Global Pharmacovigilance Market - Forecasts from 2022 to 2027

The global pharmacovigilance market is expected to grow at a compound annual growth rate of 10.49% over the forecast period to reach a market size of US$9.535 billion in 2027 from US$4.743 billion in 2020.



Pharmacovigilance, also referred to 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, leads to increased drug consumption, indicating a high demand for drug monitoring and fueling 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.

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.

Growth Factors

An increased prevalence of ADRs:

According to the Centers for Disease Control and Prevention, about 6.7 percent of hospitalised patients experience a severe adverse drug reaction (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 hospitalised 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.

Restraints:

Inconsistent reporting of adverse reactions:

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.

COVID-19's Impact on the Global Pharmacovigilance Market:

The COVID-19 pandemic has had a positive impact on the global pharmacovigilance market. Due to the pandemic, medications like Lopinavir/Ritonavir, hydroxychloroquine (HCQ), and Remdesivir were repurposed to treat coronavirus infection. Many COVID-19 vaccines were also rolled out on an emergency basis, which could result in unidentified adverse reactions. Thus, the increased prevalence of adverse medication reactions is expected to increase the demand for pharmacovigilance services during pandemics.

Competitive  insight

• October 2021 - ProPharma Group, an Odyssey Investment Partners portfolio company, acquired Pharmica Consulting, a life science consulting company that provides Project Management (PM) consulting services and proprietary operations software to pharmaceutical and biotech companies for clinical trial execution.
• September 2021 - The Indian Pharmacopoeia Commission, the national coordinating centre for the Pharmacovigilance Programme of India, was re-designated as a WHO collaborating centre to assist the WHO in areas of pharmacovigilance in public healthcare programs and regulatory services in developing and underdeveloped nations throughout Asia and beyond.

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
• UK
• Italy
• Spain
• Others
• Middle East and Africa
• Saudi Arabia
• UAE
• South Africa
• Others
• Asia Pacific
• China
• India
• Japan
• South Korea
• Taiwan
• Thailand
• Indonesia
• Others