• Pharmaceutical Market
    The Pharmaceutical Market
    $1 trillion spent annually
    for prescription medicines

The Pharmaceutical Industry

The roots of the pharmaceutical industry go back to the 1800's beginning from apothecaries (similar to modern pharmacies today) who prepared and distributed natural products / plant extracts - those days quinine and morphine were typical examples, followed later by extracts from tissues.

Today's pharmaceutical industry is one of the largest in the world, supporting our health and helping to cure or improve many diseases. The global pharmaceutical market in value terms is almost $1 trillion. Approximately 70% of the sales of prescription medicines are generated in North America (c. $500bn) and Europe (c. $200bn). Prescription medicines are typically reimbursed by the health systems of each country. Prescription medicines have authorised claims on efficacy and safety and in order to receive these, they must follow the regulatory path of drug development.

Pharmaceutical Industry

The Largest Pharmaceutical Companies

Johnson & Johnson
Roche
Pfizer
Novartis
Bayer
GlaxoSmithKline
Merck & Co
Sanofi
Abbvie
Abbott
Eli Lilly
Amgen
Bristol-Myers Squibb
AstraZeneca
Gilead Sciences
Boehringer Ingelheim
Merck Serono
Novo Nordisk
Allergan
Takeda
Shire
Celgene

Drug Development


Developing pharmaceutical compounds is a very complicated, coslty and risky process. On average, a new compound, or a New Chemical Entity (NCE) can take more than 10 years from discovery to reach the market and cost estimates range from $200-800m, while going through the development stages.
Drug Development

The different stages of development

Preclinical Tests

This early testing begins after the lead molecule is optimised and final. It includes lab in-vitro and in-vivo studies to show biological activity of the compound against the targeted disease, including safety evaluation.

Investigational New Drug Application (IND)

Following a successful outcome in preclinical tests, an IND is filed with the FDA to allow the test of the compound in people. The IND includes detailed information on the preclinical tests, as well as details in chemistry, manufacturing etc.

Phase I

The main objective of the first phase of clinical development is to test the safety of the NCE in a small number (usually 15-50) of healthy volunteers and also provides an indication of the potential dosing range and some information on the NCE's pharmacokinetics and metabolism. Compounds in phase I have a 15-20% chance of making to the market.

Phase II

If phase I is completed successfully, the NCE is then progressed into phase II, where it is adinistered under a detailed protocol to a larger number of patients to test the NCE's efficacy and safety. Sometimes, phase II is split into IIa and IIb, providing a little distinction between an early indication of proof of concept and a more robust one. Numbers of patients for a phase II vary, but as a guide, tend to be 20-50 in phase IIa and up to 200-300 in phase IIb. Compounds in phase II have a 25-35% chance of making to the market.

Phase III

If proof of concept has been established in phase II satisfactorily, the compound then progresses to a detailed and large phase of clinical development, that basically confirms all the findings and expectations in a setting that provides enough data to show statistically significant difference in the efficacy of the NCE and also test safety to a great extent. Numbers of patients in phase III vary based on the disease, sometimes reaching thousands and the studies (may be combination of multi-center, multi-country trials) may last for a few years - depending on the chronic nature of the disease. Compounds in phase III have a 60-70% chance of making to the market.


New Drug Application (NDA) / Marketing Authorisation Application (MAA)

Finally, all the data is compiled into a large volume of documents in a special format that comprise the NDA which is filed with the FDA, and the equivalent regulatory authorities around the world (e.g. a Marketing Authorisation Application (MAA) is filed with the EMA in Europe). The files tend to take 1-2 years to review and approve (or reject) and the process is rarely shortened for an expedited review if there is a large unmet medical need.


Approval

The Marketing Authorisation is the successful outcome of a compound's development and is the pre-requisite to market the new pharmaceutical. The approval is followed by a pricing and re-imbursement process.


The challenges for new medicines

In the last two centuries and more particularly during the last century, the pharmaceutical industry has managed to develop many new molecules that helped to save millions of lives. Many diseases are now addressed by existing medicines, although many are still not able to be treated appropriately. The process often begins with a "target", being a particular molecule or biological entity for which new chemicals are being designed and tested. Typically thousands of molecules have to be screened before a "hit" is effective and the "lead" moleculed is optimised. After that, the new compound has to to undergo extensive safety tests before being allowed to be tested in people (in the "clinic", hence the term "Clinical Development"). The drug development process is complicated and costly. Many strict guidelines have to be followed, for example "GLP" (Good Laboratory Practice), "GCP" (Good Clinical Practice) and "GMP" (Good Manufacturing Practice) and if these are not followed properly, the authorities will not give approval. New drugs are protected by patents which provide the manufacturer exclusivity for 20 years from the patent grant, which means that by the time development is complete, a new drug will have exclusivity for around 10 years, which in turn is a reason for a price which is appropriate to recover the costs of research and development of the particular project but also of the other projects that have failed.

We are a science-driven healthcare UK company based in London, with an international network.

Our focus is on novel products with evidence-based natural compound formulas to support people's health.

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