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Clinical trial is a medical research study performed on humans to check the safety and efficacy of drugs, devices and therapeutic products before they are finally launched in the market. Proper management of clinical trials has become a priority for hospitals, pharmaceutical companies and clinical research organizations (CRO).Clinical trial management system (CTMS) is a software solution for proper management, storage and analysis of drugs associated clinical data. CTMS is primarily employed to manage the large amount of data involved in a clinical trial including planning, preparation and reporting. CTMS also provides data to a business intelligence system. It provides a user-friendly infrastructure that enables clinicians to manage trials of varying complexity.

North America is a traditional clinical trial region. The percentage share of global clinical trials conducted in North America has reduced. This was due to regulatory and legal considerations, which shifted the clinical trial market from North America to developing countries such as India and China. Countries in Central and Eastern Europe provide abundant opportunities to life science companies for clinical development. Similarly, improved industry regulatory laws and patent expiration laws in various countries including Japan, China and India, have led to the expansion of the clinical trials market in Asia, which has lower cost of conducting clinical trials compared to Europe or the U.S.

Increasing R&D investment in pharmaceuticals, life science and clinical research industries, rising prevalence of diseases and increased clinical research outsourcing are key growth drivers for the CTMS market. In addition, integration of CTMS with a Hospital Information System (HIS) provides more accurate and time saving documentation over paper based information systems. On the other hand, long approval time for clinical trials and difficulties related to recruiting and enrolling patients for clinical trials are some of the major concerns for the industry. Approval from Institutional Review Board (IRB), contract and budget negotiation and approval, availability of appropriate patient population and protocol design and legal review are major factors that delay a drug approval process. Similarly, increasing regulatory requirements in many countries has resulted in increased complexity for clinical trial protocols.

This report provides an in-depth analysis of estimation of the CTMS market for the period 2013-2019, considering 2013 as the base year for calculation. In addition, data pertaining to current market dynamics including market drivers, restraints, trends and recent developments has been provided in the report. The CTMS market is categorized on the basis of type of CTMS, end users, components, mode of delivery and geography. Based on mode of delivery, the CTMS market comprises on-premise CTMS, Web based CTMS and cloud based CTMS. The end user market comprises pharmaceuticals, clinical research organizations and healthcare providers.

In the geographical analysis, the report identifies and analyses market size and forecast of North America, Europe, Asia and Rest of the World (RoW). North America is further segmented into the U.S. and rest of North America. Similarly, Europe is further segmented into Germany, France and Poland. Asia is further segmented into South Korea and China. Some of the major players in the CTMS market are Oracle Corporation, Bio-Optronics, MedNet Solutions, PAREXEL International Corporation, Medidata Solutions and BioClinica. These key market players have been profiled on the basis of attributes such as company overview, recent developments, growth strategies, sustainability and financial overview.

Table Of Contents

Global Market Study on Clinical Trial Management System: Asia to Witness Highest Growth by 2019
Chapter 1 Preface 12

1.1 Report Description 12

1.2 Research Methodology 13

1.3 Assumptions 13

Chapter 2 Market Synopsis 14

Chapter 3 Porter Five Forces Analysis 16

3.1 Bargaining power of suppliers 16

3.2 Bargaining power of buyers 16

3.3 Threat of new entrants 17

3.4 Threat of substitutes 17

3.5 Intensity of rivalry 17

Chapter 4 Industry Overview 18

4.1 Market Definition 18

4.2 Market Drivers 20

4.2.1 Increasing research and development (RandD) investment in the pharmaceutical industry 20

4.2.2 Increasing prevalence of disease is supporting importance of clinical trials in different regions of the world 22

4.2.3 Assimilation of clinical trial management systems with Hospital Information System (HIS) 22

4.2.4 Increased clinical research outsourcing and implementation of clinical trials by contract research organizations 23

