Pharmacovigilance Market Size By Clinical Trial Phase (Preclinical, Phase I, Phase II, Phase III, Phase IV), By Service Provider (In-house, Contract Outsourcing), Industry Analysis Report, Regional Outlook, Application Potential, Competitive Market Share & Forecast, 2019 – 2025

Published Date: Dec 2019  |  Report ID: GMI853  |  Authors: Sumant Ugalmugle, Rupali Swain

Report Format: PDF   |   Pages: 165   |   Base Year: 2018

Summary Table of Contents Industry Coverage Methodology

Industry trends

Pharmacovigilance Market size crossed USD 4.3 billion in 2018 and is anticipated to register over 10.6% CAGR up to 2025.

Pharmacovigilance Market

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Pharmacovigilance is the science and activities involved in the detection, understanding, assessment and prevention of adverse drug effects or other drug-related problems. Adverse drug reaction (ADR) is an undesirable and unwanted effect of a medication that occurs during its clinical use. Rising number of ADRs is a major concern of the pharmacovigilance field and will contribute to significant increase in the demand for clinical data management services over the forecast period. As per the National Centre for Biotechnology Information (NCBI), number of mortalities due to ADRs amplified more than two-fold in 2014, further leading to surge in hospitalizations. Rising demand for continuous pharmacovigilance for effective surveillance of ADRs will render several growth opportunities for the market expansion.

Pharmacovigilance industry size witnessed remarkable developments owing to rising number of adverse drug reactions, side effects coupled with potential threats to the consumers. Pharmacovigilance was implemented in developed nations earlier in 1970s, including the U.S. and UK, following numerous consumer health protection acts. Increasing number of pharmaceutical companies, as well as global harmonization practices will further assist advancements in the market. Furthermore, emergence of personalized medicines and rising number of ADRs should spur industry size in the foreseeable future.

Pharmacovigilance Market Report Coverage
Report Coverage Details
Base Year: 2018 Market Size in 2018: 4.4 Billion (USD)
Historical Data for: 2014 to 2017 Forecast Period: 2019 to 2025
Forecast Period 2019 to 2025 CAGR: 10.6% 2025 Value Projection: 8.9 Billion (USD)
Pages: 165 Tables, Charts & Figures: 80
Geographies covered (17): U.S., Canada, Germany, UK, Spain, Italy, France, Japan, China, India, Australia, Argentina, Brazil, Mexico, South Africa, UAE, Saudi Arabia, Qatar, Israel
Segments covered: Clinical trial phase, Service provider and Region
Companies covered (26): Accenture, Boehringer Ingelheim, Bristol-Myers Squibb, Clinquest Group, Cognizant, Ecron Acunova, F. Hoffmann-La Roche, GlaxoSmithKline, HCL Technologies, IBM Corporation, ICON plc, iGATE Corporation, Infosys, InVentiv Health Clinical, Ipca Laboratories, IQVIA, ITclinical, Janssen Research & Development, Laboratory Corporation of America Holdings, Novartis, Oracle Corporation, PAREXEL International Corporation, Pfizer, Sanofi Aventis, TCS, Wipro
Growth Drivers:
  • Growth in adoption rate of outsourcing services in Asia Pacific
  • Increasing consumption of drugs in developed regions
  • Rise in adverse drug reactions (ADR) and drug toxicity
  • Increasing acceptance of personalized medicine in developed regions
  • Effective global harmonization practices
Pitfalls & Challenges:
  • Dearth of skilled personnel
  • High risk associated with data security

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Outsourcing pharmacovigilance activities to relieve resource pressure of the firms

Increasing acceptance and adoption of outsourcing services by healthcare companies will stimulate pharmacovigilance (PV) market growth during the forthcoming years. Outsourcing eliminates the risk of business overhead costs as well as deployment of a pharmacovigilance resources. Outsourcing strategy increases the cost-effectiveness and efficiency by relieving resource pressure of the manufacturing companies. Positively shifting trends in pharmacovigilance outsourcing owing to increasing benefits will lead to market expansion in the coming years.

Accelerating demand for personalized medicines will foster market expansion in the foreseeable future. Innovations in personalized medicine will offer growth potential to the market in ways to develop and quantitate risks and benefits of personalized medicines. Increasing advancement in targeted drugs such as new clinical trial phase development will further propel demand for pharmacovigilance services in the coming years. However, dearth of skilled healthcare professionals needed to analyse data and implement solutions may restrict pharmacovigilance market growth. Moreover, increased risk of data security that can be misused by pharmacovigilance personnel may hamper market demand over the coming years.

