Pharmacovigilance Market

Pharmacovigilance Market Outlook (2023 to 2033)

The pharmacovigilance market is anticipated to increase, from US$ 6.87 billion in 2023 to US$ 23.31 billion in 2033. According to FMI, the market is expected to expand at a CAGR of 13% over the course of the projected period.

As a result of the development of chronic illnesses, which necessitates the use of pharmacovigilance more frequently, there is an increased demand for novel pharmaceuticals that are created through meticulous clinical research.

It is anticipated that demand for pharmacovigilance services is likely to increase, as adverse drug reactions (ADRs) happen more frequently. Additionally, a combination of rising expectations for drug safety and rising patient consumption of medications is the main driver of the pharmacovigilance market expansion during the forecast period.

Moreover, clinicians must perform comprehensive tests and data analysis to assure minimal adverse effects, which forces big pharmaceutical companies to work with renowned pharmacovigilance service providers.

Furthermore, the advent of COVID-19 has given pharmaceutical companies a variety of opportunities to create novel vaccines, resulting at the beginning of multiple clinical trials. This function now makes it easier to enter the pharmacovigilance market, which is the most important stage of any medicine development process.

Therefore, during the anticipated time, the growth of the pharmacovigilance market is likely to be supported by such favorable initiatives.

What Strives The Pharmacovigilance Market?

Lack of Awareness:

Inconsistent reporting is a result of patients' lack of knowledge regarding adverse events (AE). The patient typically becomes worried and reports all of their symptoms as an adverse event (AE). But not all reported adverse events (AEs) are necessarily serious, which forces committees in pharmaceutical firms to make bad decisions that result in the drug's withdrawal.

The necessary software, services, and training are missing in low- and middle-income nations for these specialized services. In addition, little is being done by governments and pharmaceutical firms to raise awareness of AE reporting. The pharmacovigilance market expansion in low- and middle-income nations is predicted to be constrained by these issues.

Data Security:

Moreover, the pharmacovigilance market may see a slowdown during the projected period due to issues like the high risk associated with data security, the absence of global regulatory harmonization, and the lack of data standardization for adverse event collecting.

Segmentation Outlook

Why are Phase-IV Clinical Trials acquiring Importance in Pharmacovigilance Market?

With a revenue share of more than 75.1% in 2022, the phase IV (post-marketing) segment took the whole market by storm.

These treatments serve as an extra layer of safety for the medications undergoing clinical trials. Due to intense drug testing on a wide demographic patient base of the highest significance following the commercialization of the drug, it is envisaged that the data gathered and evaluated during this stage is of the highest relevance.

Phase-IV clinical trials have gained substantial importance in the pharmacovigilance market due to their role in post-market surveillance. Conducted after a drug's approval, these trials monitor its safety and efficacy in a broader patient population, offering real-world evidence beyond controlled settings. They are vital for identifying rare adverse events and interactions with different patient profiles, leading to better risk management and patient safety.

Phase-IV trials provide data on a drug's comparative effectiveness, supporting healthcare decision-making and regulatory compliance. They contribute to drug lifecycle management by facilitating label updates, new indications, and market access negotiations. Moreover, Phase-IV trials play a critical role in generating real-world data and evidence, complementing traditional clinical trial information and helping assess a drug's cost-effectiveness. Hence, Phase-IV clinical trials have become indispensable for continuous drug evaluation, ensuring safer and more effective healthcare practices.

Why is Targeted Spontaneous Reporting Attracting Major Investments in the Pharmacovigilance Market?

In 2022, spontaneous reporting accounted for the biggest share with almost 31.1%.

This is because the technique is widely used in the detection of novel, severe, and uncommon ADRs and is both effective and affordable. The extensive use of monitoring reports produced using this methodology by the pharmaceutical industry and regulatory bodies is another factor contributing to the segment's rapid expansion.

Spontaneous reporting plays a vital role in the pharmacovigilance market since it enables the early detection of adverse events related to medications and medical products. This ensures timely interventions to protect patient safety. Regulatory compliance mandates pharmaceutical companies to implement robust pharmacovigilance systems, including effective spontaneous reporting mechanisms. By adhering to these regulations, companies demonstrate their commitment to public health and enhance their market reputation.

