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 2023 – 2032


The global pharmacovigilance market size was estimated at USD 8 billion in 2022 and is expected to reach over USD 18.34 billion by 2032, poised to grow at a registered CAGR of 8.70% from 2023 to 2032.

Pharmacovigilance Market Size 2023 to 2032

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Key Takeaway

  • North America market has generated 31% of total revenue share in 2022.
  • Asia Pacific region is expanding at a CAGR of 10.9% between 2023 to 2032.
  • By end user, the pharmaceutical companies dominate the market with the largest revenue share 42.8% in 2022.
  • By service provider, the contract outsourcing segment has generated a revenue share of 60% in 2022.
  • By clinical trial phase, the phase IV segment has garnered a revenue share of 76% in 2022.
  • By process flow, signal detection has held a revenue share of around 39.6% in 2022.
  • By therapeutic area, the oncology segment has captured a revenue share of over 26.8% in 2022 with a CAGR of 11.2%.
  • By type, spontaneous reporting has accounted revenue share of 30.4% in 2022.

Pharmacovigilance Market Size in the U.S. 2023 To 2032

The U.S. pharmacovigilance market size was valued at USD 1.44 billion in 2022 and is predicted to be worth around USD 3.36 billion by 2032, growing at a CAGR of 7.5% between 2023 to 2032.

U.S. Pharmacovigilance Market Size 2023 To 2032

Based on the region, the North America segment dominated the global pharmacovigilance market in 2022, 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.

Growth Factors

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.

Scope of the Pharmacovigilance Market

Report Coverage Details
Market Size in 2023 US$ 8.66 Billion
Growth Rate CAGR of 8.70% from 2023 to 2032
Revenue Projection By 2032 US$ 18.34 Billion
Largest Market North America
Fastest Growing Market Asia Pacific
Base Year 2023
Forecast Period 2023 to 2032
Segments Covered Clinical Trial Phase, Service Provider, End User, Region
Companies Mentioned ICON Plc, Pharmaceutical Product Development LLC, Parexel International Corporation, IQVIA, Quanticate, Bioclinica, Covance Inc., Accenture Plc, IBM Corporation, Novartis

 

Clinical Trial Phase Insights

The phase IV segment has dominated the market with highest revenue share in 2022. 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.

Service Provider Insights

The contract outsourcing segment has accounted hhighest revenue share in 2022. 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.

Pharmacovigilance Market Share, By Service Provider, 2020 (%)

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.  

End User Insights

Based on the end user, the pharmaceutical companies has hed highest revenue share in 2022. 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.

Some of the prominent players in the global pharmacovigilance market include:

  • ICON Plc
  • Pharmaceutical Product Development LLC
  • Parexel International Corporation
  • IQVIA
  • Quanticate
  • Bioclinica
  • Covance Inc.
  • Accenture Plc
  • IBM Corporation
  • Novartis

Segments Covered in the Report

By Clinical Trial Phase

  • Phase I
  • Phase II
  • Phase III
  • Phase IV

By Service Provider

  • In-house
  • Contract Outsourcing

By End User

  • Hospitals
  • Pharmaceutical Companies
  • Others

By Therapeutic Area

  • Oncology
  • Neurology
  • Cardiology
  • Respiratory Systems
  • Others

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

By Geography

  • North America
    • U.S.
    • Canada
  • Europe
    • U.K.
    • Germany
    • France
  • Asia-Pacific
    • China
    • India
    • Japan
    • South Korea
  • Rest of the World

Frequently Asked Questions

How much is the pharmacovigilance market worth?
According to Precedence Research, the global pharmacovigilance market size was reached at US$ 8 billion in 2022 and is predicted to be worth around US$ 18.34 billion by 2032.
What is the pharmacovigilance market growth?
The global pharmacovigilance market is poised to grow at a CAGR of 8.70% from 2023 to 2032.
Which are the driving factors of the pharmacovigilance market?
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.
Who are the major players operating in the pharmacovigilance market?
The major players operating in the pharmacovigilance market are ICON Plc, Pharmaceutical Product Development LLC, Parexel International Corporation, IQVIA, Quanticate, Bioclinica, Covance Inc., Accenture Plc, IBM Corporation, Novartis.
Which region will lead the global pharmacovigilance market?
The North America is the largest segment for pharmacovigilance market in terms of region and will lead in near future.
Which region hit highest CAGR in the global pharmacovigilance market?
The Asia-Pacific region is the fastest growing region in the pharmacovigilance market. The region’s growth is also expected to be aided by key market player’s increasing their investment in innovative drug research.

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