Overactive bladder (OAB) is classified as a syndrome rather than a disease which comprises of a combination of various symptoms such as frequent urination, urgency to urinate, urine leakage and the need to urinate at least twice every night. There are several causes which may lead to overactive bladder such as weak pelvic muscles, nerve damage due to trauma or diseases, Urinary Tract Infection (UTI), obesity, hormonal imbalance post menopause, medications, caffeine and alcohol. Parkinson’s disease, Multiple sclerosis and stroke are few of the diseases that lead to an overactive bladder. Overactive bladder can be treated via use of medications, surgery, Botox bladder treatment as well as certain behavioral changes such as diet change and bladder retraining. Anticholinergic medications, also known as anti-muscarinic that are commonly prescribed for overactive bladder are Oxybutynin, Darifenacin, Fesoterodine, Trospium and Solifenacin. These anticholinergic medications acts by blocking the receptors present on the walls of urinary bladder to reduce the muscle activity and thus giving relief from the problem of urine urgency and frequency. The common side effects associated with anticholinergic medications are xerostomia (dry mouth), blurred vision and constipation. In addition, Beta-3 adrenergic drug such as Mirabegron (Myrbetriq) can be used to relax bladder muscles and increase the bladder capacity to hold the urine for longer period of time. Both anti-muscarinic and beta-3 adrenergic drugs are agonists, thus can be used together for an enhanced efficiency.
Global Overactive Bladder Therapeutics Market: Dynamics
An increase in the geriatric population and increasing awareness about available treatments for overactive bladder syndrome are the major driver of market growth for overactive bladder therapeutics. For instance, according to the National Association for Continence, in 2018, 1 in 3 adults over the age of 30 suffered from nocturia globally. In addition, according to a report published by the the U.S. Department of Health & Human Services 2018, around 25 million individuals in the U.S. suffered from urinary incontinence
Major key players involved in the manufacturing of overactive bladder therapeutics have been adopting various aggressive business strategies such as collaboration, acquisitions, product launch, product approvals and patents. This helps to provide a positive push towards growth of the market. For instance, in May 2018 Astellas Pharma Inc., received the U.S. Food and Drug Administration (U.S. FDA) approval for use of mirabegron in combination with solifenacin succinate to treat symptoms associated with overactive bladder syndrome. Moreover, in February 2020, Allergan, an AbbVie company launched their U.S. FDA approved Botox for the treatment of overactive bladder syndrome in patients who were either intolerant or did not respond well to commonly used anticholinergic and beta-3 adrenergic drugs. Botox is the first U.S. FDA approved neurotoxin used in the treatment of overactive bladder syndrome in children.
In addition, U.S. FDA is aiming at increasing the number of approvals for generic drugs as well as reducing the cost for the same in order to encourage more companies to launch their drugs into the market. For instance, in December 2020 Urovant Sciences received U.S. FDA approval for GEMTESA (Vibegron) to treat symptoms of urinary urgency, leakage and high urinary frequency in adults suffering from overactive bladder syndrome.
Also, robust pipeline of drugs which are currently under phase II and III clinical trials that would be expected to be launched soon thus offering a lucrative growth for overactive bladder syndrome therapeutic market. For instance, in 2018 Taris Biomedical LLC entered the phase II clinical trials for its drug candidate TAR-302 which is claimed to be highly effective and exhibit fewer side effects than other available drugs in the market for the treatment of overactive bladder syndrome.
Global Overactive Bladder Therapeutics Market: Restraints
The major restraint to the overactive bladder therapeutics market is the occurrence of unfavourable side effects associated with the prescribed drug or treatment. For instance, in 2020 an article published by the National Center for Biotechnology Information (NCBI) reported that anticholinergic drug- Oxybutynin used in the treatment of overactive bladder syndrome may cause dry mouth, dizziness and constipation as the most common side effects. Beta-3 adrenergic drug such as Mirabegron (Myrbetriq) show common adverse drug events such as hypertension, Urinary tract Infection (UTI), diarrhea, headache, dry mouth and constipation. Also, Botox treatment poses a high risk of Urinary Tract Infections. For instance, clinical trial studies carried out by Allergan for its Botox treatment list UTI, dry eyes, painful urination and headache as the common side effects associated with the treatment. All these factors are responsible for hampering the growth of the overactive bladder therapeutics market in the forecast period. Furthermore, patent expiry of key drugs such as Detrol and Oxybutynin which are commonly prescribed for the treatment of overactive bladder syndrome can affect the market growth in a negative way. For instance, Oxybutynin patent issued to Watson Pharmaceuticals, Inc. in 2016 would expire in 2029.
