Table of Content
1. INTRODUCTION
1.1 OBJECTIVES OF THE STUDY
1.2 MARKET DEFINITION
1.3 OVERVIEW OF GLOBAL IN VITRO DIAGNOSTIC (IVD) REGULATORY AFFAIRS OUTSOURCING MARKET
1.4 CURRENCY AND PRICING
1.5 LIMITATION
1.6 MARKETS COVERED
2. MARKET SEGMENTATION
2.1 KEY TAKEAWAYS
2.2 ARRIVING AT THE GLOBAL IN VITRO DIAGNOSTIC (IVD) REGULATORY AFFAIRS OUTSOURCING MARKET SIZE
2.2.1 VENDOR POSITIONING GRID
2.2.2 TECHNOLOGY LIFE LINE CURVE
2.2.3 MULTIVARIATE MODELLING
2.2.4 TOP TO BOTTOM ANALYSIS
2.2.5 STANDARDS OF MEASUREMENT
2.2.6 VENDOR SHARE ANALYSIS
2.2.7 DATA POINTS FROM KEY PRIMARY INTERVIEWS
2.2.8 DATA POINTS FROM KEY SECONDARY DATABASES
2.3 GLOBAL IN VITRO DIAGNOSTIC (IVD) REGULATORY AFFAIRS OUTSOURCING MARKET: RESEARCH SNAPSHOT
2.4 ASSUMPTIONS
3. MARKET OVERVIEW
3.1 DRIVERS
3.2 RESTRAINTS
3.3 OPPORTUNITIES
3.4 CHALLENGES
4. PREMIUM INSIGHTS
4.1 PESTEL ANALYSIS
4.2 PORTER’S FIVE FORCES MODEL
5. INDUSTRY INSIGHTS
5.1 MICRO AND MACRO ECONOMIC FACTORS
5.2 PENETRATION AND GROWTH PROSPECT MAPPING
5.3 KEY PRICING STRATEGIES
5.4 INTERVIEWS WITH SPECIALIST
5.5 ANALYIS AND RECOMMENDATION
6. INTELLECTUAL PROPERTY (IP) PORTFOLIO
6.1 PATENT QUALITY AND STRENGTH
6.2 PATENT FAMILIES
6.3 LICENSING AND COLLABORATIONS
6.4 COMPETITIVE LANDSCAPE
6.5 IP STRATEGY AND MANAGEMENT
6.6 OTHER
7. COST ANALYSIS BREAKDOWN
8. TECHNONLOGY ROADMAP
9. INNOVATION TRACKER AND STRATEGIC ANALYSIS
9.1 MAJOR DEALS AND STRATEGIC ALLIANCES ANALYSIS
9.1.1 JOINT VENTURES
9.1.2 MERGERS AND ACQUISITIONS
9.1.3 LICENSING AND PARTNERSHIP
9.1.4 TECHNOLOGY COLLABORATIONS
9.1.5 STRATEGIC DIVESTMENTS
9.2 NUMBER OF PRODUCTS IN DEVELOPMENT
9.3 STAGE OF DEVELOPMENT
9.4 TIMELINES AND MILESTONES
9.5 INNOVATION STRATEGIES AND METHODOLOGIES
9.6 RISK ASSESSMENT AND MITIGATION
9.7 FUTURE OUTLOOK
10. REGULATORY COMPLIANCE
10.1 REGULATORY AUTHORITIES
10.2 REGULATORY CLASSIFICATIONS
10.2.1 CLASS I
10.2.2 CLASS II
10.2.3 CLASS III
10.3 REGULATORY SUBMISSIONS
10.4 INTERNATIONAL HARMONIZATION
10.5 COMPLIANCE AND QUALITY MANAGEMENT SYSTEMS
