From Lab to Shelf: The Journey of Medicines and APIs in Global Trade

It’s important to be in touch with the pharmaceutical industry as an importer or exporter of medicines. A successful trader is well aware of the latest developments and opportunities in the world of medical products.

 

Our free pharmaceuticals import export data shows thousands of pharmaceutical drugs that are being traded all over the world. Being familiar with how new drugs are created is crucial to succeed as a pharma trader.

 

The Trade Vision is a premier data provider and market intelligence company with

decades of experience in import-export statistics. Access our data on the go with

comprehensive reports from over 100 countries.

Drug Development: An Overview

Pharmacovigilance is the science of ensuring the safety of medicines. Each country has its own regulatory body that takes care of this function. The actual procedure of drug development is very similar throughout the world.

 

The US, UK, Switzerland, Germany, France, and Europe have been leading in the development of new medicines for decades.

 

An average drug takes around 12 years to be developed and costs about €1.15 billion. It goes through five different phases before it is issued a license to be made available to the public.

Stages of Developing A New Drug

The process starts with the study of any particular disease or ailment. The neural and bio pathways are carefully mapped, and possible interception points or weaknesses are identified. How long this takes varies greatly depending on the nature of the disease.

 

Drug discovery is the second step. Here, possible molecules and compounds are identified that tackle potential targets, like genes or proteins. This stage typically takes between three to five years. Around five to ten thousand compounds are usually considered at this stage.

 

Then comes the testing stage, where we move from theoretical to practical experimentation. Cells, animals, and computational models are used to see if the drugs are working as expected. By now, the Active Pharmaceutical Ingredients (API) are narrowed down to about ten to twenty candidates.

Clinical Trials

The fourth step is the most prominent one, where trials begin on human beings. The trials are further split up into three phases. Phase 1 is done with between 20 and 100 healthy people to see if the drugs have any negative side effects.

 

Phases 2 and 3 are done with an increasing number of people, often with control groups in double-blind studies. The people in control groups are given placebos, or sugar pills, to remove any influences that may affect the outcome. After about 11 years and over 1.1 billion euros, the developer narrows the drug down to just two candidates.

Patenting and Finding Opportunities

Once a drug has passed the clinical trials, the company can submit an application for a license. This contains the research, manufacturing process, and the findings of the clinical trials within it. It's important to note that the regulatory body is involved in each step of the process.

 

A typical drug has a patenting period of about 20 years that stops the developer’s competitors from making use of their formula. This period allows the companies to earn back some of the money they have invested over the decade or so.

 

Companies are quick to file for patents for molecules that show promise early on in the research process. By the time a drug is licensed and approved, more than half of the patent period is typically over.

 

As a trader in this field, you need to keep an eye on patents being filed by big companies. Mull over pharmaceuticals import export data, keep a tab on the regulatory body of your target country, and study prominent companies to succeed in the pharmaceutical industry.