Global Pharmacovigilance Market Size By Service Provider (In-house, Contract Outsourcing and Others), By Product Life Cycle (Pre-clinical, Phase I, Phase II), By Type (Spontaneous Monitoring, Intensified ADR Monitoring), By Process Flow (Case Data Management, Signal Detection), By Therapeutic Area (Oncology, Cardiology), By End-Use (Pharmaceuticals, Biotechnology Companies), By Region- Market Size Share and Trends Analysis, Forecast 2023-2032

Report Overview

The global pharmacovigilance market size is expected to be worth around USD 19 billion by 2032 from USD 7.8 billion in 2022, growing at a CAGR of 9.3% during the forecast period from 2022 to 2032.

Drug consumption has increased worldwide as a result of an increase in the prevalence of chronic diseases like oncological diseases, diabetes, and cardiovascular and respiratory conditions. As a result, more and more people are looking for novel drugs developed through extensive clinical trials. A crucial part of drug discovery and development is pharmacovigilance (PV). The number of adverse drug reactions (ADRs) is expected to rise simultaneously with the demand for PV services.

Market Scope

By Type Analysis

Due to widespread application in pharmacovigilance and advantages, such as the simple simulation of data sets for improved drug comparison, spontaneous reporting held the largest type-based revenue share.

Due to its widespread use in the detection of new, serious, and uncommon ADRs, spontaneous reporting held the largest share. Additionally, this section serves as a cost-effective strategy. The significant expansion of the market can also be attributed to the extensive use of these surveillance reports by pharmaceutical companies and regulatory authorities. Due to its growing use in the detection of numerous adverse clinical events, cohort event monitoring (CEM) appeared as the second-largest pharmacovigilance market segment.

This type’s rising popularity can be attributed to the combination of CEM, statistical tools, and data mining systems like longitudinal health records. This active method of surveillance, which can be used with both new and old medicines, is driving the market. The European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP) anticipates that targeted spontaneous reporting will be the fastest-growing segment during the forecast period due to rising government initiatives to incorporate reporting methods other than spontaneous reporting.

In addition, the market expansion is anticipated to be further fueled by the advantages of targeted spontaneous reporting, such as lower labor costs, increased affordability, and use in routine monitoring. After patients have been discharged from hospitals, risk factors are increasingly being identified through electronic health record (EHR) mining. In hospitals and research institutions, electronic health records are essential sources of medical data regarding clinical events.

It is anticipated that the segment’s expansion during the forecast period will be fueled by the advantages of EHR, such as enhanced clinical workflow and patient management, automated access, improved quality of care, and improved clinical decision-making.

By Product Life Cycle Analysis

Phase IV held a dominant share of the product life cycle due to extensive post-marketing surveillance of pharmaceuticals and an increasing number of ADR incidents in the market.

The phase IV (post-marketing) segment commanded a greater share of the overall pharmacovigilance market. These solutions add an extra layer of protection for the drugs in clinical trials. Because unanticipated adverse drug reactions can be detected in this stage, Phase IV is an essential part of clinical trials. Due to extensive drug testing on a large patient base at this stage, it is anticipated that the data collected and evaluated will be of the utmost importance following the drug’s commercialization.

During the forecast period, it is anticipated that the phase III segment will experience profitable growth of 10.5%. The purpose of Phase III trials is to establish a drug’s efficacy. Prior to the drug’s commercialization, these trials also provide additional information regarding potential drug interactions, drug safety, and effectiveness. Over the forecast period, it is anticipated that the aforementioned factors will increase revenue generation in the sector.

By Process Flow Analysis

Spontaneous Reporting Systems, or SRSs, are the most common method by which healthcare professionals voluntarily notify other regulatory bodies of suspected cases.

The primary method by which healthcare professionals voluntarily report suspected cases to other regulatory bodies is through spontaneous reporting systems or SRSs. Accurate signal detection necessitates database knowledge, high-quality data, and data summary, visualization, and evaluation tools. Businesses are currently utilizing big data and artificial intelligence (AI) to enhance signal evaluation.