Phase I clinical trials primarily focus on pharmacokinetic and pharmacodynamic assessment of the drugs

Global Pharmacovigilance Market, By Clinical Trial Phase

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Pharmacovigilance market by clinical trial phases is segmented into preclinical studies, phase I, phase II, phase III and phase IV studies. Phase I clinical trials segment is expected to witness around 10% CAGR during the forecast timeframe. Phase I clinical trials examine the route of drug administration, concentration, maximum tolerated dose (MTD) and its side effects. Phase I trials inspect the pharmacological and metabolic activities of medicine in humans. The aim of this phase is to determine the advantages as well as side effects of the drug in initial phase. Thus, increasing phase I trials will create a huge demand for pharmacovigilance services, thereby escalating the market progress.

Preference towards in-house pharmacovigilance activities to maintain data safety and confidentiality will favor segment growth

Based on service providers, pharmacovigilance market is divided into in-house pharmacovigilance service providers and contract outsourcing. In-house pharmacovigilance segment was valued around 2 billion in 2018 and will witness considerable growth during the analysis period. Issues associated with data confidentiality, data safety, accountability and commitment with outsourcing organizations are some of the prime factors favouring companies to choose in-house pharmacovigilance. Majority of large sized companies prefer in-house due to presence of advanced technology and infrastructure coupled with availability of skilled professionals and strong financial stability. High data security and confidentiality facilitated by in-house pharmacovigilance will augment market growth during the forthcoming years.

Lower labor cost and attractive marketplace for conducting clinical trials to pave the way for Asia Pacific pharmacovigilance industry growth

Asia Pacific Pharmacovigilance Market, By Country,

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Asia Pacific pharmacovigilance market accounted for significant industry share in 2018 and is poised to exceed USD 2.5 billion by 2025. Strict regulations for reporting adverse drug reactions coupled with large number of companies offering pharmacovigilance outsourcing services across the region will foster the market growth. In addition, increasing funding for clinical trials will further spur the regional market outlook over the analysis period.

Indian market held around 22% industry share in 2018. Global pharmaceutical firms have found India to be a favoured marketplace for clinical trials due to large clinical research space and attractive opportunities. Improved compliance with the international guidelines such as the WHO Good Clinical Practice (ICH-GCP)/International Conference on Harmonization (ICH) and the rules set down by the U.S. FDA offers enormous opportunities for clinical trials in the country. Increased awareness among public, training of medical professions and existence of stringent regulations for reporting of ADRs will thus accelerate the market progress in the foreseeable future.

Pharmacovigialcne to provide ample growth opportunities to the industry players worldwide

Few notable industry players operating in global market include Accenture, TCS, Infosys, Cognizant, IBM Corporation, InVentiv Health Clinical, IQVIA (Quintiles IMS), ICON and PAREXEL. These key industry players implement various strategic initiatives that render competitive advantage to the companies.

Some of the recent industry developments:

  • In September 2016, Boehringer Ingelheim announced a long-term collaboration with ViraTherapeutics, a biopharma company developing immunotherapeutic for cancer treatment. This collaboration is intended to develop a novel technology for oncology and to investigate clinical testing of Vesicular Stomatitis Virus Glycoprotein (VSV-GP) in phase I trial.
  • In June 2015, QuintilesIMS launched Infosario One Mobile App, a mobile based application that enables access to important clinical trial information. The application provides instant access to start-up, recruitment and compliance information as well as updates on data queries. This product launch enabled company to garner high market share and sustain market competition.

The pharmacovigilance market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2014 to 2025, for the following segments:

By Clinical Trial Phase, 2014 - 2025 (USD Million)

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

By Service Provider, 2014 - 2025 (USD million)

  • In-house
  • Contract outsourcing

The above information is provided for the following regions and countries:

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • UK
    • Spain
    • Italy
    • France
  • Asia Pacific
    • Japan
    • China
    • India
    • Australia
  • Latin America
    • Argentina
    • Brazil
    • Mexico
  • Middle East Asia & Africa
    • South Africa
    • UAE
    • Saudi Arabia
    • Qatar
    • Israel


Frequently Asked Questions (FAQ) :

The market size of pharmacovigilance crossed USD 4.3 billion in 2018.
The industry share of pharmacovigilance is set to register over 10.6% CAGR up to 2025.
Pharmacovigilance is the science and activities involved in the detection, understanding, assessment and prevention of adverse drug effects or other drug-related problems. Adverse drug reaction (ADR) is an undesirable and unwanted effect of a medication that occurs during its clinical use.
Asia Pacific market accounted for significant industry share in 2018 and is poised to exceed USD 2.5 billion by 2025, according to a new report published by Global Market Insights, Inc.
Accenture, TCS, Infosys, Cognizant, IBM Corporation, InVentiv Health Clinical, IQVIA (Quintiles IMS), ICON and PAREXEL are the key players operating in the global market.

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Premium Report Details

  • Published Date: Dec 2019
  • Pages: 165
  • Tables: 71
  • Charts / Figures: 9
  • Companies covered: 26
  • Countries covered: 17

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