Pharmacovigilance, defined by the World Health Organization (WHO) as ‘the science and activities relating to the detection, assessment, understanding and prevention of adverse effects of drugs’, is one of the fastest growing industries in the field of life sciences.
Why is Pharmacovigilance needed across all countries and pharmaceutical markets? It is primarily because despite the wide range of benefits we get from modern medicine, there are adverse drug reactions (ADR) which may lead to permanent side effects, serious illnesses, paralysis and even death. The field of Pharmacovigilance is essential for monitoring public health and institutionalizing the safe use of medicine.
With the global pharmaceutical market worth over $1 trillion and growing at a projected cumulative annual growth rate (CAGR) of 6% from 2014 to 2020, added to the increasing geriatric population and rising burden of chronic and nonchronic disease, it is no surprise that the worldwide market for Pharmacovigilance services is projected to be worth $6.1 billion in revenue by 2020.
In this article, we (1) examine the global macro insights that influence the current drug safety landscape, (2) drill down on the emerging Asian market and (3) analyze the top 7 technology trends that are shaping the Pharmacovigilance industry over the next decade.
Global Macro Insights
Growing Disease Burden
In the United States, chronic disease has increased at a rate of 18% between 2008 and 2015, while nonchronic disease is up at 15% over the same period, based on the 2015 WHO Report on Life Expectancy. Interestingly enough, a massive 48.7% of the population have been on at least one prescription drug in the last thirty days. (1) Meanwhile, infectious and parasitic disease and (2) respiratory infection were the two leading causes of death in 2015.
How does this affect Pharmacovigilance? The increase in both chronic and and nonchronic disease is the main driver of demand for the production of medicine. Therefore, the growth in worldwide diseases is directly proportional to the consumption of pharmaceutical products and the consequent occurrence of ADRs. With thousands of drugs expected to hit the market in the next few years, there is an increased clamor for drug monitoring and regulating, hence driving the Pharmacovigilance industry to grow at a CAGR of 14.2%.
Harmonization of Regulations
Given that drug safety is an issue of global scale and significance, there has been a movement to create standard regulations and guidelines for drug testing, safety and Pharmacovigilance. Developing international standards and devoting resources for implementation on a national and regional level has been in play since 2000. With technology improving connectivity and data sharing, this trend is expected to increase in coverage and drug scope.
The European Union has created the Good Pharmacovigilance Practices (GVP), following the implementation of the Pharmacovigilance Legislation in 2012, which monitors ADRs of all major medicines in its member states. Pharmacovigilance providers are mandated to follow standard guidelines and procedural safety checks across all phases of drug testing. With Pharmacovigilance on the rise in Asia, it can be foreseen that more unified regulatory framework on a regional level will aim to standardize and harmonize the practices, procedures and reporting of the industry.
What does this mean for service providers? This signals them to increase transparency and heighten their operational standards to ensure accurate ADR detection.
While these are the trends that shape the global landscape of Pharmacovigilance, we shift attention to zoom in on one of the fastest growing markets for this industry – Asia.
Spotlight on Asia as a Key Market for Pharmacovigilance
While North America holds the largest share (35%) of the global pharmacovigilance market, the Asia Pacific market is projected to be the fastest growing segment in the next decade. This growth is fueled by biotechnology, healthcare and pharmaceuticals setting up shop in the region, the growing Asian population and the prevalence of generic drugs in China and India. Moreover, the favorable regulatory environment for drug testing and clinical trial, the availability of low cost and skilled labor and the recent implementation of government programs aimed at increasing healthcare access have all contributed to Asia as the most promising hub for PVO. The costs of life sciences services (clinical trials, Pharmacovigilance) are approximately 50 – 70% cheaper than identical services offered in European companies.
The Philippines in particular is a key country of interest for Pharmacovigilance services, with robust growth numbers across the following key categories listed below.
Market Size: Pharmaceuticals
Market Size: Medical Devices
Number of Medicines Registered
Health Workforce per 10,000
10.2 physicians, 53 nurses, 5.4 licensed pharmaceutical personnel
Source: WHO 2013 Comparative Analysis Report on Pharmacovigilance
In terms of regulation, there is a Pharmacovigilance Framework implemented in the Philippines through Republic Act 7394 ensuring the safety of medicine. There is also a mandated update for safety records every 6 months and a required monitoring of new drugs for 3 years. In terms of law, policy and regulation, as well as availability of world-class health and medical talent, the Philippine environment is favorable for PVO.
After examining both the global and Asian climate that impact this industry, we identify the top technology trends that are shaping all aspects of the PVO service delivery chain.
7 Key Industry Trends for Pharmacovigilance
Contract Outsourcing to Drive Operational Efficiency
With the increased demand for drug safety and monitoring, a growing number of multinational pharmaceutical companies are turning to Pharmacovigilance Outsourcing (PVO). Third party vendors offer several key benefits versus setting up an in-house Pharmacovigilance structure, with the cost efficiencies driven by the economies of scale of external providers being the number one factor.
The changing regulatory environment, which necessitates attracting scarce medical talent and maintaining a robust compliance system, is another reason pharmaceuticals form long term partnerships with specialized Pharmacovigilance service providers. The market for contract outsourcing was valued at $1 billion in 2015 and is expected to grow to $4 billion by 2024.