10.6 REGULATORY CHALLENGES AND STRATEGIES
11. REIMBURSEMENT FRAMEWORK
12. OPPUTUNITY MAP ANALYSIS
13. INSTALLED BASE DATA
14. VALUE CHAIN ANALYSIS
15. HEALTHCARE ECONOMY
15.1 HEALTHCARE EXPENDITURE
15.2 CAPITAL EXPENDITURE
15.3 CAPEX TRENDS
15.4 CAPEX ALLOCATION
15.5 FUNDING SOURCES
15.6 INDUSTRY BENCHMARKS
15.7 GDP RATION IN OVERALL GDP
15.8 HEALTHCARE SYSTEM STRUCTURE
15.9 GOVERNMENT POLICIES
15.10 ECONOMIC DEVELOPMENT
16. GLOBAL IN VITRO DIAGNOSTIC (IVD) REGULATORY AFFAIRS OUTSOURCING MARKET, BY SERVICE
16.1 OVERVIEW
16.2 REGULATORY WRITING & SUBMISSIONS
16.3 REGULATORY REGISTRATION & CLINICAL TRIAL APPLICATIONS
16.4 REGULATORY CONSULTING
16.5 LEGAL REPRESENTATION
16.6 DATA MANAGEMENT SERVICES
16.7 CHEMISTRY MANUFACTURING AND CONTROLS (CMC) SERVICES
16.8 OTHERS
17. GLOBAL IN VITRO DIAGNOSTIC (IVD) REGULATORY AFFAIRS OUTSOURCING MARKET, BY INDICATION
17.1 OVERVIEW
17.2 ONCOLOGY
17.3 NEUROLOGY
17.4 CARDIOLOGY
17.5 CLINICAL CHEMISTRY AND IMMUNOASSAYS
17.6 PRECISION MEDICINE
17.7 INFECTIOUS DISEASES
17.7.1 SEPSIS
17.7.2 VIROLOGY
17.7.3 BACTERIOLOGY
17.7.4 MICROBIOLOGY AND MYCOLOGY
17.7.5 HEPATITIS B
17.7.6 HEPATITIS C
17.7.7 SYPHILIS
17.7.8 TUBERCULOSIS
17.7.9 MALARIA
17.7.10 HUMAN PAPILLOMAVIRUS (HPV) INFECTION
17.7.11 OTHERS
17.8 DIABETES
17.9 GENETIC TESTING
17.10 HIV/AIDS
17.11 HAEMATOLOGY
17.12 DRUG TESTING/PHARMACOGENOMICS
17.13 BLOOD TRANSFUSION
17.14 OTHERS
18. GLOBAL IN VITRO DIAGNOSTIC (IVD) REGULATORY AFFAIRS OUTSOURCING MARKET, BY STAGE
18.1 OVERVIEW
18.2 PRECLINICAL
18.3 CLINICAL
18.4 PMA (POST MARKET AUTHORIZATION)
19. GLOBAL IN VITRO DIAGNOSTIC (IVD) REGULATORY AFFAIRS OUTSOURCING MARKET, BY CLASS
19.1 OVERVIEW
19.2 CLASS I
19.3 CLASS II
19.4 CLASS III
20. GLOBAL IN VITRO DIAGNOSTIC (IVD) REGULATORY AFFAIRS OUTSOURCING MARKET, BY TYPE
20.1 OVERVIEW
20.2 POINT-OF-CARE (POC) IVD PRODUCT
20.3 LABORATORY-DEVELOPED TESTS (LDTS) IVD PRODUCT
20.4 COMPANION DIAGNOSTICS IVD PRODUCT
20.5 DIRECT-TO-CONSUMER (DTC) TESTING IVD PRODUCT
