Pharmacovigilance Market Size To Reach $11.78 Billion By 2030

Pharmacovigilance Market Growth & Trends

The global pharmacovigilance market size is projected to reach USD 11.78 billion by 2030, according to a new report by Grand View Research, Inc. It is anticipated to witness growth at a CAGR of 6.5% from 2025 to 2030. The key factor responsible for the market growth is the growing incidence of Adverse Drug Reactions (ADR). ADR imposes a significant load on healthcare systems and is one of the evident grounds for morbidity in developed nations. As per the National Center for Biotechnology Information (NCBI), about 1 in 20 hospitalizations in Europe yearly are owing to ADR. Pharmacovigilance (PV) services play a vital role in the clinical trial phase by aiding manufacturers in recognizing the negative consequences associated with the drug.

Furthermore, a February 2022 article published in the Journal of Current Medicine Research and Practice titled “Characterization of Seriousness and Outcome of Adverse Drug Reactions in Patients Receiving Cancer Chemotherapy Drugs - A Prospective Observational Study” revealed that serious ADRs in the U.S. result in over 100,000 deaths annually and have been a major health concern since the past decade. ADRs, such as fatal arrhythmia and liver failure, can result in drug withdrawal from the market as the risks related to the drug usage outweigh its associated benefits. The COVID-19 pandemic presented both opportunities and challenges for PV service providers, leading to the development of innovative platforms for a competitive edge.

For instance, in December 2020, EVERSANA, a commercial services provider in the life sciences industry, collaborated with ArisGlobal, a life sciences software company specializing in automating drug development processes. This partnership was aimed to digitally transform end-to-end PV procedures, ensuring safer and more effective healthcare worldwide. The market for technologically advanced and user-friendly software systems, like cloud-based PV and drug safety platforms, is anticipated to support industry growth over the forecast period. For instance, Clinevo Technologies offers Clinevo Safety, a cloud-based solution encompassing various functionalities, such as Case Processing, Regulatory Submissions/AS2 Gateway, PV Intake, Analytics, and Safety Signals.

This all-in-one platform is driving the market forward. Furthermore, organizational initiatives support the growth of emerging markets like Brazil. For instance, a collaborative Patient Safety and PV program was introduced in Brazil, involving the pharmaceutical industry, academia, clinical practice, and health authorities. Offered by FIPFARMA (Fundação Instituto de Pesquisas Farmacêuticas) and Pharmacy College (Universidade de São Paulo), the program conducted a 30-hour online course in two cohorts (2020 and 2022). It covered crucial topics, such as Healthcare and Pharmacovigilance Overview, Drug Safety & Management, and Patient Safety Culture. Workshops addressed real Challenges Healthcare Professionals (HCPs) faced and encouraged collaborative problem-solving.

Video conferences effectively engaged and educated HCPs, facilitating knowledge sharing and promoting a mindset shift. This initiative positively impacted participants and enhanced PV practices in Brazil. Key pharma companies in developed nations are concentrating on outsourcing PV services to decrease costs and reduce operational expenses. This is expected to create an opportunity for Contact Research Organizations (CROs) in developing territories to acquire more industry share. Manufacturers are renovating their product development procedures to fulfill the growing patient needs worldwide. These factors are predicted to augment the demand for PV services over the forecast period.

Furthermore, PV industry players are implementing strategies like acquisitions, collaborations, expansions, and product launches to broaden their offerings and expand their market presence. For example, in February 2022, Ergomed plc, a specialized services provider to the pharmaceutical industry, acquired ADAMAS Consulting Group Limited. ADAMAS is an international consultancy that offers quality assurance services in pharmaceutical manufacturing, clinical trial auditing, and PV systems. The acquisition, valued at £25.6 million (in pounds), is expected to favor Ergomed’s earnings, with further growth and strategic advantages anticipated in the future.

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Pharmacovigilance Market Report Highlights

• Phase IV dominated the market with a revenue share of over 75.90% in 2024. This was driven by increased ADR incidents and post-marketing surveillance

• contract outsourcing segment held the largest market share in in the service provider segment in 2024, as pharmaceutical organizations aimed to reduce operational costs by outsourcing services

• Spontaneous reporting segment dominated the pharmacovigilance market in 2024 with the largest share. Its applications include efficient and cost-effective detection of new, serious, and rare ADRs

• Oncology held the largest share of over 27.14% in the therapeutic area segment in 2024, fueled by biopharmaceutical companies’ research efforts in chronic cancer treatments

• Case data management is anticipated to grow at the fastest CAGR in the process flow segment during the forecast period

• The biotechnology companies segment is expected to grow at the fastest CAGR during the forecast period. This is due to their focus on R&D for novel products, such as biologics, therapies, and gene therapies

• North America held the largest revenue share of over 32.11% in 2024 due to investments in new drug development, favorable regulations, and a strong presence of research units and clinical trials

• Companies are adopting strategies like new product launches, collaborations, and acquisitions to gain a competitive advantage

Pharmacovigilance Market Segmentation

Grand View Research has segmented the global pharmacovigilance market report based on service provider, product life cycle, type, process flow, therapeutic area, end use, and region:

Pharmacovigilance Product Life Cycle Outlook (Revenue, USD Million, 2018 - 2030)

• Pre-clinical

• Phase I

• Phase II

• Phase III

• Phase IV

Pharmacovigilance Service Provider Outlook (Revenue, USD Million, 2018 - 2030)

• In-house

• Contract Outsourcing

Pharmacovigilance Type Outlook (Revenue, USD Million, 2018 - 2030)

• Spontaneous Reporting

• Intensified ADR Reporting

• Targeted Spontaneous Reporting

• Cohort Event Monitoring

• EHR Mining

Pharmacovigilance End Use Outlook (Revenue, USD Million, 2018 - 2030)

• Pharmaceuticals

• Biotechnology Companies

• Medical Device Manufacturers

• Others

Pharmacovigilance Therapeutic Area Outlook (Revenue, USD Million, 2018 - 2030)

• Oncology

• Neurology

• Cardiology

• Respiratory Systems

• Others

Pharmacovigilance Process Flow Outlook (Revenue, USD Million, 2018 - 2030)

• 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

Pharmacovigilance Regional Outlook (Revenue, USD Million, 2018 - 2030)

• North America

  • U.S.

  • Canada

  • Mexico

• Europe

  • UK

  • Germany

  • France

  • Italy

  • Spain

  • Denmark

  • Sweden

  • Norway

  • Russia

  • Rest of Europe

• Asia Pacific

  • Japan

  • China

  • India

  • Australia

  • Thailand

  • South Korea

  • Rest of Asia Pacific

• Latin America

  • Brazil

  • Argentina

  • Rest of Latin America

• The Middle East and Africa

  • South Africa

  • Saudi Arabia

  • UAE

  • Kuwait

  • Rest of MEA

List of Key Players in the Pharmacovigilance Market

• Accenture

• IQVIA Inc.

• Cognizant

• Clinquest Group B.V. (Linical Americas)

• IBM

• Laboratory Corporation of America Holdings

• ArisGlobal

• Capgemini

• ITClinical

• ICON plc.

• TAKE Solutions Limited

• Parexel International (MA) Corporation

• Wipro

• United BioSource LLC

• BioClinica Inc. (Clario)

• ClinChoice (formerly FMD K&L)