Pharmacovigilance Market Size, Share & Industry Analysis, By Type (Service and Software), By Deployment (In-house and Outsource), By End-User (Contract Research Organizations (CROs), Pharmaceutical & Biotechnfology Companies, and Others), and Regional Forecast, 2024-2032

The global pharmacovigilance market size was valued at USD 7.42 billion in 2023. The market is projected to grow from USD 8.32 billion in 2024 to USD 23.45 billion by 2032, exhibiting a CAGR of 13.8% during the forecast period.

Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It aims to ensure the safety and efficacy of medications by monitoring and evaluating their use in real-world settings. These services play a crucial role across the entire drug development and commercialization process, encompassing preclinical, clinical, and post-marketing phases to ensure the safety and efficacy of the pharmaceutical products. It involves collecting, analyzing, and interpreting data from healthcare providers, patients, and regulatory authorities to identify potential risks associated with drugs. By continuously monitoring drug safety, pharmacovigilance plays a crucial role in improving public health outcomes and guiding regulatory decisions to minimize harm from medications. The rise in Adverse Drug Reactions (ADRs) necessitates an increased focus on drug safety monitoring. The growing number of reported ADR cases has increased the demand for services and technologies to track, analyze, and manage drug safety data effectively. The increase in the reporting of adverse drug reactions to the regulatory agencies of different countries is expected to surge the demand for services.

For instance, according to the Performance Report 2021-2022 published by Australia's Therapeutic Goods Administration, around 59,639 adverse event notifications were received in 2020-21, and 125,873 adverse event notifications were received in 2021-22. The global market is expected to grow appreciably due to such scenarios.

Additionally, pharmaceutical companies and healthcare organizations are investing in these solutions to ensure compliance, enhance patient safety, and mitigate risks associated with drug-related adverse events. Furthermore, substantial investments in R&D initiatives, decentralized clinical trials, and increasing product launches in the drugs & vaccines sector have boosted the need for safety monitoring of new products, significantly increasing the demand for services and software. Also, the increasing focus of key players on partnerships and launches of new platforms is expected to propel the market growth during the forecast period.

In 2020, the COVID-19 pandemic positively impacted the global market with the increasing utilization of services during this period and advancements in collecting and utilizing data for drug safety. However, in 2021, the major players in the market reported an increase in the revenue for these services with increasing clinical trials and launches of novel vaccines. In 2022, there was growth in drug safety monitoring for new products due to their rising sales. In 2023, the increasing research and development initiatives and product launches in the drugs & vaccines sector will lead to the stable growth of the market during the forecast period 2024-2032.

Pharmacovigilance Market Trends

Application of Artificial Intelligence to Combat Complex Challenges in these Services is a Prominent Market Trend

The adoption of artificial intelligence in pharmacovigilance significantly enhances the efficiency and effectiveness of drug safety monitoring processes. AI helps to quickly identify potential adverse events and patterns from vast amounts of data from diverse sources.

Furthermore, the implementation of AI in PV can increase the efficiency of PV professionals and allow them to perform more value-based work. As AI improves the capability to detect and assess the ADRs, it leads to better-informed decision-making for regulatory agencies, PV professionals, and pharmaceutical companies.

Additionally, the increasing efforts of major players in the market to introduce Artificial Intelligence (AI)-powered solutions and revolutionize these service offerings are likely to propel the market growth.

• For instance, in April 2023, Parexel International Corporation entered a collaboration agreement with Partex to leverage Artificial Intelligence (AI)-powered solutions to accelerate drug discovery and development for biopharmaceutical end users globally. Such a rise in the adoption of AI to enhance processes is expected to bolster the market's growth prospects.

Pharmacovigilance Market Growth Factors

Increasing Initiatives to Boost Public Awareness About Adverse Drug Event Reporting Will Fuel Market Expansion

The rising public awareness regarding the importance of drug safety and the potential risks associated with medications plays a significant role in driving the growth of the global market. As people become more informed about ADRs, there is a need for vigilant monitoring of medication safety, thus increasing the demand for robust services. Heightened public awareness leads to greater reporting of adverse events by patients and healthcare professionals.

