HOME Top Market Reports Pharmacovigilance and Drug Safety Software Market by Functionality (Adverse Event Reporting, Fully Integrated Software), Delivery Mode (On-premise, On-demand/Cloud based (SAAS)), End-user (Pharma & Biotech Companies, CROs, BPOs) - Global Forecast to 2019

Pharmacovigilance and Drug Safety Software Market by Functionality (Adverse Event Reporting, Fully Integrated Software), Delivery Mode (On-premise, On-demand/Cloud based (SAAS)), End-user (Pharma & Biotech Companies, CROs, BPOs) - Global Forecast to 2019

By: marketsandmarkets.com
Publishing Date: March 2015
Report Code: HIT 3268

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Pharmacovigilance (PV) software comprises drug safety management software solution that enables to create, classify, review, submit, and maintain pharmacovigilance data and adverse event reports. This PV software is used by pharma and biotech companies, contract research organizations (CROs), business process outsourcing firms (BPOs), and other pharmacovigilance service providers.

The global pharmacovigilance software market is poised to grow at a CAGR of 6.5% during 2014-2019, and is expected to reach a value of $154.1 Million in 2019. Factors such as rising incidence rates of adverse drug reactions (ADRs) and increasing adoption of pharmacovigilance software by outsourcing companies are driving the growth of the global drug safety software market. In addition; government regulatory bodies (such as the U.S. FDA and EMEA) have intensified safety regulations for prior and post commercialization of drugs, which has increased pressure on the pharmaceutical and biotechnology companies to manufacture safe drugs and evaluate their results post sales. Thus, growing complexity related to drug safety regulations is expected to drive the growth of the market during the forecast period.

North America is expected to account for the largest share of the drug safety software market, followed by Europe, in 2014. However, Asian and Latin American countries represent high growth markets, owing to a rise in research outsourcing by pharmaceutical giants and growing public and private investments in pharmaceutical R&D in these emerging nations. Some of the key players in the global pharmacovigilance software market include ArisGlobal (U.S.), Ennov Solutions Inc. (U.S.), EXTEDO GmbH (U.S.), Online Business Applications, Inc. (U.S.), Oracle Corporation (U.S.), Sarjen Systems Pvt. Ltd (India), Sparta Systems, Inc. (U.S.), and United BioSource Corporation (U.S.), among others.

Scope of the Report

This research report categorizes the pharmacovigilance software market into the following segments:

Pharmacovigilance and Drug Safety Software Market, By Functionality

  • Adverse Event Reporting Software
  • Drug Safety Audits Software
  • Issue Tracking Software
  • Fully Integrated Software

Pharmacovigilance and Drug Safety Software Market, By Delivery Mode

  • On-premise Delivery Mode
  • On-demand/Cloud based (SaaS) Delivery Mode

Pharmacovigilance and Drug Safety Software Market, By End User

  • Pharma and Biotech Companies
  • Contract Research Organizations (CROs)
  • Business Process Outsourcing (BPO) Firms
  • Other Pharmacovigilance Service Providers

Pharmacovigilance and Drug Safety Software Market, By Region

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • U.K.
    • France
    • Rest of Europe
  • Asia-Pacific
    • Japan
    • India
    • China
    • Rest of Asia-Pacific
  • Rest of the World (RoW)
    • Latin America
    • Middle East
    • Africa

Table of Contents

1 Introduction (Page No. - 18)
    1.1 Objectives of the Study
    1.2 Market Definition
    1.3 Market Scope
           1.3.1 Market Segmentation
           1.3.2 Years Considered for the Study
    1.4 Limitation
    1.5 Market Stakeholders

2 Research Methodology (Page No. - 22)
    2.1 Research Data
           2.1.1 Secondary Data
                    2.1.1.1 Key Data From Secondary Sources
           2.1.2 Primary Data
                    2.1.2.1 Key Data From Primary Sources
                    2.1.2.2 Key Industry Insights
                    2.1.2.3 Breakdown of Primaries
    2.2 Market Size Estimation
                    2.2.1.1 Bottom-Up Approach
                    2.2.1.2 Top-Down Approach
    2.3 Market Breakdown and Data Triangulation
    2.4 Research Assumptions

3 Executive Summary (Page No. - 31)
    3.1 Introduction
    3.2 Current Scenario
    3.3 Future Outlook
    3.4 Conclusion