The continuous growth of drug pipelines necessitates improved pharmacovigilance capabilities. This leads to investments in technologies and data analytics that streamline spontaneous reporting processes. Additionally, global harmonization efforts in pharmacovigilance standards drive companies to invest in infrastructure and capabilities to meet international requirements. Furthermore, the industry's shift toward patient-centric care has elevated the importance of listening to patients' experiences and concerns. Spontaneous reporting empowers patients to participate actively in drug safety by reporting adverse events they encounter.

Sabyasachi Ghosh

Principal Consultant

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What is the Regional Analysis of the Pharmacovigilance Market?

North America Outlook

North America held the largest revenue share of over 30.0% in 2021 owing to the presence of key pharmaceutical and medical devices players, contributing to the overall revenue in this region. The rising level of drug abuse and associated adverse drug reactions is a leading cause of morbidity and death.

This acts as a high-growth rendering factor for the pharmacovigilance market in North America. Rising investment in novel drug development by major players is also anticipated to propel regional market growth.

The United States has one of the leading pharmaceutical markets globally, making it a crucial region for pharmacovigilance activities. The country's stringent regulatory framework and a strong emphasis on patient safety have fueled the market growth. The increasing number of adverse drug events and drug recalls has led pharmaceutical companies and regulatory authorities to prioritize pharmacovigilance activities. The United States Food and Drug Administration (FDA) plays a vital role in pharmacovigilance, setting strict guidelines for drug safety monitoring and post-market surveillance. The FDA's oversight and commitment to patient safety have contributed to shaping the pharmacovigilance practices in the country. The United States has seen a growing focus on patient-centric pharmacovigilance, where patient-reported outcomes and experiences are actively sought and valued. As the pharmaceutical industry continues to innovate and introduce new therapies, the importance of robust pharmacovigilance practices is likely to only grow in ensuring the safe use of medications in the United States.

Europe Outlook

Currently, a number of clinical trials are anticipated to be carried out to evaluate the effectiveness of different medication candidates, offering up new growth opportunities for UK-based providers of pharmacovigilance solutions.

The London Trials, which are scheduled to start in the summer of 2021, is an example. The Hammersmith Medicines Research organization is managing these trials.

The increasing adoption of personalized medicine in the United Kingdom has led to a surge in the number of medications tailored to individual patient profiles. This trend necessitates rigorous pharmacovigilance efforts to monitor patient responses and identify any adverse reactions specific to certain genetic groups. Healthcare stakeholders in the United Kingdom are increasingly relying on real-world evidence to complement clinical trial data. Pharmacovigilance initiatives are leveraging RWE to gain deeper insights into drug safety and efficacy in real-world settings, thereby improving patient outcomes. The expanding pharmaceutical sector in the United Kingdom, driven by research and development activities, has increased the number of drugs reaching the market. This growth has amplified the demand for pharmacovigilance services to ensure comprehensive drug safety monitoring.

As a leader in innovation and technology, Germany has adopted advanced pharmacovigilance tools such as artificial intelligence, machine learning, and big data analytics to streamline adverse event reporting and signal detection. This has improved efficiency and accuracy in identifying potential safety issues with drugs. The rise in biopharmaceutical companies in Germany has fueled the need for pharmacovigilance services. Biologics require specialized safety monitoring, leading to an increased demand for expert pharmacovigilance support. Germany boasts a robust and well-organized healthcare system. Its comprehensive network of hospitals, clinics, and healthcare professionals ensures timely and accurate reporting of adverse drug reactions. This is contributing to the effectiveness of pharmacovigilance efforts.

Asia Pacific Outlook

Due to the abundance of outsourcing companies, Asia Pacific is anticipated to experience the quickest CAGR during the projection period. Improvements in productivity, cost-effectiveness, and resource sharing, as a result, are predicted to drive up regional demand for pharmacovigilance in the ensuing years.

The regional market is also being driven by expanding investments, rising spending among patients, and supportive government activities for satisfying population needs.

