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 End User: Hospitals, Pharmaceutical Companies, and Others) - Global Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2024 – 2033
The global pharmacovigilance market size was estimated at USD 8.72 billion in 2023 and is expected to reach over USD 20.64 billion by 2033, poised to grow at a registered CAGR of 9% from 2024 to 2033.
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The U.S. pharmacovigilance market size was estimated at USD 1.90 billion in 2023 and is predicted to be worth around USD 4.80 billion by 2033, at a CAGR of 9.7% from 2024 to 2033.
Based on the region, the North America segment dominated the global pharmacovigilance market in 2023, in terms of revenue and is estimated to sustain its dominance during the forecast period. The increased prevalence of drug addiction and the resulting adverse drug reactions is a major cause of morbidity and mortality. This is a high-growing rendering factor for North American market growth. The regional market is expected to rise as key manufacturers increase their investments in novel drug development. As a result of the high volume of pharmaceuticals produced, the number of clinical studies and the demand for post-marketing supervision has increased, adding to the regional market’s overall expansion.
On the other hand, the Asia-Pacific is estimated to be the most opportunistic segment during the forecast period. In the coming years, greater productivity, resource sharing, and cost efficiency are expected to propel regional demand for pharmacovigilance. In addition, the regional market is being driven by expanding patient awareness, rising investment, and supportive government actions to address the needs of the population.
The Europe pharmacovigilance market size was calculated at USD 2.56 billion in 2023 and is projected to expand around USD 6.36 billion by 2033, poised to grow at a CAGR of 9.5% from 2024 to 2033.
| Year | Market Size (USD Billion) |
| 2023 | 2.56 |
| 2024 | 2.81 |
| 2025 | 3.08 |
| 2026 | 3.37 |
| 2027 | 3.69 |
| 2028 | 4.04 |
| 2029 | 4.42 |
| 2030 | 4.84 |
| 2031 | 5.30 |
| 2032 | 5.81 |
| 2033 | 6.36 |
The medications and vaccinations have revolutionized illness prevention and treatment. Medicinal products may have side effects in addition to their advantages, some of which may be unwanted or unexpected. The pharmacovigilance is the science and practice of detecting adverse reactions to medicines and vaccines.
The rising prevalence of chronic diseases is expected to propel the market growth. The pharmacovigilance market is growing due to expanding usage of outsourcing services, increasing drug development rates, and rising drug consumption. The pharmaceutical industry’s high spending, as well as an increase in adverse drug reactions (ADRs) and prescription errors, are propelling the pharmacovigilance market growth. The non-profit organization’s growing awareness of pharmacovigilance may boost market growth.
The pharmacovigilance industry is developing due to the expiration of branded pharmaceuticals by patients and the increasing number of new drug innovations. The increased spending on oncology treatment and research, as well as ongoing need for cancer medications, are driving up demand for pharmacovigilance.
The increased medication consumption and development rates, growing trend of outsourcing pharmacovigilance services, and rising rates of adverse drug responses are all driving the growth of pharmacovigilance market during the forecast period. As a result of sedentary lifestyles, changing lifestyle patterns, lack of physical activities, and poor diets, the incidence of lifestyle-related diseases such as cardiac disorders, diabetes, and hypertension is on the rise, which indicates a high demand for drug monitoring and propels the pharmacovigilance market growth during the forecast period.
The rising prevalence of a wide range of ailments across all age groups and around the world is driving demand for therapeutic medications to address these illnesses. The necessity for regular medication monitoring has increased as a result of rising drug consumption, supporting the pharmacovigilance market growth during the forecast period.
