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The global pharmacovigilance (PV) market size was USD 4.84 billion in 2019 and is projected to reach USD 12.25 billion by 2027, exhibiting a CAGR of 12.3% during the forecast period.
The main objective of the PV industry is to enhance patient care and safety with respect to the use of medicines. It also supports public health programs by providing reliable and balanced information for the correct assessment of the adverse effects of medicines. The PV industry comprises of series of tasks such as identifying, reporting, and analyzing the adverse drug reactions (ADRs) for the generation of necessary data points required for regulatory action. Moreover, increased consumption of medicines by the patient population combined with greater expectations of drug safety is the major factor responsible to surge the PV market growth in the coming years. PV outsourcing is gaining momentum in terms of revenue and expansion owing to advancements in the PV software and services. The existence of an information technology platform has paved a bright path for the global market. Additionally, the emergence of COVID-19 has opened multiple opportunities for the pharmaceutical companies in the invention of novel vaccines, which have initiated a number of clinical trials. This has even opened doors to the PV market as it is the most important phase of any drug development process.
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Cloud-based Reporting of Adverse Drug Reactions to Facilitate Market Growth
This market is set to transform a faster rate over the coming years. Software companies are continuously developing and introducing advanced platforms to ensure smooth and automated ADR reporting. At present, lack of awareness among patients regarding ADR reporting has led to its under-reporting. The introduction of mobile applications or patient-friendly applications can uplift ADR reporting among patients. For instance, the Department of Pharmacology of India, KMC Manipal, and Information & Communication developed a mobile application to report adverse drug reactions to ensure patient safety in 2019. This department is also recognized as a monitoring center for the PV program in the country. Furthermore, introduction of innovative software for ADR reporting will enhance the market potential during the forecast period. Consequently, cloud-based ADR reporting has become an important aspect as it is creating an impact in regulating drug entities post-marketing.
Increasing Public Awareness for Safer Medicines to Stimulate Market Value
Safety and efficacy are the two important parameters that a drug needs to pass through during each clinical trial phase. Nowadays, populations are more aware about the side effects of OTC medicines and thus demand safer medications. This is likely to boost this market value owing to surveillance of marketed medications for possible ADRs. Moreover, government initiatives and programs and pharmaceutical companies’ awareness campaigns are creating a greater impact in spreading reliable information about medicines, proper use of medicines, side-effects of medicines, and others. For example, Uppsala Monitoring Centre (UMC) every year conducts a social media campaign to promote patient and public awareness about the safe use of medicines as well as reporting of suspected ADRs. In 2019, UMC launched a campaign focusing on polypharmacy and safe use of medicines in the elderly population. Therefore, such positive initiatives are likely to foster growth and development of this market during the forecast period.
Outsourcing of PV Services to Expedite Market Growth
Today’s pharmacovigilance market allows a choice for the pharmaceutical companies as well as the hospitals to outsource the PV service. PV outsourcing has maximum advantages to the manufacturing companies with respect to time constraints and facilities that an outsourced service can provide. Outsourcing also allows the companies to undergo customization as per their requirements, which can increase the speed of the evaluation process. Owing to the advantages of outsourcing services, there is a growing demand for these services in the market and has created multiple opportunities for outsourcing service providers. These providers are focused on enhancing their service portfolio to offer clients more sophisticated solutions. For instance, in 2017, Virtusa Corporation, an IT outsourcing company, launched a PV solution for adverse event intake and Cognitive Adverse Event Case Processing (CAECP). Thus, increasing demand for outsourcing operations at minimal cost is responsible for the emergence of new players in this market, thus expediting the market growth from 2020 till the end of 2027.
Inconsistent Reporting of Adverse Events in Low and Middle-income Countries to Restrict Market Growth
Owing to the lack of patient awareness about adverse event (AE), there is an inconsistency in reporting. In case of any adverse event, the patient tends to be anxious and report all their discomfort as AE. But, every reported AE may not be serious, subsequently forcing committees in pharmaceutical companies to take incorrect decisions, leading to the withdrawal of the drug. In low- and middle-income countries, appropriate training and services/software are lacking for these niche services. Besides, fewer efforts are taken by governments and pharmaceutical companies in spreading awareness regarding AE reporting. These factors are anticipated to restrict this market growth in low- and middle-income countries.
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PV Services to Lead Segmental Dominance in the Market
On the basis of type, the global market has been classified as service and software. The services segment held a dominant position in the year 2019, generating the highest and having the largest market share. Rising incidence of infectious diseases worldwide due to lifestyle changes and smoking habits are increasing the demand for effective medicines. The surging demand for effective medicines has resulted in an increasing number of clinical trials, thus boosting this segment’s prospects to no bounds. For instance, owing to the COVID-19 outbreak, pharmaceutical companies all over the globe have entered a race to bring out a novel vaccine against the disease. This has led to a generation of multiple clinical trials, creating immense opportunities for PV services. Moreover, public concerns for drug safety have urged the launch of PV service platforms, thus elevating the market potential. For example, in June 2018, APCER in collaboration with ArisGlobal launched a seamless cloud-based PV service platform. Thus, growing demand for technologically advanced PV services coupled with the above factors is anticipated to foster the dominant position of the service segment during the forecast period.
