临床前 CRO 市场基于(主要地区、市场参与者、规模和份额)- 预测至 2031 年

  • Report Code : TIPRE00003316
  • Category : Life Sciences
  • No. of Pages : 150
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2023 年临床前 CRO 市场规模估计为 55.2 亿美元,预计到 2031 年将达到 111.9 亿美元;预计到 2031 年的复合年增长率为 9.2%。临床试验数量的增加可能仍是临床前 CRO 市场的主要趋势。

 

临床前 CRO 市场分析

罕见病的发病率不断上升,制药公司将药物开发外包给 CRO 的数量不断增加,这推动了临床前 CRO 市场的增长。此外,临床前开发的改进降低了成本,缩短了时间,这也推动了临床前 CRO 市场的增长。例如,制药公司将获得 FIH 申请所需的时间缩短了 40% 或更多,药物从候选药物提名到开始临床试验仅需 12 到 15 个月。这样的时间安排不仅使患者能够快速获得创新药物,而且还使制药公司能够通过更长的药物独占期来实现高收入目标。

 

临床前 CRO 市场概览

临床前 CRO 或临床前合同研究组织提供将药品或医疗器械从绘图板到分销所需的经验、知识和技能。大多数赞助组织不具备在特殊监督下进行测试所需的设施和人员,也不具备针对特定药物和医疗器械的适当设置,因此选择承包此类研究。

 

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临床前 CRO 市场:

Preclinical CROs 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。

 

临床前 CRO 市场驱动因素和机遇

 

对 CRO 的偏好日益增加  

随着临床试验越来越成为复杂的程序,正确执行和监督研究型组织中发生的操作非常重要。为了避免由于执行不当而导致的错误,研究型组织正在外包临床试验以开发其产品。CRO 通过使用高质量设施和深厚的专业知识提供的服务协助成功实施临床试验。CRO 已开始通过其高效且具有成本效益的运营成为临床试验行业的骨干,这些运营使试验发起人受益。根据赛默飞世尔科技发表的博客,2022 年,大约 4 分之 3 的临床试验是由 CRO 进行的。CRO 不仅可以确保药物开发商的临床计划,还可以提供丰富的专业知识、提高时间和成本效率,并提供定制的高质量数据。开发具有成本效益的解决方案并减少药物开发过程中 CRO 的错误也推动了临床前 CRO 市场的增长。

 

生物仿制药和生物制剂的兴起——临床前 CRO 市场的机遇Biosimilar and Biologics – An Opportunity of Preclinical CROs Market

生物治疗是制药行业中增长最快的领域。生物治疗的有效性和安全性与治疗各种无法治愈的疾病的能力相关,是推动生物仿制药和生物制剂增长的主要因素。技术进步和对癌症、类风湿性关节炎等疾病理解的显著提高,生物仿制药和生物制剂的开发创造了需求。制药和生物制药公司正在大力投资研发活动,以开发创新和先进的生物分子。公司正在利用其在生物制剂制造方面的专业知识,通过满足未满足的条件来创造更多收入。近年来,生物制剂许可申请 (BLA) 有所增加。生物制剂是大型复杂分子,其大小是小分子仿制药的 1,000 倍。在一种新的生物制药产品在美国上市之前,FDA 必须批准新药的 NDA 或生物制剂的 BLA。 FDA 批准 NDA 或 BLA 之前所需的步骤通常包括临床前研究,随后进行多个阶段的临床试验。为了节省生物制剂和生物仿制药开发过程中这些测试服务所需的内部成本和时间,公司更愿意将这些服务外包给临床前 CRO。预计这将是未来几年全球临床前 CRO 增长的潜在机会。

 

临床前 CRO 市场报告细分分析

有助于得出临床前 CRO 市场分析的关键部分是服务和最终用户。

  • 根据服务,临床前 CRO 市场细分为生物分析和 DMPK 研究、毒理学和其他服务。毒理学部分在 2023 年占据了最大的市场份额。
  • 根据最终用户,临床前 CRO 市场分为生物制药公司、政府和学术机构以及医疗器械公司。生物制药公司部门在 2023 年占据了最大的市场份额。

 

临床前 CRO 市场份额(按地区)分析

临床前 CRO 市场报告的地理范围主要分为五个地区:北美、亚太、欧洲、中东和非洲、南美和中美。

北美主导了临床前 CRO 市场。该市场的增长主要得益于研发支出的增加。此外,由于专利到期,各制药公司都面临利润率低的问题,因此,制造商开始通过合同研究组织外包这些研究来减少内部研发活动。这导致临床前 CRO 经历了显着增长。生物技术和制药公司降低药物开发成本而展开的对抗预计将推动北美临床前 CRO 市场的发展。此外,孤儿病和罕见病领域对服务和药物的需求增加预计将刺激药物制造商通过 CRO 咨询专业治疗和全球站点关系,以帮助他们设计更智能的药物并招募患者进行临床试验。此外,预计亚太地区将在未来几年录得最高复合年增长率。 

 

 

临床前 CRO 市场区域洞察

Insight Partners 的分析师已详细解释了预测期内影响临床前 CRO 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临床前 CRO 市场细分和地理位置。

Preclinical CROs Market
  • 获取临床前 CRO 市场的区域特定数据

临床前 CRO 市场报告范围

报告属性细节
2023 年的市场规模55.2亿美元
2031 年市场规模111.9亿美元
全球复合年增长率(2023 - 2031)9.2%
史料2021-2022
预测期2024-2031
涵盖的领域按服务
  • 生物分析和 DMPK 研究
  • 毒理学
  • 其他服务
按最终用户
  • 生物制药公司
  • 政府及学术机构
  • 医疗器械公司
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
  • Covance 公司
  • 查尔斯河
  • 欧陆科技
  • PRA 健康科学
  • 药明康德
  • Medpace 公司
  • 医药产品开发有限责任公司
  • 精鼎国际公司
  • ICON 股份有限公司
  • MD 生物科学

市场参与者密度:了解其对商业动态的影响

临床前 CRO 市场正在快速增长,这得益于终端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。

在临床前 CRO 市场运营的主要公司有:

  1. Covance 公司
  2. 查尔斯河
  3. 欧陆科技
  4. PRA 健康科学
  5. 药明康德
  6. Medpace 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。


Preclinical CROs Market

 

  • 获取临床前 CRO 市场顶级关键参与者概览

 

临床前 CRO 市场新闻和最新发展

通过收集初步和二次研究后的定性和定量数据来评估临床前 CRO 市场,其中包括重要的公司出版物、协会数据和数据库。以下是医疗保健欺诈分析和策略市场发展列表:

  • 总部位于美国的全球合同研究组织 QPS 已在台湾台北开设了第二家临床前研究设施。该设施占地 2,793 平方英尺,将促进研究扩展到其他毒理学研究,并新推出药理学研究能力。(来源:Cision US Inc,新闻稿,2022 年)

 

临床前 CRO 市场报告覆盖范围和交付成果

“临床前 CRO 市场规模和预测(2021-2031 年)”报告对以下领域进行了详细的市场分析:

  • 范围内所有主要细分市场的全球、区域和国家层面的市场规模和预测
  • 市场动态,如驱动因素、限制因素和关键机遇
  • 未来的主要趋势
  • 详细的 PEST/波特五力分析和 SWOT 分析
  • 全球和区域市场分析涵盖关键市场趋势、主要参与者、法规和最新市场发展
  • 行业格局和竞争分析,涵盖市场集中度、热点图分析、知名参与者和最新发展
  • 详细的公司简介
  • 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

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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.

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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.