The pharmacovigilance market is expected to register a CAGR of nearly 7.54% during the forecast period, with a revenue of approximately USD 5.6 billion in 2020, and it is expected to reach 8.6 billion by 2026.
The evolving threat of COVID-19 infection is adversely affecting communities, industries, businesses, and lives around the world. Medical monitoring and safety reporting are essential as several potential therapies are being used in the treatment of coronavirus-induced infection. The medications like Lopinavir/Ritonavir, hydroxychloroquine (HCQ), and Remdesivir are being repurposed to treat coronavirus infection. The chances of the suspected adverse drug reaction for some of these medicines have already been submitted to the individual case safety reports database named VigiBase managed by Uppsala Monitoring Centre (UMC). Thus, the rising incidence of adverse drug reactions is anticipated to accelerate the demand for pharmacovigilance services amid pandemics.
The key factors propelling this market are increasing drug consumption and drug development rates, growing incidence rates of adverse drug reactions and drug toxicity, and increasing trend of outsourcing pharmacovigilance services. The increasing incidence of lifestyle diseases, such as diabetes, hypertension, and cardiac disorders, as a result of sedentary lifestyles, lack of physical activities, changing lifestyle patterns, and poor diets lead to increased consumption of drugs, which, in turn, indicates the high demand for drug monitoring and further fuels the growth of the pharmacovigilance market. For instance, cardiovascular disorders have a high burden, globally. For instance, as per the estimates of the Heart Disease and Stroke Statistics 2019, around 116.4 million, or 46% of adults in the United States were estimated to have hypertension.
In addition, as per the American Cancer Society, in 2020, approximately 1.8 million new cancer cases were reported and approximately 606,520 cancer deaths were reported in the United States. Thus, the increasing burden of a diverse range of diseases among all age groups and its burden, globally, drive the demand for therapeutics drug in the treatment of these disorders. With the growing drug consumption, the need for the regular monitoring of drugs has also augmented, eventually boosting the pharmacovigilance market.
Rising government's effort to improve management in pharmacovigilance practices is also likely to boost the market growth. For instance, in 2018, Ministry of AYUSH launched a new Central Sector scheme for promoting pharmacovigilance of Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) Drugs. The scheme is aimed at developing the culture of documenting adverse effects and undertake safety monitoring of Ayurveda, Siddha, Unani and Homoeopathy drugs and surveillance of misleading advertisements appearing in the print and electronic media. Such initiatives are estimated to propel the market growth in the upcoming years.
However, owing to the factors such as high risk associated with data security and lack of global regulatory harmonization and lack of data standardization for adverse event collection, the growth of pharmacovigilance market is expected to get hindered.
Key Market Trends
Pharmaceutical Companies are Expected to Hold the Highest Market Share in the End User Segment
In the end-user segment of the pharmacovigilance market, pharmaceutical companies are believed to have the largest market size. The coronavirus pandemic has led to a significant number of deaths around the world, which has made pharmaceuticals safety reporting and monitoring highly necessary in the context of potential treatment therapies.
The role of pharmaceutical companies is to invest in the R&D of new compounds, have the commitment to bring a new drug to market to enhance the patients' health and quality of life, strict governance to conduct clinical trials, product development activities as well as conduct relations with patients and healthcare professionals in accordance with ethical and legal principles.
Outsourcing the pharmacovigilance process is implemented by pharma companies to avoid fixed overhead costs and high upfront investments, secure additional capacity and increase resource flexibility. Outsourcing pharmacovigilance proves to be a cost-effective endeavor for small and medium-sized companies.
In recent years, drugs are being consumed and developed at significantly high rates. The intake of drugs for longer periods by a large population can lead to adverse effects not seen in the clinical trials. For instance, in 2020, Dexmedetomidine HCL in 0.9% Sodium Chloride Injection by Fresenius Kabi USA were recalled due to cross-contamination of lidocaine which could result in a potentially life-threatening allergic reaction. Thus, the growing need for medical information by the regulatory authorities is also anticipated to fuel the growth of this segment.
