The global pharmacovigilance and drug safety software market is expected to grow at a CAGR of around 7.8% from 2020 to 2027 and expected to reach the market value of around US$ 294.6 Mn by 2027.
Clinical research depends heavily on software. Pharmacovigilance and drug safety software reduce administrative burden and workload by consolidating information in a single location, and it supports the trial by facilitating collaboration among all healthcare professionals. Meeting deadlines is the most difficult challenge for many pharmacovigilance and drug safety research teams, especially when they are supported by manual and time-consuming processes. Several organizations’ 2019 goal was to find a new and different approach that addresses the need for increased transparency, improved compliance, increased efficiency, and cost effectiveness while minimizing human involvement through automation and insights. The incorporation of pharmacovigilance and drug safety software greatly improves the speed and efficiency with which the study data is maintained, managed, planned, performed, and reported. As a result, these software are excellent tools in the clinical research domain for collecting trial-specific data in order to track study performance, schedule, monitor, and so on.
Market Dynamics
Rising incidences of adverse drug reactions (ADRs) bolster the demand for pharmacovigilance and drug safety software market
According to the British Medical Association, adverse reactions are becoming more common, and no medicine can ever be guaranteed to be completely safe. Furthermore, according to a study of hospital admissions in the United Kingdom published in 2004, 6.5% of people admitted to hospital had an ADR, and in 80% of those cases, the ADR was the direct cause of the admission. Furthermore, the study discovered that more than 2% of those admitted to the hospital with ADR died. To address this, pharmacovigilance and drug safety software play an important role in detecting, investigating, communicating, and implementing appropriate actions. Effective pharmacovigilance and drug safety software has gained widespread attention due to the detection of ADRs, allowing for more effective advice to be given to those prescribing and using medication and ensuring higher standards of safety and efficacy. But apart from that, the Uppsala Monitoring Centre in Sweden runs the World Health Organization (WHO) Program for International Drug Monitoring. The program allows participating countries to work together to monitor drug safety. At the moment, the program has 79 member countries and 18 associate members. Each member country's designated National Centre submits individual case reports of suspected ADRs to be stored in a common database. The MHRA is the designated National Centre for the United Kingdom. The WHO database currently contains approximately 3.4 million ADR case records, making it a valuable data source for pharmacovigilance. However, access to these data is primarily restricted to National Centers.
COVID-19 impact on pharmacovigilance and drug safety software market
The global pandemic, long predicted by experts in the field of infectious diseases and global public health, has arrived and brought the life to which had grown accustomed to an abrupt halt. Monitoring the safety of medicines was on top priority during the pandemic. A collection of therapies for consideration in the treatment of corona virus infections has been identified and is currently being deployed in several countries. According to the World Health Organization (WHO), the use of newer drugs such as "remdesivir" and of repurposed drugs such as "hydroxychloroquine and lopinavir/ritonavir" are being explored for effective against COVID-19. Reports of suspected adverse drug reactions (ADRs) for these different therapies was recorded in "Vigibase", the global database of individual case study safety reports, managed by the Uppsala Monitoring Center (personal knowledge). Furthermore, pharmacovigilance has grown in popularity, with a wide range of opportunities that bring pharmacovigilance and drug safety software closer to healthcare systems by providing clinicians with supportive data for making appropriate treatment decisions in the absence of data from randomized clinical trials. Additionally, provide supporting data that includes both treatment benefits and risks.
Market Segmentation
The global pharmacovigilance and drug safety software market is segmented based on functionality, delivery mode, and end-user. By functionality, the market is segmented as adverse event reporting software, drug safety audits software, issue tracking software, and fully integrated software. By delivery mode, the market is bifurcated into on-premise delivery mode and on-demand/cloud based (SaaS) delivery mode. By end-user, the market is segregated as pharmacy and biotech companies, contract research organizations (CROs), business process outsourcing (BPO) firms, and other pharmacovigilance service providers.
Based on functionality, the drug safety audit software segment will record highest market share in the forthcoming years. Further, by delivery mode, on-demand/cloud based SaaS delivery mode is projected to hold significant CAGR in the forecast period. Furthermore, by end-user, the contract research organizations (CROS) and business process outsourcing (BPOs) firms is expected to hold the largest market share for the global pharmacovigilance and drug safety software market.
Regional Landscape
In the coming years, North America is expected to have the largest market share. As a result of government-aided initiatives that encourage the use of pharmacovigilance software systems, the regional market is expected to grow significantly in the coming years. For example, the favorable Food and Drug Initiatives (FDA) provide scientists and application developers with access to its massive database via open search-based program, which is highly supported to increase usage rates during the forecast period. For records, Mini-Sentinel is a novel project launched by the US FDA that promotes active surveillance systems capable of providing statistically relevant data in less time. This type of initiative contributes to the expansion of the global pharmacovigilance and drug safety software market.
