Managing director, Ian Muir comments on trends and challenges in the contract solid dose manufacturing market and Aesica’s service offering, including the company’s new development centre at Queenborough.
Aesica on the solid dosage market: At Aesica we are in the process of finishing a purpose-built, standalone Development Centre on our Queenborough commercial site, which is also a solid dose manufacturing site. One of the main areas of focus for the Development Centre will be the formulation, development and clinical scale manufacture of capsules and tablets.
Aesica believes that this will create a smooth transition from development to commercial for solid dosage products as both development and commercial sit on the same site. A specific field that Aesica believes has significant potential is high potent products, particularly high potent solid dose products. Therefore Aesica has invested and is continuing to invest in high potency capabilities/capacity in both development and commercial-scale manufacturing. In turn, this has generated a lot of interest with customers in both our development and commercial areas. We continue to grow our partnership with our strategic customers for the continuous manufacturing of tablets. This process is at the cutting edge of manufacturing processes for solid dose products.
The direction our business is headed: We are recognizing the needs of the customer and we are trying to work closely with them as a strategic partner rather than through the traditional customer-CMO relationship. At Aesica, we are striving to become a one source pharmaceutical partner from API through to formulation development to finished dose manufacturing. We believe customers would like to see this strategic partnership as a way of simplifying their own supply chain and thus reducing the number of CMOs they do business with.
How we would describe the current state of the solid dosage manufacturing market? It’s as strong as ever. Solid dosage products, in particular tablets, continue to be one of the cheapest and the most economical of medical products. Tablets could be considered to be an old technology but demand will continue to remain high. The solid dosage market also continues to embrace new technology such as continuous manufacturing, to further improve efficiencies of the manufacturing processes.
Patient compliance for solid dose products is also a major factor. Todays NCEs tend to be poorly soluble and or poorly bioavailable. New technologies have been developed during the last few years to deal with these challenges. In addition, these technologies have an end goal of producing a solid dose product — such as soft gel capsules or hot melt extruded products — that can then be compressed into tablets.
How is the market performing this year compared to last year? Currently, the solid dose market is stable and we expect this to continue in the future. However, the effect of recent mega-mergers, such as Pfizer-Allergan, for example, have not yet been felt. What we will see in the coming years, as our new development facility comes online, is products that will be developed with a view to being transferred into our commercial facility. We expect these products to be specialized, meaning our solid dose factory will adapt to become even more flexible to meet the needs to these products.
Key drivers in the contract solid dosage business: The increase in demand for specialized dosage forms such as paediatric/geriatric, taste masked, anti-abuse and controlled release technologies are some of the key drivers. Pharma may not have the capacity or capability to manufacture these products.
With this increase in specialized dosage forms, the CMO will hold the experience or the knowhow and therefore pharma companies will leave these products with the CMO. Flexibility in manufacturing and packaging, especially for older but medically critical products, is another key area. Big Pharma doesn’t want the hassle of small volumes with multiple SKUs going to different countries. CMOs must show both flexibility and process efficiency to make these products viable. Another trend is moving towards strategic partnerships with Big Pharma as pharmaceutical companies look to reduce the number of CMOs they deal with.
The opportunities for growth: As pharma looks to reduce the number of CMOs, existing molecules will need to be transferred to another CMO. Some of these products may have been registered a long time ago and therefore may not pass the necessary standards of today and hence they could need reformulation or analytical development.
Generics will play a key part in the solid dose market for CMOs. As products come off patent, the generic manufacturers will require capacity to manufacture these products and will look at CMOs for this. The majority of NCEs are for the biopharmaceutical market. The NCEs that are for the solid dose market will have some challenges such as poor solubility/bioavailability, high potency or they may require controlled release applications. Unless CMOs are flexible in their service offering, pharma will not consider them.
Regulatory health authorities are also becoming much more challenging, which limits the number of facilities that specialized products can be manufactured from — again limiting a CMO’s capability to offer the service. An example of this is in the generics market, where FDA requires each site to pay a GUFDA facility fee to manufacture generic products for the US market. If a certain CMO is only manufacturing one or two products, this could be quite costly. The CMO might ask: “Why should I bear this cost?”
How customer expectations are evolving: Customers are expecting CMOs to show flexibility in their service offering. As previously mentioned, products are becoming more specialized, and customers do not want to be tasked with the complex tasks and hassle of having to manufacture these products themselves. Instead, they will leave it to the CMO.
Also, on the packaging side, where there is a great deal of complexity with different packaging formats and delivery to different countries, customers are expecting CMOs to deal with these issues. This then leads to customers demanding reliability and quality from their chosen CMO.