体外诊断市场基于(关键地区、市场参与者、规模和份额)- 到 2030 年的预测

  • Report Code : TIPBT00002657
  • Category : Medical Device
  • Status : Published
  • No. of Pages : 210
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【研究报告】2022年体外诊断市场规模为723.938亿美元,预计到2030年将达到11210351万美元;预计 2022 年至 2030 年市场复合年增长率为 5.6%
市场洞察和分析师观点:
体外诊断包括用于分析生物样本(例如尿液、血液或血液)的实验室测试和医疗设备组织,取自人体。这些测试在监测和诊断各种医疗状况方面发挥着至关重要的作用。慢性病患病率的增加、技术的进步和老年人口的增长是推动体外诊断市场增长的值得注意的因素。分子诊断的进步使世界各地的研究小组和医疗保健人员能够根据个人的基因组成改进个性化治疗计划。由于基础设施的进步和健康相关意识的提高,发展中地区的增长机会也与 2022 年至 2030 年体外诊断市场的预计增长有关。
增长驱动因素:
根据 CDC 数据,冠状动脉疾病(CAD)是成人死亡的最常见原因。 2021 年,约有 375,476 人死于 CAD。世界卫生组织《2022 年国家糖尿病统计报告》中发布的估计表明,全球约有 4.22 亿人患有糖尿病,其中大多数生活在低收入和中等收入国家。此外,每年有150万人死亡与糖尿病直接相关。超重、遗传条件、衰老、久坐的生活方式等正在增加糖尿病的患病率。根据英国癌症研究中心发布的报告估计,2020年全球新增癌症病例约1810万例,预计到2040年将增加至2800万例。因此,心血管疾病等传染病和慢性病的患病率不断上升、癌症、糖尿病和呼吸系统疾病推动了体外诊断市场的增长。
IVD 用于临床、实验室和门诊环境,专门用于帮助检测疾病,从而帮助选择适当的治疗方案。 IVD 技术与数字健康解决方案的整合正在全球范围内受到关注。数据分析、人工智能和远程监控增强了诊断测试的价值,从而实现更好的患者管理和结果。与数字健康解决方案集成的 IVD 技术可以纳入临床决策支持系统。正如世界卫生组织所认识到的,数字健康解决方案可以帮助检测疾病。人工智能健康机器人和类似的其他新兴解决方案可能会为患者护理带来机会,并解决高成本和时间要求等挑战。在基于基因组测试的诊断中,深度学习可以识别癌细胞,确定其类型,并根据特定样本的图像预测肿瘤中可能发生哪些突变。体外诊断中的人工智能和机器学习 (AI/ML) 正在彻底改变医疗设备的开发。这些现代诊断系统促进基于数字图像分析的诊断,从而改善医疗决策。智能诊断是一种可扩展性极强的 IVD 解决方案,它使用人工智能,其性能优于基于实验室的诊断,而价格仅为实验室诊断的一小部分。此外,这种类型的诊断可以通过独特的化学和生物特征检测和分析得出新兴特征。因此,IVD 与数字健康技术的整合可能会在未来几年为体外诊断市场提供利润丰厚的机会。
战略见解
报告细分和范围:
全球体外诊断市场分为产品和服务、技术和应用。根据产品和服务,市场分为试剂和试剂盒、仪器以及软件和服务。从技术角度来看,体外诊断市场分为免疫分析/免疫化学、临床化学、分子诊断、微生物学、血糖自我监测、凝血和止血、血液学、尿液分析等。体外诊断市场按应用细分为传染病、糖尿病、肿瘤学、心脏病学、自身免疫性疾病、肾病学等。按最终用户划分,体外诊断市场分为医院、实验室、家庭护理等。体外诊断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、西班牙和欧洲其他地区)、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)以及南美洲和中美洲(巴西、阿根廷) ,以及南美洲和中美洲其他地区)。
细分分析:
根据产品和服务,体外诊断市场分为试剂和试剂盒、仪器以及软件和服务。 2022年,由于自检试剂盒和POC设备的普及,试剂和试剂盒细分市场占据最大市场份额。试剂和试剂盒市场的预计增长归因于自检试剂盒和 POC 设备的巨大普及,以及简化工作并提供准确结果的自动化仪器的可用性和采用率的增加。病毒和真菌感染病例的增加以及卫生条件不足促进了试剂的使用。试剂和试剂盒以及其他消耗品在研究过程中也经常使用。对尿液、血液、粪便和组织样本进行体外诊断测试,以诊断各种病症,从轻度感染到癌症等危及生命的疾病。 Abbott、F. Hoffmann-La Roche Ltd 和 Bio-Rad Laboratories, Inc. 是提供试剂盒和试剂的主要公司之一。各国政府在 COVID-19 爆发期间实施了大规模筛查计划,推动了体外诊断市场的增长。 2020 年,雅培实验室 (Abbott Laboratories) 加大了 COVID-19 检测试剂盒的生产力度,其中包括一种可以实现大规模 COVID-19 筛查的新工具。
