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Insight '05 hanna john r. starr inc. & engqvist.ppt

Do New Drugs for Incontinence
Threaten the Absorbent
Products Growth Trend?
By Pricie Hanna, John R. Starr, Inc. and
Helena Engqvist, Engqvist Consulting
Insight 2005
October 12, 2005
Engqvist
John R. Starr, Inc.
Consulting
Adult Incontinence Trends
ØAdult incontinence impacts 200 million people − Aging population − Increasing risk factors for incontinence ØMany new products and treatment alternatives − Via media, internet and direct-to-consumer advertising− Motivating people to seek better solutions Engqvist
John R. Starr, Inc.
Consulting
Adult Incontinence Market Opportunity –
North American and Western European Outlook 2003 – 2008
Study Addressed Key Questions
ØHow big is the market potential and what is the growth ØWhich treatments, products and solutions are most ØHow much do the various solutions cost? ØWhat is the impact of new drugs, devices and surgical procedures on absorbent products and vice versa? Engqvist
John R. Starr, Inc.
Consulting
Adult Incontinence Market Opportunity –
North American and Western European Outlook 2003 – 2008
Key Content and Scope of Study
ØDemographics of incontinent population in key markets – Western Europe: Six largest country markets • Germany, United Kingdom, France, Italy, Spain, Sweden ØMarket size, penetration and growth outlook Engqvist
John R. Starr, Inc.
Consulting
The Adult Incontinence Market Opportunity
Engqvist
John R. Starr, Inc.
Consulting
Adult Incontinence Market Opportunity –
North American and Western European Outlook 2003 – 2008
Key Content and Scope of Study
(Continued)
Engqvist
John R. Starr, Inc.
Consulting
Adult Incontinence Market Opportunity –
North American and Western European Outlook 2003 – 2008
Key Content and Scope of Study
(Continued)
• Urge Incontinence from Overactive Bladder (OAB) • Stress Incontinence ØComparative costs by treatment and product type ØCompany profiles of leading manufacturers Engqvist
John R. Starr, Inc.
Consulting
Driving Forces for Incontinence Products
Incontinent
Products &
Therapies
Decisions on
Decision
Incontinence
Benefits &
Influencers
Disadvantages
Solutions
Technical
Industry
Cost-In-Use
Strategies
Information
Economics
Source: Adult Incontinence Market Opportunity, North American and Western European Outlook, 2003 to 2008 Engqvist
by John R. Starr, Inc. and Engqvist Consulting John R. Starr, Inc.
Consulting
Key Issues Impacting Outlook
ØFuture impact of continuation of current trends - Choices of solutions- Impact of reimbursement systems ØIdentification of new solutions in pipeline by ØExpected consumer and institutional market education Engqvist
John R. Starr, Inc.
Consulting
What is Incontinence?
Ø Incontinence is the loss of bladder or bowel control which is a symptom with many causes.
Ø The types of urinary incontinence are:
– Urge incontinence: urgent, uncontrolled need to urinate caused
– Stress incontinence: involuntary leakage during exercise,
coughing, sneezing, laughing or other body movements caused by weak or damaged pelvic muscles.
– Mixed incontinence: combination of urge and stress
– Other types of incontinence include overflow, reflex and
Engqvist
John R. Starr, Inc.
Consulting
Fecal Incontinence
Ø Fecal incontinence is the unintended passage of liquid or solid stool as a result of diarrhea, constipation, sphincter damage, reduced rectal elasticity, weak pelvic floor muscles or damage to the sensory nerves that control the sphincter.
Ø Fecal incontinence is often combined with urinary Engqvist
John R. Starr, Inc.
Consulting
Prevalence of Incontinence
Ø Recent epidemiologic studies across multiple markets show high prevalence for
– Stress Urinary Incontinence (SUI), especially women
– Overactive Bladder (OAB), both genders
• Urge incontinence (UI or wet OAB due to leakage)
– Mixed Urinary Incontinence (MUI)
Engqvist
John R. Starr, Inc.
Consulting
Prevalence of Incontinence
Ø Risk Factors for Incontinence
Engqvist
John R. Starr, Inc.
Consulting
The Increasingly Aging Population
30 USA: 22.4% in 2020
Aged 60+ Populations
20 World: 13.6% in 2020
30 Europe: 26.2% in 2020
Engqvist
John R. Starr, Inc.
Consulting
2003 Prevalence of Incontinence
in Six Major Western European Countries,
United States and Canada
– 51 million people = 10.8% of adult population – 44 million people = 9.3% of adult population Source: Adult Incontinence Market Opportunity, North American and Western European Outlook, 2003 to 2008by John R. Starr, Inc. and Engqvist Consulting Engqvist
John R. Starr, Inc.
