C-Reactive Protein (CRP) Test Market Size, Share & Trends Analysis Report By Assay Type, By Detection Range, By Disease Area (Cardiovascular Disease, Cancer, Rheumatoid Arthritis), By End Use, And Segment Forecasts, 2018 - 2025

Industry Insights

The global C-reactive protein test market size was estimated at USD 1.57 billion in 2016 and anticipated to expand at a CAGR of 1.3% over the forecast period. It is driven by high R&D in the field of C-reactive protein (CRP) testing and rising burden of various chronic and inflammatory diseases.

Favorable government policies in the field are also expected to boost growth over the forecast period. Recent development of paper-based diagnostic devices is expected to drive growth. These devices are portable and easy to use for clinical diagnosis of C-reactive protein in patients. Such devices can be used to monitor relevant inflammatory proteins.

These new paper-based tests are capable of measuring serum stain length inside the paper-micro channel. These tests usually take 5 minutes per assay, which is lesser than 3 to 4 hours taken by traditional lab-based CRP tests.Paper-based CRP testing devices use wax printing method to define hydrophobic boundaries for fluidic and point-of-care devices and can ultimately reduce cost of manufacturing and operations.

Increase in government initiatives to develop primary healthcare settings and strengthen their infrastructure is expected to drive growth over the forecast period. The government is playing a crucial role in guiding general physicians to use point-of-care CRP testing devices in primary healthcare settings for rapid detection of infectious disease. Such efforts are expected to drive the growth of C-reactive protein testing devices in the following years.

Major initiatives undertaken by international organizations such as WHO and NIH in the field of emerging inflammatory diseases such as lupus and endometriosis have promoted investigations for studying the role of proteins in these medical conditions. This is expected to drive demand for CRP testing over the forecast period.

Increase in research for studying the role of CRP as a marker of melanoma progression is also offering growth opportunities. For instance, a study was conducted to investigate the association between CRP levels in blood samples of patients living with melanoma. According to the study, C-reactive protein measurements can be used as a prognostic biomarker in the detection of melanoma.

Assay Type Insights

Immunoturbidimetric assay is the fastest growing segment. This growth can be attributed to high R&D investments by players and increase in availability of C-reactive protein testing products in the market. Additionally, immunoturbidimetric tests are increasingly accepted for specific protein assays such as CRP. According to Randox Laboratories Ltd., such systems measure absorbance of light and are ideal for detection of proteins, as analyte concentration is inversely proportional to transmitted light signal.

Development of point-of-care CRP testing devices is responsible for driving revenue generation as well. For example, QuickRead CRP, developed by Orion Diagnostica Oy, is an immunoturbidimetric method based on ready-to-use kits for quantitative detection of C-reaction protein levels in plasma, serum, and whole blood samples. This system provides results in minutes and is specially developed for primary health settings by the company. In addition, various latex-enhanced immunoturbidimetric systems with high sensitivity are available in the market.

Research conducted on the role of high sensitivity C-reactive protein measurements in HIV patients revealed that CRP levels aid in predicting HIV infections. Researchers have found that high CRP levels are associated with depletion of vitamins and minerals in an HIV-infected individual. A study was conducted to evaluate this method and concluded it as a reliable and rapid method for detecting C-reactive protein levels for clinical purposes. This research was conducted by investigators at the Swedish University of Agricultural Sciences, Sweden.

Detection Range Insights

The high sensitivity C-reactive protein (hs-CRP) segment accounted for the largest share in the C-reactive protein testing market. Detection ranges for high sensitivity C-reactive proteins is <10 mg/L to >10.0 mg/L. According to American Heart Association (AHA) and Centers for Disease Control and Prevention (CDC), hs-CRP acts as an independent marker for estimation of cardiovascular disorders such as myocardial infarction.

Ongoing investigations on inflammatory markers in patients with rheumatoid arthritis (RA) found the association between high hs-CRP levels and disease activities in RA. According to the study, a higher level of serum hs-CRP is a potential biomarker, which can be used in the pathogenesis of RA. Additionally, development of various hs-CRP-based POC testing devices by various market entities is predicted to boost advancements in the field.

Disease Area Insights

Cardiovascular disorders account for the largest share in terms of adoption. Globally increasing incidence of cancer and cardiovascular disorders is anticipated to drive demand. This high incidence rate is expected to encourage researchers to undertake investigational studies in CRC for cardiovascular disorders. Government support in this area is also promoting the growth of this segment.

According to data by WHO, cardiovascular diseases (CVDs) are a major cause for mortality. In 2015, around 17.7 million people died due to CVDs and it accounted for 31.0% of all global deaths. According to an estimate, 7.4 million people died due to coronary heart disorders and around 6.7 million deaths were caused due to stroke.

Government support and initiatives are also likely to aid implementation and adoption. For instance, a global action plan for prevention and control of non-communicable diseases was designed by WHO between 2013 and 2020 to reduce the unavoidable burden of such disorders. The objective of this program is to reduce premature deaths resulting from non-communicable diseases by 25.0% by the end of 2025.

