Clinical Reference Laboratory Market

Clinical Reference Laboratory Market Outlook (2023 to 2033)

The global clinical reference laboratory market is valued at US$ 234.5 billion in 2023 and is projected to reach a size of US$ 412 billion by the end of 2033, expanding at a CAGR of 5.8% from 2023 to 2033.

Clinical laboratories identify and quantify various chemicals, which can reveal abnormal metabolic processes, infectious and non-infectious disorders, and inflammatory conditions based on changes in biomolecule levels.

Effective medical diagnostic procedures and public health rely on the timely and precise diagnosis of severe illnesses and their proper treatment. To detect illnesses and monitor routine health conditions, the utilization of laboratory centrifuges is increasing significantly.

The healthcare industry is expected to witness an increase in the utilization of medical samples, leading to high demand for clinical laboratory services worldwide. Advancements in areas such as hematology, neo-natal screening, serology, and immune histochemistry have created new avenues for market expansion.

• In March 2022, Mindray launched its latest hematology analyzers, the BC-700 Series, designed for small-to-midsize laboratories. These analyzers offer complete blood count (CBC) and erythrocyte sedimentation rate (ESR) testing capabilities.

Pathology services have emerged as a pillar of development for the medical sector. Inferences made from human clinical reference laboratories have helped establish several therapy paths. The field of molecular biology encompasses a wide range of research areas that require constant testing and experimentation. The demand for clinical trials in this field is therefore growing.

Due to a shortage of financing and decreasing reimbursement coverage, hospital finances are quickly becoming constrained. The decreasing cost of laboratory expenses in hospitals is a significant factor driving the outsourcing of laboratory services.

The clinical reference laboratory services sector has grown due to the smooth integration of biochemical research findings into the industry. Standalone labs are capable of efficiently handling large volumes of advanced clinical diagnostic services and delivering superior outcomes at lower costs, resulting in economies of scale for service providers. The market is also expected to benefit from new players entering the standalone clinical lab market, contributing to its expansion.

To meet diagnostic demands, clinical laboratory tests employ a variety of methodologies and technological frameworks. The most widely used technologies in laboratory information management systems include ELISA, chromatography, immunochemistry, spectroscopy, and molecular biology. To determine the concentration of medicines and their metabolites, bioanalytical services are a crucial tool in drug discovery and development.

• For instance, LabCorp expanded its bioanalytical footprint in Asia Pacific in November 2021 by opening a bioanalytical laboratory in Singapore.

Report Attributes	Details
Market Size in 2022	US$ 221.64 Billion
Estimated Market Value (2023)	US$ 234.5 Billion
Forecasted Market Value (2033)	US$ 412 Billion
Global Market Growth Rate (2023 to 2033)	5.8% CAGR
North America Market Share (2023)	35%
Key Companies Profiled	OPKO Health Inc.; Quest Diagnostics Incorporated; Myriad Genetics; LabCorp; NeoGenomics; Unilabs; Sonic HealthCare Limited; KingMed Diagnostics; SYNAB International GmbH; ARUP Laboratories

Why is Demand for Clinical Reference Laboratory Services Growing Worldwide?

“Rising Prevalence of Chronic Disorders Driving Demand for Clinical Trials”

Increasing need for clinical trials is driven by the rising prevalence of chronic diseases worldwide. It is expected that these laboratories offering clinical trials will gain more significance in the projected period due to reduced hospital budgets resulting from declining medical reimbursements.

Value-based outsourcing of hospitals is expected to drive the growth of clinical reference medical laboratories in the years to come. The clinical laboratory services sector is expanding due to several factors, including the increasing prevalence of chronic diseases and the growing demand for early diagnostic testing. It is expected that rapid advancements in sample preparation and data management during the forecast period will drive market growth.

“Increasing Collaborations between Clinical Reference Laboratories and Risk Management Providers”

The growth of the clinical reference laboratory market is expected to be boosted by the increasing collaborations between reference laboratories and risk management providers in the projected period.

Local vendors pose a significant threat to global vendors in terms of customer acquisition. To address these challenges, established companies are focusing on building relationships with organizations such as health plan providers, integrated delivery networks (IDN), and risk-bearing institutions.

Reference laboratories can retain a steady clientele, speed up expansion, and attain operational efficiencies due to these agreements. By leveraging cutting-edge IT systems and offering effective diagnostic insights, these partnerships enable the unrestrained exchange of knowledge to strengthen the healthcare system.

What Hindrances are Encountered by Clinical Reference Laboratory Service Providers?

“Stringent Regulations Governing Clinical Diagnostic Testing Limiting Demand for Laboratory Testing Services”

Stringent regulations governing laboratory testing are expected to in turn restrict demand for these services. Vendors providing laboratory testing services may be impacted by the complex and constantly changing global laws and regulations.

Frequent changes in the law hinder vendors' capacity to run their firms rapidly in a cutthroat marketplace. Reference tests play a critical role in clinical diagnostic testing technology, as inaccurate or unreliable results can have severe and even fatal implications for patients' health. Regulatory bodies worldwide have thus implemented stringent rules and guidelines to ensure the accuracy and reliability of these tests.

How Can New Market Players Penetrate This Highly Competitive Space?

