e-Clinical Trial Technologies: Market Research Report

December 2018 | 321 pages | ID: E2064155CB1EN
Global Industry Analysts, Inc

Abstracts

This report analyzes the worldwide markets for e-Clinical Trial Technologies in US$ Million. The Global market for e-Clinical Trial Technologies in this report is analyzed by the following Segments: Electronic Data Capture (EDC) Solutions, Clinical Trial Management System (CTMS), Electronic Patient Reported Outcome (ePRO), and Randomization and Trial Supply Management (RTSM). The Global Electronic Data Capture (EDC) Market in this report is analyzed by the following Clinical Trial Phase: Phase I, Phase II, Phase III, and Phase IV. The Global Clinical Trial Management System (CTMS) Market in this report is analyzed by the following Product Type: Web-based CTMS, Cloud-based CTMS, and On-Premise CTMS. The report provides separate comprehensive analytics for the US, Canada, Europe, Asia-Pacific, and Rest of World.

Annual estimates and forecasts are provided for the period 2016 through 2024.

Also, a five-year historic analysis is provided for these markets.

Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs.

The report profiles 84 companies including many key and niche players such as -

• Almac Group
• ArisGlobal LLC
• BioClinica
• Clinipace Worldwide
• Cmed Technology Ltd.
• DATATRAK International, Inc.

Contents

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations
Disclaimers
Data Interpretation & Reporting Level
Quantitative Techniques & Analytics
Product Definitions and Scope of Study
Product Segment Definitions
Electronic Data Capture (EDC) Solutions
Clinical Trial Management System (CTMS)
Electronic Patient Reported Outcome (ePRO)
Randomization and Trial Supply Management (RTSM)

II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW

A Prelude

Table 1. Increase in R&D Costs of a New Approved Drug: 1980s to 2010s

Cost-Containment: An Important Factor Increasing the Uptake of e-Clinical Trial Technologies

Table 2. Number of Companies with Active Pipelines: 2010 to 2017 (includes corresponding Graph/Chart)

Table 3. Top Ten Pharma Companies based on Number of Drugs in Pipeline: 2017 (includes corresponding Graph/Chart)

Global Market Overview
Increasing Investments in Clinical Research Drive the Global e-Clinical solutions Market

Table 4. Global Pharmaceutical R&D Spending (US$ Billion) for the Years 2010 through 2017 (includes corresponding Graph/Chart)

Clinical Trials Adopt Technologies for Various Phases
e-Clinical Trial Technologies Market by Delivery Mode
Major Players
Market Gravitates from Developed Countries to Developing Countries

Table 5. Distribution of Clinical Trials by Location: As of January 09, 2018 (includes corresponding Graph/Chart)

Table 6. Cost of Patient Visits in Select Countries (2016): A Comparison (includes corresponding Graph/Chart)

Table 7. Cost Per Patient Per Visit in Select Countries: 2016 (includes corresponding Graph/Chart)

Outsourcing of Clinical Studies to Developing Countries Benefits Market
Globalization Boosts e-Clinical Trials Market

Table 8. Total Number of Registered Clinical Studies: 2010-2017 (As of December 11, 2017) (includes corresponding Graph/Chart)

Table 9. Total Number of Registered Clinical Trials with Results posted Worldwide: 2010-2017 (As of December 11, 2017) (includes corresponding Graph/Chart)

Table 10. Total Number of Studies based on Region: 2017 (As of December 11, 2017) (includes corresponding Graph/Chart)

Key Challenges for e-Clinical Trials
Role of Contract Research Organizations (CROs) in Clinical Activity
Major CROs with Internally Developed CTMS Systems
CRO Acquisitions: Clinical Trial Technologies

2. SEGMENT ANALYSIS

Electronic Data Capture (EDC)
EDC Segment Witnesses Rapid Growth

Table 11. Increasing Clinical Trial Failure Rate: 1990 and 2010 (includes corresponding Graph/Chart)

Table 12. Estimated Share of Electronic Data Capture Usage for New Drug Trials (includes corresponding Graph/Chart)

