Pharmacovigilance is a key component of an effective drug regulation system for monitoring and evaluating adverse drug reactions (ADRs). Pharmacovigilance activities are an important part of clinical research and are growing at a significant pace. At present, the global network of pharmacovigilance centers, harmonized by Uppsala Monitoring Centre, are operating on the global level for appropriate functioning of the process of drug safety monitoring across the world. Large volume of international ADR reports collected in a central database would serve as a contributing factor to the effort of national drug regulatory authorities, thus improving the safety profile of drugs that would help avoid drug related disasters. In addition, growing public health awareness and expectation in relation to the safe use of medicines and medical interventions are some of the major factors contributing to the growth of the global pharmacovigilance market. Furthermore, increasing number of national pharmacovigilance centers globally is playing a definitive role in augmenting public awareness about drug safety, thereby supporting the growth of the pharmacovigilance market in the next few years. However, the pharmacovigilance market is facing several hurdles and challenges to develop a better health care system. Challenges that are acting as major restraining factors for pharmacovigilance market are web-based drug information and sales, perceptions to harm and benefit, high risk associated with data security and unavailability of skilled professionals.
Based on phases of drug development, the global pharmacovigilance market has been segmented into preclinical studies, clinical trial phase I, II, III and IV or post marketing surveillance. The phase IV or post marketing surveillance segment accounted for the largest share of the pharmacovigilance market in terms of revenue in 2013. Rise in the number of safety concerns pertaining to the marketed product, increasing need for developing systems for comparing safety profiles of similar pharmaceutical products and growth in public health awareness campaigns regarding drug safety issues among the people are the major factors attributed to the high growth of the segment. In addition, the clinical trial phase III segment is expected to grow at the highest CAGR due to the rising need for drug safety monitoring and evaluation in phase III before the drug manufacturer can apply for market authorization application. Additionally, phase III clinical trial focuses on drug safety and efficacy in diverse sub-groups, wherein the risk-benefit ratio is developed, monitored and updated accordingly. Biopharmaceutical companies are in the process of developing advanced clinical trial phases that would be more specific to drug safety. Rigorous pharmacovigilance activities are expected to be made compulsory during the commencement of various clinical trial phases that would be helpful in actively managing high-risk medicines.
Based on methods of performing pharmacovigilance, the market has been categorized into spontaneous reporting, intensified ADR reporting, targeted spontaneous reporting, cohort event monitoring, and EHR mining. Spontaneous reporting method was the largest segment in terms of revenue in 2013. Factors attributed to the growth of the segment are easy simulation of realistic datasets that provides better drug evaluation and comparison, and better assessment of automatic signal generation methods proposed within pharmacovigilance. The segment is also expected to maintain its lead during the forecast period from 2014 to 2020, as in this method, healthcare professionals are encouraged to report adverse reactions after which preventive measures such as adding warnings to the product labeling or recalling the product are taken. Moreover, spontaneous reporting is the most appropriate method of detecting new ADRs and generates safety signals that require further examination.
Based on types of services, the pharmacovigilance market has been segmented into in-house and contract outsourcing. The contract outsourcing service segment accounted for the largest share in 2013. The segment is estimated to grow at the highest CAGR during the forecast period. The major factor driving the growth of the segment is the increasing need of pharmaceutical companies to shift focus from non-core to core business activities by outsourcing their pharmacovigilance services. Moreover, outsourcing of pharmacovigilance services is aimed at minimizing operational cost and financial loss incurred from product approval delays or recalls, thereby propelling the growth of the contract outsourcing service segment.
Geographically, North America accounted for the largest share of the global pharmacovigilance market in 2013. Factors attributed to the growth of the pharmacovigilance market in North America are increasing mortality rate due to ADRs and escalating patient concerns regarding the safety and efficacy of pharmaceutical products. According to the Centers for Disease Control and Prevention (CDC), ADRs account for more than 100,000 deaths annually and are among the top 10 leading causes of death in the U.S. Moreover, cost benefit obtained by shifting high costs of in-house pharmacovigilance activities to CROs is boosting the growth of the market in North America. However, Asia Pacific is anticipated to witness the highest growth during the forecast period. Factors attributed to the high growth are increased demand for stringent health care regulations in Asia, presence of large patient pool and increasing volume of clinical trials being conducted in this region. According to an article published in the National Center for Biotechnology Information in 2014, serious ADRs are witnessed in 6.7% of patients in India. Additionally, demand for effective pharmacovigilance services and drug safety in increasing in the region due to large number of clinical trials and clinical research activities being carried out in various countries in Asia.
