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Pharmacovigilance Market Size, Share & COVID-19 Impact Analysis, By Type (Service and Software), By Deployment (In-house and Outsource), By End-User (Hospitals, Pharmaceutical Companies, and Others), and Regional Forecast, 2021-2028

Region : Global | Format: PDF | Report ID: FBI102746



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The global pharmacovigilance market size was valued at USD 5.56 billion in 2020 and is projected to grow from USD 6.28 billion in 2021 to USD 14.85 billion in 2028, exhibiting a CAGR of 13.1% during 2021-2028. North America dominated the global market with a share of 39.56% in 2020.

The industry's main objective is to enhance patient care and safety with respect to the use of medicines. It also supports public health programs by providing reliable and balanced information for the correct assessment of the adverse effects of medicines. The industry comprises a series of tasks such as identifying, reporting and analyzing the Adverse Drug Reactions (ADRs) to generate necessary data points required for regulatory action. 

Moreover, increased consumption of medicines by the patient population combined with greater expectations of drug safety is the major factor responsible for the surge in pharmacovigilance market growth in the upcoming years.  

Key Takeaways:

  • The global market exhibited a stellar growth of 15.1% in 2020 compared to the average year-on-year growth during 2017-2019. 

  • North America holds the largest market share, contributing USD 2.23 billion in 2020.

  • On the basis of type, Service segment generating the highest and having the largest market share.

Demand for Pharmacovigilance in Disease Management of COVID-19 Infection to Improve Business Prospects

Pharmacovigilance outsourcing is gaining momentum in revenue and expansion due to advancements in software and services. The existence of an information technology platform has paved a bright path for the global market. Additionally, the emergence of COVID-19 has opened multiple opportunities for pharmaceutical companies to invent novel vaccines, which have initiated several clinical trials. This factor has opened doors for the market, the most important phase of any drug development process. 

Additionally, in November 2020, European Medicines Agency and national competent authorities deployed the pharmacovigilance plan of the EU Regulatory Network for COVID-19 Vaccines. It states the rules for collecting and reviewing the new information emerging after the authorization and uptake of COVID-19 vaccines. The role of professionals in this is supreme, as it touches on all aspects, from case handling to risk management and signal detection.


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Cloud-based Reporting of Adverse Drug Reactions to Facilitate Market Growth

The market is expected to transform at a faster rate over the upcoming years. Software companies are continuously developing and introducing advanced platforms to ensure smooth and automated ADR reporting. At present, a lack of awareness among patients regarding ADR reporting has led to its under-reporting. The introduction of mobile applications or patient-friendly applications can uplift ADR reporting among patients. 

For instance, the Department of Pharmacology of India, KMC Manipal, and Information & Communication developed a mobile application to report adverse drug reactions to ensure patient safety in 2019.

This department is also recognized as a monitoring center for the PV program in the country. Furthermore, the introduction of innovative software for ADR reporting will enhance the market potential during the forecast period. Consequently, cloud-based ADR reporting has become an important aspect as it impacts regulating drug entities post-marketing.     


Increasing Public Awareness for Safer Medicines to Stimulate Market Value

Safety and efficacy are the two important parameters that a drug needs to pass through during each clinical trial phase. Nowadays, the population is more aware of the side effects of OTC medicines, which, thereby boosting the demand for safer medications. This factor is likely to boost the market growth owing to surveillance of marketed medications for possible ADRs. Moreover, government initiatives and programs and pharmaceutical companies’ awareness campaigns create a greater impact in spreading reliable information about medicines, proper use of medicines, side effects, and others. 

For example, Uppsala Monitoring Centre (UMC) conducts a social media campaign every year to promote patient and public awareness about the safe use of medicines and reporting of suspected ADRs.

For instance, In March 2021, The American Society of Pharmacovigilance officially launched the national awareness campaign to inspire victims of adverse drug events to share their stories and build community support while commending healthcare professionals and organizations for discussing how they can provide support for medication safety. Therefore, such positive initiatives are likely to foster the pharmacovigilance market growth during the forecast period.