4 Premium Insights (Page No. - 35)

5 Market Overview (Page No. - 40)
    5.1 Introduction
    5.2 Market Segmentation
    5.3 Market Dynamics
           5.3.1 Drivers
           5.3.2 Restraints
           5.3.3 Opportunities
           5.3.4 Challenges

6 Industry Insights (Page No. - 68)
    6.1 Introduction
    6.2 Value Chain Analysis
    6.3 Porter’s Five Forces Analysis
           6.3.1 Threat From New Entrants
           6.3.2 Threat From Substitutes
           6.3.3 Bargaining Power of Suppliers
           6.3.4 Bargaining Power of Buyers
           6.3.5 Intensity of Competitive Rivalry

7 Pharmacovigilance and Drug Safety Software Market, By Functionality (Page No. - 73)
    7.1 Introduction
    7.2 Adverse Event Reporting Software
    7.3 Drug Safety Audits Software
    7.4 Issue Tracking Software
    7.5 Fully Integrated Software

8 Pharmacovigilance and Drug Safety Software Market, By Delivery Mode (Page No. - 81)
    8.1 Introduction
    8.2 On-Premise Delivery Mode
    8.3 On-Demand/Cloud Based (Saas) Delivery Mode

9 Pharmacovigilance and Drug Safety Software Market, By End-Users (Page No. - 88)
    9.1 Introduction
    9.2 Pharma and Biotech Companies
    9.3 Contract Research Organizations (CROS)
    9.4 Business Process Outsourcing (BPO) Firms
    9.5 Other Pharmacovigilance Service Providers

10 Geographic Analysis (Page No. - 93)
     10.1 Introduction
     10.2 North America
             10.2.1 U.S.
             10.2.1 Canada
     10.3 Europe
             10.3.1 Germany
             10.3.1 U.K.
             10.3.1 France.
             10.3.1 Rest of Europe
     10.4 Asia-Pacific
             10.4.1 Japan
             10.4.1 China
             10.4.1 India
             10.4.1 Rest of Asia-Pacific
     10.5 ROW (Rest of the World)
             10.5.1 Latin America
             10.5.1 Middle East
             10.5.1 Africa

11 Competitive Landscape (Page No. - 123)
     11.1 Overview
     11.2 Market Share Analysis, By Key Players, 2014
     11.3 Competitive Situation and Trends
     11.4 Recent Developments
             11.4.1 Mergers & Acquisitions
             11.4.2 Agreements, Partnerships, Collaborations & Joint Ventures
             11.4.3 New Product Launches
             11.4.4 Expansions
             11.4.5 Other Developments

12 Company Profile (Page No. - 140)
     12.1 AB-Cube
     12.2 Arisglobal
     12.3 Extedo GMBH.
     12.4 Ennov.
     12.5 Online Business Applications, Inc
     12.6 Oracle Corporation.
     12.7 Sarjen Systems Pvt. Ltd
     12.8 Sparta Systems, Inc
     12.9 United Biosource Corporation
     12.1 Umbra Global

*Details on Financials, Products & Services, Key Strategy, & Recent Developments Might Not Be Captured in Case of Unlisted Companies.

13 Appendix (Page No. - 190)


List of Tables (74 Tables)