The global pharmacovigilance market is fragmented due to the presence of numerous established as well as emerging organizations. The top companies operating in the pharmacovigilance market are Cognizant Technology Solutions, Accenture plc, Bristol-Myers Squibb, Covance, Inc., Clinquest Group B.V., ICON plc, F. Hoffmann-La Roche Ltd., inVentiv Health, Inc., GlaxoSmithKline plc, iGATE Corporation, Novartis International AG, Wipro Limited, Quintiles Transnational Holdings, Inc., Synowledge LLC, Pharmaceutical Product Development, LLC, (PPD), Sanofi, PAREXEL International Corporation, Pfizer, Inc., and iMEDGlobal Corporation.
Pharmacovigilance Market: Overview
The increasing occurrence of adverse drug reaction (ADR) and the rising policies implemented by governments on drug safety regulations globally will fuel the growth of the global pharmacovigilance market. The market for pharmacovigilance has been growing in leaps and bounds owing to the increasing aging population, raising the introduction of new drugs. Furthermore, health regulatory authorities including EMEA and the U.S. FDA are pressurizing on submission of data through electronic mediums. This will also positively impact the growth of the global pharmacovigilance market.
This report presents quantitative information sets and elaborates upon the market dynamics such as the future prospects, drivers, and challenges. The competitive analysis tools such as attractive investment proposition have also been employed in order to present an accurate understanding of the overall market. The top regional segment driving the growth of the global pharmacovigilance market also forms a key part of this study.
In the competitive landscape section of the report, the main sustainability strategies implemented by the leading players and their impact on the development of the market have also been presented. The key market regulating factors have also been detailed under this study. Key monitoring tools such as SWOT analysis and Porter’s five forces analysis have also been utilized in order to provide a detailed understanding of the competition present in the overall pharmacovigilance market.
Pharmacovigilance Market: Drivers and Restraints
The increasing awareness amongst individuals on the safe utilization of medical interventions and medicines is amongst the key factors providing impetus to the development of the pharmacovigilance market. In addition, the rising count of national pharmacovigilance centers worldwide is positively impacting the growth of the overall market for pharmacovigilance. These centers are increasing awareness regarding safety of drugs amongst individuals, hence catapulting demand for pharmacovigilance.
On the other hand, the huge risk of data security and increasing perception on benefits or harmful effects of various drugs are amongst the key factors restraining the development of the market. In addition, the trend of web-based sales and drug information and the lack of skilled professionals may negatively impact the growth of the global pharmacovigilance market.
Pharmacovigilance Market: Region-wise Outlook
On the basis of geography, the global pharmacovigilance market is segmented into Europe, North America, Asia Pacific, and Rest of the World (RoW). Of these, the North America pharmacovigilance market held a significant share in the past owing to the rising mortality rate in this region because of increasing occurrence rate of ADRS and the growing concern on patients about the efficacy and safety of pharmaceutical products.
However, Asia Pacific is predicted to emerge as the most lucrative region in the market in the coming years. This is due to the rising demand for strict regulations on healthcare in Asia Pacific and the large pool of patients within this region. In addition, the growing need for effective pharmacovigilance services owing to the increasing count of clinical trials taking place in a number of Asia Pacific nations will also boost the development of the overall market.
Key players Mentioned in the Report are:
The top players in this market are Clinquest Group B.V., Accenture, Plc, Cognizant Technology Solutions, iMED Global Corporation, Covance, Inc. ICON, Plc, inVentiv Health, Inc., Pharmaceutical Product Development LLC, Parexel International Corporation, PRA Health Sciences, Inc., F. Hoffmann-La Roche Ltd., Quintiles Transnational Holdings Inc, Sanofi , Wipro Limited, and Synowledge LLC, among others.
Major regions analyzed under this research report are:
- North America
- Asia Pacific
- Rest of the World
This report gives you access to decisive data such as:
- Market growth drivers
- Factors limiting market growth
- Current market trends
- Market structure
- Market projections for the coming years
Key highlights of this report:
- Overview of key market forces propelling and restraining market growth
- Up-to-date analyses of market trends and technological improvements
- Pin-point analyses of market competition dynamics to offer you a competitive edge
- An analysis of strategies of major competitors
- An array of graphics and SWOT analysis of major industry segments
- Detailed analyses of industry trends
- A well-defined technological growth map with an impact-analysis
- Offers a clear understanding of the competitive landscape and key product segments