生物制剂安全测试市场基于(关键地区、市场参与者、规模和份额)- 到 2031 年的预测

  • Report Code : TIPRE00004393
  • Category : Life Sciences
  • No. of Pages : 150
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生物制剂安全测试市场预计在 2023 年至 2031 年期间的复合年增长率为 11.4%,市场规模将从 2023 年的 XX 百万美元扩大到 2031 年的 XX 百万美元。

报告按产品和服务(试剂盒和试剂、服务和仪器)、测试类型(内毒素测试、无菌测试、细胞系认证和特性测试、细胞系认证、生物负载测试、残留宿主污染物检测测试、外来因子检测测试和其他)、应用(疫苗开发、血液制品测试、细胞和基因治疗、组织和组织相关产品测试以及干细胞研究)、最终用户(制药和生物技术公司、CRO 和 CDMO、学术和研究中心)进行细分

报告目的

The Insight Partners 发布的《生物制剂安全测试市场》报告旨在描述当前形势和未来增长、主要驱动因素、挑战和机遇。这将为各种业务利益相关者提供见解,例如:

  • 技术提供商/制造商:了解不断变化的市场动态并了解潜在的增长机会,从而能够做出明智的战略决策。
  • 投资者:对市场增长率、市场财务预测以及整个价值链中存在的机会进行全面的趋势分析。
  • 监管机构:监管市场政策和警察活动,旨在最大限度地减少滥用行为,维护投资者的信任和信心,维护市场的完整性和稳定性。

 

生物制剂安全测试市场细分

 

產品與服務

  • 试剂盒和试剂
  • 服务
  • 仪器

测试类型

  • 内毒素检测
  • 无菌测试
  • 细胞系认证和特性测试
  • 细胞系认证
  • 生物负载测试
  • 残留宿主污染物检测测试
  • 外来因子检测试验
  • 其他的

应用

  • 疫苗研发
  • 血液制品检测
  • 细胞和基因治疗
  • 组织及组织相关产品测试
  • 干细胞研究

最终用户

  • 制药及生物技术公司
  • CRO 和 CDMO
  • 学术及研究中心

最终用户

  • 制药及生物技术公司
  • CRO 和 CDMO
  • 学术及研究中心

 

定制此报告以满足您的需求

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生物制剂安全测试市场:战略洞察

Biologics Safety Testing Market
  • 获取此报告的关键市场趋势。
    这个免费样品将包括数据分析,从市场趋势到估计和预测。

 

生物制剂安全测试市场增长动力

  • 监管要求不断提高:生物制剂安全测试监管要求的提高是市场增长的主要驱动力之一。例如,FDA 和 EMA 已经制定并执行了其他测试此类生物制剂的标准,如果严格执行,将迫使各组织改进其安全测试技术。这种“升级”不仅是由专利到期推动的,也是由测试的额外要求推动的,从而导致新的市场探索。
  • 生物制剂需求不断增长:生物制剂在治疗慢性和复杂疾病方面的有效性不断提高,这促使其被越来越多人接受。这导致生物制剂安全测试市场的增长。生物制药行业的扩张意味着越来越多的生物制剂将被开发并上架。因此,这需要对此类产品进行有效的安全评估。这意味着,由于这些测试的制造和与这些疗法的安全相关的其他服务,生产能力很大,而不必承担高昂的成本。
  • 越来越重视质量保证:生物制药市场对质量保证问题的关注度不断上升,推动了生物制剂安全测试市场的发展。制造商对​​严格的测试流程的兴趣日益浓厚,以避免产品召回和不良反应风险,这推动了该市场的需求。不仅仅是市场的增长,还有别有用心,例如提供可靠的生物制剂安全测试,这将引起患者的关注,这是导致市场需求上升的另一个因素。

生物制剂安全测试市场未来趋势

  • 采用自动化和高通量测试:该市场的上升趋势表明采用自动化和高通量测试。这些技术允许在实验室分析大样本,从而更容易优化此类测试流程。高生产率、减少错误和提高安全评估的可靠性与对结果的需求增加有关。此外,这些还缩短了与生物制剂开发相关的时间。
  • 先进分析技术的集成:生物制剂安全测试的面貌正在通过先进的分析技术发生变化。其中包括下一代测序和质谱分析。这些新技术能够更精确地检测杂质、污染物和遗传变异,并提高灵敏度。生物制药公司将随着监管的变化而改变,提高安全测试和合规性的准确性,从而保护患者的安全。
  • 强调基于风险的方法:生物制剂安全测试是一种趋势,源于更加强调实施基于风险的方法。现在,越来越多的公司不再仅仅应用传统的测试方法,而是在寻找和减轻可能对其产品产生不利影响的特定生物制剂风险。这种方法使组织能够更有效地利用资源,并确保在各个开发点的最佳安全条件。

生物制剂安全测试市场机会

  • 个性化医疗的增长:生物制剂安全测试市场在个性化医疗领域具有巨大的发展空间。根据患者资料进行定制治疗进一步增加了对特定安全测试的需求。公司可以利用这一点,提供定制测试解决方案,满足个性化生物制剂安全测试的特定需求。因此,可以提高患者的治疗效果并增加市场份额。
  • 与生物制药公司的合作:与生物制药公司的合作为测试提供商提供了一个急需的生物制剂安全性窗口。在这方面,与他们的合作使测试实验室掌握了有关生物制剂的最新发展,从而可以相应地调整其服务。事实上,合作完善了测试方法、效率水平和审查流程的开发,这些开发符合当前行业标准和安全性审查流程的指导方针。
  • 向新兴市场扩张:地域扩张是推动生物制剂安全测试市场增长的关键增长动力之一。这些地区正在不断建立自己的生物制药行业,对安全测试服务的需求只会进一步增加。战略性地开始进军这些市场的公司可以利用对生物制剂及其相关测试解决方案的激增需求,扩大其全球影响力,并为服务不足的人群提供更好的医疗保健结果。

