Global Pharmacovigilance: Ensuring Drug Safety for a Growing Population

 

1. Total Market Size:

The global pharmacovigilance market is projected to reach a staggering USD 24-30 billion by 2030, with a Compound Annual Growth Rate (CAGR) of 8-12%. This exponential growth is driven by several factors, including:

• Rising prevalence of chronic diseases: As populations age and unhealthy lifestyles become more prevalent, the demand for new drugs and increased focus on drug safety escalate.
• Stringent regulatory frameworks: Regulatory bodies like the FDA and EMA are continuously strengthening pharmacovigilance requirements, ensuring thorough monitoring and adverse event reporting.
• Technological advancements: Artificial intelligence (AI), machine learning (ML), and Big Data analytics are revolutionizing data analysis, enhancing signal detection and improving safety monitoring efficiencies.
• Globalization of clinical trials: Increased outsourcing of clinical trials to regions with diverse patient populations necessitates robust pharmacovigilance systems to capture drug safety data across various demographics.

2. Market Size by Region:

2.1 North America (US & Canada):

• Market size: USD 9-11 billion (dominated by the US market due to strict regulations and large-scale research activities).
• Key drivers: Focus on early-phase trials, large patient pool, rising chronic diseases.
• Sub-segments: Spontaneous reporting, signal detection, risk management, data analytics.

2.2 Europe:

• Market size: USD 6-8 billion (driven by mature regulatory frameworks and a strong emphasis on patient safety).
• Key drivers: EMA regulations, aging population, decentralized clinical trials.
• Sub-segments: Pharmacovigilance planning, adverse event reporting, signal management, compliance.

2.3 Asia:

2.3.1 Japan:

• Market size: USD 3-4 billion (boosted by an aging population, advanced healthcare infrastructure, and government support for R&D).
• Key drivers: Aging population, strong pharmaceutical industry, regulatory updates.
• Sub-segments: Pharmacovigilance system updates, risk management plans, drug safety communication.

2.3.2 China:

• Market size: USD 4-5 billion (experiencing rapid growth due to a vast patient population, increasing R&D investments, and regulatory reforms).
• Key drivers: Rapidly growing pharmaceutical market, government initiatives, local talent acquisition.
• Sub-segments: GCP compliance, pharmacovigilance infrastructure development, regulatory consultancy.

2.3.3 India:

• Market size: USD 1.2-1.5 billion (attracting attention due to cost-effective clinical trials and a large diverse patient population).
• Key drivers: Cost-effectiveness, government initiatives, large patient pool.
• Sub-segments: Medical coding of adverse events, data management, regulatory consultancy.

2.3.4 Southeast Asia:

• Market size: USD 0.7-1 billion (emerging market with rising awareness, improving healthcare infrastructure, and government support).
• Key drivers: Regulatory harmonization, government initiatives, local service providers.
• Sub-segments: Training programs, local regulatory expertise, clinical trial support.

2.4 Other Regions:

• Australasia & Oceania (Australia & New Zealand): USD 0.4-0.5 billion (mature market with stringent regulations and focus on ethical considerations).
• Eastern Europe: USD 0.5-0.6 billion (growing market with lower costs and diverse populations, but faces language barriers and varied regulations).
• Latin America: USD 0.6-0.8 billion (potential for growth due to large patient pool and R&D activities, but needs improved infrastructure and skilled workforce).

3. Employment in Pharmacovigilance:

The global pharmacovigilance industry employs over 2 million people directly or indirectly, with regional variations in numbers and salary expectations.