体外诊断市场根据传染病、糖尿病、肿瘤学应用进行细分、心脏病学、自身免疫性疾病、肾病学等。 2022年,传染病领域占据最大的市场份额。预计该细分市场在 2022-2030 年期间将实现最高的复合年增长率。
根据技术,体外诊断市场分为免疫测定/免疫化学、临床化学、分子诊断、微生物学、血糖自诊断监测、凝血和止血、血液学、尿液分析等。 2022年,免疫分析/免疫化学领域占据最大的市场份额。然而,由于新产品的推出和技术的不断发展,分子诊断领域预计将在 2022 年至 2030 年期间实现最快的复合年增长率。此外,COVID-19 对免疫测定和分子诊断产生了积极影响。
体外诊断市场根据最终用户分为医院、实验室、家庭护理等。 2022年,医院领域占据最大的市场份额。此外,医疗保健基础设施的持续扩张将导致现有医院设施的改善,这可能会引发对在这些设施中进行 IVD 测试的需求。住院人数的不断增加,加上慢性病患病率的激增,预计将推动 2022 年至 2030 年医院领域体外诊断市场的增长。发展中国家对先进医院设施的巨大需求,以应对不断增加的患者群体和日益严重的公共卫生问题。因此,由于体外诊断的优越优势,预计越来越多的医院将促进其采用。此外,医院提供的福利,例如以患者为中心的适当护理和报销设施的可用性,推动了该细分市场的市场增长。
按技术划分的体外诊断市场 – 2022 年和 2030 年
区域分析:
根据地理位置,体外诊断市场分为五个关键区域:北美、欧洲、亚太地区、南美洲和中美洲、中东和非洲。对北美市场的分析主要集中在三个主要国家——美国、加拿大和墨西哥。 2022年,美国将占据北美体外诊断市场的最大份额。预计在预测期内,美国将占据北美体外诊断市场的最大份额。该国的市场增长归因于慢性病和传染病的患病率不断上升、对有效疾病诊断的关注以及对先进医疗保健系统的更高需求。癌症和心血管疾病等慢性疾病是美国残疾和死亡的主要原因。根据国家慢性病预防和健康促进中心的数据,该国每10人中就有6人至少患有一种慢性病。根据美国疾病控制与预防中心 (CDC) 的报告,2021 年,美国约有 1820 万 20 岁及以上的成年人患有冠状动脉疾病 (CAD)。 CAD 是该国人口死亡的主要原因。
美国医院协会还估计,约有 1.33 亿人患有至少一种慢性病,预计到 2030 年,这一数字将达到 1.7 亿。慢性病的高发病率疾病导致对诊断程序的巨大需求,这反过来又推动了美国体外诊断市场的发展。对预防性护理的日益重视和提高医疗保健设施的可及性将进一步推动未来几年的市场增长。
体外诊断市场机会:
IVD 用于临床、实验室和门诊环境,其目的是帮助检测疾病,从而帮助选择适当的治疗方案。 IVD 技术与数字健康解决方案的整合正在全球范围内受到关注。数据分析、人工智能和远程监控增强了诊断测试的价值,从而实现更好的患者管理和结果。与数字健康解决方案集成的 IVD 技术可以纳入临床决策支持系统。正如世界卫生组织所认识到的,数字健康解决方案可以帮助检测疾病。人工智能健康机器人和类似的新兴解决方案可能会为患者护理带来机会,并解决高成本和时间要求等挑战。在基于基因组测试的诊断中,深度学习可以识别癌细胞,确定其类型,并根据特定样本的图像预测肿瘤中可能发生哪些突变。体外诊断中的机器学习和人工智能正在彻底改变医疗设备的开发。这些现代诊断系统促进基于数字图像分析的诊断,改善医疗决策。智能诊断是一种可扩展性极强的 IVD 解决方案,它使用人工智能,其性能优于基于实验室的诊断,而价格仅为实验室诊断的一小部分。此外,这种类型的诊断可以通过独特的化学和生物特征检测和分析得出新兴特征。因此,将 IVD 与数字健康技术相结合可能会在未来几年为体外诊断市场提供利润丰厚的机会。
竞争格局和主要公司:
在全球体外诊断市场上运营的一些著名体外诊断制造商包括 Abbott Laboratories、F. Hoffmann-La Roche Ltd、Danaher Corp、Siemens AG、Sysmex Corp、Thermo Fisher Scientific Inc、Becton Dickinson and Co、bioMerieux SA、Bio-Rad Laboratories Inc、Qiagen NV。这些公司专注于新技术、现有产品的进步和地域扩张,以满足全球日益增长的消费者需求并扩大其专业产品组合的产品范围。例如,2020年10月,雅培与Quanterix Corporation签署了非排他性特许权使用费许可协议。根据该协议,雅培获得了 Quanterix 用于体外诊断 (IVD) 应用的基于微珠的技术专利组合。此外,Quanterix 还收取初始许可费、监管和上市里程碑费用、根据与雅培未来发展相关的成就而定的里程碑费用,以及销售许可产品的特许权使用费。
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