Moreover, increasing initiatives by government bodies to make the public aware with campaigns can play a major role in spreading reliable information about available medicines, proper use of medicines, side effects, and others.

• For example, the 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. Such awareness programs lead to proactive reporting and thus, enhance the adoption of these services.


• In addition, in November 2023, the Federal Office for Safety in Health Care (BASG) participated in the international social media movement MedSafety Week to educate the public about the significance of reporting adverse drug reactions.

Such initiatives and the active participation of government bodies in making the public aware of adverse events will propel the global pharmacovigilance market growth.

Increasing Demand for Contract Outsourcing by Pharmaceutical Companies for Pharmacovigilance Services to Fuel Market Growth

The pharmacovigilance market is expected to experience robust growth due to the increasing preference of pharmaceutical companies for outsourcing services. Outsourcing these services offers several advantages to pharmaceutical companies as it allows them to access a broader range of expertise and resources, including specialized management, regulatory compliance, and safety reporting. Additionally, it helps pharmaceutical companies reduce costs and overhead expenses, and focus on their core competencies and strategic priorities without being burdened by the complexities of drug safety monitoring.

Furthermore, pharmaceutical companies are collaborating with the service providers to expand their capabilities in the market.

• For instance, in April 2023, PHARMALEX GMBH merged with Cpharm, a pharmacovigilance and medical services provider, to expand the service portfolio of both companies in the Australia and New Zealand region. Such collaborations of pharma companies will lead to the growth of the market.

RESTRAINING FACTORS

Absence of Adequate Funding and Skilled Professionals for these Activities May Hinder Market Expansion

In spite of the high demand for pharmacovigilance services, insufficient funding and a shortage of adequately trained professionals pose challenges to the growth of the global market. The lack of financial support prevents the establishment of effective mechanisms for tracking and ensuring the availability of safe drugs, making it difficult to address the specific challenges posed by different diseases and medications.

• According to an article published by the National Institutes of Health (NIH) in 2023, a paper was published to provide an overview of the availability of potential sources of funds, which could be explored to ensure medical safety and offer a potential framework to ensure sustainable funding of PV in Africa. It was found that there were no legal provisions for PV financing in Africa.

Additionally, a shortage of trained professionals leads to delays in reporting, inadequate monitoring of drug safety, and difficulties in meeting regulatory requirements. These challenges not only impact the effectiveness of activities, but also diminish efforts to ensure medication safety and regulatory compliance. Addressing funding constraints and investing in training initiatives are crucial steps to overcome these obstacles and foster the sustainable growth of the market.

Pharmacovigilance Market Segmentation Analysis

By Type Analysis

Growing Outsourcing Practices Enabled Services Segment to Dominate Market

On the basis of type, the global market has been classified into services and software.

The services segment held a dominant position in 2023, generating the highest revenue and capturing the largest market share. The increasing incidence of infectious diseases worldwide due to lifestyle changes and smoking habits is boosting the demand for effective medicines. This factor has resulted in an increasing number of clinical trials, thus boosting this segment’s growth.

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

Furthermore, an increasing number of pharmaceutical companies are outsourcing activities to specialized service providers to streamline their operations, expand their presence in various locations, reduce costs, and access specialized expertise.

• For instance, in January 2024, ProPharma Group (ProPharma), a Research Consulting Organization (RCO), acquired Clinres Farmacija, a Europe-based clinical trial and pharmacovigilance company, to expand its footprint in post-marketing regulatory services and pharmacovigilance.

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

The software segment is the fastest growing segment expected to record the highest CAGR during the forecast period. The segment’s growth is attributed to constant technological advancements, particularly in the areas of automation, artificial intelligence, and machine learning. Additionally, partnerships with the key players to provide services based on software have led to the growth of the segment.