3.1 Major Employment Hubs:

• US: 40,000-60,000 (high demand for skilled professionals, competitive job market).
• Europe: 30,000-40,000 (strong presence of specialized CROs and pharmacovigilance service providers).
• Japan: 15,000-20,000 (emphasis on regulatory compliance and local expertise).
• China: 20,000-30,000 (rapid growth, increasing demand for qualified professionals, talent development initiatives needed).
• India: 10,000-15,000 (growing market, skillset gap exists, potential for job

4. Current and Future Pharmacovigilance Trends:

4.1 Global Trends:

• Digitalization: AI, ML, and Big Data are revolutionizing data analysis, improving signal detection, and enabling real-time safety monitoring.
• Decentralized Clinical Trials (DCTs): Increased adoption of DCTs to improve patient access and data diversity, necessitating robust remote pharmacovigilance solutions.
• Patient-Centricity: Patients are becoming more involved in safety reporting and decision-making, leading to the development of patient-friendly reporting tools and engagement strategies.
• Real-World Data (RWD): Growing usage of RWD from electronic health records and wearables to complement traditional clinical trial data and provide insights into drug safety in real-world settings.
• Harmonization of Regulations: Efforts to standardize pharmacovigilance regulations across regions are underway to streamline global processes and improve drug safety information exchange.

4.2 Regional Trends:

• US: Focus on personalized medicine, early-phase trial safety, and active safety surveillance (PASS).
• Europe: Emphasis on compliance with EMA regulations, post-marketing surveillance, and risk management plans.
• UK: Brexit impact on regulatory landscape will be closely monitored, along with increased R&D in niche therapeutic areas.
• India: Cost-effectiveness remains a key driver, along with government initiatives to improve pharmacovigilance infrastructure and training.
• Japan: Focus on aging population and geriatric drug safety, along with regulatory updates and local data utilization.
• China: Rapid growth driven by government support for R&D and increased regulatory compliance requirements.
• Australia & Canada: Focus on maintaining high ethical standards and patient safety in clinical trials, alongside adoption of digital technologies.
• Southeast Asia: Rising awareness of pharmacovigilance, regional regulatory harmonization efforts, and development of local service providers.
• Eastern Europe: Potential for growth due to lower costs and diverse populations, but challenges include varied regulations and language barriers.
• Latin America: Improving infrastructure and skilled workforce needed to capitalize on the large patient pool and growing R&D activities.

5. Key Pharmacovigilance Service Providers:

• IQVIA: Global leader with comprehensive solutions for pharmacovigilance, drug safety, and compliance.
• Parexel: Strong expertise in global safety solutions, clinical research, and data management.
• Syneos Health: Integrated approach combining clinical development, commercialization, and pharmacovigilance services.
• Exco InTouch: Dedicated pharmacovigilance solutions with a focus on risk management and signal detection.
• WuXi AppTec: Leading player in China with global reach, offering integrated R&D and pharmacovigilance services.
• Aptiv Solutions: Specializes in drug safety technology and data analytics, supporting pharmacovigilance processes.
• Covance: CRO with strong pharmacovigilance capabilities, experience in global clinical trials.
• PRA Health Sciences: Global CRO offering pharmacovigilance services alongside clinical research expertise.
• ICON plc: Provides end-to-end drug development solutions, including comprehensive pharmacovigilance offerings.
• Veeva Systems: Cloud-based life sciences platform providing Veeva Vault Safety for pharmacovigilance data management.

6. Major Pharmacovigilance Software:

The global clinical research market is expected to reach $76.8 billion by 2027, with significant activity in:

• TARAPV : TARA PV is a fully functional system offering an interface that is consistently simple, intuitive and most importantly, a user-friendly cloud based pharmacovigilance solution.
• Argus Safety: Widely used platform for safety data management, reporting, and signal detection.
• Oracle Argus Cloud: Cloud-based version of Argus Safety offering scalability and accessibility.
• Pharmatix Vigilance Safety Suite: Comprehensive safety data management system with global regulatory compliance features.
• Medidata Safety Connect: Cloud-based safety platform with clinical trial integration and data visualization tools.
• Veeva Vault Safety: Part of Veeva Systems' platform, offering cloud-based safety data management and regulatory compliance tools.
• SafetyNet by Almac Group: Comprehensive pharmacovigilance software with advanced analytics and reporting capabilities.
• AERIS by OpenText: Cloud-based pharmacovigilance platform with global functionality and regulatory compliance features.
• Evisort by MedTech Innovator: AI-powered pharmacovigilance software for enhanced signal detection and risk management.
• Drug Safety Cloud by Exco InTouch: SaaS platform for risk management, signal detection, and regulatory compliance.
• SafetyWatch by Aptiv Solutions: Cloud-based pharmacovigilance platform with integrated risk assessment and signal management tools.