4.3 Impact Analysis of Market Drivers 24

4.4 Market Restraints 24

4.4.1 Longer approval time for clinical trials 24

4.4.2 Strict regulations to enrol patients for clinical trials 25

4.5 Impact Analysis of Market Restraints 26

4.6 Market Trends 26

4.6.1 Rising number of collaborations and partnerships 26

4.6.2 Increasing number of mergers and acquisitions 27

Chapter 5 Global Market Size and Forecast 29

Chapter 6 Market Size and Forecast by Mode of Delivery 31

6.1 Cloud based clinical trial management system 31

6.2 Web based clinical trial management system 32

6.3 On-premise clinical trial management system 32

Chapter 7 Market Size and Forecast by End User 34

7.1 Pharmaceuticals 34

7.2 Clinical Research Organizations (CROs) 34

7.3 Healthcare Providers 35

Chapter 8 Market Size and Forecast by Type 37

8.1 Enterprise based clinical trial management system 37

8.2 Site based clinical trial management system 37

Chapter 9 Market Size and Forecast by Components 39

9.1 Software 39

9.2 Hardware 40

9.3 Services 40


Chapter 10 Market Size and Forecast by Geography 42

10.1 North America 42

10.1.1 The U.S. 49

10.2 Europe 53

10.2.1 Germany 61

10.2.2 France 65

10.2.3 Poland 68

10.3 Asia 71

10.3.1 South Korea 79

10.3.2 China 82

10.4 Rest of the World 86

Chapter 11 Competitive Scenario 87

11.1 Competitive Benchmarking 87

Chapter 12 Company Profiles 89

12.1 Oracle Corporation 89

12.1.1 Company Overview 89

12.1.2 Products and Services 90

12.1.3 Financial Performance 90

12.1.4 Recent Developments 91

12.2 Merge Healthcare Incorporated 92

12.2.1 Company Overview 92

12.2.2 Products and Services 93

12.2.3 Financial Performance 93

12.2.4 Recent Developments 94

12.3 Medidata Solutions Inc. 95

12.3.1 Company Overview 95

12.3.2 Products and Services 95

12.3.3 Financial Performance 96

12.3.4 Recent Developments 96

12.4 PAREXEL International Corporation 98

12.4.1 Company Overview 98

12.4.2 Products and Services 98

12.4.3 Financial Performance 98

12.4.4 Recent Developments 99

12.5 BioClinica 100

12.5.1 Company Overview 100

12.5.2 Products and Services 100

12.5.3 Financial Performance 100

12.5.4 Recent Developments 101

12.6 MedNet Solutions, Inc. 103

12.6.1 Company Overview 103

12.6.2 Products and Services 103

12.6.3 Financial Performance 103

12.6.4 Recent Developments 103

12.7 Bio-Optronics, Inc. 105

12.7.1 Company Overview 105

12.7.2 Products and Services 105

12.7.3 Financial Performance 105

12.7.4 Recent Developments 105

12.8 DSG, Inc. 107

12.8.1 Company Overview 107

12.8.2 Products and Services 107

12.8.3 Financial Performance 107

12.8.4 Recent Developments 107

12.9 eClinForce, Inc. 108

12.9.1 Company Overview 108

12.9.2 Products and Services 108

12.9.3 Financial Performance 108

12.9.4 Recent Developments 108

12.10 Forte Research Systems, Inc. 109

12.10.1 Company Overview 109

12.10.2 Products and Services 109

12.10.3 Financial Performance 109

12.10.4 Recent Developments 109

List of Tables

TABLE 1 Market Snapshot: CTMS market (2013 and 2019) 14

TABLE 2 RandD investment in pharmaceutical industry, by country (USD million) in 2010 and 2011 21

TABLE 3 Globally rising prevalence of diabetics, by number of cases (million, 2010 and 2030) 22

TABLE 4 Drivers for CTMS market: Impact analysis 24

TABLE 5 Estimated average timelines for clinical trial approval in various countries 25

TABLE 6 Restraints for CTMS market: Impact analysis 26

TABLE 7 Major collaborations and partnerships by CTMS companies (2011- February 2014) 27

TABLE 8 Some of the major mergers and acquisitions in CTMS market (2011-Februrary 2014) 28

TABLE 9 Global clinical trial management system market size, by region 2009-2012 (USD million) 29

TABLE 10 Global clinical trial management system market size, by region 2013-2019 (USD million) 30

TABLE 11 Global clinical trial management system market size, by mode of delivery 2009-2012 (USD million) 32

TABLE 12 Global clinical trial management system market size, by mode of delivery 2013-2019 (USD million) 33

TABLE 13 Global clinical trial management system market size, by end user 2009-2012 (USD million) 35

TABLE 14 Global clinical trial management system market size, by end user 2013-2019 (USD million) 36

TABLE 15 Global clinical trial management system market size, by type 2009-2012 (USD million) 38

TABLE 16 Global clinical trial management system market size, by type 2013-2019 (USD million) 38

TABLE 17 Global clinical trial management system market size, by component 2009-2012 (USD million) 40

TABLE 18 Global clinical trial management system market size, by component 2013-2019 (USD million) 41

TABLE 19 The North American clinical trial management market size, by segment 2009-2012 (USD million) 43

TABLE 20 The North American clinical trial management market size, by segment 2013-2019 (USD million) 43

