Pharmacovigilance Market Size, Share & Trends Analysis Report By Service Provider (In-house, Contract Outsourcing), By Product Life Cycle, By Therapeutic Area, By Process Flow, By End-Use, By Type, And Segment Forecasts, 2023 - 2030

Report Overview

The global pharmacovigilance market size was valued at USD 6.70 billion in 2022 and is anticipated to grow at a compound annual growth rate (CAGR) of 7.0% from 2023 to 2030. The increasing prevalence of chronic diseases worldwide, such as diabetes, cancer, respiratory disorders, and cardiovascular diseases, has led to increased drug consumption and the need for extensive clinical trials to develop new drugs. Pharmacovigilance is crucial in ensuring drug safety and monitoring Adverse Drug Reactions (ADRs), driving the demand for PV services.Furthermore, academic initiatives promoting Pharmacovigilance (PV) are expected to contribute to the market's expansion.

For example, in August 2020, Parexel International Corp. and Chitkara Institution in India collaborated to offer a 2-year M.Sc. program in Pharmacovigilance & Clinical Research, highlighting the industry’s commitment to advancing pharmacovigilance practices. The COVID-19 pandemic had a limited positive impact on the market. While it severely affected communities, industries, and lives worldwide, it also led to an increased preference for decentralized clinical trials. Furthermore, the public health emergency raised awareness about the importance of reporting adverse reactions and events, resulting in higher demand for PV solutions.Rising R&D activities give market players a competitive advantage.

Leading pharmaceutical, medical device, and biotechnology companies allocate a notable portion of their revenues to R&D activities, aiming to maintain their market position through innovation. For instance, according to the 2020 annual report, Roche, Novartis, and Merck invested approximately 24.1%, 18.5%, and 28.3% of their annual revenues in R&D, respectively. With increased research activities and related costs, companies face challenges complying with complex global regulatory requirements. These factors highlight the growing importance of expertise and excellence in various areas, such as product lifecycle management, driving the demand for outsourcing services, including PV and drug safety monitoring.

The competitive market for new molecules drives the demand for improved manufacturing, pharmacovigilance, clinical data management, R&D streamlining, and medical writing. Pharmaceutical companies increasingly outsource pharmacovigilance services to enhance flexibility, timelines, and outcomes. Outsourcing provides benefits, such as regulatory compliance, quality improvement, productivity enhancement, and strategic outcomes. According to Veeva Systems’ February 2021 blog, small biotech and pharma companies often lack in-house safety expertise. Modern PV applications enable companies to outsource safety services while maintaining control and data visibility, fostering transparency and collaboration with service providers or Contract Research Organizations (CROs).

In addition, midsize and large companies typically have an internal drug safety team and database, working with vendors to scale and reduce PV costs.Furthermore, innovative drug production and strict government regulations drive the market. Regulatory guidelines for clinical trials are being drafted by the EU's European Medical Agency (EMA) and the U.S. FDA. Advancements in information systems and Adverse Drug Reaction (ADR) databases have enhanced reporting accuracy. Research experts can use this data for future clinical studies, fostering market growth.

Product Life Cycle Insights

On the basis of product life cycles, the market is segmented into pre-clinical, phase 1, phase 2, phase 3, and phase 4 segments. The phase IV (post-marketing) segment dominated the market with a revenue share of over 75% in 2022. This phase is crucial for detecting unexpected ADRs through intensive testing on a large and relevant patient population after commercialization. The phase III segment is projected to witness growth at the fastest CAGR of 7.2% during the forecast period.

Furthermore, the rising cancer prevalence is driving market players to conduct clinical studies for the development of effective therapies. In January 2022, the European Commission estimated approximately 4 million new cancer cases in 2020. In addition, the American Cancer Society projects nearly 1.9 million new cases in the U.S. in 2022. These findings highlight the need for robust clinical research studies guided by pharmacovigilance principles, which are expected to enhance the overall market growth.