The cost of maintaining compliance levels is prohibiting the market expansion. The pharmacovigilance market expansion is being hampered by a scarcity of qualified healthcare personnel.
| Report Coverage | Details |
| Pharmacovigilance Market Size in 2023 | USD 8.72 Billion |
| Pharmacovigilance Market Size by 2033 | USD 20.64 Billion |
| Pharmacovigilance Market Growth Rate from 2024 to 2033 | CAGR of 9% |
| Largest Market | North America |
| Fastest Growing Market | Asia Pacific |
| Base Year | 2023 |
| Forecast Period | 2024 to 2033 |
| Segments Covered | By Clinical Trial Phase, By Service Provider, and By End User |
| Regions Covered | North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa |
The phase IV segment has dominated the market with highest revenue share in 2023. The technologies used for clinical trial phase IV, provide as an extra layer of protection for medications in clinical studies. Phase IV is important and essential step in clinical trials as it allows for the detection of negative medication effects. As a result of thorough drug testing on large patient demographics of the highest relevance after commercialization of the drug, the data collected and reviewed during this stage is predicted to be of the highest relevance.
On the other hand, the phase III is expected to grow at rapid pace during the forecast period. Phase III trials are used to determine and confirm a drug’s efficacy. Before a medicine is commercialized, these trials provide further information about probable drug interactions, effectiveness, and drug safety. Over the forecast period, the aforementioned factors are expected to drive revenue generation in the segment.
The contract outsourcing segment has accounted highest revenue share in 2023. This is owing to the advantages of outsourcing, such as risk minimization, resource flexibility, lower fixed costs, and upfront investment reduction. The pharmacovigilance audits, standard operating procedures, and other specialized services are provided by contract outsourcing businesses.
On the other hand, as a result of substantial research and development by large pharmaceutical and biotechnological businesses for the creation of new pharmaceuticals, the in-house segment is expected to rise moderately over the forecast period. In the following years, this is projected to benefit the industry’s growth prospects.
Based on the end user, the pharmaceutical companies has hed highest revenue share in 2023. Due to increased new product development activities in this sector, the pharmaceutical companies segment is expected to rise significantly in the next years. Drug development and consumption have increased dramatically in recent years. The adverse effects not identified in clinical studies can occur when medications are used by a wide population for longer periods of time.
On the other hand, the hospitals segment is expected to grow at rapid pace during the forecast period. The hospitals and clinics have started to outsource the pharmacovigilance process to avoid large high initial investments and fixed overhead costs, gain additional capacity, and boost resource flexibility. The hospitals can save money by outsourcing pharmacovigilance.
Key Companies & Market Share Insights
The various developmental strategies such as partnerships, new product launches, acquisition, joint venture, R&D investments, and mergers fosters market growth and offers lucrative growth opportunities to the market players. The Medicines and Healthcare Products Regulatory Agency (MHRA) created a new online reporting system in May 2020 to track suspected COVID-19 side effects. This was done in order to establish a knowledge base around safe pandemic disease treatment.
Segments Covered in the Report
By Clinical Trial Phase
By Service Provider
By End User
