Burst of Innovation in Novel Drugs, Therapies and How They Are Delivered to Patients Spell a Busy Year for CMOs
Each year industry leaders prognosticate about the year ahead and its challenges and opportunities. However, this year may be a bit different.
Last year we heard the tides churning and brewing up major new drugs, therapies, personalized medicine and mechanisms for delivering medications to patients, but this year the waves of innovation are really cresting.
This all spells good news for Contract Manufacturing Organizations (CMOs), Contract Development & Manufacturing Organizations (CDMOs) and Contract Research Organizations (CROs) that work with their sponsoring organizations to bring such innovations to life.
From medical-grade polymers that provide new ways to deliver medicine to patients, to pharma foods that will treat chronic diseases, this new year will completely transform how we develop and deliver new treatments that focus on personalized patient experiences and better outcomes.
While this new year in pharmaceutical innovation is exciting, it also brings about its own set of challenges. Based on two decades of industry experience, here is my take on the five breakthroughs, hits and misses and challenges that will shape the industry in 2018:
- Wide use of medical-grade polymers will increase. From novel drug delivery systems to new materials in ophthalmic applications, medical-grade polymers are being used in a range of different applications and we expect demand to continue to grow. For example, biodegradable polymers will increasingly be implanted into the body which will lower the need for additional surgeries to remove devices. Other polymer materials will be woven into medical devices to prevent infection, which is often caused by the biofilm that naturally occurs between the human tissue and the device. Additionally, polymers that deliver insulin, anti-cancer or anti-infection drugs will more often be put directly into the body to automatically deliver the proper dosage at the right time.
- Digital drugs will catch on – but not in generic form. For example, the FDA approved an antipsychotic pill that lets doctors track whether patients are taking their meds, as a way to ensure patient compliance. Another digital drug attaches sensors to asthma inhalers to monitor when they’re used. We can expect more of these types of innovations to hit the market, but given the lower margins on generic drugs the extra costs won’t be justifiable just yet, and will continue to be available in pricier branded form only.
- Shortage of skilled workers will increase. In Massachusetts alone, the industry is projected to need to fill 11,600 new jobs by 2022. While there’s a major nationwide effort to promote STEM majors, that’s not enough to ensure there are enough skilled people necessary to fill key positions. Recruiting and training quality employees will be important but maintaining talented employees will be a challenge, as well as a competitive advantage for CMOs retaining top talent.
- Pharma foods will drive demand for GMP manufacturing. Specially designed foods or supplements with pharmacological additives to improve health will grow in use in 2018. While the category is not new, the new level of activity and development will have a significant impact on pharma. Because of this, the value of incorporating Good Manufacturing Practices (GMP) will increasingly be sought by pharma food manufacturers, since they undergo clinical testing and must meet FDA guidelines.
- Growth through M&As will heat up. While we saw lots of mergers and acquisitions among pharmaceutical firms take place in 2017, based on a strong, competitive market and a Department of Justice (DOJ) that seems to be more welcoming to mergers & acquisitions (M&As), we can expect to see more deals take place in 2018. This will occur since pharma is being pushed to fill product pipelines faster than individual R&D departments can develop new compounds or transform them for commercialization.
The new year will bring innovation, opportunity, as well as its share of challenges for the pharmaceutical market, but it all spells good news for pharma firms, CMOs, and most importantly for the patients who will benefit the most.
Ed Price is President of PCI Synthesis (www.pcisynthesis.com), a pharmaceutical development CMO based in Newburyport, MA and the largest small molecule drug substance manufacturer in New England.
PCI Synthesis is also a commercial manufacturer of NCEs, generic active pharmaceutical ingredients (APIs), and other specialty chemical products for the medical device industry. As a CDMO, PCI Synthesis provides emerging and mid-sized pharmaceutical companies access to the expertise needed to develop and manufacture complex small molecules.