IVD Contract Research Organization Market Growth Report 2031
体外诊断合同研究组织市场规模预计将从 2023 年的 55.1 亿美元增至 2031 年的 100.4 亿美元。预计 2023-2031 年期间市场复合年增长率将达到 7.80%。技术进步和研发活动的增加可能仍将是市场的主要趋势。
IVD合同研究组织市场分析
由于临床研究的增加,诊断合同研究组织市场预计将更快扩张。市场增长的主要驱动力是对复杂诊断工具的需求不断增长。由于外包活动的采用率高且临床研究数量不断增加,预计亚太地区将增长最快。全球 IVD 合同研究组织市场的企业,如 NAMSA、Proxima Clinical Research, Inc. 和 ICON PLC,都采用了有机和无机增长战略。这些战略既促进了市场扩张,也促进了参与者的商业增长,包括产品发布、合作和收购。
IVD合同研究组织市场概览
多种疾病(包括自身免疫性疾病、癌症和细菌感染)的发病率不断上升,导致体外诊断需求不断增长。因此,对复杂而高效的体外诊断的需求日益增长,以识别疾病并帮助监测和治疗患者的病情。为了满足市场需求,许多行业参与者专注于提供优质的体外诊断产品,从而导致 IVD 产品发布量增加。由于 IVD 临床研究组织需要进行临床前研究以保证产品的有效性和精确度,这些组织的市场正在扩大。例如,Invitae 于 2022 年 2 月宣布 FusionPlex Dx 和 LiquidPlex Dx 现已在欧洲上市。它提供最好的 CE-IVD 产品,使欧洲的肿瘤学家和病理学家能够有效、及时地为患者提供指导其癌症治疗的关键信息。为了对抗癌症,它为精准肿瘤学提供了至关重要的卓越创新。
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IVD 合同研究组织市场:
复合年增长率(2023 - 2031)7.80%- 2023 年市场规模
55.1 亿美元 - 2031年市场规模
100.4亿美元
市场动态
- 体外诊断需求的增加和临床试验的增加有利于市场增长
- 技术进步和研发活动的增加
- 即时诊断检测的增加和来自发展中经济体的潜在机会为市场创造了巨大的机遇
关键人物
- Proxima 临床研究公司 Clinical Research, Inc.
- 克林奈
- 研究诊断
- 南美汽车零部件供应商协会
- 奈克利斯
- 艾肯公司PLC
- 工具箱医疗创新
- 直流输电网络
- 华商国际控股有限公司
- AKRN 科学咨询公司
区域概况
- 北美
- 欧洲
- 亚太
- 南美洲和中美洲
- 中东和非洲
市场细分
- 临床化学
- 分子诊断
- 免疫化学
- 伴随诊断
- 血液学
- 组织学和细胞学
- 微生物学
- 临床研究
- 生物统计和数据管理服务
- 治疗专业知识
- 监管服务
- 报销支持服务
- 检测开发服务
- 示例 PDF 通过定性和定量分析展示了内容结构和信息的性质。
IVD 合同研究组织市场驱动因素和机遇
体外诊断需求的增加和临床试验的增加有利于市场增长
随着癌症、心血管疾病、自身免疫性疾病和健康问题等疾病的发病率不断上升,对有助于治疗的复杂而有效的体外诊断和疾病监测的需求也随之增加。根据美国国家干细胞基金会 (NSCF) 2022 年的报告,自身免疫性疾病困扰着全球约 4% 的人口;在美国,它们影响了总人口的 5-8%。自身免疫性疾病有 80 多种不同的类型。因此,IVD 合同研究组织的市场正在扩大。在评估市场上药物或设备的安全性和有效性时,临床试验是必不可少的。这些研究有助于我们了解最有效的治疗和诊断方法。随着疾病发病率不断上升,对复杂的 IVD 诊断的需求也随之增加,这刺激了临床试验并扩大了 IVD 合同研究组织市场。
此外,由于研发增加和 IVD 诊断开发投资增加,外包活动的采用也随之增长。外包在药物和设备开发服务中越来越受欢迎,因为它可以节省金钱和时间。因此,现在有更多的合同研究公司可以协助制造商创造尖端的 IVD 诊断。例如,预计 2022 年美国将有 4250 个合同研究组织在运营。
因此,由于研发投入的增加、疾病和临床试验的普及以及合同研究组织本身,IVD合同研究组织的市场正在扩大。
即时诊断检测的增加和来自发展中经济体的潜在机会为市场创造了巨大的机遇
基础设施和医疗设施得到改善,人们更倾向于采用先进和成功的治疗方法,而非传统治疗方法。与传统检测服务相比,即时诊断检测 (POCT) 因其快速的结果和治疗患者的能力而需求上升。即时诊断检测的兴起带来了对 IVD 的需求,这为 IVD 合同研究组织市场提供了众多机会。由于中国和印度等新兴经济体,亚太地区预计将大幅增长。亚太国家正成为跨国诊断和医疗设备生产商的外包中心,越来越受欢迎。由于制造和运营成本低以及全球对 IVD 产品的需求不断增长,IVD 合同研究组织的市场预计将扩大。
此外,由于临床研究的贡献不断增加、医疗机构集中化、研究人员素质高、积极性高、临床试验设施一流,亚洲的科学基础和能力也在不断扩大。鉴于亚太地区约占世界人口的 60%,因此其患者群体十分多样化。因此,IVD 合同研究组织市场预计将因上述因素而迎来新机遇。
IVD合同研究组织市场报告细分分析
有助于得出 IVD 合同研究组织市场分析的关键部分是类型和服务。
- 根据类型,IVD 合同研究组织市场细分为临床化学、分子诊断、伴随诊断、免疫化学、微生物学、血液学、组织学和细胞学等。临床化学领域在 2023 年占据了最大的市场份额。
- 根据服务,市场分为临床研究、生物统计和数据管理服务、治疗专业知识、监管服务、报销支持服务、检测开发服务等。生物统计和数据管理服务部门在 2023 年占据了最大的市场份额。
