The global pharmacovigilance market size was exhibited at USD 9.07 billion in 2022 and it is expected to hold around USD 16.23 billion by 2030, growing at a CAGR of 7.5% from 2022 to 2030.

Pharmacovigilance refers to monitoring medical drugs' effects once they are licensed. It is the practice of identifying and analyzing previously unreported adverse reactions. Medicines have changed the prevention and treatment of diseases. However, medicinal products may also have side effects. Some of these side effects can be undesirable and unexpected. It covers the detection, assessment, understanding, and prevention of side effects of any medicine or vaccine.

All medicines and vaccines have to undergo strict testing for safety and efficacy. It involves studying these medical products in several selected individuals for some time. It is also called drug safety. It focuses on adverse drug reactions (ADR). It identifies the hazards of pharmaceutical products. It lowers the harm that may come to patients. It is concerned with safety and efficacy. It is a huge and encompassing discipline.  

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Growth Factors 

The global market is majorly driven by the increase in the prevalence of chronic diseases such as oncological diseases, diabetes, and cardiovascular and respiratory diseases. In line with this, the rising drug consumption worldwide significantly contributes to market growth. Furthermore, demand for new drug development has surged. Pharmacovigilance is a part of drug development procedures. The growing prevalence of Adverse Drug Reactions catalyzes market growth. The market was positively influenced by the COVID-19 pandemic. The pandemic impacted businesses, communities, industries, and lives.

Medical monitoring was used to treat the coronavirus-induced infection. Medicines were being repurposed to treat coronavirus. The pandemic has also disrupted traditional onsite clinical trials. These trials were necessary for the development of innovative solutions. The increasing adoption of new technologies and heavy investments in research and development activities creates a positive outlook for the market. A competitive environment has increased demand for pharmacovigilance, improved manufacturing operations, streamlined R&D, and improved manufacturing operations. The regulatory mandates on clinical trial conduct are expected to propel market growth. The increasing awareness regarding safe medication practices catalyzes market growth.  

Pharmacovigilance Market Report Scope

Report Highlights: 

• Based on the service provider, contract outsourcing dominated the market and accounted for the largest revenue share. This is due to its benefits, such as lower fixed costs, risk mitigation, reduction of upfront investments, and resource flexibility. COO provides solutions such as customized services, Standard Operating Procedures (SOP), and PV audits. This is also due to the rising demand for CROs. It delivers end-to-end clinical trial solutions. It offers various benefits such as cost efficiency, resource flexibility, and expansion of operative capabilities. Outsourcing PV services offer various benefits, such as achieving aggressive cost targets. It allows faster trial approval and helps lower clinical trials' complexity. The in-house is expected to witness a promising CAGR in the coming years. This is due to the heavy investments in research and development activities for developing new drugs by pharma companies.  
• Based on the product life cycle, phase IV (post-marketing) dominated and led the overall market. It is a safety measure for drugs going through clinical trials. It is a vital stage of clinical trials. The unsuspected ADR can be detected in this stage. The data collected is expected to be of the highest relevance. Phase III is expected to witness a promising CAGR in the coming years. These trials are conducted to determine the efficacy of drugs. It provides additional information regarding drug safety, drug interactions, and effectiveness before the commercialization of the drug. All these factors are expected to boost the segment's growth.  
• Based on the type, Spontaneous reporting dominated the market and held the largest share. It is widely used to detect new, severe, and rare ADRs. It is an efficient and inexpensive method. The surveillance reports generated by it are widely used. Cohort Event Monitoring (CEM) is the second-largest segment. It is used to detect adverse clinical events. It is an active form of a surveillance method. Targeted spontaneous reporting is expected to witness a promising CAGR in the coming years. This is due to rising government initiatives. It offers various benefits, such as lower labor costs, greater affordability, and usage in routine monitoring. Electronic Health Record (EHR) mining detects risk factors for patients after discharge. It is a source of medical information. It offers various benefits, such as improved care quality, clinical decision-making, improvement of clinical workflow, and patient management. 
• Based on the therapeutic area, oncology dominated the market and held the largest share. The cancer drugs need to be monitored. It boosts the demand for pharmacovigilance services. The increasing incidence of cancer has led to R&D and clinical research. Pharmacovigilance helps in the spontaneous reporting of adverse drug reactions. Moreover, recent advancements in cancer treatments have adverse effects.  