EDC Platforms Utilized by Select CROs
Competition
Medidata Solutions Inc. – A Leading EDC Provider
Select Customers of Medidata's Rave
Select Customers of Oracle’s EDC
Factors influencing EDC Selection
Vendors Track Record
Regulatory Compliance
Data Security Standards
Trend towards Third-Party EDC Systems Gains Momentum
EDCs Boost Use of Clinical Trials
EDC for Monitoring Patient Logistics
EDC and Direct Monitoring of Patients
EDC for Managing Medical Records
Clinical Trial Management Systems (CTMS) Market
Tangible Cost-Savings Bolster Rapid Uptake of CTMS Solutions
Web-based Systems Dominate, Cloud-Based to Witness Fastest Growth
Increased Demand for Cloud-based and Other Advanced CTMS
Key Players in the CTMS Market
Select Major Clinical Trial Management Systems (CTMS) Providers Worldwide
Impact of CTMS and other Services on Pharma Industry
Electronic Patient Record Outcome (ePRO)
Electronic Patient Record (ePRO) Solutions Replace Paper–Based PRO systems
Select ePRO Vendors
Major Technology Trends Expected to Revolutionize the ePro Market
Big Data
Wearable Health Trackers Becoming Mainstream
BYOD Strategy
Growing Usage of Tablets and Mobile
Real-time Feedback and Insights
Adopting Cloud and Multi-tenant SaaS
Consumerization of User Experience
ePatient-Reported Outcomes (PROs) Gain Importance in Oncology Studies
Randomization and Trial Supply Management (RTSM)
Preference Grows for Customized/Configured RTSM
Interactive Voice Response System (IVRS)
Multifarious Operational Benefits Drive IVRS Adoption
Globalization of Clinical Trials Throws Up Challenges for IVR/IWR System Developers

3. KEY GROWTH DRIVERS AND MARKET TRENDS

Surging Global Population Offers Increased Growth Opportunities

Table 13. Top 25 Countries Worldwide in Terms of Population: 2015 & 2016 (In Million) (includes corresponding Graph/Chart)

Pharmaceutical Firms and CROs to Drive Adoption Rate
Rise in Clinical Trial Complexities Propels e-Clinical Trial Technologies Demand

Table 14. Increasing Complexity of a Typical Phase 3 Clinical Trial: 2002 Vs.2 012

CROs – The Targeted Customers for e-Clinical Trial Technologies

Table 15. Leading CROs Worldwide by Revenue: 2016 (includes corresponding Graph/Chart)

Outsourcing of R&D Projects to Propel CRO Market, Driving Demand

Table 16. Global Biopharma % R&D Outsourcing (2014-2020) (includes corresponding Graph/Chart)

Noteworthy Contracts of Major CROs
CROs Adept with New Technologies to See More Business in Future
Increased Importance of e-Clinical Integration
Big Data and Patient Centricity: Areas to Increase Focus Upon

Table 17. Percentage of Companies Utilizing Advanced Technologies in Clinical Trials (includes corresponding Graph/Chart)

Table 18. Utilization of Advanced Technologies in Clinical Trials across North America and Europe (includes corresponding Graph/Chart)

Esource Documentation Witnesses Increased Traction
Increased Adoption of electronic Trial Master File (eTMFs)
Risk-Based Monitoring Witnesses New Modifications
Growing Implementation of e-Consent
Increased Investments in Virtual Clinical Trials
Open Source – Emerging Solutions in Clinical Trials Domain
Select Open Source Technologies for Clinical Trials by Application Area
Benefits over Proprietary Technologies to Encourage Adoption
EDC- The Most Attractive Application for Open Source
Conversion to CDISC – An Emerging Application for Open Source Solutions
Mobile Technologies to Help Trial Operators in Tackling Challenges

Table 19. Smartphone Penetration as a Proportion (%) of Total Mobile Users in Select Countries (2017) (includes corresponding Graph/Chart)

Table 20. World Smartphones Market by Region/ Country (2016): Percentage Breakdown of Annual Unit Shipments for US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Middle East & Africa (includes corresponding Graph/Chart)

Table 21. 4G Network Availability (In %) in Select Countries (2016) (includes corresponding Graph/Chart)

