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Pharmacovigilance Outsourcing Market: Global Opportunity Analysis and Industry Forecast, 2020-2027

A10915
Pages: NA
Jun 2021 | 46 Views
 
Author(s) : Onkar Sumant
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Pharmacovigilance Outsourcing Market Outlook - 2027

Pharmacovigilance, also known as drug safety is defined as the science and activities relating to the collection, detection, assessment, monitoring, understanding and preventing the adverse effects of pharmaceutical drugs. As the pharmaceutical industry expands in size and global reach, it faces new and more complex challenges. These fall especially heavily on Pharmacovigilance groups which must keep up with product innovation, advances in technology, and changing regulatory requirements while at the same time delivering on their risk management responsibilities. The demand for robust compliance systems and experienced talent has raised the cost of maintaining the infrastructure necessary to support pharmacovigilance; hence, it is necessary for industries to outsource such services.

Market scope and structural analysis:

Report Metric

Details

  Market size available for years

  2019–2027

  Base year considered

  2019

  Forecast period

  2020–2027

  Forecast units

  Value (USD)

  Segments covered  

  Type, End-users, Region

  Regions covered

•North America (U.S., Canada, Mexico)

•Europe (France, Germany, UK, Italy, Spain, Rest of Europe)

•Asia-Pacific (Japan, China, India, Australia, South Korea, Rest of Asia-Pacific)

•LAMEA (Brazil, South Arabia, South Africa, Rest of LAMEA)

  Companies covered

  • Paraxel.
  • Bioclinica.
  • 4C Pharma Solutions.
  • PRA Health Sciences.
  • ICON.
  • Cognizant.
  • TCS.
  • Accenture.


Covid-19 scenario analysis:

When it comes to speeding up the identification of potential treatment options for COVID-19 and finding a way to slow or decrease the morbidity and mortality, pharmacovigilance data plays an important role. It’s critical to understand what a drug can and cannot do and the pharmacovigilance industry is under great responsibility of finding the side effects of the drugs and vaccine. The pandemic COVID-19 has transformed the pharmaceutical industry as they are now operating in a different pharmacovigilance (PV) paradigm, adapting as there are daily changes and requirement. While patient safety remains the first priority, AEs will continue to come in for processing, and daily PV activities will continue. New therapeutic information for the treatment of COVID-19 and potential COVID-19drug interactions to consider are part of the influx of clinical and PV data.

Pharmacovigilance Outsourcing Market requirements:

Pharmacovigilance outsourcing (PVO) transfers the execution of drug safety functions and processes to a third party provider. These include primary PV activities like case processing, as well as governance activities like compliance management. The processes ultimately outsourced depend upon criteria which differ by organization.

Core activities include:

  • Collecting adverse drug reaction (ADR) data and information 
  • Case processing activities 
  • Preparing and development of Risk Management Plans (RMPs) and Risk Evaluation Mitigation Strategy (REMS)
  • Creating and submitting expedited and aggregate PV reports

Management activities include:

  • Preparing standard operating procedures (SOPs) and other controlled quality documents 
  •  Assisting with internal and external compliance reporting
  •  Testing and monitoring business processes and systems for compliance
  •  Performing trend analyses and predictive modelling for compliance operations 
  • Preparing detailed descriptions of the Pharmacovigilance System 
  • Preparing or reviewing safety data exchange agreements with third parties / business partners 
  • Inspection readiness training 
  • PV system upgrades 
  • Audit, development of corrective action plans, and Corrective and Preventative Action (CAPA) implementation

Potential benefits of PV outsourcing:

  • A well implemented PVO program can drive significant benefit for the organization, including:  
  • Converting fixed resource costs into variable, workload dependent charges
  • Reducing the number of resources to recruit, manage, and/or train 
  • Improving on-demand access to unique expertise, intellectual property, and multidisciplinary knowledge 
  • Increased business model and capacity flexibility 
  • Improved efficiencies and Return on Investment (ROI) Outsourcing provides well-documented cost benefits.

Pharmacovigilance service types & PV Outsourcing Vendor Capability Continuum:

Capability of Vendor

Description

Vendor Maturity

  Highly Specialized

Companies that focus on a single area of function (e.g., signal detection)

  Mature

  Broad Coverage

Companies with broad capabilities across the different areas of PV

  Mature

  Full Service

Companies that manage the end to end PV activities

  Emerging


Top Impacting Factors: Market Scenario Analysis, Trends, Drivers and Impact Analysis:

Drivers:

Increased preference for outsourcing services:

According to the National Centre for Biotechnology Information (NCBI), approximately 5% of total hospitalizations in Europe each year, are due to ADR (adverse drug reaction) 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. 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 Pharmacovigilance outsourcing market with lucrative opportunities.

Benefits of outsourcing Pharmacovigilance Services:

Leading pharma companies in developed countries are focusing on outsourcing PV services to reduce cost and to 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.

Pharmacovigilance Outsourcing Restrains:

  • Talent shortages: Maintaining compliance amidst increasing regulatory complexity, especially in a global context, requires individuals skilled in risk management and knowledgeable of regulatory and compliance operations; these professionals are in short supply and high demand. Organizations are struggling to increase operational budgets to provide training and to gain access to an extended talent pool.

  • Sub-optimal compliance processes: Organizations want to focus on improving and streamlining their compliance processes to make them more predictable; however, continual changes in the regulatory landscape can undermine compliance process investments, leading to suboptimal and non-compliant processes. This may result in higher compliance costs (i.e., through rework) and lower quality levels.

  • Technology infrastructure investments: Organizations are constantly investing in technology and related infrastructure to help meet compliance needs. With frequent changes to existing regulations, as well as the introduction of new regulations, frequent technology investments are needed to keep pace.

Key Market players and strategies:

The companies operating in the pharmacovigilance market are undertaking strategic initiatives, such as collaborations with the PV service providers to gain access to medical information and to manage PV workflows. For instance, in September 2019, Accenture collaborated with Bayer to implement the company's INTIENT Clinical platform to simplify and speed its drug development processes, thereby widening business. The company collaborated with BioCelebrate in 2017 to develop a platform for aggregating and analyzing clinical information for improved drug developing efficiency, thus enhancing its R&D capabilities. Such initiatives help companies maintain their Pharmacovigilance outsourcing market position.

Key segments covered:

Segments

Sub-segments

  Type

  • Adverse drug reaction capture (ADR)
  • Case Processing
  • Reporting and submission
  • Report publishing
  • Quality check
  • Risk management
  • Knowledge management
  • Enabling architecture

  End Users

  • Pharmaceutical Industry
  • Research organization
  • Hospitals

  Region

  • North America
  • Europe
  • Asia-Pacific
  • LAMEA

 

Benefits of the Report:

  • The following study explains the Pharmacovigilance and pharmacovigilance outsourcing market along with the trends and the market requirements.
  • The report presents information related to key drivers, restraints, and opportunities along with detailed analysis of the Pharmacovigilance outsourcing market.
  • The current market is quantitatively analyzed from 2020 to 2027 to highlight the global pharmacovigilance outsourcing market.
  • The exhaustive analysis of the pharmacovigilance outsourcing market by services that are required helps in understanding the types of services that are currently being needed along with the services and collaboration that would gain prominence in the future.

Questions answered:

  • What is the pharmacovigilance and the services required in the market?
  • What the current trends and approaches that will influence the market in the next few years?
  • What are the driving factors, restraints, and opportunities in the market?
  • What are the projections for the future that would help in taking further strategic steps?
 
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