Laboratory Developed Test Market to Grow at a CAGR of 7.0% to reach US$ 7,269.3 million from 2021 to 2028
实验室开发测试市场规模预计将从 2021 年的 45.2475 亿美元增至 2028 年的 72.693 亿美元；预计 2021-2028 年期间的复合年增长率为 7.0%。
实验室开发测试 (LDT) 是一种在单个实验室内设计和使用的体外诊断测试。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标本中提取的 DNA。实验室和药房扩大自动化体外诊断 (IVD) 方法的使用范围，以提供精确且无误的分析，这推动了实验室开发测试市场的增长。
实验室开发测试市场的增长主要归因于癌症和遗传疾病发病率的增加以及大量产品上市等因素。然而，监管环境的变化阻碍了市场的增长。例如，在欧洲，从 2022 年 5 月起，所有体外诊断测试都必须遵守体外设备法规 (IVDR)；该法规旨在确保医疗测试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问题。
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实验室开发测试市场：
复合年增长率（2021 - 2028 年）7.0％- 2021 年市场规模
45.2 亿美元 - 2028 年市场规模
72.7 亿美元
市场动态
- 財政部
- 財政部
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- 財政部
- 財政部
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- 財政部
- 財政部
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关键人物;主力;重要一员
- Quest Diagnostics 公司
- F.霍夫曼-拉罗氏有限公司，
- 凯杰公司
- Illumina 公司
- 欧陆科技
- 生物降解塑料
- 自适应生物技术
- 生物诊疗学
- Rosetta Genomics 有限公司
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
类型- 临床生物化学
- 重症监护
- 血液学
- 微生物学
- 分子诊断
- 免疫学
- 其他的
应用- 学术机构
- 临床研究组织
- 医院实验室
- 专业诊断中心
- 其他的
- 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。
市场洞察
个性化医疗的持续研究为实验室开发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，个性化药物很可能成为通过目前尚未发现的有效治疗或治愈方法治疗疾病的有效手段。根据个性化药物联盟的数据，个性化药物在 2005 年仅占 FDA 批准的新分子实体的 5%；然而，在 2016 年，这一数字上升到 25% 以上。此外，42% 的所有化合物和 73% 的肿瘤化合物都有可能成为个性化药物。过去五年，生物制药公司在个性化药物方面的研发投资几乎翻了一番，预计未来五年他们的投资将进一步增加 33%。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数据。
个性化医疗正成为癌症治疗的标志；这是一种不断发展的方法，基于根据个人基因组成定制治疗方案。2019 年，FDA 批准了 12 种个性化药物，用于调查和解决疾病的根本原因，从而将精准医疗与临床护理相结合。个性化医疗需求的不断增长为实验室开发测试市场参与者的增长提供了巨大的增长机会。
基于类型的洞察
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。分子诊断部分预计将在 2021 年占据最大的市场份额。然而，预计血液学部分将在预测期内实现最高的复合年增长率。
基于应用的洞察
根据应用，实验室将测试市场应用扩展到学术机构、临床研究组织、医院实验室、专业诊断中心等。预计医院实验室部分将在 2021 年占据最大的市场份额。然而，预计专业诊断中心部分将在预测期内实现最高的复合年增长率。
产品发布和审批是企业扩大全球影响力和产品组合的常用策略。此外，实验室开发的测试市场参与者专注于合作策略来扩大客户群，这反过来又使他们能够在全球范围内维护自己的品牌名称。
报告将实验室开发测试市场细分如下
根据类型，实验室开发测试市场细分为临床生物化学、重症监护、血液学、微生物学、分子诊断、免疫学等。根据应用，实验室开发测试市场细分为学术机构、临床研究组织、医院实验室、专业诊断中心等。根据地域，实验室开发测试市场细分为北美（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、韩国和亚太其他地区）、中东和非洲（阿联酋、沙特阿拉伯、南非和中东和非洲其他地区）以及南美洲和中美洲（巴西、阿根廷和南美洲和中美洲其他地区）。
实验室开发测试市场报告范围
| 报告属性 | 细节 |
|---|---|
| 2021 年市场规模 | 45.2亿美元 |
| 2028 年市场规模 | 72.7 亿美元 |
| 全球复合年增长率（2021 - 2028） | 7.0％ |
| 历史数据 | 2019-2020 |
| 预测期 | 2022-2028 |
| 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。
公司简介
- Quest Diagnostics 公司
- F.霍夫曼-拉罗氏有限公司，
- 凯杰公司
- Illumina 公司
- 欧陆科技
- 生物降解塑料
- 自适应生物技术
- 生物诊疗学
- Rosetta Genomics 有限公司
- 卫安医疗
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
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 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.
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.
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.
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.
The List of Companies - Laboratory Developed Test Market
- Quest Diagnostics Incorporated
- F. HOFFMANN-LA ROCHE LTD.,
- QIAGEN
- Illumina, Inc.,
- Eurofins Scientific
- Biodesix
- Adaptive Biotechnologies
- Biotheranostics
- Rosetta Genomics Ltd.,
- Guardant Health
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.
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