Table 22. Average 4G Network Speeds (in Mbps) in Select Countries (2016) (includes corresponding Graph/Chart)

Smartphones & Tablets: The New Age ePRO Devices

4. PRODUCT PROFILE

Defining e-Clinical Trials
e-Clinical Solutions Enhance Clinical Trial Efficiency
Key Advantages offered by Integrated e-Clinical Solutions include:
Effective Deployment of an e-Clinical Solution
Enterprise-Level Benefits
Benefits Offered by e-Clinical Trials
Transparency
Dynamic Program Management
Effective Trial Drug Supply
Effective Study Randomization
Enhanced Collaboration
Dynamic Site Management
Less Frequent Investigational Site Visits
Faster Go No-Go Decisions
Better Planning
Regulatory Compliance
CDISC Standards
Clinical Trials – In a Nutshell
Summarization of Clinical Trial Phases & Time Line for Drug Development
Systems Used in e-Clinical Trials
Electronic Data Capture Solutions (EDC)
Benefits of EDC
EDC and Paper CRFs – A Comparison
Recent Advancements in EDC
Clinical Trial Management System (CTMS)
CDMS to CTMS: The Evolutionary Move to eDevelopment
CROs - The Targeted Customers for CTMS
Clinical Trial Image Management System (CTMS)
Electronic Patient Reported Outcome (ePRO)
Electronic Diaries
Randomization and Trial Supply Management (RTSM)
Interactive Voice Response Systems (IVRS)
Technologies Used in IVR
Interactive Web Response Systems (IWRS)

5. PRODUCT/SERVICE INTRODUCTIONS

ArisGlobal Introduces LifeSphere Clinical
Oracle Health Sciences Unveils Oracle Clinical One
MedNet Solutions Introduces iMedNet
Prelude Dynamics Introduces Two Solutions
PAREXEL Unveils Patient Sensor Solution
Prelude Dynamics Introduces VISION
Veeva Systems Unveils Veeva Vault EDC and eSource
Bioclinica Introduces Safety and Regulatory Software Products
DZS Clinical Services Unveils ClinPlus 3.1 e-Clinical Software
Bioclinica Introduces OnPoint Direct
Bioclinica Demonstrates EDC System from EHR to CDASH CRFs
BioClinica Introduces e-Clinical CRO Partner Alliance Program
DATATRAK Introduces UX CTMS

6. RECENT INDUSTRY ACTIVITY

Novum Selects OmniComm’s TrialMaster EDC
OmniComm Inks Contract with Beijing Hospital of the Ministry of Health
Montrium Partners with MAPS
MedNet Solutions Partners with arivis
OmniComm Systems Secures EU-U. S. Privacy Shield Certification
SRD Selects OmniComm’s TrialMaster EDC Technology
AB Cube Joins Health App xChange
Anju Software Acquires ClinPlus
DATATRAK Partners with Sisense
Orbita Collaborates with ERT
MedNet Solutions Obtains Privacy Shield Certification
Medidata Acquires Mytrus
Medidata Partners with Karyopharm
OmniComm Collaborates with Bio-Optronics
OmniComm Systems Signs Agreement with MediStat
OmniComm Signs Landmark Contracts with Major Clinical Research Organizations
Almac Group Collaborates with Exostar
ERT Takes Over Exco InTouch
Almac Group Partners with inVentiv Health
OmniComm Provides EDC Services to a Major Research Hospital
Bracket Acquires CLINapps
e-ClinicalHealth Collaborates with Clinerion
Orbus Therapeutics Selects DSG to Provide Fully Supported eCaseLink EDC System
Cinven Acquires Bioclinica
Top 15 Pharma Company Selects TrialOne to Automate its Entire Phase I/BA & BE Clinic
Parallel 6 Joins Bioclinic’s eHealth App xChange
Pfizer Selects Oracle’s Clinical Trial Technologies
IMS Health Merges with Quintiles
OmniComm System Inks five-year, Multi-Million Dollar Agreement with CROMSOURCE
OmniComm Inks Agreement with Canadian Pharmaceutical Drug Developer
Bioclinica Provides RBM Solution for Clinical Trials
Bioclinica Takes Over Clinverse
Parallel 6 Acquires nPruv
Clinlogix Partners with MedNet Solutions
OmniComm Inks five year, Multi-Million Dollar Agreement with Major CRO
Global Biopharmaceutical Selects TrialMaster EDC for CNS Drug Trials
Integrium Inks Licensing Agreement for DSG’s eCaseLink Solutions & Services
BioClinica Partners with Kinapse
ERT Acquires Boston-based PHT Corporation
Clinical Ink Mergers with CentrosHealth
PRA Health Sciences Acquires Value Health Solutions
OmniComm Systems Buys IRT Technology From Clinquest