By Therapeutic Area
By Type
By Process Flow
By Geography
Chapter 1. Introduction
1.1. Research Objective
1.2. Scope of the Study
1.3. Definition
Chapter 2. Research Methodology
2.1. Research Approach
2.2. Data Sources
2.3. Assumptions & Limitations
Chapter 3. Executive Summary
3.1. Market Snapshot
Chapter 4. Market Variables and Scope
4.1. Introduction
4.2. Market Classification and Scope
4.3. Industry Value Chain Analysis
4.3.1. Process Flow Procurement Analysis
4.3.2. Sales and Distribution Channel Analysis
4.3.3. Downstream Buyer Analysis
Chapter 5. COVID 19 Impact on Pharmacovigilance Market
5.1. COVID-19 Landscape: Pharmacovigilance Industry Impact
5.2. COVID 19 - Impact Assessment for the Industry
5.3. COVID 19 Impact: Global Major Government Policy
5.4. Market Trends and Opportunities in the COVID-19 Landscape
Chapter 6. Market Dynamics Analysis and Trends
6.1. Market Dynamics
6.1.1. Market Drivers
6.1.2. Market Restraints
6.1.3. Market Opportunities
6.2. Porter’s Five Forces Analysis
6.2.1. Bargaining power of suppliers
6.2.2. Bargaining power of buyers
6.2.3. Threat of substitute
6.2.4. Threat of new entrants
6.2.5. Degree of competition
Chapter 7. Competitive Landscape
7.1.1. Company Market Share/Positioning Analysis
7.1.2. Key Strategies Adopted by Players
7.1.3. Vendor Landscape
7.1.3.1. List of Suppliers
7.1.3.2. List of Buyers
Chapter 8. Global Pharmacovigilance Market, By Clinical Trial Phase
8.1. Pharmacovigilance Market, by Clinical Trial Phase Type, 2024-2033
8.1.1. Preclinical Phase I
8.1.1.1. Market Revenue and Forecast (2021-2033)
8.1.2. Phase II
8.1.2.1. Market Revenue and Forecast (2021-2033)
8.1.3. Phase III
8.1.3.1. Market Revenue and Forecast (2021-2033)
8.1.4. Phase IV
8.1.4.1. Market Revenue and Forecast (2021-2033)
Chapter 9. Global Pharmacovigilance Market, By Service Provider Type
9.1. Pharmacovigilance Market, by Service Provider Type, 2024-2033
9.1.1. In-house
9.1.1.1. Market Revenue and Forecast (2021-2033)
9.1.2. Contract Outsourcing
9.1.2.1. Market Revenue and Forecast (2021-2033)
Chapter 10. Global Pharmacovigilance Market, By End User
10.1. Pharmacovigilance Market, by End User Type, 2024-2033
10.1.1. Hospitals
10.1.1.1. Market Revenue and Forecast (2021-2033)
10.1.2. Pharmaceutical Companies
10.1.2.1. Market Revenue and Forecast (2021-2033)
10.1.3. Others
10.1.3.1. Market Revenue and Forecast (2021-2033)
Chapter 11. Global Pharmacovigilance Market, By Therapeutic Area
11.1. Pharmacovigilance Market, by Therapeutic Area Type, 2024-2033
11.1.1. Oncology
11.1.1.1. Market Revenue and Forecast (2021-2033)
11.1.2. Neurology
11.1.2.1. Market Revenue and Forecast (2021-2033)
11.1.3. Cardiology
11.1.3.1. Market Revenue and Forecast (2021-2033)
11.1.4. Respiratory Systems
11.1.4.1. Market Revenue and Forecast (2021-2033)
11.1.5. Others
11.1.5.1. Market Revenue and Forecast (2021-2033)
Chapter 12. Global Pharmacovigilance Market, By Type
12.1. Pharmacovigilance Market, by Type, 2024-2033
12.1.1. Spontaneous Reporting
12.1.1.1. Market Revenue and Forecast (2021-2033)
12.1.2. Intensified ADR Reporting
12.1.2.1. Market Revenue and Forecast (2021-2033)
12.1.3. Targeted Spontaneous Reporting
12.1.3.1. Market Revenue and Forecast (2021-2033)
12.1.4. Cohort Event Monitoring
12.1.4.1. Market Revenue and Forecast (2021-2033)
12.1.5. EHR Mining
12.1.5.1. Market Revenue and Forecast (2021-2033)
Chapter 13. Global Pharmacovigilance Market, By Process Flow
13.1. Pharmacovigilance Market, by Service Provider Type, 2024-2033
13.1.1. Case Data Management
13.1.1.1. Market Revenue and Forecast (2021-2033)
13.1.2. Signal Detection
13.1.2.1. Market Revenue and Forecast (2021-2033)
13.1.3. Risk Management System
13.1.3.1. Market Revenue and Forecast (2021-2033)
Chapter 14. Global Pharmacovigilance Market, Regional Estimates and Trend Forecast
