Pharmacovigilance Market By Clinical Trial Phase (Preclinical, Phase I, Phase II, Phase III, and Phase IV), By Service Provider (In-House and Contract Outsourcing), By Type (Intensified ADR Reporting, Spontaneous Reporting, Targeted spontaneous reporting, EHR Mining, and Cohort Event Monitoring (CEM)), By End User (Hospitals, Research Organizations, and Others), Industry Trends, Estimation & Forecast, 2023-2030

Market Definition

Pharmacovigilance helps to detect, understand, prevent unintended effects, adverse drug reactions, and any other possible medication errors. Pharmacovigilance aims to determine which adverse events cross the line of a drug’s efficacy. Pharmacovigilance analysis conducted on Phase I, Phase II, and Phase III clinical trials provide drug companies data on the safety profile of the drug. The data can be used for R&D and can be submitted to regulatory authorities to allow new markets to be accessed.

Pharmacovigilance market was valued at 7.9 billion US$ in 2022 and is projected to reach 17.4 billion US$ by 2030, at a CAGR of 10.3% during the forecast period.

Market Dynamics

Rising incidence of adverse drug reactions (ADR) and drug toxicity is expected to accelerate the demand for pharmacovigilance services. For instance, according to the Centers for Disease Control and Prevention, approximately 1.3 million adverse drug events cause emergency department visits each year of which 350,000 patients are hospitalized for further treatment after emergency visits for adverse drug events each year. According to the U.S Food and Drug Administration, about 350,000 ADRs occur in U.S. nursing homes each year. According to the State Agency of the Medicines Republic of Latvia, in 2018, the prevalence of adverse drug reaction reports has increased by 12% in Latvia, which is 659 reports. According to the Adverse Drug Reaction Canada, There are around 200,000 severe ADRs cases each year, and around 95% of ADRs are not reported in Canada. Adverse drug reaction has killed up to 22,000 Canadians each year, which includes 5,000 Canadian children. Pharmacovigilance helps to detect, understand, and prevent adverse reactions to medicines. Pharmacovigilance also helps to improve the safety and rational use of medicines, thereby improving patient care and public health. Further, the rising adoption of outsourcing pharmacovigilance services is a key driving factor of the market. However, the risk associated with data management in pharmacovigilance might hamper the market growth. Poor pharmacovigilance data management can jeopardize patient safety and risk of investing in wrong product development which causes huge loss to a pharmaceutical company. Moreover, increasing government initiatives to improve the management of pharmacovigilance practices would provide lucrative opportunities for the market in the coming years.

Market Segmentation

The global pharmacovigilance market is mainly classified based on the clinical trial phase, service provider, type, and end-user. Clinical Trial Phase is further segmented into Preclinical, Phase I, Phase II, Phase III, and Phase IV. By service provider, the market is divided into In-House and Contract Outsourcing. By type, the market is further divided into Intensified ADR Reporting, Spontaneous Reporting, Targeted spontaneous reporting, EHR Mining, Cohort Event Monitoring (CEM). By end-user, the global pharmacovigilance market is divided as Hospitals, Research organizations, and Others.

Contract outsourcing is expected to dominate the global pharmacovigilance market in 2022, owing to the benefits associated with outsourcing pharmacovigilance such as case processing, as well as governance activities like compliance management. Contract outsourcing for pharmacovigilance helps to collect adverse drug reaction (ADR) data and information, develop Risk Management Plans (RMPs) and Risk Evaluation Mitigation Strategy (REMS), reduction of upfront investments, resource flexibility, and lowered cost.

Regional Analysis

Based on geography, the global pharmacovigilance market is divided into North America, Europe, Asia-Pacific, South America, and Middle East & Africa. North America is further divided in the U.S., Canada, and Mexico, whereas Europe consists of the UK, Germany, France, Italy, and Rest of Europe. Asia-Pacific is segmented into India, China, Japan, South Korea, and Rest of Asia-Pacific. The South America region includes Brazil, Argentina, and the Rest of South America, while the Middle East & Africa is categorized into GCC Countries, Egypt, South Africa, and Rest of Middle East & Africa.

