Table of Content
1 INTRODUCTION
1.1 OBJECTIVES OF THE STUDY
1.2 MARKET DEFINITION
1.3 OVERVIEW OF NORTH AMERICA MEDICAL DEVICE TESTING MARKET
1.4 LIMITATIONS
1.5 MARKETS COVERED
2 MARKET SEGMENTATION
2.1 MARKETS COVERED
2.2 GEOGRAPHICAL SCOPE
2.3 YEARS CONSIDERED FOR THE STUDY
2.4 CURRENCY AND PRICING
2.5 DBMR TRIPOD DATA VALIDATION MODEL
2.6 MULTIVARIATE MODELLING
2.7 SERVICE TYPE LIFELINE CURVE
2.8 PRIMARY INTERVIEWS WITH KEY OPINION LEADERS
2.9 DBMR MARKET POSITION GRID
2.1 MARKET TESTING TYPE COVERAGE GRID
2.11 VENDOR SHARE ANALYSIS
2.12 SECONDARY SOURCES
2.13 ASSUMPTIONS
3 EXECUTIVE SUMMARY
4 PREMIUM INSIGHTS
4.1 PESTEL ANALYSIS
4.2 PORTER'S FIVE FORCES
5 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: REGULATIONS
6 MARKET OVERVIEW
6.1 DRIVERS
6.1.1 RISING NEED FOR VERIFICATION VALIDATION OF MEDICAL DEVICES
6.1.2 INCREASING DEMAND FOR IN-VITRO TESTS
6.1.3 ESCALATION IN INNOVATION AND TECHNOLOGIES
6.2 RESTRAINTS
6.2.1 BARRIERS TO THE LOCAL DEVELOPMENT OF MEDICAL DEVICES
6.2.2 HIGH COST OF MEDICAL DEVICES
6.3 OPPORTUNITIES
6.3.1 RISE IN HEALTHCARE EXPENDITURE
6.3.2 DEVELOPMENT IN AI AND IOT IN VARIOUS MEDICAL DEVICES
6.3.3 STRATEGIC INITIATIVES OF KEY PLAYERS
6.4 CHALLENGES
6.4.1 HIGH COMPETITION IN MEDICAL TECHNOLOGY INDUSTRY
6.4.2 LONG LEAD TIME FOR OVERSEAS QUALIFICATION
7 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE
7.1 OVERVIEW
7.2 TESTING SERVICES
7.3 INSPECTION SERVICES
7.4 CERTIFICATION SERVICES
8 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY TESTING TYPE
8.1 OVERVIEW
8.2 CHEMICAL/BIOLOGICAL TESTING
8.3 MICROBIOLOGY AND STERILITY TESTING
8.3.1 STERILITY TEST & VALIDATION
8.3.2 BIO BURDEN DETERMINATION
8.3.3 ANTIMICROBIAL ACTIVITY TESTING
8.3.4 PYROGEN & ENDOTOXIN TESTING
8.3.5 OTHERS
8.4 PHYSICAL TESTING
8.4.1 ELECTRICAL SAFETY TESTING
8.4.2 FUNCTIONAL SAFETY TESTING
8.4.3 EMC TESTING
8.4.4 ENVIRONMENTAL TESTING
8.4.5 OTHERS
8.5 CYBERSECURITY TESTING
8.6 OTHERS
9 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY PHASE
9.1 OVERVIEW
9.2 PRECLINICAL
9.3 CLINICAL
10 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE
10.1 OVERVIEW
10.2 OUTSOURCED
10.3 IN-HOUSE
11 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY DEVICE CLASS
11.1 OVERVIEW
11.2 CLASS I
11.3 CLASS III
11.4 CLASS II
12 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY PRODUCT
12.1 OVERVIEW
12.2 NON-ACTIVE MEDICAL DEVICE
12.3 ORTHOPEDIC AND DENTAL MEDICAL DEVICE
12.4 ACTIVE IMPLANT MEDICAL DEVICE
12.5 VASCULAR MEDICAL DEVICE
12.6 ACTIVE MEDICAL DEVICE
12.7 IN-VITRO DIAGNOSTICS MEDICAL DEVICE
12.8 OPTHALMIC MEDICAL DEVICE
12.9 OTHERS
13 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY GEOGRAPHY
13.1 NORTH AMERICA
13.1.1 U.S.
13.1.2 CANADA
13.1.3 MEXICO
14 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: COMPANY LANDSCAPE
14.1 COMPANY SHARE ANALYSIS: NORTH AMERICA
15 SWOT ANALYSIS
16 COMPANY PROFILE
16.1 LABORATORY CORPORATION OF AMERICA HOLDINGS
16.1.1 COMPANY SNAPSHOT
16.1.2 REVENUE ANALYSIS
16.1.3 COMPANY SHARE ANALYSIS
16.1.4 PRODUCT PORTFOLIO
16.1.5 RECENT DEVELOPMENTS
16.2 CHARLES RIVER LABORATORIES.
16.2.1 COMPANY SNAPSHOT
16.2.2 REVENUE ANALYSIS
16.2.3 COMPANY SHARE ANALYSIS
16.2.4 PRODUCT PORTFOLIO
16.2.5 RECENT DEVELOPMENTS
