What are “3 Key Trends” shaping the CDMO industry in 2022 and beyond? Catalent Pharma Solutions’ chief marketing officer, Elliott Berger, shares his thoughts with Contract Pharma.

Meeting demand in advanced therapeutics

The accelerating growth of advanced modalities such as cell and gene therapy has led to more companies forgoing expensive projects to install internal manufacturing capabilities. Instead, they are seeking partners that can provide the sophisticated manufacturing practices and specialist expertise and technologies necessary across the different modalities to progress therapies towards commercialization.

In these areas, innovation and understanding has increased rapidly, and there is a need for development and manufacturing partners that can rapidly overcome challenges. These challenges include developing robust processes at larger scale, optimizing analytical methods, im-proving yields and integrating both upstream and downstream processing with supply chains of raw materials to increase efficiency.

CDMOs are also a vital part of the manufacturing supply chain of these therapies and therefore need to ensure that capacity is available to innovators to meet demand. This is leading to researchers having to seek out collaborative partners earlier in the development process to ensure capacity is available when necessary.

Increased complexity

As drug production requirements become more complex even beyond the new modalities, bio-pharma companies are looking to CDMOs with specific, specialized scientific expertise and the proven ability to apply this knowledge to better address their needs. Examples of this include the need to handle the increased prevalence of high-potency drugs, the emergence of ever-more complex monoclonal antibodies, and the need to create spray-dried dispersions (SDDs) to overcome solubility challenges. The use of outsourcing partners in these fields avoids the capital expense of building the necessary containment facilities, while accessing the appropriate knowledge and experience.

A lack of available capacity can become a bottleneck, and this can be seen in areas such as gene therapy development, where outsourcing partners are few, and manufacturing capacity often needs to be booked several months in advance. This makes CDMOs strategic components in the pharma supply chain. Delays in programs can have a significant impact on future scheduled projects, but companies with expertise and capacity in faster-growing areas of the pipeline, such as high-potency APIs, mammalian biologics and cell and gene therapies, have the potential to outperform typical industry growth rates.

Virtual pharma business model

Much of the innovation in biopharma pipelines is being driven by smaller biotechs, which we define as companies with revenues of less than $250 million, or listed companies with a market cap lower than $2.5 billion. There are about 5,500 of these companies, and we estimate that by 2026 they will contribute more than 60% of biopharma growth, and yet have little or no scale-up capabilities in-house. These companies are looking to partner with CDMOs, through a “virtual pharmaceutical” business model that gives access to flexible capabilities, and allows them to both simplify and accelerate development, hit milestones and retain ownership with-out having to invest significant capital into infrastructure.

These smaller companies often have limited in-house resource to manage CDMO partnerships, and therefore often turn to either a small number of partners, or a single CDMO that can provide integrated services to achieve the development milestones.

While the financial markets for public biotech companies are currently down, the small biotech industry is benefiting from the venture capital community having available investment for the development of novel treatments and modalities. This represents a significant opportunity for CDMOs to forge partnerships.

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Catalent is a global provider of advanced delivery technologies, development and manufacturing solutions for drugs, biologics, cell and gene therapies and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance, and ensuring reliable global clinical and commercial product supply.