Table 1 Global Pharmacovigilance Software Market Size, By Functionality, 2012–2019 ($Million)
Table 2 Global Adverse Event Reporting Pharmacovigilance Software Market Size, By Region, 2012–2019 ($Million)
Table 3 Global Drug Safety Audits Pharmacovigilance Software Market Size, By Region, 2012–2019 ($Million)
Table 4 Global Issue Tracking Pharmacovigilance Software Market Size, By Region, 2012–2019 ($Million)
Table 5 Global Fully Integrated Pharmacovigilance Software Market Size, By Region, 2012–2019 ($Million)
Table 6 Global Drug Safety Software Market Size, By Delivery Mode, 2012–2019 ($Million)
Table 7 Global On-Premise Based Pharmacovigilance Software Market Size, By Region, 2012–2019 ($Million)
Table 8 Global On-Demand/Cloud Based Drug Safety Software Market Size, By Region, 2012–2019 ($Million)
Table 9 Global Pharmacovigilance Software Market Size, By End User, 2012–2019 ($Million)
Table 10 Global Pharmacovigilance Software Market Size for Pharma and Biotech Companies, By Region, 2012–2019 ($Million)
Table 11 Global Pharmacovigilance Software Market Size for Contract Research Organizations (CROS), By Region, 2012–2019 ($Million)
Table 12 Global Drug Safety Software Market Size for Business Process Outsourcing (BPO) Firms, By Region, 2012–2019 ($Million)
Table 13 Global Pharmacovigilance Software Market Size for Other Pharmacovigilance Service Providers, By Region, 2012–2019 ($Million)
Table 14 Global Pharmacovigilance Software Market Size, By Region, 2012–2019 ($Million)
Table 15 North American Pharmacovigilance Software Market, By Country (2014-2019)
Table 16 North American Pharmacovigilance Software Market, By Functionality (2014-2019)
Table 17 North American Drug Safety Software Market, By Delivery Mode (2014-2019)
Table 18 North American Pharmacovigilance Software Market, By End User (2014-2019)
Table 19 U.S. Pharmacovigilance Software Market, By Functionality (2014-2019)
Table 20 U.S. Drug Safety Software Market, By Delivery Mode (2014-2019)
Table 21 U.S. Pharmacovigilance Software Market, By End User (2014-2019)
Table 22 Canada Pharmacovigilance Software Market, By Functionality (2014-2019)
Table 23 Canada Pharmacovigilance Software Market, By Delivery Mode (2014-2019)
Table 24 Canada Drug Safety Software Market, By End User (2014-2019)
Table 25 European Pharmacovigilance Software Market, By Country (2014-2019)
Table 26 European Pharmacovigilance Software Market, By Functionality (2014-2019)
Table 27 European Market, By Delivery Mode (2014-2019)
Table 28 European Pharmacovigilance Software Market, By End User (2014-2019)
Table 29 Germany Pharmacovigilance Software Market, By Functionality (2014-2019)
Table 30 Germany Market, By Delivery Mode (2014-2019)
Table 31 Germany Drug Safety Software Market, By End User (2014-2019)
Table 32 U.K. Pharmacovigilance Software Market, By Functionality (2014-2019)
Table 33 U.K. Market, By Delivery Mode (2014-2019)
Table 34 U.K. Pharmacovigilance Software Market, By End User (2014-2019)
Table 35 France Pharmacovigilance Software Market, By Functionality (2014-2019)
Table 36 France Drug Safety Software Market, By Delivery Mode (2014-2019)
Table 37 France Market, By End User (2014-2019)
Table 38 Rest of Europe Pharmacovigilance Software Market, By Functionality (2014-2019)
Table 39 Rest of Europe Pharmacovigilance Software Market, By Delivery Mode (2014-2019)
Table 40 Rest of Europe Market, By End User (2014-2019)
Table 41 Asia-Pacific Pharmacovigilance Software Market, By Country (2014-2019)
Table 42 Asia-Pacific Pharmacovigilance Software Market, By Functionality (2014-2019)
Table 43 Asia-Pacific Pharmacovigilance Software Market, By Delivery Mode (2014-2019)
Table 44 Asia-Pacific Drug Safety Software Market, By End User (2014-2019)
Table 45 Japan Market, By Functionality (2014-2019)
Table 46 Japan Pharmacovigilance Software Market, By Delivery Mode (2014-2019)
Table 47 Japan Drug Safety Software Market, By End User (2014-2019)
Table 48 China Pharmacovigilance Software Market, By Functionality (2014-2019)
Table 49 China Market, By Delivery Mode (2014-2019)
Table 50 China Drug Safety Software Market, By End User (2014-2019)
Table 51 India Pharmacovigilance Software Market, By Functionality (2014-2019)
Table 52 India Drug Safety Software Market, By Delivery Mode (2014-2019)
Table 53 India Market, By End User (2014-2019)
Table 54 Rest of Asia-Pacific Pharmacovigilance Software Market, By Functionality (2014-2019)
Table 55 Rest of Asia-Pacific Market, By Delivery Mode (2014-2019)
Table 56 Rest of Asia-Pacific Drug Safety Software Market, By End User (2014-2019)
Table 57 ROW Pharmacovigilance Software Market, By Country (2014-2019)
Table 58 ROW Drug Safety Software Market, By Functionality (2014-2019)
Table 59 ROW Market, By Delivery Mode (2014-2019)
Table 60 ROW Drug Safety Software Market, By End User (2014-2019)
Table 61 Latin America Drug Safety Software Market, By Functionality (2014-2019)
Table 62 Latin America Market, By Delivery Mode (2014-2019)
Table 63 Latin America Pharmacovigilance Market, By End User (2014-2019)
Table 64 Middle East Pharmacovigilance Software Market, By Functionality (2014-2019)
Table 65 Middle East Market, By Delivery Mode (2014-2019)
Table 66 Middle Drug Safety Software East Market, By End User (2014-2019)
Table 67 Africa Pharmacovigilance Software Market, By Functionality (2014-2019)
Table 68 Africa Pharmacovigilance Software Market, By Delivery Mode (2014-2019)
Table 69 Africa Pharmacovigilance Software Market, By End User (2014-2019)
Table 70 Top 5 Agreements, Partnerships, and Alliances, 2012-2014
Table 71 Top 5 New Services Launches, 2012-2014
Table 72 New Product Catalog Launches and Product Enhancements, 2012-2014
Table 73 Top 5 New Facility Launches and Expansions, 2012-2014
Table 74 Top 5 Other Developments, 2012-2014
 