“New Market Entrants Should Focus on Low-cost Digital Therapy Solutions”

New entrants are offering low-cost testing and therapy solutions to gain a competitive edge.

• PathAI is a start-up that uses artificial intelligence and machine learning to improve the accuracy and speed of pathology diagnoses. The company's platform analyzes digital pathology images and provides insights to pathologists to help them make more informed decisions.
• One recent development from PathAI is the company's acquisition of a digital pathology company called Artificial Intelligence Technology Solutions (AITechS). The acquisition was announced in March 2022 and is expected to strengthen PathAI's position as a leader in the digital pathology market.

Country-wise Insights

Why is the United States a Lucrative Market for Clinical Reference Laboratory Service Companies?

“Strong Presence of Well-established Clinical Laboratory Testing Service Companies”

Several major companies operate in the United States and their continued growth is expected to significantly drive the expansion of the market during the forecast period. The United States is projected to play a crucial role in capturing a substantial share of the global clinical reference laboratory market compared to other countries.

Rising incidence of health problems in the country, favorable regulatory environment, and a well-developed healthcare system are key drivers for the high demand for clinical reference laboratory services in the country.

• In August 2022, LabCorp, a leading global life sciences company, announced the completion of its acquisition of the outreach laboratory operation and certain related assets from RWJBarnabas Health, an academic healthcare system in New Jersey.

What are the Factors Driving Demand for Clinical Reference Laboratory Services in Germany?

“Rising Awareness Regarding Preventive Health Screening in Germany Boosting Demand for Clinical Laboratory Testing Services”

Europe is expected to hold a leading share of the market during the forecast period. Demand for clinical reference laboratory services is anticipated to grow due to various factors. There is an increasing trend towards laboratory outsourcing in Germany. Increasing adoption of the latest technologies by major companies and rising incidence of chronic diseases among the expanding elderly population are also driving demand for these services.

Government programs aimed at raising awareness of preventive screening, increasing support from public and private entities for research on the development of clinical laboratory tests, and rising adoption of genome-based laboratory testing are also contributing to the growth of this market.

Why is the Number of Clinical Laboratories Increasing in India and China?

“Technological Advancements in Genome-based Diagnostics Driving Demand for Clinical Laboratory Testing Services”

Demand for clinical laboratory services in the Asia Pacific region is expected to grow significantly during the forecast period, owing to increased efforts to strengthen the health infrastructure in this region. This demand will also be driven by advancements in the fields of oncology, genome-based testing, and cytogenetics.

Rising healthcare costs, an increase in hospitals and clinical diagnostic labs in China and India, as well as an expanding body of research on clinical laboratory testing methods in China, are contributing to the growth of the market in these countries.

• Roche Diagnostics' Indian division launched the Cobas 100% integrated solutions analyzer in September 2021, which is a sophisticated device suitable for various hospitals and laboratories operating in the country.

Category-wise Insights

Why is the Preference for Hospital-based Testing Increasing Worldwide?

“Increasing Number of Patients with Complex Medical Conditions”

The hospital-based segment is expected to remain a significant contributor to the market throughout the forecast period. Hospitals are the major end users of clinical laboratory services and are increasingly adopting these services. As more hospitals integrate laboratories into their facilities, the hospital-based segment is expected to occupy a leading share of the market.

Increasing adoption of hospital-based testing can be attributed to hospitals' awareness campaigns and the high turnover of patients with serious and complex medical conditions. This is mainly due to the large number of patients seeking treatment for complex and serious medical conditions, which require more expensive testing and a faster turnaround time.

Why Will Clinical Trials Always Be in High Demand?

“Increasing Incidence of Cancer and Heart Diseases Necessitating Detailed Molecular Diagnostics & Testing”

The success of a biochemical research project relies on the integrity upheld by scientists and laboratory professionals. With the increasing prevalence of serious medical conditions such as cancer and heart failure, there is a growing need for molecular diagnostics and testing.

The clinical reference laboratory services market is expected to experience significant growth in the coming years. The demand for clinical laboratory services is being driven by the need to investigate genetic abnormalities in detail, as well as advancements in the field of cytogenetics. The need for clinical diagnostics is anticipated to increase along with the expanding cancer burden.

• Globocan Statistics 2020 revealed that in 2016, there were 19.3 million new cases of cancer globally across both genders. The same source reported a rapid increase in cancer incidence worldwide. It is projected that by 2040, there will be 30.2 million new cases of cancer among both males and females.

Competitive Landscape

The clinical reference laboratory industry is highly competitive, with both local and international companies vying for customers. Companies in the clinical reference laboratory market are also competing fiercely by offering innovative services, allowing them to establish a significant presence in the industry. Due to their increasing reliance on technology, few new players are expected to enter the market in the future, which will further consolidate the market share of existing players.

• In September 2022, Bionano Genomics Inc. launched Bionano Labs, a new company that integrates Lineagen's former clinical testing services with Bionano's optical genome mapping (OGM) data capabilities.

Clinical Reference Laboratory Industry Research Segmentation

• By Type :

  • Standalone
  • Clinical-based
  • Hospital-based

• By Application :

  • Clinical Trials
  • Laboratory Medicine

• By Region :

  • North America
  • Latin America
  • Europe
  • Asia Pacific
  • Middle East & Africa