Furthremore, recent advancements in cancer treatments, such as targeted therapy, have some serious adverse effects and can compromise a patient's quality of life. For example, from 2014 to 2018 monoclonal antibodies were ranked among the top ten entries for spontaneous adverse drug reaction reports with approximately 406,352 records. Constantly emerging technology and changing reporting systems in pharmacovigilance are driving the segment.
As of 2020, a major pharmaceutical company, such as Astra, has over 100 permanent, experienced staff in pharmacovigilance within its R&D organization in Sweden and the United Kingdom, and a similar number in local operating companies worldwide. This development has been driven by the increased recognition of the role of pharmacovigilance, the investigation, and marketing of a wider range of diverse medicinal products and more stringent and detailed regulatory requirements. Such developments that are occurring in the pharmaceutical companies are helping the pharmacovigilance market grow.
North America Dominates the Market and Expected to do Same in the Forecast Period
North America currently dominates the market for pharmacovigilance and is expected to continue its stronghold for a few more years. Due to the shifting of high costs of in-house pharmacovigilance activities to CROs, the pharmacovigilance system in the United States is moving from a passive to a proactive role in the healthcare system. As per the Institute of Medicine report published in March 2020, nearly 98,000 Americans were dying annually due to medication errors. Estimates of annual patient deaths due to medication errors have since risen steadily to 440,000 lives, which make medication errors the country's third-leading cause of death. Therefore, a need for modifying the current protocols for quick communication between healthcare providers and the FDA needs to be strengthened.
Due to the recent COVID-19, the scientists, clinicians, and FDA are pivoting quickly to push drugs into clinical trials for the treatment of COVID-19. Thus, due to the pandemic situation, there has been a speed up in the identification of potential treatment options for COVID-19 and finding a way to slow or decrease the morbidity and mortality rate. Thus, in this scenario, the pharmacovigilance data plays an important role.
Also, the key health authorities, including the US FDA released guidance for stakeholders, providing guidance on the conduct of clinical trials and post-marketing surveillance, during the COVID-19 pandemic. Although these agencies acknowledge the challenges involved, safety reporting activities are expected to continue as usual, as patient safety is the priority. Therefore, above mentioned factors are in further driving the growth of the market.
Furthermore, the key players are also involved in product launches and strategic collaborations to strengthen their market positions. For instance, in 2019, Accenture launched an INTIENT, a technology platform that improves the continuity and flow of data across life sciences enterprises, supporting the delivery of innovative treatments for patients. Hence, all these factors are propelling the market growth.
The pharmacovigilance market is moderately competitive and consists of several major players. In terms of market share, a few of the major players currently dominate the market. Companies like Accenture, IBM Corporation, Wipro, Cognizant, and Capgemini hold the substantial market share in the pharmacovigilance market. The market is competitive in nature with key participants involved in continuous product development, collaborations, partnerships, and alliances to augment market penetration. For instance, in December 2019, Accenture and UCB announced the collaboration to accelerate data processing and help in improving patient safety, thereby widening their businesses in their respective markets.
