Now that we are fully immersed in 2019, our general manager, Barbara Morgan, gives her thoughts on what lies ahead for the pharmaceutical development and manufacturing industry this year.
The advent of non-traditional dosage forms and technologies
Around 90% of drugs in the development pipeline are poorly water-soluble APIs, so we are seeing increases in non-traditional dosage forms and processing techniques. Traditional methods for making oral solid dosage forms are often not viable as these APIs have limited bioavailability. To that end, there are a number of technologies available to increase drug solubility and improve their delivery, such as amorphous solid dispersions and nanoparticle formulations.
Alongside this we are also witnessing an increase in 505(b)2 approvals – an FDA regulatory pathway that usually involves taking an existing API into a different route of administration or new dosage form. These approvals grew 50% last year and this regulatory pathway is increasingly popular. It typically involves innovative dosage forms or drug delivery methods that are considered complex.
The end of the blockbuster
High-volume blockbuster drug production is no longer the industry norm and is also not reflected in the current drug development pipelines. Coupled with this, there has been a scaling down of manufacturing facilities and a transition to a more flexible approach.
As new drugs in the development pipeline require more modular and diverse capabilities, contract manufacturers have had this consideration at the front of their minds when expanding facilities. The growing trend is towards personalized medicine and medicines that have smaller batch sizes, which requires manufacturers to be much more nimble.
Rise in focus on complex generics
Given the pricing pressure on generic drugs, we foresee continued interest in complex generics, which have lengthier and more expensive development programs and often involve clinical trials but allow a market space that is more highly valued and more exclusive. The FDA has aided in this endeavour by providing more support and focus to this space, trying to increase the amount of attention given to some of these drugs that are critical but often tough to tackle.
Drug shortages, especially in sterile products
The pricing pressures on generics and the rise in the use of injectables have also had a ripple effect on the availability of many drugs, but especially those in the sterile space. There is a compound effect happening here: the complexity of the sterile manufacturing process, the limited number of available facilities that can make them, the pressure to lower drug prices and the fact that some of these sterile products in short supply are large volume but low value. We are hoping to play a small part in relieving some of these issues, at least those that concern small batch sterile products or supply chain risk mitigation for companies looking to qualify a second facility. Our new commercial facility coming on line this year is custom-built to handle sterile solutions, suspensions, and powders.
For more information on how Lubrizol Life Science Health can help you reach your drug development goals this year, have a look at our list of services and contact us to discuss your project with our team.