Initiatives by various organizations such as American Cancer Society and Breast Cancer Organization are also expected to drive the market. For instance, recently, the American Cancer Society approved funding worth USD 39.0 million for cancer research. These initiatives are expected to introduce technological advancements in cancer research and diagnosis.

Rising incidence of endometriosis is also expected to drive demand for CRP testing over the forecast period. Currently, more than 10 million women are suffering from endometriosis and this number is expected to increase further in the coming years. This high prevalence rate is anticipated to propel market growth through 2025.

End-use Insights

Clinics accounted for the largest revenue share in 2016 and the segment is expected to maintain its dominance in the coming years. Growing primary healthcare infrastructure in various regions is anticipated to support the growth of this segment.

Government support is also anticipated to boost segment growth. For instance, the National Institute for Health and Care Excellence (NICE) has conducted a Medtech Innovation Briefing (MIB), which provides information on diagnostic and medical technologies to aid physicians in decision-making processes. NICE has also conducted an MIB on the Alere’s Afinion CRP testing device and recommended it for C-reactive protein level testing in primary healthcare settings.

Regional Insights

North America dominated the market with the largest revenue share in 2016. Factors likely to be responsible for the dominance of this segment are presence of established players, technological advancements, and well-established healthcare infrastructure.

Increase in investigations are also driving market growth. For instance, a study was conducted by the National Cancer Institute of NIH on lung cancer, which demonstrated the relation between elevated CRP levels and chronic pulmonary inflammation in lung carcinogenesis. In addition, various investigations conducted by American Association for Cancer Research revealed the association of prediagnostic levels of CRP with colorectal cancer mortality.

Asia Pacific is expected to emerge as the fastest growing segment due to emerging economies and increase in R&D expenditure. Moreover, government support and collaborations among players are anticipated to fuel revenue growth in this region.

Several studies are being conducted by researchers at the National Institute for Nutrition and Health and China Center for Disease Control in association with other institutions. Such investigations are expected to promote advancements in the field and fuel market growth over the forecast period.

C-Reactive Protein Testing Market Share Insights

Some of the major players are HORIBA Ltd.; Thermo Fisher Scientific, Inc.; F Hoffmann-La Roche Ltd.; Quest Diagnostics; Abbott; Siemens Healthineers; Danaher; Ortho Clinical Diagnostics; Orion Diagnostica Oy; Laboratory Corporation of America Holdings; Merck & Co., Inc.; Abaxis, Inc.; BODITECH MED, INC.; Getein Biotech, Inc.; and Randox Laboratories Ltd.

Currently, major players are forming strategic partnerships with other market players to expand their product portfolios. They are looking to expand their R&D, distribution, and management facilities to gain a competitive edge in the market.

For instance, in March 2017, Ortho Clinical Diagnostics announced the expansion of its distribution agreement with Astute Medical Inc., for test kits. According to the new agreement, Ortho Clinical Diagnostics gained the rights for the distribution of test kits in Europe and help lab customers better understand disease conditions.

Companies such as Abbott and Abaxis, Inc. announced an exclusive distribution agreement, under which Abbott has exclusive rights to distribute and sell Abaxis’s Piccolo Xpress chemistry analyzer and consumables in U.S. and China. This association is expected to increase revenue and visibility of both brands in the market.

Initiatives undertaken by various companies to develop novel testing devices are also anticipated to drive market growth. In 2015, Randox Laboratories Ltd. announced that it is developing a new blood test for diagnosis of early stage bowel cancer. It is expected to be available at USD 29.34. Such product development strategies are expected to boost market growth over the forecast period.

Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country level and provides an analysis on latest industry trends and opportunities in each of the sub-segments from 2014 to 2025. For the purpose of this report, Grand View Research has segmented the global C-reactive protein testing market report on the basis of assay type, detection range, disease area, end use, and region:

• Assay Type Outlook (Revenue, USD Million, 2014 - 2025)

  • Immunoturbidimetric assay

  • ELISA

    • Clinical

    • Non-Clinical

  • Chemiluminescence immunoassay (CLIA)

  • Others

• Detection Range Outlook (Revenue, USD Million, 2014 - 2025)

  • hs-CRP

  • Conventional CRP

  • cCRP

• Disease Area Outlook (Revenue, USD Million, 2014 - 2025)

  • Cardiovascular diseases

  • Cancer

  • Rheumatoid arthritis

  • Inflammatory bowel disease

  • Endometriosis

  • Lupus

  • Others

• End-use Outlook (Revenue, USD Million, 2014 - 2025)

  • Clinics

  • Hospitals

  • Laboratories

  • Assisted living healthcare facilities

  • Home

  • Others

• Regional Outlook (Revenue, USD Million, 2014 - 2025)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

  • Asia Pacific

    • Japan

    • China

  • Latin America

    • Brazil

  • Middle East and Africa (MEA)

    • South Africa