TABLE 21 The North American clinical trial management system market size, by mode of delivery 2009-2012 (USD million) 44

TABLE 22 The North American clinical trial management system market size, by mode of delivery 2013-2019 (USD million) 45

TABLE 23 The North American clinical trial management system market size, by end user 2009-2012 (USD million) 46

TABLE 24 The North American clinical trial management system market size, by end user 2013-2019 (USD million) 46

TABLE 25 The North American clinical trial management system market size, by type 2009-2012 (USD million) 47

TABLE 26 The North American clinical trial management system market size, by type 2013-2019 (USD million) 48

TABLE 27 The North American clinical trial management system market size, by component 2009-2012 (USD million) 49

TABLE 28 The North American clinical trial management system market size, by component 2013-2019 (USD million) 49

TABLE 29 The U.S. clinical trial management system market size, by mode of delivery 2009-2012 (USD million) 50

TABLE 30 The U.S. clinical trial management system market size, by mode of delivery 2013-2019 (USD million) 51

TABLE 31 The U.S. clinical trial management system market size, by end user 2009-2012 (USD million) 52

TABLE 32 The U.S. clinical trial management system market size, by end user 2013-2019 (USD million) 52

TABLE 33 The European clinical trial management market size, by segment 2009-2012 (USD million) 54

TABLE 34 The European clinical trial management market size, by segment 2013-2019 (USD million) 55

TABLE 35 The European clinical trial management system market size, by mode of delivery 2009-2012 (USD million) 56

TABLE 36 The European clinical trial management system market size, by mode of delivery 2013-2019 (USD million) 57

TABLE 37 The European clinical trial management system market size, by end user 2009-2012 (USD million) 58

TABLE 38 The European clinical trial management system market size, by end user 2013-2019 (USD million) 58

TABLE 39 The European clinical trial management system market size, by type 2009-2012 (USD million) 59

TABLE 40 The European clinical trial management system market size, by type 2013-2019 (USD million) 60

TABLE 41 The European clinical trial management system market size, by component 2009-2012 (USD million) 61

TABLE 42 The European clinical trial management system market size, by component 2013-2019 (USD million) 61

TABLE 43 The German clinical trial management system market size, by mode of delivery 2009-2012 (USD million) 62

TABLE 44 The German clinical trial management system market size, by mode of delivery 2013-2019 (USD million) 63

TABLE 45 The German clinical trial management system market size, by end user 2009-2012 (USD million) 64

TABLE 46 The German clinical trial management system market size, by end user 2013-2019 (USD million) 64

TABLE 47 The French clinical trial management system market size, by mode of delivery 2009-2012 (USD million) 65

TABLE 48 The French clinical trial management system market size, by mode of delivery 2013-2019 (USD million) 66

TABLE 49 The French clinical trial management system market size, by end user 2009-2012 (USD million) 67

TABLE 50 The French clinical trial management system market size, by end user 2013-2019 (USD million) 67

TABLE 51 Poland clinical trial management system market size, by mode of delivery 2009-2012 (USD million) 68

TABLE 52 Poland clinical trial management system market size, by mode of delivery 2013-2019 (USD million) 69

TABLE 53 Poland clinical trial management system market size, by end user 2009-2012 (USD million) 70

TABLE 54 Poland clinical trial management system market size, by end user 2013-2019 (USD million) 70

TABLE 55 The Asian clinical trial management market size, by segment 2009-2012 (USD million) 72

TABLE 56 The Asian clinical trial management market size, by segment 2013-2019 (USD million) 73

TABLE 57 The Asian clinical trial management system market size, by mode of delivery 2009-2012 (USD million) 74

TABLE 58 The Asian clinical trial management system market size, by mode of delivery 2013-2019 (USD million) 74

TABLE 59 The Asian clinical trial management system market size, by end user 2009-2012 (USD million) 75

TABLE 60 The Asian clinical trial management system market size, by end user 2013-2019 (USD million) 76

TABLE 61 The Asian clinical trial management system market size, by type 2009-2012 (USD million) 77

TABLE 62 The Asian clinical trial management system market size, by type 2013-2019 (USD million) 77

TABLE 63 The Asian clinical trial management system market size, by component 2009-2012 (USD million) 78

TABLE 64 The Asian clinical trial management system market size, by component 2013-2019 (USD million) 79

TABLE 65 The South Korean clinical trial management system market size, by mode of delivery 2009-2012 (USD million) 80

TABLE 66 The South Korean clinical trial management system market size, by mode of delivery 2013-2019 (USD million) 81

TABLE 67 The South Korean clinical trial management system market size, by end user 2009-2012 (USD million) 82

