There are several trends set to influence the pharmaceutical sector in 2022.
Many CDMOs, including Lifecore, have already begun adapting by expanding their capacity and cold chain offerings in anticipation.
In this article, we explore the following biotech industry trends and how CDMOs can keep up.
The speed and strength of the US vaccine rollout and advanced developments in novel fill/finish treatments have been hugely impactful for the industry.
The global injectable drug delivery market has seen rapid growth over the past few years, currently forecast to reach USD 510.32 million in 2022 CAGR of 7.88%.
The impact of the Omicron variant of the COVID-19 virus and likelihood of further mutations means that the need for greater fill/finish capacity is set to continue as booster jabs and new vaccines are manufactured.
Research has shown that up to 55% of all drugs in development are injectables, with biotechnology advances such as mRNA therapies, monoclonal antibodies, antivirals, metabolic, cardiovascular, ophthalmics, and respiratory therapies remaining in high demand.
These treatments may also be highly complex to formulate and fill, requiring drug manufacturers to turn to CDMOs such as Lifecore who have the capabilities to meet these complex commercial manufacturing requirements and those of lesser complexity as well.
In 2001, there were just over a thousand companies with active R&D pipelines across pharma and biotech. By 2020, this figure had reached over 5,000.
In addition, up to 75% of new drug development in small to midsize pharma has been outsourced in the past decade.
As a growing proportion of investigational therapies sponsored by smaller and or/virtual pharma companies progress through preclinical phases and prepare for trial, they will often lack the experience or capacity to manufacture increasingly complex new investigational therapies, which leads to a greater rate of outsourcing.
These complexities often include overcoming bioavailability challenges, which invariably results in highly viscous products, which require highly specialized fill/finish capabilities to manufacture.
Pharma companies developing these therapies must adapt by outsourcing to CDMO partners, such as Lifecore, that have the technical expertise, knowledge, infrastructure and culture to handle these complexities.
The global pandemic exposed the fragility of global supply chains, with the US government among many who have ramped up their incentives to onshore critical pharmaceutical supplies in response.
This is set to continue into 2022 and beyond, with pharma companies likely to drive greater demand for domestic capacity. This means that those currently relying on supplies from international partners may need to rethink their partnerships for more localized support.
Looking ahead for 2022
While the past two years of the COVID-19 pandemic highlighted fragilities in the pharmaceutical supply chain, we have also seen increased innovation across the pharmaceutical industry.
As a full service CDMO specializing in complex and difficult to formulate drug products, Lifecore is equipped to support the industry’s pioneers in making their progress possible from three state-of-the-art CDMO facilities in Chaska, MN.
Explore our services to discover how we can take your drug product from preclinical development through to commercialization.