U.S. C-Reactive Protein Testing Market Size, Share & COVID-19 Impact Analysis, By Product (Reagent & Kits and Instruments), By Assay Type (Chemiluminescence Immunoassay (CLIA), Enzyme-Linked Immunosorbent Assay (ELISA), Immunoturbidimetric Assay, and Others), By Detection Range (Conventional CRP and Hs-CRP), By Setting (Laboratory Testing, and Point-of-Care (POC) Testing), By End User (Hospitals & Clinics, Diagnostic Laboratories, and Others), and Country Forecast, 2023-2030

The U.S. c-reactive protein testing market size was worth USD 691.6 million in 2022 and is projected to grow at a CAGR of 5.1% during the forecast period.

C-reactive protein is an acute phase protein produced by the liver as a response to inflammation in the body. This protein serves as a non-specific marker of inflammation. Additionally, the protein level in the blood helps diagnose several life-threatening diseases, such as cardiovascular diseases, cancer, rheumatoid arthritis, and others.

• For instance, according to an article published by NCBI in December 2020, in rheumatoid arthritis (RA), the levels of c-reactive protein are routinely assessed. These results are also important in inflammatory pathways associated with RA.

C-reactive protein testing is important in reducing the antibiotic prescriptions given to healthcare professionals to treat any disease. Several studies have been conducted to evaluate the use of this protein testing in primary care settings to reduce antibiotic prescriptions. These tests are increasingly being supported to improve antibiotic control and reduce diagnostic uncertainty.

The COVID-19 pandemic resulted in a positive impact on the market with an increased testing among U.S. patients. The U.S. witnessed exponential market growth in 2020 due to the increased use of these tests to understand the severity of the COVID-19 infection based on levels of this protein.

LATEST TRENDS

Emphasis on the Development of Technologically Advanced Products 

In recent years, the market is witnessing an increasing trend of development and launch of point-of-care testing products for c-reactive protein. The operating players focus on introducing POC tests to capture the untapped market avenues. Furthermore, the development of high sensitivity c-reactive protein assays also served as a growing trend in the market.

• For instance, Orion Diagnostica Oy has launched QuickRead CRP test, which can be used on QuikRead go point of care instrument. This test provides results in two minutes.

DRIVING FACTORS

Rising Prevalence of Chronic Diseases to Drive Demand for C-Reactive Protein Testing

The country’s prevalence of chronic diseases, including cancer, cardiovascular diseases, and autoimmune diseases such as inflammatory bowel disease, is increasing. This test is commonly used in determining the severity of these disease conditions. High levels of this protein in the body indicate chronic inflammation.

A rise in demand for this test to diagnose and manage various chronic diseases is expected to drive market expansion in the coming years.

• According to an article published in NCBI in January 2023, in the U.S., the number of new cancer cases is predicted to be 1,958,310, and it is predicted that cancer will cause 609,820 deaths across the U.S. in the same year.                                          

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In the U.S., cancer is the leading cause of death, with lung cancer accounting for around 7% of cancer related deaths in the country.

RESTRAINING FACTORS

Availability of Alternative Tests to Limit Product Adoption 

One of the important factors impeding the U.S. c-reactive protein testing market growth is the availability of alternative tests specific to particular disease conditions. As this test is not a self-sufficient diagnostic test for any particular disease, healthcare professionals do not rely on the results of this test for disease management.

As this test is a non-specific marker of inflammation, there is a requirement for a specific test for the accurate diagnosis of any disease. Thus, the availability of such alternative disease diagnostic methods slowdowns the market’s growth to a certain extent.

SEGMENTATION

By Product Analysis

Based on product type, the market is segmented into reagents & kits and instruments.

The reagents & kits segment held the dominating position in the market in 2022. Key factors supporting the segment’s dominance include low prices and the repeated purchases of these products with the increasing number of tests being performed in the country.

On the other hand, the instruments segment is expected to witness comparatively slower growth during the forecast period. The growth of this segment is driven by an increasing number of regulatory approvals resulting in increased availability of products in the market.