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Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

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Frequently Asked Questions


Which region is expected to witness significant demand for in-vitro diagnostics market in the coming years?

Global in-vitro diagnostics market is segmented by region into North America, Europe, Asia Pacific, the Middle East & Africa and South & Central America. Europe held the largest market share of the in-vitro diagnostics market in 2022. With several European market players focusing on research and development activities in the field of imaging technology, the regional market for in-vitro diagnostics market is likely to propel in Europe region during the forecast period.

Who are the key players in the in-vitro diagnostics market?

The in-vitro diagnostics market majorly consists of the players such Abbott Laboratories, F. Hoffmann-La Roche Ltd, Danaher Corp, Siemens AG, Sysmex Corp, Thermo Fisher Scientific Inc, Becton Dickinson and Co, bioMerieux SA, Bio-Rad Laboratories Inc, and Qiagen NV.

Which are the top companies that hold the market share in in-vitro diagnostics market?

Abbott and F.Hoffman-La-Roche are the top two companies that hold huge market shares in the in-vitro diagnostics market.

Which application held the largest share in the in-vitro diagnostics market?

The infectious diseases segment dominated the global in-vitro diagnostics market and held the largest market share of 39.8% in 2022.

Which products & services segment leads the in-vitro diagnostics market?

The reagent & kits segment held the largest share of the market in the global in-vitro diagnostics market and held the largest market share of 79.00% in 2022.

What are the driving factors for the in-vitro diagnostics market across the globe?

Key factors that are driving the growth of this market are increasing prevalence of chronic diseases, technological advancements, and the growing geriatric population are expected to boost the market growth for the in-vitro diagnostics over the years.

What is the market CAGR value of in-vitro diagnostics market during forecast period?

The CAGR value of the in-vitro diagnostics market during the forecasted period of 2022-2030 is 5.6%.

What is in-vitro diagnostics?

In vitro diagnostics (IVD) are tests done on samples such as blood or tissues that have been taken from the human body. In-vitro diagnostics are specialized to detect diseases or other conditions that can be used to monitor a person's overall health to help cure, treat, or prevent diseases. Additionally, in-vitro diagnostics may also be utilized for precision medicine to identify patients who are likely to benefit from specific treatments or therapies. Therefore, these in-vitro diagnostics can include next-generation sequencing tests that scan a person's DNA to detect genomic variations.

The List of Companies - In-Vitro Diagnostics Market

  1. Abbott Laboratories 
  2. F. Hoffmann-La Roche Ltd 
  3. Danaher Corp 
  4. Siemens AG 
  5. Sysmex Corp 
  6. Thermo Fisher Scientific Inc
  7. Becton Dickinson and Co
  8. bioMerieux SA 
  9. Bio-Rad Laboratories Inc
  10. Qiagen NV

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.

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  • Validates and strengthens in-house secondary research findings
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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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