1 INTRODUCTION
1.1 OBJECTIVES OF THE STUDY
1.2 MARKET DEFINITION
1.3 OVERVIEW
1.4 CURRENCY AND PRICING
1.5 LIMITATIONS
1.6 MARKETS COVERED
2 MARKET SEGMENTATION
2.1 MARKETS COVERED
2.2 GEOGRAPHICAL SCOPE
2.3 YEARS CONSIDERED FOR THE STUDY
2.4 DBMR TRIPOD DATA VALIDATION MODEL
2.5 MULTIVARIATE MODELING
2.6 PRIMARY INTERVIEWS WITH KEY OPINION LEADERS
2.7 DBMR MARKET POSITION GRID
2.8 VENDOR SHARE ANALYSIS
2.9 MARKET END USER COVERAGE GRID
2.1 SECONDARY SOURCES
2.11 ASSUMPTIONS
3 EXECUTIVE SUMMARY
4 PREMIUM INSIGHTS
4.1 PORTER’S FIVE FORCES
4.2 PESTEL ANALYSIS
4.2.1 POLITICAL FACTORS
4.2.2 ECONOMIC FACTORS
4.2.3 SOCIAL FACTORS
4.2.4 TECHNOLOGICAL FACTORS
4.2.5 ENVIRONMENTAL FACTORS
4.2.6 LEGAL FACTORS
4.3 R&D ANALYSIS
4.3.1 COMPARATIVE ANALYSIS
4.3.2 DRUG DEVELOPMENTAL LANDSCAPE
4.3.3 IN-DEPTH INSIGHTS ON REGULATORY MILESTONES
4.3.4 THERAPEUTIC ASSESSMENT
4.3.5 ASSET-BASED COLLABORATIONS AND PARTNERSHIPS
4.4 HEALTHCARE TARIFFS IMPACT ANALYSIS
4.4.1 OVERVIEW
4.4.2 TARIFF STRUCTURES
4.4.2.1 GLOBAL VS. REGIONAL TARIFF STRUCTURES
4.4.3 PHARMACEUTICAL TARIFFS AND TRADE BARRIERS
4.4.3.1 IMPORT DUTIES ON PRESCRIPTION DRUGS VS. GENERICS
4.4.3.2 IMPACT ON DRUG AFFORDABILITY AND ACCESS
4.4.3.3 KEY TRADE AGREEMENTS AFFECTING TARIFFS
4.4.4 IMPACT OF TARIFFS ON PROVIDERS AND PATIENTS
4.4.4.1 COST BURDEN ON HOSPITALS AND HEALTHCARE FACILITIES
4.4.4.2 EFFECT ON PATIENT AFFORDABILITY AND INSURANCE COVERAGE
4.4.4.3 TARIFFS AND MEDICAL TOURISM
4.4.5 TRADE AGREEMENTS AND HEALTHCARE TARIFFS
4.4.5.1 WTO REGULATIONS
4.4.5.2 IMPACT OF TRADE WARS ON THE HEALTHCARE SUPPLY CHAIN
4.4.5.3 ROLE OF FREE TRADE AGREEMENTS (FTAS) IN REDUCING TARIFFS
4.4.6 IMPACT OF TARIFFS ON HEALTHCARE COSTS AND ACCESSIBILITY
4.4.7 IMPORTANCE OF TARIFFS IN THE HEALTHCARE SECTOR
4.5 PATENT ANALYSIS-
4.6 MARKETED DRUG ANALYSIS
4.6.1 10-YEAR MARKET FORECAST
4.6.2 DRUGS
4.6.3 BRANDED DRUGS
4.6.4 GENERIC DRUGS
4.6.5 THERAPEUTIC INDICATION
4.6.6 PHARMACOLOGICAL CLASS OF THE DRUG
4.6.7 DRUG PRIMARY INDICATION
4.6.8 MARKET STATUS
4.6.9 MEDICATION TYPE
4.6.10 DRUG DOSAGE FORM
4.6.11 DOSAGE AVAILABILITY
4.6.12 PACKAGING TYPE
4.6.13 DRUG ROUTE OF ADMINISTRATION
4.6.14 DOSING FREQUENCY
4.6.15 DRUG INSIGHT
4.6.16 AN OVERVIEW OF THE DRUG DEVELOPMENT ACTIVITIES
4.6.17 REGULATORY MILESTONE, SAFETY DATA, AND EFFICACY DATA
4.6.18 MARKET EXCLUSIVITY DATA
4.6.19 FORECAST MARKET OUTLOOK
4.6.20 CROSS COMPETITION
4.6.21 THERAPEUTIC PORTFOLIO
4.6.22 CURRENT DEVELOPMENT SCENARIO