Outsourcing of PV Services to Expedite Market Growth

Today’s this market allows a choice for the pharmaceutical companies and hospitals to outsource the PV service. Outsourcing offers distinct advantages to the manufacturing companies with respect to time constraints and facilities that an outsourced service can provide. Outsourcing also allows the companies to undergo customization as per their requirements, increasing the speed of the evaluation process.

There is a growing demand for these services in the market, which created multiple opportunities for outsourcing service providers. These providers are focused on enhancing their service portfolio to offer clients more sophisticated solutions. For instance, in 2019, Bayer launched a SafeTrack digital application to report adverse events on International Patient Safety Day. The application is an easy, convenient online platform that allows quick reporting of an AE.


Inconsistent Reporting of Adverse Events in Low and Middle-income Countries to Restrict Market Growth

Due to the lack of patient awareness about adverse events (AE), there is inconsistent reporting. In case of any adverse event, the patient tends to be anxious and report all their discomfort as AE. But, every reported AE may not be serious, subsequently forcing committees in pharmaceutical companies to take incorrect decisions, leading to the withdrawal of the drug. In low- and middle-income countries, appropriate training and services/software are lacking for these niche services. 

Besides, fewer efforts are taken by governments and pharmaceutical companies in spreading awareness regarding AE reporting. These factors are anticipated to restrict the market growth in low- and middle-income countries.


By Type Analysis

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Services to Lead Segmental Dominance in Market

On the basis of type, the global market has been classified as service and software.

The services segment held a dominant position in 2020, generating the highest and having the largest market share. The increasing incidence of infectious diseases worldwide due to lifestyle changes and smoking habits increases the demand for effective medicines. The surging demand for effective medicines has resulted in an increasing number of clinical trials, thus boosting this segment’s prospects to no bounds. 

For instance, owing to the COVID-19 outbreak, pharmaceutical companies all over the globe have entered a race to bring out a novel vaccine against the disease. This factor has led to a generation of multiple clinical trials, creating immense opportunities for PV services.

Moreover, public concerns for drug safety have urged the launch of service platforms, thus elevating the market potential. For example, in November 2020, Veristat announced the acquisition of Certus PV Services Inc. to expand its pharmacovigilance and safety services.  Thus, growing demand for technologically advanced services coupled with the above factors is anticipated to foster the dominant position of the service segment during the forecast period.

On the other hand, the software is expected to have the highest CAGR during the forecast period owing to the rising demand for advanced and automated software required for operations.

By Deployment Analysis

Focus on Cost Reduction Strategy to Uphold In-house Pharmacovigilance

Based on deployment, the market segments include in-house and outsource. Because of cost constraints and lower budgets, pharmaceutical companies have deployed an efficient in-house system within the industry, thereby minimizing costs and generating efficient results in less amount of time. Also, the need for instant results and constant surveillance of the marketed drug has resulted in the shift towards in-house operations, thus leading the segment to a dominant position.

On the flip side, owing to the challenges faced by the in-house facilities such as inexperienced professionals, quality management systems (QMS), and others have called for pharma companies to outsource PV operations. As a result, this segment is anticipated to emerge as the fastest-growing segment during the forecast period. The outsource facilities have professional personnel and well-developed procedural documentation. 

Thus, outsourcing activities allows the end-users to manage the clinical trials and deliver appropriate results on time. For Instance, in 2019, Veera Systems launched Veera Vault Safety, a cloud-based application that enables features such as real-time management of adverse events.

By End-User Analysis

Robust Research & Development by Pharma Companies to Boost Sales of Pharmacovigilance Services

The end-user segment of the global market is classified into hospitals, pharmaceutical companies, and others. Pharmaceutical companies held the leading position in the global market in 2020. Robust R&D by pharmaceutical companies in launching effective medicines has created immense opportunities for this market in providing its services or software. The continuous launch of medicines has resulted in the adoption of pharmacovigilance services by these companies.

The clinical trials conducted at hospitals result in multiple ADRs or AEs, forcing them to approach PV services, thus increasing the value of this market. The hospitals segment is anticipated to have considerable growth during the forecast period.


North America Pharmacovigilance Market Size, 2020 (USD billion)

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On the geographical front, the pharmacovigilance market is classified into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

The market size in North America stood at USD 2.23 billion in 2020, marking its lead position. North America leads the market share, owing to the highest number of pharmacovigilance activities in the region. Moreover, the region has well-established infrastructure with advanced software in managing the activities.

