Published
  • No. of Pages : 169
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病毒过滤是一种有效的病毒清除技术,可应用于多个生物制品领域。全球病毒过滤市场预计将从 2017 年的 21.394 亿美元增至 2025 年的 55.554 亿美元。预计 2018 年至 2025 年间,该市场将以 13.0% 的复合年增长率增长。

生物制药行业由于慢性病患病率的上升,近年来出现了快速增长。与小分子不同,生物药物是使用动物、植物和合成来源的混合物配制的。一些生物治疗产品是使用哺乳动物细胞系或人血浆生产的。所有这些都使污染的机会增加十倍。这些产品被病毒污染的风险是危险的;因此,监管机构要求制造商评估病毒污染的风险,并采取必要措施减轻风险。病毒过滤市场广泛用于生物制药产品的纯化,以避免风险并遵守监管机构制定的安全规范。制药公司加大了对病毒过滤的投资,因为它将在生物制药药品的安全方面发挥巨大作用。

在实验室中,病毒很容易污染空气、水和测试样品。因此,病毒过滤的必要性势在必行。连续生物工艺在单克隆抗体生产中迅速发展,提供了潜在的优势,例如更小的设施占地面积、更低的投资成本、灵活性和工艺经济性。在此过程中,连续的下游处理依赖于病毒过滤。病毒过滤市场方法使用膜屏障截留病毒颗粒,以维持无污染的环境。它是一种强大、可靠的病毒清除技术,被各种垂直行业的最终用户所使用。全球病毒过滤市场的增长是由生物制剂和生物制药产品制造的增加、严格的监管规范以及研发和外包活动投资的增加推动的。

驱动因素

病毒过滤的快速增长制药和生物技术行业

过去几年,制药行业取得了巨大的发展。对新药、先进疗法、快速数字化和不断变化的法规的需求给制造商和合同研究组织 (CRO) 带来了医疗保健挑战。根据世界卫生组织 (WHO) 的数据,全球人口每年增长 1.24%,导致药品和药物的需求过剩。到2017年,医药行业的增长比之前的预测高出30%,继续保持在前五位行业的地位,并为全球经济增加了价值。一些药品制造商生产价格实惠的药品,以满足发展中经济体的中等收入人群的需求。每一种新药物配方都必须进行强制性病毒清除测试,以评估已知或未知病毒痕迹的消除情况。

严格的监管框架

主要监管机构,例如食品和药物管理局。药品管理局 (FDA)、欧洲药品管理局 (EMA) 和其他机构持续跟踪和监控制药和生物技术行业的发展。制造商遵守更新后的法规,遵循现行的良好生产规范 (GMP) 和良好实验室规范 (GLP)。任何偏离规定方案的行为都可能导致相关制造商或外包组织的临床试验终止。美国 FDA 为制药公司发布了有关人类细胞系或动物来源产品的病毒安全性评估指南。医疗保健管理机构执行的如此严格的法规要求在药物开发过程中进行病毒清除测试。

限制

病毒清除替代技术的可用性

偶然的情况病毒制剂在生物药物生产中具有固有的污染风险。监管机构已经提前解决了这些问题。病毒过滤的成功取决于对合适方法的偏好。适当的方法是各种生物学和临床因素的函数。一些著名的方法包括添加低 pH 缓冲液、温度保持和去污剂处理,以灭活生物处理溶液中的病毒。在这些可行的方法中,仅当溶液无法通过高压灭菌进行灭菌时才采用病毒过滤技术。这不再需要过滤,从而阻碍了全球病毒过滤市场的增长。

战略见解

市场细分

按产品划分

生物制药工艺中的高过滤度支撑细分市场主导地位

根据产品,全球病毒过滤市场分为过滤系统、试剂盒和试剂、服务等。其中,试剂盒和试剂细分市场在2017年占据了显着的市场份额。在实验室规模的测试和生物制药生产过程中,试剂盒和试剂可以有效地从重组蛋白、单克隆抗体和组织提取物中去除病毒。即用型商业试剂盒专门用于病毒 DNA 纯化、qPCR 和免疫学应用。这些试剂盒的膜设计用于从水溶液和底物中去除特定大小的病毒。值得注意的是,这些试剂盒和试剂简单、安全,不需要太多专业知识和简单的方案。

过滤系统领域是 2017 年全球病毒过滤市场的第二大占有者。这些过滤系统通常用于去除细小病毒或其他含有蛋白质外壳的特定类型。过滤系统比其他病毒去除技术更有优势,因为它们不会使样品的蛋白质变性。此外,这些系统有助于提高总吞吐量并降低总体病毒过滤成本。因此,它们在医疗器械制造和制定研究程序中被大量采用。