By Assay Type Analysis

Based on assay type, the market is classified into Chemiluminescence Immunoassay (CLIA), Enzyme-Linked Immunosorbent Assay (ELISA), immunoturbidimetric assay, and others.

In 2022, the immunoturbidimetric assay segment dominated the U.S. market. The majority of the currently available products are based on this technology, in turn dominating this market.

On the other hand, the enzyme-linked immunosorbent assay (ELISA) segment is anticipated to exhibit considerable growth over the forecast period. Several advantages offered by ELISA assays support the increasing use of these assays in the market. These advantages include low cost, high specificity, ease of preparation, low detection limit, ease of operation, and others.

By Detection Range Analysis

Based on detection range, the market is categorized into conventional CRP and Hs-CRP.

The conventional segment accounted for the highest market share in 2022. The growth can be attributed to the high prevalence of autoimmune diseases and other inflammatory conditions in the U.S. population.

On the other hand, as the Hs-CRP test is commonly used to predict the risk of heart disease, the increasing number of individuals suffering from cardiovascular diseases increases the demand for this test, driving the segment’s growth.

By Setting Analysis

Based on product type, the market is segregated into laboratory testing, and point of care (POC) testing.

The laboratory segment accounted for the largest U.S. c-reactive protein testing market share in 2022. Key factors supporting the segment’s dominance include the easy availability of these tests in laboratory settings and the increasing patient pool opting for this testing in laboratories.

On the other hand, the Point Of Care (POC) segment is anticipated to grow at the fastest growth rate over the forecast period. This can be attributed to the increasing product launches and advancements in technologies for C-reactive protein testing.

By End User Analysis

Based on end user, the market is divided into hospitals & clinics, diagnostic laboratories, and others.

In 2022, the diagnostic laboratories segment captured the dominating share of the market. This can be attributed to healthcare professionals’ increasing prescription of this test. Professionals use this test to diagnose and monitor inflammatory conditions, including trauma, sepsis, and malignancies.

The hospitals & clinics segment is estimated to grow significantly over the forecast period. High prevalence of chronic diseases results in increased hospitalization and longer hospital stays that positively impact the segment’s growth.

KEY INDUSTRY PLAYERS

The competitive landscape for the U.S. c-reactive protein testing market is highly fragmented, with the presence of both established and emerging players. An organization's influence doesn’t singularly determine the market's growth trajectory. Key players in this market include Abbott, F. Hoffmann-La Roche Ltd., Siemens Healthcare Private Limited, and Quest Diagnostics Incorporated. These companies are focusing on expanding their product portfolio through various strategic initiatives. Other prominent entities operating in the market include Thermo Fisher Scientific, Inc., Laboratory Corporation of America Holdings, Abaxis, and Creative Diagnostics.

LIST OF KEY COMPANIES PROFILED:

• Abbott (U.S.)
• F. Hoffmann-La Roche Ltd. (Switzerland)
• Siemens Healthcare Private Limited (Germany)
• Quest Diagnostics Incorporated (U.S.)
• Thermo Fisher Scientific, Inc. (U.S.)
• Laboratory Corporation of America Holdings (U.S.)
• Abaxis (U.S.)
• Creative Diagnostics (U.S.)

KEY INDUSTRY DEVELOPMENTS: 

• December 2022 – The U.S. FDA granted 510(k) clearance for Siemens Healthcare Diagnostics Products GmbH’s CardioPhase hsCRP prognostic test.
• April 2022: The U.S. FDA approved ProciseDx’s ProciseDx instrument and C reactive protein test.

REPORT COVERAGE

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The market report provides a detailed analysis of the market. It focuses on key market segments such as product, assay type, detection range, setting, and end user. Additionally, it includes detailed insights on market dynamics, new product launches, key industry developments such as mergers, partnerships, & acquisitions, and the impact of COVID-19 on the market. Additionally, the report consists of several factors that have contributed to the market’s growth. The report also provides the competitive landscape of the U.S. market.

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