14.1. North America
14.1.1. Market Revenue and Forecast, by Clinical Trial Phase (2021-2033)
14.1.2. Market Revenue and Forecast, by Service Provider (2021-2033)
14.1.3. Market Revenue and Forecast, by End User (2021-2033)
14.1.4. Market Revenue and Forecast, by Therapeutic Area (2021-2033)
14.1.5. Market Revenue and Forecast, by Type (2021-2033)
14.1.6. Market Revenue and Forecast, by Process Flow (2021-2033)
14.1.7. U.S.
14.1.7.1. Market Revenue and Forecast, by Clinical Trial Phase (2021-2033)
14.1.7.2. Market Revenue and Forecast, by Service Provider (2021-2033)
14.1.7.3. Market Revenue and Forecast, by End User (2021-2033)
14.1.7.4. Market Revenue and Forecast, by Therapeutic Area (2021-2033)
14.1.8. Market Revenue and Forecast, by Type (2021-2033)
14.1.8.1. Market Revenue and Forecast, by Process Flow (2021-2033)
14.1.9. Rest of North America
14.1.9.1. Market Revenue and Forecast, by Clinical Trial Phase (2021-2033)
14.1.9.2. Market Revenue and Forecast, by Service Provider (2021-2033)
14.1.9.3. Market Revenue and Forecast, by End User (2021-2033)
14.1.9.4. Market Revenue and Forecast, by Therapeutic Area (2021-2033)
14.1.10. Market Revenue and Forecast, by Type (2021-2033)
14.1.11. Market Revenue and Forecast, by Process Flow (2021-2033)
14.1.11.1.
14.2. Europe
14.2.1. Market Revenue and Forecast, by Clinical Trial Phase (2021-2033)
14.2.2. Market Revenue and Forecast, by Service Provider (2021-2033)
14.2.3. Market Revenue and Forecast, by End User (2021-2033)
14.2.4. Market Revenue and Forecast, by Therapeutic Area (2021-2033)
14.2.5. Market Revenue and Forecast, by Type (2021-2033)
14.2.6. Market Revenue and Forecast, by Process Flow (2021-2033)
14.2.7.
14.2.8. UK
14.2.8.1. Market Revenue and Forecast, by Clinical Trial Phase (2021-2033)
14.2.8.2. Market Revenue and Forecast, by Service Provider (2021-2033)
14.2.8.3. Market Revenue and Forecast, by End User (2021-2033)
14.2.9. Market Revenue and Forecast, by Therapeutic Area (2021-2033)
14.2.10. Market Revenue and Forecast, by Type (2021-2033)
14.2.10.1. Market Revenue and Forecast, by Process Flow (2021-2033)
14.2.11. Germany
14.2.11.1. Market Revenue and Forecast, by Clinical Trial Phase (2021-2033)
14.2.11.2. Market Revenue and Forecast, by Service Provider (2021-2033)
14.2.11.3. Market Revenue and Forecast, by End User (2021-2033)
14.2.12. Market Revenue and Forecast, by Therapeutic Area (2021-2033)
14.2.13. Market Revenue and Forecast, by Type (2021-2033)
14.2.14. Market Revenue and Forecast, by Process Flow (2021-2033)
14.2.14.1.
14.2.15. France
14.2.15.1. Market Revenue and Forecast, by Clinical Trial Phase (2021-2033)
14.2.15.2. Market Revenue and Forecast, by Service Provider (2021-2033)
14.2.15.3. Market Revenue and Forecast, by End User (2021-2033)
14.2.15.4. Market Revenue and Forecast, by Therapeutic Area (2021-2033)
14.2.16. Market Revenue and Forecast, by Type (2021-2033)
14.2.16.1. Market Revenue and Forecast, by Process Flow (2021-2033)
14.2.17. Rest of Europe
14.2.17.1. Market Revenue and Forecast, by Clinical Trial Phase (2021-2033)
14.2.17.2. Market Revenue and Forecast, by Service Provider (2021-2033)
14.2.17.3. Market Revenue and Forecast, by End User (2021-2033)
14.2.17.4. Market Revenue and Forecast, by Therapeutic Area (2021-2033)
14.2.18. Market Revenue and Forecast, by Type (2021-2033)
14.2.18.1. Market Revenue and Forecast, by Process Flow (2021-2033)
14.3. APAC
14.3.1. Market Revenue and Forecast, by Clinical Trial Phase (2021-2033)
