Pharmacovigilance Market: Up-to-date Analyses of Market Trends and Technological Improvements 2018–2026

Pharmacovigilance is the science related to the valuation, detection, understanding, and prevention of adverse drug effects and other issue related to drugs. In response to the thalidomide disaster identified in 1961, WHO established its Program for International Drug Monitoring. WHO through its Collaborating Centre for International Drug Monitoring, Uppsala, promotes pharmacovigilance in different countries. Around 135 countries were a members of the WHO pharmacovigilance program in 2010. Pharmacovigilance aims at increasing patient safety related to the use of medicines in addition to supporting the public health programs by providing reliable information for effective assessment of the risk-benefit profile of medicines.

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The global pharmacovigilance market is anticipated to expand at a rapid pace during the forecast period owing to increase in incidence of adverse drug reactions. WHO report on pharmaceutical consumption stated that medicines used to treat chronic diseases held a large proportion of the total volume of drug consumption in the non-hospital sector. This has increased the number of medicines made available to health care consumers. Rise in drug consumption has significantly increased the need for new drug development. This, in return, is expected to drive the market. Key players in the pharmaceutical industry are involved in rigorous research & development activities to develop novel therapeutics. Companies are now aiming at transforming their product development process to meet patient requirement worldwide. These aspects are expected to increase demand for pharmacovigilance services during the forecast period. Moreover, leading pharmaceuticals companies in developed countries are focusing on outsourcing pharmacovigilance service to reduce cost and minimize operational expenses. This is anticipated to create opportunity for contract research organizations in developing regions. Companies are engaging strategic initiatives such as collaboration with the pharmacovigilance service providers to get access to medical information and manage pharmacovigilance workflows. For instance, in 2017, Accenture entered into a collaborative agreement with a leading pharmacovigilance service provider to develop a platform for the collection and investigation of clinical information for drug efficacy, thus improving its R&D proficiencies. These factors propel the pharmacovigilance market.

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The global pharmacovigilance market can be segmented based on phase of drug development, method, service provider type, service type, and region. In terms of phase of drug development, the market can be classified as preclinical phase or phase 0, clinical trial phase I, phase II trials, phase III trials, and phase IV trials or post-marketing surveillance phase. Based on method, the pharmacovigilance market can be categorized into intensified adverse drug reaction reporting, spontaneous reporting, cohort event monitoring, targeted reporting, and EHR mining. In terms of service provider type, the market can be divided into in-house, contract outsourcing, research institutes, and others. Based on service type, the pharmacovigilance market can be segregated into processing, signal detection, aggregate reporting, and others.

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In terms of geography, the global pharmacovigilance market can be segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominates the pharmacovigilance market owing to the rise in drug development activities by major players in the region. Europe accounts for the second largest share of the pharmacovigilance market. Rigid government policies and regulations for drug manufacturing procedure are likely to drive the pharmacovigilance market in Europe. The market in Asia Pacific is expanding at a rapid pace due to the rise in incidences of adverse drug reactions. Additionally, several local manufacturers are engaged in the development of generic drugs, especially in China and India. Therefore, it is important to have a stringent pharmacovigilance and drug safety monitoring program in these countries to ensure the public health safety. This fuels the pharmacovigilance market in the Asia Pacific. Middle East & Africa holds small share of the global market due to poor therapeutic facilities and less development of the pharmaceutical industry.

Key players in the global pharmacovigilance market are Accenture, Bristol-Myers Squibb, Cognizant, Pfizer Inc., Covance, Inc., F. Hoffmann-La Roche Ltd, GlaxoSmithKline plc, Wipro Limited, Novartis AG, IQVIA, Sanofi S.A., and Tata Consultancy Services Limited.

Pharmacovigilance Market is expected to reach around US$6.1 bn before the end of 2020

Pharmacovigilance is defined as the science and activities involved in detecting, assessing, evaluating and preventing adverse reactions and related problems of medicinal products. Identifying safety issues related to medicinal products in the primitive phases of clinical trial development process is important for reducing the risks and costs involved in bringing a new drug or device into the market. At present, pharmacovigilance is accepted as a continuous process of evaluation that involves steps to improve the safe usage of medicines. A leading U.S.-based market research firm, Transparency Market Research, analyses the global market for pharmacovigilance services and predicts a compounded annual growth rate (CAGR) of 12.9% for the period 2013 to 2019.