• For instance, in February 2022, Accenture plc. helped Astellas Pharma Inc. develop a cloud-based core IT platform that serves as the foundation for a data-driven and advanced management model for the company’s operations. The platform has been rolled out in the U.S., Japan, and EMEA.

By Deployment Analysis

Focus on Cost Reduction Strategy Accelerates Outsourcing Activities

Based on deployment, the market is segmented into in-house and outsource.

The outsource segment holds a dominant pharmacovigilance market share and is projected to witness the fastest growth during the forecast period. Many pharmaceutical and biotechnology companies are hiring third-party companies for drug safety monitoring. Outsourcing provides pharmaceutical companies with flexibility and agility to adapt to changing regulatory requirements, market dynamics, and business priorities. Due to cost constraints and lower budgets, pharmaceutical companies have deployed an efficient outsource system within the industry, thereby minimizing costs and generating efficient results in less time.

• According to an article published by The Health Foundation in March 2023, most of the pharmaceutical companies in the U.K. have outsourced their early-stage and late-stage R&D.

Also, the need for instant results and constant surveillance of the marketed drug has resulted in the shift toward 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, lead to a lower market share of the segment in the market.

By End-User Analysis

Pharmaceutical & Biotechnology Companies Lead by Boosting Sales of these Services

By end-user, the market is classified into Contract Research Organizations (CROs), pharmaceutical & biotechnology companies, and others.

The pharmaceutical & biotechnology companies segment held the largest market share in 2023. Robust R&D by pharmaceutical companies for 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 these services by these companies.

Additionally, the increasing inspection activities for adverse drug reactions by pharma companies is expected to propel the growth of the segment.

• For instance, in March 2023, Lupin Limited announced the successful completion of the U.S. Food and Drug Administration’s (FDA) inspection of the company's pharmacovigilance group for reporting adverse drug events associated with procedures and products, with zero observations. Such positive results for the pharmaceutical and biotechnology companies will propel the growth of the segment.

Furthermore, the Contract Research Organization (CRO) segment held the second-highest position in the market. The growth of the segment is attributed to the advanced clinical research solutions provided by the CROs with increasing clinical trial activities. CROs specialize in providing outsourced services to pharmaceutical and biopharmaceutical companies. The contract outsourcing provides specialized services and cost-effective solutions for advanced surveillance and thus, the segment has gained dominance in the market.

REGIONAL INSIGHTS

Based on region, the global market is studied across North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

North America dominated the market share and was valued at USD 3.01 billion in 2023. The dominance of the region is attributed to the huge pharmaceutical market size, high healthcare expenditure, advanced infrastructure, and presence of key market players in the region with advanced services and software for drug safety monitoring. Moreover, a stringent regulatory environment, mainly in the U.S., will drive the demand for these services. Additionally, the expansion of the emerging players in the region for providing services will eventually support the region's growth.

• For instance, in February 2024, Ergomed Group expanded its presence in the U.S. by opening a new office in Boston. The company, through the new office, will provide solutions in both rare complex diseases and oncology to the local biotechnology community.

Europe held a substantial market share in 2023. This growth is attributed to the rise in awareness about ADR reports, stringent regulatory guidelines, and presence of leading and emerging players in the region.

Asia Pacific is expected to experience the most significant growth rate throughout the forecast period. The growth is attributed to an increase in awareness regarding ADR reporting, supportive government initiatives, stringent regulatory guidelines, launch of new drugs & vaccines, and expansion of market players in the region. Such factors will boost the adoption of these services in the region.

• In May 2023, Laboratory Corporation of America Holdings, along with the BML Research Institute and General Laboratory, announced the expansion of its clinical laboratory testing capabilities in Japan.

Latin America and the Middle East & Africa will hold a comparatively smaller portion of the market share during the forecast period. The market in these regions is projected to grow due to increasing initiatives for advancing the healthcare infrastructure, rising research & development for new pharmaceutical product launches, and expansion of key players to offer services in the region.

