Pharmacovigilance Market - Forecasts from 2024 to 2029

The global pharmacovigilance market is expected to grow at a compound annual growth rate of 10.54% over the forecast period to reach a market size of US$11.688 billion in 2029 from US$5.798 billion in 2022.

Pharmacovigilance, also known as drug safety, is the science and activities involved with the detection, evaluation, comprehension, and prevention of adverse effects or other medicine or vaccine-related problems. All medicines and vaccines are submitted to rigorous testing for safety and efficacy in clinical trials before they are licenced for use.

The major driving factors of this market include rising drug consumption and drug development rates, rising rates of adverse drug reactions and drug toxicity, and an increasing tendency to outsource pharmacovigilance services. The rising prevalence of lifestyle-related diseases, such as diabetes, hypertension, and cardiovascular diseases (CVDs), as a result of sedentary lifestyles, a lack of physical activity, changing lifestyle patterns, and poor diets, leading to increased drug consumption, indicating a high demand for drug monitoring and fuelling the market growth.

According to the World Health Organization (WHO), 17.9 million people died from CVDs in 2019, accounting for 32% of all global deaths. About 85 % of these fatalities were caused by a heart attack or a stroke. Globally, an estimated 1.28 billion individuals aged 30-79 years have hypertension, with the majority(2/3rd) residing in low- and middle-income nations. Furthermore, diabetes is directly responsible for an anticipated 1.5 million fatalities in 2019.

On the other hand, factors such as high data security risk, a lack of global regulatory harmonization, and a lack of data standards for adverse event collection are expected to pose challenges to the global pharmacovigilance market.

Market Drivers:

An increased prevalence of ADRs is anticipated to drive the global pharmacovigilance market.

The global pharmacovigilance market is expected to grow due to the rise in Adverse Drug Reactions (ADRs). Factors contributing to this growth include rising drug utilization, diverse patient populations, stringent regulatory requirements, drug safety concerns, advanced monitoring technologies, globalization of clinical trials, patient-centric approach, market expansion in developing regions, collaboration between pharmaceutical companies and pharmacovigilance service providers, and post-marketing surveillance activities. Regulatory authorities worldwide require robust pharmacovigilance activities to ensure drug safety, and advanced monitoring technologies like data analytics and artificial intelligence are enhancing the ability to detect and monitor ADRs more effectively.

According to the Centers for Disease Control and Prevention, about 6.7 percent of hospitalized patients experience a severe ADR, with a mortality rate of 0.32 percent. If these figures are assumed to be true, then there are about 2,216,000 severe ADRs in hospitalized patients per year, which results in over 106,000 deaths. If these statistics are assumed to be true, then ADRs are the fourth-largest cause of death, followed by pulmonary illness, diabetes, AIDS, pneumonia, accidents, and automobile accidents. Therefore, the rising global prevalence of ADRs will increase demand in the pharmacovigilance market.

Market Restraints:

Inconsistent reporting of adverse reactions could hinder the global pharmacovigilance market

Pharmacovigilance is concerned with drug quality, dosage mistakes, and adverse drug responses that influence the healthcare system by impacting a large patient population. An adverse reaction does not necessarily occur during a visit to the healthcare center. It may occur several hours after the medication has been administered. Patients failing to report adverse reactions leads to inconsistency in diagnosis and research, which can be life-threatening. Furthermore, administering medicines for extended periods to a large population might result in adverse reactions that have not previously been detected in scientific studies.

For instance, Fresenius Kabi USA recalled Dexmedetomidine HCL in 0.9 % Sodium Chloride Injection in 2020 owing to lidocaine cross-contamination, which could have resulted in a potentially fatal allergic reaction. In 2021, due to the presence of nitrosamine and N-nitroso-varenicline at or above the FDA’s interim permissible consumption limit, Pfizer voluntarily recalled all batches of its Chantix 0.5 mg and 1 mg Tablets to the patient (consumer/user) level. Long-term use of N-nitroso-varenicline may be linked to elevated cancer risk in humans, although there is no immediate danger to individuals using this drug.

North America region is expected to grow significantly.

The global pharmacovigilance market is expected to be dominated by the North American region. The number of drug abuse and associated adverse drug reactions in the United States has increased significantly. According to the U.S. Department of Health and Human Services, ADRs account for an estimated one-third of all hospital adverse events and affect about 2 million hospital stays each year in inpatient settings. Increasing hospital stays from 1.7 to 4.6 days.

ADEs in outpatient settings account for about 3.5 million doctor visits each year, as well as an estimated 1 million emergency room visits and over 125,000 hospitalizations. The pharmacovigilance system in the United States is transitioning from a passive to a proactive role in the healthcare system as a result of the high costs of in-house pharmacovigilance operations being outsourced to contract research organizations.

Key Developments:

• March 2023-LEO Pharma and ICON partnered to expedite clinical trial execution in medical dermatology, aiming to enhance patients' lives by providing access to innovative trials and new medicines. The partnership includes a hybrid sourcing model, focusing on lean scalability in clinical development, co-investment in decentralized trials, access to ICON's in-house ancillary services, economies of scope and scale, and external data. The partnership will support LEO Pharma's 2030 strategy, bringing innovative treatments to patients faster and supporting a more sustainable business.
• February 2023-Parexel, a clinical research organization, launched a series called New Medicines, Novel Insights, providing global insights into drug development trends and evidence-based guidance to the biopharmaceutical industry. The first report, Advancing Rare Disease Drug Development, explores challenges in rare disease drug development and shares best practices. The series emphasizes patient-focused drug development, regulatory navigation, adaptive trials, and patient access. It aims to make clinical development faster, more efficient, and patient-friendly.
• January 2023-IQVIA, a global provider of analytics and clinical research services, partnered with Alibaba Cloud in China for its first collaboration. The company provides solutions hosted in Mainland China using Salesforce on Alibaba Cloud, allowing customers to use or extend their investments on the platform. IQVIA offer rich clinical to commercial products, including its Orchestrated Customer Engagement suite, compliant with Chinese data residency regulations. The partnership enables IQVIA to accelerate and expand the development of solutions tailored to China's localized needs.

Market Segmentation:

By Clinical Trial Phase

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

By Service Provider

• Contract Outsourcing
• In-house

By End-User

• Pharmaceuticals
• Biotechnology Companies
• Medical Device Manufacturers
• Others

By Geography

• North America
• USA
• Canada
• Mexico
• South America
• Brazil
• Argentina
• Others
• Europe
• Germany
• France
• United Kingdom
• Italy
• Spain
• Others
• Middle East and Africa
• Saudi Arabia
• UAE
• South Africa
• Others
• Asia Pacific
• China
• India
• Japan
• South Korea
• Taiwan
• Thailand
• Indonesia
• Others