Pharmacovigilance (PV) refers to the science and activities associated with detection, understanding, assessment, and prevention of adverse effects or any other drug-related problem. The focus of pharmacovigilance is on ADR (adverse drug reactions) and drug toxicity. The global pharmacovigilance market size was worth $ YY billion in 2018 and is estimated to reach $ YY billion by 2026, growing at a CAGR of 12.43 % during the forecast period (2019-2026).
The global phenylketonuria (PKU) treatment market is growing due to factors such as rising incidence rates of adverse drug reactions, increasing drug consumption, and outsourcing of pharmacovigilance services.
The rising incidences of lifestyle diseases, such as hypertension, cardiac disorders, and diabetes caused by sedentary lifestyles, changing lifestyle patterns, lack of physical activities and poor diets, leads to high consumption of drugs. Increasing consumption of drugs leads to high demand for monitoring of drugs, thus boosting the growth of the pharmacovigilance market.
In addition, increasing adverse drug reactions (ADRs) is also driving the growth of the market during the forecast period. According to the National Centre for Biotechnology Information (NCBI), the number of fatalities due to ADRs has increased twice more than in 2017, which led to rise in hospitalizations. Also, in 2018, there was 10% increase in ADR rate in Brazil per medication introduced during hospitalization. Thus, rising number of ADRs needs continuous pharmacovigilance, hence driving the market growth.
The pharmaceutical companies are investing heavily in the R&D of new drugs to enhance the patients’ health and quality of life. For instance, Astra, a pharmaceutical company has more than 100 permanent, experienced staff in pharmacovigilance within its R&D organization in Sweden and the United Kingdom, and a similar number in local operating companies worldwide. Hence, increasing advancement in development of drugs is expected to drive the growth of the pharmacovigilance market during the forecast period.
However, lack of skilled healthcare professionals and high risk for data security that can be misused by the pharmacovigilance personnel are some of the factors hampering the growth of the market.
Market Segmentation
On the basis of service provider, the pharmacovigilance market is segmented into outsourcing and in-house pharmacovigilance. Among these, the outsourcing pharmacovigilance accounted for the largest market share shares in 2018, owing to cost-effectivity and better monitoring of drug safety. Outsourcing eliminates the risk of business overhead costs as well as deployment of a pharmacovigilance resources. Hence, there is a positive shift in pharmacovigilance outsourcing due to more benefits such as handling of large data volume coupled with regulatory compliance which further boost the growth of the market. Increasing acceptance and adoption of outsourcing services by healthcare companies is expected to drive the growth of the pharmacovigilance market. Several small pharmaceutical companies outsource some of its drug safety work to a third-party while 85% of medium sized and 40% large size companies outsource pharmacovigilance.
By type of reporting, the market is segmented into intensified ADR reporting, spontaneous reporting, cohort event monitoring (CEM), targeted spontaneous reporting, and EHR mining. Among these, the spontaneous reporting segment is expected to hold highest market share over the forecast period, due to extensive 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 the significant market share of spontaneous reporting.
On the other hand, the cohort event monitoring (CEM) is estimated to grow at the fastest growth rate, owing to rising demand 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, driving growth of this segment.
Geographical Analysis
North America is dominating the global pharmacovigilance market in 2018 and is expected to hold the highest market share during the forecast period (2019-2026), owing to the shifting of high costs of in-house pharmacovigilance activities to CROs. According to Journal of American Medical Association (2017), 1 out of 3 drugs in the United States have the safety issues. Hence, there is a need for modifying the current protocols for quick communication between healthcare providers and the FDA needs to be strengthened.
Competitive Landscape
The global pharmacovigilance market is moderately competitive and consists of several major players. Some of the major players in the market include: Cognizant, Accenture, Foresight Group International AG, IBM Corporation, Laboratory Corporation of America Holdings, ArisGlobal, Capgemini, ICON PLC, Wipro Ltd, BioClinica, among others.
The key players are adopting various growth strategies such as product launches, mergers & acquisitions, partnerships, and collaborations which are contributing to the growth of the pharmacovigilance market globally. For instance,
In May 2019, Lupin has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for the Post-marketing Adverse Drug Experience (PADE) inspection, indicating successful closure of the inspection.
In January 2019, Quanticate has launched QVigilance to provide dedicated pharmacovigilance (PV) and risk management services. QVigilance will be focused on supporting small and mid-size companies transitioning from clinical trials to post-marketing and establishing compliant PV systems.
In January 2019, Iqvia has developed a SaaS safety platform designed to reduce the cost and complexity of pharmacovigilance activities and help companies add value back into their business.
In June 2018, LabCorp, a leading global life sciences company, has acquired Sciformix Corporation, a scientific process outsourcing company focused on pharmacovigilance and regulatory solutions for biopharmaceutical and medical devices clients.
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