Secondary Data Sources that Contribute to Widespread ADR Reporting
With increasing data sources driven by widespread access to the internet and the growth of social media, it has never been easier for consumers to report ADRs directly to manufacturers or to regulatory bodies. Before the digital era, the path to reporting user ADRs would take a significant amount of time. Back then, patients would report the side effects they experience to doctors, who in turn would report it quarterly (or at times semi-annually) to the regulatory agencies. The delay in data sourcing would incur several more ADRs to go unnoticed.
In today’s world, this has all changed. ADRs can be reported by a click of a finger, through online channels in real-time. Secondary data sources include Electronic Medical Records, Electronic Health Records, Online Journals, Online Data Submissions and Social Media. The Food and Drug Administration (FDA) has encouraged this instantaneous reporting by creating programs such as the Sentinel Initiative, which aims to collect, synthesize and analyze large amounts of secondary data sources in order to identify ADRs in real time.
Cloud-Based Reporting to Bring a Robust Global Database of ADRs
The ability to store and analyze massive amounts of data in the cloud has brought together a robust global database for disease, medicines and their side effects. Cloud-based technology creates a fully integrated system for all parties – healthcare providers, physicians, users, research institutions – to store and access any registered drug and its potential side effects. Aside from increasing transparency, this global database is a means of learning cross-pollination between countries for ADR patterns and symptom occurrence insights. Cloud technology takes away the distance and time-lag barriers, and creates a real-time dynamic data set for all Pharmacovigilance markets.
Big Data to Protect and Assimilate Huge Amounts of Information
With Cloud technology increasing the threshold of data storage, big data is a field that comes to play in the capture, storage, processing, transfer and information security for large amounts of medical records. The Pharmacovigilance industry will become more and more dependent on big data technology for end-to-end assimilation of information as well as keeping the integrity and security of the data. With the sheer volume and variety of secondary data sources, big data becomes a powerful tool to swiftly organize, classify, and even profile the veracity of reported ADRs for pharmaceutical companies and regulatory agencies to analyze. At the end of the day, the output of big data are integrated and consolidated data that is ready for data science and subsequent decision-making. Through high capacity data utilization, many potentially fatal ADRs can be thwarted and pharmaceuticals can quickly take adverse drugs off the market.
Data Analytics to Mine Insights
Mining the data from the cloud and big data sets bring about impactful insights on the occurrence of ADRs across different countries and regions. Applying data analytics in Pharmacovigilance processes increases the speed of signal detection, which essentially seeks information that point to causal relationships between drugs and reported adverse or beneficial events.
By mining insights from the data, PVO companies are able to map patterns and historical trends in order to isolate the interaction or presence of drug components that can correlate with ADRs, leading to safer and more effective drugs with fewer side effects. Mapping data trends lessens the cost-intensive practice of clinical trial and error methods to test data. Instead, data analytics combined with increasingly powerful data visualization tools can verify datasets of reported ADRs to better recognize patterns, trends and correlations. When drug regulation protocol are shared and reapplied across different markets, this can influence the Pharmacovigilance industry towards adopting global standard guidelines.
Automation for Non-Value-Adding Tasks in the PVO Process
With pharmaceutical and medical talent becoming more scarce, it is pivotal to the success of any PVO provider to ensure that their time is invested in value-adding activities in the Pharmacovigilance platform. Automation enables increased labor efficiency by removing administrative and clerical tasks that can be relegated to computers and robots. These include manual drug filing, updates to drug label information and clinical overviews, drug active ingredients checks, and report generation.
Automation frees up labor capacity, hence reducing overall PVO costs while increasing accuracy and quality of ADR detection. Furthermore, automation tools improve the visibility and monitoring of all pharmacovigilance processes related to a single drug, while ensuring timely follow-ups and flags when safety-related activities arise. Some automation software can be further customized to reduce the time lag from signal detection to characterization to adjudication.
Artificial Intelligence to Turn PVO into a Predictive Science
Artificial intelligence (AI) is predicted to change the way humans work, communicate and learn, with applications spanning medicine, transportation, education and other industries. It is important to note that developments in this field may have significant impact on Pharmacovigilance, ultimately turning the field into a proactive science. AI has the potential to fill in what traditional Pharmacovigilance services currently lack: the ability to assimilate large amounts of cloud-based data, map patterns, and correlate with genetics and disease occurrences in order to effectively predict ADRs.
In the future, automated signal detection systems driven by Machine Learning can improve accuracy of medical reporting. There will be a tremendous amount of time, labor and system resource cost saved by mitigating the trial and error procedures of Pharmacovigilance and clinical trials. Through AI, Pharmacovigilance would be able to take a more proactive stance on drug safety regulation.
The market for Pharmacovigilance is rapidly evolving to meet the increased demand of medicines, driven by the growing disease burden and aging geriatric population. What does this mean for pharmaceuticals? There is a need to reassess and qualify the best Pharmacovigilance delivery model, which includes vetting the right PVO partners who are able to deliver efficient reports while minimizing risks of ADRs. What does this mean for PVO providers? The ability to compete and thrive in the changing drug safety landscape is directly correlated to their investment in harnessing and utilizing technology trends.
After all, Pharmacovigilance is a field that at its core has a simple mission: to safeguard public health and promote the safe use of medicine. Thanks to advancements in technology, we are brought closer to a future with less and less deaths from preventable ADRs.