Issues generated by COVID-19 in distribution and supply chain will be key considerations
Seqens CDMO North America (formerly known as PCI Synthesis, Inc.), a pharmaceutical manufacturer of new chemical entities (NCEs), active pharmaceutical ingredients (APIs), and other specialty chemical products, issued its annual list of trends that will affect the emerging pharmaceutical and generic drug sectors, as well as Contract Development and Manufacturing Organizations (CDMOs), in 2021.
“While there’s good news about vaccines that will save lives and bring back a sense of normalcy, COVID-19 will continue to impact the life sciences sector. We expect supply chain and logistics to get a lot of coverage as the industry continues to ramp up to meet the unprecedented need to vaccinate the global population,” said Ed Price, founder, Seqens CDMO NA. “Companies and regulators need to make long-term systemic changes to ensure the U.S. and the world can be better positioned to handle potential disruption from a future pandemic. This will include finding new ways to protect supply chains and streamline processes to more easily work with regulators and get faster approvals while ensuring patient safety.”
Below are six trends that Seqens CDMO NA expects to impact the industry next year:
- Supply chain issues need to be addressed. In the aftermath of Covid-19, companies need to minimize supply chains risk by finding and working with alternatives sources. There are steps that the industry as well as the federal government can take to remove some of the uncertainty involved in importing raw materials, doing so cost effectively and efficiently.
- COVID-19 vaccine delivery and rippling effect on other drugs. As Pfizer, Moderna, AstraZeneca and others gear up to produce billions of vaccines, we expect shortages of other medicines, including generics, due to the necessary prioritization of raw materials and manufacturing capacity to produce COVID-19 vaccines.
- Despite demand for lower prices, drug prices will likely rise. Factors include not just possible drug shortages and the ongoing costs to develop new medicines, but also the many layers of drug delivery partners that add costs without adding value.
- Congress will look more closely at the FDA’s approval process. Given the tremendous achievement in developing COVID-19 vaccines, the FDA may develop speedier processes to handle future health crises. The FDA will need to streamline EUAs and other emergency processes while maintaining safety standards.
- Growth of startups continued despite the pandemic: Covid-19 did not bring biotech startup launches to a grinding halt. More than 100 startups focusing on drug discovery and development launched with their series A funding in 2020. We expect that to continue in 2021.
- Growing role of CDMOs will help startups and small biotechs: CDMOs have acquired customers’ plants as big pharma gravitates toward exiting large-scale manufacturing. CDMOs also provide essential services to the small biotech ventures at the forefront of drug discovery. That critical role has shown up in headlines all year as companies, anxious to secure adequate manufacturing capacity, put in place the infrastructure required to quickly meet demand for the COVID-19 tests, treatments and vaccines in development.
About Seqens CDMO North America
Seqens CDMO North America (formerly PCI Synthesis) is a Pharmaceutical Development CDMO (Contract Development and Manufacturing Organization) based in Newburyport, Mass., a division of Seqens CDMO, an integrated global leader in pharmaceutical synthesis and specialty ingredients with 24 manufacturing sites and 3 R&D centers in Europe, North America and Asia.
Seqens CDMO North America is also a commercial manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and other specialty chemical products for the medical device industry. Seqens CDMO North America provides emerging and mid-sized pharmaceutical companies access to the expertise needed to develop and manufacture complex small molecules. For more information, visit www.seqens.com.