Chemiluminescence Immunoassay (CLIA) Analyzers Market

Chemiluminescence Immunoassay (CLIA) Analyzers Market Outlook (2023 to 2033)

Expanding at a CAGR of 6.5%, the global chemiluminescence immunoassay (CLIA) analyzers market is estimated to increase from a valuation of US$ 6.4 billion in 2023 to US$ 12 billion by the end of 2033

Hospitals are preferred by patients leading to high demand for chemiluminescence immunoassay solutions in hospital settings, besides the rise in hospital visits as a result of the growing incidence of infectious diseases.

The definition of chemiluminescence is the emission of light during a chemical process without the major production of heat. The term "chemiluminescence immunoassay analyzer" refers to a type of light detector designed specifically to measure the development of antigen-antibody complexes via light emission.

The surging prevalence of chronic and acute diseases, new developments in chemiluminescence immunoassay analyzers, and the growing specificity of CLIA analyzers are contributing to market expansion. Chemiluminescence immunoassay techniques are widely used to detect chronic diseases such as cancer, diabetes, obesity, and autoimmune diseases as well as cardiovascular and infectious diseases.

CLIA is also used by several academic and pharmaceutical establishments to monitor therapeutic drugs. Major market drivers include pharmaceutical companies' increased efforts to identify and develop new medications as well as the growing awareness of early detection of chronic diseases.

One of the main factors propelling the market growth is the widespread use of CLIA analyzers in numerous applications, including endocrinology and oncology, hepatitis and retroviruses, cardiac indications, auto-immune illnesses, bone and mineral disorders, and others. The rapid adoption of advanced immunoassay analyzers, technological advancements in disease diagnosis, and huge demand for preventive diagnosis and treatment monitoring are driving market growth.

Moreover, large-scale laboratories are taking advantage of quality and service constraints faced by small and mid-volume laboratories to capture a larger share of the market using CLIA techniques. International conglomerates operating in clinical labs are expanding their base through mergers and acquisitions in emerging markets. The consolidation among laboratories is resulting in rising test volumes, leading to the rising adoption of complete laboratory automation and integration.

The requirement for higher levels of international certification and result in comparability when using high throughput automated immunoassays is anticipated to drive the market for chemiluminescence immunoassay analyzers. Key market players are concentrating on the creation and introduction of advanced CLIA solutions. The market is being supported by industry players' investments in R&D activities to create and promote new products to meet these demands.

Report Attributes	Details
Chemiluminescence Immunoassay Analyzers Market Size (2023)	US$ 6.4 Billion
Projected Market Value (2033)	US$ 12 Billion
Global Market Growth Rate (2023 to 2033)	6.5% CAGR
Market Share of Reagents	50%
Key Companies Profiled	Abbott Laboratories; Beckman Coulter, Inc.; Roche Holding AG; Sysmex Corporation; Randox Laboratories Ltd.; Tosoh Corporation; Immunodiagnostic Systems; Inova Diagnostics, Inc.; Siemens Healthineers

Why are Sales of Chemiluminescence Immunoassay Analyzers Increasing Rapidly across the World?

“Surging Adoption of High Throughput Automated Immunoassay Analyzers”

The increasing rate of assay standardization is a primary emphasis of doctors and pathologists working in in-patient or out-patient settings of the chemiluminescence immunoassay analyzers market. When providing test results to patients, the major goal of calibrating the assays is to compare the results of the test to the accepted standards.

Chemiluminescence immunoassay analyzers are produced according to standards established by regulatory bodies. To make their results more comparable to those of other manual assay techniques, chemiluminescence immunoassay analyzer manufacturers also provide internal reference standard material.

The chemiluminescence immunoassay approach is widely used in the field of clinical diagnostics to identify chronic diseases. The primary global causes of disability and death are these chronic illnesses. The prevalence of these diseases is significantly increasing, which is projected to increase demand for efficient diagnostic techniques such as chemiluminescence immunoassay.

“Rapid Innovations in Diagnostic Technology”

The field of diagnostics is developing quickly, and in the past ten years, significant strides have been made in the identification of antibodies, moving this field of diagnosis closer to that of an automated clinical chemistry laboratory. It is predicted that as a result of technological advancements in illness diagnosis, an increase in demand for treatment monitoring, and the need for preventative diagnosis, several tests are extensively utilizing chemiluminescence immunoassay analyzers.

There is a growing need for high-throughput facilities. Additionally, large-scale laboratories are using chemiluminescence immunoassay procedures to gain market share by taking advantage of the service and quality challenges faced by small and mid-volume laboratories.

Assays or tests that are suggested to assist healthcare professionals in making treatment decisions for patients based on the best response to therapy are known as companion diagnostics. The potential exists to significantly alter the drug development process and commercialize drug candidates by producing safe medications with increased therapeutic effectiveness rapidly and affordably through the co-creation of companion diagnostics and therapeutic products.

The market for companion diagnostics is anticipated to exhibit a significant growth potential due to an increase in the need for specialized therapies and safer medications.

What May Slightly Affect the Global Demand for Chemiluminescence Immunoassay Analyzers?

“Lack of Qualified Medical Experts and Strict Government Regulations”

The lack of qualified labor and medical experts, as well as the strict government regulations may limit the market expansion. High setup cost of chemiluminescence immunoassay analyzers is restraining market growth, according to pricing trends.

Local firms with extensive distribution networks have increased market penetration as a result of the availability of products at relatively lower average selling prices in some geographic areas. This is putting pressure on prices for big manufacturers. There are innovative options available that are comparatively less expensive per treatment, which is also having an impact on the chemiluminescence immunoassay analyzers market growth.

Which Regional Market is Catching the Attention of Chemiluminescence Immunoassay Analyze Suppliers?