Service Provider Insights

On the basis of service providers, the global industry has been further segmented into in-house and contract outsourcing. The contract outsourcing service provider segment dominated the global market in 2022 and accounted for the largest share of 60.2% of the overall revenue. Contract outsourcing enables companies to leverage the expertise of globally present service providers, offering distinct advantages for multinational operations.

As pharmacovigilance regulations and reporting requirements vary across jurisdictions, outsourcing ensures compliance with local obligations and facilitates global safety reporting. For instance, in April 2023, the merger between Pharmalex GmbH and Cpharm Australia exemplifies this trend. By expanding its presence in Australia and New Zealand, Pharmalex Group can serve organizations of various sizes and enhance PV and medical services coverage. This collaboration fosters growth opportunities and strengthens relationships with the local client base, benefiting both organizations.

Type Insights

On the basis of types, the market has been further categorized into spontaneous reporting, intensified ADR reporting, targeted spontaneous reporting, cohort event monitoring, and EHR mining. The spontaneous reporting segment led the market with the highest revenue share of 30.24% in 2022. It is widely used for efficient and cost-effective detection of new, serious, and rare ADRs. The utilization of surveillance reports generated through spontaneous reporting by regulatory authorities and pharmaceutical industries contributes to its significant market share.

The targeted spontaneous reporting segment Is estimated to register the fastest CAGR of 7.6% from 2023 to 2030. It focuses on a well-defined patient group and specifically monitors identified risks associated with particular drug regimens, such as tuberculosis and HIV/AIDS. Furthermore, the rising government initiatives to incorporate reporting methodologies other than spontaneous reporting by the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP) are expected to drive the fastest growth of the targeted spontaneous reporting segment over the forecast period.

Therapeutic Area Insights

In 2022, the oncology segment held the dominant market share of over 25% and is projected to register the fastest CAGR of over 7.5% during the forecast period. Pharmacovigilance in oncology focuses on the specialized monitoring and evaluation of safety data associated with anticancer drugs and therapies. It entails the systematic collection and analysis of adverse events unique to cancer patients, identification of potential drug-related risks, and the implementation of proactive risk management strategies to ensure the safe and effective utilization of cancer treatments.

Furthermore, an increasing number of research activities undertaken by various biopharmaceutical firms for cancer treatments and the rising government support to improve the living condition of cancer victims propelling the research activities is anticipated to accelerate the need for pharmacovigilance in clinical research activities. For instance, the White House in 2023 announced an ambitious project to reduce the death rate of Cancer by at least 50.0% in the next 25 years. To support the initiative, USD 2 billion was granted for R&D purposes in the Cancer Moonshot initiative, which will support clinical, laboratory, public health, and others for cancer treatment. These factors are responsible for the growth and dominance of the segment during the forecast period.

Process Flow Insights

In 2022, the signal detection segment dominated the market with a revenue share of over 35.0%. Signal detection refers to identifying various safety signals and actively searching for such signals across registries and plausible healthcare data sources. Regulators require biopharmaceutical firms to maintain spontaneous reporting systems; most commonly, signals are generated from such reporting systems. Furthermore, process data can be stored in databases maintained by the sponsors, a technology partner, or a contract research organization. Moreover, FAERS, VigiBase, and EudraVigilance are other potential sources of potential signals.

The signal source may vary from spontaneous reporting, interventional studies, and clinical & non-clinical studies to literature, social media, free text, etc.; thus, effective signal detection is important.Companies are implementing strategic measures to enhance their signal detection capabilities. For example, in January 2022, TriNetX acquired Advera Health Analytics, Inc., enabling the provision of refined and validated safety signals to life sciences companies.The case data management segment is expected to exhibit the fastest growth rate of over 7% during the forecast years. This growth is attributed to the generation of adverse event information from diverse sources, including spontaneous reports, clinical trials, post-marketing programs, and literature.