20.6 OTHERS IVD PRODUCT
21. GLOBAL IN VITRO DIAGNOSTIC (IVD) REGULATORY AFFAIRS OUTSOURCING MARKET, BY DEPLOYMENT MODE
21.1 OVERVIEW
21.2 CLOUD
21.3 ON-PREMISES
22. GLOBAL IN VITRO DIAGNOSTIC (IVD) REGULATORY AFFAIRS OUTSOURCING MARKET, BY ORGANIZARION SIZE
22.1 OVERVIEW
22.2 SMALL & MEDIUM ENTERPRISES (SMES)
22.3 LARGE ENTERPRISES
23. GLOBAL IN VITRO DIAGNOSTIC (IVD) REGULATORY AFFAIRS OUTSOURCING MARKET, BY END USER
23.1 OVERVIEW
23.2 PHARMACEUTICAL COMPANIES
23.2.1 BY ORGANIZATION SIZE
23.2.1.1. SMALL & MEDIUM ENTERPRISES (SMES)
23.2.1.2. LARGE ENTERPRISES
23.2.2 BY SERVICE
23.2.2.1. REGULATORY WRITING & SUBMISSIONS
23.2.2.2. REGULATORY REGISTRATION & CLINICAL TRIAL APPLICATIONS
23.2.2.3. REGULATORY CONSULTING
23.2.2.4. LEGAL REPRESENTATION
23.2.2.5. DATA MANAGEMENT SERVICES
23.2.2.6. CHEMISTRY MANUFACTURING AND CONTROLS (CMC) SERVICES
23.2.2.7. OTHERS
23.3 MEDICAL DEVICE COMPANIES
23.3.1 BY ORGANIZATION SIZE
23.3.1.1. SMALL & MEDIUM ENTERPRISES (SMES)
23.3.1.2. LARGE ENTERPRISES
23.3.2 BY SERVICE
23.3.2.1. REGULATORY WRITING & SUBMISSIONS
23.3.2.2. REGULATORY REGISTRATION & CLINICAL TRIAL APPLICATIONS
23.3.2.3. REGULATORY CONSULTING
23.3.2.4. LEGAL REPRESENTATION
23.3.2.5. DATA MANAGEMENT SERVICES
23.3.2.6. CHEMISTRY MANUFACTURING AND CONTROLS (CMC) SERVICES
23.3.2.7. OTHERS
23.4 BIOTECHNOLOGY COMPANIES
23.4.1 BY ORGANIZATION SIZE
23.4.1.1. SMALL & MEDIUM ENTERPRISES (SMES)
23.4.1.2. LARGE ENTERPRISES
23.4.2 BY SERVICE
23.4.2.1. REGULATORY WRITING & SUBMISSIONS
23.4.2.2. REGULATORY REGISTRATION & CLINICAL TRIAL APPLICATIONS
23.4.2.3. REGULATORY CONSULTING
23.4.2.4. LEGAL REPRESENTATION
23.4.2.5. DATA MANAGEMENT SERVICES
23.4.2.6. CHEMISTRY MANUFACTURING AND CONTROLS (CMC) SERVICES
23.4.2.7. OTHERS
23.5 OTHERS
24. GLOBAL IN VITRO DIAGNOSTIC (IVD) REGULATORY AFFAIRS OUTSOURCING MARKET, BY REGION
24.1 GLOBAL IN VITRO DIAGNOSTIC (IVD) REGULATORY AFFAIRS OUTSOURCING MARKET, (ALL SEGMENTATION PROVIDED ABOVE IS REPRESENTED IN THIS CHAPTER BY COUNTRY)
