Clinical Reference Laboratory Services Market by End-user, Service, and Geography - Global Forecasts to 2025

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• Market Driver

One of the key factors driving the clinical reference laboratory services market is the increasing prevalence of chronic and infectious diseases. Medical diagnostic procedures are in high demand due to the rising prevalence of chronic and infectious diseases. Furthermore, reference laboratories are providing services for the rapid detection of infectious diseases that require specialized laboratory testing instruments and skills, such as swine flu, hepatitis A and B, and HIV. These labs also provide low-cost diagnostic tests for common chronic diseases like cancer, diabetes, and cardiovascular disease. Furthermore, during peak seasons of infection, the lack of expertise in hospitals and clinics to perform critical diagnostic testing procedures for pandemic and highly communicable diseases, such as swine flu and Zika virus infection, necessitates the outsourcing of these tests to specialized reference laboratories. According to the World Bank Group, 1.4 million people die each year from hepatitis virus infections of various types. Hepatitis B vaccination based on blood test results has increased over time, according to the CDC, from 12.3% in 1999-2002 to 25.2% in 2015-2018. Furthermore, the CDC estimates that since 2010, influenza has caused 9-45 million cases, 140,000-810,000 hospitalizations, and 12,000-61,000 deaths. As a result, the global clinical reference laboratory services market will continue to grow during the forecast period due to the rising prevalence of chronic and infectious diseases.

• Market Challenge

Stringent regulations will be a major challenge for the clinical reference laboratory services market during the forecast period. Vendor-provided laboratory testing services are influenced by or subjected to complex and frequently changing laws and regulations around the world. Vendors' ability to operate their businesses quickly in a competitive market is hampered by frequent changes in laws. Furthermore, reference tests are important because they provide results for clinical diagnostic testing, and test results that are inaccurate can have serious and life-threatening consequences for patients' health. As a result, regulatory agencies all over the world have put in place strict regulations and defined standards. CLIA, for example, oversees the operation of clinical laboratories in the United States, ensuring that they meet various operational, technical, quality, and personnel requirements in order to provide reliable, accurate, and timely service. Similarly, the FDA in the US regulates devices, instruments, kits, software, and reagents used in reference test services. Similarly, in Europe, laboratory testing is governed by the European Parliament and Council Regulation (EC) No 882/2004 on official controls. The EU requires national reference laboratories to operate in accordance with EN ISO/EN 17011 and EN ISO/IEC 17025, which are updated on a regular basis. By limiting the operational capacities of reference laboratories, these standards and regulations limit the market's growth.

The Clinical Reference Laboratory Services Market is segmented by end-user (hospitals and private clinics, corporate offices and companies, and government entities), service (stand-alone reference laboratories, hospital-based reference laboratories, and clinic-based reference laboratories). Hospitals and private clinics segment will be significant during the forecast period. Hospitals and clinics outsource a significant number of clinical testing procedures that cannot be performed in in-house laboratories. Hence, the hospitals and private clinics segment is the major revenue-contributing end-user segment of the market. Hospital budgets are rapidly constraining, owing to the lack of funding and declining reimbursement coverage. The reducing cost of laboratory expenditure in hospitals is a primary driver for the outsourcing of laboratory services.

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• amedes Holding GmbH
• Clinical Reference Laboratory Inc.
• Exact Sciences Corp.
• Mayo Medical Laboratories
• OPKO Health Inc.
• Quest Diagnostics Inc.
• Sonic Healthcare Ltd.
• SYNLAB Bondco Plc
• Unilabs AB

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1 Executive Summary

2 Market Landscape

• 2.1 Market ecosystem
• Exhibit 01: Parent market

• 2.2 Market characteristics
• Exhibit 02: Market characteristics

• 2.3 Value chain analysis
• Exhibit 03: Value chain analysis- Life sciences tools and services

3 Market Sizing

• 3.1 Market definition
• Exhibit 04: Offerings of vendors included in the market definition