Asia Pacific, on the other hand, is expected to have the fastest growing CAGR in the coming years. China, Singapore, Taiwan, and South Korea are the prominent countries in the Asia Pacific region that have gained significant importance and are a strong contributor to the growth of the global pharmacovigilance and drug safety software market. Aside from that, Latin American countries are expected to be high growth markets, owing to an increase in research outsourcing by pharmaceutical behemoths and growing public and private investments in pharmaceutical R&D in these emerging regions.
Competitive Landscape
The market is competitive in nature owing to presence of prominent healthcare functionality companies. These prominent players involved in pharmacovigilance and drug safety software market are ArisGlobal, Ennov, EXTEDO, Online Business Applications, Inc., Oracle Corporation, Sarjen Systems Pvt. Ltd, Sparta Systems, Inc., United BioSource LLC, and among others
Market Segmentation
Market By Functionality
Adverse Event Reporting Software
Drug Safety Audits Software
Issue Tracking Software
Fully Integrated Software
Market By Delivery Mode
On-premise Delivery Mode
On-demand/Cloud based (SaaS) Delivery Mode
Market By End User
Pharma and Biotech Companies
Contract Research Organizations (CROs)
Business Process Outsourcing (BPO) Firms
Other Pharmacovigilance Service Providers
Market By Geography
North America
• U.S.
• Canada
Europe
• U.K.
• Germany
• France
• Spain
• Rest of Europe
Asia-Pacific
• China
• Japan
• India
• Australia
• South Korea
• Rest of Asia-Pacific
Latin America
• Brazil
• Mexico
• Rest of Latin America
Middle East & Africa
• GCC
• South Africa
• Rest of Middle East & Africa
CHAPTER 1. Industry Overview of Pharmacovigilance and Drug Safety Software
1.1. Definition and Scope
1.1.1. Definition of Pharmacovigilance and Drug Safety Software
1.1.2. Market Segmentation
1.1.3. Years Considered for the Study
1.1.4. Assumptions and Acronyms Used
1.1.4.1. Market Assumptions and Market Forecast
1.1.4.2. Acronyms Used in Global Pharmacovigilance and Drug Safety Software Market
1.2. Summary
1.2.1. Executive Summary
1.2.2. Pharmacovigilance and Drug Safety Software Market By Functionality
1.2.3. Pharmacovigilance and Drug Safety Software Market By Delivery Mode
1.2.4. Pharmacovigilance and Drug Safety Software Market By End User
1.2.5. Pharmacovigilance and Drug Safety Software Market by Regions
CHAPTER 2. Research Approach
2.1. Methodology
2.1.1. Research Programs
2.1.2. Market Size Estimation
2.1.3. Market Breakdown and Data Triangulation
2.2. Data Source
2.2.1. Secondary Sources
2.2.2. Primary Sources
CHAPTER 3. Market Dynamics And Competition Analysis
3.1. Market Drivers
3.1.1. Driver 1
3.1.2. Driver 2
3.2. Restraints and Challenges
3.2.1. Restrain 1
3.2.2. Restrain 2
3.3. Growth Opportunities
3.3.1. Opportunity 1
3.3.2. Opportunity 2
3.4. Porter’s Five Forces Analysis
3.4.1. Bargaining Power of Suppliers
3.4.2. Bargaining Power of Buyers
3.4.3. Threat of Substitute
3.4.4. Threat of New Entrants
3.4.5. Degree of Competition
3.5. Market Concentration Ratio and Market Maturity Analysis of Pharmacovigilance and Drug Safety Software Market
3.5.1. Go To Market Strategy