 
List of Figures (57 Figures)
 
Figure 1 Global Pharmacovigilance Software Market, By Functionality
Figure 2 Global Pharmacovigilance Software Market, By Delivery Mode
Figure 3 Global Drug Safety Software Market, By End User
Figure 4 Pharmacovigilance Software Market, By Region
Figure 5 Research Design
Figure 6 Incidence of Cancer, By Region, 2008 vs. 2012
Figure 7 Number of New Cancer Cases, By Country (2012 vs. 2020)
Figure 8 Prevalence of Cancer for the Next 3 and 5 Years, By Country
Figure 9 Burden of Cardiovascular Disease, By Region – From 2005 to 2030
Figure 10 Public Healthcare Expenditure (% of Total Healthcare Expenditure) in Developed Markets – 2010 to 2012
Figure 11 Bottom-Up Approach
Figure 12 Top-Down Approach
Figure 13 Assumptions of the Research Study
Figure 14 Limitations of the Research Study
Figure 15 Global Pharmacovigilance Software Market, By Functionality, 2014
Figure 16 Global Market for Functionality, By Region, 2014 vs. 2019
Figure 17 Adverse Event Reporting Software Segment is Expected to Double in the Forecast Period
Figure 18 Drug Safety Audits Software Segment is Growing at A High CAGR in the North America
Figure 19 North America Region Commands the Largest Share of the Global Drug Safety Software Market, 2014
Figure 20 Asia-Pacific Region is the Fastest Growing Market in the  Global Pharmacovigilance Software Market, 2014
Figure 21 More Than 60% of the Market Share is Covered By the Adverse Event Reporting Software Segment, 2014
Figure 22 North American Pharmacovigilance Software Market Size is Expected to Double By 2019
Figure 23 Increasing Privatization of the Healthcare Sector is Propelling the Market Growth
Figure 24 Adverse Event Reporting Software to Drive the Market Growth in North America
Figure 25 Fully Integrated Drug Safety Software Market is Expected to Double in the Next Five Years
Figure 26 Adverse Event Reporting and Fully Integrated Pharmacovigilance Software Market Are Driving the Market Growth
Figure 27 The Top Two Product Segments Will Account for More Than 80% of the Total Market By 2019
Figure 28 North America Accounts for the Largest Share of the Global Drug Safety Software Market in 2014
Figure 29 Fully Integrated Software to Grow at the Fastest Rate in During the Forecast Period
Figure 30 North America Dominates the Global Drug Safety Software Market
Figure 31 Global Market, By Delivery Mode
Figure 32 Global Market, By Region
Figure 33 On-Premise Delivery Mode is Having More Than 60% Market Share in the Global Pharmacovigilance Software Market
Figure 34 On-Demand/Cloud Based Delivery Mode is the Fastest Growing Segment in the Global Market
Figure 35 Huge Demand for Pharmacovigilance Software in Emerging Markets: A New Growing Opportunity for Market Players
Figure 36 Complex Regulations in Certain Countries for Drug Safety is A Key Challenge Market
Figure 37 Value Chain Analysis (2014)
Figure 38 Porter’s Five Forces Analysis
Figure 39 Global Pharmacovigilance Software Market, By End User
Figure 40 Contract Research Organizations (CROS) Segment Held the Lagest Market Share in the Global Market, By End User
Figure 41 Business Process Outsourcing (BPO) Firms Segment is the Fastest Growing Market in the Global Market, By End User
Figure 42 On-Premise Segment is Driving the Growth of the Global Pharmacovigilance Software Market
Figure 43 North America Commanded Largest Share of the Market in 2014
Figure 44 North America Will Continue to Dominate the Adverse Event Reporting Market in the Next Five Years
Figure 46 Asia-Pacific to Grow at the Highest CAGR in the Market in the Next Five Years
Figure 47 North America Commanded Lion’s Share of the Fully Integrated Market in 2014
Figure 48 Asia-Pacific to Grow at the Highest CAGR in the On-Demand/Cloud Based Pharmacovigilance  Software Market in the Forecast Period
Figure 49 North America Will Drive the Growth of the Drug Safety Software Market for Contract Research Organizations (CROS) in the Forecast Period
Figure 50 Asia-Pacific to Grow at the Highest CAGR in the Pharmacovigilance Market for Business Process Outsourcing (BPO) Firms in the Next Five Years
Figure 51 North America Market Snapshot: Demand Will Be Driven By Presence of Large Number Contract Research Organizations (CROS)
Figure 52 Europe Market Snapshot: Increasing Private Healthcare Sector in Central and Eastern Europe Are Key Factors to Drive the Market Growth
Figure 53 Asia-Pacific Market Snapshot: High Demand for Pharmacovigilance By Low-Budget Pharma and Biotech Companies Will Continue Drive the Market Growth
Figure 54 Leading Market Players Adopted Agreements, Partnerships, and Alliances as Key Growth Strategies During 2012-2014
Figure 55 Global Drug Safety Software Market Share, By Key Player, 2014
Figure 56 Agreements, Partnerships, and Alliances Are the Key Strategies
Figure 57 Oracle Corporation Company: Company Snapshot