14.3.2. Market Revenue and Forecast, by Service Provider (2021-2033)
14.3.3. Market Revenue and Forecast, by End User (2021-2033)
14.3.4. Market Revenue and Forecast, by Therapeutic Area (2021-2033)
14.3.5. Market Revenue and Forecast, by Type (2021-2033)
14.3.6. Market Revenue and Forecast, by Process Flow (2021-2033)
14.3.7. India
14.3.7.1. Market Revenue and Forecast, by Clinical Trial Phase (2021-2033)
14.3.7.2. Market Revenue and Forecast, by Service Provider (2021-2033)
14.3.7.3. Market Revenue and Forecast, by End User (2021-2033)
14.3.7.4. Market Revenue and Forecast, by Therapeutic Area (2021-2033)
14.3.8. Market Revenue and Forecast, by Type (2021-2033)
14.3.9. Market Revenue and Forecast, by Process Flow (2021-2033)
14.3.10. China
14.3.10.1. Market Revenue and Forecast, by Clinical Trial Phase (2021-2033)
14.3.10.2. Market Revenue and Forecast, by Service Provider (2021-2033)
14.3.10.3. Market Revenue and Forecast, by End User (2021-2033)
14.3.10.4. Market Revenue and Forecast, by Therapeutic Area (2021-2033)
14.3.11. Market Revenue and Forecast, by Type (2021-2033)
14.3.11.1. Market Revenue and Forecast, by Process Flow (2021-2033)
14.3.12. Japan
14.3.12.1. Market Revenue and Forecast, by Clinical Trial Phase (2021-2033)
14.3.12.2. Market Revenue and Forecast, by Service Provider (2021-2033)
14.3.12.3. Market Revenue and Forecast, by End User (2021-2033)
14.3.12.4. Market Revenue and Forecast, by Therapeutic Area (2021-2033)
14.3.12.5. Market Revenue and Forecast, by Type (2021-2033)
14.3.12.6. Market Revenue and Forecast, by Process Flow (2021-2033)
14.3.13. Rest of APAC
14.3.13.1. Market Revenue and Forecast, by Clinical Trial Phase (2021-2033)
14.3.13.2. Market Revenue and Forecast, by Service Provider (2021-2033)
14.3.13.3. Market Revenue and Forecast, by End User (2021-2033)
14.3.13.4. Market Revenue and Forecast, by Therapeutic Area (2021-2033)
14.3.13.5. Market Revenue and Forecast, by Type (2021-2033)
14.3.13.6. Market Revenue and Forecast, by Process Flow (2021-2033)
14.4. MEA
14.4.1. Market Revenue and Forecast, by Clinical Trial Phase (2021-2033)
14.4.2. Market Revenue and Forecast, by Service Provider (2021-2033)
14.4.3. Market Revenue and Forecast, by End User (2021-2033)
14.4.4. Market Revenue and Forecast, by Therapeutic Area (2021-2033)
14.4.5. Market Revenue and Forecast, by Type (2021-2033)
14.4.6. Market Revenue and Forecast, by Process Flow (2021-2033)
14.4.7. GCC
14.4.7.1. Market Revenue and Forecast, by Clinical Trial Phase (2021-2033)
14.4.7.2. Market Revenue and Forecast, by Service Provider (2021-2033)
14.4.7.3. Market Revenue and Forecast, by End User (2021-2033)
14.4.7.4. Market Revenue and Forecast, by Therapeutic Area (2021-2033)
14.4.8. Market Revenue and Forecast, by Type (2021-2033)
14.4.9. Market Revenue and Forecast, by Process Flow (2021-2033)
14.4.10. North Africa
14.4.10.1. Market Revenue and Forecast, by Clinical Trial Phase (2021-2033)
14.4.10.2. Market Revenue and Forecast, by Service Provider (2021-2033)
14.4.10.3. Market Revenue and Forecast, by End User (2021-2033)
14.4.10.4. Market Revenue and Forecast, by Therapeutic Area (2021-2033)
14.4.11. Market Revenue and Forecast, by Type (2021-2033)
14.4.12. Market Revenue and Forecast, by Process Flow (2021-2033)
14.4.13. South Africa
14.4.13.1. Market Revenue and Forecast, by Clinical Trial Phase (2021-2033)
14.4.13.2. Market Revenue and Forecast, by Service Provider (2021-2033)
