临床前 CRO 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 : TIPRE00003316
  • Category : Pharmaceuticals
  • Status : Published
  • No. of Pages : 155
Buy Now

[研究报告]临床前CRO市场规模预计将从2018年的42.822亿美元增长到2027年的84.129亿美元;预计 2019 年至 2027 年复合年增长率为 8.1%。

 

分析师观点

临床前 CRO 市场目标支持跨地区的合规法规。一旦采用,它可以提供一个全面的、知识丰富的环境,使早期新药研究 (IND) 成为可能。临床前 CRO 市场分析包括罕见疾病患病率上升以及制药公司为药物开发向 CRO 外包活动数量增加等驱动因素,这些因素是临床前 CRO 市场增长的最有影响力的因素。此外,临床研究的技术进步是 2023-2028 年市场增长的未来趋势。根据报告中的细分,从服务细分来看,毒理学细分市场所占份额最高;从最终用户来看,生物制药公司占据市场最大份额。

< p>临床前 CRO 是一个提供研究和临床专业知识的支持中心。旨在通过动物试验引导候选药物并将其推进临床阶段的开发。此外,临床前研究服务还涉及多项与评估动物模型药物疗效和安全性相关的研究以及完整的研究性新药 (IND) 备案研究。此外,制药组织使用临床前 CRO 的主要目标是快速有效地向市场交付。

战略见解

临床前CRO的主要服务包括:

  • 项目管理
  • 医学测试
  • 毒理学
  • 最大剂量研究
  • li>
  • 监管合规
  • 安全性和功效报告
  • 质量分析
  • 物种专业知识

 < /p>

此外,临床前开发的改进可降低成本并缩短时间。例如,制药公司将达到 FIH 申请所需的时间缩短了 40% 或更多,药物从候选提名到临床试验开始仅需 12 至 15 个月。这样的时间表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市场独占期药物实现高收入目标。

市场洞察

制药公司向 CRO 进行药物开发外包活动的数量不断增加

制药服务外包始于临床开发和制造等领域。此外,快速发展的市场动态鼓励制药公司扩大商业活动中的外包活动范围。例如,制药公司大量投资于研发以发现和开发新药,这可能既耗时又昂贵。因此,通过将研发外包给 CDMO 服务,制药公司可以减少资本支出并节省现金。此外,CDMO 可以投资支持研发的专用设备和设施,从而使制药公司避免进行大量资本投资。

此外,通过减少资本CDMO 可以提供必要的制造能力和专业知识,使制药公司能够将资源集中到其他业务领域。上述因素是预测期内全球临床前 CRO 市场显着增长的原因。

服务洞察

基于服务,临床前 CRO 市场分为生物分析和 DMPK 研究、毒理学和其他服务。毒理学领域在 2019 年占据了最大的市场份额,为 45.7%。毒理学研究用于通过确定药物对器官结构和/或功能的影响来表征药物的毒性特征。毒理学研究揭示了对毒性的严重性和可逆性以及剂量范围和暴露的评估。此外,体内临床前毒理学研究等药理学研究旨在评估毒性作用的发生、严重程度和持续时间、剂量依赖性和可逆性(或不可逆性)程度。此外,像IITRI这样的顶级公司也是按照GLP标准提供临床前毒理学和药物安全性评价服务的优质提供商。此外,该公司还提供全方位的体内毒理学测试服务,支持向美国食品药品监督管理局 (FDA) 和其他监管机构提交申请,涉及完整的 IND 项目和化学毒性评估。上述因素导致了有影响力的细分市场增长,从而主导了预测期内的整体市场增长。

最终用户洞察

基于最终用户,全球临床前 CRO 市场分为生物制药公司、政府和医疗机构。学术机构和医疗器械公司。 2019年,生物制药公司占据了最大的市场份额,达到50.25%。临床前开发受益于新药申请(NDA)的推进,从而加速了生物制药公司创新产品的创新、价值和质量的提高。这种未开发的潜力将增加临床前开发的曝光度。此外,随着临床前研究从目标识别到新药的早期发现、实验生成数据、目标调节、制造、改进,最终产生研究性新药 (IND)。因此,领先的生物制药公司正在寻找新的方法来简化新药发现临床前开发的流程和实践。上述因素导致了有影响力的细分市场增长,从而主导了预测期内的整体市场增长。

临床前 CRO 市场(按服务) - 2019年和2027年

区域分析

北美在临床前CRO市场中占据主导地位,占据最大份额。该地区的市场增长归因于大型企业推出创新产品,特别是临床前 CRO 以及该地区不断推出的产品。在北美地区,美国临床前CRO解决方案的份额最高为60%。根据美国科学促进会 (AAAS) 的报告,美国每年在临床前研究上花费 280 亿美元。由于临床前研究投入如此之高,美国制药公司提取了有关特定或罕见疾病治疗的有用信息。凭借有希望的临床前研究,美国 FDA 允许在受感染的患者群体中测试治疗方法。

同样,预计亚太地区的复合年增长率最高为 12.0%预测期内全球临床前 CRO 市场。在亚太地区,中国将在预测期内占全球临床前CRO市场的最大复合年增长率。归因因素包括新药临床试验(IND)申请和创新药新药申请(NDA)(2010年1月至2020年12月期间在中国申请并批准)。上述因素是预测期内亚太地区临床前 CRO 市场增长的独立因素。

该报告涵盖了全球运营的领先企业临床前CRO市场。其中包括 LabCorp、Charles River Laboratories、Eurofins Scientific、PRA Health Sciences、WuXi AppTec、Medspace, Inc.、Pharmaceutical Product Development, LLC.、Paraxel International Corporation、ICON Plc 和 MD Biosciences。

2022 年 7 月,Biogen, Inc. 宣布美国 FDA 已接受“Tofersen”的新药申请 (NDA),这是一种治疗超氧化物歧化酶 1 (SOD1) 肌萎缩侧索硬化症 (ALS) 的研究药物。 ALS 是一种罕见的、进行性和致命性的神经退行性疾病,会导致大脑和脊髓中负责控制随意肌运动的运动神经元丧失。

公司简介

  • LabCorp
  • 查尔斯河实验室
  • Eurofins Scientific
  • PRA Health Sciences
  • 药明康德
  • Medspace, Inc.
  • 医药产品开发有限公司
  • Paraxel International Corporation
  • ICON Plc
  • MD生物科学。
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.

The List of Companies

  1. Covance, Inc.
  2. Charles River
  3. Eurofins Scientific
  4. PRA Health Sciences
  5. WuXi AppTec
  6. Medpace, Inc.
  7. Pharmaceutical Product Development, LLC
  8. Parexel International Corporation
  9. ICON Plc
  10. MD Biosciences

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.

Your data will never be shared with third parties, however, we may send you information from time to time about our products that may be of interest to you. By submitting your details, you agree to be contacted by us. You may contact us at any time to opt-out.

Related Reports