• 3.2 Market segment analysis
• Exhibit 05: Market segments

• 3.3 Market size 2020

• 3.4 Market outlook: Forecast for 2020 - 2025
• Exhibit 06: Global - Market size and forecast 2020 - 2025 ($ billion)
• Exhibit 07: Global market: Year-over-year growth 2020 - 2025 (%)

4 Five Forces Analysis

• 4.1 Five Forces Summary
• Exhibit 08: Five forces analysis 2020 & 2025

• 4.2 Bargaining power of buyers
• Exhibit 09: Bargaining power of buyers

• 4.3 Bargaining power of suppliers
• Exhibit 10: Bargaining power of suppliers

• 4.4 Threat of new entrants
• Exhibit 11: Threat of new entrants

• 4.5 Threat of substitutes
• Exhibit 12: Threat of substitutes

• 4.6 Threat of rivalry
• Exhibit 13: Threat of rivalry

• 4.7 Market condition
• Exhibit 14: Market condition - Five forces 2020

5 Market Segmentation by Application

• 5.1 Market segments
• Exhibit 15: Application - Market share 2020-2025 (%)

• 5.2 Comparison by Application
• Exhibit 16: Comparison by Application

• 5.3 Clinical chemistry - Market size and forecast 2020-2025
• Exhibit 17: Clinical chemistry - Market size and forecast 2020-2025 ($ billion)
• Exhibit 18: Clinical chemistry - Year-over-year growth 2020-2025 (%)

• 5.4 Human and tumor genetics - Market size and forecast 2020-2025
• Exhibit 19: Human and tumor genetics - Market size and forecast 2020-2025 ($ billion)
• Exhibit 20: Human and tumor genetics - Year-over-year growth 2020-2025 (%)

• 5.5 Medical microbiology and cytology - Market size and forecast 2020-2025
• Exhibit 21: Medical microbiology and cytology - Market size and forecast 2020-2025 ($ billion)
• Exhibit 22: Medical microbiology and cytology - Year-over-year growth 2020-2025 (%)

• 5.6 Other esoteric tests - Market size and forecast 2020-2025
• Exhibit 23: Other esoteric tests - Market size and forecast 2020-2025 ($ billion)
• Exhibit 24: Other esoteric tests - Year-over-year growth 2020-2025 (%)

• 5.7 Market opportunity by Application
• Exhibit 25: Market opportunity by Application

6 Market Segmentation by Service

• 6.1 Market segments

• 6.2 Stand-alone reference laboratories

• 6.3 Hospital-based reference laboratories

• 6.4 Clinic-based reference laboratories

7 Market Segmentation by End-user

• 7.1 Market segments

• 7.2 Hospitals and private clinics

• 7.3 Corporate offices and companies

• 7.4 Government entities

8 Customer landscape

• 8.1 Customer landscape

9 Geographic Landscape

• 9.1 Geographic segmentation

• 9.2 Geographic comparison

• 9.3 North America - Market size and forecast 2020-2025

• 9.4 Europe - Market size and forecast 2020-2025

• 9.5 Asia - Market size and forecast 2020-2025

• 9.6 ROW - Market size and forecast 2020-2025

• 9.7 Key leading countries

• 9.8 Market opportunity by geography

10 Drivers, Challenges, and Trends

• 10.1 Market drivers

• 10.2 Market challenges

• 10.3 Market trends

11 Vendor Landscape

• 11.1 Vendor landscape

• 11.2 Landscape disruption

12 Vendor Analysis

• 12.1 Vendors covered

• 12.2 Market positioning of vendors

• 12.3 amedes Holding GmbH

• 12.4 Clinical Reference Laboratory Inc.

• 12.5 Exact Sciences Corp.

• 12.6 Mayo Medical Laboratories

• 12.7 OPKO Health Inc.

• 12.8 Quest Diagnostics Inc.

• 12.9 Sonic Healthcare Ltd.

• 12.10 SYNLAB Bondco Plc

• 12.11 Unilabs AB

13 Appendix

• 13.1 Scope of the report

• 13.2 Currency conversion rates for US$

• 13.3 Research methodology

• 13.4 List of abbreviations

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