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Renal Biomarkers: Technologies and Global Markets

Renal Biomarkers: Technologies and Global Markets

REPORT HIGHLIGHTS

The in vitro diagnostic renal biomarker market was valued at $771 million in 2013 and $812 million in 2014. The market is expected to reach $1.1 billion by 2019, a compound annual growth rate (CAGR) of 7% from 2014 to 2019.

This report provides:

A comprehensive analysis of renal biomarkers global markets and technologies.

Analyses of global market trends, with data from 2013, estimates for 2014, and projections of compound annual growth rates (CAGRs) through 2019.

Details pertaining to the history and current state of chronic kidney disease (CKD), background information on renal biomarkers, and current industrial technologies used for diagnosis.

In-depth analyses of the predominant biomarkers in the market, namely creatinine, and emerging biomarkers like NGAL, KIM-1, L-FABP and many others.

Discussion concerning intellectual property, the regulatory requirement, and the competitive landscape of the industry.

Comprehensive profiles of major players in the renal biomarkers field.


SCOPE OF REPORT

The report presents current and projected assay forecasts during the forecast period (2014 to 2019). In addition, the study also includes emerging assays with regulatory approval and others expected to achieve Food and Drug Administration (FDA) approved by 2015 within the forecast period. Estimates are used for 2014, except in cases where actual results have been reported. For large market segments such as creatinine and cystatin C, the report discusses their analytical sensitivities and cutoff references in detail, as well as the glomerular filtration rate estimation for diagnosis and prognosis values. The study also focuses on ongoing efforts in developing biomarkers for acute kidney injury.

The report includes analysis of leading and emerging competitors in the current worldwide diagnostic market for kidney diseases. Profiles of manufacturers of leading products as well as biotechnology companies with products in development are discussed, along with their specific product strategies. Detailed profiles of current market leaders are included, as well as profiles of companies with innovative products poised to advance within the forecast period. Market figures are based on revenues at the manufacturers’ level and are projected at 2014-dollar value. Inflation is not computed into projection figures. Trends are assessed based on projected sales for existing products, new product introductions, expanded indications for existing products, and projected changes in the prevalence of diagnosis for respective diseases. In addition, the report includes forecasts by product, product category and company from 2013 through 2019. The study is arranged to offer an overview of the diagnostic market accompanied by product, company and region.

Excluded from this report are non-proteomic diagnoses (i.e., molecular diagnostics), imagining technology or pharmaceutical biomarkers. Sales figures are reported in U.S. dollars and in each case reflect currency fluctuations within the performance of sales change. Sales figures do not account for variation in local currencies. All market share data presented is on a global basis, unless specifically noted.

