Pharmacovigilance Market Size, Share, Trends, Growth, Production, Consumption, Revenue, Company Analysis and Forecast 2021-2028

The global Pharmacovigilance market size is expected to be worth around US$ 14.98 billion by 2028, according to a new report by Vision Research Reports.

The global Pharmacovigilance market size was valued at US$ 6.36 billion in 2020 and is anticipated to grow at a CAGR of 11.9% during forecast period 2021 to 2028.

Growth Factors

The increasing incidence of Adverse Drug Reactions (ADR) is the key growth factor. ADR imposes a substantial burden on healthcare systems and is one of the prominent causes of morbidity in developed countries. According to the National Center for Biotechnology Information (NCBI), approximately 5% of total hospitalizations in Europe each year are due to ADR. Pharmacovigilance services play an integral role in this clinical trial phase by assisting manufacturers in identifying adverse effects associated with the drug.

According to the World Health Organization's (WHO) report on pharmaceutical consumption, medicines to treat chronic diseases accounted for a larger proportion of the total volume of drug consumption in non-hospital setups. Hence, there has been a significant rise in the number of medicines made available to healthcare consumers. The rising demand for drugs has significantly heightened the need for the development of novel therapeutics via extensive clinical trials, which is expected to serve this market with lucrative opportunities.

Moreover, leading pharma companies in developed countries are focusing on outsourcing PV services to reduce costs and minimize operational expenses. This is anticipated to serve as an opportunity for contact research organizations in developing regions to gain more revenue share. Manufacturers are now focusing on remodeling their product development processes in an attempt to cater to patient needs across the globe. These factors are anticipated to fuel the demand for pharmacovigilance services during the forecast period.

Report Highlights

Contract outsourcing held the dominant share of 59.24% in 2020 and is expected to witness the fastest growth in the forthcoming years. This is due to the benefits associated with outsourcing such as risk mitigation, resource flexibility, reduction of upfront investments, and lower fixed cost. Contract outsourcing organizations provide solutions, such as process design Standard Operating Procedure (SOP), PV audits, and other customized services.

The dynamic growth of the contract outsourcing segment can also be attributed to the rapidly emerging CROs providing end-to-end clinical trial solutions, especially in the emerging economies of Asia Pacific, such as India, China, and Japan, enabling resources sharing, cost efficiency, resource flexibility, and expansion of operative capabilities. Outsourcing PV services are accompanied by benefits such as delivering services pertinent to highly complex regulatory requirements, helping to add scalability to accommodate growing product portfolios, and achieving aggressive cost targets. Contract outsourcing also helps reduce the complexity of clinical trials, allows faster approval of trials, and helps effective utilization of internal resources.

The in-house segment is anticipated to witness moderate growth over the forecast period as a consequence of extensive R&D by major pharmaceutical and biotechnological companies for the development of new drugs. This is expected to serve this industry with growth potential in the forthcoming years.

The phase III segment is expected to witness lucrative growth over the forecast period. Phase III trials are done to determine and establish the efficacy of drugs. These trials also provide additional information regarding possible drug interactions, drug safety, and effectiveness before the commercialization of the drug. The aforementioned factors are expected to drive revenue generation in the segment over the forecast period.

Spontaneous reporting held the largest share of 30.34% in 2020 owing to its wide usage in the detection of new, serious, and rare ADRs and its popularity as an efficient and inexpensive method. Wide usage of surveillance reports generated through this method by pharmaceutical industries and regulatory authorities is also responsible for the significant share of spontaneous reporting.

Cohort Event Monitoring (CEM) is projected to witness significant growth over the forecast period owing to increasing application in the detection of a wide range of adverse clinical events. Conjugation of CEM with statistical tools and data mining systems, such as longitudinal health records, is responsible for the growing popularity of this type. It serves as an active form of surveillance method, which can also be used for new as well as older medicines, thus driving the segment.

Targeted spontaneous reporting is anticipated to witness the fastest growth in the near future owing to rising government initiatives to incorporate reporting methodologies other than spontaneous reporting by the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Moreover, the benefits associated with targeted spontaneous reporting such as lower labor costs, greater affordability, feasibility in poor resource settings, and usage in routine monitoring are expected to fuel the segment growth.

Signal detection dominated the market with a revenue share of 39.24% in 2020. Spontaneous Reporting Systems (SRSs) use the dominant source of signals through which the suspected cases get voluntarily reported by the healthcare professionals to the other regulatory bodies. Accurate signal detection depends on various factors such as knowledge of the database, quality data, and tools designed to summarize, visualize, and evaluate the data. Nowadays, Artificial Intelligence (AI) and big data are being used by companies for better assessment of signals.

The case data management segment is expected to witness the fastest growth over the forecast period. The adverse event information can be generated from various modes, such as post-marketing programs, clinical trials, spontaneous reports, and literature.

The oncology segment held the largest share of 26.54% as of 2020. Monitoring the safety of cancer drugs is very important due to the associated side effects, which is propelling the demand for pharmacovigilance services. The drugs mostly have intrinsic biological toxicity and narrow therapeutic window, which can lead to serious adverse reactions in the body. The increasing incidence of cancer resulted in accelerated R&D and clinical research.

