The pharmaceuticals industry is huge! In 2017 alone, the total worldwide sale of prescription and over the counter drugs was $825 billion (£670 billion), with oncology drugs contributing $104 billion (£84 billion)! However, these sales and drugs do not just appear overnight. Let’s discuss the life-cycle of a drug.





The life-cycle of a drug.





It typically takes at least ten years for a new medicine to complete the journey from initial discovery to marketplace.





The journey is as follows:

Drug discovery Pre-clinical development Clinical development Regulatory approval





Why does drug development take so long ?





The pharmaceutical industry in one of the most regulated industries in the world, and rightly so. The regulation of drug development prioritises the health and safety of patients. Regulated drug testing underpins the timeline and success of a drug’s development.





Pre-clinical phases Our journey begins with years of comprehensive laboratory research of a drug’s effect in animal and human cells. If this laboratory research is successful, researchers send the data to the Food and Drug Administration (FDA) or European Medicines Agency (EMA), for approval to continue research and testing in humans (clinical trials).

Clinical trial phases

Human testing of a drug is typically conducted in four phases. Each phase is considered as a separate trial, and, after completion of a phase, trial investigators submit their data to the FDA or EMA before continuing to the next phase. All enrolled patients provide informed consent to be involved in a clinical trial. Some trials are randomised, which means the patients taking part are allocated a treatment group at random. Many phase III trials are also double-blinded. This means that neither the patient nor the trial investigator knows if the patient is receiving the drug or placebo. Both methods help avoid bias and make results more reliable.

How much does drug development cost?





The amount of money spent to develop any drug is dependent on how much it costs to carry out the studies required to confirm it is safe and effective and, therefore, able to achieve regulatory approval. This value can range for $10 million to $2 billion depending on the therapy.

However, what really increases the costs of drug development is that ~90% of medicines being tested in clinical trials do not reach market. The average cost to research and develop each successful drug is estimated to be $2.7 billion. This value includes the cost of failures. The thousands of compounds that are screened and assessed early in the research and development process but did not pass the pre-clinical or clinical trial phases cost money!

Key Takeaway





Developing drugs is a costly, potentially risky and time-consuming business. However, we need pharmaceutical companies to manage these risks for us! Globally we have an aging population and with that, a rise in chronic diseases and complex medical conditions. Drugs cannot be rushed to market as it compromises the safety of patients and the integrity of the regulatory process.

Hope you found this article useful! Let me know what you all think. Any pharma questions let us know too! #SciSouls #science #biology #pharmaceuticals #chemistry #health #medicine #drugs References





Deloitte 2019 Global life sciences outlook. Available here: https://www2.deloitte.com/global/en/pages/life-sciences-and-healthcare/articles/global-life-sciences-sector-outlook.html





European Medicines Agency. Available here: https://www.ema.europa.eu/en/medicines





Food & Drug Administration. Available here: https://www.fda.gov/drugs





Osterholm, M.T. and Olshaker, M., 2017. Deadliest enemy: our war against killer germs. Hachette UK.





Van Norman, G.A., 2016. Drugs and devices: comparison of European and US approval processes. JACC: Basic to Translational Science, 1(5), pp.399-412.





World Preview 2018, Outlook to 2022, EvaluatePharma, 2018Herper M. The Cost Of Developing Drugs Is Insane. That Paper That Says Otherwise Is Insanely Bad. 2017. Available here: https://www.forbes.com/sites/matthewherper/2017/10/16/the-cost-of-developing-drugs-is-insane-a-paper-that-argued-otherwise-was-insanely-bad/#551503bb2d45