7 Industry Trends Shaping the Future of Pharmacovigilance – Part 1 of 2

Mike Togle
March 8, 2017

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

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$2.91B
Market Size: Medical Devices$297M
Number of Medicines Registered32,069 units
Health Workforce per 10,00010.2 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

Contract Outsourcing Trend

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.

(Continue to Part 2 of the Study)

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