Pharmacovigilance helps in the early detection and spontaneous reporting of adverse drug reactions. Moreover, recent advancements in cancer treatments, such as targeted therapy, have some serious adverse effects and can compromise a patient’s quality of life. For instance, monoclonal antibodies were listed among the top 10 entries for spontaneous ADR reports with around 406,352 records from 2014 till 2018. Constantly changing reporting systems and emerging technology in pharmacovigilance are driving the segment.

The biotechnology companies segment is anticipated to witness lucrative growth in the forthcoming years owing to increasing new product development activities in this sector. In recent years, drugs are being developed and consumed at increasingly high rates. The use of drugs over longer periods by a large population can lead to adverse effects not seen in the clinical trials. For instance, Vioxx (an osteoarthritic/ acute pain medication) and Avandia (an anti-diabetic) were marketed for some time before a pattern of safety problems were detected with their use. The growing need for medical information by the regulatory authorities is also anticipated to fuel the growth of this segment.

North America held the largest revenue share of 33.97% in 2020 owing to the presence of key pharmaceutical and medical device 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.

Asia Pacific is expected to register a lucrative CAGR of 13.6% during the forecast period owing to the availability of various outsourcing organizations. Consequentially, there is improved productivity, cost efficiency, and resource sharing that is anticipated to propel the regional demand for pharmacovigilance in the forthcoming years. Furthermore, increasing awareness among patients, rising investments, and supportive government initiatives for meeting the requirements of the population are the factors driving the regional market.

Key Players

• Accenture

• Linical Accelovance

• Cognizant

• Laboratory Corporation of America Holdings

• IBM Corporation

• ArisGlobal

• ICON plc.

• Capgemini

• ITClinical

• FMD K&L

• IQVIA

• TAKE Solutions Ltd.

• PAREXEL International Corporation

• BioClinica Inc.

• Wipro Ltd.

• United BioSource Corporation

Market Segmentation

• Service Provider Outlook

  • In-house

  • Contract Outsourcing

• Product Life Cycle Outlook 

  • Pre-clinical

  • Phase I

  • Phase II

  • Phase III

  • Phase IV

• Type Outlook 

  • Spontaneous Reporting

  • Intensified ADR Reporting

  • Targeted Spontaneous Reporting

  • Cohort Event Monitoring

  • EHR Mining

• Process Flow Outlook

  • Case Data Management

    • Case Logging

    • Case Data Analysis

    • Medical Reviewing & Reporting

  • Signal Detection

    • Adverse Event Logging

    • Adverse Event Analysis

    • Adverse Event Review & Reporting

  • Risk Management System

    • Risk Evaluation System

    • Risk Mitigation System

• Therapeutic Area Outlook

  • Oncology

  • Neurology

  • Cardiology

  • Respiratory Systems

  • Others

• End-use Outlook

  • Pharmaceuticals

  • Biotechnology Companies

  • Medical Device Manufacturers

  • Others

• Regional Outlook 

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Russia

  • Asia Pacific

    • Japan

    • China

    • India

  • Latin America

    • Brazil

    • Mexico

  • Middle East and Africa

    • South Africa

    • Kingdom of Saudi Arabia

The Pharmacovigilance market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.

The report provides size (in terms of volume and value) of Pharmacovigilance market for the base year 2020 and the forecast between 2021 and 2028. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.

This report focuses on the global Pharmacovigilance market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Pharmacovigilance market development in United States, Europe and China.

It is pertinent to consider that in a volatile global economy, we haven’t just conducted Pharmacovigilance market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.

In terms of production side, this report researches the Pharmacovigilance capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.

In terms of consumption side, this report focuses on the consumption of Pharmacovigilance by regions (countries) and application.

Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global Pharmacovigilance market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2028. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.

With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major Pharmacovigilance market companies.

Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Pharmacovigilance market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.

The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.

Overall, this is an in-depth research report specifically for the Pharmacovigilance industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.

The Pharmacovigilance market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to Pharmacovigilance market.

Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of Pharmacovigilance market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.

Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new Pharmacovigilance market. These factors have benefited the growth of the global market for Pharmacovigilance. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.

New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for Pharmacovigilance. The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).

In this study, the years considered to estimate the market size of Pharmacovigilance are as follows:

• Historic Year: 2017-2020
• Base Year: 2020
• Forecast Year 2021 to 2028

Reasons to Purchase this Report:

- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players

Research Methodology:

In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.

This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.

Market Size Estimation

Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).

The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.

Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.

All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.

Market Breakdown and Data Triangulation

After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.

Secondary Sources

Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.

Primary Sources

 In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.

The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.

The study objectives of this report are:

• To analyze and study the global market capacity, production, value, consumption, status (2017-2020) and forecast (2021-2028);
• Focuses on the key manufacturers, to study the capacity, production, value, market share and development plans in future.
• Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
• To define, describe and forecast the market by type, application and region.
• To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
• To identify significant trends and factors driving or inhibiting the market growth.
• To analyze the opportunities in the market for stakeholders by identifying the high growth segments.
• To strategically analyze each submarket with respect to individual growth trend and their contribution to the market
• To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market
• To strategically profile the key players and comprehensively analyze their growth strategies.