As one of the world's leading pharmaceutical markets, China has witnessed significant growth in its pharmacovigilance sector. The pharmaceutical industry's rapid growth in China directly impacts the pharmacovigilance market. Increased drug production and consumption necessitate more stringent pharmacovigilance measures. China has embraced technological innovations in healthcare, including AI and big data analytics. These advancements have enabled faster and more accurate identification of ADRs, improving overall drug safety surveillance. China's rich history of traditional medicine has led to unique challenges in pharmacovigilance. The coexistence of traditional and modern medicines requires a tailored approach to monitoring and reporting adverse events. The growth of e-commerce in China has also affected pharmacovigilance efforts. It has opened up new channels for the sale of pharmaceutical products, necessitating robust monitoring to detect and address potential safety issues.

The pharmacovigilance market in India has experienced significant growth in recent years. As India's pharmaceutical industry continues to grow, the importance of pharmacovigilance becomes even more effective in maintaining drug safety standards. With an increasing population and growing middle class, the demand for quality healthcare services in India has surged. As a result, the market has witnessed higher demand for drug safety monitoring and reporting. India has emerged as a preferred destination for global pharmaceutical companies to outsource their Pharmacovigilance processes. The availability of a skilled workforce and cost-effectiveness have made India an attractive outsourcing hub for Pharmacovigilance services. India has a significant market for over-the-counter drugs. Since some OTC drugs may not require a prescription, monitoring their adverse effects can be challenging. Pharmacovigilance efforts need to encompass both prescription and non-prescription drugs.

Japan has a strong healthcare infrastructure and a well-established reporting system for adverse drug reactions. The Japanese population is proactive in reporting ADRs, which has led to an increase in the number of pharmacovigilance activities. Many pharmaceutical companies in Japan are outsourcing pharmacovigilance services to specialized third-party providers. This trend is driven by the need to focus on core competencies and ensure compliance with stringent regulations. Japan possesses one of the most prominent aging populations globally. As the elderly are more susceptible to adverse drug reactions, there is a growing focus on monitoring drug safety in this demographic. With the increasing influence of technology, the market in Japan is expected to remain dynamic and essential for ensuring drug safety during the forecast period.

How Are Startups Utilising The Potential In The Pharmacovigilance Market?

Service providers from many regions are developing cutting-edge technologies to support the pharmacovigilance business. The technology comprises real-time products, AI-based solutions, and fresh drugs in the pipeline.

For instance:

• HEPAprint, a British business, creates predictive software to stop negative medication reactions. The software forecasts the potential effects medications may have on particular genetic markers using artificial intelligence (AI) and individual genetic data.
• Pharmacovigilance is supported by digital Software-as-a-Service (SaaS) from the German startup MEDIKURA Digital Health. The start-up makes it possible to collect structured data from end users and includes all required parties, including pharmacists, physicians, patients, and manufacturers.
• AI-based pharmacovigilance solutions are offered by Indian firm Navro Technology Solutions. The business enables pharmaceutical companies to shorten the time required to report adverse drug reactions with the aid of deep learning and AI.

What Is The Competitive Analysis Of The Pharmacovigilance Market?

The patent expiration of branded pharmaceuticals is encouraging new clinical trials to discover new candidates, which is causing prominent companies in the pharmacovigilance market to see an improvement in their revenue prospects. Some market participants use collaborations with top pharmaceutical companies as a key strategy.

