The global pharmacovigilance market is registering growth at a CAGR of 10.6% during the forecast period 2022 to 2030 and to reach valuation USD 18.36 billion by 2030, according to Vision Research Reports.
The global pharmacovigilance market is registering growth at a CAGR of 10.6% during the forecast period 2022 to 2030 and to reach valuation USD 18.36 billion by 2030, according to Vision Research Reports.
Growth Factors
Increasing incidence of Adverse Drug Reactions (ADRs) is the key growth driver. ADR imposes a substantial burden on healthcare systems and is one of the prominent causes of morbidity in developed countries. According to the National Center for Biotechnology Information (NCBI), approximately 5% of total hospitalizations in Europe each year are due to ADR. Pharmacovigilance services play an integral role in this clinical trial phase by assisting manufacturers in identifying adverse effects associated with the drug.
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An increase in the prevalence of chronic diseases such as oncological diseases, diabetes, and cardiovascular and respiratory disorders has led to an increase in drug consumption worldwide. Therefore, the demand for new drug development via extensive clinical trials has increased. Pharmacovigilance (PV) is the inevitable part of drug discovery and development procedures.
Report Coverage
| Report Scope | Details |
| Market Size | US$ 18.36 billion by 2030 |
| Growth Rate | CAGR of 10.6% From 2022 to 2030 |
| Largest Market | North America |
| Base Year | 2021 |
| Forecast Period | 2022 to 2030 |
| Segments Covered | Service Provider, Product life cycle, Type, Process Flow, Therapeutic area, End-use |
| Regional Scope | North America, Europe, Asia Pacific, Latin America, Middle East & Africa |
| Companies Mentioned | Accenture; LinicalAccelovance; Cognizant; Laboratory Corporation of America Holdings; IBM Corporation; ArisGlobal; ICON plc.; Capgemini; ITClinical; FMD K&L; IQVIA; TAKE Solutions Ltd.; PAREXEL International Corporation; BioClinica Inc.; Wipro Ltd.; United BioSource Corporation |
By Service Provider Analysis
Contract outsourcing held the largest share of over 55.0% in 2021 and is expected to witness the fastest growth in the forthcoming years. The growth can be attributed to the benefits associated with outsourcing such as risk mitigation, resource flexibility, reduction of upfront investments, and lower fixed cost.
The dynamic growth of the contract outsourcing segment can also be attributed to the rapidly emerging CROs providing end-to-end clinical trial solutions, especially in the emerging economies of Asia Pacific, such as India, China, and Japan, enabling resources sharing, cost efficiency, resource flexibility, and the expansion of operative capabilities. Contract outsourcing also helps reduce the complexity of clinical trials, allows faster approval of trials, and helps effective utilization of internal resources.
By Product Life Cycle Analysis
The phase IV (post-marketing) segment led the overall market with a revenue share of over 75.0% in 2021. These solutions act as an additional safety measure for the drugs undergoing clinical trials.
The phase III segment is expected to witness lucrative growth over the forecast period. Phase III trials are done to determine and establish the efficacy of drugs. These trials also provide additional information regarding possible drug interactions, drug safety, and effectiveness before the commercialization of the drug.
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By Type Analysis
Spontaneous reporting held the largest share of over 30.0% in 2021 owing to wide usage in the detection of new, serious, and rare ADRs and serves as an efficient and inexpensive method.
Cohort Event Monitoring (CEM) emerged as the second-largest segment in 2021 owing to the increasing application in the detection of a wide range of adverse clinical events. Conjugation of CEM with statistical tools and data mining systems such as longitudinal health records are responsible for the growing popularity of this type.
Targeted spontaneous reporting is projected to be the fastest-growing segment over the forecast period owing to the rising government initiatives to incorporate reporting methodologies other than spontaneous reporting by the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP).
Electronic Health Record (EHR) mining is increasingly used to identify risk factors for patients after discharge from hospitals. Electronic health records are imperative sources of medical information about clinical events in hospitals and research organizations.
By Therapeutic Area Analysis
The oncology segment held the largest revenue share of over 25.0% in 2021. Monitoring the safety of cancer drugs is very important due to the associated side effects, which is propelling the demand for pharmacovigilance services.
Pharmacovigilance helps in the early detection and spontaneous reporting of adverse drug reactions. Moreover, recent advancements in cancer treatments, such as targeted therapy, have some serious adverse effects and can compromise a patient’s quality of life.
By Process Flow Analysis
Signal detection dominated the market with a revenue share of over 35.0% in 2021. Spontaneous Reporting Systems (SRSs) use the dominant source of signals through which the suspected cases get voluntarily reported by the healthcare professionals to the other regulatory bodies.
Artificial Intelligence (AI) and big data are being used by companies for better assessment of signals. The case data management segment is expected to exhibit the fastest growth rate over the forecast period.
By End-use Analysis
Pharmaceuticals held the largest revenue share of over 40.0% in terms of revenue. Outsourcing the pharmacovigilance process is practiced by pharma companies to avoid high upfront investments and fixed overhead costs, increase resource flexibility, and secure additional capacity.
The biotechnology segment is anticipated to witness lucrative growth in the forthcoming years owing to increasing new product development activities in this sector. In recent years, drugs are being developed and consumed at increasingly high rates.
By Regional Analysis
North America held the largest revenue share of over 30.0% in 2021 owing to the presence of key pharmaceutical and medical devices players, contributing to the overall revenue in this region.
Asia Pacific is expected to register the fastest CAGR of 12.1% during the forecast period owing to the availability of various outsourcing organizations. Consequentially, there is improved productivity, cost efficiency, and resource sharing that is anticipated to propel the regional demand for pharmacovigilance in the forthcoming years.
Key Players
- Accenture
- LinicalAccelovance
- Cognizant
- Laboratory Corporation of America Holdings
- IBM Corporation
- ArisGlobal
- ICON plc.
- Capgemini
- ITClinical
- FMD K&L
- IQVIA
- TAKE Solutions Ltd.
- PAREXEL International Corporation
- BioClinica Inc.
- Wipro Ltd.
- United BioSource Corporation
Market Segmentation
- By Service Provider
- In-house
- Contract Outsourcing
- By Product Life Cycle
- Pre-clinical
- Phase I
- Phase II
- Phase III
- Phase IV
- By Type
- Spontaneous Reporting
- Intensified ADR Reporting
- Targeted Spontaneous Reporting
- Cohort Event Monitoring
- EHR Mining
- By Process Flow
- Case Data Management
- Case Logging
- Case Data Analysis
- Medical Reviewing & Reporting
- Signal Detection
- Adverse Event Logging
- Adverse Event Analysis
- Adverse Event Review & Reporting
- Risk Management System
- Risk Evaluation System
- Risk Mitigation System
- Case Data Management
- By Therapeutic Area
- Oncology
- Neurology
- Cardiology
- Respiratory Systems
- Others
- By End-use
- Pharmaceuticals
- Biotechnology Companies
- Medical Device Manufacturers
- Others
- Regional
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East and Africa
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