On the basis of functionality, the global pharmacovigilance software market is classified into four major segments, namely, adverse event reporting software, drug safety audits software, issue tracking software, and fully integrated software.

The global drug safety software market is divided into two segments on the basis of delivery mode, namely, on-premise delivery mode and on-demand/cloud based (SaaS) delivery mode. This market is also divided into pharma and biotech companies, contract research organizations (CROs), business process outsourcing (BPO) firms, and other pharmacovigilance service providers on the basis of type of end user.

The global pharmacovigilance software market is expected to grow at a CAGR of 6.5% from 2014 to 2019. Factors such as increasing incidence rates of adverse drug reactions (ADRs) and growing adoption of pharmacovigilance software by organizations such as CROs and BPOs are driving the growth of the global pharmacovigilance software market. In addition; government regulatory bodies (such as the U.S. FDA and EMEA) have intensified safety regulations for prior and post commercialization of drugs, which has increased pressure on the pharmaceutical and biotechnology companies to manufacture safe drugs and evaluate their results post sales. Thus, growing complexity related to drug safety regulations is expected to drive the growth of the market during the forecast period.

On the basis of regions, this market is classified into four regions and their respective countries, namely, North America (U.S. and Canada), Europe (Germany, U.K., France, and Rest of Europe), Asia-Pacific (Japan, India, China, and Rest of Asia-pacific), and the Rest of the World (Latin America, Middle East, and Africa). North America is expected to account for the largest share of the drug safety software market, followed by Europe, in 2014. However, Asian and Latin American countries represent high growth markets, owing to a rise in research outsourcing by pharmaceutical giants and growing public and private investments in pharmaceutical R&D in these emerging nations.

New service launches; agreements, and partnerships; software developments; and geographical expansions are some of the key strategies adopted by most of the market players to achieve growth in the pharmacovigilance software market.

ArisGlobal (U.S.), Ennov Solutions Inc. (U.S.), EXTEDO GmbH (U.S.), Online Business Applications, Inc. (U.S.), Oracle Corporation (U.S.), Sarjen Systems Pvt. Ltd (India), Sparta Systems, Inc. (U.S.), and United BioSource Corporation (U.S.) are some of the key players operating in the global drug safety software market.

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