Rising Prevalence of Adverse Drug Reactions Drives Global Pharmacovigilance Market

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.

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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.

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.

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.

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Global Pharmacovigilance Market Rising due to Increasing Demand for Better Patient Safety at Minimized Costs

Over the last few years, technology has intervened in every sphere of our lives and for good. The contributions of the latest technologies across myriad industries have been diverse. The global pharmacovigilance market today has more diverse products and services to offer that suit the dynamic consumer preferences. Without the latest technological advances, this may have remained a distant utopia. While the innovations introduced recently have metamorphosed how industries consolidate and manage data, the pharmaceuticals sector has been the most prominent beneficiary of these advances.

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Among the myriad advances introduced to ensure that the global population is provided the best therapeutics and therapeutic approaches, pharmacovigilance has exhibited noteworthy contributions. Pharmacovigilance is a school of pharmacological science that encompasses every data gathering and scientific activity related to the prevention, understanding, detection, and assessment of adverse effects of pharmaceutical products and medical devices. It is an indispensable module of an efficacious drug regulation system that monitors and evaluates adverse drug reactions (ADRs).

Pharmacovigilance has become an important branch of clinical research and its demand is increasing at a substantial pace. Transparency Market Research, in its latest report, states that the global pharmacovigilance market, which stood at US$2.4 bn in 2013, will reach US$6.1 bn in 2020. If the figures hold true, the market will exhibit a promising 14.20% CAGR between 2014 and 2020.

Pharmacovigilance Ensures Better Patient Safety and Minimizes Costs

Recently, the ill effects of substandard pharmaceutical products, medication errors, and ADRs have been shown up in several studies. The incidence of such occurrences across the world has been so high that estimating the actual scale of these adverse impacts has become a herculean task. Whilst the majority of the documented evidence on ADR and medicine quality comes from industrialized nations, the situation in low- and middle-income countries is more urgent because of their poor healthcare infrastructure and unreliable quality and supply of medicines. Pharmacovigilance, broadly speaking, addresses three major discrepancies in the healthcare system, which include:

•    Product quality

•    Medication errors

•    Adverse drug reactions

Product Quality:

Quality issues are common in pharmaceutical products that are deteriorated, adulterated, or defective due to primitive pharmaceutical practices, poor labeling, inadequate storage and distribution, and tampering. The availability of counterfeit products in the market also falls under this category.

Adverse Drug Reactions:

Adverse drug reactions or ADRs are harmful responses that occur in patients upon ingestion of prescribed medication. The most common ADRs include allergic reactions, reactions triggered by interaction with other medications, and adverse effects from withdrawal. The WHO identifies serious ADR as any reaction that could be life-threatening, fatal, or significantly disabling, thereby prolonging hospitalizations.

Medication Errors:

A medication error has been defined by the NCC MERP (National Coordinating Council for Medication Error Reporting and Prevention) as any event of inappropriate medical use while the medication is under the control of any healthcare professional, harming a patient in a way that could be prevented.

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Pharmacovigilance has never been more important than it is in today’s zero-tolerance environment of drug safety. As the demand for ensuring patient safety at minimum cost increases, life sciences firms will seek ways to more aggressively identify and manage emerging safety risks. Presently, the worldwide network of pharmacovigilance centers is harmonized by Uppsala Monitoring Center for the effective functioning of drug safety monitoring around the world.

Global Pharmacovigilance Market: Snapshots and Analysis of Growth Factors for the period from 2013 to 2020

The pharmacovigilance market offers services pertaining to drug regulation systems used to monitor and evaluate all kinds of adverse reactions to drugs. The pharmacovigilance market, at present, is on the verge of rapid growth, due to rise in drug toxicity and adverse drug reaction cases. As per a new research report presented by Transparency Market Research, a U.S. based business intelligence firm, the pharmacovigilance market is forecast an expansion from its valuation of US$2,426.6 million in 2013 to US$6,104.1 million by the end of 2020. The expected CAGR of the market is 14.2% for the period from 2013 to 2020.

Analyzing the Global Pharmacovigilance Market

The pharmacovigilance market is globally split due to its implementation at numerous emerging as well as established organizations. Cognizant Technology Solutions, Bristol-Myers Squibb, Novartis International AG, and Accenture plc are some of the companies that operate in the global pharmacovigilance market. 

Following are the prime factors that are expected to drive the pharmacovigilance market for the period from 2013 to 2020:

• Rise in consumption of drugs means rise in demand from Pharmacovigilance Market

Rise in the occurrence of chronic and acute diseases has resulted in a rise in consumption of medicines. The number of drug toxicity cases has gone up in the recent past. This lead to a rise in demand from the pharmacovigilance market to control adverse reactions to drugs. 

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• Rise in demand for drug monitoring outsourcing services further boosts demand from pharmacovigilance market

Drug monitoring outsourcing services are largely adopted in the recent past. Traditional CROs and BPOs are two of the preferred drug monitoring outsourcing service providers, recommended by pharmaceutical manufacturers. CROs include companies such as Covance Inc. and Quintiles Transactional, whereas Infosys Ltd, Tata Consultancy Services, and Cognizant are some of the top BPOs. Going forward, the pharmacovigilance market is expected to register a steepening growth curve. More and more CROs and BPOs sign agreements with drug manufacturers. 

Recently, CSSi LifeSciences signed an agreement with PRC Clinical to offer drug monitoring services for pharmaceuticals in U.S. 

CSSi LifeScience has so far offered services to regions in the Middle East, Europe, and Asia. PRC Clinical, a CRO, has offered phase I-IV clinical monitoring services for many medical device companies. Experts from PRC Clinical, and CSSi LifeScience together will be supporting global and local clinical trials throughout the drug development process.

• Rising Demand from Emerging Economies Good News for Pharmacovigilance Market

The pharmacovigilance market is globally operated through its various channels to appropriately carry out the procedure of monitoring the drugs safely. As per the clinical trial phase segmentation, the pharmacovigilance market gets divided into preclinical studies and phase I-IV trial. The pharmacovigilance market is further segmented into targeted reporting, spontaneous reporting, reporting HER mining, cohort event monitoring, and intensified ADR. As per the service providers, the pharmacovigilance market is segmented into contract outsourcing and in-house services.

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Considering the growing demand for drug monitoring services across the globe, the pharmacovigilance market has a huge scope in emerging economies. The developing healthcare infrastructure in emerging countries and rising government support to healthcare innovations is responsible for the same.

Infographic: Pharmacovigilance Market and Service Providers Expected to Reach USD 5.0 Billion Globally in 2019

According to a new market report published by Transparency Market Research "Pharmacovigilance Market [Clinical Trial Phases (Pre-Clinical Studies, Phase I, Phase II, Phase III, Phase IV or Post-Marketing Surveillance) and Service Providers (In-House   and Contract Outsourcing] - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013 - 2019," the global pharmacovigilance market was valued at USD 2,147.3 million in 2012 and is estimated to reach a market worth USD 5,008.2 million in 2019 at a CAGR of 12.9% from 2013 to 2019.