到 2028 年护理点分子诊断市场规模分析

  • Report Code : TIPRE00003144
  • Category : Medical Device
  • Status : Published
  • No. of Pages : 208
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[研究报告] 即时分子诊断市场预计将达到53.8118亿美元百万 < /span>到 2028 年,从 2,230.94 美元到 2021 年 百万美元;预计 2021 年至 2028 年复合年增长率为 13.4%。

市场洞察和分析师观点:

护理点分子诊断包括便携式设备以及分析和诊断。用于检测和诊断人类样本中疾病的试剂盒,例如咽拭子、血液、血清和粪便。由于分子诊断简单、方便、周转时间短以及改善患者治疗效果的潜力,分子诊断正在从集中式实验室转向分散式护理点分子检测。由于这些优点,它可以应用于资源匮乏或偏远地区的诊断。传染病发病率的不断上升极大地推动了对有效诊断的需求。对控制和消除传染病的诊断工具、及时检测病原体、进行有效治疗和疾病控制的需求不断增加,将在预测期内推动市场发展。此外,现代技术正在使分子诊断领域发生显着的变革。全球床旁分子诊断市场规模预计将从 2021 年的 22.3094 亿美元增至 2028 年的 53.8118 亿美元。预计 2021-2028 年该市场将以 13.4% 的复合年增长率增长。

增长动力和挑战:

传染病发病率上升

传染病蔓延的加剧提高了检测水平和检测率。将传染病的分子诊断测试从实验室转移到护理点设置有可能彻底改变测试的速度和数量。分子诊断是一种更灵敏的产品和服务,可以检测较小浓度的传染性病原体,从而比以前更早地检测到疾病。护理点分子诊断有可能最大限度地缩短获得可行结果所需的时间,并促进早期感染检测、适当的感染控制措施以及参加治疗临床试验。 A/B 型流感、呼吸道合胞病毒 (RSV) 和医院获得性感染 (HAI) 流行率的上升增加了对即时分子检测的需求。流感和呼吸道合胞病毒 (RSV) 即时检测可以改善患者治疗和感染控制。最近,即时分子诊断在检测 COVID-19 感染方面发挥了至关重要的作用。对于 COVID-19 感染检测,基于 RT-PCR 的诊断测试耗时、昂贵,并且需要先进的设备和专业人员。高昂的诊断费用和缺乏检测试剂盒使得监测社区传播变得困难。因此,迫切需要快速、经济且有效的方法来检测人类中的 COVID-19 病毒感染。简单有效的即时分子诊断设备可以进行现场检测,有助于预防感染和控制其传播。因此,对快速有效的即时检测传染病的分子试剂盒的需求不断增长,推动了市场的增长。

战略见解

市场限制

定价压力由于报销削减

医疗诊断市场目前缺乏不同方法的报销,这对患者的诊断至关重要。缺乏报销对市场产生了负面影响,主要经济体的大型市场增长乏力。全球各国的即时分子诊断测试都面临着类似的报销不足问题。报销制度通常不利于诊断测试。由于诊断测试报销不足,测试价格定得太低,最终降低了行业的盈利能力和市场规模。此外,低效的报销结构构成了开发更好的诊断测试的障碍。此外,报销削减可能会对临床实践产生负面影响,因为它面临着不愿意使用诊断方法和未来缺乏改进的测试的问题。此外,各国在具体治疗方面都有自己的报销结构和政策。例如,美国和德国当局向医院补偿治疗疾病的总费用。因此,如果患者住院时间超过预期,医院将承担费用。如果医院和医疗中心认为额外的检测会导致利润损失或每位患者的经济损失,这种情况可能会阻碍诊断工具的使用。因此,由于严格的报销结构,床旁分子诊断设备的原始设备制造商 (OEM) 面临着众多官僚和定价挑战。因此,报销问题给即时分子诊断设备制造商带来了定价压力,这成为即时分子诊断市场整体增长的主要制约因素。

报告细分和范围:

“全球护理点分子诊断” ;根据产品和用途进行细分服务、技术、应用程序、最终用户和地理位置。根据产品和服务,全球护理点分子诊断市场分为检测和试剂盒、仪器、服务和软件。基于技术的即时分子诊断市场分为PCR、等温核酸扩增技术(INAAT)和其他技术。基于应用的即时分子诊断市场分为传染病、肿瘤学、血液学、产前检测、内分泌学和其他应用。基于最终用户的床旁分子诊断市场分为医院和诊所、诊断实验室、研究和学术机构等。

床旁分子诊断市场健康市场的诊断商业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)、中东和美国非洲(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:

根据技术,分子诊断床边市场分为PCR、等温核酸扩增技术(INAAT)和其他技术。到 2021 年,PCR 细分市场可能会占据最大的市场份额,但 INAAT 细分市场预计在预测期内将以最快的速度增长。核酸等温扩增在恒温下快速有效地积累核酸序列。扩增技术是作为 PCR 的替代方案而开发的,用于生物传感目标,例如 DNA、RNA、小分子、蛋白质、细胞和离子。通过等温扩增方法产生的扩增子可用于构建在生物医学、生物成像和生物传感中具有多种应用的多功能核酸纳米材料。临床样本复杂的生化性质、临床样本中存在的低丰度核酸靶标以及现有的生物传感器技术表明,需要某种形式的核酸扩增才能从床旁使用的小样本中获得临床相关的灵敏度

护理点分子诊断市场分析(按技术) 2021 年和 2028 年

根据产品和服务,护理点分子诊断市场分为检测和试剂盒、仪器、服务和软件。 2021 年,检测和试剂盒领域可能会占据最大的市场份额,并预计在预测期内以最快的速度增长。护理点分子诊断检测和试剂盒专为医生办公室、医院重症监护室、门诊诊所和社区卫生站而设计。这些检测方法和试剂盒有助于早期诊断呼吸道感染以及女性健康和性健康状况。检测试剂盒主要用于生命科学研究、环境监测以及药物发现和开发。它们还用于各种应用,例如研究疾病途径、筛选潜在候选药物以及评估生物制药生产过程。 POC ELISA(酶联免疫吸附测定)试剂盒广泛用于检测和定量样品中的蛋白质和抗原。目标特异性 ELISA 试剂盒用于简化免疫检测实验。

基于应用的床旁分子诊断市场分为传染病、肿瘤学、血液学、产前检测、内分泌学和其他应用。到 2021 年,传染病领域可能会占据最大的市场份额,但肿瘤学预计在未来几年将以最快的速度增长。全球约有 5000 万人患有癫痫症,使其成为全球最常见的神经系统疾病之一。北美按年龄调整的癫痫发病率在每 10 万人中 16 例到每 10 万人中 51 例之间。年龄调整后的患病率范围为每 1000 人中的 2.2 人到每 1000 人中的 41 人,具体取决于报告国家。部分性癫痫可能占癫痫发作的三分之二。社会经济地位较低的人群中发病率增加。大约 25% 至 30% 的新发癫痫发作被认为是由其他原因引起或继发的。癫痫发病率在年轻和老年群体中最高,并且在 50 岁以后稳步上升。老年人癫痫发作和癫痫最常见的原因是脑血管疾病。

苯二氮卓类药物,如地西泮、咪达唑仑或劳拉西泮,可以作为治疗持续癫痫发作的一线药物。即使在完成了一项备受期待的苯二氮卓类难治性癫痫持续状态随机试验——既定的癫痫持续状态治疗试验(ESETT)之后,最好的二线药物仍不清楚。二线药物包括磷苯妥英、丙戊酸、左乙拉西坦等。