7. FOCUS ON SELECT PLAYERS

Almac Group (UK)
ArisGlobal LLC (USA)
BioClinica (USA)
Clinipace Worldwide (USA)
Cmed Technology Ltd (UK)
DATATRAK International, Inc. (USA)
DSG Inc. (USA)
DZS Software Solutions, Inc. (USA)
eResearch Technology, Inc. (USA)
IBM Watson Health (USA)
Medidata Solutions, Inc. (USA)
MedNet Solutions (USA)
Nextrials Inc. (USA)
OmniComm Systems, Inc. (USA)
Oracle Corp. (USA)
PAREXEL International Corp. (USA)
PAREXEL Informatics Inc (USA)
Prelude Dynamics LLC (USA)
SAS Institute Inc. (USA)
Target Health Inc. (USA)

8. GLOBAL MARKET PERSPECTIVE

Table 23. World Recent Past, Current & Future Analysis for e-Clinical Trial Technologies by Geographic Region - US, Canada, Europe, Asia-Pacific (Including Japan), and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 24. World Historic Review for e-Clinical Trial Technologies by Geographic Region - US, Canada, Europe, Asia-Pacific (Including Japan), and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 25. World 14-Year Perspective for e-Clinical Trial Technologies by Geographic Region - Percentage Breakdown of Dollar Revenues for US, Canada, Europe, Asia-Pacific (Including Japan), and Rest of World Markets for Years 2011, 2017 & 2024 (includes corresponding Graph/Chart)

Table 26. World Recent Past, Current & Future Analysis for e-Clinical Trial Technologies by Application - EDC, CTMS, ePROs, and RTSM Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 27. World Historic Review for e-Clinical Trial Technologies by Application - EDC, CTMS, ePROs, and RTSM Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 28. World 14-Year Perspective for e-Clinical Trial Technologies by Application - Percentage Breakdown of Dollar Revenues for EDC, CTMS, ePROs, and RTSM Markets for Years 2011, 2017 & 2024 (includes corresponding Graph/Chart)

Table 29. World Recent Past, Current & Future Analysis for Electronic Data Capture (EDC) by Clinical Trial Phase - Phase I, II, III, and IV Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 30. World Historic Review for Electronic Data Capture (EDC) by Clinical Trial Phase - Phase I, II, III, and IV Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 31. World 14-Year Perspective for Electronic Data Capture (EDC) by Clinical Trial Phase - Percentage Breakdown of Dollar Revenues for Phase I, II, III, and IV Markets for Years 2011, 2017 & 2024 (includes corresponding Graph/Chart)

Table 32. World Recent Past, Current & Future Analysis for Clinical Trial Management Systems (CTMS) by Delivery Mode - Web-based CTMS, Cloud-based CTMS and On-Premise CTMS Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 33. World Historic Review for Clinical Trial Management Systems (CTMS) by Delivery Mode - Web-based CTMS, Cloud-based CTMS and On-Premise CTMS Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 34. World 14-Year Perspective for Clinical Trial Management Systems (CTMS) by Delivery Mode - Percentage Breakdown of Dollar Revenues for Web-based CTMS, Cloud-based CTMS and On-Premise CTMS Markets for Years 2011, 2017 & 2024 (includes corresponding Graph/Chart)

Table 35. World Recent Past, Current & Future Analysis for Electronic Patient Reported Outcomes (ePRO) Market Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 36. World Historic Review for Electronic Patient Reported Outcomes (ePRO) Market Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

