Shortage of contractors for advanced drug delivery manufacturing
specialist manufacturers that can rise to the challenge of making
these complicated devices, although such companies are currently
thin on the ground.
Several new technologies emerging from the biopharma pipelines are tipped for blockbuster status, led by insulin delivery products and followed closely behind by products in other large disease areas such as asthma.
As a result, the US advanced drug delivery market is tipped to grow more than 18 per cent and exceed $76bn (€60bn) by 2014. However, only a handful of contract manufacturing organisations (CMOs) exist that can fulfil the task of making such specialised devices on a large scale.
The first of these next-generation devices, Exubera, has recently been given market approval and is now being manufactured in preparation for launch by two chosen CMOs, Tech Group in the US and Bespak in the UK.
The Exubera deal provided the stepping stone for the Tech Group to diversify its business and customer base and move from simply doing injection moulding of components and subunits for original equipment manufacturers (OEMs) to now being a specialist maker of whole delivery devices. Mike Treadaway, general manager of Tech Group's drug delivery device division, spoke to In-PharmaTechnologist.com about this emerging area of device manufacturing.
"Our whole company has been rapidly growing over the last twelve months and our move into this new area of manufacturing has been a major driver in this," he said.
There are not many combination devices on the market, this is a specialist area of device manufacturing and there are still only a handful of companies that have the expertise or the capacity to handle such projects - Tech Group and Bespak, as well as Nypro, Phillips Plastics and Rexam, said Treadaway.
"As a result, we now have manufacturing contracts with most of the large pharma companies who are working on new drug delivery methods, such as injectables, inhalables and transdermal delivery," he said.
Tech Group has 14 manufacturing facilities and is able to keep all its customers' projects separate by spreading them throughout these different sites.
The example of Tech Group's experience so far with Exubera further highlights this vendor shortage.
"Exubera is a pretty unique case as far as contract manufacturing goes," said Treadaway.
Nektar Therapeutics, the company that developed the device and licensed it to Pfizer, chose two CMOs to work together and play equal roles in making the delivery device, a project that started six years ago.
"Normally Tech Group and Nektar would be competitors, but on this project we worked together as one team. It is highly unusual, but it worked for us in this case because both companies are large enough to have dedicated teams working soley on the Exubera project, so there was no conflict of interest," said Treadaway.
To get the project up and running, Tech Group and Bespak both spent millions of dollars building duplicate factories at their respective locations, containing exactly the same equipment and infrastructure so that the two factories are interchangeable and produce the same standard of device.
"Tech Group was responsible for building the injection moulds and tooling for both sites, while Bespak was in charge of sourcing the automation systems," said Treadaway.
The reason Nektar decided to split the manufacturing between two companies was partly because it minimised the risk if anything went wrong at one of the plants, but mainly because, at the time, no one CMO has sufficient capacity to build a compound device as complicated as the Exubera device and meet expected demand.
The scenario hasn't really changed much since then, and it is clear that plenty of opportunities exist for new companies to claim a stake in this budding area of manufacturing, although Tredaway warns that the road is rocky.
"It has taken us ten years to develop these capabilities and there is also a lot of risk involved in investing so much money in building manufacturing capabilities for such complex devices when it is uncertain whether they will even be approved for the market or not," said Treadaway.
"I'm sure many companies will try to get into this area of manufacturing, although I'm sure that many will also fail."