16.3 TUV SUD
16.3.1 COMPANY SNAPSHOT
16.3.2 REVENUE ANALYSIS
16.3.3 COMPANY SHARE ANALYSIS
16.3.4 PRODUCT PORTFOLIO
16.3.5 RECENT DEVELOPMENTS
16.4 WUXI APPTEC
16.4.1 COMPANY SNAPSHOT
16.4.2 REVENUE ANALYSIS
16.4.3 COMPANY SHARE ANALYSIS
16.4.4 PRODUCT PORTFOLIO
16.4.5 RECENT DEVELOPMENTS
16.5 SGS SA
16.5.1 COMPANY SNAPSHOT
16.5.2 REVENUE ANALYSIS
16.5.3 COMPANY SHARE ANALYSIS
16.5.4 PRODUCT PORTFOLIO
16.5.5 RECENT DEVELOPMENTS
16.6 NORTH AMERICAN SCIENCE ASSOCIATES, LLC
16.6.1 COMPANY SNAPSHOT
16.6.2 PRODUCT PORTFOLIO
16.6.3 RECENT DEVELOPMENTS
16.7 HOHENSTEIN
16.7.1 COMPANY SNAPSHOT
16.7.2 PRODUCT PORTFOLIO
16.7.3 RECENT DEVELOPMENTS
16.8 BIOMEDICAL DEVICE LABS
16.8.1 COMPANY SNAPSHOT
16.8.2 PRODUCT PORTFOLIO
16.8.3 RECENT DEVELOPMENTS
16.9 BUREAU VERITAS
16.9.1 COMPANY SNAPSHOT
16.9.2 REVENUE ANALYSIS
16.9.3 PRODUCT PORTFOLIO
16.9.4 RECENT DEVELOPMENTS
16.1 CIGNITI
16.10.1 COMPANY SNAPSHOT
16.10.2 REVENUE ANALYSIS
16.10.3 PRODUCT PORTFOLIO
16.10.4 RECENT DEVELOPMENTS
16.11 ELEMENT MATERIALS TECHNOLOGY
16.11.1 COMPANY SNAPSHOT
16.11.2 PRODUCT PORTFOLIO
16.11.3 RECENT DEVELOPMENTS
16.12 EUROFINS SCIENTIFIC
16.12.1 COMPANY SNAPSHOT
16.12.2 REVENUE ANALYSIS
16.12.3 PRODUCT PORTFOLIO
16.12.4 RECENT DEVELOPMENTS
16.13 GATEWAY ANALYTICAL.
16.13.1 COMPANY SNAPSHOT
16.13.2 PRODUCT PORTFOLIO
16.13.3 RECENT DEVELOPMENTS
16.14 IMR TEST LABS
16.14.1 COMPANY SNAPSHOT
16.14.2 PRODUCT PORTFOLIO
16.14.3 RECENT DEVELOPMENTS
16.15 INTERTEK GROUP PLC
16.15.1 COMPANY SNAPSHOT
16.15.2 REVENUE ANALYSIS
16.15.3 PRODUCT PORTFOLIO
16.15.4 RECENT DEVELOPMENTS
16.16 NELSON LABORATORIES, LLC- A SOTERA HEALTH COMPANY
16.16.1 COMPANY SNAPSHOT
16.16.2 PRODUCT PORTFOLIO
16.16.3 RECENT DEVELOPMENTS
16.17 NSF.
16.17.1 COMPANY SNAPSHOT
16.17.2 PRODUCT PORTFOLIO
16.17.3 RECENT DEVELOPMENTS
16.18 PACE
16.18.1 COMPANY SNAPSHOT
16.18.2 PRODUCT PORTFOLIO
16.18.3 RECENT DEVELOPMENTS
16.19 Q LABORATORIES
16.19.1 COMPANY SNAPSHOT
16.19.2 PRODUCT PORTFOLIO
16.19.3 RECENT DEVELOPMENTS
16.2 TUV RHEINLAND
16.20.1 COMPANY SNAPSHOT
16.20.2 REVENUE ANALYSIS
16.20.3 PRODUCT PORTFOLIO
16.20.4 RECENT DEVELOPMENTS
16.21 UL LLC
16.21.1 COMPANY SNAPSHOT
16.21.2 PRODUCT PORTFOLIO
16.21.3 RECENT DEVELOPMENTS
17 QUESTIONNAIRE
18 RELATED REPORTS
List of Table
TABLE 1 FDA REGULATIONS BASED ON DEVICES TYPE
TABLE 2 PRICES OF ESSENTIAL MEDICAL DEVICES
TABLE 3 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE, 2021-2030 (USD MILLION)
TABLE 4 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY TESTING TYPE, 2021-2030 (USD MILLION)
TABLE 5 NORTH AMERICA MICROBIOLOGY AND STERILITY TESTING IN MEDICAL DEVICE TESTING MARKET, BY TESTING TYPE, 2021-2030 (USD MILLION)
TABLE 6 NORTH AMERICA PHYSICAL TESTING IN MEDICAL DEVICE TESTING MARKET, BY TESTING TYPE, 2021-2030 (USD MILLION)
TABLE 7 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY PHASE, 2021-2030 (USD MILLION)
TABLE 8 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2021-2030 (USD MILLION)
TABLE 9 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY DEVICE CLASS, 2021-2030 (USD MILLION)
TABLE 10 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY PRODUCT, 2021-2030 (USD MILLION)