Europe accounts for the second position in the market owing to its focus on the risk assessment of medicinal products. The region has set up various surveillance systems such as the European Medicines Agency, EudraVigilance database, and others to access and monitor ADRs. Additionally, the adoption of software to leverage pharmacovigilance activities has also resulted in the growth of the market in the European region.

Furthermore, Asia Pacific is anticipated to emerge as the fastest-growing region due to developing countries' adoption of these services and software. Also, outsourcing of these facilities to developed countries has increased the market size in Asia Pacific.  As countries such as India and China are the most populated, ADRs and AEs are higher if risk assessment activities are not appropriately conducted.

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On the other hand, Latin America and Middle East & Africa are anticipated to have slower progress due to lesser adoption of these services and software coupled with under-reporting of ADRs.


Adoption of Multi Strategies by the Industry Players to Develop PV Business to Fuel Competition

The market is home to multiple players. Vendors such as Cognizant Technology Solutions, Accenture plc, IQVIA, and many others have successfully established their position through various acquisitions, advanced solutions, and excellent customer-provider relationships. These companies focus on delivering end-to-end solutions to customers by improvising constant strategic developments and providing professional services to pharmaceutical companies. 

Furthermore, companies launch advanced automated software for these services to leverage the market potential. The integration of new tools such as business process management to escalate the efficiency of processes can help companies grow in the global market.



  • June 2021– SSI Strategy, LLC announced the acquisition of Fiore Healthcare Advisors, LLC. This acquisition aims to expand SSI’s already strong Clinical Research and Drug Safety offerings by onboarding a team of experienced Safety Physicians and Clinical Research support.

  • April 2021– ResoluteAI, the research platform for science, announced a release of a set of tools to streamline post market surveillance and PV analysis.


An Infographic Representation of Pharmacovigilance (PV) Market

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The market research report provides a detailed analysis of the market and focuses on key aspects such as leading key players and deployment type. Besides this, the report offers insights into the pharmacovigilance market trends and highlights key industry developments. In addition to the aforementioned factors, the report encompasses several factors that have contributed to the market's growth over recent years. It further highlights some of the growth-stimulating factors and restraints, helping the reader gain in-depth knowledge of the market.

Report Scope & Segmentation



Study Period


Base Year


Estimated Year


Forecast Period


Historical Period



Value (USD billion)


Type, Deployment, End-User, and Geography

By Type


  • Service

  • Software

By Deployment


  • In-house

  • Outsource

By End-User


  • Hospitals

  • Pharmaceutical Companies

  • Others

By Geography


  • North America (By Type, By Deployment, By End-User, and by Country)

    • U.S. (By Type)

    • Canada (By Type)

  • Europe (By Type, By Deployment, By End-User, and by Country)

    • U.K. (By Type)

    • Germany (By Type)

    • France (By Type)

    • Italy (By Type)

    • Spain (By Type)

    • Rest of Europe (By Type)

  • Asia Pacific (By Type, By Deployment, By End-User, and by Country)

    • China (By Type)

    • Japan (By Type)

    • India (By Type)

    • Australia (By Type)

    • Southeast Asia (By Type)

    • Rest of Asia Pacific (By Type)

  • Latin America (By Type, By Deployment, By End-User, and by Country)

    • Brazil (By Type)

    • Mexico (By Type)

    • Rest of Latin America (By Type)

  • Middle East & Africa (By Type, By Deployment, By End-User, and by Country)

    • GCC (By Type)

    • South Africa (By Type)

    • Rest of Middle East & Africa (By Type)

Frequently Asked Questions

The value of the global market was USD 5.56 billion in 2020.

Fortune Business Insights says that the market is projected to reach USD 14.85 billion by 2028.

The value of the market in North America was USD 2.23 billion in 2020.

The market is projected to rise at a CAGR of 13.1% during the forecast period (2021-2028).

The services segment is set to lead this market.

The increase in public awareness for safer medicines and outsourcing services are the key factors driving the global market.

Covance Inc., Ergomed, and Cognizant are the top players in the global market.

North America is expected to hold the highest market share.

Cloud-based reporting of adverse drug reactions is the key trend of the market.

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