Pulmonary insulin poised to make strong debut in diabetes therapy markets according to analysis of the European commercial potential for inhalation drug delivery in diabetes
Burgeoning demand for insulin-dependent diabetes mellitus medication and surging international diabetes incidence figures, coupled with the unmet need for non-invasive alternatives to injection, make diabetes one of the most attractive therapy areas for inhalation drug delivery.
Numerous companies developing technologies for non-invasive systemic delivery of insulin will see their product launches get off to a promising start as the first pulmonary insulin will stride onto the diabetes therapy scene in late 2004.
Inhaled insulin could become a reality soon, with drugmakers Aventis and Pfizer set to spearhead the introduction of products designed to be more convenient than injections of insulin commonly used by diabetics.
The two pharmaceutical giants are currently performing additional clinical trials on the first product delivering insulin using the inhalation route to treat patients with Type 1 and Type 2 diabetes, marketed under the name Exubera.
A new study by Frost and Sullivan, the international marketing consulting company, remarks that positive results from these trials could strengthen acceptance of Exubera and diminish the standing of competing technologies.
A negative outcome, however, could not only have an adverse impact on Exubera, but the anticipated treatment satisfaction of inhalable insulin may fall into disrepute. Underlining the fact that pulmonary aerosol administration of insulin is a realistic and patient-friendly prospect, Novo Nordisk and its partner Aradigm are forecast to penetrate the market in early 2006 with an electronic inhaled insulin system called the AERx insulin diabetes management system (iDMS).
Frost and Sullivan cautions that prevailing patient safety fears and scepticism about clinical effectiveness associated with the novel way of delivering insulin will continue to present a stumbling block in the uptake of inhalable insulin.
Meanwhile, Eli Lilly is expected to enter the European market with the third pulmonary delivery device.
Further products are currently in clinical trials, but without a marketing partner.
The battle to capture a larger share of the European patient base is hotting up between the top players.
Insulins account for a massive 62.1% share of sales in the total European diabetes medications market, worth $2,000 million in 2001 and expected to reach $3,800 million by 2009.
Novo Nordisk and Eli Lilly have tightened their grip on the European insulin market, jointly accounting for 79.7% of total sales.
The imminent launch of new analogues, and a wider European roll-out of existing ones, will stimulate insulin sales over the forecast period.
Growth in the oral agents (OA) segment, representing the remaining 37.9% of overall 2001 sales, will largely be prompted by the rapidly growing Type 2 diabetics population.
Physicians will be administering insulin earlier in the treatment of Type 2 diabetics, opening up an opportunity for inhalation insulin to augment market share.
Furthermore, premium-priced new generation OAs are expected to drive a segment otherwise strongly influenced by low prices of generic compounds such as metformin and glibencamide.
Morten Soegaard, research analyst at Frost and Sullivan, explains: "The evaluation of the commercial potential of the emerging pulmonary insulin market is subject to a number of assumptions and pre-launch conditions. The nascent technologies in this arena could still fail to get approval from European authorities.
Even with regulatory approval, uncertainties still exist regarding labelling, time of launch as well as reimbursement status at national level." In forecasting revenues, the task is further complicated by the advent of competing insulin delivery technologies currently in clinical trials, as well as emerging treatments for diabetes outside the insulin class.
Clinical trial outcomes and regulatory rulings represent the technical risks for inhaled insulin. Pricing, reimbursement and competing technologies constitute the most important business risks," Mr Soegaard continues. Europe is not likely to see inhalation insulin used in first-line treatment.
The price of daily treatment, concerns over long-term effects, crude dosing accuracy and lack of ability to provide basal insulin are the main barriers towards widespread administration of pulmonary products.
Frost and Sullivan is confident that patient demand will be strong, in some regions even strong enough to encourage the individual to cover part of the additional costs themselves.
For the large majority of European patients, however, supply of reimbursed inhalation insulin will be determined by healthcare providers at national level.
Demand will be marginally weakened by the introduction of other non-invasive delivery technologies predicted to gain a foothold in the market during the forecast period.
"The promise of oral insulin poses a major threat to the fortunes of pulmonary delivery, with the notion of oral insulin simply rendering inhalation delivery obsolete not being unimaginable. Emerging treatments for Type 2 diabetics, such as GLP-1, can make strong inroads into the Type 2 segment, possibly depriving inhalation insulin of its long-term growth potential," the study concludes.
Price: €5000, report code: 3724.