TABLE 11 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY COUNTRY, 2021-2030 (USD MILLION)
TABLE 12 U.S. MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE, 2021-2030 (USD MILLION)
TABLE 13 U.S. MEDICAL DEVICE TESTING MARKET, BY TESTING TYPE, 2021-2030 (USD MILLION)
TABLE 14 U.S. MICROBIOLOGY AND STERILITY TESTING IN MEDICAL DEVICE TESTING MARKET, BY TESTING TYPE, 2021-2030 (USD MILLION)
TABLE 15 U.S. PHYSICAL TESTING IN MEDICAL DEVICE TESTING MARKET, BY TESTING TYPE, 2021-2030 (USD MILLION)
TABLE 16 U.S. MEDICAL DEVICE TESTING MARKET, BY PHASE, 2021-2030 (USD MILLION)
TABLE 17 U.S. MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2021-2030 (USD MILLION)
TABLE 18 U.S. MEDICAL DEVICE TESTING MARKET, BY DEVICE CLASS, 2021-2030 (USD MILLION)
TABLE 19 U.S. MEDICAL DEVICE TESTING MARKET, BY PRODUCT, 2021-2030 (USD MILLION)
TABLE 20 CANADA MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE, 2021-2030 (USD MILLION)
TABLE 21 CANADA MEDICAL DEVICE TESTING MARKET, BY TESTING TYPE, 2021-2030 (USD MILLION)
TABLE 22 CANADA MICROBIOLOGY AND STERILITY TESTING IN MEDICAL DEVICE TESTING MARKET, BY TESTING TYPE, 2021-2030 (USD MILLION)
TABLE 23 CANADA PHYSICAL TESTING IN MEDICAL DEVICE TESTING MARKET, BY TESTING TYPE, 2021-2030 (USD MILLION)
TABLE 24 CANADA MEDICAL DEVICE TESTING MARKET, BY PHASE, 2021-2030 (USD MILLION)
TABLE 25 CANADA MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2021-2030 (USD MILLION)
TABLE 26 CANADA MEDICAL DEVICE TESTING MARKET, BY DEVICE CLASS, 2021-2030 (USD MILLION)
TABLE 27 CANADA MEDICAL DEVICE TESTING MARKET, BY PRODUCT, 2021-2030 (USD MILLION)
TABLE 28 MEXICO MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE, 2021-2030 (USD MILLION)
TABLE 29 MEXICO MEDICAL DEVICE TESTING MARKET, BY TESTING TYPE, 2021-2030 (USD MILLION)
TABLE 30 MEXICO MICROBIOLOGY AND STERILITY TESTING IN MEDICAL DEVICE TESTING MARKET, BY TESTING TYPE, 2021-2030 (USD MILLION)
TABLE 31 MEXICO PHYSICAL TESTING IN MEDICAL DEVICE TESTING MARKET, BY TESTING TYPE, 2021-2030 (USD MILLION)
TABLE 32 MEXICO MEDICAL DEVICE TESTING MARKET, BY PHASE, 2021-2030 (USD MILLION)
TABLE 33 MEXICO MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2021-2030 (USD MILLION)
TABLE 34 MEXICO MEDICAL DEVICE TESTING MARKET, BY DEVICE CLASS, 2021-2030 (USD MILLION)
TABLE 35 MEXICO MEDICAL DEVICE TESTING MARKET, BY PRODUCT, 2021-2030 (USD MILLION)
List of Figure
FIGURE 1 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: SEGMENTATION
FIGURE 2 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: DATA TRIANGULATION
FIGURE 3 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: DROC ANALYSIS
FIGURE 4 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: GLOBAL VS REGIONAL MARKET ANALYSIS
FIGURE 5 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: COMPANY RESEARCH ANALYSIS
FIGURE 6 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: INTERVIEW DEMOGRAPHICS
FIGURE 7 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: DBMR MARKET POSITION GRID
FIGURE 8 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: MARKET TESTING TYPE COVERAGE GRID
FIGURE 9 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: VENDOR SHARE ANALYSIS
FIGURE 10 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: SEGMENTATION