• In October 2023, Fortrea announced that it would focus on patient safety by managing PV and post-approval operations to help promote product safety, quality, and regulatory compliance for the drug development processes in Latin America. Such initiatives by key players are expected to propel the growth of the regional market during the forecast period.

List of Key Companies in Pharmacovigilance Market

Service Offerings and Geographical Presence of Key Companies Anticipated their Market Expansion

Some of the leading companies in the market are IQVIA Inc., Laboratory Corporation of America Holdings, Accenture, and Cognizant. A strong geographical presence, diverse service and software portfolio, and strong emphasis on technological advancements are some of the significant elements contributing to the dominance of these companies in the market.

• For instance, in October 2023, IQVIA Inc. entered a collaboration agreement with Argenx to advance treatment options for patients with rare autoimmune diseases through integrated and innovative technology-enabled PV safety services and solutions.

Some of the other players in the market include Ergomed Group, Parexel International Corporation, Quanticate, ICON plc., Syneos Health, HCL Technologies Limited, and others. These companies are focusing on geographical expansion and diversifying their service and software ranges to increase their market share.

LIST OF KEY COMPANIES PROFILED:

• IQVIA Inc. (U.S.)


• Laboratory Corporation of America Holdings (U.S.)


• Parexel International Corporation (U.S.)


• Accenture (Ireland)


• Cognizant (U.S.)


• Ergomed Group (U.K.)


• Thermo Fisher Scientific Inc. (Pharmaceutical Product Development, LLC) (U.S.)


• ICON plc. (Ireland)


• Quanticate (U.K.)

KEY INDUSTRY DEVELOPMENTS:

• February 2024: Ergomed plc's PrimeVigilance acquired Panacea to increase the global presence of the company in PV, regulatory affairs, quality assurance, auditing, and support services to the pharmaceutical, biotech, and medical device sectors.


• November 2023: Accenture plc. collaborated with Salesforce, Inc. to integrate AI and develop Salesforce Life Sciences Cloud, which will help increase productivity and transform patient and professional experience.


• September 2023: ICON plc. partnered with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to execute a clinical trial to evaluate the effectiveness of next-generation COVID-19 vaccine candidates.


• February 2022: Ergomed plc acquired ADAMAS Consulting Group Limited, an international specialist consultancy offering a broad range of quality assurance services. The acquisition led to the expansion of Ergomed’s global presence and broadened its service offerings to clients.

REPORT COVERAGE

The report provides a detailed analysis of the market and focuses on key aspects, such as leading key players and deployment types. Besides this, it offers insights into the market trends and highlights key industry developments. In addition to the factors mentioned above, the report encompasses several factors that have contributed to the market's growth in 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

ATTRIBUTE	DETAILS
Study Period	2019-2032
Base Year	2023
Estimated Year	2024
Forecast Period	2024-2032
Historical Period	2019-2022
Growth Rate	CAGR of 13.8% from 2024-2032
Unit	Value (USD Billion)
Segmentation	By Type Service Software
By Deployment  In-house  Outsource
By End User Contract Research Organizations (CROs) Pharmaceutical & Biotechnology Companies Others
By Region North America (By Type, Deployment, End-User, and Country) U.S. (By Type) Canada (By Type) Europe (By Type, Deployment, End-User, and Country/Sub-Region) Germany (By Type) U.K. (By Type) France (By Type) Italy (By Type) Spain (By Type) Rest of Europe (By Type) Asia Pacific (By Type, Deployment, End-User, and Country/Sub-Region) 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, Deployment, End-User, and Country/Sub-Region) Brazil (By Type) Mexico (By Type) Rest of Latin America (By Type) Middle East & Africa (By Type, Deployment, End-User, and Country/Sub-Region) GCC (By Type) South Africa (By Type)Rest of the Middle East & Africa (By Type)