Challenges In The CDMO Market
By Ian Muir, managing director, Aesica
Major Market Concerns Over The Next Two Years
If you look at the CDMO market holistically, it is clear that continued growth within the sector market remains strong. At the same time, the market is becoming more competitive, with pharma customers looking for a smaller number of best fit CDMOs that offer high value services that will help them satisfy a range of industry challenges.
It is imperative that CDMOs are reliable and provide consistent, high quality delivery services to their customers and the market. Solutions and practices are needed that enhance both cost effectiveness and process efficiency. Furthermore, there is a pressing need to simplify and streamline supply chains, generating cost savings and optimising performance across an ever broader offering.
The Most Pressing Industry Challenges
In today’s competitive market place, the need for CDMOs to provide exceptional value in the supply chain is of paramount importance. Addressing challenges in the supply chain is also particularly pressing due to the need to streamline and accelerate the route of drugs to market and to reduce the cost and complexity of development for pharmaceutical customers. These challenges also need to be faced head-on because of the increasing need to reduce working capital and free cash to support the development of new products.
The scale-up challenge is also highly important as pharma is under pressure to meet all its production requirements in full.
CDMOs increasingly need to demonstrate a strong track record of implementing QbD, PAT, and continuous improvement. Meeting the continuous processing challenge is becoming ever more critical due to the need to significantly shorten drug development time, optimize cost efficiency, reduce wastage during production, and to find ways to execute drug development with smaller quantities of available high-value API’s.
The Most Creative Solutions?
Without a doubt, over the last few years we have seen the industry take a look at innovation in development to better integrate the different disciplines in the development cycle. The industry has begun to implement better design experiments and use manufacturing technologies and solutions to drive a more efficient use of the available drug substance. What we are now seeing is a commitment both from the regulator and, more pertinently, from some CDMOs to bring these practices and equipment trains, such as continuous processing, into the mainstream. This involves a strong commitment and maturity to partner closely with customers, address their particular set of needs, and to make changes in response that strengthen the CDMO’s offerings across capabilities, reliability, sustainability, and quality of execution. This approach ensures that suppliers offer best-in- class services that enhance the value of their offering to customers. Post-launch, there is increasing pressure to streamline supply chains and reduce working capital. Single source solutions are a highly effective answer to the mounting supply chain challenge.
What Should Industry’s Common Goals Be?
A clear commitment is to increase the value of services that suppliers provide to their customers with a constant focus on maintaining appropriate quality standards. This includes improving the supply chain with single source solutions, taking a flexible and adaptable approach to technology and processes to best meet customer requirements, consistent delivery of high quality services, and getting products to market faster.
The pharmaceutical manufacture and supply chain has developed over the years to serve major global markets with drug products with large sales volumes and broad application in the general population. As the number of blockbusters decreases, global wealth is redistributed, and markets take an increasingly individual approach to regulation. In response, the manufacture and supply chain models needs to adapt. Add to this the therapeutic trend to more individualized medicines, and the gap between the historical pharma model and that of the major on line businesses is clear. The challenge is how to bridge this in a safe and regulated way.
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