FIGURE 11 INCREASING DEMAND FOR IN-VITRO TESTS AND DEVELOPMENT IN AI AND IOT IN VARIOUS MEDICAL DEVICES ARE EXPECTED TO DRIVE THE NORTH AMERICA MEDICAL DEVICE TESTING MARKET IN THE FORECAST PERIOD OF 2023 TO 2030
FIGURE 12 TESTING SERVICES SEGMENT IS EXPECTED TO ACCOUNT FOR THE LARGEST SHARE OF THE NORTH AMERICA MEDICAL DEVICE TESTING MARKET IN 2023 & 2030
FIGURE 13 DRIVERS, RESTRAINTS, OPPORTUNITIES, AND CHALLENGES OF GLOBAL MEDICAL DEVICE TESTING MARKET
FIGURE 14 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY SERVICE TYPE, 2022
FIGURE 15 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY SERVICE TYPE, 2023-2030 (USD MILLION)
FIGURE 16 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY SERVICE TYPE, CAGR (2023-2030)
FIGURE 17 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY SERVICE TYPE, LIFELINE CURVE
FIGURE 18 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY TESTING TYPE, 2022
FIGURE 19 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY TESTING TYPE, 2023-2030 (USD MILLION)
FIGURE 20 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY TESTING TYPE, CAGR (2023-2030)
FIGURE 21 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY TESTING TYPE, LIFELINE CURVE
FIGURE 22 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY PHASE, 2022
FIGURE 23 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY PHASE, 2023-2030 (USD MILLION)
FIGURE 24 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY PHASE, CAGR (2023-2030)
FIGURE 25 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY PHASE, LIFELINE CURVE
FIGURE 26 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY SOURCING TYPE, 2022
FIGURE 27 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY SOURCING TYPE, 2023-2030 (USD MILLION)
FIGURE 28 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY SOURCING TYPE, CAGR (2023-2030)
FIGURE 29 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY SOURCING TYPE, LIFELINE CURVE
FIGURE 30 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY DEVICE CLASS, 2022
FIGURE 31 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY DEVICE CLASS, 2023-2030 (USD MILLION)
FIGURE 32 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY DEVICE CLASS, CAGR (2023-2030)
FIGURE 33 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY DEVICE CLASS, LIFELINE CURVE
FIGURE 34 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY PRODUCT, 2022
FIGURE 35 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY PRODUCT, 2023-2030 (USD MILLION)
FIGURE 36 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY PRODUCT, CAGR (2023-2030)
FIGURE 37 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY PRODUCT, LIFELINE CURVE
FIGURE 38 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: SNAPSHOT (2022)
FIGURE 39 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY COUNTRY (2022)
FIGURE 40 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY COUNTRY (2023 & 2030)
FIGURE 41 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY COUNTRY (2023 & 2030)
FIGURE 42 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: BY SERVICE TYPE (2023-2030)
FIGURE 43 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: COMPANY SHARE 2022 (%)