Global Overactive Bladder Therapeutics Market: Drug Type Insights
Anticholinergics are the first choice of drugs for the treatment of overactive bladder syndrome this segment holds a significant market position in the overactive bladder therapeutics market. Also, rapid product approvals by the U.S. Food and Drug Administration (U.S. FDA) for generic drugs contribute towards the growth of anticholinergic segment. For instance, in January 2020 Oxytrol was approved by the U.S. FDA as the first over the counter treatment of overactive bladder syndrome in women above the age of 18. Furthermore, a shift in the preference of end users towards botox treatment rather than an invasive surgery or oral medications has been expected to give a boost to the growth potential of botox segment in the overactive bladder therapeutics market for the forecast period. Botox treatment is the common choice of patients who are suffering from overactive bladder syndrome but are intolerant to anticholinergic drugs.
Global Overactive Bladder Therapeutics Market: Regional Insights
North America is the largest market share holder of overactive bladder therapeutics attributable to a rise in the prevalence of overactive bladder syndrome, increasing geriatric population and medical advancements. For instance, according to Global Forum on Incontinence (GFI) in 2018, 9% of North American population was dealing with urinary incontinence. Additionally, in 2020 the National Association for Incontinence reported that approximately 25 million adults suffer from urinary incontinence (leakage) in U.S.
The second largest market for overactive bladder therapeutics is considered to be Europe due to increase in research and development investments and rise in the occurrences of overactive bladder syndrome. For instance, in Europe the TRUST ITN project proposed a research training based collaboration between 8 European universities and 3 enterprises with the aim of a better understanding of overactive bladder syndrome related symptoms and to develop novel approaches for its treatment. Other than the mentioned factors, supportive government initiatives also play a prominent role in the growth of overactive bladder syndrome therapeutics market in Europe. For instance, the U.K.’s National Institute for Health and Care Excellence (NICE) provides the benefit of reimbursement every year for patients adopting Botox Therapy for treatment of overactive bladder syndrome.
The Asia-Pacific market is anticipated to grow over the forecast period owing to a rise in the awareness about the overactive bladder syndrome and aggressive marketing strategies of the manufacturers. Additionally, an increase in the U.S Food and Drug Administration approvals for drugs used in the treatment of overactive bladder syndrome drives the growth of market in the Asia Pacific region. For instance, in April 2020 Granules Pharmaceuticals, Inc, owned by Granules India Ltd. got U.S. FDA approval for use of Trospium Chloride capsules for treatment of urine urgency and urine incontinence in patients suffering from overactive bladder syndrome.
Global Overactive Bladder Therapeutics Market: Competitive landscape
Pfizer Inc., Johnson & Johnson, Aurobindo Pharma Ltd., Astellas Pharma Inc., Merck & Co. Inc., Mylan NV, Teva Pharmaceutical Industries Ltd., Ono Pharmaceutical Co. Ltd., Allergan, AbbVie Inc., Sanofi, Cogentix Medical and Endo International Plc. are the major players of global overactive bladder therapeutics market.
These key players are more focused on the fast growing segment of the market to survive and succeed in a cut throat market scenario. Moreover the market players are focused in collaboration and license agreement which is expected to drive the market growth. For instance, in March 2021 Japanese firm KYORIN Pharmaceutical and Eisai Co. Ltd. signed a license agreement for development and marketing of Vibegron drug as a treatment for overactive bladder syndrome in Thailand, Malaysia, Brunei and the Philippines.
Global Overactive Bladder Therapeutics Market: Taxonomy
By Drug Type
By Disease Type
By Distribution channel
By Region
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About Author
Ghanshyam Shrivastava - With over 20 years of experience in the management consulting and research, Ghanshyam Shrivastava serves as a Principal Consultant, bringing extensive expertise in biologics and biosimilars. His primary expertise lies in areas such as market entry and expansion strategy, competitive intelligence, and strategic transformation across diversified portfolio of various drugs used for different therapeutic category and APIs. He excels at identifying key challenges faced by clients and providing robust solutions to enhance their strategic decision-making capabilities. His comprehensive understanding of the market ensures valuable contributions to research reports and business decisions.
Ghanshyam is a sought-after speaker at industry conferences and contributes to various publications on pharma industry.
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