The pharmacovigilance market is anticipated to increase, from USD 6.87 billion in 2023 to USD 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.
| Attributes | Details |
|---|---|
| Historical Value (2022) | USD 6.28 billion |
| Current Year Value (2023) | USD 6.87 billion |
| Expected Forecast Value (2033) | USD 23.31 billion |
| Historical CAGR (2018 to 2022) | 7.9% |
| Projected CAGR (2023 to 2033) | 13% |
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.
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| Drivers | As a result of increased public awareness of OTC drug adverse effects; there is a greater need for safer drugs. This feature is anticipated to accelerate the demand for pharmacovigilance due to the monitoring of medications that are readily available on the market for potential adverse drug responses. |
|---|---|
| Example | Every year, the Uppsala Monitoring Centre (UMC) runs a social media campaign to raise patient and public awareness of the importance of reporting suspected ADRs and the safe use of medications. |
| Drivers | Credible information on medicines, their correct usage, side effects, and other topics are transmitted more widely thanks to government initiatives, programs, and pharmaceutical firms' awareness campaigns. |
|---|---|
| Example | The American Society of Pharmacovigilance officially launched a national awareness campaign in March 2021 to encourage people who have experienced adverse drug events to share their experiences and foster community support, while praising organizations and healthcare professionals for talking about how they can support medication safety. |
| Drivers | Regarding time restrictions and the facilities that an outsourced service may supply, outsourcing offers clear benefits to manufacturing organizations. Additionally, outsourcing permits businesses to customize services in accordance with their needs, accelerating the evaluation process. |
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| Example | On International Patient Safety Day in 2019, Bayer unveiled the SafeTrack digital application, which allows users to report negative incidents. The program is a simple, practical internet tool that enables prompt reporting of an AE. |
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.
| Segment | 2022 Value Share in Global Market |
|---|---|
| Phase IV | 75.1% |
| Spontaneous Reporting | 31.1% |
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.
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.
Principal Consultant
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.
| Country | United States |
|---|---|
| 2022 Value Share in Global Market | 30.9% |
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.
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.
| Countries | Value CAGR (2023 to 2033) |
|---|---|
| United Kingdom | 12.1% |
| Country | 2022 Value Share in Global Market |
| Germany | 6.9% |
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.
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.
| Countries | Value CAGR (2023 to 2033) |
|---|---|
| China | 16.8% |
| India | 15.4% |
| Country | 2022 Value Share in Global Market |
| Japan | 5.1% |
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.
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
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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
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.
Chronic illness patients are the key consumers of the global market.
Phase 4 is poised to stay attractive, projecting a significant CAGR by 2033.
The market is estimated to secure a valuation of USD 6.87 billion in 2023.
The market is estimated to reach USD 23.31 billion by 2033.
The hospital sector holds high revenue potential.
1. Executive Summary 2. Market Overview 3. Market Background 4. Global Market Analysis 2018 to 2022 and Forecast, 2023 to 2033 5. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Phase of Drug Development 5.1. Preclinical Studies 5.2. Phase I 5.3. Phase II 5.4. Phase III 5.5. Phase IV 6. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Type of Methods 6.1. Spontaneous Reporting 6.2. Intensified ADR Reporting 6.3. Targeted Spontaneous Reporting 6.4. Cohort Event Monitoring 6.5. EHR Mining 7. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Service Type Provider 7.1. In-house Pharmacovigilance 7.2. Contract Outsourcing 8. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Region 8.1. North America 8.2. Latin America 8.3. Western Europe 8.4. Eastern Europe 8.5. South Asia and Pacific 8.6. East Asia 8.7. Middle East and Africa 9. North America Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 10. Latin America Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 11. Western Europe Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 12. Eastern Europe Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 13. South Asia and Pacific Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 14. East Asia Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 15. Middle East and Africa Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 16. Key Countries Market Analysis 17. Market Structure Analysis 18. Competition Analysis 18.1. Accenture Plc. 18.2. Bristol-Myers Squibb 18.3. Clinquest Group B.V. 18.4. Cognizant Technology Solutions 18.5. Covance Inc. 18.6. F. Hoffmann-La Roche Ltd. 18.7. GlaxoSmithKline Plc. 18.8. ICON Plc 18.9. iGATE Corporation 18.10. iMED Global Corporation 18.11. inVentiv Health Inc. 18.12. Novartis AG 18.13. PAREXEL International Corporation 18.14. Pfizer Inc. 18.15. Pharmaceutical Product Development LLC. (PPD) 18.16. PRA Health Sciences Inc. 18.17. Quintiles Transnational Holdings Inc. 18.18. Sanofi SA 18.19. Synowledge LLC 18.20. Wipro Ltd. 19. Assumptions & Acronyms Used 20. Research Methodology
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Pharmacovigilance Market
