The world’s population is growing, with 7.7 billion people on the planet today. People are living longer, and a longer life leads to more health issues. Drug companies are fighting to meet the demands of the aging population, and when new drugs are developed, one problem is meeting the consumer demand.
Biopharmaceutical companies have difficulty operating on their own and manufacturing enough drugs to reach the masses.
The trend has led to CDMO Companies being a main form of outsourcing, which allows drug companies to push drugs to market faster while still maintaining a high level of quality in the process.
CDMOs Help Bridge the Gap
CDMO companies help alleviate the financial costs on drug companies. Delivery is becoming more complex, and formulation synthesis requires higher consideration. Pharma companies are relying more on CDMO organizations to:
- Accelerate development
- Control costs
- Access expertise
These companies allow pharma companies to gain access to robust manufacturing and quality control centers. There’s also the benefit of accessing new talent and experts in the field that work for the CDMO companies.
One trend, seen especially with cancer drugs, is the growing importance of safety with highly potent active pharmaceutical ingredients (HPAPIs). HPAPI handling requires the utmost in safety, and smaller pharma companies may lack the internal expertise to handle these ingredients properly.
CDMOs often have immense experience working with HPAPIs, allowing the pharma company to focus more on clinical trials and testing their new drugs. But it doesn’t just stop there. These companies can be outsourced to provide help even with the application process.
Investigational new drugs (INDs) have a lengthy application process which the CDMO can handle. The seasoned CDMO company will have a wealth of experience in the application process and can help drug companies:
- Supply all necessary information on the application
- Determine risks
- Determine accurate timelines
When companies have a blockbuster drug that needs to hit the market fast, they will often go through the US FDA Fast Track program which will require a shorter development cycle than other drugs. Meeting these cycle timelines is essential for helping release life-saving medication, and a lot of pharma companies cannot meet these demands on their own.
CDMOs can come in and offer assistance through the Fast Track cycle so that companies can push life-saving products to the market faster. The result is less lives lost, better treatment options and the ability for pharma companies to push the boundaries of new drugs.
Rapid response is needed when working with life-threatening illnesses and diseases. Through outsourcing and working with government programs, pharmaceutical companies are able to deliver drugs to market faster, allow for greater overall access to drugs and continue to meet stringent quality control guidelines.
The ability to rapidly scale-up or scale-down is an added bonus, allowing drug manufacturers the option to ramp up initially delivery and slow it down as needed. The ability to work with CDMOs is leading to faster, more robust clinical trials, lower safety risks and the ability to meet market demand faster.