4.7 MARKET ACCESS
4.7.1 10-YEAR MARKET FORECAST
4.7.2 CLINICAL TRIAL RECENT UPDATES
4.7.3 ANNUAL NEW FDA-APPROVED DRUGS
4.7.4 DRUG MANUFACTURER AND DEALS
4.7.5 MAJOR DRUG UPTAKE
4.7.6 CURRENT TREATMENT PRACTICES
4.7.7 IMPACT OF UPCOMING THERAPY
4.8 EPIDEMOLOGY
4.8.1 INCIDENCE BY GENDER: POCT-RELEVANT CONDITIONS
4.8.2 TREATMENT RATE: IMPACT ON POCT
4.8.3 MORTALITY RATE: THE NEED FOR TIMELY DIAGNOSIS
4.8.4 DRUG ADHERENCE AND THERAPY SWITCH: POCT'S ROLE IN MANAGEMENT
4.8.5 PATIENT TREATMENT SUCCESS RATES: THE POCT ADVANTAGE
4.9 SUPPLY CHAIN ECOSYSTEM
4.9.1 PROMINENT COMPANIES
4.9.2 KEY COMPONENTS OF THE ECOSYSTEM:
4.9.3 SMALL & MEDIUM SIZE COMPANIES (INNOVATORS)
4.9.4 END USERS
4.1 INNOVATION TRACKER & STRATEGIC ANALYSIS
4.10.1 MAJOR DEALS AND STRATEGIC ALLIANCES ANALYSIS
4.10.1.1 JOINT VENTURES
4.10.1.2 MERGERS & ACQUISITIONS
4.10.1.3 LICENSING & PARTNERSHIPS
4.10.1.4 TECHNOLOGY COLLABORATIONS
4.10.1.5 STRATEGIC DIVESTMENTS
4.10.2 NUMBER OF PRODUCTS IN DEVELOPMENT
4.10.3 STAGE OF DEVELOPMENT
4.10.4 TIMELINES & MILESTONES
4.10.5 INNOVATION STRATEGIES & METHODOLOGIES
4.10.6 RISK ASSESSMENT & MITIGATION
4.10.7 FUTURE OUTLOOK
4.11 PIPELINE ANALYSIS – CANADA AND USA POINT OF CARE TESTING MARKET
4.11.1 CLINICAL TRIALS AND PHASE ANALYSIS
4.11.2 TECHNOLOGY PIPELINE
4.11.3 PHASE III CANDIDATES
4.11.4 PHASE II CANDIDATES
4.11.5 PHASE I CANDIDATES
4.11.6 OTHERS (PRE-CLINICAL AND RESEARCH)
4.11.7 CONCLUSION
5 REGULATION COVERAGE
6 MARKET OVERVIEW
6.1 DRIVERS
6.1.1 RISING PREVALENCE OF CHRONIC AND INFECTIOUS DISEASES INCREASING DEMAND FOR RAPID, DECENTRALIZED DIAGNOSTICS
6.1.2 ADVANCED HEALTHCARE INFRASTRUCTURE AND STRONG MOBILE/WEARABLE ADOPTION IN CANADA AND THE U.S.
6.1.3 GROWING PATIENT PREFERENCE FOR FAST, CONVENIENT, NEAR-PATIENT TESTING OPTIONS
6.1.4 INCREASING GOVERNMENT INITIATIVES AND FUNDING TO SUPPORT DIGITAL HEALTH AND DECENTRALIZED DIAGNOSTICS
6.2 RESTRAINTS
6.2.1 HIGH COSTS FOR ADVANCED POCT DEVICES AND REAGENTS
6.2.2 VARIABILITY IN DEVICE PERFORMANCE AND QUALITY ACROSS BRANDS, COMPLICATING STANDARDIZATION AND CLINICAL ADOPTION
6.3 OPPORTUNITIES
6.3.1 INCREASING USE IN DRUG ABUSE, INFECTIOUS DISEASE, AND ONCOLOGY SCREENING, DRIVING MARKET DIVERSIFICATION
6.3.2 EXPANDING USE OF MOLECULAR POCT AND LATERAL FLOW IMMUNOASSAYS, INCLUDING PHARMACIES AND REMOTE/RURAL CARE
6.3.3 INTEGRATION OF ARTIFICIAL INTELLIGENCE AND MACHINE LEARNING FOR ENHANCED DIAGNOSTIC ACCURACY AND CLINICAL DECISION SUPPORT
