Market Definition
The Pharmacovigilance (PV) Market is a vital component of the pharmaceutical and healthcare industry, dedicated to ensuring the safety of medications and protecting public health. This market encompasses a comprehensive range of activities, systems, and technologies aimed at monitoring, detecting, and preventing adverse effects and other drug-related problems. Pharmacovigilance plays a crucial role in post-marketing surveillance, providing valuable insights to regulatory authorities, pharmaceutical companies, and healthcare professionals.
Market Outlook
The global Pharmacovigilance Market was valued at 6.4 billion in 2022 and it is anticipated to grow up to USD 18.4 billion by 2032, at a CAGR of 11.1% during the forecast period.
The Pharmacovigilance Market is experiencing substantial growth, driven by the increasing complexity of drug development, the expansion of global pharmaceutical markets, and the heightened focus on patient safety. As the pharmaceutical landscape evolves, pharmacovigilance becomes integral in identifying and mitigating potential risks associated with medications. The market is characterized by continuous innovations in safety monitoring methodologies, signal detection, and the integration of advanced technologies, reflecting the industry’s commitment to enhancing drug safety.
Factors propelling the market include the growing number of pharmaceutical products, the globalization of clinical trials, and the increasing regulatory requirements for drug safety. Pharmacovigilance contributes to the early detection of adverse drug reactions, the improvement of risk-benefit assessments, and the overall enhancement of drug safety profiles, positioning the market for sustained growth. As regulatory agencies emphasize the importance of robust pharmacovigilance systems, the Pharmacovigilance Market is poised to remain a cornerstone of pharmaceutical oversight.
While the Pharmacovigilance Market experiences robust growth, it faces challenges such as the influx of data, the need for standardized reporting, and the evolving regulatory landscape. Overcoming these challenges requires collaboration within the pharmaceutical industry, regulatory bodies, and the development of sophisticated pharmacovigilance tools and methodologies.
Opportunities within the market arise from the ability to address specific industry needs and provide innovative pharmacovigilance solutions. The convergence of data analytics, artificial intelligence, and real-world evidence creates opportunities for market players to contribute to the efficiency and effectiveness of drug safety monitoring. Proactive engagement with pharmaceutical companies, regulatory authorities, and research institutions, coupled with a commitment to continuous improvement and compliance, positions companies to capitalize on the expanding opportunities within the Pharmacovigilance Market.
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Research Objectives
- Estimates and forecast the overall market size for the total market, across product, service type, type, end-user, and region
- Detailed information and key takeaways on qualitative and quantitative trends, dynamics, business framework, competitive landscape, and company profiling
- Identify factors influencing market growth and challenges, opportunities, drivers and restraints
- Identify factors that could limit company participation in identified international markets to help properly calibrate market share expectations and growth rates
- Trace and evaluate key development strategies like acquisitions, product launches, mergers, collaborations, business expansions, agreements, partnerships, and R&D activities
- Thoroughly analyze smaller market segments strategically, focusing on their potential, individual patterns of growth, and impact on the overall market
- To thoroughly outline the competitive landscape within the market, including an assessment of business and corporate strategies, aimed at monitoring and dissecting competitive advancements.
- Identify the primary market participants, based on their business objectives, regional footprint, product offerings, and strategic initiatives
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Market Segmentation
The report analyses the global Pharmacovigilance Market based on clinical trial phases, service provider, types of reporting, End-user, and Region.
Global Pharmacovigilance Market by Clinical Trial Phase
Based on the clinical trail phases, the Pharmacovigilance market is divided into Preclinical I, phase I, phase II, phase III, phase IV. The phase IV (post-marketing) segment led the overall market with over 75.8% share in 2022. These solutions act as an additional safety measure for the drugs undergoing clinical trials. Phase IV is an imperative stage of clinical trials as unsuspected adverse drug reactions can be detected in this stage. Therefore, the data collected and assessed during this stage is expected to be of the highest relevance owing to intensive drug testing on a large patient base of highest relevance after commercialization of the drug.
The phase III segment is expected to witness lucrative growth of 10.5% in the forecast period. Phase III trials are done to determine and establish the efficacy of drugs. These trials also provide additional information regarding possible drug interactions, drug safety, and effectiveness before the commercialization of the drug. The aforementioned factors are expected to boost revenue generation in the segment over the forecast period.