North America is dominating the global pharmacovigilance market in 2019, due to the rising incidence of adverse drug reactions (ADR) and drug toxicity in the North American region, increasing investment for drug development by major players, and introduction of cognitive adverse event case processing for pharmacovigilance operations. For instance, Virtusa Corporation, a global business consulting and IT outsourcing company has introduced its latest pharmacovigilance (PV) solution for Adverse Event (AE) Intake and Cognitive Adverse Event Case Processing (AECP). Pharmacovigilance solution is built on case management technology from Pegasystems, the solution enables life sciences companies to increase productivity while ensuring lowering costs, enhancing patient safety, and compliance.

Competitive landscape

Key players operating in the pharmacovigilance industry include Accenture, Cognizant, Linical Accelovance, Covance Inc., ArisGlobal, IBM Corporation, ITClinical, ICON plc, FMD K&L, TAKE Solutions Ltd, IQVIA, BioClinica Inc., Wipro Ltd, United BioSource Corporation, and Capgemini.

The increasing number of new drug developments, partnerships between companies to perform pharmacovigilance services, and commercialization of new pharmacovigilance services are some of the strategies adopted by the major companies. For instance, Quartesian, a multinational Clinical Research Organization (CRO), has introduced its suite of clinical trial data pharmacovigilance services. Quartesian’s new pharmacovigilance offerings include Case Management, SAE Reconciliation, Safety Management Planning, Literature Case Reporting, and more.

Pharmacovigilance Market Key Segments

By Clinical Trial Phase
• Preclinical
• Phase I
• Phase II
• Phase III
• Phase IV

By Service Provider
• In-House
• Contract Outsourcing

By Type
• Intensified ADR Reporting
• Spontaneous Reporting
• Targeted spontaneous reporting
• EHR Mining
• Cohort Event Monitoring (CEM)

By End-User
• Hospitals
• Research organizations
• Others

Key Global Pharmacovigilance Industry Players

• Accenture
• Cognizant
• Linical Accelovance
• Covance Inc.
• ArisGlobal
• IBM Corporation
• ITClinical
• ICON plc
• FMD K&L
• TAKE Solutions Ltd
• IQVIA
• BioClinica Inc.
• Wipro Ltd
• United BioSource Corporation
• Capgemini

Table of Content

1. Market Introduction
1.1. Executive Summary
1.2. Market Definition
1.3. Market Scope

2. Research Methodology
2.1. Primary Research
2.2. Research Methodology
2.3. Assumptions & Exclusions
2.4. Secondary data sources

3. Pharmacovigilance Market Overview
3.1. Report Segmentation & Scope
3.2. Key Market Trend
3.3. Drivers
3.3.1. Rising Incidence of Adverse Drug Reactions (ADR) and Drug Toxicity
3.3.2. Rising Adoption of Outsourcing Pharmacovigilance Services
3.4. Restraints
3.4.1. Risk Associated with Data Management in Pharmacovigilance
3.5. Opportunity
3.5.1. Increasing government Initiatives to Improve Management of Pharmacovigilance Practices.
3.6. Porter’s Five Forces Analysis
3.6.1. Porter’s Five Forces Analysis
3.7. Market Share Analysis

4. Clinical Trial Phase Overview
4.1. Introduction
4.1.1. Market Size & Forecast
4.2. Preclinical
4.2.1. Market Size & Forecast
4.3. Phase I
4.3.1. Market Size & Forecast
4.4. Phase II
4.4.1. Market Size & Forecast
4.5. Phase III
4.5.1. Market Size & Forecast
4.6. Phase IV
4.6.1. Market Size & Forecast

5. Service Provider Overview
5.1. Introduction
5.1.1. Market Size & Forecast
5.2. In-House
5.2.1. Market Size & Forecast
5.3. Contract Outsourcing
5.3.1. Market Size & Forecast

6. Type Overview
6.1. Introduction
6.1.1. Market Size & Forecast
6.2. Intensified ADR Reporting
6.2.1. Market Size & Forecast
6.3. Spontaneous Reporting
6.3.1. Market Size & Forecast
6.4. Targeted spontaneous reporting
6.4.1. Market Size & Forecast
6.5. EHR Mining
6.5.1. Market Size & Forecast
6.6. Cohort Event Monitoring (CEM)
6.6.1. Market Size & Forecast

7. End-User Overview
7.1. Introduction
7.1.1. Market Size & Forecast
7.2. Hospitals
7.2.1. Market Size & Forecast
7.3. Research organizations
7.3.1. Market Size & Forecast
7.4. Others
7.4.1. Market Size & Forecast

