San Francisco, 14 January 2030: The Report Pharmacovigilance Market Size, Share & Trends Analysis Report By Product Life Cycle, By Service Provider (In-house, Contract Outsourcing), By Type, By Therapeutic Area, By Process Flow, By End Use, By Region, And Segment Forecasts, 2024 - 2030

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 6.8% from 2024 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.

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 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.

Pharmacovigilance Market Report Highlights

• Phase IV dominated the market with a revenue share of over 75.85% in 2023. This was driven by increased ADR incidents and post-marketing surveillance
• Contract outsourcing accounted for over 60.63% market share in the service provider segment in 2023, as pharmaceutical organizations aimed to reduce operational costs by outsourcing services
• The spontaneous reporting type segment led the market with a revenue share of over 30.22% in 2023. Its applications include efficient and cost-effective detection of new, serious, and rare ADRs
• Oncology held the largest share of over 26.95% in the therapeutic area segment in 2023, fueled by biopharmaceutical companies’ research efforts in chronic cancer treatments
• Case data management is anticipated to grow at the fastest CAGR of 7.3% in the process flow segment during the forecast period
• Biotechnology companies are expected to have the fastest CAGR of 8.0% in the end-use segment. 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 32.55% in 2023 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

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.

The rising incidence of Adverse Drug Reactions (ADRs) owing to drug abuse and the prevalence of diseases that require a combination of drugs are the major growth drivers for the market. In addition, an upward shift in the production of novel drugs and the presence of stringent government regulatory frameworks for drug safety are significantly boosting the market growth. For instance, the U.S. FDA and the EU’s European Medical Agency (EMA) formulate regulatory guidelines for all phases of clinical trials. Moreover, advancements in the development of ADR databases and information systems have enabled accurate reporting of information, which can be further utilized by research professionals for prospective clinical studies, thereby fueling overall growth.

A rise in the incidence of chronic diseases, such as cancers, diabetes, and cardiovascular & respiratory disorders, has led to an increase in drug consumption worldwide. According to a WHO report on pharmaceutical consumption, medicines to treat chronic diseases accounted for a larger proportion of the total volume of drug consumption in nonhospital setups. Increasing drug development activities in areas such as personalized medicines, biosimilars, orphan drugs, and companion diagnostics, along with adaptive trial designs, is projected to boost the demand for pharmacovigilance services in the coming years.

Furthermore, the increasing incidence of ADR and drug toxicity is fueling the market growth. According to the National Center for Biotechnology Information (NCBI), approximately 5% of total hospitalizations in a year are due to ADR in Europe. 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 Adverse Drug Reactions (ADRs) in the U.S. result in over 100,000 deaths annually and have been a major health concern since the past decade.