Clinical Reference Laboratory Market Overview, Growth, Trends, Analysis, Research Report (2021-2031)

Clinical Reference Laboratory Market Size and Forecast (2021-2031), Global and Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: Service Provider (Hospital-Based, Standalone, and Clinic-Based), Application (Laboratory Medicine, Clinical Trials, and Others), and Geography (North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America)

  • Report Code : TIPRE00039108
  • Category : Medical Device
  • Status : Published
  • No. of Pages : 195
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The clinical reference laboratory market size is projected to reach US$ 74.08 billion by 2031 from US$ 45.35 billion in 2023. The market is expected to register a CAGR of 6.3% during 2023–2031. The use of artificial intelligence in clinical reference laboratories is likely to remain a key trend in the market.

Clinical Reference Laboratory Market Analysis

The increasing prevalence of chronic diseases and the emergence and outbreak of various infectious diseases have fueled the demand for novel treatment options and newer therapeutic categories and created the need for better treatment options in existing therapeutic categories. Accurate diagnostics are critical for identifying disease biomarkers and detecting organisms, particularly in cancer and tuberculosis. Clinical reference laboratories play an important role in modern healthcare. The reference laboratories provide services for the quick diagnosis of infectious diseases that require specialized laboratory testing equipment and expertise, such as swine flu and hepatitis A and B. These laboratories also offer low-cost diagnostic testing for common chronic conditions such as cancer, diabetes, and cardiovascular diseases. Thus, the rising prevalence of infectious and chronic diseases is driving the growth of the clinical reference laboratory market

 Strategic initiatives by the laboratory service providers, such as acquisition and alliance with reference labs, are among the most cost-effective ways to obtain the benefits of better patient care and cost efficiency is expected to offer significant opportunities for the market growth.

Clinical Reference Laboratory Market Overview

Clinical reference laboratories play an important role in the healthcare system by providing essential diagnostic and testing services that help doctors make decisions. As technology advances and the healthcare landscape evolves, the clinical reference laboratory services market observes important trends that will shape the future of precision medicine. Moreover, during the COVID-19 pandemic, it became evident that medical reference labs are critical for rapid testing, establishing novel techniques, generating and analyzing data, and serving as knowledge hubs. Reference labs are more than just high-volume testing facilities; they are the hubs of expertise and data.

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Clinical Reference Laboratory Market: Strategic Insights

Clinical Reference Laboratory Market

  • CAGR (2023 - 2031)
    6.3%
  • Market Size 2023
    US$ 45.35 Billion
  • Market Size 2031
    US$ 74.08 Billion

Market Dynamics

GROWTH DRIVERS
  • Rising Prevalence of Chronic and Infectious Diseases
FUTURE TRENDS
  • Increasing Number of Clinical Trials
OPPORTUNITIES
  • Strategic Initiatives with Reference Lab

Key Players

  • Sonic HealthCare Limited,
  • Unilabs,
  • Quest Diagnostics,
  • Arup Laboratories,
  • Clinical Reference Laboratories,
  • Synlab International GmbH,
  • Laboratory Corporation of America Holdings,
  • Myriad Genetics Inc,
  • TOPLAB,
  • Boca Biolistic LLC

Regional Overview

  • North America
  • Europe
  • Asia-Pacific
  • South and Central America
  • Middle East and Africa

Market Segmentation

Service Provider
  • Hospital-Based
  • Stand Alone
  • Clinical Based
Application
  • Laboratory Medicine
  • Clinical Trials
  • Others
  • Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.

Clinical Reference Laboratory Market Drivers and Opportunities

Increasing Number of Clinical Trials to Favor Market

Clinical trials assist in evaluating whether a new treatment or prevention method, such as a new medicine, diet, or medical technology, is safe and effective. The trials are primarily conducted during the drug development phase. In January 2023, the National Library of Medicine (NLM) reported that there were 38,837 active clinical studies in the US and 105,172 active trials globally. According to the European Medicine Agency, in the European Union (EU), ~4,000 clinical trials are approved annually, with the pharmaceutical industry accounting for roughly 60%. Due to the growing prevalence of chronic diseases, the number of clinical trials is increasing to develop various effective treatments.