This detailed overview provides insights into the current and future trends shaping the global pharmacovigilance landscape. With technological advancements, regulatory harmonization efforts, and patient-centricity gaining momentum, the pharmacovigilance industry is poised for significant growth and transformation in the years to come.

MEDICAL WRITING – INTRODUCTION

By Dr. Suneet Sood, Monash University & Kamal Shahani, Cliniminds

In the series of short write ups on a medical writing career, we would cover various aspects of medical & scientific writing. This first article covers the introduction and the scope of medical writing.

 Medical writing is, in its broadest sense, writing for the healthcare and life sciences industry. The term “writing” included only the print medium, but now also includes any writing work that is carried out for television (e.g. advertisements), radio (e.g. speeches), and internet. Healthcare related typically refers to medicine, but medical writers also involve themselves in writing for agriculture and veterinary related content.

In this short write up, we would cover the scope and types of medical writing.

 The Scope of Medical Writing

 For persons who wish to become medical writers, the scope is immense. 

Medical writing is today a billion-dollar industry.

The writer can involve themselves in one of two types of writing:

1.      Regulatory Writing        

2.      Publication Writing

Medical writing is conventionally classified into these two types, because the laws governing regulatory writing are considerably more stringent than those governing publication writing. Consequently, someone who is involved in regulatory writing is more likely to require a formal training course than one who will confine themselves to publication writing.

Having said that, everyone needs training!

Regulatory writing is that which is typically carried out by the contract research organizations for the pharmaceutical industry or by the pharmaceutical companies for regulatory compliances. They typically create large texts for firms conducting drug trials. Today the ethical constraints for all trials are so tight that there is a large body of rules that guides this form of writing. The rules ensure that the documents adhere to the International Conference of Harmonization’s Good Clinical Practice guidelines. Medical writers at Pharmaceutical companies write several regulatory documents for submissions to various global regulatory agencies.

Thus, a medical writer involved in regulatory writing will prepare clinical trial reports, write out the investigator brochures, generate new drug applications, compile annual reports, write out clinical study reports, and so on.

In contrast, the medical writer who focuses on publication writing will typically write for magazines, journals, even books. Publication writing includes pharmaceutical marketing and advertising, writing magazine articles, and so on, for the public (see box). Publication writing includes newsletters, speeches, posters, abstracts and other journal content, educational materials, compilation of drug monographs, internet content, and ghostwriting, as well as editing and other activities of publishing houses.

Publication writing

Pharmaceutical marketing and advertising

Magazine articles

Professional Newsletters

Physician speeches Posters

Conference Coverage

Journal abstracts and articles Medical education materials Patient educational materials Internet content

Editing, proofing, publishing Ghostwriting

The debate is not whether there is enough work for medical writers. The debate is, “is there a limit?” Medical writers can get jobs in pharmaceutical companies, contract research organizations, agencies that specialize in communications work, content providers, or institutions that cater for education. Freelance writers have a high demand if they are good. The most skilled writers will create content. Medical writers will also be editors and proofreaders, and may have a role in marketing for medical products. However, all writers should aim to become content creators. Medical writing is a sort of business. Skill, marketing, and durability in the profession make a great difference. Still, the rewards are good overall. In United States of America medical writers earn between US$60,000 and 100,000 or more annually. In India medical writers earn between Rs.400,000 and 20,00,000 or more annually depending upon your level and experience. A lot depends on the market a writer targets. Most of the better earners will have taken a writing course. Very few top earners will be self-taught. As professionals, most should be members of an established medical writing institution/ association.

The scope for publication writing is also immense. One can produce advertising articles, internet content, magazine articles, marketing materials, newsletters, training manuals, and more.