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TABLE OF CONTENTS
- 1.1 Study Deliverables
- 1.2 Study Assumptions
- 1.3 Scope of the Study
2 RESEARCH METHODOLOGY
3 EXECUTIVE SUMMARY
4 MARKET DYNAMICS
- 4.1 Market Overview
- 4.2 Market Drivers
- 4.2.1 Increasing Drug Consumption And Drug Development Rates
- 4.2.2 Growing Incidence Rates of Adverse Drug Reaction and Drug Toxicity
- 4.2.3 Increasing Trend of Outsourcing Pharmacovigilance Services
- 4.3 Market Restraints
- 4.3.1 High Risk Associated with Data Security
- 4.3.2 Lack of Global Regulatory Harmonization and Lack of Data Standardization for Adverse Event Collection
- 4.4 Porter's Five Forces Analysis
- 4.4.1 Threat of New Entrants
- 4.4.2 Bargaining Power of Buyers/Consumers
- 4.4.3 Bargaining Power of Suppliers
- 4.4.4 Threat of Substitute Products
- 4.4.5 Intensity of Competitive Rivalry
5 MARKET SEGMENTATION
- 5.1 By Clinical Trial Phase
- 5.1.1 Preclinical
- 5.1.2 Phase I
- 5.1.3 Phase II
- 5.1.4 Phase III
- 5.1.5 Phase IV
- 5.2 Service Provider
- 5.2.1 In house
- 5.2.2 Contract Outsourcing
- 5.3 By Type of Reporting
- 5.3.1 Spontaneous Reporting
- 5.3.2 Intensified ADR Reporting
- 5.3.3 Targeted Spontaneous Reporting
- 5.3.4 Cohort Event Monitoring
- 5.3.5 EHR Mining
- 5.4 By End User
- 5.4.1 Hospitals
- 5.4.2 Pharmaceutical Companies
- 5.4.3 Other End Users
- 5.5 Geography
- 5.5.1 North America
- 184.108.40.206 United States (By Clinical Trial Phase, By Type of Reporting, and By End User)
- 220.127.116.11 Canada (By Clinical Trial Phase, By Type of Reporting, and By End User)
- 18.104.22.168 Mexico (By Clinical Trial Phase, By Type of Reporting, and By End User)
- 5.5.2 Europe
- 22.214.171.124 Germany (By Clinical Trial Phase, By Type of Reporting, and By End User)
- 126.96.36.199 United Kingdom (By Clinical Trial Phase, By Type of Reporting, and By End User)
- 188.8.131.52 France (By Clinical Trial Phase, By Type of Reporting, and By End User)
- 184.108.40.206 Italy (By Clinical Trial Phase, By Type of Reporting, and By End User)
- 220.127.116.11 Spain (By Clinical Trial Phase, By Type of Reporting, and By End User)
- 18.104.22.168 Rest of Europe (By Clinical Trial Phase, By Type of Reporting, and By End User)
- 5.5.3 Asia-Pacific
- 22.214.171.124 China (By Clinical Trial Phase, By Type of Reporting, and By End User)
- 126.96.36.199 Japan (By Clinical Trial Phase, By Type of Reporting, and By End User)
- 188.8.131.52 India (By Clinical Trial Phase, By Type of Reporting, and By End User)
- 184.108.40.206 Australia (By Clinical Trial Phase, By Type of Reporting, and By End User)
- 220.127.116.11 South Korea (By Clinical Trial Phase, By Type of Reporting, and By End User)
- 18.104.22.168 Rest of Asia-Pacific (By Clinical Trial Phase, By Type of Reporting, and By End User)
- 5.5.4 Middle East and Africa
- 22.214.171.124 GCC (By Clinical Trial Phase, By Type of Reporting, and By End User)
- 126.96.36.199 South Africa (By Clinical Trial Phase, By Type of Reporting, and By End User)
- 188.8.131.52 Rest of Middle East and Africa (By Clinical Trial Phase, By Type of Reporting, and By End User)
- 5.5.5 South America
- 184.108.40.206 Brazil (By Clinical Trial Phase, By Type of Reporting, and By End User)
- 220.127.116.11 Argentina (By Clinical Trial Phase, By Type of Reporting, and By End User)
- 18.104.22.168 Rest of South America (By Clinical Trial Phase, By Type of Reporting, and By End User)
6 COMPETITIVE LANDSCAPE
- 6.1 Company Profiles
- 6.1.1 Accenture
- 6.1.2 ArisGlobal
- 6.1.3 BioClinica
- 6.1.4 Capgemini
- 6.1.5 Cognizant
- 6.1.6 FMD K&L Inc.
- 6.1.7 Foresight Group International AG
- 6.1.8 IBM Corporation
- 6.1.9 ICON PLC
- 6.1.10 IQVIA
- 6.1.11 ITClinical
- 6.1.12 Laboratory Corporation of America Holdings
- 6.1.13 Linical Accelovance
- 6.1.14 PAREXEL International Corporation
- 6.1.15 United BioSource Corporation
- 6.1.16 TAKE Solutions Ltd.
- 6.1.17 Wipro Ltd
7 MARKET OPPORTUNITIES AND FUTURE TRENDS