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The European laboratory developed test market is projected to reach US$ 8,988.78 million by 2028 from US$ 5,664.43 million in 2021; it is estimated to grow at a CAGR of 6.8% from 2021 to 2028.
The increasing incidence of cancer and genetic disorders and the growing number of product launches across Europe are factors propelling the laboratory developed testing market. However, the changing regulatory landscape is hampering the growth of the laboratory development test market.LDTs are developed and used within laboratories and not distributed or sold to other laboratories or healthcare facilities. These tests are designed to overcome the challenge of the unavailability of commercial tests. Many LDTs are genetic tests developed for rare diseases. Thus, the frequency of development and introduction of new LDTs is high. In November 2020, Aditx Therapeutics, Inc received a CLIA certification for AditxtScore laboratory operations for immune monitoring, which allowed them to launch the AditxtScore test to diagnose COVID-19. The increasing emergence of SARS-CoV-2 variants has highlighted the need to identify, trace, and track mutations across the complete viral genome. In January 2021, Eurofins launched the NovaType test for detecting and monitoring new variants of SARS-CoV-2. This RT-PCR assay is clinically validated for identifying B.1.1.7 and B.1.351 variants with a short time. NovaType is already available as an LDT in Germany, and it will be made available in over 50 Eurofins laboratories worldwide for testing patients for COVID-19. Also, the rising demand for personalized medicine is offering significant growth opportunities for the players operating in the European laboratory developed test market
Countries across Europe are witnessing a resurgence in COVID-19 cases after successfully mitigating the pandemic. Many countries are declaring more cases each day than the first wave in 2020. The governments of many countries are working toward scaling up testing capacity, which is further driving the laboratory developed test market. Many market players have launched products to meet the growing demand. For instance, in August 2020, Eurofins Technologies (Luxembourg) launched a range of testing kits for serology-based antibody detection by ELISA of patients exposed to COVID-19. These tests are designed to meet the region-specific requirements for COVID-19. Viracor Eurofins received Food and Drug Administration (FDA) and Emergency Use Authorization (EUA) for its SARS-CoV-2 laboratory developed test. Other Eurofins laboratories have developed alternative RT-PCR options to meet local regulatory obligations and mitigate reagent supply chain issues globally. However, other non-emergency tests witnessed a drop due to lockdown measures and overburdened healthcare institutions.
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EUROPE LABORATORY DEVELOPED TEST MARKET SEGMENTATION
By Type
- Clinical Biochemistry
- Critical Care
- Haematology
- Coagulation and Hemostasis,
- Hemoglobin Testing
- Blood Count Testing
- Others
- Immunology
- Microbiology
- Molecular Diagnostics
- Other Test Types
By Application
- Academic Institutes
- Clinical Research organizations
- Hospitals laboratory
- Specialty Diagnostic Centers
- Others
By Country
- Italy
- France
- Germany
- Spain
- UK
- Rest of Europe
Company Profiles
- Quest Diagnostics Incorporated
- F.HOFFMANN-LA ROCHE LTD
- QIAGEN
- Illumina, Inc.
- Eurofins Scientific
- Guardant Health
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.
- Quest Diagnostics Incorporated
- F.HOFFMANN-LA ROCHE LTD
- QIAGEN
- Illumina, Inc.
- Eurofins Scientific
- 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 many reports and advised several clients 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 organizations 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 the 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/Sales 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.
- 3.1 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.
- 3.2 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.
- 3.3 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.
- 3.4 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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