IVD合同研究组织市场份额分析(按地区)
IVD合同研究组织市场报告的地理范围主要分为五个区域:北美、亚太、欧洲、中东和非洲、南美和中美。
北美 IVD 合同研究组织市场分为美国、加拿大和墨西哥。医疗器械和诊断领域的创新不断增长、研发活动不断增加、营销中心完善以及对各种 IVD 监测和治疗医疗器械的需求不断增长,导致新产品的推出,这可能是该地区市场增长的原因。对预防保健的日益重视加上医疗设施的增强,预计将推动美国体外诊断市场的发展。市场参与者专注于为成倍增加的患者群体开发先进的诊断系统,从而实现快速疾病检测。例如,2019 年 2 月,美国诊断服务公司 Grail 从微软和亚马逊获得了约 15 亿美元的财政援助,用于开发快速癌症检测的新技术。此外,CRO 负责的监管合规工作轻松,进一步促进了市场增长
IVD 合同研究组织市场报告范围
报告属性 | 细节 |
---|---|
2023 年的市场规模 | 55.1亿美元 |
2031 年市场规模 | 100.4亿美元 |
全球复合年增长率(2023 - 2031) | 7.80% |
史料 | 2021-2022 |
预测期 | 2024-2031 |
涵盖的领域 | 按类型
|
覆盖地区和国家 | 北美
|
市场领导者和主要公司简介 |
|
- 示例 PDF 通过定性和定量分析展示了内容结构和信息的性质。
IVD合同研究组织市场新闻和最新发展
IVD 合同研究组织市场通过收集一级和二级研究后的定性和定量数据进行评估,其中包括重要的公司出版物、协会数据和数据库。IVD 合同研究组织市场的一些发展如下:
- Parexel 是全球最大的临床研究组织 (CRO) 之一,提供全方位的 I 期至 IV 期临床开发服务,该公司宣布,它在第 19 届年度 Scrip 奖的全方位服务提供商类别中被评为“最佳合同研究组织”。Scrip 的最佳 CRO 排名是该公司今年早些时候在 2023 年 WCG CenterWatch 全球站点关系基准调查中被评为最佳合作 CRO,并获得了 2023 年临床研究站点协会 (SCRS) Eagle 奖,该奖项表彰了致力于通过强大的站点合作伙伴关系推动临床研究专业的 CRO。(来源:Parexel,新闻稿,2023 年 11 月)
IVD 合同研究组织市场报告覆盖范围和交付成果
“IVD 合同研究组织市场规模和预测(2021-2031 年)”报告对市场进行了详细分析,涵盖以下领域:
- IVD 合同研究组织市场规模以及范围涵盖的所有关键细分市场的全球、区域和国家/地区预测
- IVD 合同研究组织的市场趋势以及市场动态,如驱动因素、限制因素和关键机遇
- 详细的 PEST/波特五力分析和 SWOT 分析
- IVD合同研究组织市场分析涵盖关键市场趋势、全球和区域框架、主要参与者、法规和最新的市场发展。
- 行业格局和竞争分析,涵盖市场集中度、热图分析、知名参与者以及 IVD 合同研究组织市场的最新发展
- 详细的公司简介
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
This text is related
to segments covered.
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
This text is related
to country scope.
Frequently Asked Questions
North America dominated the IVD contract research organization market in 2023
Key factors driving the market are increasing demand for in-vitro diagnostics, increased clinical trials, and new product launches by market players.
The market is expected to register a CAGR of 7.80% during 2023–2031.
Proxima Clinical Research, Inc., Toolbox Medical Innovations, Clinexa, ResearchDx, NAMSA, Nexelis, ICON PLC, DCN Dx, CMIC HOLDINGS Co., LTD, AKRN Scientific Consulting SL.
Technological advancements and increased research & development activities will likely remain a key trend in the market.
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- 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.
- 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:
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.
- 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.
- 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.