Global Pharmacovigilance Market by Service Provider
By service provider, the industry is bifurcated into In-house, and Contract Outsourcing. Contract outsourcing held the dominant revenue share of over xx% in 2022 and is expected to witness the fastest CAGR of 10.6% for the forecast period. This can be attributed to the benefits associated with outsourcing such as risk mitigation, resource flexibility, reduction of upfront investments, and lower fixed costs. Contract outsourcing organizations provide solutions such as process design Standard Operating Procedure (SOP), PV audits, and other customized services.
The dynamic growth of the contract outsourcing segment can also be attributed to the rapidly emerging CROs providing end-to-end clinical trial solutions, especially in the emerging economies of Asia Pacific, such as India, China, and Japan, thereby enabling resources sharing, cost efficiency, resource flexibility, and expansion of operative capabilities. Outsourcing PV services is accompanied by benefits such as delivering services pertinent to highly complex regulatory requirements, helping to add scalability to accommodate growing product portfolios, and achieving aggressive cost targets. Contract outsourcing also helps reduce the complexity of clinical trials, allows faster approval of trials, and helps effective utilization of internal resources.
Global Pharmacovigilance Market by Type of Reporting
Based on Type of Reporting, the industry is categorized into Spontaneous Reporting, Intensified ADR Reporting, Targeted Spontaneous Reporting, Cohort Event Monitoring, and EHR Mining. Spontaneous reporting held the largest share of over xx% in 2022 owing to wide usage in the detection of new, serious, and rare ADRs. Moreover, this segment 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 growth of the segment.
Cohort Event Monitoring (CEM) emerged as the second-largest segment in 2021 owing to its increasing application in the detection of a 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 type. It serves as an active form of surveillance method, which can also be used for new as well as older medicines, thus driving the segment.
Global Pharmacovigilance Market by End-user
Based on end-user, the Pharmacovigilance market is divided into Pharmaceuticals, Biotechnology Companies, Medical Device Manufacturers, and Others. In 2022, pharmaceuticals held the largest revenue share of over xx%. Outsourcing the pharmacovigilance process is practiced by pharma companies to avoid high upfront investments and fixed overhead costs, increase resource flexibility, and secure additional capacity. Outsourcing pharmacovigilance proves to be a cost-effective endeavor for small and medium-sized companies.
The biotechnology segment is anticipated to witness lucrative growth in the forthcoming years owing to increasing new product development activities in this sector. In recent years, drugs are being developed and consumed at increasingly high rates. The use of drugs over longer periods by a large population can lead to adverse effects not seen in clinical trials. For instance, Vioxx (an osteoarthritic/ acute pain medication) and Avandia (an anti-diabetic) were marketed for some time before a pattern of safety problems was detected with their use. The growing need for medical information among the regulatory authorities is also anticipated to drive the segment.
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Major Players
Market players are focusing on strategic collaborations to enhance their product offerings. Some prominent participants in the global Pharmacovigilance market include Accenture, Cognizant, Laboratory Corporation of America Holdings, IBM Corporation, ArisGlobal, ICON plc., Capgemini, ITClinical, FMD K&L, IQVIA among others.
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Research Scope
- Scope – Highlights, Trends, Insights. Attractiveness, Forecast
- Market Sizing – Product Type, End User, Offering Type, Technology, Region, Country, Others
- Market Dynamics – Market Segmentation, Demand and Supply, Bargaining Power of Buyers and Sellers, Drivers, Restraints, Opportunities, Threat Analysis, Impact Analysis, Porters 5 Forces, Ansoff Analysis, Supply Chain
- Business Framework – Case Studies, Regulatory Landscape, Pricing, Policies and Regulations, New Product Launches. M&As, Recent Developments
- Competitive Landscape – Market Share Analysis, Market Leaders, Emerging Players, Vendor Benchmarking, Developmental Strategy Benchmarking, PESTLE Analysis, Value Chain Analysis
- Company Profiles – Overview, Business Segments, Business Performance, Product Offering, Key Developmental Strategies, SWOT Analysis
- Market Size in 2022 – $6.4 Billion
- Market Size in 2032 – $18.4 Billion
- CAGR % – 11.1 %
- Historic Period – 2016 – 2021
- Forecast Period – 2023 – 2032
- Base Year – 2022
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