Chemiluminescence Immunoassay Market Size, Share & Trends Analysis Report By Product (Instruments, Consumables), By Sample Type (Blood, Urine), By Application, By End-use, By Region, And Segment )- Global Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2024-2033

Chemiluminescence Immunoassay Market Size and Growth

The global chemiluminescence immunoassay market size was valued at USD 14.90 billion in 2023 and is anticipated to reach around USD 31.87 billion by 2033, growing at a CAGR of 7.9% from 2024 to 2033.

Chemiluminescence Immunoassay Market Key Takeaways

• The North America chemiluminescence immunoassay market held the largest share of 40.7% in 2023 and is expected to dominate the market over the forecast period.
• The Asia Pacific chemiluminescence immunoassay market is projected to grow at the fastest CAGR of 6.5% over the forecast period.
• The consumables segment dominated the market with a share of 66.45% in 2023 and is anticipated to grow at the fastest CAGR over the forecast period.
• The instruments segment is anticipated to experience considerable growth over the forecast period. In 2023
• The blood sample type segment led the market and accounted for a share of 55.86% in 2023.
• The urine sample type segment is expected to experience significant growth during the forecast period.
• The infectious disease segment held the largest share of over 29.67% in 2023.
• The oncology segment is projected to grow at the fastest CAGR of 4.4% over the forecast period.
• The hospitals segment dominated the market and accounted for a revenue share of 36.01% in 2023.
• The pharmaceutical & biotechnology companies segment is expected to grow at the fastest CAGR of 5.8% from 2024 to 2033.

U.S. Chemiluminescence Immunoassay Market Size, Industry Report, 2033

The U.S. chemiluminescence immunoassay market size was estimated at USD 4.29 billion in 2023 and is predicted to be worth around USD 9.44 billion by 2033, at a CAGR of 8.2% from 2024 to 2033.

The North America chemiluminescence immunoassay market held the largest share of 40.7% in 2023 and is expected to dominate the market over the forecast period. The presence of established healthcare infrastructure, widespread utilization of advanced CLIA solutions, and increasing frequency of chronic diseases are key contributors to the regional market growth.

U.S. Chemiluminescence Immunoassay Market Trends

The chemiluminescence immunoassay market in the U.S. accounted for a share of 34.9% of the global market. This is fueled by the industry’s partnerships with local companies to tackle technological hurdles in creating valuable chemicals, ingredients, and products from renewable biomass, providing an alternative to conventional feedstock. These items are used in consumer and industrial areas, such as personal care, food and nutrition, household items, and agriculture.

Europe Chemiluminescence Immunoassay Market Trends

The Europe chemiluminescence immunoassay market held a substantial share in 2023, driven by the increased incidence of chronic & infectious diseases and the need for efficient & accurate diagnostic solutions. Other key factors fueling market growth include the presence of major industry players with solid R&D capabilities, advancements in technology, and increased healthcare investments.

The chemiluminescence immunoassay market in the UK is expected to experience promising growth in the coming years. There is an anticipated increase in investments in CLIA technologies due to the government’s focus on improving healthcare infrastructure, promoting development, and strengthening diagnostic capabilities.

Asia Pacific Chemiluminescence Immunoassay Market Trends

The Asia Pacific chemiluminescence immunoassay market is projected to grow at the fastest CAGR of 6.5% over the forecast period. One of the main factors driving the regional market growth is the rising recognition of chronic diseases in developing economies like China and India. Moreover, increasing acceptance of CLIA systems and the introduction of new CLIA systems by domestic companies are expected to aid the advancement of the local market. 

The chemiluminescence immunoassay market in China is expected to have significant growth in the coming years. In China, the biotechnology sector and its related industries are making quick progress, as experts from the China National Center of Biotechnological Development point towards the country’s growing status as a biotechnology powerhouse. As biotechnologies become more widespread, China and other local participants are proactively creating guidelines and ethical frameworks to foster the expansion of this emerging industry.

Chemiluminescence Immunoassay Market Growth 

The market growth can be attributed to the growing emphasis on early disease detection and increased efforts by pharmaceutical companies in drug discovery and development, particularly for chronic diseases such as infectious diseases, autoimmune diseases, cardiovascular diseases, diabetes, obesity, and cancer.

In recent years, the number of cases of infectious diseases has increased significantly. However, due to the work of global organizations and the World Health Organization, antiviral treatments have effectively controlled the diseases. Moreover, diagnosis has played a significant role in managing the diseases.