Table 37. World Recent Past, Current & Future Analysis for Randomization and Trial Supply Management (RTSM) Market Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 38. World Historic Review for Randomization and Trial Supply Management (RTSM) Market Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

III. MARKET

1. THE UNITED STATES

A. Market Analysis
United States: The Largest Market for e-Clinical Trial Technologies Worldwide

Table 39. The US Life Science R&D Spending (In US$ Billion): 2014- 2016 (includes corresponding Graph/Chart)

Table 40. Increased Funding for Clinical Trials and Supportive Activities in the US: 2013 to 2018 (includes corresponding Graph/Chart)

The US Leads the Pharma R&D Companies

Table 41. R&D Companies Distribution by Region: 2017 (includes corresponding Graph/Chart)

Drug Developers Rely on CROs to Improve Trial Efficiency and Cost Savings
Growing Demand from CROs Drives the CTMS Market
Increasing Adoption of Adaptive Clinical Trials
Risk-based Monitoring Catches Pace
Paradigm Shift in Oncology Clinical Trial
New FDA Standards
FDA Binding Guidance Comes into Effect
Product/Service Introductions
Strategic Corporate Developments
Select Key Players
B. Market Analytics

Table 42. The US Recent Past, Current & Future Analysis for e-Clinical Trial Technologies Market Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 43. The US Historic Review for e-Clinical Trial Technologies Market Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

2. CANADA

A. Market Analysis
Current & Future Analysis
Strategic Corporate Development
B. Market Analytics

Table 44. Canadian Recent Past, Current & Future Analysis for e-Clinical Trial Technologies Market Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 45. Canadian Historic Review for e-Clinical Trial Technologies Market Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

3. EUROPE

A. Market Analysis
Current & Future Analysis
Clinical Trial Regulation to Strengthen EU’s Position in Clinical Research
EMA Focuses on Enhancing Patient Safety in First-In-Human Clinical Trials
Brexit Referendum to Threaten UK’s Position as Leading Hub for Clinical Trials
Strategic Corporate Development
Select Key Players
B. Market Analytics

Table 46. European Recent Past, Current & Future Analysis for e-Clinical Trial Technologies Market Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 47. European Historic Review for e-Clinical Trial Technologies Market Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

4. ASIA-PACIFIC

A. Market Analysis
Asia-Pacific: The Fastest Growing Region for e-Clinical Trial Technologies

Table 48. Total Number of Clinical Studies Conducted in Asia: 2017 (includes corresponding Graph/Chart)

R&D Outsourcing in Life Sciences on the Rise
An Overview of Key Markets
Japan
China
China Rapidly Emerges as a Compelling Destination for Clinical Trials
India
A Thriving Clinical Trials Market
Reasons for Outsourcing to India
Approval Process in India
Regulatory Issues
Improper Functioning of CROs
Clinical Study Liabilities
Access to Treatment Following Clinical Trial
Legislation to Monitor Drug Trials
Australia
Australia to Retain Position as Compelling Hub for Early-Phase Clinical Research
Initiatives Taken by Australian Government for Popularizing Clinical Trials
Strategic Corporate Developments
B. Market Analytics

Table 49. Asia-Pacific (including Japan) Recent Past, Current & Future Analysis for e-Clinical Trial Technologies Market Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 50. Asia-Pacific (including Japan) Historic Review for e-Clinical Trial Technologies Market Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

5. REST OF WORLD

A. Market Analysis
Current & Future Analysis
Latin America
Strategic Corporate Development
B. Market Analytics

Table 51. Rest of World Recent Past, Current & Future Analysis for e-Clinical Trial Technologies Market Analyzed with Annual Revenue Figures in US$ Million for Years 2016 through 2024 (includes corresponding Graph/Chart)

Table 52. Rest of World Historic Review for e-Clinical Trial Technologies Market Analyzed with Annual Revenue Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 84 (including Divisions/Subsidiaries - 87)
The United States (57)
Canada (3)
Japan (1)
Europe (22)
  France (2)
  Germany (3)
  The United Kingdom (9)
  Italy (1)
  Rest of Europe (7)
Asia-Pacific (Excluding Japan) (4)