 

生物制剂安全测试市场区域洞察

Insight Partners 的分析师已详细解释了预测期内影响生物制剂安全测试市场的区域趋势和因素。本节还讨论了北美、欧洲、亚太地区、中东和非洲以及南美和中美洲的生物制剂安全测试市场细分和地理位置。

Biologics Safety Testing Market
  • 获取生物制剂安全测试市场的区域特定数据

生物制剂安全测试市场报告范围

报告属性细节
2023 年的市场规模XX 百万美元
2031 年市场规模XX 百万美元
全球复合年增长率(2023 - 2031)11.4%
史料2021-2022
预测期2024-2031
涵盖的领域按产品和服务
  • 试剂盒和试剂
  • 服务
  • 仪器
按测试类型
  • 内毒素检测
  • 无菌测试
  • 细胞系认证和特性测试
  • 细胞系认证
  • 生物负载测试
  • 残留宿主污染物检测测试
  • 外来因子检测试验
  • 其他的
按应用
  • 疫苗研发
  • 血液制品检测
  • 细胞和基因治疗
  • 组织及组织相关产品测试
  • 干细胞研究
按最终用户
  • 制药及生物技术公司
  • CRO 和 CDMO
  • 学术及研究中心
覆盖地区和国家北美
  • 我们
  • 加拿大
  • 墨西哥
欧洲
  • 英国
  • 德国
  • 法国
  • 俄罗斯
  • 意大利
  • 欧洲其他地区
亚太
  • 中国
  • 印度
  • 日本
  • 澳大利亚
  • 亚太其他地区
南美洲和中美洲
  • 巴西
  • 阿根廷
  • 南美洲和中美洲其他地区
中东和非洲
  • 南非
  • 沙特阿拉伯
  • 阿联酋
  • 中东和非洲其他地区
市场领导者和主要公司简介
  • Avance Biosciences 公司
  • 查尔斯河国际实验室有限公司
  • Cytovance Biologics 公司
  • 欧陆科技
  • 龙沙集团有限公司
  • 默克公司
  • 瑞士通用公证行
  • 无锡新药开发有限公司
  • 赛多利斯公司

 

生物制剂安全测试市场参与者密度:了解其对业务动态的影响

生物制剂安全测试市场正在快速增长,这得益于最终用户需求的不断增长,而这些需求又源于消费者偏好的不断变化、技术进步以及对产品优势的认识不断提高等因素。随着需求的增加,企业正在扩大其产品范围,进行创新以满足消费者的需求,并利用新兴趋势,从而进一步推动市场增长。

市场参与者密度是指在特定市场或行业内运营的企业或公司的分布情况。它表明在给定市场空间中,相对于其规模或总市场价值,有多少竞争对手(市场参与者)存在。

在生物制剂安全测试市场运营的主要公司有:

  1. Avance Biosciences 公司
  2. 查尔斯河国际实验室有限公司
  3. Cytovance Biologics 公司
  4. 欧陆科技
  5. 龙沙集团有限公司

免责声明上面列出的公司没有按照任何特定顺序排列。


Biologics Safety Testing Market

 

  • 了解生物制剂安全测试市场主要参与者概况

 

 

主要卖点

 

  • 全面覆盖:报告全面涵盖了生物制剂安全测试市场的产品、服务、类型和最终用户的分析,提供了整体概况。
  • 专家分析:报告基于对行业专家和分析师的深入了解而编写。
  • 最新信息:该报告涵盖了最新信息和数据趋势,确保了其与业务的相关性。
  • 定制选项:此报告可以定制以满足特定客户要求并恰当地适应业务策略。

因此,生物制剂安全测试市场研究报告有助于引领解读和了解行业情景和增长前景。尽管可能存在一些合理的担忧,但本报告的总体优势往往大于劣势。

  • 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

This text is related
to country scope.

Frequently Asked Questions


What is the expected CAGR of the biologics safety testing market?

  The biologics safety testing market is estimated to grow with a CAGR of 11.4% from 2023 to 2031.

Which region is expected to witness fastest growth rate by 2031?

Asia Pacific region is likely to witness fastest growth rate during the forecast period.

Which are the leading players operating in the biologics safety testing market?

The biologics safety testing market majorly consists of the players such as Agilent Technologies, Inc.,Almac Group, and BioMérieux SA among others.

What are the future trends of the biologics safety testing market?

Adoption of automation and high-throughput testing are likely to remain the key trend during the forecast period

What are the driving factors impacting the biologics safety testing market?

The market drivers include increasing regulatory requirements and rising demand for biologics are driving the biologics safety testing market

Which region dominated the biologics safety testing market in 2023?

North America dominated the biologics safety testing market in 2023

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The List of Companies

1. Avance Biosciences Inc.
2. Charles River Laboratories International, Inc.
3. Cytovance Biologics, Inc.
4. Eurofins Scientific Se
5. Lonza Group Ltd.
6. Merck KGaA
7. SGS S. A.
8. Wuxi Apptec
9. Sartorius AG
10. Toxikon Corporation
11. Thermo Fisher Scientific Inc.
12. Pace Analytical Services 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.