TABLE 68 The South Korean clinical trial management system market size, by end user 2013-2019 (USD million) 82

TABLE 69 The Chinese clinical trial management system market size, by mode of delivery 2009-2012 (USD million) 83

TABLE 70 The Chinese clinical trial management system market size, by mode of delivery 2013-2019 (USD million) 84

TABLE 71 The Chinese clinical trial management system market size, by end user 2009-2012 (USD million) 85

TABLE 72 The Chinese clinical trial management system market size, by end user 2013-2019 (USD million) 85

TABLE 73 Some of the Oracle Corporation categories and products 90

TABLE 74 Some of the Merge Healthcare categories and products 93

TABLE 75 Some of the Medidata Solutions products and applications 95

TABLE 76 Some of the PAREXEL International Corporation categories, products and services 98

TABLE 77 Some of the BioClinica categories and products 100

TABLE 78 Some of the MedNet Solutions categories and products 103

TABLE 79 Some of the Bio-Optronics products and application 105

TABLE 80 Some of the DSG products and application 107

TABLE 81 Some of the eClinForce products 108

TABLE 82 Some of the Forte Research Systems products and application 109

List of Figures

FIG. 1 CTMS Market: Porters Five Force Analysis 16

FIG. 2 Applications of clinical trial management system 19

FIG. 3 Process of CTMS 20

FIG. 4 Global clinical trial management system market, by region 2013E (% share) 29

FIG. 5 Global clinical trial management system market, by mode of delivery 2013E (% share) 31

FIG. 6 Global clinical trial management system market, by end user 2013E (% share) 34

FIG. 7 Global clinical trial management system market, by type 2013E (% share) 37

FIG. 8 Global clinical trial management system market, by components 2013E (% share) 39

FIG. 9 The North American clinical trial management system market, by country 2013E (% share) 42

FIG. 10 The North American clinical trial management system market, by mode of delivery 2013E (% share) 44

FIG. 11 The North American clinical trial management system market, by end user 2013E (% share) 45

FIG. 12 The North American clinical trial management system market, by type 2013E (% share) 47

FIG. 13 The North American clinical trial management system market, by component 2013E (% share) 48

FIG. 14 The U.S. clinical trial management system market, by mode of delivery 2013E (% share) 50

FIG. 15 The U.S. clinical trial management system market, by end user 2013E (% share) 51

FIG. 16 The European clinical trial management system market, by country 2013E (% share) 54

FIG. 17 The European clinical trial management system market, by mode of delivery 2013E (% share) 56

FIG. 18 The European clinical trial management system market, by end user 2013E (% share) 57

FIG. 19 The European clinical trial management system market, by type 2013E (% share) 59

FIG. 20 The European clinical trial management system market, by component 2013E (% share) 60

FIG. 21 The German clinical trial management system market, by mode of delivery 2013E (% share) 62

FIG. 22 The German clinical trial management system market, by end user 2013E (% share) 63

FIG. 23 The French clinical trial management system market, by mode of delivery 2013E (% share) 65

FIG. 24 The French clinical trial management system market, by end user 2013E (% share) 66

FIG. 25 Poland clinical trial management system market, by mode of delivery 2013E (% share) 68

FIG. 26 Poland clinical trial management system market, by end user 2013E (% share) 69

FIG. 27 The Asian clinical trial management system market, by country 2013E (% share) 72

FIG. 28 The Asian clinical trial management system market, by mode of delivery 2013E (% share) 73

FIG. 29 The Asian clinical trial management system market, by end user 2013E(% share) 75

FIG. 30 The Asian clinical trial management system market, by type 2013E (% share) 76

FIG. 31 The Asian clinical trial management system market, by component 2013E (% share) 78

FIG. 32 The South Korean clinical trial management system market, by mode of delivery 2013E (% share) 80

FIG. 33 The South Korean clinical trial management system market, by end user 2013E (% share) 81

FIG. 34 The Chinese clinical trial management system market, by mode of delivery 2013E (% share) 83

FIG. 35 The Chinese clinical trial management system market, by end user 2013E (% share) 84

FIG. 36 Competitive landscape of the global CTMS market 87

FIG. 37 Oracle Corporation total revenue and net income 2011-2013 (USD Million) 90

FIG. 38 Merge Healthcare net sales and net income 2011-2013 (USD Million) 93

FIG. 39 Medidata Solutions total revenue and net income 2011-2013 (USD Million) 96

FIG. 40 PAREXEL International Corporation total service revenue and net income 2011-2013 (USD Million) 99

FIG. 41 BioClinica total revenue and net income 2010-2012 (USD Million) 101

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