按应用

进行多项临床测试的制药公司推动了该细分市场的市场份额

根据应用,病毒过滤市场领域分为生物制剂、医疗器械、水净化和空气净化。其中,生物制剂领域在2017年引领市场,收入份额最大。在生物治疗中,一些物质要么在体内天然存在,要么在实验室培养。这些过程涉及多种导致病毒污染的情况。因此,在向监管机构提交测试结果之前,通过病毒清除测试评估与血浆衍生疗法相关的病毒安全性。所有进行临床试验测试的制药公司和 CRO 预计将在未来几年促进相关领域的增长。

水净化领域预计将在整个预测期内大幅扩张。水中的肠道病毒会对人类和动物造成严重的健康危害。它们对水生环境有很强的抵抗力,会造成水污染。过滤是一种经济有效且清晰的方法,可以产生出色的消毒效果并防止病毒在水中繁殖。从含有大量水的培养基中纯化病毒抗原也变得至关重要。消除水中的病毒体可实现最佳的疫苗接种效果。

区域市场

北美是最大的病毒过滤市场,其中美国占有最大的市场份额,其次是加拿大。生物制药和生物技术公司、主要市场参与者以及各个学术和研究机构提出了对病毒过滤系统的需求,进一步刺激了北美全球病毒过滤市场的增长。

欧洲在病毒过滤系统中占据重要地位。全球病毒过滤市场,由于政府和私人对生物制品和药品研究的资助,预计将出现强劲的增长。此外,创新技术的推出可能是推动欧洲该市场增长的主要因素。由于拥有大型生物技术公司、高科技研究实验室以及大量的研发资金,德国是欧洲最大的生物技术中心。

病毒过滤市场利润丰厚的地区

欧洲和北美见证了许多发展。这就是预计这些地区的市场在预测期内表现良好的可能原因。

亚太地区研究中心和政府资助的增加推动了该地区市场的增长。政府机构提供资助以增加年轻研究人员的参与。

中东和中东地区非洲由三个主要国家组成:阿拉伯联合酋长国(阿联酋)、沙特阿拉伯和南非。该地区的市场是由多个研究机构开展的广泛研究项目以及基础设施和研究设施的可用性推动的。政府在研发、医疗保健和技术先进设备的可用性方面的举措推动了病毒过滤市场的增长。由于最近的技术发展,中美洲病毒过滤市场不断增长。低成本优势和较高的工作效率是制造企业在南美设立基地的主要吸引力。

主要市场参与者:

  • MERCK KGAA(德国)
  • Sartorius AG(德国)
  • Danaher (Pall Corporation)(美国)
  • Thermo Fisher Scientific Inc(美国)
  • 通用电气(美国)
  • Charles River(美国)
  • 无锡药明康德(中国)
  • Lonza(瑞士)
  • 旭化成株式会社(日本) )
  • Clean Cells(法国)

主要进展:

  • 2018 年 2 月:默克推出 Viresolve Barrier 胶囊过滤器,以减少生物反应器污染风险。这些胶囊可去除细胞培养基中的病毒、支原体和细菌。
  • 2017 年 9 月:赛多利斯在哥廷根启动了一个新的设施中心,用于制造天平、超纯水系统和水分分析仪等实验室仪器。
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  • 2016 年 9 月:Pall Corporation 推出 Pegasus Prime 病毒去除过滤器,为关键制造流程提供小病毒截留功能。
  • 2016 年 4 月:Charles River Laboratories 收购了安全评估的主要提供商 WIL Research 、合同开发和制造服务。

报告覆盖范围

全球病毒过滤市场研究报告提供了有关市场份额、规模、趋势和机遇的详细见解。它简要介绍了影响市场波动的驱动因素和限制因素的作用。此外,还详细阐述了行业格局、市场概况和全球业务分析,以帮助确定未来的业务投资。随

Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

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to segments covered.

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
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Frequently Asked Questions


Which product segment is expected to garner the highest traction within the virus filtration market?

In 2017, the kits & reagents segment held a largest market share of 54.4% of the virus filtration market, by product. This segment is also expected to dominate the market in 2025 owing to increasing demand for kits and reagents in biotechnology and pharmaceutical companies.

Which segment is witnessing fastest growth rate in the virus filtration market?

The services segment is anticipated to witness the fastest growth rate of 14.9% during the forecast period, 2018 to 2025.

What are the driving factors for the virus filtration market across the globe?

The growth of the Virus filtration in market is attributed to the rising application of Virus filtration, launch of new virus filtration system, adoption of inorganic strategies by market players and rising demand for virus filtration technologies in biotechnology and pharmaceuticals.

The List of Companies

1. Merck KGaA
2. Sartorius AG
3. Danaher (Pall Corporation)
4. Thermo Fisher Scientific, Inc.
5. General Electric
6. Charles River
7. Wuxi Apptec
8. Lonza
9. Asahi Kesai Corporation
10. Clean Cells

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. 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.

  1. 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:

Research Methodology

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.

  1. 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.

  1. 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.

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