According to the IDF Diabetes Atlas, approximately 537 million adults have diabetes, representing 1 in 10 people. This number is projected to increase to 643 million and 783 million by 2030 and 2045, respectively. Most of those affected, over 75%, reside in low- and middle-income countries. In one year, diabetes-related deaths totaled 6.7 million, or one death every five seconds. The growing prevalence of infectious and chronic diseases is driving the expansion of the CLIA industry.

CLIA is a state-of-the-art immunoassay method that is one of the most recent advancements in the industry. The CLIA technique has various benefits compared to traditional methods like ELISA and RIA. Despite its numerous advantages, the CLIA technique still has several associated limitations. One example is the considerable setup cost required, a significant disadvantage of the CLIA method. The market growth is expected to be hindered due to the challenge of adopting expensive devices in emerging economies like India, Brazil, and South Africa.

Chemiluminescence Immunoassay Market Report Scope

Chemiluminescence Immunoassay Market Trends

• The field of chemiluminescence immunoassay (CLIA) has undergone significant technological advancements, enhancing its sensitivity, speed, and automation capabilities. These advancements include the introduction of novel assay formats, enhanced instrumentation with advanced optical detection systems, and the development of sophisticated reagents tailored specifically for CLIA applications.
• Moreover, automation features have streamlined laboratory workflows, reducing human error and enabling high-throughput analysis. Therefore, these innovations have transformed CLIA into a versatile and indispensable diagnostic tool, with broad applications in clinical laboratories and research settings worldwide.

Chemiluminescence Immunoassay Market Dynamics

DRIVER: Rising incidence of chronic and infectious diseases across the globe

During recent years, there has been a significant rise in the occurrence of infectious as well as diseases. With rising prevalence the rate of their diagnosis has increased significantly across the globe. The WHO underlined the global concern of HIV, which claimed over 38.4 million in 2021. Due to the efforts of international organizations and the WHO, the disease has been managed with antiviral therapies. Diagnosis has substantially helped disease management. Besides, according to the IDF Diabetes Atlas, globally, about 537 million adults (20–79 years) are living with diabetes—1 in 10. This number is predicted to rise to 643 million by 2030 and 783 million by 2045. Over 3 in 4 adults with diabetes live in low- and middle-income countries. Diabetes is responsible for 6.7 million deaths in 2021—1 every 5 seconds. The increased prevalence of infectious and chronic diseases is hence a driving factor for the growth of the CLIA market.

OPPORTUNITY: Increasing number of collaborations and partnerships in the CLIA market

Collaboration and partnership are essential in the field of CLIA to drive innovation, expand applications, and advance the development and adoption of new technologies. Here are some key aspects of collaboration and partnership in the context of CLIA. Some of the recent developments include in February 2022, Sysmex established a business tie-up with KAINOS Laboratories to strengthen the former company’s offering of immunochemistry diagnostic reagents and develop diagnostic reagents for HISCL systems. These developments help in the growth of both the players involved, which eventually helps in the growth of the market.

RESTRAINT: High cost of CLIA related products

The high cost of CLIA systems and reagents can be a significant challenge to its widespread adoption and implementation. CLIA requires specialized equipment and instrumentation, including chemiluminescence analyzers, luminometers, and other laboratory devices. These instruments are often high-end and technologically advanced, which come with significantly higher costs for their purchase, maintenance, and calibration. Also, CLIA utilizes specific reagents and consumables, such as antibodies, detection agents, substrates, and assay plates. These systems may be sometimes unaffordable to small scale laboratories, or academic or research organizations which can hamper the adoption of CLIA systems, hence impacting growth of the market.

CHALLENGE: Lack of skilled professionals and aging workforce

The dearth of a skilled workforce has been a challenge for several decades, resulting in an aging workforce and declining enrolment in training programs. It takes almost five to ten years of continuous practice in clinical laboratory work for technicians to gain expertise.

Europe reportedly has low numbers of clinical technicians. The Gatsby Foundation stated in 2019 that over 1.5 million people serve in the health, engineering, science, and technology domains. Over 50,000 retire every year, and 700,000 technicians will be required to meet the soaring demands in the next decade. The Duquesne University School of Nursing has stated that by 2025, there will be a shortage of over 29,400 nurse practitioners and more than 400,000 home health aides.

