临床试验市场增长报告|规模和份额 2028

  • Report Code : TIPRE00006203
  • Category : Pharmaceuticals
  • Status : Published
  • No. of Pages : 198
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【研究报告】2022年临床试验市场规模市场估值为550.5194亿美元,预计到2028年将达到760.2344亿美元;预计 2023 年至 2028 年复合年增长率为 5.5%。

市场洞察和分析师观点:

临床试验是为测试人们的医疗、手术或行为干预而进行的研究。这些临床研究试验是确定新治疗或预防(例如新药、饮食或医疗设备)对人体安全性和有效性的主要方法。临床试验通常旨在了解新疗法是否比现有疗法更有效或副作用更小。

临床试验市场主要由持续努力驱动制药和生物技术以及医疗器械公司的产品创新。促进市场进步的其他因素包括临床试验的全球化、相关技术的快速进步以及对 CRO 进行临床试验的需求增加。此外,“Global Clinical Trials Connect 2022”等会议也将举办。为该市场中的公司提供一个了解临床试验和临床研究进展的平台。然而,快速增加的试验成本阻碍了临床试验市场的增长。

增长动力和挑战:

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增加临床试验的采用和外包

进行临床试验是为了确定安全性、新疗法、预防方法和医疗设备的有效性和功效。试验主要在药物开发过程中进行。根据美国国家医学图书馆 (NLM) 提供的数据,2020 年在 NLM (ClinicalTrials.gov) 注册了约 52,000 项新研究,到 2023 年增加到约 58,000 项。2023 年 1 月,NLM 报告了 38,837 项正在进行的临床试验在美国和全球范围内进行了 105,172 项活跃试验。据欧洲药品管理局称,欧盟 (EU) 每年授权约 4,000 项临床试验,其中约 60% 的临床试验与制药行业相关。由于全球慢性病患病率不断上升,越来越多的用于开发不同有效治疗方法的临床试验正在推动临床试验市场的增长。此外,临床试验是高度复杂的过程。基于研究的组织可能无法正确执行这些流程或监督运营。为了避免因执行不当而出现错误,研究型组织将临床试验外包给临床研究组织 (CRO),后者利用其高质量的设施和深厚的主题专业知识来开展临床试验。 CRO 已开始通过其高效且具有成本效益的运营使试验申办者受益,成为临床试验行业的支柱。根据 Thermo Fisher Scientific 网站上发布的一篇博客,到 2022 年,约四分之三的临床试验是由 CRO 进行的,目的是让药物开发商的临床项目放心,提供丰富的专业知识,推动时间和成本效率,并交付定制的高质量数据。因此,开发具有成本效益的解决方案并减少药物开发过程中 CRO 的错误是推动临床试验市场规模的因素之一。

昂贵且耗时-消费过程

临床试验最后阶段的治疗分子数量不断增加,在新药研发上投入了金钱和宝贵的时间。根据文章“ADME/Tox 在早期药物发现中的重要性”,该研究于 2022 年发表,考虑到目前的药物发现和开发管道,在 1,000 个分子中,只有 10 个筛选的药物预计进入临床前测试阶段,只有 9.6% 将进入临床试验。药物审批过程预计平均需要 15 年,其中 II 期和 III 期是临床试验中最昂贵的阶段。一款药物的预批准支出高达25.6亿美元,在批准后阶段进一步增加至28.7亿美元。根据2022年发表的题为《为什么90%的临床药物开发失败以及如何改进?》的研究显示,尽管实施了许多策略,但90%的临床药物开发还是失败了。进入临床研究后,十分之九的候选药物在 I、II、III 期临床试验和药物审批过程中失败。临床前阶段被拒绝的候选药物不计入临床阶段药物90%的失败率,因为它们甚至没有进入I期临床试验。如果考虑临床前候选药物,药物发现和开发的失败率将上升到90%以上。新药开发需要大量资源和时间,而后期的临床阶段会导致巨大的成本。每一种批准用于临床的新药的发现和开发都是一个漫长、昂贵且具有挑战性的过程,需要超过 10-15 年的时间,平均成本超过 1-20 亿美元。由于开发药物或医疗器械的投资成本高昂,有限的公司投资于临床试验过程,这阻碍了临床试验市场的增长。