On the other hand, the software is expected to have the highest CAGR during the forecast period owing to rising demand for advanced and automated software for PV operations.
Focus on Cost Reduction Strategy to Uphold In-house Pharmacovigilance
Based on deployment, the market segments include in-house and outsource. Owing to cost constraints and the lower budget of the pharmaceutical companies, they have deployed an efficient in-house pharmacovigilance system within the industry. This has resulted in minimizing costs and generating efficient results in less amount of time. Also, the need for instant results and constant surveillance of the marketed drug has resulted in in-house PV facilities, thus leading the segment to a dominant position.
On the flip side, owing to the challenges faced by the in-house facilities such as inexperienced PV professionals, quality management systems (QMS), and others have called for pharma companies to outsource PV operations. As a result, this segment is anticipated to emerge as the fastest-growing segment during the forecast period. The outsource facilities have professional personnel and well- developed procedural documentation. Thus, outsourcing of PV activities allows the end-users to timely manage the clinical trials and deliver appropriate results.
Robust Research & Development by Pharma Companies to Boost Sales of PV Services
The end-user segment of this global market is classified into hospitals, pharmaceutical companies, and others. Pharmaceutical companies held the leading position in the global market in 2019. Robust R&D by pharmaceutical companies in launching effective medicines has created immense opportunities for this market in providing its services or software. The continuous launch of medicines has resulted in the adoption of pharmacovigilance services by these companies. Pharmaceutical companies segment is also likely to have the highest CAGR during the forecast period owing to the increasing outsourcing of PV activities.
The clinical trials conducted at hospitals result in multiple ADRs or AEs, forcing them to approach PV services, thus increasing the value of this market. The hospitals segment is anticipated to have considerable growth during the forecast period.
North America Pharmacovigilance Market Size, 2019 (USD Billion)
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On the geographical front, the global pharmacovigilance market is classified into North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa. The market size in North America stood at USD 1.94 billion in 2019, marking its lead position. North America leads this market share, owing to the highest number of PV activities in the region. Coupled with this is the large number of deaths due to ADRs, resulting in the rigorous need for PV. Moreover, the region has well-established PV centers with advanced software in managing the activities. Europe accounts for the second position in the market owing to its focus on risk assessment of the medicinal products. The region has set up various surveillance systems such as the European Medicines Agency, EudraVigilance database, and others to access and monitor ADRs. Additionally, the adoption of PV software to leverage the PV activities has also resulted in the pharmacovigilance market growth in the European region. Furthermore, Asia-Pacific is anticipated to emerge as the fastest-growing region owing to the adoption of PV services and software by developing countries. Also, outsourcing of PV facilities to the developed countries has increased the market size in Asia-Pacific. As countries such as India and China are the most populated, chances of ADRs and AEs are higher if risk assessment activities are not appropriately conducted. Hence, PV has emerged as a crucial part of the drug development process in these countries. On the other hand, Latin America and Middle East & Africa are anticipated to have slower progress in the market owing to lesser adoption of PV services and software coupled with under-reporting of ADRs.
Adoption of Multi Strategies by the Industry Players to Develop PV Business to Fuel Competition
This market is home to multiple players. Vendors such as Cognizant Technology Solutions, Accenture plc, IQVIA, and many others have successfully established their position through various acquisitions, advanced PV solutions, and excellent customer-provider relationship. These companies are focused on delivering end-to-end solutions to customers by improvising constant strategic developments and providing professional PV services. The companies are also putting efforts in launching advanced automated software for these services to leverage the market potential. The integration of new tools such as business process management to escalate the efficiency of processes can help the companies to proliferate in the global market.
The pharmacovigilance market report provides a detailed analysis of the market and focuses on key aspects such as leading key players, and deployment type. Besides this, the report offers insights into the Pharmacovigilance market trends and highlights key industry developments. In addition to the aforementioned factors, the report encompasses several factors that have contributed to the growth of the market over recent years. It further highlights some of the growth-stimulating factors and restraints, helping the reader to gain in-depth knowledge about the market.
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Value (USD billion)
By End User
Fortune Business Insights says that the global market size is projected to reach USD 12.25 billion by 2027.
In 2019, the market value stood at 4.84 billion.
Growing at a CAGR of 12.3%, the market will exhibit increasing growth in the forecast period (2020-2027).
The service segment is expected to lead in this market during the forecast period.
Increasing outsourcing services is the key factor driving the global market.
The key players in the market are IQVIA, Covance Inc., Parexel International Corporation, and others.
North America dominated the market share in 2019.
Increased awareness among the healthcare industry and pharmaceutical companies about the significance of advanced software and issuance of pharmacovigilance guidelines by governments is expected to drive the adoption of the PV service/software during the forecast period.
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