Sixty years ago, the pharmaceutical industry focused on developing new active ingredients that involved long processes lasting at least ten years and costing millions, in which approximately five years would be spent on developing a new product that then required another five years for the approved clinical trials.
Forty years later, the industry identified a business opportunity in the form of generics by taking advantage of all that development capacity in the past and manufacturing products whose patents had already expired. Companies centered their investments on improving legacy technologies and existing processes instead of on developing new active ingredients, resulting in drastically fewer new APIs (active pharmaceutical ingredients). The market for generic medications was profitable, and it was also faster and cheaper to launch products to the market.
The segment for generic medications is starting to lose its market share and prices for those APIs have fallen sharply due to increased competition and advanced intermediaries that are manufacturing in China. Many companies have stopped making these types of medications because they are no longer profitable.
In this day and age, the pharmaceutical industry needs new products. Pharmaceutical preparations made from natural products are a potential strategy and line of business.
Natural products have always been the basis of many medications in the past as well as in the present, and they are an endless source of active ingredients. Natural extracts are composed of many active ingredients that work together towards specific goals and they usually have extremely low or zero toxicity.
The pharmaceutical industry’s interest in the nutraceutical industry has helped evolve the latter by requiring improved quality controls throughout the supply chain and by defining its own rules for proper production and marketing based on GMPs (good manufacturing practices).
Fran Cremades
Technical Director and Quality Control
R&D&i, Process Development and Scale-up
