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Trends and Developments in the European Urinary Incontinence
HBS Consulting, Jan 2003
Treatments Market
The Urinary Incontinence market is at present still characterised by a large untapped potential, both in terms of sufferers without treatment and in monetary terms.
Much data has been published on the prevalence of Urinary Incontinence (UI) and its cost to society. Different sources quote different figures, but even taking the World Health Organization's (WHO's) conservative estimates that worldwide direct and indirect costs of Urinary Incontinence exceed $16 billion annually and assuming that it affects about 50 million people in the major pharmaceutical markets (USA, Top 5 Europe and Japan) it becomes clear that it is a widespread condition with severe economic and psychosocial impact.
HBS Consulting has investigated the treatment patterns, patient behaviour and the market potential for the treatment of urinary incontinence of the major European countries (UK, Germany, France and Italy) for drug and alternative treatments like physiotherapy or electro stimulation.
Current total market value is just over € 200 million
The combined market value of drug and device sales is just over € 207 million, of which device sales represent about 12.7%.
Drug segment expands slower in volume than value
While sales value grows by over 10% per annum, volume growth stays below this at relatively moderate rates of 4.0% in 2002. Only the change in reimbursement legislation in Italy could cause a significant volume growth of 8.9% in 2003.
UK overtakes Germany in drug sales
While in 2001 market sizes were almost equal, with UK sales just below German sales, UK sales value and volume of drugs for overactive bladder, urgency and incontinence exceed German sales in 2002. This is primarily attributable to the success of Tolterodine.
Shift of focus from management to treatment
Although a range of therapy options is known since decades, focus (and subsequently the commercial benefit) was so far primarily on devices for the management of the condition rather than on treatment. Only in the last 4 years has Urinary Incontinence (UI) received increasing attention from public, healthcare system and industry. This is in part attributable to public or patient initiatives raising the awareness of the condition among the general population, but to an even greater extent to the pharmaceutical and medical device industry aiming at tapping into the commercial potential of the UI therapy market.
Need for new agents or methods
Despite the therapy options currently available, there is still a need for new agents or methods that offer greater efficacy, improved side effect profiles, greater convenience for the patient or improved cost efficiency for healthcare systems.
Conventional methods such as behavioural therapy or pelvic floor exercises may offer good efficacy and high tolerability, but are unsuitable to some patients (e.g. elderly or physically impaired patients) and not well accepted as they require personal effort.
Drug therapy is generally well accepted, but only widely available in FUI treatment, and side effects lead to reduced patient compliance. Neuromodulation techniques, which include some promising and innovative methods, are poorly accepted among physicians - despite favourable clinical data - due to Trends and Developments in the European Urinary Incontinence
Treatments Market - lack of knowledge, unfavourable reimbursement and similarly poor patient compliance as physiotherapy.
Procedural therapy, regardless of its invasiveness, is least favoured by patients and will remain to be considered an option of last resort for the foreseeable future.
Largest untapped market potential lies in drug therapy for SUI
At the moment at least 12 new pharmaceutical agents and 12 devices or methods for the treatment of Overactive Bladder (OAB), Urge (FUI) or Stress Incontinence (SUI) are under development. The largest potential lies in the development of pharmaceutical agents that are beneficial in SUI treatment, as only 2 of the drug candidates target the SUI market. Such agents, even if used adjunctive to conventional therapy options, would open a new market segment that almost parallels the Overactive Bladder (OAB) market. Within the FUI segment, only highly specific agents acting on the causes of FUI and with significantly improved efficacy and tolerability will have a chance thus current investments in new drug development in the indication of OAB may not pay back for some companies as expected.
Impact of clinical efficacy and tolerability should not be overestimated
It must be stated that the impact of clinical efficacy and tolerability on the choice of the therapy option should not be overestimated! While it certainly is important, other issues such as convenience for the patient, which seems to influence patient compliance more than adverse events, play an equally important role.
Legislation regarding reimbursement status and prescription play a major role
Important trends in the countries under review include:
- Aut idem drug substitution by pharmacists in Germany
- Cost containment policy of health funds regarding incontinence aids in Germany
- Encouragement of private purchase of neuromodulation devices in the UK
- No reimbursement of new incontinence drugs without proven superior therapeutic efficacy in France
- Reclassification of incontinence drugs expected for 2003 in Italy
- Electrotherapy is explicitly excluded from reimbursement since February 2002 in Italy
Direct-to-Consumer Advertising opportunities exist despite legislative restrictions
Although Direct-To-Consumer Advertising in the conventional sense is not possible, it is possible to successfully achieve the main aim of taking information to the patient and creating interest in the treatment for instance through:
1) Disease awareness campaigns
2) Sponsorship of and cooperation with public support groups and associations
3) Internet based promotion
4) Therapy specific media contributions
5) Featuring of products in promotional material of healthcare institutions
Increasing patient numbers are main driver of market growth
Increasing patient numbers are the most important driver in the medium to long term. The low proportion of patients currently treated leaves a large potential for current and new treatment options. This is also true for the device segment, where the growth of 5 to 10% per annum is primarily attributable to the low current penetration rate.
The drug market is stronger driven than the device market
The introduction of new drug treatment options as well as new formulations of current drug types with lower side effects and improved efficacy strengthen the preference of prescribers for drug therapies and increase the compliance of patients.
Restraints are related to individual drug types and thus do not influence the overall market to any significant extent. In the device market the situation is different: Innovative technologies with high medical efficacy such as Sacral Nerve Stimulation have not achieved market penetration almost all restraints are related to all device types similarly.
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