The insulin delivery devices thriving in today's market will slowly be replaced as new and better technologies continue to rise from the R&D pipeline. For current market leader, Novo Nordisk, this threat is particularly dangerous.
While inhaled insulin devices won't replace injections in the near future, there are predictions that they could capture up to $1.5bn (€1.3bn)worth of market share a year, and there is no doubt that with the launch of Exubera this year, this impact will start to hurt the current players.
If Exubera sells well, Nektar Therapeutics, who partnered with Pfizer in developing the product, will benefit greatly, along with the two contract manufacturers that Nektar has enlisted to make the delivery devices, Bespack in the UK and West (formerly TechGroup) in Arizona.
Their success will inevitably be at the expense of traditional insulin device manufacturers of syringes, pens and other gadgets, who will begin to feel the pinch.
This pinch will grow stronger, as other budding biotech companies with non-injectable insulin delivery devices in the pipelines, such as, Alkermes, Generex, MannKind, and Innovata, move in for their share of the market over the next few years.
When this occurs, companies involved in all aspects of traditional injectable insulin manufacturing will suffer, right across the spectrum, from manufacturers of syringes and pens, to sharps containers.
Traditionally insulin has been injected under the skin with a needle and syringe. Until the late 1990s, Becton Dickinson (BD) dominated the insulin delivery systems industry, commanding 63 per cent of the market with its syringes.
However, the arrival of new insulin pens pulled the rug out from BD, as the popularity of these pens grew throughout the world, particularly in Europe. Now in some countries, 70-90 per cent of all insulin is delivered by pen.
Novo Nordisk, who dominates the world insulin market, now also has a stranglehold on the world insulin delivery device market, holding a 70 per cent share with its range of pen devices, Vinayak Arora, analyst for market research firm >RocSearch India, told In-PharmaTechnologist.com.
Eli Lilly also holds a presence in this market, holding a 15 per cent share with its insulin pens, and other smaller players include Owen Mumford and Disetronic.
BD, who saw its monopoly disintegrate, has managed to adapt to this dramatic market shift, moving its focus to making insulin pen needles to compensate for reduced syringe sales, while also continuing to manufacture traditional and pre-fillable syringes for a broad range of drugs.
However, the new threat arising from the biotech boom, looking to eventually wipe out injectable devices altogether, is like nothing this industry has seen before, and BD and many other existing companies now involved in pen manufacturing may struggle to adapt their businesses to the new technologies.
Pharma giant Novo Nordisk is invested heavily in both the injectable insulin and pen device markets, being the market leader in both areas, and clearly has the most to lose if any of the next generation of non-injectable products manages to capture a significant chunk of its business as the market shifts away from injectable delivery.
Of particular concern is that Novo's pipeline is also still focused heavily on injectable insulins and contains only one inhaled insulin product that is lagging well behind Pfizer and Lilly's competitor products in the clinical development stage.
However, the shift towards non-injectable insulin could also be particularly dire for a variety of other device manufacturers who have their livelihood invested in this industry.
For example, a number of companies, having survived the onslaught of insulin pens, still make traditional syringes for insulin delivery, including BD, Abbott, Aimsco, Can-Am Care, Medicore and UltiMed. These companies will soon need to brace themselves for a new challenge.
Several other companies who work behind the scenes manufacturing components and systems for injectable drug delivery will also need to rethink their business focus.
These include Owen Mumford, BD, Palco, HypOview, Medicool, MEDgenesis, CanAm Care, Apothecary Products and Whittier Medical, who are all involved in making devices that work with syringes to help patients inject themselves more easily.
They also include businesses such as West Pharmaceutical Services that produces stoppers and seals for vials, and closures and disposable components used in syringes, as well as firms such as Sharps Compliance and Plastiproducts who make sharps containers.
Several makers of other devices that have been developed over the years to administer insulin may also soon experience a decline in business.
These include Medi-Ject Corp (owned by Antares Pharma), Activa, Equidyne, and Bioject Corp, all who make insulin jet injectors, which send a fine spray of insulin through the skin by a high-pressure air mechanism instead of needles.
Other manufacturers include MiniMed, Animas and Disetronic, who make external insulin pumps, consisting of a reservoir for insulin, a battery-operated pump and a computer chip that controls insulin delivery, connected to plastic tubing that ends with a needle inserted just under the skin near the abdomen.
Both insulin jet injectors and insulin pumps have been around for several years but haven't managed to capture a significant amount of interest within the market, partly because they require regular cleaning and maintenance and can be very expensive compared with traditional injectable devices.
Due to this, the next generation of non-injectable insulin devices may prove a particular challenge for these sectors.
What is clear though, is that the formerly placid insulin delivery systems industry is facing a period of rapid change and the stakes are high.