CHAPTER 1 INTRODUCTION
STUDY GOALS AND OBJECTIVES
REASONS FOR DOING THE STUDY
SCOPE OF REPORT
INTENDED AUDIENCE
METHODOLOGY AND INFORMATION SOURCES
ANALYST'S CREDENTIALS
RELATED BCC RESEARCH REPORTS
BCC RESEARCH WEBSITE
DISCLAIMER
CHAPTER 2 SUMMARY
SUMMARY TABLE RENAL BIOMARKER MARKET BY REGION, THROUGH 2019 ($ MILLIONS)
SUMMARY FIGURE A RENAL BIOMARKER MARKET BY REGION, 2013-2019 ($ MILLIONS)
SUMMARY FIGURE B ESTIMATED GLOBAL POPULATION WITH RENAL DISEASE, 2013-2019 (NO. OF CASES)
CHAPTER 3 OVERVIEW
BACKGROUND OF RENAL DISEASE
FIGURE 1 CLASSIFICATION OF ACUTE KIDNEY INJURY
SYMPTOMS
DIAGNOSIS
CLASSIFICATION OF KIDNEY INJURY AND DISEASE
TABLE 1 DEFINITION CRITERIA FOR KIDNEY INJURY/DISEASE
TREATMENT FOR ACUTE KIDNEY FAILURE
RELATIONSHIP BETWEEN ACUTE KIDNEY INJURY AND CHRONIC KIDNEY
DISEASE
FIGURE 2 POTENTIAL OUTCOMES OF ACUTE KIDNEY INJURY
CONNECTION BETWEEN CARDIOVASCULAR AND RENAL DISEASE
EPIDEMIOLOGY OF RENAL DISEASE
DECREASED ESTIMATED GFR
TABLE 2 STAGES OF CHRONIC KIDNEY DISEASE
FIGURE 3 NUMBER OF HOSPITALIZATIONS WITH ACUTE KIDNEY INJURY, FROM 1979-2002
FIGURE 4 TRENDS OF KIDNEY DISEASE INCIDENT RATE IN THE U.S., FROM 1980-2005
TABLE 3 INCIDENCE OF ESRD BY COUNTRY, 2011 (PER MILLION POPULATION)
TABLE 4 PREVALENCE OF ESRD BY COUNTRY, 2011
TABLE 5 PERCENTAGE OF INCIDENT ESRD PATIENTS DUE TO DIABETES BY COUNTRY, 2011 (%)
TABLE 6 KIDNEY TRANSPLANT RATES BY COUNTRY, 2011 (RATE IN PATIENTS PER MILLION)
REVENUE ANALYSIS OF THE GLOBAL RENAL DIALYSIS EQUIPMENT AND ACCESSORIES MARKET
GLOBAL MARKET SUMMARY
TABLE 7 GLOBAL MARKET FOR RENAL DIALYSIS EQUIPMENT AND ACCESSORIES, THROUGH 2018 ($ MILLIONS)
TABLE 8 SHARE OF THE RENAL DIALYSIS EQUIPMENT AND ACCESSORIES MARKET BY PRODUCT SEGMENT, 2013 AND 2018 (%)
TABLE 9 SHARE OF THE TOTAL DIALYSIS EQUIPMENT AND ACCESSORIES MARKET BY REGION, 2013 AND 2018 (%)
ARTIFICIAL KIDNEYS FOR GRADUAL REPLACEMENT OF DIALYSIS
PORTABLE, CARTRIDGE-BASED HEMODIALYSIS DEVICE
WEARABLE PERITONEAL DIALYSIS DEVICE
PRICING AND REIMBURSEMENT TRENDS
TABLE 10 REIMBURSEMENT OF DIALYSIS SERVICES PER WEEK BY SELECTED COUNTRIES, 2011-2013 ($)
THE U.S.
CANADA
JAPAN
GERMANY
FRANCE
ITALY
THE U.K.
BRAZIL
OTHER COUNTRIES-CHINA, INDIA AND SPAIN
FUTURE DIRECTION OF RENAL BIOMARKERS
CLINICAL VALUES OF RENAL BIOMARKERS
Alpha-1/Beta2-microglobulin
Alanine-aminopeptidase (Ala-AP)
Alkaline Phosphatase (ALP)
Albumin
Calprotectin
Clusterin
Creatinine
Cystatin C
FGF23
Hepcidin
Interleukin-18 (IL-18)
Kidney Injury Molecule-1 (KIM-1)
Liver Fatty Acid-Binding Protein (L-FABP)