24.1.1 NORTH AMERICA
24.1.1.1. U.S.
24.1.1.2. CANADA
24.1.1.3. MEXICO
24.1.2 EUROPE
24.1.2.1. GERMANY
24.1.2.2. FRANCE
24.1.2.3. U.K.
24.1.2.4. ITALY
24.1.2.5. SPAIN
24.1.2.6. RUSSIA
24.1.2.7. TURKEY
24.1.2.8. BELGIUM
24.1.2.9. NETHERLANDS
24.1.2.10. SWITZERLAND
24.1.2.11. REST OF EUROPE
24.1.3 ASIA-PACIFIC
24.1.3.1. JAPAN
24.1.3.2. CHINA
24.1.3.3. SOUTH KOREA
24.1.3.4. INDIA
24.1.3.5. AUSTRALIA
24.1.3.6. SINGAPORE
24.1.3.7. THAILAND
24.1.3.8. MALAYSIA
24.1.3.9. INDONESIA
24.1.3.10. PHILIPPINES
24.1.3.11. REST OF ASIA-PACIFIC
24.1.4 SOUTH AMERICA
24.1.4.1. BRAZIL
24.1.4.2. ARGENTINA
24.1.4.3. REST OF SOUTH AMERICA
24.1.5 MIDDLE EAST AND AFRICA
24.1.5.1. SOUTH AFRICA
24.1.5.2. EGYPT
24.1.5.3. ISRAEL
24.1.5.4. UAE
24.1.5.5. SAUDI ARABIA
24.1.5.6. REST OF MIDDLE EAST AND AFRICA
24.1.6 KEY PRIMARY INSIGHTS: BY MAJOR COUNTRIES
25. GLOBAL IN VITRO DIAGNOSTIC (IVD) REGULATORY AFFAIRS OUTSOURCING MARKET, COMPANY LANDSCAPE
25.1 COMPANY SHARE ANALYSIS: GLOBAL
25.2 COMPANY SHARE ANALYSIS: NORTH AMERICA
25.3 COMPANY SHARE ANALYSIS: EUROPE
25.4 COMPANY SHARE ANALYSIS: ASIA-PACIFIC
25.5 MERGERS & ACQUISITIONS
25.6 NEW PRODUCT DEVELOPMENT & APPROVALS
25.7 EXPANSIONS
25.8 REGULATORY CHANGES
25.9 PARTNERSHIP AND OTHER STRATEGIC DEVELOPMENTS
26. GLOBAL IN VITRO DIAGNOSTIC (IVD) REGULATORY AFFAIRS OUTSOURCING MARKET, COMPANY PROFILE
26.1 FREYR SOLUTIONS
26.1.1 COMPANY OVERVIEW
26.1.2 COMPANY SNAPSHOT
26.1.3 REVENUE ANALYSIS
26.1.4 PRODUCT PORTFOLIO
26.1.5 RECENT DEVELOPMENTS
26.2 AXSOURCE CONSULTING INC.
26.2.1 COMPANY OVERVIEW
26.2.2 COMPANY SNAPSHOT
26.2.3 REVENUE ANALYSIS
26.2.4 PRODUCT PORTFOLIO
26.2.5 RECENT DEVELOPMENTS
26.3 LORENZ LIFE SCIENCES GROUP
26.3.1 COMPANY OVERVIEW
26.3.2 COMPANY SNAPSHOT
26.3.3 REVENUE ANALYSIS
26.3.4 PRODUCT PORTFOLIO
26.3.5 RECENT DEVELOPMENTS
26.4 LABORATORY CORPORATION OF AMERICA HOLDINGS
26.4.1 COMPANY OVERVIEW
26.4.2 COMPANY SNAPSHOT
26.4.3 REVENUE ANALYSIS
26.4.4 PRODUCT PORTFOLIO
26.4.5 RECENT DEVELOPMENTS
26.5 REG IQ PTY LTD.
26.5.1 COMPANY OVERVIEW
26.5.2 COMPANY SNAPSHOT
26.5.3 REVENUE ANALYSIS
26.5.4 PRODUCT PORTFOLIO
26.5.5 RECENT DEVELOPMENTS
26.6 PROMEDICA INTERNATIONAL, A CALIFORNIA CORPORATION (IUVO BIOSCIENCES)
26.6.1 COMPANY OVERVIEW
26.6.2 COMPANY SNAPSHOT
26.6.3 REVENUE ANALYSIS
26.6.4 PRODUCT PORTFOLIO
26.6.5 RECENT DEVELOPMENTS
