As the ‘epidemic’ of the 21st century, the number of diabetes suffers is expected to double over the next 20 years. More than 246 million people had the disease in 2006 and a report from the International Diabetes Federation shows that this figure could rocket to 380 million by 2030.
Although this will present a hardship for many individuals and families, the pharmaceutical industry is working hard to cash in and capture the market.
In 2000, the global retail sales of diabetes drugs were worth $8.1bn and some analysts say this has already more than doubled, now sitting at around $20bn.
Although the market offering for insulin delivery is already vast, more innovative and painless designs are in the pipeline to treat the chronic metabolic disorder, caused by a failure of the body to produce insulin and or an inability of the body to respond adequately to the circulation of insulin.
Pre-filled syringes and injection devices
Some of the most cutting-edge designs went on show in the US at the Parenteral Drug Associations conference ‘The Universe of Pre-Filled Syringes and Injection Devices’, during October in San Diego, California.
Pre-filled syringes and injection devices continue to be a growing market, improving administration, compliance, safety, costs and accuracy of drug delivery.
Syringes and injection devices dominate the US market. Modern lightweight, disposable, plastic syringes with micro-fine needles are evolving to increase patient comfort and convenience.
Advances in materials, manufacturing processes, injection processes and safety devices went on show at the conference, which was also looking at regulatory requirements and evolving market trends.
Keynote speakers included Dr Thomas Schoenknecht from Fortune 500 company Amgen, who spoke about requirements from the agencies to ensure a standard product quality. Also on the lectern was ten-time Olympic medallist swimmer, end user and BD Medical – Pharmaceutical Systems spokesman, Gary Hall, Jr. He shared his experience of using injection devices to manage his Type 1 diabetes.
While syringes, needles and injection devices, from pens to jet injectors, still dominate the insulin market, demand is growing for more painless ways of insulin delivery and a host of companies are working on new ways of delivering the drug.
While drug giant Pfizer axed its insulin inhaler Exuberant, which encountered problems such as the inability of the system to deliver consistent dosage and costing twice the price of injected insulin, other companies including Novo Nordisk and Eli Lilly are still in the race to capture the market.
As Novo Nordisk chief financial officer Jasper Brandgaard was quoted saying at the company’s six-monthly reporting in August, the insulin market is a predictable one where the rise in patient numbers is set to continue.
“The fight is really about what share of new patients you’re getting,” he explained.
The $7.8bn Danish pharmaceutical group controls 53% of the total insulin market but it has been witnessing fierce competition among insulin makers.
Last month the company launched its new FlexPen, an insulin injection device, at the European Association for the Study of Diabetes Annual Meeting.
“This next generation of FlexPen is very welcome because it makes the injection process more comfortable for patients,” said Professor Andreas Pfutzer, Institute for Clinical Research and Development, Mainz, Germany. “It introduces key features that will go a long way towards improving their compliance with prescribed treatment.”
The device will be available to patients around the world from late 2008 with new design features including coloured cartridges, labels and packaging designed to aid insulin type identification for patients. It features a twist mechanism to attach new-generation needles and requires 30% less force when injecting.
Less painful injections is one way forward but there is still huge demand for convenient and safe alternatives for delivering insulin for those who have an aversion to needles.
Althea Therapeutics announced in October 2007 that it had achieved steady basal levels of insulin in patients with type 1 diabetes, using a transferal patch.
The patch, based on the company’s PassPort delivery system, could help overcome significant compliance and safety problems associated with the repeated need for insulin injections, said company CEO Dr Eric Tomlinson.
“By meeting specific concerns expressed by patients that refuse or avoid insulin injections, the basal insulin transferral patch has the potential to enable a wider acceptance and earlier introduction of insulin therapy that can lead to improved management of diabetes,” he said.
Other developments include insulin capsules like those being worked on by Israel-based biotechnology company Roamed Pharmaceuticals for the treatment of Type 2 diabetes. While Type 2 diabetes can be controlled through diet and oral medications there is yet to be developments in this area for Type 1 diabetics.
Oramed announced this month its oral insulin medication for Type 1 diabetics was entering phase 2a clinical trials.
“A capsule option would be a first choice for diabetics if it was available and a best-case solution,” said Nadir Kieran, chief executive of Oramed Pharmaceuticals Inc. “The commencement of trials of our oral insulin capsule on Type 1 diabetics signals another major step forward for our company in the treatment of diabetes. Oral insulin delivery is an idea with huge potential not only for patients who dislike needles but, with the insulin market generating $25bn a year in worldwide revenues it represents an enormous opportunity for drug developers as well.”
In the future insulin may be delivered by implanted or transferral systems. Insulin pumps are already popular in the US, where the small mobile phone-size devices which send a continuous flow of insulin into the body through a hypodermic tip make manufacturers $1.3bn a year.
Implantable insulin pumps are currently under development in Europe and the US. This would see devices the size of a hockey puck inserted under the skin.
Another future option for insulin administration may be the intranasal route. The main advantages of this method are ease of delivery and fast absorption time. Previous clinical trials in a few individuals have demonstrated effectiveness, but nasal irritation, loss of sense of smell and the effects of nasal congestion on insulin absorption have caused problems.
In addition, gene therapy and the potential for implanting insulin-producing pancreatic cells are also being researched.
With diabetes now the fifth leading cause of death across developed markets and figures from PricewaterhouseCoopers (PwC) suggesting the disease is forecast to grow by 7.1% across the globe by 2013, the market for once-a-day drug delivery and non-invasive drug delivery systems continues to offer significant potential for market expansion.
PwC predicts the largest markets for growth will emerge as the G7 countries westernise. India is predicted to lead the way with 73.5 million people expected to have the disease by 2025. As such, companies like US-based Eli Lilly, which announced a joint venture with Indian Jubilant Organisms in October 2008, are looking to secure their place in the market.
Meanwhile. Ypsomed announced in December 2007 that it has started a subsidiary in New Delhi, India, in a move to reinforce its position in the insulin pen needle industry.
The pharmaceutical firm said it sees “great potential for pen needles and pen systems in India”, as 85% of all insulin there is administered with normal syringes, and just 15% using cartridges and pen systems.
The next few years promise dramatic change in the treatment of diabetes, much of which will be driven by rapidly developing technology.
Every company is striving for two common goals: patient convenience and better control of the disease. As such, the development of new drugs from novel classes will become increasingly important in the future.