Consulting
Examples of Treatments
of Urinary Incontinence
Alternative
behavioral
treatments
Physical
exercises
Absorbent
evaluation
and training
products
with Doctor
and Uro-
therapist
Realization
Treatments for Urinary Incontinence
Engqvist
John R. Starr, Inc.
Consulting
Influence and Impact of Medical Professionals
Ø Low, but increasing, percentage of incontinent population consult doctors and specialists for treatment – Absorbent products for additional protection and back-up after – Drugs for difficult OAB symptoms, including Urge Incontinence – Surgery for severe Stress Urinary Incontinence Ø General practitioners still need more information about incontinence and various treatment solutions, especially new alternatives Engqvist
John R. Starr, Inc.
Consulting
Treatments & Coping Strategies Used by U.S.
Women with Urinary Incontinence Symptoms
% Women
with
Symptoms
Feminine
Pelvic Floor
Panty Liners
Absorbent
Training
Homeopathic
Materials
Diokno A.C., Burgio K., Fultz N., Kinchen K.S., Obenchain R., Bump R.C., Engqvist
“Medical and Self-Care Practices Reported by Women with Urinary Incontinence,” The American Journal of Managed Care, 2004, Vol. 10, No. 2 John R. Starr, Inc.
Consulting
Treatments & Coping Strategies Used by U.S.
Women with Urinary Incontinence Symptoms
Ø Absorbent Materials = 84.4%
– 12.5% Other Absorbent Materials (Tissue, etc.) Ø Pelvic Floor Exercise = 19.9%
Ø Drugs and Surgery = 12.2%
– 2.1% Surgery and 2.2% Herbal/Homeopathic Remedies Diokno A.C., Burgio K., Fultz N., Kinchen K.S., Obenchain R., Bump R.C., “Medical and Self-Care Practices Reported by Women with Urinary Incontinence,” The American Journal of Managed Care, 2004, Vol. 10, No. 2 Engqvist
John R. Starr, Inc.
Consulting
Consumption and Market Potential for
Absorbent Products in Six European
Countries and North America in 2003
Current Penetration: 27%
Consumption
Volume
Potential Market
6 European
Countries
Engqvist
John R. Starr, Inc.
Consulting
Key Players – Disposable Absorbent
Products for Adult Incontinence in
North America and Europe
Ø SCAØ Kimberly-ClarkØ Tyco InternationalØ Paul HartmannØ PaperPakØ OntexØ Procter & Gamble affiliatesØ First Quality Products Engqvist
John R. Starr, Inc.
Consulting
Key Trends in Disposable Absorbent
Products for Adult Incontinence
− Bladder control pads, liners and guards − Increased market penetration versus feminine pads and other − Increased self-sufficiency and dignity− In consumer (at home) and institutional markets Ø Increasing availability of well-designed light Ø Light to moderate capacity absorbent products for back-up protection during medical treatments Engqvist
John R. Starr, Inc.
Consulting
New Absorbent Products for Incontinence
Ø Major focus: females with bladder leakage − pants for moderate to heavy incontinence − bladder control pads or liners for light incontinence Ø New product examples in North American retail market: – Kimberly-Clark – Poise Panty for incontinent females
– SCA – Serenity Discreet Activewear unisex pants
• Stayfree Advanced Protection bladder leakage pads for
“menstrual, bladder and post-natal protection” • Carefree Dry Ideal pantiliner for occasional light incontinence
Engqvist
John R. Starr, Inc.
Consulting
New Drugs Entering the Market
Ø Several drugs for OAB and SUI are on the market – New drugs being introduced in 2004 and 2005 Ø Many new drugs for OAB and SUI in the pipeline – Large clinical studies provide evidence of benefits – Comparisons between efficacy and side effects of different drugs Ø Alternative mechanisms for drug delivery – Patches – direct drug transfer through the skin Engqvist
John R. Starr, Inc.
Consulting
Key Players – Pharmaceuticals
Global Players
Smaller, but important players
Ø Boehringer-IngelheimØ Eli LillyØ YamanouchiØ NovartisØ Procter & GambleØ GlaxoSmithKline Engqvist
John R. Starr, Inc.
Consulting
Key Launches of Drugs for
Incontinence by Active
Ingredient and Condition
Ø Duloxetine, SUI
Ø Darifenacin, OAB
Ø Oxytrol® Patch, OAB
Ø Tolterodine, OAB
Ø Oxybutynin, OAB
Ø Solifenacin, OAB
Ø Propiverine, OAB
Ø Flavoxate, OAB
Ø Trospium, OAB
1960 – 1996
1997 – 2002
2003 – 2004 +
Engqvist
OAB = Overactive Bladder
John R. Starr, Inc.
Consulting
SUI = Stress Urinary Incontinence
What drugs for incontinence
are in the approval pipeline?