Thus, the increasing number of clinical trials is driving the clinical reference laboratory market growth.

Strategic Initiatives with Reference Laboratories

Strategic initiatives by the laboratory service providers, such as acquisition and alliance with reference labs, are among the most cost-effective ways to obtain the benefits of better patient care and cost efficiency.

On April 3, 2024, Eurofins Scientific, a testing laboratories company, acquired Ascend Clinical LLC, a clinical reference laboratory specializing in testing services for kidney diseases in the US. The acquisition further strengthens Eurofins network's footprint in transplant testing and associated renal care, broadening its clinical client base. Ascend has gained access to Eurofins' extensive laboratory network and analytical portfolio and has established industry relationships.

In October 2023, Labcorp, a global leader in innovative and comprehensive laboratory services, announced that it would acquire Baystate Health, Inc.'s (Baystate Health) outreach laboratory business and certain operating assets, including laboratory service centers operated by Baystate Health throughout Massachusetts. This strategic alliance will strengthen Labcorp and Baystate Health's existing reference laboratory relationship to improve the efficiency of routine and specialty lab testing. Thus, the increasing number of acquisitions and alliances with reference laboratories is expected to offer significant opportunities for the market growth.

Clinical Reference Laboratory Market Report Segmentation Analysis

Key segments that contributed to the derivation of the clinical reference laboratory market analysis are service provider and application.

  • By service provider, the market is segmented into hospital-based, standalone, and clinical-based. In 2023, the hospital-based segment held the largest share of the market. The standalone segment is anticipated to register the highest CAGR during 2023–2031.
  • Based on application, the clinical reference laboratory market is divided into laboratory medicine, clinical trials, and others. In 2023, the laboratory medicine segment held the largest share of the market. The clinical trials segment is estimated to register the highest CAGR during the forecast period.

Clinical Reference Laboratory Market Share Analysis by Geography

The geographic scope of the clinical reference laboratory market report is mainly divided into five regions: North America, Asia Pacific, Europe, Middle East & Africa, and South & Central America.

North America dominated the clinical reference laboratory market. The market growth in this region can be attributed to an increase in the number of clinical trials and the presence of key players in the region. The US holds the largest share of the clinical reference laboratory market in North America. The US is one of the leading clinical research destinations. Nearly half of the total clinical trials are performed in the US. Additionally, most pharmaceutical research companies choose to perform clinical trials in the US owing to fast approval timelines, a favorable regulatory framework, and established medical infrastructure. Moreover, data generated for clinical trials in the US is accepted globally. According to the World Health Organization (WHO) report in 2021, the US registered the highest number of clinical trials (157,618).

Clinical Reference Laboratory Market Report Scope

Report Attribute Details
Market size in 2023 US$ 45.35 Billion
Market Size by 2031 US$ 74.08 Billion
Global CAGR (2023 - 2031) 6.3%
Historical Data 2021-2022
Forecast period 2023-2031
Segments Covered By Service Provider
  • Hospital-Based
  • Stand Alone
  • Clinical Based
By Application
  • Laboratory Medicine
  • Clinical Trials
  • Others
Regions and Countries Covered North America
  • US
  • Canada
  • Mexico
Europe
  • UK
  • Germany
  • France
  • Russia
  • Italy
  • Rest of Europe
Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • Rest of Asia-Pacific
South and Central America
  • Brazil
  • Argentina
  • Rest of South and Central America
Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Rest of Middle East and Africa
Market leaders and key company profiles
  • Sonic HealthCare Limited,
  • Unilabs,
  • Quest Diagnostics,
  • Arup Laboratories,
  • Clinical Reference Laboratories,
  • Synlab International GmbH,
  • Laboratory Corporation of America Holdings,
  • Myriad Genetics Inc,
  • TOPLAB,
  • Boca Biolistic LLC
    • Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.

