Pharmacovigilance (PV) Market Analysis By Clinical Trial Phase (Pre-Clinical, Phase I, Phase II, Phase III, Phase IV), By Service Provider (In-House, Contract Outsourcing), By Type, By End Use And Segment Forecasts, 2018 - 2025

Industry Insights

The global pharmacovigilance (PV) market size was estimated at USD 3.40 billion in 2016 and is anticipated to witness a CAGR of 13.1% over the forecast period. Increasing incidence of Adverse Drug Reactions (ADRs) is expected to accelerate the demand for pharmacovigilance services over the forecast period. 

Growing prevalence of chronic diseases is another major contributor for the PV growth. Treatment of these chronic diseases require uptake of combination of drugs resulting in ADR. To curb this problem, PV services are used. According to statistics published in Journal of American Medical Association (JAMA), in 2014, ADR is one of the leading causes of mortality in the U.S. resulting in more than 100,000 deaths every year.

U.S. pharmacovigilance market revenue by clinical trial phase, 2014 - 2025 (USD million)

In addition, presence of nonprofit organization for spreading the awareness related to PV such as International Society of Pharmacovigilance (ISoP) is expected to facilitate the adoption of PV during the forecast period as it is focusing on enhancing proper and safe usage of drugs at global level.Increasing government initiatives pertaining to adoption of PV services is anticipated to propel the industry growth in coming years. For instance, the Patient Registries Initiative taken by European Medicines Agency (EMA) which aiming at facilitating establishment of new registries and make better use of existing one.

Moreover, an upward shift in production of new drugs and presence of stringent government regulatory framework for drug safety is also responsible to propel the significant development of the industry. For instance, EMA and the U.S. FDA formulate regulatory guidelines for all phases of clinical trials. The advancements in development of ADR databases and information systems enabled reporting accurate information, which can be further utilized by research professionals for prospective studies, thereby fueling the overall demand for the market. 

Clinical Trial Phase Insights

Pharmacovigilance industry is estimated and analyzed on the basis of clinical trial phase in this study including preclinical, Phase I, II, III, and IV markets. The Phase IV (Post marketing) clinical trial segment dominated the market in 2016.

PV solutions act as an additional safety measure for the drug undergoing clinical trials. Phase IV is imperative stage of entire clinical trials as unsuspected adverse drug reactions can be detected in this stage. Therefore, the data collected and assessed during this stage is expected to be of the highest relevance.

The above mentioned can be attributed to intensive drug testing on large demographics patient base of highest relevance after commercialization of drug. The Phase III segment is expected to witness lucrative growth.

Phase III trials are done in order to determine and establish the drug efficacy. These trials also provide additional information regarding possible drug interactions, drug safety and effectiveness before commercialization of the drug in the market. Aforementioned factors are expected to increase revenue generation in the near future.

Service Provider Insights

Contract outsourcing held the dominant share as of 2016 and is expected to witness fastest growing segment in coming years.  It is due to the benefits associated with outsourcing such asrisk mitigation, resource flexibility,reduction of upfront investments, and reduction in 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 contract outsourcing segment can also be attributed to the rapidly emerging CROs providing end to end clinical trial solutions especially in the emerging Asia Pacific economics 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 complexregulatory requirements, helps in adding scalability to accommodate growing product portfolios, and helps in achieving aggressive cost targets. Contract outsourcing also enables to reduce the complexity of clinical trials; allows faster approval of trials and helps in effective internal resource utilization.

In house segment is anticipated to be growing at a moderate rate as a consequence of extensive R&D for development of new drugs by major pharmaceutical and biotechnological companies. This is expected to serve this industry with growth potential.

Type Insights

Spontaneous reporting held the largest share of the pharmacovigilance market as of 2016, owing to wide usage in detection of new, serious and rare ADRs and serves 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 capitalizing the market share of spontaneous reporting.

Cohort event monitoring (CEM) is predicted to be the fastest growing segment owing to its increasing application in detection of wide range of adverse clinical events. Conjugation of CEM with statistical tools and data mining systems such as longitudinal health records are responsible for the growing popularity of this segment. It serves as an active form of surveillance method which can also be used for new as well as older medicines. This has increased the growth of this segment.

Targeted spontaneous reporting is anticipated to witness positive growth owing to rising government initiatives to incorporate reporting methodologies other than spontaneous reporting by 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 push the market further.