14.4.13.3. Market Revenue and Forecast, by End User (2021-2033)
14.4.13.4. Market Revenue and Forecast, by Therapeutic Area (2021-2033)
14.4.13.5. Market Revenue and Forecast, by Type (2021-2033)
14.4.13.6. Market Revenue and Forecast, by Process Flow (2021-2033)
14.4.14. Rest of MEA
14.4.14.1. Market Revenue and Forecast, by Clinical Trial Phase (2021-2033)
14.4.14.2. Market Revenue and Forecast, by Service Provider (2021-2033)
14.4.14.3. Market Revenue and Forecast, by End User (2021-2033)
14.4.14.4. Market Revenue and Forecast, by Therapeutic Area (2021-2033)
14.4.14.5. Market Revenue and Forecast, by Type (2021-2033)
14.4.14.6. Market Revenue and Forecast, by Process Flow (2021-2033)
14.5. Latin America
14.5.1. Market Revenue and Forecast, by Clinical Trial Phase (2021-2033)
14.5.2. Market Revenue and Forecast, by Service Provider (2021-2033)
14.5.3. Market Revenue and Forecast, by End User (2021-2033)
14.5.4. Market Revenue and Forecast, by Therapeutic Area (2021-2033)
14.5.5. Market Revenue and Forecast, by Type (2021-2033)
14.5.6. Market Revenue and Forecast, by Process Flow (2021-2033)
14.5.7. Brazil
14.5.7.1. Market Revenue and Forecast, by Clinical Trial Phase (2021-2033)
14.5.7.2. Market Revenue and Forecast, by Service Provider (2021-2033)
14.5.7.3. Market Revenue and Forecast, by End User (2021-2033)
14.5.7.4. Market Revenue and Forecast, by Therapeutic Area (2021-2033)
14.5.8. Market Revenue and Forecast, by Type (2021-2033)
14.5.8.1. Market Revenue and Forecast, by Process Flow (2021-2033)
14.5.9. Rest of LATAM
14.5.9.1. Market Revenue and Forecast, by Clinical Trial Phase (2021-2033)
14.5.9.2. Market Revenue and Forecast, by Service Provider (2021-2033)
14.5.9.3. Market Revenue and Forecast, by End User (2021-2033)
14.5.9.4. Market Revenue and Forecast, by Therapeutic Area (2021-2033)
14.5.9.5. Market Revenue and Forecast, by Type (2021-2033)
14.5.9.6. Market Revenue and Forecast, by Process Flow (2021-2033)
Chapter 15. Company Profiles
15.1. ICON Plc
15.1.1. Company Overview
15.1.2. Product Offerings
15.1.3. Financial Performance
15.1.4. Recent Initiatives
15.2. Pharmaceutical Product Development LLC
15.2.1. Company Overview
15.2.2. Product Offerings
15.2.3. Financial Performance
15.2.4. Recent Initiatives
15.3. Parexel International Corporation
15.3.1. Company Overview
15.3.2. Product Offerings
15.3.3. Financial Performance
15.3.4. Recent Initiatives
15.4. IQVIA
15.4.1. Company Overview
15.4.2. Product Offerings
15.4.3. Financial Performance
15.4.4. Recent Initiatives
15.5. Quanticate
15.5.1. Company Overview
15.5.2. Product Offerings
15.5.3. Financial Performance
15.5.4. Recent Initiatives
15.6. Bioclinica
15.6.1. Company Overview
15.6.2. Product Offerings
15.6.3. Financial Performance
15.6.4. Recent Initiatives
15.7. Covance Inc.
15.7.1. Company Overview
15.7.2. Product Offerings
15.7.3. Financial Performance
15.7.4. Recent Initiatives
15.8. Accenture Plc
15.8.1. Company Overview
15.8.2. Product Offerings
15.8.3. Financial Performance
15.8.4. Recent Initiatives
15.9. IBM Corporation
15.9.1. Company Overview
15.9.2. Product Offerings
15.9.3. Financial Performance
15.9.4. Recent Initiatives
15.10. Novartis
15.10.1. Company Overview
15.10.2. Product Offerings
15.10.3. Financial Performance
15.10.4. Recent Initiatives
Chapter 16. Research Methodology
16.1. Primary Research
16.2. Secondary Research
16.3. Assumptions
Chapter 17. Appendix
17.1. About Us
17.2. Glossary of Terms
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