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According to this research, the overall pharmacovigilance market is expected to grow at an attractive CAGR during the forecast period 2013 to 2019. The global pharmacovigilance market can be segmented by clinical trial phase, by methods and by type of service providers. Further, clinical trial phases can be sub-segmented into preclinical studies, phase I trial, phase II trial, phase III trial and phase IV (post marketing surveillance). Among these, phase IV trial accounts for the largest share of the overall clinical trial phases. Similarly, based on the type of methods pharmacovigilance market can be further segmented into spontaneous reporting, targeted reporting, cohort event monitoring, electronic health record(EHR) monitoring, and intensified adverse drug reaction(ADR) reporting. Among these methods, spontaneous reporting accounts for the largest share of the overall pharmacovigilance methods.

Finally, based on type of service providers, pharmacovigilance market is categorized into in-house and contract outsourcing, of which contract outsourcing accounts for the largest share of the overall pharmacovigilance service providers. It is estimated that the global pharmacovigilance market will grow significantly owing to rise in drug toxicity cases, innovation of advanced technologies to alleviate risk and rise in drug consumption. However, varied and stringent regulatory approval processes along with lack of skilled labor are likely to impede the growth of the global pharmacovigilance market.

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Geographically, North America accounts for largest market share of the overall pharmacovigilance market owing to large number of pharmaceutical companies; high quality services offered; innovation of novel technologies and presence of large number of outsourcing service providers. However, Asia-Pacific region is considered to be the most attractive market for global pharmacovigilance market and is expected to grow at a noteworthy CAGR during the forecast period.

This growth is due to the stringent government regulations for drug approvals, high enrollment rate, and increase in awareness about drug safety across a large population base. However, Europe and Rest of the World(RoW) regions are expected to exhibit a relatively lower growth rate as compared to the Asia-Pacific region during the forecast period.The major players providing pharmacovigilance services include iGATE Corporation, PRA International Inc., Synowledge LLC, OptumInsight Inc., iMedGlobal, TCS, Covance Inc., Cognizant Technology Solutions, PAREXEL International Corp. and Quintiles.

Global Pharmacovigilance Market to Reach US$6.1 bn by 2020 owing to Increasing Consumption of Drugs

Pharmacovigilance is a crucial part of healthcare and is absolutely vital in improving the accuracy of medicine. Monitoring adverse drug reactions and evaluating the risk posed by the same to the consumers is the ambit of the pharmacovigilance industry. Pharmacovigilance is a continuous process and relies on its continuity to produce progressively more reliable results. The rising awareness about the importance of this process is leading to steady growth of the global pharmacovigilance market.

An NIH study released in February this year evaluated the withdrawal of 462 medicinal products from 1953 to 2013. The report concluded that not only were the reasons for withdrawal inconsistent across the world, but there were several discrepancies in the process as well. The study recommends increased coordination within international agencies and higher transparency in reporting adverse drug reactions to improve the current scenario. A 2012 report by the NIH had also shown that there was a significant increase in the number of people suffering from adverse drug reactions in the U.S. from 1999 to 2006, with rural areas and the geriatric demographic as the key victims.

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The pharmacovigilance industry is thus driven by the consistent support provided by such reviews. According to Transparency Market Research, the global pharmacovigilance market was valued at US$2.4 bn in 2013. Exhibiting a robust 14.20% CAGR from 2014 to 2020, the market is expected to rise to a valuation of US$6.1 bn.

Which is the largest product segment of the global pharmacovigilance market?

The global pharmacovigilance is segmented on the basis of clinical trial phase into phase I, phase II, phase III, and post-marketing surveillance. Of these, post-marketing surveillance or phase IV exhibited the highest utilization of pharmacovigilance procedures.

However, the phase III segment is expected to exhibit the highest CAGR in the forecast period due to the growing realization of the importance of carrying out pharmacovigilance procedures before it is marketed. Clinical studies to remove as much harmful material as possible before the substance is put on the market are becoming increasingly important in the global pharmacovigilance industry. Nevertheless, phase IV will remain the dominant segment of the global pharmacovigilance market, since the effects of a medicinal substance may vary minutely according to the genetic profile of a particular community and can thus only be studied after the substance has been sold.

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Which is the largest regional segment of the pharmacovigilance market?

Regionally, North America was the largest market in 2013 and held a 35% share in the global pharmacovigilance market. The North America pharmacovigilance market is driven by the increasing reporting of ADRs and the proactive support to pharmacovigilance practices provided by government healthcare agencies. The high technological sophistication of the healthcare sector in the U.S. and Canada also allows for easy storage of and access to ADR reports.

The Asia Pacific pharmacovigilance market is expected to exhibit the highest growth rate of all regional markets in the forecast period due to the increasing patient pool and the increasing number of clinical trials being conducted in the region. The Asia Pacific market is currently restrained by the widespread of regional alternative medicines, which usually have no provision for an equivalent of pharmacovigilance. However, this restraint is expected to be eradicated by the growing healthcare industry in countries such as India, China, and South Korea.