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.