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Why 90% of New Medicine Never Reach the Market

Jan 20, 2023

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Medicines have been around for hundreds of years now. The first Medicines ever used were produced in the 16th century. But why are Medicines so important? There are many reasons why Medicines are essential. Not only can they help to cure certain illnesses, but they can also help to slow down the progress of many untreatable conditions too. As well as this, Medicines can be used to reduce pain, inflammation, and swelling.

Currently, in the US, thousands of different types of Medicines are on the market, but this doesn't mean we should stop producing more Medicines. New Medicines are needed to treat new diseases, overcome previously untreatable conditions, and they are required to kill drug-resistant bacteria and fungi.

However, while new Medicines are constantly being created, research suggests that many new Medicines never actually reach the market. It is believed that only 10% of all new Medicines end up reaching our shelves. If you want to find out more about this, then keep reading below:

How Are New Medicines Created?


There are many stages to drug development:

  1. Discovery and development – the first step is to discover new Medicines. This is a complex process that takes place in a laboratory.

  2. Preclinical research – at this stage, Medicines undergo animal and laboratory testing

  3. Clinical research – the next step is to test the new Medicines on humans. This ensures they are safe and effective for use.

  4. FDA review – once the Medicines have been tested, the FDA will review all of the data before deciding on whether to approve it.

  5. FDA Pose-Market Safety Monitoring – once a drug is deemed safe, it will then be monitored by the FDA.


Why Don't 90% of Medicines Reach the Market?


Evidence suggests that only 1 in 10 Medicines pass clinical trials, but why is this? A recent analysis identified four main reasons why so many Medicines fail to get FDA approval:

  • The main reason was because of the lack of clinical efficacy. This means the Medicines didn't have the intended outcome in people.

  • Another reason was that the Medicines had side effects or unmanageable toxicity.

  • 10% of Medicines had poor pharmacokinetic properties, meaning they weren't absorbed or excreted from the body properly

  • The final reason was that there was little commercial interest in the Medicines.


Improving the Drug Development Process


Over the past few years, scientists have worked hard to improve the drug development process. They have implemented several new tools and strategies for the process, including high-throughput screening, which uses machines to automate thousands of tests in the lab, and artificial intelligence-based drug design. However, despite this, the success rate still hasn't altered much.

While this may be true, it is believed that there is hope for the future. Many researchers believe that if we focus on the earliest stages of drug development, this could help increase the success rate. But how do we do this? It is argued that this can be done with gene editing technology.

An example of gene editing technology is the one created by Hera Bio Labs, which uses cell line development to verify the right molecular target that causes a disease and work out whether the drug is actually targeting it.

Over the past few years, thanks to the COVID-19 pandemic, we've all realized just how vital Medicines are. This not only includes Medicines already available on the market but also new Medicines that are yet to be approved. However, while this may be true, research suggests that almost 90% of all new Medicines never make it to the shelves. This is disheartening to hear. Let's hope that in the future, more Medicines will become available to treat illnesses and conditions that currently cannot be treated.