Major concerns within the market during the next 2 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 OTIF 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 optimizing performance across an ever-broader offering.
The most pressing industry challenges
In today’s competitive marketplace, 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 owing 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, as well as addressing the 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 owing to the need to significantly shorten drug development time, optimize cost efficiencies and reduce wastage during production and to find ways to execute drug development with smaller quantities of available high value APIs.
The most creative solutions?
Without a doubt, during 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 and also look to better design of experiments and use of 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 CMO’s offering 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. For example, CDMOs like ours have simplified the supply chain and increased customer control by putting in place full service, end-to-end pharmaceutical development and manufacturing processes, comprising capabilities in formulation and development for both API and finished dosage forms, manufacturing at all scales, and packaging services. Moreover, by bringing Bespak and Aesica together, Consort Medical has created a single-source supply chain for both delivery device and drug development with full, end-to-end capabilities provided in the design, industrialization and manufacture of medical delivery devices.
Furthermore, we have introduced a supply chain management programme, designed specifically to reduce the number of contact points our strategic partners have to manage – essentially, we manage the process of working with their CDMOs to provide our pharma customers with one point of interaction for a bundle of products and I think this type of arrangement will clearly increase during the coming years.
What the industry’s common goals should 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 issues that need to be better addressed
The pharmaceutical manufacture and supply chain has developed during recent 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, the manufacture and supply chain model needs to adapt. Add to this the therapeutic trend to ever 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.