Over the forecast period, the segment of case data management is anticipated to grow at the fastest rate. Post-marketing programs, clinical trials, spontaneous reports, and literature all have the potential to generate adverse event information.

By Therapeutic Area Analysis

Due to the side effects of cancer drugs, monitoring their safety is crucial.

These services aid in the prevention, detection, and management of drug-induced adverse effects in oncology, as well as the avoidance of prescription orders that are not required. Both new targeted therapy and conventional systemic anti-cancer medications have potential side effects that patients should be aware of.

The oncology market was expected to grow at the fastest rate. Due to the associated side effects, monitoring the safety of cancer drugs is crucial, driving demand for pharmacovigilance services. The majority of the drugs have intrinsic biological toxicity and a limited therapeutic window, both of which have the potential to cause serious side effects in the body. Research and development and clinical research accelerated as a result of the rising incidence of cancer.

The early detection and spontaneous reporting of adverse drug reactions are aided by pharmacovigilance. Additionally, recent advancements in cancer treatment, like targeted therapy, can have a negative impact on a patient’s quality of life. From 2014 to 2018, monoclonal antibodies accounted for approximately 406,352 of the top ten entries for spontaneous ADR reports. In a similar vein, serious adverse drug reactions (ADRs) have emerged as a major health concern over the past ten years and contributed to over 100,000 deaths annually in the United States alone, according to an article that was published in 2019 by BMC informatics. The segment is being driven by constantly evolving reporting systems and new technology.

By Service Provider Analysis

Due to the shift in pharmaceutical companies’ focus toward outsourcing services in order to reduce operational costs, contract outsourcing held a significant share.

During the forecast period, contract outsourcing is anticipated to expand at the fastest. This is due to the benefits of outsourcing, which include lower fixed costs, lower upfront investments, lower risk, and increased resource flexibility. Contract outsourcing companies offer PV audits, process design Standard Operating Procedures (SOP), and other individualized services.

The rapidly emerging CROs that provide end-to-end clinical trial solutions, particularly in the emerging economies of Asia Pacific, such as India, China, and Japan, can also be credited with the dynamic growth of the contract outsourcing segment. Sharing resources, saving money, being flexible with resources, and expanding operative capabilities are all made possible by this.

Outsourcing PV services has many advantages, including the ability to meet ambitious cost targets, increase scalability to accommodate expanding product portfolios, and provide services pertinent to extremely complex regulatory requirements. Clinical trials can be simplified, trials can be approved more quickly, and internal resources can be used more effectively with contract outsourcing.

Due to major pharmaceutical and biotechnological companies’ extensive R&D for the development of new drugs, the in-house market is anticipated to experience moderate growth over the forecast period. This should serve this industry, which has the potential for growth in the coming years.

By End-User Analysis

The hospital sector has the largest market share due to the rise in ADR-related hospital admissions.

Research organizations are anticipated to expand at the quickest rate as research funding for the creation of efficient pharmaceuticals increases. The pharmaceutical industry is expanding thanks to the introduction of new treatments that work. Pharmaceuticals held the most market share. Pharma companies outsource the pharmacovigilance process in order to secure additional capacity, increase resource flexibility, and save money on upfront costs and fixed overhead.

Pharmacovigilance outsourcing is a low-cost option for small and medium-sized businesses. Due to the growing number of activities related to the development of new products in this pharmacovigilance industry, it is anticipated that the biotechnology sector will experience lucrative growth in the upcoming years. Drugs have been developed and consumed at ever-increasing rates in recent years.

There may be side effects not observed in clinical trials when a large population consumes drugs for an extended period of time. For instance, the osteoarthritis/acute pain medication Vioxx and the diabetes medication Avandia were both on the market for some time before a pattern of safety issues with their use was discovered. The segment is also anticipated to be driven by regulatory authorities’ growing demand for medical information.