Product Insights & Trends

The consumables segment dominated the market with a share of 66.45% in 2023 and is anticipated to grow at the fastest CAGR over the forecast period. This can be credited to the growing need for supplies like reagents and stains in therapeutic drug monitoring, endocrinology, and disease diagnosis.

The instruments segment is anticipated to experience considerable growth over the forecast period. In 2023, the segment was led by automated instruments, which are widely used in high-volume testing settings, such as large hospitals and research institutes, where efficiency and accuracy are crucial. A rise in the instrument sector is due to the growing efforts of leading companies to create and launch advanced CLIA systems.

Sample Type Insights & Trends

The blood sample type segment led the market and accounted for a share of 55.86% in 2023. This is due to the rising incidence of chronic diseases, such as cancer and cardiovascular disorders, which often require frequent blood-based testing for diagnosis, monitoring, and treatment management. Blood-based CLIA tests offer high sensitivity and specificity, making them valuable tools for detecting biomarkers linked to these conditions.

The urine sample type segment is expected to experience significant growth during the forecast period. The increasing use of urine-based tests for disease diagnosis and monitoring drives this growth. Urine tests are non-invasive and cost-effective, making them popular for routine health checkups and disease surveillance.

Application Insights & Trends

The infectious disease segment held the largest share of over 29.67% in 2023. The expansion of CLIA technology is attributed to the introduction of new tests for diagnosing infectious diseases. This diversity of applications highlights the adaptability and significance of CLIA technology in addressing complex medical conditions and driving healthcare innovations.

The oncology segment is projected to grow at the fastest CAGR of 4.4% over the forecast period. According to a 2020 report by the World Health Organization, cancer was a significant cause of mortality worldwide, responsible for approximately 10 million deaths that year. The growing incidence of cancer cases and the increasing awareness of early cancer detection in developing countries are key drivers propelling the market’s growth.

End-use Insights & Trends

The hospitals segment dominated the market and accounted for a revenue share of 36.01% in 2023. This is due to the growing need for CLIA solutions in hospitals and the increasing number of hospital visits caused by the rising occurrence of cancer and infectious diseases. Moreover, the rise in hospital admissions due to the new coronavirus outbreak is anticipated to boost the need for CLIA solutions within hospital settings.

The pharmaceutical & biotechnology companies segment is expected to grow at the fastest CAGR of 5.8% from 2024 to 2033. This is due to the high sensitivity and specificity of CLIA technology, making it an ideal tool for detecting biomarkers associated with various health conditions. Pharmaceutical and biotech companies use CLIA for research, development, and manufacturing of diagnostic kits & reagents.

Chemiluminescence Immunoassay Market Top Key Companies:

• Abbott Laboratories
• Beckman Coulter Inc.
• DiaSorin S.p.A.
• Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• F. Hoffmann-La Roche AG
• Siemens Healthineers
• Ortho Clinical Diagnostics

Recent Developments

• In May 2023, PerkinElmer officially launched Revvity, a novel science-based solutions company, which utilizes cutting-edge innovation to enhance lives by offering a comprehensive range of products
• In December 2022, approval was granted to Sysmex in Japan for the manufacturing and marketing of the HISCL β-Amyloid 1-42 Assay Kit and the HISCL β-Amyloid 1-40 Assay Kit to detect amyloid beta (Aβ) levels in the blood

Chemiluminescence Immunoassay Market Report Segmentation

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Chemiluminescence Immunoassay market.

By Product

• Instruments
  • Automated
  • Semi-automated
• Consumables
• Reagents
  • Luminophore markers
  • Enzymatic markers
• Software & services

By Technology

• Chemiluminescence Enzyme Technology (CLEIA)
• Electrochemiluminescence immunoassay (ECLI)
• Microparticle Chemiluminescence Immunoassay

By Sample Type 

• Blood
• Urine
• Saliva
• Other Sample Types

By Application 

• Infectious Disease
• Endocrinology
• Oncology
• Cardiology
• Allergy Diagnostics
• Autoimmune Disorders
• Blood Screening
• Bone & Mineral Disorders
• Toxicology
• Newborn Screening
• Therapeutic Drug Monitoring
• Metabolic Disorder
• Gastroenterology
• Neurology
• Respiratory
• Other Applications

By End-use 

• Hospitals
• Clinical Laboratories
• Pharmaceutical & Biotechnology Companies
• Other End-uses

By Region

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East & Africa (MEA)