实验室开发的测试市场基于(关键地区、市场参与者、规模和份额)- 到 2031 年的预测

  • Report Code : TIPRE00019603
  • Category : Medical Device
  • Status : Published
  • No. of Pages : 183
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实验室开发的测试市场预计将从 2021 年的 45.2475 亿美元增至 2028 年的 72.693 亿美元;预计 2021 年至 2028 年复合年增长率为 7.0%。

实验室开发测试 (LDT) 是一种设计和使用的体外诊断测试在一个实验室内。这些测试可用于估计或区分分析物,例如蛋白质、生物分子/化合物(葡萄糖、胆固醇等)以及从人类受试者采集的样本中提取的 DNA。实验室和药房自动化体外诊断 (IVD) 方法的扩展可提供精确、无差错的分析,这正在推动实验室开发的测试市场的增长。    

实验室开发的测试市场的增长主要归因于癌症和遗传性疾病发病率的增加以及大量产品的推出等因素。然而,不断变化的监管环境正在阻碍市场增长。例如,在欧洲,从 2022 年 5 月起,所有体外诊断测试都将强制遵守体外设备法规 (IVDR);该法规旨在确保医学检测的临床有效性和安全性,从而改变诊断行业,这是市场参与者非常关心的。

实验室开发的检测市场的利润丰厚的区域

市场洞察

对个性化药物的持续研究为实验室开发的测试市场参与者提供了增长机会

LDT在个性化药物的开发中发挥着至关重要的作用这很可能被证明是通过远未有效的治疗或治愈方法来应对疾病的有希望的手段。根据个性化医疗联盟的数据,2005 年个性化药物仅占 FDA 批准的新分子实体的 5%;然而,2016年,这一数字上升至25%以上。此外,在研产品中 42% 的化合物和 73% 的肿瘤学化合物有潜力用作个性化药物。生物制药公司在过去五年中对个性化药物的研发投资几乎增加了一倍,预计未来五年将进一步增加33%的投资。生物制药研究人员还预测,未来五年个性化药物的开发将增长 69%。实验室测试用于诊断疾病、预测和监测药物反应以及获取复杂预测算法所需的信息学数据。

个性化药物正在成为癌症的标志治疗;这是一种不断发展的方法,基于根据个体基因组成定制治疗方法。 2019年,FDA批准了12种个性化药物,以调查和解决疾病的根本原因,从而将精准医疗与临床护理结合起来。对个性化医疗的需求不断增长,为实验室开发的测试市场参与者的成长提供了巨大的增长机会。

基于类型的见解

实验室开发的测试市场按类型分为临床生物化学、重症监护、血液学、微生物学、分子诊断、免疫学等。分子诊断领域预计将在 2021 年占据最大的市场份额。然而,预计血液学领域在预测期内的市场复合年增长率最高。


实验室开发按类型测试市场 – 2021年和2028年


基于应用的洞察

通过应用,实验室将测试市场应用开发到学术机构、临床研究组织、医院实验室、专科诊断中心等。预计到 2021 年,医院实验室细分市场将占据最大的市场份额。然而,预计专科诊断中心细分市场在预测期内的复合年增长率最高。

 

战略见解

产品发布和批准是公司扩大全球足迹和产品组合时普遍采用的策略。此外,实验室开发的测试市场参与者专注于扩大客户群的合作伙伴战略,这反过来又使他们能够在全球范围内保持自己的品牌声誉。

报告实验室开发的测试市场细分如下

根据类型,实验室开发的测试市场分为临床生物化学、重症监护、血液学、微生物学、分子诊断、免疫学等。根据应用,实验室开发的测试市场分为学术机构、临床研究组织、医院实验室、专业诊断中心等。根据地理位置,实验室开发的测试市场分为北美(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、韩国和亚太地区其他地区)、中东和非洲非洲(阿联酋、沙特阿拉伯、南非以及中东和非洲其他地区)以及南美洲和中美洲(巴西、阿根廷以及南美洲和中美洲其他地区)。

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公司简介

  • Quest Diagnostics Incorporated
  • F. HOFFMANN-LA ROCHE LTD.,
  • QIAGEN
  • Illumina, Inc.,
  • Eurofins Scientific
  • Biodesix
  • 适应性生物技术
  • 生物治疗学
  • Rosetta Genomics Ltd.、
  • Guardant Health
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.