Key Market Segments

Based By Service Provider

• In-house
• Contract Outsourcing
• Others

Based On the Product Life Cycle

• Pre-clinical
• Phase I
• Phase II
• Phase III
• Phase IV

Based By Type

• Spontaneous Monitoring
• Intensified ADR Monitoring
• Targeted Spontaneous Reporting
• Cohort Event Monitoring
• Others

Based By Process Flow

• Case Data Management
• Signal Detection
• Risk Management System
• Others

Based By Therapeutic Area

• Oncology
• Neurology
• Cardiology
• Pulmonology
• Others

Based By End-User

• Pharmaceuticals
• Biotechnology Companies
• Medical Device Manufacturers
• Others

Market Dynamics

Drivers

A major driver for the industry is the rising prevalence of chronic diseases.

The disease causes persistent and frequently excruciating pain, which is driving up the demand for pain relievers. As a result, the market is being driven by an increasing number of cancer survivors and drug demand. A number of other chronic conditions, including diabetes, cardiovascular disease, and autoimmune diseases, necessitate the use of drug combinations that can result in adverse drug reactions (ADRs). Pharmacovigilance is utilized to address this issue.

Aside from that, the industry is moving forward, thanks to the strict regulatory framework established by the government and the rising production of new pharmaceuticals. For instance, regulatory standards for various stages of clinical studies are developed by the European Medicines Agency and the Food and Drug Administration of the United States. The pharmacovigilance market is also expanding as a result of government initiatives and charitable organizations raising awareness of drug safety. In addition, the industry’s expansion is being driven by the global COVID-19 pandemic and the rising demand for appropriate medications to combat it.

Restraints

Lack of awareness regarding pharmacovigilance in some countries is hampering the pharmacovigilance market growth. In addition, the lack of regulations and standards for pharmacovigilance in some countries is negatively impacting the market growth. Some factors like limited resources and budget constraints to conduct pharmacovigilance to some of the companies, technical limitations, data accuracy issues, data privacy and security issue and high cost associated with the implementation of the system are further inhibiting the growth rate of the market.

Opportunity

By identifying risk factors for adverse drug reactions (ADRs)

Pharmacovigilance is a methodical innovation developed by the pharmaceutical industry. In the process of developing and manufacturing drugs, this is an unavoidable aspect. Pharmacovigilance pharmacists ensure that medications are used safely and appropriately by identifying risk factors for adverse drug reactions (ADRs). Additionally, it encourages the investigation of previously unknown ADRs and their interactions with known ADRs.

Trends

The Pharmaceutical Companies Segment is Expected to Hold a Major Market Share

During the forecast period, it is anticipated that pharmaceutical companies will maintain their substantial market share. Both the production and consumption of drugs have significantly increased in recent years. A lot of people who take drugs for a long time may experience side effects that are unpleasant or even harmful. For instance, due to the presence of Nitrosamine Drug Substance Related Impurity (NDSRI), Aurobindo Pharma USA recalled Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg from the US market in October 2022.

As regulatory authorities’ demand for medical data grows, this market is expected to grow. Over the anticipated time frame, the primary driver of the segment’s growth will be pharmaceutical companies’ growing use of services. In preparation for potential regulatory actions, IQVIA, for instance, established a ground-breaking partnership with NRx Pharmaceuticals in September 2021 to provide services and medical data. Pharmaceutical companies might use services to cut down on pollution in the environment, which would help the market grow.

COVID-19 Impact Analysis

The market is positively impacted by the COVID-19 pandemic. However, because a number of potential treatments are being used to treat the coronavirus-induced infection, safety reporting, and medical monitoring are required.

The market benNitrosamine Druefits from the COVID-19 pandemic. The COVID-19 virus is wreaking havoc on individuals, communities, businesses, and sectors all over the world. However, safety reporting and medical monitoring are required because a coronavirus-induced infection is being treated with a variety of potential medications. To treat coronavirus infection, Remdesivir and other antiretroviral medications like Lopinavir/Ritonavir and hydroxychloroquine (HCQ) are being repurposed. UMC’s VigiBase database of individual case safety reports has already been informed of the possibility of suspected ADRs for some of these medications. This demonstrates how the pandemic led to an increase in the demand for PV services.