护理点分子诊断市场分析、区域分析:< /strong>

根据地理位置,全球床旁分子诊断市场分为五个关键区域:北美、欧洲、亚太地区、南美和中东地区。中美洲、中东和非洲非洲。在北美,美国是床旁分子诊断市场的最大市场。可穿戴医疗设备、芯片实验室技术的引入以及智能手机使用量的增加推动了美国市场对即时分子诊断设备的需求。未来几年,该行业将因识别艾滋病毒、结核病和疟疾等传染病的快速测试的日益普及而发生转变,使临床医生和患者能够在智能手机上可视化结果并做出适当的治疗决策。诊断行业的最新进展正在推动美国即时分子诊断市场的发展,旨在提供快速诊断,以便快速做出临床决策,以协助治疗方案。

此外,美国是受 COVID-19 大流行影响最严重的国家之一。需要对病毒进行快速检测和检测,以便及时治疗。全球范围内(包括美国)迫切需要能够实现分散、快速、灵敏且低成本的 COVID-19 感染诊断的护理点 (POC) 检测技术。因此,COVID-19 大流行为美国即时分子诊断市场带来了利润丰厚的增长机会。此外,该国慢性病发病率的迅速增加主要推动了市场的发展。例如,根据美国癌症协会的数据,2020年美国估计新诊断出180万癌症病例。乳腺癌、肺癌和支气管癌、前列腺癌、结肠癌和直肠癌、黑色素瘤和肝癌是常见癌症。

此外,根据美国疾病控制与预防中心2020年发布的研究,大约有3420万美国人患有糖尿病。根据同一项研究,美国年轻人患糖尿病的发病率更高。此类疾病的流行将推动该国对即时分子诊断的需求。此外,近年来创新和增强的医疗技术显着增加。这种扩张的结果是开发了先进的医疗设备,并刺激了医疗保健业务的发现和突破。此外,美国拥有多家致力于尖端护理点分子诊断的公司。预计这一因素将进一步推动美国即时分子诊断市场的发展。

实时 PCR (qPCR) 的引入扩大了分子诊断的范围。医疗领域。近年来,美国市场的突破性测试源于在 POC 背景下或在患者附近进行的分子诊断测试。分子检测可以提高传统近患者和快速诊断检测的特异性和敏感性,将美国的POC分子诊断市场推向新的高度。这种诊断测试在实验室环境中的日益使用预计将增加其需求。对特定病症的早期和精确诊断以提供适当治疗的需求不断增加,这将催生新技术,从而推动美国 POC 分子诊断市场的发展。

行业发展和未来机遇:

全球即时分子诊断市场主要参与者采取的各种举措如下:

  1. 2021 年 2 月,罗氏宣布向 FDA 申请 SARS-CoV-2 快速抗原检测紧急使用授权,使医疗保健专业人员能够在现场快速做出决策
  2. 2021年3月,生物梅里埃宣布其专门从事分子综合症传染病检测的子公司BioFire Diagnostics已获得美国食品和药物管理局(FDA)De Novo BIOFIRE® 授权RP2.1 面板。
  3. 2020 年 11 月,Enzo Biochem 公布了一项分析结果,显示在该公司专有的 GENFLEX™ 上进行的测试进行了测试。分子诊断平台能够成功检测当前已知的 COVID-19 变体的存在。虽然该公司的 PCR 检测无法区分不同的变异,但可以进一步分析阳性样本以进行变异识别。目前市场上的快速抗原检测不具备此功能。
  4. 2021 年 5 月,Biocartis Group NV 宣布与全球科学主导的生物制药公司阿斯利康 (LSE) 签署了一项新协议/STO/纳斯达克:AZN),旨在提供快速且易于使用的 Idylla™ 访问; Biocartis 选定医院地点的 EGFR 测试产品欧洲和全球经销商市场支持 EGFR 突变患者的识别。

Covid-19 影响:

美国的 COVID-19 病例数量是北美所有国家中最多的。这对该地区的各个行业以及供应链和分销链产生了负面影响。在大流行期间,生命科学公司将重点转向开发治疗危及生命的疾病的新药。此外,对快速检测设备的需求也有所增加,这在北美即时分子诊断市场的增长中发挥着突出作用。此外,COVID-19 的持续传播正在增加对即时分子诊断试剂盒的需求。这些套件的采用正在促进新产品的开发和发布。 2021 年 3 月,Eurofins 旗下的 Clinical Enterprise, Inc. 获得了美国食品和药物管理局 (FDA) 的紧急使用授权 (EUA),用于其 EmpowerDX COVID-19 家庭采集套件的直接面向消费者 (DTC) 版本。同样,2020 年 7 月,Eurofins USA 的临床诊断公司宣布推出聚合 PCR 检测来检测 SARS-CoV-2,这将大大降低客户每次 PCR 检测的成本。

竞争格局和主要公司:

一些著名的公司全球即时分子诊断市场的参与者包括 BioMérieux SA、F. Hoffmann-La Roche Ltd.、Danaher Corporation、Enzo Biochem, Inc.、Abbott、binx health, Inc.、Meridian BioScience, Inc.。 、Biocartis、Quidel Corporation、Bio-Rad Laboratories, Inc. 等。这些公司专注于新产品的推出和地域扩张,以满足全球不断增长的消费者需求,并增加其专业产品组合的产品范围。它们拥有广泛的全球业务,这使它们能够为大量客户提供服务,从而增加其市场份额。

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
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Frequently Asked Questions


What are point-of-care molecular diagnostics?

Point-of-care molecular diagnostics include portable devices, and assays & kits used to detect and diagnose diseases in human samples, such as throat swab, blood, serum, and stool. Molecular diagnostics are shifting from centralized laboratories to decentralized point-of-care molecular testing, due to its simplicity, convenience, rapid turnaround time, and potential to improve patient outcomes.

What are the driving factors for the point-of-care molecular diagnostics market across the globe?

Increasing demand for diagnostic tools to control and eliminate infectious diseases, timely detection of causative agent, allowing effective treatment and disease control will fuel the market during the forecast period.

Who are the developments carrying out by major players in the point-of-care molecular diagnostics market?

Various companies have made organic growth strategies in the point-of-care molecular diagnostics market. Some of the activities undertaken by the company, which have promoted its growth are, launches, enhancements and expansion & relocation activities. Companies such as F. Hoffmann-La Roche Ltd, Danaher amongst others are some of the companies that have been implementing various organic strategies that have helped the growth of the company.

Which region is dominated the Point-of-Care Molecular Diagnostics market?

North America dominates the global point-of-care molecular diagnostics market. Ongoing efforts by major market participants to strengthen their market position is an important factor contributing to the major share. Furthermore, several clinical studies investigating the efficiency and accuracy of novel molecular tests are also expected to contribute towards the market growth over the forecast period. Growing demand for rapid diagnosis and development of newer molecular diagnostic tests for DNA analysis have poised the region as a major market space.

Which region is the fastest growing in the Point-of-Care Molecular Diagnostics market?

Asia Pacific is expected to be the fastest growing region in the point-of-care molecular diagnostics market. The growth of the point-of-care molecular diagnostics market in this region is primarily due to rising incidences of chronic diseases associated with geriatric population, expansion of key market players in this region, insufficient sophisticated central laboratory testing services, and potential cost effectiveness of POC molecular diagnosis.

Which segment is held the largest share in the point-of-care molecular diagnostics market?

In 2021, the assays and kits segment is estimated to account for the largest market share in the global point-of-care molecular diagnostics market. POC molecular diagnostic assays and kits are specially designed for point of care such as hospital critical care units, physician offices, outpatient clinics, and community health posts. POC molecular diagnostics assays and kits enable the early diagnosis of infectious diseases, cancer, and women’s health and sexual health conditions among others.

The List of Companies - Point-of-Care Molecular Diagnostics Market

  1. bioMérieux SA
  2.  F. Hoffmann-La Roche Ltd.
  3. Danaher Corporation
  4.  Enzo Biochem, Inc.
  5. Abbott
  6. binx health, Inc.
  7. Meridian BioScience, Inc.
  8. Biocartis
  9. Quidel Corporation
  10. Bio-Rad Laboratories, Inc.

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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