Publication writing itself is directed at two main audiences: the public (popular) and the scientific (professional). Writing for the public includes content for popular newspapers and magazines, educational materials, advertising products such as flyers, and others. Scientific writing includes content for newsletters, reviews for journals that cater to practitioners, and internet content for professionals. Scientific writing may even include writing for specialty medical journals, and medical writers are lobbying hard to make it acceptable for investigators to enlist their services to produce medical papers.

For those who are interested in taking medical writing more seriously, even as a profession, the question we need to address is: are there jobs for medical writers? The answer is, “Of course there are jobs.” Writing for The pharmaceutical and clinical research industry itself is a multibillion dollar business. A simple Google search showed that the industry turnover has multiplied since the nineties. The same holds true for publication writing.

Formal training in medical and scientific writing is important for the professionals who would like to take a plunge in medical writing career or medical doctors who would like to conduct and publish their research. A formal training course would be helpful.

About Cliniminds : Cliniminds offers wide range of health sciences programs since 2004. Cliniminds also offers specialized program in Medical & Scientific Writing. Next batch for Live eLearning is commencing from Sunday, 2 August 2020. For more information, please contact info@cliniminds.com or +91 98100 68241.

CLINICAL TRIAL & 13 Principles of ICH GCP

In Clinical Trials to achieve Quality readiness one needs to understand the Principles of Good Clinical Practices. GCP has been well defined in EU Directive 2001/20/EC, under Clause 2 of Article 1, which discusses about scientific quality requirements for designing and conducting clinical trials.

The data obtained from Clinical trials should be credible as well Clinical trials should protect the rights, safety and wellbeing participating subjects as per National Research Act and Belmont Report, to ensure the authenticity of data and protection of human subjects The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) created Good Clinical Practices in the year 1996, which eventually became mandatory to be followed in the year 2004 for conducting trials on all Investigational Medicinal Products (IMP).

Principles of GCP are summarized as follows

1.Clinical Trials should be conducted as per Declaration of Helsinki, which provides ethical guidelines on human experimentation.

2.Before the initiation of clinical trial, the risks for subject and society should be weighed against its anticipated benefits. 

3.The safety and rights of the participating subjects should considered with utmost importance over the benefits of trial. 

4.Clinical information and non-clinical information on the investigational medical product should be adequate to support the trial.

5.Specifics of clinical trials should be well defined and explained in Protocol

6.Protocol should be approved by Institutional review board (IRB)/independent ethics committee (IEC), following which clinical trial should be conducted in compliance with Protocol. 

7.During the trial, qualified physician would be responsible for the well the being of the subject 

8.The staff conducting the trail should be qualified in education, training and experience to perform task allocated to them.

9.Prior to the clinical trial signed informed consent should be obtained from the subject

10.To allow accurate reporting, interpretation and verification of clinical trial data, measures to and record and maintain the data should be sought out.

11.The records identifying the confidentiality of subject should be protected in respect to privacy and confidentiality regulations.

12.The Investigational medicinal product in Clinical Trials should be manufactured as per Good manufacturing practices (GMP) and should be used in accordance to the protocol. 

13.Quality systems should be maintained to ensure quality in Clinical Trials.

Reference: GCP 13 Principles
(Url:  https://www.abdn.ac.uk/hsru/documents/GCP%2013%20Principles.pdf )

Cliniminds (www.clinimids.com ) welcomes all the students and professional who are seeking a bright career in Clinical Research and Pharmacovigilance. We have 14 + years of lineage and our faculties are seasoned experts with vast experience from the Industry. We provide 100% assured placement support, for more information contact us @ 9560102587 or email us at pharmacovigilance@cliniminds.com

Clinical Research- opening new doors to Duchenne muscular dystrophy

Duchenne muscular dystrophy (DMD) is a muscular dystrophy characterized by severe muscle weakness due breaking of skeletal muscles. DMD mostly occurs in boys at around age of 4. The aetiology of DMD is said to be attributed to the mutation of a gene called dystrophin located at locus Xp21 or on Chromosome X. Dystrophin is responsible for connecting the cytoskeleton of each muscle, without dystrophin, excess calcium would enter into the cell and cause the cell to burst.

