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시장 스포트라이트 : 과민성 방광

Market Spotlight: Overactive Bladder

리서치사 Datamonitor Healthcare
발행일 2021년 05월 상품코드 939991
페이지 정보 영문 36 Pages 배송안내 1-2일 (영업일 기준)
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US $ 1,318 ₩ 1,872,000 PDF (Single User License)


시장 스포트라이트 : 과민성 방광 Market Spotlight: Overactive Bladder
발행일 : 2021년 05월 페이지 정보 : 영문 36 Pages

본 상품은 영문 자료로 한글과 영문 목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문목차를 참고해주시기 바랍니다.

세계 과민성 방광(OAB)용 치료제의 임상시험 상황과 시장 동향 전망에 대해 분석했으며, 질환의 개요 및 역학적 예측, 현재의 주요 치료제(출시/파이프라인 제품) 및 임상시험의 진행 상황, 현재의 미충족 요구와 향후 시장 기회, 임상시험/시장의 미래에 관한 전문가의 견해 등의 정보를 정리하여 전해드립니다.

목차

개요

주요 포인트

질환의 배경

치료법

  • 라이프스타일의 변경과 제어 기술
  • 의학적/외과적 치료
  • 제품·디바이스

역학

시판약

파이프라인약

최근 이벤트와 애널리스트의 의견

  • 과민성 방광에 대한 복수의 약(2019년 6월 25일)
  • 과민성 방광용 비베그론(2019년 3월 19일)

주요 향후 이벤트

규제상의 주요 동향

성공의 가능성

라이선스 계약/자산 인수 거래

  • 의료 업계를 좌우하는 거래 내용(2019년 10월)

모특허

매출 기회

임상시험 환경

  • 임상시험 의뢰자의 분류 : 상황별
  • 임상시험 의뢰자의 분류 : 상(단계)별

참고 문헌

  • 처방약의 정보

부록

KSA 20.06.17

Overactive bladder is characterized by urinary urgency, and is generally accompanied by increased voiding frequency, nocturia, and incontinence. The disease affects men and women across the world, and has an adverse effect on quality of life. Prevalence and symptom severity increase with age, and the symptoms of overactive bladder persist for years in the majority of patients. Postmenopausal status has been associated with increased risk for overactive bladder in women, while in men, the presence of prostate problems increases risk. Diseases such as depression, heart disease, arthritis, hypertension, benign prostatic hypertrophy, neurological conditions, prostatitis, mobility limitations, and recurrent urinary tract infections (UTIs) are predictors of overactive bladder in men. In women, depression, irritable bowel syndrome, neurological conditions, arthritis, sleep apnea, and recurrent UTI all have a greater possibility of being associated with overactive bladder. Furthermore, behavioral and lifestyle factors also play a role in the development of overactive bladder.

Key Takeaways

Datamonitor Healthcare estimates that in 2019, there were 545.0 million prevalent cases of overactive bladder worldwide among adults aged 20 years and older, and forecasts that number to increase to 607.6 million prevalent cases by 2028.

The approved drugs in the overactive bladder space target the calcium channel, muscarinic acetylcholine receptor, SNARE proteins, and beta-3 adrenergic receptor. The majority of these drugs are administered via the oral route, with the remainder being available in intramuscular, intravesical, intradermal, intraarticular, topical, and transdermal formulations.

The largest proportion of industry-sponsored drugs in active clinical development for overactive bladder are in Phase II, with no drugs in Phase III.

Therapies in development for overactive bladder focus on a wide variety of targets. The largest proportion of pipeline drugs are administered via the oral or intravesical routes, while one product is also being tested in an intramuscular formulation.

High-impact upcoming events for drugs in the overactive bladder space comprise topline Phase III trial results for Gemtesa, and an estimated PDUFA date for Myrbetriq.

The overall likelihood of approval of a Phase I urology-other asset is 9.3%, and the average probability a drug advances from Phase III is 75%. Drugs, on average, take 10.0 years from Phase I to approval, compared to 9.0 years in the overall urology space.

The distribution of clinical trials across Phase I-IV indicates that just over half of trials in overactive bladder have been in the early and mid-phases of development, with 54% of trials in Phase I-II, and 46% in Phase III-IV.

The US has a substantial lead in the number of overactive bladder clinical trials globally. Germany leads the major European markets, while Japan has the top spot in Asia.

Clinical trial activity in the overactive bladder space is dominated by completed trials. Astellas has the highest number of completed clinical trials for overactive bladder, with 176 trials. Astellas also leads industry sponsors with the highest overall number of clinical trials for overactive bladder, followed by Pfizer.

TABLE OF CONTENTS

CONTENTS

OVERVIEW

KEY TAKEAWAYS

DISEASE BACKGROUND

TREATMENT

  • Lifestyle modifications and control techniques
  • Medical and surgical treatment
  • Products and devices

EPIDEMIOLOGY

MARKETED DRUGS

PIPELINE DRUGS

RECENT EVENTS AND ANALYST OPINION

  • BotuGel for Overactive Bladder (August 27, 2020)

KEY UPCOMING EVENTS

KEY REGULATORY EVENTS

  • Pediatric Approval For Myrbetriq
  • Vibegron's Approval To Look Out For In Q4

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • Eisai To Sell Kyorin's OAB Agent In Four Asian Countries
  • Urovant Partners With Sunovion On Vigebron Commercialization

REVENUE OPPORTUNITY

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

BIBLIOGRAPHY

APPENDIX

LIST OF FIGURES

  • Figure 1: Trends in prevalent cases of overactive bladder, 2019-28
  • Figure 2: Overview of pipeline drugs for overactive bladder in the US
  • Figure 3: Pipeline drugs for overactive bladder, by company
  • Figure 4: Pipeline drugs for overactive bladder, by drug type
  • Figure 5: Pipeline drugs for overactive bladder, by classification
  • Figure 6: BotuGel for Overactive Bladder (August 27, 2020): Phase IIa - APOLLO
  • Figure 7: Key upcoming events in overactive bladder
  • Figure 8: Probability of success in the urology-other pipeline
  • Figure 9: Clinical trials in overactive bladder
  • Figure 10: Top 10 drugs for clinical trials in overactive bladder
  • Figure 11: Top 10 companies for clinical trials in overactive bladder
  • Figure 12: Trial locations in overactive bladder
  • Figure 13: Overactive bladder trials status
  • Figure 14: Overactive bladder trials sponsors, by phase

LIST OF TABLES

  • Table 1: Prevalent cases of overactive bladder, 2019-28
  • Table 2: Marketed drugs for overactive bladder
  • Table 3: Pipeline drugs for overactive bladder in the US
  • Table 4: BotuGel for Overactive Bladder (August 27, 2020)
  • Table 5: Historical global sales, by drug ($m), 2016-20
  • Table 6: Forecasted global sales, by drug ($m), 2021-25
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