• Based on the process flow, Signal detection dominated the market and accounted for the largest revenue share. Spontaneous Reporting Systems are used to report suspected cases voluntarily and utilize the dominant source of signals. The companies use Artificial Intelligence (AI) and big data for better assessment of signals. Case data management is expected to witness a promising CAGR in the coming years.  
• Based on the end-use, pharmaceuticals dominated the market and held the largest revenue share. Pharmaceutical companies outsource the pharmacovigilance process to avoid fixed overhead costs, secure additional capacity, and have high upfront investments. It is cost-effective for small and medium-sized companies. Biotechnology is expected to witness a promising CAGR in the coming years. This is due to the rising product development activities. Drugs are developed and consumed at high rates. Drug consumption for more extended periods can lead to adverse effects.  

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Regional Snapshot 

Based on the region, North America dominated the market and held the largest revenue share. This is due to a large number of pharmaceutical and medical device players. The rising level of drug abuse leads to morbidity and death. This factor significantly contributes to the market growth across the region. Rising investment in novel drug development catalyzes regional market growth.

The high number of clinical trials contributes to the overall growth. Asia Pacific is expected to witness a promising CAGR in the coming years. This is due to the availability of various outsourcing organizations. Resource sharing, cost efficiency, and enhanced productivity catalyze regional market growth. Heavy investments, increasing awareness among patients, and supportive government initiatives are the factors fueling regional growth. 

Market Dynamics: 

Driver: Increasing public awareness of safer medicines  

Increasing public awareness of safer medicines significantly contributes to global market growth. In line with this, a drug must pass through safety and efficacy parameters during each clinical trial phase. People are aware of the side effects of OTC medicines. It positively influences the demand for safer medications. The surveillance of marketed medications boosts market growth.

Government initiatives and programs create an impact in spreading information about medicines. These factors likely catalyze the pharmacovigilance market growth during the forecast period. 

Opportunity: Outsourcing of PV services 

The outsourcing of PV services offers numerous opportunities for the market players. Pharmaceutical companies and hospitals choose to outsource the PV service. It offers various benefits to manufacturing companies. It allows companies to undergo customization. There is a growing demand for these services. Outsourcing service providers are focused on enhancing their service portfolio.  

Restraint: Inconsistent Reporting of adverse events 

The inconsistent reporting of adverse events restricts market growth. There is a lack of patient awareness about adverse events. It leads to inconsistent reporting. If any adverse event occurs, the patient tends to be anxious. They report it as an adverse event. Not every reported adverse event can be severe. This makes pharmaceutical companies make incorrect decisions. Governments and pharmaceutical companies make fewer efforts to spread awareness about adverse event reporting. These factors are expected to restrict market growth.  

Challenge: Data security 

The pharmacovigilance market growth will likely see a slowdown during the forecasted period owing to the high risk associated with data security. The lack of data standardization and global regulatory harmonization hamper the market growth.  

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Key Developments: 

• In December 2019, Accenture and UCB collaborated to stimulate data processing and improve patient safety.  
• In September 2019, Bayer Zydus Pharma introduced SafeTrack, a novel adverse event reporting mechanism, in Mumbai. It is designed for convenience and ease of use. 

Major Key Players

• ICON Plc
• Pharmaceutical Product Development LLC
• Parexel International Corporation
• IQVIA
• Quanticate
• Bioclinica
• Covance Inc.
• Accenture Plc
• IBM Corporation
• Novartis

Market Segmentation

By Clinical Trial Phase

• Preclinical Phase I
• Phase II
• Phase III
• Phase IV

By Service Provider

• In-house
• Contract Outsourcing

By End User

• Hospitals
• Pharmaceutical Companies
• Others

By Therapeutic Area

• Oncology
• Neurology
• Cardiology
• Respiratory Systems
• Others

By Type

• Spontaneous Reporting
• Intensified ADR Reporting
• Targeted Spontaneous Reporting
• Cohort Event Monitoring
• EHR Mining

By Process Flow

• 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

Regional Segmentation

• North America (U.S., Canada, Mexico)
• Europe (Germany, France, U.K., Italy, Spain, Rest of Europe)
• Asia-Pacific (China, Japan, India, Southeast Asia and Rest of APAC)
• Latin America (Brazil and Rest of Latin America)
• Middle East and Africa (GCC, North Africa, South Africa, Rest of MEA)

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