6.4 CHALLENGES
6.4.1 MAINTAINING ACCURACY, RELIABILITY, AND REGULATION COMPLIANCE ACROSS DECENTRALIZED TESTING ENVIRONMENTS
6.4.2 ADDRESSING DATA PRIVACY AND CYBERSECURITY RISKS AS MORE POCT DEVICES CONNECT TO HEALTH NETWORKS
7 CANADA AND U.S. POINT OF CARE TESTING MARKET, BY PRODUCT/DISEASE
7.1 OVERVIEW
7.2 RESPIRATORY INFECTION
7.2.1 SARS-COV-2
7.2.2 INFLUENZA A/B
7.2.3 RESPIRATORY SYNCYTIAL VIRUS (RSV)
7.2.4 BORDETELLA PERTUSSIS
7.2.5 OTHERS
7.3 GASTROENTERIC INFECTIONS
7.3.1 CLOSTRIDIOIDES DIFFICILE
7.3.2 NOROVIRUS
7.3.3 ROTAVIRUS
7.3.4 SALMONELLA, SHIGELLA, CAMPYLOBACTER, E. COLI (STEC)
7.3.5 GIARDIA
7.4 SEXUALLY TRANSMITTED DISEASE (STD)
7.5 HEPATITIS
7.6 BLOODSTREAM INFECTIONS (BSI)
7.7 BLOOD YEAST INFECTIONS (FUNGAL BSI)
7.8 OTHERS
8 CANADA AND U.S. OF CARE TESTING MARKET, BY METHOD/TECHNOLOGY
8.1 OVERVIEW
8.2 NAAT (NUCLEIC ACID AMPLIFICATION TESTS)
8.3 LAMP (LOOP-MEDIATED ISOTHERMAL AMPLIFICATION)
8.4 MICROFLUIDICS / LAB-ON-A-CHIP
8.5 OTHERS
9 CANADA AND U.S. POINT OF CARE TESTING MARKET, BY PANEL TYPE
9.1 OVERVIEW
9.2 SIMPLEX ASSAY
9.3 MULTIPLEX PANEL (SYNDROMIC TESTING)
9.4 DUPLEX ASSAY
9.5 TRIPLEX ASSAY
10 CANADA AND U.S. POINT OF CARE TESTING MARKET, BY TESTING LOCATION
10.1 OVERVIEW
10.2 LABORATORY BASED POINT-OF-CARE-TESTING (POCT)
10.3 AT-HOME POINT-OF-CARE-TESTING (POCT)
11 CANADA AND U.S. POINT OF CARE TESTING MARKET, BY END USER
11.1 OVERVIEW
11.2 HOSPITALS
11.3 HOME CARE
11.4 CLINICS
11.5 LABORATORIES
11.6 AMBULATORY SURGERY CENTERS
11.7 ELDERLY CARE CENTERS
11.8 OTHERS
12 CANADA AND U.S. POINT OF CARE TESTING MARKET, BY DISTRIBUTION CHANNEL
12.1 OVERVIEW
12.2 DIRECT TENDER
12.3 RETAIL SALES
12.4 ONLINE SALES
12.5 OTHERS
13 CANADA AND U.S. POINT OF CARE TESTING MARKET: COMPANY LANDSCAPE
13.1 COMPANY SHARE ANALYSIS: U.S.
13.2 COMPANY SHARE ANALYSIS: CANADA
14 SWOT ANALYSIS
15 COMPANY PROFILE
15.1 DANAHER CORPORATION.
15.1.1 COMPANY SNAPSHOT
15.1.2 REVENUE ANALYSIS