< u>战略洞察

报告细分和范围:

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“全球临床试验市场”根据研究设计、阶段、适应症和地理位置进行细分。根据研究设计,临床试验市场分为介入性、观察性和扩展性。根据阶段,临床试验市场分为 I 期、II 期、III 期和 IV 期。根据最终用途,临床试验市场分为自身免疫/炎症、疼痛管理、肿瘤、中枢神经系统疾病、糖尿病、肥胖、心血管等。

临床试验市场根据地理位置分为北美(美国、加拿大和墨西哥)、欧洲(德国、法国、意大利、英国、俄罗斯和欧洲其他地区)、亚太地区(澳大利亚、中国、日本、印度、韩国和亚太地区其他地区)、中东和非洲(南非、沙特阿拉伯、阿联酋以及中东和非洲其他地区)以及南美和非洲中美洲(巴西、阿根廷以及南美洲和中美洲其他地区)

细分分析:

根据研究设计,临床试验市场分为介入性、观察性和扩展性。 2022 年,介入细分市场占据最大市场份额,而预计该细分市场在预测期内的复合年增长率最高,为 5.8%。介入研究是一种临床研究,其中人类参与者在特定时期接受一种或多种介入药物/治疗,以评估药物/治疗对健康的影响。新的潜在药物/医疗器械/疗法必须经过介入测试阶段,以证明其安全有效,然后才能获得美国食品和药物管理局 (FDA) 的批准。大多数干预研究都是安慰剂对照的,其中一组参与者接受安慰剂,另一组接受正在研究的药物。然后研究人员比较两组,以评估正在研究的药物的有效性。

全球临床试验市场,按研究设计– 2022 年和 2028 年

阶段见解

根据阶段,临床试验市场分为第一阶段、第二阶段、第三阶段和第四阶段。第三阶段细分市场在 2022 年占据最大的市场份额,预计在预测期内将实现市场最高的复合年增长率。 III期临床试验阶段是在大患者群体中进行的。该阶段有助于确定活性药物成分的短期和长期功效。因此,进行评估是为了了解配制药物的总治疗价值和相关治疗价值。维持III期临床试验中使用的药物的有效性、安全性和准确性至关重要,否则可能会对试验中的患者产生不利影响。 Shertech Manufacturing 为其客户提供 III 期临床试验服务以及与功效和副作用相关的全面、明确的数据。它还有助于遵守 FDA 标准,帮助将药物引入市场并完成所需的许可申请。

适应症见解

临床试验市场按适应症分为自身免疫/炎症、疼痛管理、肿瘤、中枢神经系统疾病、糖尿病、肥胖、心血管疾病等。到 2022 年,肿瘤学领域将占据最大的临床试验市场份额,预计在预测期内复合年增长率最高。癌症患病率的增加和老年人口的增加促进了肿瘤领域临床试验市场的增长。美国癌症协会估计,到2023年,美国将出现约1,958,310例新癌症病例和609,820例癌症死亡。尽管癌症诊断、预防和治疗程序取得了重大进展,但原发性癌症(例如前列腺癌、肺癌、乳腺癌和结肠癌)的治疗仍存在显着的未满足的医疗需求。这可能会增加癌症研究和开发活动。制药公司正致力于开发新药以满足消费者的需求。印度孟买塔塔纪念医院进行的一项临床试验发现,在头颈癌的标准治疗中添加超低剂量的免疫治疗药物纳武单抗(Opdivo),有助于延长患者的寿命。< /span>

区域分析:

基于地理、临床试验市场分为北美(美国、加拿大和墨西哥)、欧洲(英国、德国、法国、意大利、西班牙和欧洲其他地区)、亚太地区(中国、日本、印度、澳大利亚、韩国和其他地区)亚太地区)、中东(阿联酋、沙特阿拉伯、南非以及中东和非洲其他地区)以及南美和非洲。中美洲(巴西、阿根廷以及南美洲和中美洲其他地区)。在预测期内,北美占据最大的临床试验市场份额。预计亚太地区在预测期内将成为临床试验市场最快的复合年增长率。中国、日本和印度是亚太地区市场的主要贡献者。因此,亚太地区的临床试验市场是由国际参与者不断增长的投资、政府的迅速支持和医疗保健基础设施的发展推动的。

行业发展和未来机遇:

  • 2023 年 1 月,Rznomics 宣布与 Charles River Laboratories International, Inc. 建立合作伙伴关系,开展病毒载体合同开发和制造组织(CDMO)。 Rznomics 将利用 Charles River 的病毒载体 CDMO 经验,启动其针对肝癌患者的基于 RNA 的抗癌基因疗法的临床开发。
  • 2023 年 3 月,LEO Pharma 和 ICON plc 宣布了一项战略合作伙伴关系此次合作将使 LEO Pharma 以以患者为中心且具有成本效益的方式扩大临床试验的执行规模。此次合作还将支持 LEO Pharma 的总体目标,即建立业内最有效、最高效的临床投资组合执行组织之一。
  • 2023 年 2 月,Syneos Health 与 Haystack Health 合作,Haystack Health 是一家医疗保健公司。 Roivant Health 投资组合公司致力于开发先进的人工智能 (AI) 和自然语言处理 (NLP) 解决方案,以改善临床试验患者的识别和招募。
  • 2023 年 2 月,Parexel 推出了新专家系列、新药物、新见解。该系列以公司全球跨职能专家的新鲜见解为特色,分析药物开发趋势并为生物制药行业提供循证指导。

竞争格局和主要公司:

IQVIA Holdings Inc、Parexel International Corp、IXICO Plc、Charles River Laboratories International Inc、ICON Plc、药明康德AppTec Co Ltd、SGS SA、Syneos Health Inc、SIRO Clinpharm Pvt Ltd、Thermo Fisher Scientific Inc 和 Laboratory Corp of America Holdings 是全球市场上的主要临床试验公司。这些公司一直在实施各种有助于其发展的战略,反过来又给市场带来了各种变化。这些公司利用了有机战略(例如发布、扩张和产品批准)和无机战略(例如产品发布、合作伙伴关系和协作)。

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


Which segment is dominating the clinical trials market?

The clinical trials market is analyzed on the basis of study design, phase, indication. Based on study design, the segment is segmented into interventional, observational, and expanded access. The interventional segment held the largest market share in 2022, and the same is anticipated to register the highest CAGR during the forecast period.

What is a clinical trial?

Clinical trials are research studies that test a medical, surgical, or behavioral intervention in people. These trials are the primary way that researchers determine if a new form of treatment or prevention, such as a new drug, diet, or medical device (for example, a pacemaker), is safe and effective in people. Often, a clinical trial is designed to learn if a new treatment is more effective or has less harmful side effects than existing treatments.

What are the driving factors for the global clinical trials market across the world?

The factors that are driving the growth of the market are growth are increasing adoption and outsourcing of clinical trials, flourishing pharmaceutical industry and increasing R&D activities in pharmaceutical industry propelling market growth.

Who are the major players in market the clinical trials market?

The clinical trials market majorly consists of the players such IQVIA Holdings Inc, Parexel International Corp, IXICO Plc, Charles River Laboratories International Inc, ICON Plc, WuXi AppTec Co Ltd, SGS SA, Syneos Health Inc, SIRO Clinpharm Pvt Ltd, Thermo Fisher Scientific Inc, and Laboratory Corp of America Holdings.

The List of Companies - Clinical Trials Market

  1. IQVIA Holdings Inc
  2. Parexel International Corp
  3. IXICO Plc
  4. Charles River Laboratories International Inc
  5. ICON Plc
  6. WuXi AppTec Co Ltd,
  7. SGS SA
  8. Syneos Health Inc
  9. SIRO Clinpharm Pvt Ltd
  10. Thermo Fisher Scientific Inc
  11.  Laboratory Corp of America Holdings

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.

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