Regional Analysis

North America holds a significant share market for pharmacovigilance.

Due to the presence of significant players in the pharmaceutical and medical device industries, which contributed to the overall revenue in this region, North America held the largest revenue share. A major cause of morbidity and mortality is rising drug abuse and related adverse drug reactions.

The North American market benefits from this as a high growth factor. Regional pharmacovigilance market expansion is also anticipated to be fueled by major players’ rising investments in novel drug development. As a result, the number of clinical trials and the requirement for post-marketing surveillance has increased as a result of the large drug production, contributing to the overall expansion.

Key Regions

• North America
  • The US
  • Canada
  • Mexico
• Western Europe
  • Germany
  • France
  • The UK
  • Spain
  • Italy
  • Portugal
  • Ireland
  • Austria
  • Switzerland
  • Benelux
  • Nordic
  • Rest of Western Europe
• Eastern Europe
  • Russia
  • Poland
  • The Czech Republic
  • Greece
  • Rest of Eastern Europe
• APAC
  • China
  • Japan
  • South Korea
  • India
  • Australia & New Zealand
  • Indonesia
  • Malaysia
  • Philippines
  • Singapore
  • Thailand
  • Vietnam
  • Rest of APAC
• Latin America
  • Brazil
  • Colombia
  • Chile
  • Argentina
  • Costa Rica
  • Rest of Latin America
• Middle East & Africa
  • Algeria
  • Egypt
  • Israel
  • Kuwait
  • Nigeria
  • Saudi Arabia
  • South Africa
  • Turkey
  • United Arab Emirates
  • Rest of MEA

Key Players Analysis

Due to the increasing number of new drug developments and the expiration of brand-name drug patents, the market is experiencing a significant expansion

The global market is fairly fragmented with many large and medium-sized players accounting for the majority of market revenue. Major players are developing various strategies, entering into mergers and acquisitions, strategic agreements and contracts, and developing, testing, and introducing more effective therapeutic drugs.

Due to the increasing number of new drug developments and the expiration of brand-name drug patents, the market is experiencing a significant expansion. This has attracted a number of pharmacovigilance service providers, both domestically and internationally. The environment of competition has streamlined research and development and improved clinical data management.

Key players are engaged in ongoing product development, partnerships, alliances, and collaborations to increase market penetration, making the pharmacovigilance market competitive. For instance, Accenture and UCB announced in December 2019 that they would collaborate to speed up data processing and assist in improving patient safety, expanding their respective markets. It is anticipated that the rising number of Contract Research Organizations (CROs) and the rising demand for outsourcing services will further fuel competition in the not-too-distant future.

Recent Developments

The major players in the global pharmacovigilance market are increasingly forming alliances and developing new products to strengthen their positions in the highly competitive market.

• In April 2022, Novartis AG has announced the clinical data for JDQ443, an investigational selective, covalent, and orally bioavailable KRASG12C inhibitor, at the annual meeting of the American Association for Cancer Research. KontRASt-01 (NCT04699188) is a phase Ib/II open-label, multi-center, dose-escalation study of JDQ443 in patients with advanced solid tumors harboring the KRAS G12C mutation, including NSCLC and colorectal cancer.
• In February 2022, PAREXEL International Corporation, a CRO, and n-Lorem Foundation, a non-profit foundation, announced a partnership in support of n-Lorem’s efforts to discover and provide experimental antisense oligonucleotide (ASO) medicines to nano-rare disease patients.

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Market Key Players

There are several major players in the market, which is moderately competitive. The market is currently dominated by a small number of major players in terms of market share. To increase market penetration, the key players are involved in continuous product development, collaborations, partnerships, and alliances.

• Accenture plc
• Bristol-Myers Squibb Company
• Clinquest Group B.V.
• Cognizant Technology Solutions Corporation
• GlaxoSmithKline plc
• ICON plc
• Novartis AG
• Hoffmann-La Roche Ltd.
• PAREXEL International Corporation
• Pfizer Inc.
• ICON plc
• Wipro Limited

Report Scope