3.5.1.1. Introduction
3.5.1.2. Growth
3.5.1.3. Maturity
3.5.1.4. Saturation
3.5.1.5. Possible Development
3.6. Technological Roadmap for Pharmacovigilance and Drug Safety Software Market
3.7. Value Chain Analysis
3.7.1. List of Key Manufacturers
3.7.2. List of Customers
3.7.3. Level of Integration
3.8. Cost Structure Analysis
3.8.1. Price Trend of Key Raw Materials
3.8.2. Raw Material Suppliers
3.8.3. Proportion of Manufacturing Cost Structure
3.8.3.1. Raw Material
3.8.3.2. Labor Cost
3.8.3.3. Manufacturing Expense
3.9. Regulatory Compliance
3.10. Competitive Landscape, 2019
3.10.1. Player Positioning Analysis
3.10.2. Key Strategies Adopted By Leading Players
CHAPTER 4. Manufacturing Plant Analysis
4.1. Manufacturing Plant Location and Establish Date of Major Manufacturers in 2019
4.2. R&D Status and Application Source of Pharmacovigilance and Drug Safety Software Major Manufacturers in 2019
CHAPTER 5. Pharmacovigilance and Drug Safety Software Market By Functionality
5.1. Introduction
5.2. Pharmacovigilance and Drug Safety Software Revenue By Functionality
5.2.1. Pharmacovigilance and Drug Safety Software Revenue (US$ Mn) and Forecast, By Functionality, 2016-2027
5.2.2. Adverse Event Reporting Software
5.2.2.1. Adverse Event Reporting Software Market Revenue (US$ Mn) and Growth Rate (%), 2016-2027
5.2.3. Drug Safety Audits Software
5.2.3.1. Drug Safety Audits Software Market Revenue (US$ Mn) and Growth Rate (%), 2016-2027
5.2.4. Issue Tracking Software
5.2.4.1. Issue Tracking Software Market Revenue (US$ Mn) and Growth Rate (%), 2016-2027
5.2.5. Fully Integrated Software
5.2.5.1. Fully Integrated Software Market Revenue (US$ Mn) and Growth Rate (%), 2016-2027
CHAPTER 6. Pharmacovigilance and Drug Safety Software Market Revenue By Delivery Mode
6.1. Introduction
6.2. Pharmacovigilance and Drug Safety Software Revenue (US$ Mn) By Delivery Mode
6.2.1. Pharmacovigilance and Drug Safety Software Revenue (US$ Mn) and Forecast By Delivery Mode, 2016 - 2027
6.2.2. On-premise Delivery Mode
6.2.2.1. On-premise Delivery Mode Market Revenue (US$ Mn) and Growth Rate (%), 2016-2027
6.2.3. On-demand/Cloud based (SaaS) Delivery Mode
6.2.3.1. On-demand/Cloud based (SaaS) Delivery Mode Market Revenue (US$ Mn) and Growth Rate (%), 2016-2027
CHAPTER 7. Pharmacovigilance and Drug Safety Software Market By End User
7.1. Introduction
7.2. Pharmacovigilance and Drug Safety Software Revenue (US$ Mn) By End User
7.2.1. Pharmacovigilance and Drug Safety Software Revenue (US$ Mn) and Forecast By End User, 2016 - 2027
7.2.2. Pharma and Biotech Companies
7.2.2.1. Pharma and Biotech Companies Market Revenue (US$ Mn) and Growth Rate (%), 2016-2027
7.2.3. Contract Research Organizations (CROs)
7.2.3.1. Contract Research Organizations (CROs) Market Revenue (US$ Mn) and Growth Rate (%), 2016-2027
7.2.4. Business Process Outsourcing (BPO) Firms
7.2.4.1. Business Process Outsourcing (BPO) Firms Market Revenue (US$ Mn) and Growth Rate (%), 2016-2027
7.2.5. Other Pharmacovigilance Service Providers
7.2.5.1. Other Pharmacovigilance Service Providers Market Revenue (US$ Mn) and Growth Rate (%), 2016-2027
CHAPTER 8. North America Pharmacovigilance and Drug Safety Software Market By Country