26.7 MAKROCARE
26.7.1 COMPANY OVERVIEW
26.7.2 COMPANY SNAPSHOT
26.7.3 REVENUE ANALYSIS
26.7.4 PRODUCT PORTFOLIO
26.7.5 RECENT DEVELOPMENTS
26.8 EMERGO BY UL
26.8.1 COMPANY OVERVIEW
26.8.2 COMPANY SNAPSHOT
26.8.3 REVENUE ANALYSIS
26.8.4 PRODUCT PORTFOLIO
26.8.5 RECENT DEVELOPMENTS
26.9 ICON PLC
26.9.1 COMPANY OVERVIEW
26.9.2 COMPANY SNAPSHOT
26.9.3 REVENUE ANALYSIS
26.9.4 PRODUCT PORTFOLIO
26.9.5 RECENT DEVELOPMENTS
26.10 WUXI APPTEC
26.10.1 COMPANY OVERVIEW
26.10.2 COMPANY SNAPSHOT
26.10.3 REVENUE ANALYSIS
26.10.4 PRODUCT PORTFOLIO
26.10.5 RECENT DEVELOPMENTS
26.11 THERMO FISHER SCIENTIFIC INC.
26.11.1 COMPANY OVERVIEW
26.11.2 COMPANY SNAPSHOT
26.11.3 REVENUE ANALYSIS
26.11.4 PRODUCT PORTFOLIO
26.11.5 RECENT DEVELOPMENTS
26.12 CHARLES RIVER LABORATORIES.
26.12.1 COMPANY OVERVIEW
26.12.2 COMPANY SNAPSHOT
26.12.3 REVENUE ANALYSIS
26.12.4 PRODUCT PORTFOLIO
26.12.5 RECENT DEVELOPMENTS
26.13 ACCELL CLINICAL RESEARCH, LLC
26.13.1 COMPANY OVERVIEW
26.13.2 COMPANY SNAPSHOT
26.13.3 REVENUE ANALYSIS
26.13.4 PRODUCT PORTFOLIO
26.13.5 RECENT DEVELOPMENTS
26.14 PAREXEL INTERNATIONAL (MA) CORPORATION
26.14.1 COMPANY OVERVIEW
26.14.2 COMPANY SNAPSHOT
26.14.3 REVENUE ANALYSIS
26.14.4 PRODUCT PORTFOLIO
26.14.5 RECENT DEVELOPMENTS
26.15 METECON GMBH
26.15.1 COMPANY OVERVIEW
26.15.2 COMPANY SNAPSHOT
26.15.3 REVENUE ANALYSIS
26.15.4 PRODUCT PORTFOLIO
26.15.5 RECENT DEVELOPMENTS
26.16 GENPACT
26.16.1 COMPANY OVERVIEW
26.16.2 COMPANY SNAPSHOT
26.16.3 REVENUE ANALYSIS
26.16.4 PRODUCT PORTFOLIO
26.16.5 RECENT DEVELOPMENTS
26.17 CRITERIUM, INC
26.17.1 COMPANY OVERVIEW
26.17.2 COMPANY SNAPSHOT
26.17.3 REVENUE ANALYSIS
26.17.4 PRODUCT PORTFOLIO
26.17.5 RECENT DEVELOPMENTS
26.18 MEDPACE
26.18.1 COMPANY OVERVIEW
26.18.2 COMPANY SNAPSHOT
26.18.3 REVENUE ANALYSIS
26.18.4 PRODUCT PORTFOLIO
26.18.5 RECENT DEVELOPMENTS
26.19 GROUPE PRODUCTLIFE S.A.
26.19.1 COMPANY OVERVIEW
26.19.2 COMPANY SNAPSHOT
26.19.3 REVENUE ANALYSIS
26.19.4 PRODUCT PORTFOLIO
26.19.5 RECENT DEVELOPMENTS
26.20 DOR PHARMACEUTICAL SERVICES
26.20.1 COMPANY OVERVIEW
26.20.2 COMPANY SNAPSHOT
26.20.3 REVENUE ANALYSIS
26.20.4 PRODUCT PORTFOLIO
26.20.5 RECENT DEVELOPMENTS
26.21 QSERVE
26.21.1 COMPANY OVERVIEW
26.21.2 COMPANY SNAPSHOT
26.21.3 REVENUE ANALYSIS
26.21.4 PRODUCT PORTFOLIO
26.21.5 RECENT DEVELOPMENTS