It was not too long before Erin realized that her two year old son Oliver Lambright was diagnosed with Duchenne muscular dystrophy, a generic disorder which occurs in one in 3000 boys. She looked at every possible treatment on the internet, only to realize that there was no cure, till she found Dr. Jean Mah, who was an Associate Professor at Cumming school of Medicine in the Department of Paediatrics, she told her family that there is ongoing clinical trial on DMD at the University of Calgary in Alberta, Canada in which around 100 patients with DMD from all over the world participated in the trial.

Clinical trials are essentials as it paves way for new line of treatment drugs. Before a drug is dispensed in a clinic,It has to undergo clinical trial. At the University of Calgary there are around 563 active trials.

Reference: UToday, University of Calgary

Url: http://ucalgary.ca/utoday/issue/2018-05-16

Cliniminds www.cliniminds.com has been on the forefront in delivering quality education in Clinical Trial Monitoring accredited from the Accreditation Council of Clinical Research Education- United States. Our course on Clinical Trial Monitoringcovers module on Clinical Research, Pharmacovigilance and Clinical Data Management. Our program comes with assured placement support.

Our Classroom sessions for new batch commences from 21^st May 2018. Enrol now to avail 10% discount. For more information contact us at 9910068241, 9560665441, 9560102587or email us at info@cliniminds.com

Artificial Intelligence Seeing through the lens of Pharmacovigilance

Pharmacovigilance as we know is a science with a set of pre defined functions to collect, analyse, monitor adverse event reports in understanding the safety profile of drug.

The set pre defined functions would include case processing through data entry of adverse event forms into safety database, medical review, aggregate reporting, signal detection, risk evaluation and mitigation strategies.

With patients awareness and regulatory compliance we may have seen a surge of adverse event data over last few years , resulting in the urgent need for the application of automation. Pharmacovigilance is the only discipline where in which timelines and quality data are evaluated on a benchmark of 100 % and a compromise in these two parameters are considered to be a zero tolerance.

Automation of above pre defined function is possible through machine learning, which is an integral components of Artificial Intelligence.

What is Artificial Intelligence ?       

Artificial intelligence may be called as an ability of a computer system to perform task that require human intelligence such as cognition through visual acuity, voice recognition, language translation leading to decision execution of a certain function.

Machine learning is based on reinforced data, where in which when an algorithm is executed to accomplish a specific task.

If it accomplishes the algorithm ends and the entire procedure in auto stored in the program, which means next time one does not need to manually execute the program, it would be auto executed in order to accomplish the task, if presented with the exact same variables as that of the earlier scenario.

In the second case if the task is not accomplished then too the procedure would be stored in the program and next time when the program is auto executed it would not take the same path thus minimizing error.

This process self-learning through experience is called machine learning For example imagine a scenario where in which you have you have received an email from a patient who has experienced nausea, followed by headache and bleeding from nose on Lisinopril, the patient also mentions that he has a history renal impairment and also that he was a chain smoker for which he took Varenicline to quit smoking.

An algorithm created on the principle of machine learning would have the capability to auto recognises and identify the suspect drug from concomitant therapy, adverse event from medical history and not only this through robotic process automation it may integrate the email with safety database, which means not only it identifies the suspect drug and the adverse event, it now also does the auto data entry, prepares auto case narrative and auto sends letters to the patient or physician for further follow up  from the safety database.

This is ‘Artificial Intelligence’, a capability attained through self-learning to process thousands of data within seconds.With automation employees engaged in manual data entry would be upskilled in the execution of AI process.

Cliniminds (www.cliniminds.com ) offers training in aggregate reporting, our students are trained on PSUR, PBRER, Addendum, Summary Bridging, DSUR, ASR, EOS Reports with Hands On’ experience on ORACLE Argus Safety and other safety databases for line listing, summary tabulation extraction.

Seminar on Pharma Data / Business Analytics & Career Opportunities

On Sunday, 7^th January 2018 Cliniminds organized Seminar on Pharmaceutical Data / Business Analytics with focus on career opportunities for the graduates and post graduates in pharmacy, medicine, dental, IT/Computer Science, life sciences and biotechnology. Demo class on the topic of Analogue Analysis was conducted for the benefit of the participants. Experts from leading pharma business analytics firms conducted interactive session with the participants.