Frequently Asked Questions


What is laboratory developed test mean?

A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed and used within a single laboratory. These tests can be utilized to estimate or distinguish an extensive assortment of analytes materials such as proteins, chemical compounds like glucose or cholesterol, or DNA, from a specimen received from human anatomy. The expansion of automated in vitro diagnostics (IVD) methods for labs and dispensaries to render precise, and error-free analysis is anticipated to fuel the increment.

What are the driving factors for the laboratory developed test market across the globe?

The growth of the laboratory developed test market is mainly attributed to factors such as the increasing incidents of cancer and genetic disorders, large number of product launches. However, changing regulatory landscape for instance, in Europe, the In-Vitro Device Regulation (IVDR) compliance will be mandatory for all in vitro diagnostic tests from May 2022; the regulation aims to secure the clinical effectiveness and safety of medical tests, thus transforming the diagnostic industry is a great concern to hinder the market growth. In August 2021, eMed, a telehealth company democratizing healthcare through digital-point-of-care solutions, and Quest Diagnostics the world's leading provider of diagnostic information services, are collaborated to bring clinician-guided rapid antigen testing for COVID-19 to employers seeking to foster safer environments by decreasing the risk of COVID-19 exposure in their workplaces which is contributing to the growth of the target market. Such strategic steps are also projected to drive the market growth.

What is the regional analysis in terms of laboratory developed test market?

The growth of the region is attributed to factors such as rising public–private partnerships, and increasing funding activities are widely enhancing the performance of medical devices. Moreover, presence of well-developed healthcare infrastructure and government support are some of the prominent factors propelling the market growth in Asia Pacific. In Asia Pacific, India is the largest market for laboratory developed test. The market growth in Asia Pacific is mainly attributed to factors such as the growing usage of laboratory developed test in combating Covid-19, increasing incidents of cancer and genetic disorders, large number of product launches. However concerns high capital investment for setting up advanced labs hinders the market growth in Asia Pacific.

What are future trends of Laboratory Developed Test Market?

The automation of LDTs can significantly boost productivity and simplify compliance procedures. Clinical laboratories are under huge pressure to manage increasing test volumes and conduct more complex diagnostic assays, which further underlines the need for flexible automation systems. Many MedTech companies are offering automation solutions to help streamline clinical laboratory processes. For instance, Roche Cobas Omni–Utility Channel is beneficial for both IVD assays and high-volume LDTs. It is designed to meet the growing needs of efficient workflows in laboratories, as it can assist in different stages ranging from sample processing to quick data interpretation. It can run up to 96 results in about 3 hours and up to 864 results in 8 hours, thereby boosting the efficiency of laboratories.

Which type is expected to dominate the market in the forecast period?

The laboratory developed test market is led by type molecular diagnostics segment is growing significantly due to the increasing attention to the development of genetic therapeutics. The growing research in human genomics is playing a vital role in developing laboratory developed tests. The technological advantages of molecular tests make them compelling diagnostic tools, and they have become valuable for detecting a wide range of genetic diseases. For instance, in November 2017, Edico Genome launched the DRAGEN Clinical Genomics Information System (CGIS).

The List of Companies - Laboratory Developed Test Market

 

  1. Quest Diagnostics Incorporated
  2. F. HOFFMANN-LA ROCHE LTD.,
  3. QIAGEN
  4. Illumina, Inc.,
  5. Eurofins Scientific
  6. Biodesix
  7. Adaptive Biotechnologies
  8. Biotheranostics
  9. Rosetta Genomics Ltd.,
  10. Guardant Health

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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