End-Use Insights

The pharmaceuticals segment dominated the market with a revenue share of over 40% in 2022. Pharmacovigilance provides consumer confidence, by effectively allowing them to participate in reporting adverse drug events. Moreover, pharmacovigilance provides pharmaceutical firms to limit drug development costs, as it provides an early warning system. In addition, non-compliance with PV practices for patients in clinical trials provides financial troubles. The biotechnology companies segment is projected to grow at the fastest CAGR of 8.0% during the forecast period.

These companies are implementing patient registry programs to gather long-term safety and effectiveness data for their innovative products. These registries enable patient outcomes monitoring, identifying potential long-term risks, and collecting real-world evidence to support product safety. Furthermore, strategic developments bring data science and IT service market players into the registry practice field. For example, in April 2022, Quantori LLC launched the Registry Science Practice in the U.S., focusing on creating registry programs for stakeholders, such as patients, clinicians, and researchers. In addition, registry programs with multimodal capabilities allow biopharmaceutical players to conduct efficient clinical trials and evaluate patient outcomes under the purview of pharmacovigilance.

Regional Insights

North America dominated the market in 2022 with a significant market share of over 30%. The region benefits from the presence of major pharmaceutical players and medical device companies, contributing significantly to its revenue. The increasing incidence of drug abuse and related ADRs contribute to regional market growth. In addition, growing patient awareness and concerns regarding drug safety positively impact the market.

The strong presence of key market players engaging in strategic initiatives, such as new product launches and mergers & acquisitions, further drives the market. Asia Pacific is projected to grow at the fastest CAGR of 8.5% during the forecast period. This growth is primarily driven by the region’s thriving generic drug market. Factors, such as the rising cases of ADRs, increasing awareness about public safety, and stringent government regulations are anticipated to fuel the market expansion in the region.

Key Companies & Market Share Insights

The market is experiencing notable growth owing to the increasing number of novel drug developments and the patent expiration of branded drugs. This has enticed many international and local service providers in the market. The presence of a competitive milieu has enhanced manufacturing operations, pharmacovigilance, clinical data management, and streamlined R&D.The market is competitive, with key players implementing strategic measures like acquisitions, partnerships, collaborations, and product development to enhance their market presence.

For instance, in December 2022, Qinecsa Solutions UK Ltd. (Qinecsa) acquired Commonwealth Informatics, Inc. (Commonwealth), a significant milestone enabling Qinecsa to establish a comprehensive vigilance platform. This integration combines exceptional pharmacovigilance services with a robust digital platform for capturing, processing, analyzing, and reporting safety data, ultimately providing an end-to-end solution for Qinecsa's customers.Some of the prominent players in the global pharmacovigilance market include:

• Accenture

• IQVIA

• Cognizant

• Clinquest Group B.V. (Linical Americas)

• IBM Corp.

• Laboratory Corporation of America Holdings

• ArisGlobal

• Capgemini

• ITClinical

• ICON plc.

• TAKE Solutions Ltd.

• Parexel International Corp.

• Wipro Ltd.

• United BioSource LLC

• BioClinica Inc.

• ClinChoice (formerly FMD K&L)

Pharmacovigilance Market Report Scope

Global Pharmacovigilance Market Report Segmentation

This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2018 to 2030. For this report, Grand View Research has segmented the global pharmacovigilance market report based on product life cycle, service provider, type, process flow, therapeutic area, end-use, and region:

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

  • Pre-clinical

  • Phase I

  • Phase II

  • Phase III

  • Phase IV

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

  • In-house

  • Contract Outsourcing

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

  • Spontaneous Reporting

  • Intensified ADR Reporting

  • Targeted Spontaneous Reporting

  • Cohort Event Monitoring

  • EHR Mining

• 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

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

  • Oncology

  • Neurology

  • Cardiology

  • Respiratory Systems

  • Others

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

  • Pharmaceuticals

  • Biotechnology Companies

  • Medical Device Manufacturers

  • Others

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

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Russia

    • Denmark

    • Norway

    • Sweden

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • Thailand

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • MEA

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait