The Rising Number Of Clinical Diagnostic Procedures Drive the Immunoassay Market

United States Immunoassay Market Overview 

Product Overview and Scope of Immunoassay

Immunoassay is a procedure, used for the detection and quantification of target antigen present in a sample. The immunoassay is performed in clinical diagnostic laboratories for the detection and diagnosis of chronic conditions such as cardiac, diabetes, infectious diseases, cancer, and others. ELISA (Enzyme-linked Immunosorbent Assay) is commonly employed for the diagnosis of cancer and other infectious disease-related conditions.

Different types of immunoassay procedures include:

•    Enzyme Immunoassay (EIA) or Enzyme-linked immunosorbent assay (ELISA)
•    Radioimmunoassay (RIA)
•    Fluoroimmnoassay (FIA)
•    Chemiluminescence immunoassay (CLIA)

The adoption of technologies in an immunoassay expands its usage for the detection of several disease-related conditions. The photonic biosensors are an emerging field used in label-free assays, Photonics detect and manipulate light. The photonic technology allows the development of miniature lab-on-chop label-free immunoassay devices. The adoption of technology increases the accuracy of an assay procedure, decreases working time, and increases assay sensitivity.

The manufacturer of immunoassay kits and instruments has done significant R&D investments in the introduction of immunoassay kits, and analyzers. The presence of manufacturers offering immunoassay kits in the USA drives the market. The USA has a significant presence of laboratories conducting diagnostic procedures. There are more than 200,000 clinical laboratories in the US offering clinical diagnostic services. The presence of manufacturers, government funding, and their investment in the introduction of immunoassay procedures, drives the market. For instance, the USFDA introduced a voluntary pilot program for CDER-regulated oncology drug products used for in-vitro diagnostic tests, or immunoassay procedure.

Market Drivers

Rising Number of Clinical Diagnostic Procedures:

The US Immunoassay market is driven by an increase in the number of clinical diagnostic procedures conducted in the US for the detection and diagnosis of cancer, cardiac-related diseases, and infectious diseases. Clinical diagnostic procedures are conducted in the US, owing to the rising number of chronic cases among patients in the US. The Centers for Disease Control and Prevention estimated around, 6 in 10 adults in the US are affected by chronic conditions such as cancer, heart disease, and diabetes. (Source: National Center for Chronic Disease Prevention and Health Promotion, 2022). Thus, the rising number of chronic conditions among patients in the US increases the clinical diagnostic test in laboratories. Advanced diagnostic laboratories conduct diagnostic tests for an accurate diagnosis of the disease. Clinical diagnostic procedure such as ELISA, test, sandwich ELISA test, and other clinical procedure uses kits and instruments to detect the presence of antigen in a clinical sample. According to the data published by the American Society for Microbiology in 2020, more than 13 Billion population in clinical diagnostic tests are conducted for several samples such as blood, tissue sample, and others in the US each year. (Source: American Society for Microbiology, 2020).

Furthermore, the presence of several manufacturers in the US offering advanced instruments and kits for immunoassay procedures. For instance, the Bio-Rad Laboratories in April 2020 designed blood-based immunoassay kits for the detection of SARS-CoV-2 during the pandemic. Thus, the rising number of clinical diagnostic procedures conducted in the US drives the immunoassays market in the US.

• Technological Advancement in Immunoassay Kits and Instruments
• The Rise in Government Funding and Support for Immunoassay

United States Immunoassay Revenue (2018-2023)

United States Immunoassay Revenue and Market Share (%) (2018-2023)

	2018	2019	2020	2021	2022	2023
United States	XX	XX	XX	XX	5,259.2	XX

United States Immunoassay market was valued at USD 5,259.2 Million, in 2022 and is expected to grow at a CAGR of 6.3% over the forecast period, from 2023 to 2030.

United States Immunoassay Market Segmentation Analysis

United States Immunoassay Market Segmentation Analysis by Product 

Reagents & Kits

• ELISA Reagents & Kits
• Rapid Test Reagents & Kits
• ELISPOT Reagents & Kits
• Western Blot Reagents & Kits

Other Reagents & Kits
Analyzers
Software Services

United States Immunoassay Market, by Product

Source: Cognitive Market Research

Based on product, the reagents & kits accounts for a significant revenue share in the immunoassay market. Reagents & kits are the vital consumables essential for performing immunoassays. The immunoassays generally rely on the particular interaction between antibodies and antigens, where reagents & kits provide the required components to facilitate this interaction. Due to which these reagents & kits have a constant demand by end-user industries. In addition, these reagents & kits have a wide range of application. They are used across a variety of industries such as diagnostics, clinical, biotechnology, pharmaceutical, hospitals, research laboratories, and others. Thus, their compatibility with different types of immunoassays such as enzyme-linked immunosorbent assays (ELISAs), radioimmunoassay (RIAs), fluorescence immunoassays (FIAs), and chemiluminescent immunoassays (CLIAs) which made them widely applicable and versatile. Moreover, the consistent innovations in reagents & kits like specialized reagents & kits tailored for particular applications led to a higher demand for these enhanced products. Therefore, reagents & kits favoring the widespread adoption of immunoassay technologies across different industries resulted into this segment to account for the significant revenue share in the immunoassay market.

United States Immunoassay Market by Technology:

Radioimmunoassay (RIA)
Rapid Test

• Enzyme-linked Immunosorbent Assay (ELISA)
• Lateral flow immunoassay (LFIA)
• Chemiluminescence Immunoassays (CLIA)
• Others

Western Blotting
Flow Cytometry
Arrays

• Microarrays
• Antibody
• Protein Arrays

Colorimetric
ELISPOT
Others

United States Immunoassay Market by Application:

•    Oncology
•    Cardiology
•    Autoimmune Diseases
•    Infectious Diseases
•    Others

United States Immunoassay Market by Specimen:

•    Blood
•    Saliva
•    Urine
•    Others

United States Immunoassay Market by End-User:

•    Hospitals & Clinics
•    Clinical Diagnostic Laboratories
•    Pharmaceutical & Biotechnology Industries
•    Academic Research Centers
•    Other

United States Immunoassay Market Players

•    Abbott Laboratories
•    Beckman Coulter
•    Bio-Rad Laboratories
•    Thermo Fisher Scientific
•    Roche Diagnostics 
•    Siemens Healthineers
•    BD (Becton, Dickinson, and Company)
•    Ortho Clinical Diagnostics
•    Quidel Corporation
•    BioMérieux
•    Others

United States Immunoassay Market Related Reports

•    Global Clinical Trails Market
•    Global Immuno-Oncology Clinical Trails Market
•    Global Oncology Drugs Market
 

United States Immunoassay Manufacturers Profiles/Analysis

Abbott 

Abbott Basic Information, Manufacturing Base, Sales Area, and Competitors

Sr. No.	Item	Description
1	Company Name	Abbott
2	Website	www.abbott.com
3	Established Date	1888
4	Headquartered	United States
5	Market Position/ History	Abbott company specializes in the manufacturing of innovative products and solutions in the field of health, science, medicine, business, and society. Abbott was founded in 1888 by Dr. Wallace C. Abbott and is headquartered in Illinois, U.S. In 1907, the company expanded outside the United States for the first time with an office in London, England. In 1942, Abbott joined a consortium of pharmaceutical makers, at the behest of the U.S. Government, to ramp up production of penicillin for wartime use. Further, in 1964, it acquired M&R Dietetics and in 1998, the company introduced Glucerna, a group of cereals, health shakes and snack bars formulated specifically for diabetics and others with dietary restrictions. In course of time, the company has done several acquisitions including St. Jude Medical, Alere Inc., and others. The company has 107,000 employees and serves customers in over 160 countries.
6	Sales Area	Worldwide
7	Manufacturing Location	Worldwide
8	No. of Employees	115,000 (As of 2022)
9	Competitors	F. Hoffmann-La Roche, Thermo Fisher Scientific,
10	CEO	Robert B. Ford
11	Ownership Type	Public
12	Contact Information	100 Abbott Park Road Abbott Park, Illinois, 60064 United States Tel: 1-847-937-6100

 

Business Segment/ Overview:

Abbott is the US based healthcare company. The company is engaged in the discovery, development, manufacture, and sale of a diversified line of health care products including Immunoassay. The company operates through four segments including pharmaceutical products, diagnostic products, nutritional products, and medical devices. The company's products include pharmaceuticals, nutritional, diagnostics, and vascular products. Abbott markets its products worldwide through affiliates and distributors.