26.22 ORTHO CLINICAL DIAGNOSTICS.
26.22.1 COMPANY OVERVIEW
26.22.2 COMPANY SNAPSHOT
26.22.3 REVENUE ANALYSIS
26.22.4 PRODUCT PORTFOLIO
26.22.5 RECENT DEVELOPMENTS
26.23 ANGSTROM BIOTECH PVT. LTD.
26.23.1 COMPANY OVERVIEW
26.23.2 COMPANY SNAPSHOT
26.23.3 REVENUE ANALYSIS
26.23.4 PRODUCT PORTFOLIO
26.23.5 RECENT DEVELOPMENTS
26.24 RQM+
26.24.1 COMPANY OVERVIEW
26.24.2 COMPANY SNAPSHOT
26.24.3 REVENUE ANALYSIS
26.24.4 PRODUCT PORTFOLIO
26.24.5 RECENT DEVELOPMENTS
26.25 REGULATORY COMPLIANCES ASSOCIATES (SOTERA HEALTH)
26.25.1 COMPANY OVERVIEW
26.25.2 COMPANY SNAPSHOT
26.25.3 REVENUE ANALYSIS
26.25.4 PRODUCT PORTFOLIO
26.25.5 RECENT DEVELOPMENTS
26.26 RESEARCHDX
26.26.1 COMPANY OVERVIEW
26.26.2 COMPANY SNAPSHOT
26.26.3 REVENUE ANALYSIS
26.26.4 PRODUCT PORTFOLIO
26.26.5 RECENT DEVELOPMENTS
26.27 CMIC HOLDINGS CO., LTD.
26.27.1 COMPANY OVERVIEW
26.27.2 COMPANY SNAPSHOT
26.27.3 REVENUE ANALYSIS
26.27.4 PRODUCT PORTFOLIO
26.27.5 RECENT DEVELOPMENTS
26.28 NORTH AMERICAN SCIENCE ASSOCIATES, LLC
26.28.1 COMPANY OVERVIEW
26.28.2 COMPANY SNAPSHOT
26.28.3 REVENUE ANALYSIS
26.28.4 PRODUCT PORTFOLIO
26.28.5 RECENT DEVELOPMENTS
26.29 QARAD BV
26.29.1 COMPANY OVERVIEW
26.29.2 COMPANY SNAPSHOT
26.29.3 REVENUE ANALYSIS
26.29.4 PRODUCT PORTFOLIO
26.29.5 RECENT DEVELOPMENTS
26.30 TRANSCRIP
26.30.1 COMPANY OVERVIEW
26.30.2 COMPANY SNAPSHOT
26.30.3 REVENUE ANALYSIS
26.30.4 PRODUCT PORTFOLIO
26.30.5 RECENT DEVELOPMENTS
26.31 CLIN-R+
26.31.1 COMPANY OVERVIEW
26.31.2 COMPANY SNAPSHOT
26.31.3 REVENUE ANALYSIS
26.31.4 PRODUCT PORTFOLIO
26.31.5 RECENT DEVELOPMENTS
26.32 VCLS
26.32.1 COMPANY OVERVIEW
26.32.2 COMPANY SNAPSHOT
26.32.3 REVENUE ANALYSIS
26.32.4 PRODUCT PORTFOLIO
26.32.5 RECENT DEVELOPMENTS
26.33 PROPHARMA GROUP
26.33.1 COMPANY OVERVIEW
26.33.2 COMPANY SNAPSHOT
26.33.3 REVENUE ANALYSIS
26.33.4 PRODUCT PORTFOLIO
26.33.5 RECENT DEVELOPMENTS
26.34 ARRIELLO IRELAND LIMITED
26.34.1 COMPANY OVERVIEW
26.34.2 COMPANY SNAPSHOT
26.34.3 REVENUE ANALYSIS
26.34.4 PRODUCT PORTFOLIO
26.34.5 RECENT DEVELOPMENTS
NOTE: THE COMPANIES PROFILED IS NOT EXHAUSTIVE LIST AND IS AS PER OUR PREVIOUS CLIENT REQUIREMENT. WE PROFILE MORE THAN 100 COMPANIES IN OUR STUDY AND HENCE THE LIST OF COMPANIES CAN BE MODIFIED OR REPLACED ON REQUEST
27. RELATED REPORTS
28. QUESTIONNAIRE
29. ABOUT DATA BRIDGE MARKET RESEARCH