Collaboration and Business Services

• In May 2023, JNPMEDI introduced its latest drug safety management solution, 'Maven Safety.' This innovative platform optimizes work efficiency while maintaining cost-effectiveness by offering a subscription-type SaaS solution. It allows users to select and utilize only the necessary functions based on the project's scale.
• In March 2022, The Drug Safety Research Unit (DSRU) inaugurated the Institute of Pharmacovigilance Sciences on a global scale. This significant launch signifies a substantial expansion in the DSRU's proficiency and its 40-year history of conducting methodological and pharmacovigilance research.
• In February 2022, Cognizant established a partnership with Medable Inc. to provide combined clinical research solutions utilizing Medable's software-as-a-service platform, focused on decentralized clinical trials.
• In February 2022, LINK Medical and Viedoc joined forces in a partnership initiated by Viedoc with the aim of enhancing trial efficiency for both LINK Medical and its clients. This collaboration facilitates an ongoing exchange of experiences, requirements, and ideas, as well as the opportunity to test and implement new features.
• In December 2021, through a managed services agreement with Springer Nature, Wipro Limited revealed its plans to introduce regulatory literature monitoring services tailored for pharmaceutical companies. This move effectively expanded the range of services offered by the company.
• In September 2021, IQVIA and NRx Pharmaceuticals entered into a groundbreaking collaboration. The objective was to offer pharmacovigilance services and medical information in readiness for potential regulatory actions.
• In June 2021, SSI Strategy, LLC revealed its acquisition of Fiore Healthcare Advisors, LLC. The main goal of this acquisition is to bolster SSI's already robust Clinical Research and Drug Safety services by integrating a team of skilled Safety Physicians and Clinical Research support professionals.
• In April 2021, ResoluteAI, the science research platform, unveiled a new set of tools designed to simplify post-market surveillance and Pharmacovigilance analysis processes.

• Accenture Plc. and UCB worked together to develop a safety solution based on Accenture's INTIENTTM Pharmacovigilance in December 2019 to utilize artificial intelligence to speed up the process of submitting individual patient safety case reports.
• Given its significant influence in the pharmaceutical pharmaceuticals sector, Bristol-Myers Squibb (BMS) relocated a portion of its drug safety monitoring operations to India in 2017. Employees of Accenture are now running the pharmacovigilance center.

Key Players

• Accenture Plc.
• Bristol-Myers Squibb
• Clinquest Group B.V.
• Cognizant Technology Solutions
• Covance Inc.
• F. Hoffmann-La Roche Ltd.
• GlaxoSmithKline Plc.
• ICON Plc
• iGATE Corporation
• iMED Global Corporation
• inVentiv Health Inc.
• Novartis AG
• PAREXEL International Corporation
• Pfizer Inc.
• Pharmaceutical Product Development LLC. (PPD)
• PRA Health Sciences Inc.
• Quintiles Transnational Holdings Inc.
• Sanofi SA
• Synowledge LLC
• Wipro Ltd.

Key players like Accenture, Cognizant, and IQVIA are benefiting from improved pharmacovigilance management.

Market players are continuously developing safety services to increase the adoption of pharmacovigilance services while concentrating on technological progress. Analytics, AI, and automation have increased the effectiveness of the businesses offering pharmacovigilance services. Automation, machine learning, and artificial intelligence are likely to soon lead to a paradigm shift in pharmacovigilance due to their sophisticated technological capabilities.

Cognizant Technology Solutions, which offers a full range of patient safety services, was recently recognized as one of the top businesses in the pharmacovigilance market in April 2021. This follows the company's ongoing efforts to improve its technologically enabled products in order to better assist clients with their digital transformation.

The market is expanding further due to rising Research and Development and the rising adoption of new technologies in clinical research. For instance, industry players like IQVIA and PRA Health Sciences are expected to boost demand in the upcoming years by incorporating virtual services into the clinical trial protocol.

Rising partnerships in the industry between software suppliers and pharmaceutical firms are also anticipated to fuel the demand for pharmacovigilance.

For instance, in November 2021, Deloitte and Sanofi worked together to develop ConvergeHEALTH Safety, a next-generation adverse events case intake platform powered by artificial intelligence (AI). This platform revolutionizes pharmacovigilance and tackles some of the most urgent operational safety issues facing the sector.

Additionally, eco-pharmacovigilance has gained prominence recently and is essential for reducing the likelihood that pharmaceutical pollutants affect the environment. As a result, pharmaceutical firms might use pharmacovigilance services to lessen environmental pollution, fueling the market's expansion.

There is a significant demand for enhanced manufacturing processes, pharmacovigilance, clinical data management, streamlined Research and Development, and medical writing as a result of the market competition for the introduction of novel compounds. For EUR 1.5 million in 2020, the UK government collaborated with the American business Genpact to create an artificial intelligence tool for screening vaccine adverse drug response (ADR) data.

Key segments

By Phase of Drug Development:

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

By Type of Methods:

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

By Service Type Provider:

• In-house Pharmacovigilance
• Contract Outsourcing

By Geography:

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East & Africa (MEA)