Engqvist
John R. Starr, Inc.
Consulting
The Regulatory Approval Process
for Pharmaceuticals
Europe: European
USA: Food and Drug
Medicines Agency
Administration (FDA)
Engqvist
John R. Starr, Inc.
Consulting
Stages in Clinical Research
Pre-Clinical
Phase III
absorbed, distributed, metabolized and excreted Engqvist
John R. Starr, Inc.
Consulting
Pipelines of
Drugs for
Alternative
drug delivery
Incontinence
mechanisms
for OAB
Drugs in
pre-
registration
10+ compounds
Multiple new
for OAB, but also
compounds in
3+ compounds
compounds for SUI
screening for OAB
Pre-Clinical
Phase III
• Botox
Various stages • Slow release medications
Engqvist
John R. Starr, Inc.
Consulting
U.S. Setback for Stress Incontinence Drug
Ø Eli Lilly and Boehringer-Ingelheim withdrew FDA
application for duloxetine for stress incontinence due to
FDA rejection of data package supporting stress
incontinence treatment in January 2005.
– Drug continues to be marketed outside U.S. for stress incontinence as Yentreve and AriClaim.
– Duloxetine drug Cymbalta is approved by FDA for depression and diabetic peripheral neuropathic pain.
Ø Currently, no drug for stress incontinence is approved in Engqvist
John R. Starr, Inc.
Consulting
Engqvist
John R. Starr, Inc.
Consulting
Collaborations in 2005 for
Promotion and Development
Ø Novartis and P&G agree to co-promote and further develop Enablex extended release tablets for overactive bladder (OAB) in U.S. market – Enablex approved for OAB by U.S. FDA in December 2004 – Includes option to collaborate in OTC commercialization Ø Yamanouchi and GlaxoSmithKline agree to co-market – Vesicare approved for OAB by U.S. FDA in November 2004 Ø Takeda and Toray, Japan, agree to jointly develop and Engqvist
John R. Starr, Inc.
Consulting
Consumer Advertising and Promotional
Programs for Incontinence Drugs
Recent U.S. Examples:
Ø Detrol LA (Pfizer) – U.S. TV and women’s magazine ads
Ø Oxytrol patch (Watson Pharma) – U.S women’s magazine ads
Ø Ditropan XL (distributed and marketed by J&J’s Ortho-McNeil
Pharmaceutical, developed and manufactured by Alza Corp.) – U.S women’s magazine ads
Ø Vesicare (distributed and marketed by GlaxoSmithKline,
developed and manufactured by Yamanouchi) – U.S. TV ads Engqvist
John R. Starr, Inc.
Consulting
Incontinence Drug Sales are Projected
to Grow at 24-27% CAGR, 2003-2008
Sales Value
In 2003
Conservative Sales
In 2008
Upside Sales
In 2008
Six European
North America
Countries
Engqvist
John R. Starr, Inc.
Consulting
Market Penetration of Incontinence Drugs
Based on Potential Market of People with
Frequent Incontinence
Ø 2003 Penetration = 4% for All Countries Studied
Ø 2008 Forecast Penetration = 12 – 14% for All
Countries Studied
– 9 – 11% in Six Western European Countries Engqvist
John R. Starr, Inc.
Consulting
Conclusions
Ø Incontinent people are increasingly aware that improved absorbent products and new medical treatments are available to better meet their needs.
Ø Advertising for new drugs will encourage more people to seek medical evaluation of their incontinence.
Ø Doctors recommend behavioral therapies, drugs or surgical Ø Absorbent products are used both as primary solutions and as back-up protection for people pursuing medical treatments (most medical treatments do not provide 100% cure).
Engqvist
John R. Starr, Inc.
Consulting
Conclusions
(Continued)
Ø Both hygiene absorbent products and drugs for incontinence have substantial growth opportunities. − Market penetration is still low, even in relatively mature market − Prevalence of incontinence is increasing Ø Improved absorbent products and new drugs are replacing older design absorbent products and less-effective, older drugs.
Ø Improved absorbent products and drug solutions will expand the total market for incontinence solutions.
Engqvist
John R. Starr, Inc.
Consulting
Conclusions
(Continued)
Ø Near term, both hygiene absorbent products and drugs for incontinence will be used as complementary rather than competitive solutions.
Ø Longer term if improved drugs offer promise of complete cures without adverse side-effects, drugs will be more competitive with absorbent products and threaten the growth trend of the hygiene industry.
Ø The progress of the pharmaceutical industry in this market should be monitored attentively by absorbent product manufacturers.
Engqvist
John R. Starr, Inc.
Consulting

Source: http://www.johnrstarr.com/Insight%20'05%20Hanna%20%20John%20R.%20Starr%20%20Inc.pdf