N-acetyl-beta-D-Glucosaminidase (NAG)
Netrin
Neutrophil Gelatinase-Associated Lipocalin (NGAL)
Retinol Binding Protein (RBP)
Sodium/Hydrogen Exchanger Isoform 3 (NHE3)
Tissue Inhibitors of Metalloproteinases-2 (TIMP-2)
Trefoil Factor 3 (TFF3)
Gamma-Glutamyl Transpeptidase
CLINICAL EVALUATION OF BIOMARKERS
Glomerular Filtration Rate (GFR)
CHAPTER 4 INDUSTRY STRUCTURE AND COMPETITIVE ANALYSIS
INDUSTRY STRUCTURE
DIAGNOSTIC METHODS
Immunoassay
Radioimmunoassay
ELISA
Chemiluminescent Enzyme Immunoassay
Light Scattering
Turbidimetry
Nephelometry
Particle Counting
New Developments
Liquid Chromatography-Mass Spectrometry
NEWLY ISSUED PATENTS
TABLE 11 RENAL BIOMARKER DIAGNOSIS ASSAY PATENT TRENDS, 2010-2014 (NO. OF PATENTS)
BY BIOMARKERS
TABLE 12 PATENTS BY BIOMARKERS, 2010-2014
BY MANUFACTURER/RESEARCH INSTITUTE
TABLE 13 PATENTS BY COMPANY/INSTITUTION, 2010-2014 (NO. OF PATENTS/%)
TABLE 14 PATENTS FOR RENAL BIOMARKER DIAGNOSIS ASSAY, 2014
TABLE 15 RENAL BIOMARKER DIAGNOSIS PATENT ORIGIN, FROM 2012-MAY 2014 (NO. OF PATENTS/%)
NEW PATENT APPLICATIONS
TABLE 16 PATENT APPLICATIONS BY BIOMARKERS, 2012-MAY 2014 (NO. OF PATENT APPLICATIONS/%)
TABLE 17 EXAMPLES OF PATENT APPLICATION BY COMPANY, JAN-MAY 2014
TABLE 18 RENAL BIOMARKER DIAGNOSIS PATENT ORIGIN, FROM 2012-MAY 2014 (NO. OF PATENTS/%)
BY SECTOR
TABLE 19 PATENT APPLICATIONS BY COMPANY, AUG-OCT, 2013
GOVERNMENT REGULATION
U.S. FDA 510(K) APPROVAL
Division Acceptance and Review
CE MARKING IN EUROPE
OTHER INTERNATIONAL REGULATORY AGENCIES
TRENDS IN PRICE AND PRICE/PERFORMANCE
GENERAL TECHNOLOGY ISSUES
SELECTIVITY AND SPECIFICITY
POSITIVE AND NEGATIVE PREDICTIVE VALUES
RECEIVER OPERATOR CHARACTERISTIC CURVES
CHAPTER 5 MARKET BY ASSAYS
SUMMARY OF MARKET BY ASSAYS
TABLE 20 GLOBAL RENAL BIOMARKER MARKET BY ASSAY, THROUGH 2019 ($ MILLIONS)
TABLE 21 GLOBAL RENAL BIOMARKER MARKET BY INSTRUMENT, THROUGH 2019 ($ MILLIONS)
TABLE 22 GLOBAL CREATININE BIOMARKER MARKET BY RENAL DISEASE, THROUGH 2019 ($ MILLIONS)
CHAPTER 6 MARKET BY REGION
SUMMARY OF MARKET BY REGION
TABLE 23 ACUTE KIDNEY INJURY BIOMARKER MARKET BY REGION, THROUGH 2019 ($ MILLIONS)
TABLE 24 CHRONIC KIDNEY DISEASE BIOMARKER MARKET BY REGION, THROUGH 2019 ($ MILLIONS)
U.S. MARKET
TABLE 25 U.S. PATIENT POPULATION WITH RENAL DISEASE, THROUGH 2019 (CASES)
TABLE 26 U.S. MARKET BY RENAL DISEASE, THROUGH 2019 ($ MILLIONS)
TABLE 27 U.S. RENAL BIOMARKER MARKET BY ASSAY, THROUGH 2019 ($ MILLIONS)
TABLE 28 U.S. CREATININE BIOMARKER MARKET BY RENAL DISEASE, THROUGH 2019 ($ MILLIONS)
EUROPEAN MARKET
