生物工艺验证市场基于(关键地区、市场参与者、规模和份额)- 到 2031 年的预测

  • Report Code : TIPRE00006427
  • Category : Life Sciences
  • No. of Pages : 150
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市场概述验证是一种建立书面证据的方法,证明在生产或测试中进行的流程、活动或程序在各个阶段都保持了所需的合规水平。验证是一种记录和证明任何流程、程序和活动将始终如一地达到所需结果的行为。它包括设备和系统的鉴定。 市场范围 “到2031年全球生物工艺验证市场分析”是对医疗保健行业的专业深入研究,特别关注全球市场趋势分析。该报告旨在提供生物过程验证市场的概述,并按过程组件、测试类型、最终用户和地理位置进行详细的市场细分。该报告提供了领先的生物过程验证市场参与者的市场状况的关键统计数据,并提供了市场的主要趋势和机会。 市场细分
    • 根据测试类型,全球生物过程验证市场分为可提取物和可浸出物、完整性测试、微生物测试。 • 根据工艺组件,全球生物工艺验证市场分为过滤元件、生物反应器 • 根据最终用户,全球生物工艺验证市场分为 CDMO、生物技术和制药公司。
市场动态 驱动因素:
    • 制药和生物技术行业的发展加快 • 越来越多地采用基于激光的技术
限制:
    • 回想一下
该报告提供了该行业的详细概述,包括定性和定量信息。它提供了基于各个细分市场的全球市场的概述和预测。它还提供了 2021 年至 2031 年五个主要地区的市场规模和预测估计,即:北美、欧洲、亚太地区 (APAC)、中东和非洲 (MEA) 以及南美洲。每个地区的生物工艺验证市场随后按各自的国家和细分市场进行细分。该报告涵盖了全球18个国家以及该地区当前趋势和机遇的分析和预测。报告从需求和供给两个方面分析了影响市场的因素,并进一步评估了预测期内影响市场的市场动态,即驱动因素、限制因素、机会和未来趋势。该报告还为所有五个地区提供了详尽的 PEST 分析,即:在评估影响北美、欧洲、亚太地区、MEA 和南美洲的政治、经济、社会和技术因素后,这些地区的生物过程验证市场。 COVID-19 对生物工艺验证市场的影响COVID-19 于 2021 年 12 月首次在中国武汉爆发,此后在全球范围内快速传播。从确诊病例和死亡人数来看,美国、印度、巴西、俄罗斯、法国、英国、土耳其、意大利和西班牙是受影响最严重的国家。由于封锁、旅行禁令和企业关闭,COVID-19 一直在影响各国的经济和行业。各种工厂和工厂的关闭影响了全球供应链,并对全球市场产品的制造、交货时间表和销售产生了负面影响。然而,由于新冠肺炎病例的增加,对生物过程验证的需求有所增加。 市场参与者 该报告涵盖了生物过程验证市场作为有机和无机增长战略的主要发展。许多公司都专注于有机增长战略,例如产品发布、产品批准以及专利和活动等其他战略。市场上出现的无机增长战略活动包括收购、伙伴关系和合作。这些活动为市场参与者扩大业务和客户群铺平了道路。随着全球市场对生物过程验证的需求不断增长,生物过程验证市场的市场支付者预计未来将获得利润丰厚的增长机会。该报告还包括生物过程验证市场中主要公司的概况及其 SWOT 分析和市场策略。此外,该报告重点关注领先的行业参与者,提供公司简介、所提供的组件和服务、过去三年的财务信息、过去五年的关键发展等信息。
    • 默克公司 • 颇尔公司(丹纳赫公司的一部分) • 赛多利斯斯泰帝生物技术有限公司 •  SGS SA • 欧陆科技 • 科百特过滤设备有限公司•  Toxikon 公司 •  Doc SRL • 迈斯纳过滤产品有限公司 •  Thermo Fisher Scientific, Inc.
Insight 合作伙伴的专业研究和分析团队由经验丰富的专业人员组成,具有先进的统计专业知识,并在现有研究中提供各种定制选项。
  • Historical Analysis (2 Years), Base Year, Forecast (7 Years) with CAGR
  • PEST and SWOT Analysis
  • Market Size Value / Volume - Global, Regional, Country
  • Industry and Competitive Landscape
  • Excel Dataset
Report Coverage
Report Coverage

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

Segment Covered
Segment Covered

This text is related
to segments covered.

Regional Scope
Regional Scope

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

Country Scope
Country Scope

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to country scope.

Frequently Asked Questions


What is the expected CAGR of the Bioprocess Validation Market?

Bioprocess Validation Market is expected to grow at a CAGR of 14.5% between 2023-2031

What are the driving factors impacting the Bioprocess Validation Market?

Major factors driving the Bioprocess Validation market include the increasing demand for biologics and biosimilars. These products by nature are regulated by stricter regulatory compliance and rigorous validation. Furthermore, advances in biomanufacturing, such as single-use systems and continuous manufacturing, need to be validated to ensure quality and consistency of final products. Additionally, with the increase in personal medicine and cell and gene therapies-based products requiring complex manufacturing, there is a better scope for strong bioprocess validation. The Bioprocess Validation market is likely to experience lucrative growth and change in the following years.

What are the future trends of the Bioprocess Validation Market?

Validation process will change dramatically with the advancements of artificial intelligence and machine learning of digital technologies, allowing users to get the predictive analytics, real-time monitoring, and automatic analysis of data. This trend of personalized medicine, along with cell and gene therapies, calls for more sophisticated and customized validation strategies. Sustainable issues and awareness about increasing environmental impacts will demand greener bioprocesses, which will have to be thoroughly validated to ensure proper regulatory compliance. This would ensure sustained growth in the market because demand for robust bioprocess validation solutions will stay strong as the industry continues to grow with the biopharmaceuticals industry.

Which are the leading players operating in the Bioprocess Validation Market?

The leading players of the market are: Merck KGaA, Pall Corporation (A Part of Danaher Corporation), Sartorius Stedim Biotech S.A., SGS S.A., Eurofins Scientific, Cobetter Filtration Equipment Co., Ltd., Toxikon Corporation, Doc S.R.L., Meissner Filtration Products, Inc., Thermo Fisher Scientific, Inc.

What are the deliverable formats of the Bioprocess Validation Market report?

The report can be delivered in PDF/PPT format; we can also share excel dataset based on the request.

What are the options available for the customization of this report? 

Some of the customization options available based on request are additional 3-5 company profiles and country-specific analysis of 3-5 countries of your choice. Customizations are to be requested/discussed before making final order confirmation, as our team would review the same and check the feasibility.

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The List of Companies

1. Merck KGaA
2. Pall Corporation (A Part of Danaher Corporation)
3. Sartorius Stedim Biotech S.A.
4. SGS S.A.
5. Eurofins Scientific
6. Cobetter Filtration Equipment Co., Ltd.
7. Toxikon Corporation
8. Doc S.R.L.
9. Meissner Filtration Products, Inc.
10. Thermo Fisher Scientific, Inc.

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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.