“High use of Automated CLIA Analyzers in North America”

North America accounts for 50% share of the global chemiluminescence immunoassay analyzers market. Rise in the demand for specific diagnoses to support rapid decision-making is boosting the demand for multiplexed and automated CLIA analyzers. An increase in government funding for chemiluminescence immunoassay-related R&D activities is also anticipated to propel the regional market.

Country-wise Insights

What Allows the United States to Hold a Significant Share of the Global Market?

“Increasing Need for Appropriate Diagnosis & Treatment Techniques in the Country”

The chemiluminescence immunoassay analyzers market in the United States is anticipated to experience rapid growth due to strong demand for point-of-care, home healthcare, and quick diagnostic tests and the presence of top chemiluminescence immunoassay analyzer manufacturers and suppliers. The existence of well-developed healthcare infrastructure and the rising incidence of chronic diseases are key factors driving market growth.

More than 1 million Americans are coping with melanoma, according to the American Academy of Dermatology Association. As a result, there is a growing need for appropriate diagnosis and treatment techniques, which has led to an increase in the usage of chemiluminescence immunoassay procedures.

What is Driving Chemiluminescence Immunoassay Analyzer Demand in Germany?

“Increase in Government Initiatives for Early Identification of Chronic Diseases”

Increased prevalence of cardiovascular diseases, the revolution in test offerings, rising physician demand for advanced diagnostic instruments with increased specificity & precision, and favorable reimbursement policies are the elements boosting market value in Germany.

The existence of multispecialty hospitals, well-established supply chain management network, and an increase in government initiatives for early identification of various chronic diseases driving market growth in Germany.

What are the Growth Prospects for Chemiluminescence Immunoassay Analyzers in Japan?

“Huge Demand for Medical Testing Services”

The market in Japan is anticipated to be driven by the huge population base, rising disposable income, and growing awareness of early diagnosis & treatment choices among patients. Local supply of novel products comprising CLIA technologies, increased healthcare expenditure, huge demand for medical testing services, and national and international accreditations to establish new laboratories are fueling market expansion in Japan.

Category-wise Insights

Why are Reagents Exhibiting High Demand Growth?

“Reagents Gaining Traction Due to Their Lower Cost & Shorter Test Time”

Based on product, the market is divided into analyzers, reagents, and consumables. Reagents account for 50% share of the global market attributed to their lower cost, shorter test time, and increasing demand from emerging markets. Reagents are substances or compounds that assist in performing a certain operation.

Reagents can be divided into four major categories based on how they perform their respective tasks, including amplification, detection, labeling, and quantification kits. The demand for reagents is anticipated to be driven by the increased development of new testing options, greater accuracy and quality, and a rising need for ultra-sensitive illness diagnosis.

Which Application Will Bring in High Revenue Streams?

“Rising Prevalence of Cancer and Need for Early Diagnosis Driving Adoption of CLIA Analyzers in Oncology”

The market is divided into endocrine disorders, oncology, infectious diseases, hepatitis & retrovirus, cardiovascular disorders, allergy, autoimmunity, drug discovery & development, and others based on application. Rising prevalence of cancer and its early diagnosis driving the adoption of chemiluminescence immunoassay analyzers in oncology.

The R&D for the detection, diagnosis, and treatment of the disease is prompted by the rising incidence of cancer cases worldwide. The development of cancer therapy and detection methods continues to be a top priority for researchers and scientists because it is one of the most widely diagnosed rare diseases.

Demand for chemiluminescence immunoassay analyzers for oncology studies is increasing. Several studies have revealed that the application of novel and confirmed biomarkers can result in the early detection of various malignancies. This is anticipated to stimulate segment expansion.

Competitive Landscape

Top chemiluminescence immunoassay analyzer providers are focused on obtaining regulatory clearances, enhancing product standards, and acquiring other businesses. These tactics are supporting market expansion.

Leading companies are introducing next-generation integrated immunoassay analyzers following safety regulations to lower the environmental impact. Prominent vendors are focusing on quality control and actively expanding their test offerings through ongoing research and development initiatives.

For instance :

• Abbott announced the FDA 510(k) clearance for Alinity ci-series instruments for immunoassay diagnostics. Earlier, the company also announced the approval of its Atellica Solutions for clinical chemistry and immunoassays.
• The latest advanced tissue staining platform, the BenchMark ULTRA PLUS system, was introduced by Roche. With particular immunohistochemistry, immunocytochemistry, or in situ hybridization reagents, the BenchMark ULTRA PLUS device is designed to automatically stain histological or cytological specimens on microscope slides for in vitro diagnostic (IVD) application.
• Beckman Coulter, Inc. offers various immunoassay systems under the clinical products segment. These include the Access 2 Immunoassay System and the UniCel Dxl 600 Access Immunoassay System.
• F. Hoffmann La Roche Ltd. offers clinical chemistry and immunology analyzers and assays for small, medium, and large-scale laboratories. Its products include the cobas4000 analyzer series, the cobas6000 analyzer series, and the cobas8000 modular analyzer series.

Key Segments of Chemiluminescence Immunoassay Analyzers Industry Research

• By Product :

  • Analyzers
    • Fully-automated
    • Semi-automated
  • Reagents
    • Luminophore Markers
    • Enzymatic Markers
  • Consumables

• By Application :

  • Endocrine Disorders
  • Oncology
  • Infectious Diseases
  • Hepatitis & Retrovirus
  • Cardiovascular Disorders
  • Allergy
  • Autoimmunity
  • Drug Discovery & Development
  • Others

• By End User :

  • Hospitals
  • Clinical Laboratories
  • Pharmaceutical & Biological Industries
  • Others

• By Region :

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