Pharma data / business analytics is one of the fast growing sectors in the life sciences domain with annual growth of 27%, and by 2021, industry size would be over US$21 billion.

The sector offers attractive career opportunities with excellent long term career opportunities for pharmacy, medical, IT/computer science, life sciences, and biotechnology graduates and post graduates.

Cliniminds offers first time in India, Specialized program in Pharma data / business analytics. For more information and assistance, please contact +91 9810068241 or info@cliniminds.com.

Pharma Data Analytics - Opening Doors to a New Vertical In Healthcare

The pharmaceutical industry is currently ranked as 2nd on the global scale with a market of estimated US $874 billion which would exponentially soar to US $ 1.22 trillion by 2022, the key drivers for this high stake is mainly due to poly-therapy used in the treatment of multiple chronic conditions like hypertension, diabetes, COPD, hyperlipedmia.

The healthcare system of India is growing at an incredible pace with a current compounded annual growth rate of (CAGR) of 22.9 % which is expected to reach a net worth of USD 150 Billion by 2020.

With easy accessibility of medicines, better nutritional supplements, better formulations and the switch from supervised to self-therapies using engineered technologies like controlled delivery systems, has impacted the pharmaceutical market to a great extent globally.

This impact has also led to many changes in the regulatory framework for instance, with respect to compliance, the marketing authorization holders (MAH) have been asked to focus more on the outcome, rather than the input Irrespective of whether MAH has a robust pharmacovigilance system in place, if the risk of a drug causing a Serious Adverse Reaction which may also be life threatening is not controlled through implementation of risk mitigation strategies, it may lead to reactive measures which may include complete withdrawal of drug from the pharmaceutical market.

Through the use of Digital/social media platforms like facebook, twitter, blog spot has led people to take health related decisions. Data from such websites when mined and analysed using predictive analytical solutions would help in understanding the patient needs and accordingly this data may be applied in understanding the current market share of the product.

Pharma analytics is a science which provides data insights through reporting, descriptive, predictive and prescriptive analytical solutions. Pharma analytics helps companies to understand current trends in pharmaceutical space.

Its core components comprises of Drug discovery analytics, Supply disruption predictiveanalytics, Product failure analytics which uses predictive analysis to understand product failures, Risk analytics used in understanding the benefit vs risk how the well risk be tolerated in a study population, Social analytics to understand the actual need of the drug in the population. Pharma analytics also enhances reporting systems to ensure effective communication and adherence to regulatory compliance. The use of Business intelligence Visualization software enables better analysis of the business data.

Direct to customer selling, aggressive marketing strategies and launch of a molecules in many countries at the same time has led the MAH to highly depend on analytics for e.g. Pharma analytics is now been profusely used in the reduction of cycle time for clinical trials.

Analytical systems are designed in such a way that they are self-learning, evolving as per feedback received from end users. Lifesciences organisations are now relying on decision made using analytical tools, Pharma analytics thus promises a huge scope in the coming years.

For more information on the career in pharma data analytics, please contact info@cliniminds.com or call +91 98100 68241.

References:

Analytics

1. Analytics in Pharma and Life Sciences; Abhishek Menon, Anupam Jain; Everest group research; page 3,6,7,9

Weblink:http://www.genpact.com/docs/default-source/resource-/analytics-in-pharma-and-life-sciences

(Last accessed on 29 Dec 2017; 16:00)

2. Life Sciences

Weblink: https://www.infosys.com/data-analytics/verticals/Pages/life-sciences.aspx

(Last accessed on 29 Dec 2017; 16:15)

3. Pharmaceutical Commerce; “Global pharma market will reach $1.12 trillion in 2022”; September 26, 2016

Weblink: http://pharmaceuticalcommerce.com/business-and-finance/global-pharma-market-will-reach-1-12-trillion-2022/

(Last accessed on 29 Dec 2017; 16:15)