EHR mining is increasingly used to identify risk factors for patients after discharge from hospitals. Electronic health records are imperative sources of medical information pertaining to clinical events in hospitals and research organizations. The associated benefits such as improved quality care, clinical decision-making, automated access, and clinical workflow improvement,and patient management are anticipated to fuel the segment over the forecast period.

End Use Insights

As of 2016, hospitals accounted for the largest revenue share of the pharmacovigilance market on the basis of end use.Hospitals serves reporter organizations, which report the ADRs, occurred during a certain time frame, to regulatory authorities in order to ascertain the need for post marketing surveillance.

Rising incidence of ADRs and medication errors are expected to drive the hospital segment growth over the forecast period. Increasing need for the identification of risk factors pertaining to ADRs is further anticipated to boost the growth of this segment.

The research organizations mainly include medicine information centers, academic research institutions, pharmacovigilance centers, and industry players. These organizations detect, investigate, evaluate patterns, report ADRs, and also investigate possible drug and food interactions.

Research organizations are expected to show lucrative growth over the forecast period owing to the rising need to investigate ADRs and develop corrective drug treatment, give safety signals to regulatory authorities and spread awareness amongst patient base.Growing need for medical information by the regulatory authorities is also anticipated to drive the growth of this segment.

Regional Insight

North America held the largest revenue share in 2016, owing to presence of key pharmaceutical and medical devices players in this region, contributing to the overall revenue in this region. Rising level of drug abuse and associated adverse drug reactions is a leading cause of morbidity and death. The aforementioned elements act as high growth rendering factors for the pharmacovigilance market in North America.

High investment in the development of new drugs by major players is also responsible to propel the growth platform in this region. Consequentially, as a result of large production of drugs, number of clinical trials and need for post-marketing surveillance in this region has increased thereby contributing to the overall growth of the industry.

Global pharmacovigilance market revenue, by region, 2016 (%)

Asia Pacific region is expected to grow at lucrative rate of 15.1%, attributing to availability of large number of outsourcing organizations. Consequentially, there is improved productivity, cost efficiency and resource sharing that is anticipated to propel the market demand in this region in coming years.

Furthermore, increasing awareness amongst patients, rising investments, and supportive government initiatives for meeting the requirements of population are the factors driving market growth during the futureperiod.

Competitive Insights

The key players are Accenture, Clinquest Group B.V., Cognizant, Laboratory Corporation of America Holdings, IBM Corporation, ArisGlobal, ICON plc., Capgemini, ITClinical, iMEDGlobal, Foresight Group International AG, TAKE Solutions Ltd., PAREXEL International Corporation, BioClinica, Wipro Ltd.,and United BioSource Corporation.

This industry is experiencing a significant boost owing to patent expiration of branded drugs and increasing number of new drug developments. This has attracted several local and international pharmacovigilance service providers in the market. Presence of competitive milieu has led to improved clinical data management, pharmacovigilance and streamlined R&D process.

The market is competitive in nature with key participants involved in continuous product development, collaborations and partnership alliances to augment market penetration. For instance, In May 2017, ArisGlobal launched a new pharmacovigilance and safety platform suite called LifeSphere Safety, thus increasing its services portfolio.

Rising number of contract outsourcing providers is expected to elevate industry rivalry in the near future. Owing to this fact, competitive rivalry for pharmacovigilance industry is expected to be high.

Report Scope

Segments covered in the report

This report forecasts revenue growth at global, regional,& country levels and provides an analysis of the industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the global pharmacovigilance market on the basis of clinical trial phase, service provider, type, end use and region:

• Clinical Trial Phase Outlook (Revenue, USD Million, 2014 - 2025)

  • Pre-clinical

  • Phase I

  • Phase II

  • Phase III

  • Phase IV

• Service Provider Outlook (Revenue, USD Million, 2014 - 2025)

  • In-house

  • Contract Outsourcing

• Type Outlook (Revenue, USD Million, 2014 - 2025)

  • Spontaneous Reporting

  • Intensified ADR Reporting

  • Targeted Spontaneous Reporting

  • Cohort Event Monitoring

  • EHR Mining

• End Use Outlook (Revenue, USD Million, 2014 - 2025)

  • Hospitals

  • Research Organizations

  • Industrial

• Regional Outlook (Revenue, USD Million, 2014 - 2025)

  • North America

    • U.S.

    • Canada

  • Europe

    • UK

    • Germany

  • Asia Pacific

    • Japan

    • China

    • India

  • Latin America

    • Brazil

    • Mexico

  • The Middle East and Africa

    • South Africa