Immunoassay Product Types Specification

Product	Description
ALINITY i	CHEMIFLEX chemiluminescent detection technology with a biotin interference-free assay design. Method: Chemiluminescence Sample Type: Serum, plasma, whole blood, urine Sample Capacity: 150 Reagent Capacity: Up to 47 Maximum Throughput: Up to 200 tests/hour
ALINITY ci-series	Combines four modules in multiple configurations for conducting the diagnostics and maximize operational efficiency. Method: Photometric, Potentiometric, Chemiluminescence Sample Type: Serum, plasma, urine, cerebrospinal fluid, hemolysate, whole blood Sample Capacity: 300 Reagent Positions: Up to 117 Maximum Throughput: Up to 1,550 test/hour
ARCHITECT i1000SR	Methods: CHEMIFLEX Maximum Throughput: Up to 100 tests/hour Sample Types: Serum, Plasma, Whole Blood, Urine Sample Tubes Height:72-102 mm Diameter:9.6-16.1 mm Sample Cup: Yes (50 µl dead volume) Sample Capacity: 65 Sample Barcode Types: Code 39, Codabar, Interleaved 2 of 5, Code 128 Sample Result Storage: 50,000 Sample Volume: 10-150 μL, Average: 62 µL Automatic Dilution: Yes Sample Probe Carryover: ≤0.1 parts per million Reagent Capacity: 25 refrigerated positions Reagent Type: 100% liquid ready-to-use Reagent Onboard Stability: 14-30 days Sample, Clot and Bubble Detection: Yes Reagent Pressure Monitoring No Sample Interference Measurement System Control Center: 1 SCC, with color touchscreen monitor, keyboard and mouse Onboard Maintenance Records Online Error Code Help Host Interface Bidirectional, serial RS-232 interface, host query option available Dimensions: 49” x 59” x 30” Weight:636 lbs, 288 kg Electrical Requirements: AC 110-120V or 200-240V, ±10%, 50 or 60 Hz self-adjusting Water Requirements: Purified water to dilute buffer concentrate Heat Output: 2400 BTU/hr, running mode Sample Loading: RSH
ARCHITECT i4000SR	Methods: CHEMIFLEX Maximum Throughput: Up to 100 tests/hour Sample Types: Serum, Plasma, Whole Blood, Urine Sample Tubes Height: 72-102 mm Diameter: 9.6-16.1 mm Sample Cup: (50 µl dead volume) Sample Capacity: 65 Sample Barcode Types: Code 39, Codabar, Interleaved 2 of 5, Code 128 Sample Result Storage: 50,000 Sample Volume: 10-150 μL, Average: 62 µL Automatic Dilution Sample Probe Carryover: ≤0.1 parts per million Reagent Capacity: 25 refrigerated positions Reagent Type: 100% liquid ready-to-use Reagent Onboard Stability: 14-30 days Reagent Pressure Monitoring No Sample Interference Measurement System Control Center: 1 SCC, with color touchscreen monitor, keyboard and mouse Onboard Maintenance Records Online Error Code Help Host Interface: Bidirectional serial RS-232 interface, host query option available Dimensions: 49” x 59” x 30” Weight: 636 lbs, 288 kg Electrical Requirements: AC 110-120V or 200-240V, ±10%, 50 or 60 Hz self-adjusting Water Requirements: Purified water to dilute buffer concentrate Heat Output: 400 BTU/hr, running mode Sample Loading: RSH