8.1. North America Pharmacovigilance and Drug Safety Software Overview
8.2. U.S.
8.2.1. U.S. Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Functionality, 2016-2027
8.2.2. U.S. Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Delivery Mode, 2016-2027
8.2.3. U.S. Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By End User, 2016-2027
8.3. Canada
8.3.1. Canada Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Functionality, 2016-2027
8.3.2. Canada Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Delivery Mode, 2016-2027
8.3.3. Canada Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By End User, 2016-2027
8.4. North America PEST Analysis
CHAPTER 9. Europe Pharmacovigilance and Drug Safety Software Market By Country
9.1. Europe Pharmacovigilance and Drug Safety Software Market Overview
9.2. U.K.
9.2.1. U.K. Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Functionality, 2016-2027
9.2.2. U.K. Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Delivery Mode, 2016-2027
9.2.3. U.K. Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By End User, 2016-2027
9.3. Germany
9.3.1. Germany Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Functionality, 2016-2027
9.3.2. Germany Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Delivery Mode, 2016-2027
9.3.3. Germany Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By End User, 2016-2027
9.4. France
9.4.1. France Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Functionality, 2016-2027
9.4.2. France Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Delivery Mode, 2016-2027
9.4.3. France Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By End User, 2016-2027
9.5. Spain
9.5.1. Spain Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Functionality, 2016-2027
9.5.2. Spain Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Delivery Mode, 2016-2027
9.5.3. Spain Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By End User, 2016-2027
9.6. Rest of Europe
9.6.1. Rest of Europe Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Functionality, 2016-2027
9.6.2. Rest of Europe Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Delivery Mode, 2016-2027
9.6.3. Rest of Europe Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By End User, 2016-2027
9.7. Europe PEST Analysis
CHAPTER 10. Asia Pacific Pharmacovigilance and Drug Safety Software Market By Country
10.1. Asia Pacific Pharmacovigilance and Drug Safety Software Market Overview
10.2. China
10.2.1. China Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Functionality, 2016 - 2027
10.2.2. China Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Delivery Mode, 2016 - 2027
10.2.3. China Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By End User, 2016 - 2027
10.3. Japan
10.3.1. Japan Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Functionality, 2016 - 2027
10.3.2. Japan Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Delivery Mode, 2016 - 2027
10.3.3. Japan Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By End User, 2016 - 2027
10.4. India
10.4.1. India Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Functionality, 2016 - 2027
10.4.2. India Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Delivery Mode, 2016 - 2027
10.4.3. India Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By End User, 2016 - 2027
10.5. Australia
10.5.1. Australia Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Functionality, 2016 - 2027
10.5.2. Australia Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Delivery Mode, 2016 - 2027
10.5.3. Australia Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By End User, 2016 - 2027
10.6. South Korea
10.6.1. South Korea Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Functionality, 2016 - 2027
10.6.2. South Korea Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Delivery Mode, 2016 - 2027
10.6.3. South Korea Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By End User, 2016 - 2027
10.7. Rest of Asia-Pacific
10.7.1. Rest of Asia-Pacific Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Functionality, 2016 - 2027
10.7.2. Rest of Asia-Pacific Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Delivery Mode, 2016 - 2027
10.7.3. Rest of Asia-Pacific Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By End User, 2016 - 2027
10.8. Asia Pacific PEST Analysis
CHAPTER 11. Latin America Pharmacovigilance and Drug Safety Software Market By Country
11.1. Latin America Pharmacovigilance and Drug Safety Software Market Overview
11.2. Brazil
11.2.1. Brazil Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Functionality, 2016 - 2027
11.2.2. Brazil Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Delivery Mode, 2016 - 2027
11.2.3. Brazil Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By End User, 2016 - 2027
11.3. Mexico
11.3.1. Mexico Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Functionality, 2016 - 2027
11.3.2. Mexico Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Delivery Mode, 2016 - 2027
11.3.3. Mexico Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By End User, 2016 - 2027
11.4. Rest of Latin America
11.4.1. Rest of Latin America Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Functionality, 2016 - 2027
11.4.2. Rest of Latin America Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Delivery Mode, 2016 – 2027
11.4.3. Rest of Latin America Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By End User, 2016 – 2027
11.5. Latin America PEST Analysis
CHAPTER 12. Middle East & Africa Pharmacovigilance and Drug Safety Software Market By Country
12.1. Middle East & Africa Pharmacovigilance and Drug Safety Software Market Overview
12.2. Saudi Arabia
12.2.1. Saudi Arabia Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Functionality, 2016 - 2027
12.2.2. Saudi Arabia Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Delivery Mode, 2016 - 2027
12.2.3. Saudi Arabia Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By End User, 2016 - 2027
12.3. UAE
12.3.1. UAE Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Functionality, 2016 - 2027
12.3.2. UAE Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Delivery Mode, 2016 - 2027
12.3.3. UAE Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By End User, 2016 - 2027
12.4. Rest of Middle East & Africa
12.4.1. Rest of Middle East & Africa Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Functionality, 2016 - 2027
12.4.2. Rest of Middle East & Africa Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By Delivery Mode, 2016 - 2027
12.4.3. Rest of Middle East & Africa Pharmacovigilance and Drug Safety Software Market Revenue (US$ Mn) and Forecast By End User, 2016 – 2027
12.5. Middle East & Africa PEST Analysis
CHAPTER 13. Player Analysis Of Pharmacovigilance and Drug Safety Software
13.1. Pharmacovigilance and Drug Safety Software Market Company Share Analysis
13.2. Competition Matrix
13.2.1. Competitive Benchmarking of key players by price, presence, market share, and R&D investment
13.2.2. New Product Launches and Product Enhancements
13.2.3. Mergers And Acquisition In Global Pharmacovigilance and Drug Safety Software Market
13.2.4. Partnership, Joint Ventures and Strategic Alliances/ Sales Agreements
CHAPTER 14. COMPANY PROFILE
14.1. ArisGlobal
14.1.1. Company Snapshot
14.1.2. Business Overview
14.1.3. Financial Overview
14.1.3.1. Revenue (US$ Mn), 2019
14.1.3.2. ArisGlobal 2019 Pharmacovigilance and Drug Safety Software Business Regional Distribution
14.1.4. Product/ Service and Specification
14.1.5. Recent Developments & Business Strategy
14.1.6. Manufacturing Plant Footprint Analysis
14.2. Ennov
14.3. EXTEDO
14.4. Online Business Applications, Inc.
14.5. Oracle Corporation
14.6. Sarjen Systems Pvt. Ltd
14.7. Sparta Systems, Inc.
14.8. United BioSource LLC
14.9. Others