8. Pharmacovigilance Market Regional Overview
8.1. Introduction
8.1.1. Market Size & Forecast
8.2. North America Pharmacovigilance Market
8.2.1. North America Market Size & Forecast, By Country
8.2.2. North America Market Size & Forecast, By Clinical Trial Phase
8.2.3. North America Market Size & Forecast, By Service Provider
8.2.4. North America Market Size & Forecast, By Type
8.2.5. North America Market Size & Forecast, By End User
8.2.6. The U.S.
8.2.6.1. Market Size and Forecast
8.2.7. Canada
8.2.7.1. Market Size and Forecast
8.2.8. Mexico
8.2.8.1. Market Size and Forecast
8.3. Europe Pharmacovigilance Market
8.3.1. Europe Market Size & Forecast, By Country
8.3.2. Europe Market Size & Forecast, By Clinical Trial Phase
8.3.3. Europe Market Size & Forecast, By Service Provider
8.3.4. Europe Market Size & Forecast, By Type
8.3.5. Europe Market Size & Forecast, By End User
8.3.6. Germany
8.3.6.1. Market Size and Forecast
8.3.7. France
8.3.7.1. Market Size and Forecast
8.3.8. UK
8.3.8.1. Market Size and Forecast
8.3.9. Italy
8.3.9.1. Market Size and Forecast
8.3.10. Spain
8.3.10.1. Market Size and Forecast
8.3.11. Rest of Europe
8.3.11.1. Market Size and Forecast
8.4. Asia-Pacific Pharmacovigilance Market
8.4.1. Asia-Pacific Market Size & Forecast, By Country
8.4.2. Asia-Pacific Market Size & Forecast, By Clinical Trial Phase
8.4.3. Asia-Pacific Market Size & Forecast, By Service Provider
8.4.4. Asia-Pacific Market Size & Forecast, By Type
8.4.5. Asia-Pacific Market Size & Forecast, By End User
8.4.6. Japan
8.4.6.1. Market Size and Forecast
8.4.7. China
8.4.7.1. Market Size and Forecast
8.4.8. Australia
8.4.8.1. Market Size and Forecast
8.4.9. India
8.4.9.1. Market Size and Forecast
8.4.10. South Korea
8.4.10.1. Market Size and Forecast
8.4.11. Rest of Asia-Pacific
8.4.11.1. Market Size and Forecast
8.5. South America Pharmacovigilance Market
8.5.1. South America Market Size & Forecast, By Country
8.5.2. South America Market Size & Forecast, By Clinical Trial Phase
8.5.3. South America Market Size & Forecast, By Service Provider
8.5.4. South America Market Size & Forecast, By Type
8.5.5. South America Market Size & Forecast, By End User
8.5.6. Brazil
8.5.6.1. Market Size and Forecast
8.5.7. Argentina
8.5.7.1. Market Size and Forecast
8.5.8. Rest of South America
8.5.8.1. Market Size and Forecast
8.6. Middle East & Africa Pharmacovigilance Market
8.6.1. Middle East & Africa Market Size & Forecast, By Country
8.6.2. Middle East & Africa Market Size & Forecast, By Clinical Trial Phase
8.6.3. Middle East & Africa Market Size & Forecast, By Service Provider
8.6.4. Middle East & Africa Market Size & Forecast, By Type
8.6.5. Middle East & Africa Market Size & Forecast, By End User
8.6.6. GCC Countries
8.6.6.1. Market Size and Forecast
8.6.7. Egypt
8.6.7.1. Market Size and Forecast
8.6.8. South Africa
8.6.8.1. Market Size and Forecast
8.6.9. Rest of Middle East & Africa
8.6.9.1. Market Size and Forecast

9. Company Profile
9.1. Accenture
9.1.1. Company Basic Information, Manufacturing Base, Sales Area and Its Competitors
9.1.2. Accenture Product Category, Application, and Specification
9.1.3. Accenture Financial Performance (2016-2018)
9.1.4. Main Business/Business Overview
9.2. Cognizant
9.3. Linical Accelovance
9.4. Covance Inc.
9.5. ArisGlobal
9.6. IBM Corporation
9.7. ITClinical
9.8. ICON plc
9.9. FMD K&L
9.10. TAKE Solutions Ltd
9.11. IQVIA
9.12. BioClinica Inc.
9.13. Wipro Ltd
9.14. United BioSource Corporation
9.15. Capgemini