As a top-tier supplier of injectable grade hyaluronic acid (HA) and provider of specialist full-service CDMO capabilities for complex injectable drug formulations, Lifecore has experienced many fluctuations in the sterile injectable sector.
With over 30 years of experience in the pharmaceutical industry, President of Lifecore Jim Hall discusses the latest trends and challenges facing the sterile injectables market and the qualities pharmaceutical companies should be looking for when choosing their CDMO partners.
Injectables are the fastest-growing portion of the overall contract development and manufacturing (CDMO) market, currently estimated at USD $510.32 million in 2022 at a CAGR of 7.88%.1
With a strong focus on developing treatments for oncology, orphan diseases and personalized therapies, there is a clear demand for more niche and smaller batch capabilities for injectable formulations.
Driving this growth is advancements in sterile injectable delivery technologies, which are vital in bringing new drugs to market and enabling existing drugs to be delivered in a more targeted and safer manner.
These advancements include prefilled syringes (PFS), with demand outpacing the overall injectable devices market. In fact by 2023, PFS devices are expected to account for 77% of all sterile manufacturing revenue.2
Both of these demands require strong and proven quality systems, speed and reliable execution with technical expertise to support all phases of development.
Drug developers must also ensure they have the capacity to support their commercial success for product launch and lifecycle management.
Typically, injectable drug development requires specialized equipment and unique technical expertise and capabilities. Putting these systems in place are the industry’s perennial challenges as many biotech and pharmaceutical companies lack these capabilities in-house.
As a result, an increasing number of pharmaceutical companies are outsourcing their sterile injectables to CDMOs with the expertise, capacity and capabilities to develop and manufacture them.
At Lifecore, we’ve spent over 35 years working with complex drug formulations centered on hyaluronic acid. Across this time, we’ve developed a unique skill set and expertise that transitions perfectly when dealing with other complex high-value molecules.
Our world-class quality system supports customers across every segment of the industry, including active pharmaceutical ingredients (APIs), excipients, biologics, medical devices and combination products.
Our culture is built around providing these critical service components, and we continually invest in our people, systems and infrastructure to deliver for our partners.
Additionally, our teams are subject matter experts in process development, engineering, design assurance, analytical development and manufacturing. Bringing their unique knowledge to each project enables us to assist our customers in bringing their novel drugs to market with entire lifecycle support.
As demand for sterile injectables continues to grow, pharmaceutical companies must ensure they have the right capabilities and processes in place to facilitate their development and manufacture.
This means that we can expect more pharmaceutical companies to explore collaborations with CDMOs who can offer these specialist capabilities and expertise.
In turn, we expect more CDMOs to expand their capabilities as we have here at Lifecore, by expanding operating capacity and development pipelines to support partners as they advance their products.
Discover how Lifecore helps make progress possible for your injectable product.