15.1.3 PRODUCT PORTFOLIO
15.1.4 RECENT DEVELOPMENT
15.2 F. HOFFMANN-LA ROCHE LTD
15.2.1 COMPANY SNAPSHOT
15.2.2 RECENT FINANCIALS
15.2.3 PRODUCT PORTFOLIO
15.2.4 RECENT DEVELOPMENTS
15.3 SIEMENS HEALTHINEERS AG
15.3.1 COMPANY SNAPSHOT
15.3.2 RECENT FINANCIALS
15.3.3 PRODUCT PORTFOLIO
15.3.4 RECENT DEVELOPMENTS
15.4 BD
15.4.1 COMPANY SNAPSHOT
15.4.2 RECENT FINANCIALS
15.4.3 PRODUCT PORTFOLIO
15.4.4 RECENT DEVELOPMENTS
15.5 ABBOTT
15.5.1 COMPANY SNAPSHOT
15.5.2 REVENUE ANALYSIS
15.5.3 PRODUCT PORTFOLIO
15.5.4 RECENT DEVELOPMENT
15.6 AGILENT TECHNOLOGIES INC.
15.6.1 COMPANY SNAPSHOT
15.6.2 RECENT FINANCIALS
15.6.3 PRODUCT PORTFOLIO
15.6.4 RECENT DEVELOPMENTS
15.7 ABAXIS, INC.
15.7.1 COMPANY SNAPSHOT
15.7.2 PRODUCT PORTFOLIO
15.7.3 RECENT DEVELOPMENT
15.8 BINX HEALTH, INC.
15.8.1 COMPANY SNAPSHOT
15.8.2 PRODUCT PORTFOLIO
15.8.3 RECENT DEVELOPMENT
15.9 BIOMERIEUX
15.9.1 COMPANY SNAPSHOT
15.9.2 RECENT FINANCIALS
15.9.3 PRODUCT PORTFOLIO
15.9.4 RECENT DEVELOPMENT
15.1 BIO-RAD LABORATORIES, INC.
15.10.1 COMPANY SNAPSHOT
15.10.2 REVENUE ANALYSIS
15.10.3 PRODUCT PORTFOLIO
15.10.4 RECENT DEVELOPMENT
15.11 CREATIVE DIAGNOSTICS
15.11.1 COMPANY SNAPSHOT
15.11.2 PRODUCT PORTFOLIO
15.11.3 RECENT DEVELOPMENT
15.12 CARDINAL HEALTH
15.12.1 COMPANY SNAPSHOT
15.12.2 REVENUE ANALYSIS
15.12.3 PRODUCT PORTFOLIO
15.12.4 RECENT DEVELOPMENT
15.13 CANADIAN HOSPITAL SPECIALTIES LIMITED
15.13.1 COMPANY SNAPSHOT
15.13.2 PRODUCT PORTFOLIO
15.13.3 RECENT DEVELOPMENT
15.14 EKF DIAGNOSTICS HOLDINGS PLC.
15.14.1 COMPANY SNAPSHOT
15.14.2 REVENUE ANALYSIS
15.14.3 PRODUCT PORTFOLIO
15.14.4 RECENT DEVELOPMENT
15.15 HENRY SCHEIN, INC.
15.15.1 COMPANY SNAPSHOT
15.15.2 REVENUE ANALYSIS
15.15.3 PRODUCT PORTFOLIO
15.15.4 RECENT DEVELOPMENT
15.16 HIPRO BIOTECHNOLOGY CO.,LTD.
15.16.1 COMPANY SNAPSHOT
15.16.2 PRODUCT PORTFOLIO
15.16.3 RECENT DEVELOPMENTS
15.17 MEDLINE INDUSTRIES, LP
15.17.1 COMPANY SNAPSHOT
15.17.2 PRODUCT PORTFOLIO
15.17.3 RECENT DEVELOPMENT