TABLE 29 EUROPE PATIENT POPULATION WITH RENAL DISEASE, THROUGH 2019 (CASES)
TABLE 30 EUROPE MARKET BY RENAL DISEASE, THROUGH 2019 ($ MILLIONS)
TABLE 31 EUROPE RENAL BIOMARKER MARKET BY ASSAY, THROUGH 2019 ($ MILLIONS)
TABLE 32 EUROPE CREATININE BIOMARKER MARKET BY RENAL DISEASE, THROUGH 2019 ($ MILLIONS)
CHINESE MARKET
TABLE 33 CHINA PATIENT POPULATION WITH RENAL DISEASE, THROUGH 2019 (CASES)*
TABLE 34 CHINA MARKET BY RENAL DISEASE, THROUGH 2019 ($ MILLIONS)
TABLE 35 CHINA RENAL BIOMARKER MARKET BY ASSAY, THROUGH 2019 ($ MILLIONS)
TABLE 36 CHINA CREATININE BIOMARKER MARKET BY RENAL DISEASE, THROUGH 2019 ($ MILLIONS)
CENTRAL AND SOUTH AMERICA MARKET
TABLE 37 CENTRAL AND SOUTH AMERICA PATIENT POPULATION WITH RENAL DISEASE, THROUGH 2019 (CASES)
TABLE 38 CENTRAL AND SOUTH AMERICA MARKET BY RENAL DISEASE, THROUGH 2019 ($ MILLIONS)
TABLE 39 CENTRAL AND SOUTH AMERICA RENAL BIOMARKER MARKET BY ASSAY, THROUGH 2019 ($ MILLIONS)*
TABLE 40 CENTRAL AND SOUTH AMERICA CREATININE BIOMARKER MARKET BY RENAL DISEASE, THROUGH 2019 ($ MILLIONS)
REST OF THE WORLD (ROW) MARKET
TABLE 41 REST OF THE WORLD PATIENT POPULATION WITH RENAL DISEASE, THROUGH 2019 (CASES)
TABLE 42 REST OF THE WORLD MARKET BY RENAL DISEASE, THROUGH 2019 ($ MILLIONS)
TABLE 43 REST OF THE WORLD RENAL BIOMARKER MARKET BY ASSAY, THROUGH 2019 ($ MILLIONS)
TABLE 44 REST OF THE WORLD CREATININE BIOMARKER MARKET BY RENAL DISEASE, THROUGH 2019 ($ MILLIONS)
CHAPTER 7 COMPANY PROFILES
MAJOR COMPANIES AND MARKET SHARE
TABLE 45 MANUFACTURERS OF DIAGNOSTICS ASSAYS GLOBAL SALES, 2012 ($ MILLIONS/%)
TABLE 46 MANUFACTURERS OF DIAGNOSTICS ASSAYS, NORTH AMERICA SALES, 2012 ($ MILLIONS/%)
TABLE 47 MANUFACTURERS OF DIAGNOSTICS ASSAYS, EUROPE SALES, 2012 ($ MILLIONS)
TABLE 48 MANUFACTURERS OF DIAGNOSTICS ASSAYS ASIA SALES, 2012 ($ MILLIONS/%)
TABLE 49 MANUFACTURERS OF DIAGNOSTICS ASSAYS REST OF THE WORLD SALES, 2012 ($ MILLIONS/%)
ABBOTT DIAGNOSTICS
KEY PRODUCTS
COMPANY STRATEGY
AFFYMETRIX INC.
KEY PRODUCTS
ALERE
KEY PRODUCTS
ASTUTE MEDICAL INC.
KEY PRODUCT
BECKMAN COULTER
KEY PRODUCTS
BECTON, DICKINSON AND COMPANY
BG MEDICINE INC.
KEY PRODUCTS
COMPANY STRATEGY
BIOMERIEUX
BIOPHYSICAL CORP.
KEY PRODUCTS
COMPANY STRATEGY
CORRELOGIC SYSTEMS INC.
KEY PRODUCTS
COMPANY STRATEGY
RADIOMETER MEDICAL
KEY PRODUCT
RANDOX LABORATORY
KEY PRODUCTS
RESPONSE BIOMEDICAL CORP.
KEY PRODUCTS
ROCHE HOLDING AG
KEY PRODUCTS
COMPANY STRATEGY
SIEMENS HEALTHCARE
KEY PRODUCTS
SINGULEX
KEY PRODUCT
THERMO FISHER SCIENTIFIC
KEY PRODUCTS

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