    Clinical Reference Laboratory Market News and Recent Developments

    The clinical reference laboratory market is evaluated by gathering qualitative and quantitative data post primary and secondary research, which includes important corporate publications, association data, and databases. The following is a list of developments in the market:

    • SYNLAB launched a revolutionary test for the diagnosis of bipolar disorder in France. myEDIT-B is the first clinically validated test for the differential diagnosis between bipolar disorder and unipolar depression, signaling a paradigm shift in the identification of this mental health disorder and thus increasing the effectiveness of the treatment approach. (April 2024, SYNLAB International GmbH, Press Release)
    • Quest Diagnostics, a leading provider of diagnostic information services, launched MelaNodal Predict, a highly advanced predictive gene expression test to help personalize treatment decisions for patients with melanoma, the deadliest form of skin cancer and one of the most common cancers in the US. (March 2023, Quest Diagnostics, Press Release)
    • Proteomics International Laboratories Ltd signed an exclusive license agreement with Sonic Healthcare USA, a Division of Sonic Healthcare Ltd (OTCMKTS: SKHHY), for the use and commercialization of the Company's PromarkerD test for diabetic kidney disease in the US. As per the agreement, Sonic Healthcare USA will be offering PromarkerD to physicians and healthcare systems through its client engagement teams across the US. (May 2023, Sonic Healthcare USA, Press Release)
    • Unilabs, the leading European diagnostic services provider, acquired Saltro one of the largest and most innovative diagnostics companies in the Netherlands. The acquisition significantly expands Unilabs' presence in the Netherlands, where its Medlon team currently provides laboratory diagnostics services in the eastern part of the country. With the addition of Saltro, Unilabs become one of the Netherlands' largest and most complete diagnostics providers. (September 2020, UNILABS, Press Release)

    Clinical Reference Laboratory Market Report Coverage and Deliverables

    The "Clinical Reference Laboratory Market Size and Forecast (2021–2031)" report provides a detailed analysis of the market covering the following areas:

    • Clinical reference laboratory market size and forecast at global, regional, and country levels for all the key market segments covered under the scope
    • Clinical reference laboratory market trends as well as market dynamics such as drivers, restraints, and key opportunities
    • Detailed PEST/Porter's Five Forces and SWOT analysis
    • Clinical reference laboratory market analysis covering key market trends, global and regional framework, major players, regulations, and recent market developments
    • Industry landscape and competition analysis covering market concentration, heat map analysis, prominent players, and recent developments for the clinical reference laboratory market
    • Detailed company profiles
    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 are the driving factors for the clinical reference laboratory market across the globe?

    The factors that are driving growth of the market are the rising prevalence of chronic and infectious diseases and increasing number of clinical trials.

    Who are the major players in the clinical reference laboratory market?

    The clinical reference laboratory market majorly consists of the players such as Sonic HealthCare Limited, Unilabs, Quest Diagnostics, Arup Laboratories, Clinical Reference Laboratories, Synlab International GmbH, Laboratory Corporation of America Holdings amongst others.

    What are clinical reference laboratory?

    The reference laboratory offers cutting edge testing services in the areas of clinical trials, genomics, toxicology, virology and others. Clinical laboratories sometimes send tests to reference laboratories as reference laboratories are well-equipment and have the supplies needed for the testing which are not frequently used in clinical laboratories.

    Which application segment is dominating the clinical reference laboratory market?

    The clinical reference laboratory market, by application, is segmented into laboratory medicine, clinical trials, and others. The laboratory medicine segment held a larger market share in 2023. The clinical trials segment is anticipated to register a higher CAGR during the forecast period.

    Which service provider segment is dominating the clinical reference laboratory market?

    Based on service provider, the clinical reference laboratory market is segmented into hospital-based, standalone, and clinical based. The hospital-based segment held a larger market share in 2023. The standalone segment is anticipated to register a higher CAGR during the forecast period.

    Which region dominates the clinical reference laboratory market?

    North America holds the largest market share in clinical reference laboratory market. The increase in the number of clinical trials and the presence of key players in the region are propelling the growth of the market in North America.

    The List of companies - Clinical Reference Laboratory Market

    1. Sonic Healthcare Ltd
    2. UNILABS
    3. Laboratory Corp of America Holdings
    4. Quest Diagnostics Inc
    5. ARUP Laboratories Inc
    6. Clinical Reference Laboratory Inc
    7. SYNLAB International GmbH
    8. Myraid Genetics Inc
    9. Boca Biolistics LLC
    10. TOPLAB

    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 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.

    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/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:

    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.

    • 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.

    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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