15.18 MERIDIAN BIOSCIENCE, INC
15.18.1 COMPANY SNAPSHOT
15.18.2 PRODUCT PORTFOLIO
15.18.3 RECENT DEVELOPMENT
15.19 NIPRO
15.19.1 COMPANY SNAPSHOT
15.19.2 RECENT FINANCIALS
15.19.3 PRODUCT PORTFOLIO
15.19.4 RECENT DEVELOPMENTS
15.2 NOVA BIOMEDICAL
15.20.1 COMPANY SNAPSHOT
15.20.2 PRODUCT PORTFOLIO
15.20.3 RECENT DEVELOPMENT
15.21 ORASURE TECHNOLOGIES INC
15.21.1 COMPANY SNAPSHOT
15.21.2 REVENUE ANALYSIS
15.21.3 PRODUCT PORTFOLIO
15.21.4 RECENT DEVELOPMENT
15.22 PTS DIAGNOSTICS
15.22.1 COMPANY SNAPSHOT
15.22.2 PRODUCT PORTFOLIO
15.22.3 RECENT DEVELOPMENT
15.23 QIAGEN
15.23.1 COMPANY SNAPSHOT
15.23.2 REVENUE ANALYSIS
15.23.3 PRODUCT PORTFOLIO
15.23.4 RECENT DEVELOPMENT
15.24 QUANTUMDX GROUP LTD.
15.24.1 COMPANY SNAPSHOT
15.24.2 PRODUCT PORTFOLIO
15.24.3 RECENT DEVELOPMENT
15.25 QUIDELORTHO CORPORATION.
15.25.1 COMPANY SNAPSHOT
15.25.2 REVENUE ANALYSIS
15.25.3 PRODUCT PORTFOLIO
15.25.4 RECENT DEVELOPMENTS
15.26 RADIOMETER MEDICAL APS
15.26.1 COMPANY SNAPSHOT
15.26.2 PRODUCT PORTFOLIO
15.26.3 RECENT UPDATES
15.27 SANNER
15.27.1 COMPANY SNAPSHOT
15.27.2 PRODUCT PORTFOLIO
15.27.3 RECENT DEVELOPMENT
15.28 SEKISUI DIAGNOSTICS
15.28.1 COMPANY SNAPSHOT
15.28.2 PRODUCT PORTFOLIO
15.28.3 RECENT DEVELOPMENT
15.29 SYSMEX CORPORATION
15.29.1 COMPANY SNAPSHOT
15.29.2 REVENUE ANALYSIS
15.29.3 PRODUCT PORTFOLIO
15.29.4 RECENT DEVELOPMENT
15.3 SANGUNIA
15.30.1 COMPANY SNAPSHOT
15.30.2 PRODUCT PORTFOLIO
15.30.3 RECENT DEVELOPMENTS
15.31 THE STEVENS COMPANY LIMITED
15.31.1 COMPANY SNAPSHOT
15.31.2 PRODUCT PORTFOLIO
15.31.3 RECENT DEVELOPMENT
15.32 THERMO FISHER SCIENTIFIC INC.
15.32.1 COMPANY SNAPSHOT
15.32.2 REVENUE ANALYSIS
15.32.3 PRODUCT PORTFOLIO
15.32.4 RECENT DEVELOPMENT
15.33 TRIMEDIC INC
15.33.1 COMPANY SNAPSHOT
15.33.2 PRODUCT PORTFOLIO
15.33.3 RECENT DEVELOPMENT
15.34 TRINITY BIOTECH
15.34.1 COMPANY SNAPSHOT
15.34.2 REVENUE ANALYSIS
15.34.3 PRODUCT PORTFOLIO
15.34.4 RECENT DEVELOPMENT
16 QUESTIONNAIRE