Developing and manufacturing drugs is more expensive and complicated than ever before. To make the development of drugs simpler and cheaper for pharma and biotech companies, many outsource to Contract Development and Manufacturing Organisations (CDMO’s). These work on scaling up the drug development process as the drug moves through clinical trials and allow companies to focus on other aspects, such as discovery and marketing; therefore, limiting the financial risks of developing a drug that fails to pass through clinical trials.
Overall, outsourcing has been found to reduce costs, which is critical given the average drug development costs $2.6 billion and takes 10 years. With the CDMO industry expecting to grow at a 6.8% CAGR until 2027, it is definite CDMOs are here to stay.
Due to the diverse demands of each client, CDMOs can provide a wide range of services including; biologics, APIs, methods of delivery (oral solids, steriles, capsules), viral vectors, and peptides. They can provide these services for certain stages of drug development, or the entire process from drug discovery to commercial manufacturing. Formulation, stability studies, analytical research, clinical trials, and scale-up are among some of the other services available.
With increasing competition, cost pressures, endless innovations and increasing consolidation activities, it can be hard for companies to know which approach to take and which CDMO to go for.
Pure players in the CDMO scene specialise in either a specific service or a specific stage of the drug development process. Pure players are often more affordable and may offer a more personal experience. Also, due to their specialist experience they are often best for niche projects and can get projects through the pipeline quicker than some larger companies that may have more ongoing projects.
Pure players are typically smaller businesses (fewer than 500 employees) who lack the necessary facilities, capabilities, or funding to provide the full service. They often partner with smaller to midsize pharma organisations due to their lower costs.
The fully integrated model are often CDMOs that are part of a bigger pharmaceutical company and have access to the parent company's expertise and resources. They are responsible for every aspect of the drug development process, all the way to scale up and commercial production. Therefore, by design fully integrated CDMOs reduce the risks which come with outsourcing as they are in control of every step.
Examples of these are some of the biggest players, such as Thermo Fisher, Pfizer CentreOne, Syngene and Lonza. These companies can afford to employ more staff and acquire smaller sites so they can offer more services. We are constantly seeing CDMO start up's develop and commercialise, which are then acquired or merged into these larger organisations and further enhance their service offerings.
However, these CDMO’s usually come with higher costs making it impractical for lower budget pharma and biotech organisations to be able to afford. Not only this, but they often have many ongoing projects and partner with some big organisations that take up a lot of their capacity. As a result, they could be less practical for smaller organisations.
In this highly competitive world, the fully integrated model seems to be the most sensible option of the two. These providers offer more certainty with their high levels of regulatory expertise, especially as good practice requirements regularly change. They also have more scope for innovation due to new methods and facilities.
This being said, nothing is ever perfect. Fully integrated approaches are expensive and collaborations with the wrong company can sometimes make things worse, rather than better, as the adoption of an integrated approach might mean low-volume and complex drugs are not pushed through research as quickly and development is delayed.
Effective collaboration is the key to the future of drug development and manufacturing and choosing which CDMO to partner with is extremely important. So as a take-home, it is most important to research a CDMO’s experience, technology, facilities and capacity before deciding on working with a specific organisation.
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