한글목차

OZAWADE는 CPAP와 같은 1차적 OSA 치료로 충분한 수면을 취하지 못하거나, CPAP 치료를 견디지 못하는 성인 OSA 환자의 각성도를 개선하고 EDS를 감소시키는 데 적응증을 가지고 있습니다. 이 치료는 OSA 및 심혈관계 위험을 전문으로 하는 의사가 시작해야 하며, 매년 OSA를 재평가해야 하며, OZAWADE는 OSA 환자의 기도폐쇄를 치료하는 약물이 아니며, OSA의 1차 치료는 유지되거나 1차 치료를 견디지 못하는 환자에게 주기적으로 재처방되어야 합니다. 재제안되어야 합니다.

2023년 1월, 아큐리스제약은 일본에서 OSA를 동반한 EDS 환자를 대상으로 한 피트리산트의 임상 3상 시험을 개시했습니다.

앞으로 몇 년동안 폐쇄성 수면무호흡증(OSA) 시장 시나리오는 전 세계적으로 광범위한 조사와 의료비 지출 증가로 인해 변화할 것입니다. 각 회사는 질환을 치료/개선하기 위한 새로운 접근법에 초점을 맞춘 치료법을 개발하고, 과제를 평가하고, OZAWADE의 우위에 영향을 미칠 수 있는 기회를 모색하고 있습니다. 다른 OSA 치료제들도 오자와이드와 치열한 시장 경쟁을 벌일 것으로 예상되며, 가까운 시일 내에 후발 신약이 출시되면 시장에 큰 영향을 미칠 것으로 예상됩니다.

이 보고서는 주요 6개국에서 폐쇄성 수면무호흡증(OSA) 치료제 OZAWADE 시장에 대해 조사했으며, 시장 개요, 경쟁 구도, 2032년까지 시장 규모 예측, 국가별 시장 분석 등의 정보를 전해드립니다.

목차

제1장 보고서 서론

제2장 OSA OZAWADE 개요

• 제품 상세
• 임상 개발
  • 임상 연구
  • 임상시험 정보
  • 안전성과 유효성
• 규제 마일스톤
• 기타 개발 활동
• 제품 개요

제3장 경쟁 구도(출시 치료법)

제4장 경쟁 구도(후기 단계 신흥 치료법)

제5장 OZAWADE 시장 평가

• OSA 치료제 OZAWADE 시장 전망
• 주요 6개국 분석
  • 주요 6개국의 OSA 치료제 OZAWADE 시장 규모
• 국가별 시장 분석
  • 독일
  • 영국

제6장 SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight에 대해

제12장 보고서 구입 옵션

영문목차

"OZAWADE Market Size, Forecast, and Market Insight - 2032" report provides comprehensive insights about OZAWADE for Obstructive sleep apnea (OSA) in the six major markets. A detailed picture of the OZAWADE for OSA in the 6MM, i.e., EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2019 -2032 is provided in this report along with a detailed description of the OZAWADE for OSA. The report provides insights about mechanism of action, dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the OZAWADE market forecast analysis for OSA in the 6MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in OSA.

Drug Summary:

OZAWADE is indicated to improve wakefulness and reduce EDS in adult patients with OSA whose sleepiness is not satisfactorily addressed by primary OSA treatment such as CPAP or those who do not tolerate this treatment. The treatment must be initiated by a physician specializing in OSA and cardiovascular risks; OSA must be re-assessed annually. OZAWADE is not a treatment for airway obstruction in patients with OSA. The primary treatment of OSA must be maintained or regularly re-proposed in patients who have not tolerated the primary treatment.

In January 2023, Aculys Pharma initiated a Phase III trial of Pitolisant treating patients with EDS associated with OSA in Japan.

Dosage

OZAWADE should be used at the lowest effective dose based on clinical response and patient tolerance. The optimal therapeutic dose must be reached in stages, without exceeding the dose of 18 mg/day:

• 1st week: an initial dosage of 4.5 mg (one tablet of 4.5 mg) per day
• 2nd week: the dosage can be increased to 9 mg (two tablets of 4.5 mg) per day
• 3rd week: the dosage can be increased to 18 mg (one tablet of 18 mg) per day or reduced to 4.5 mg (one tablet of 4.5 mg) per day.

Scope of the Report:

The report provides insights into:

• A comprehensive product overview including the OZAWADE description, mechanism of action, dosage and administration, research and development activities in Obstructive sleep apnea (OSA).
• Elaborated details on OZAWADE regulatory milestones and other development activities have been provided in this report.
• The report also highlights the OZAWADE research and development activities in OSA across Europe and Japan.
• The report also covers the patents information with expiry timeline around OZAWADE.
• The report contains forecasted sales of OZAWADE for OSA till 2032.
• Comprehensive coverage of the late-stage emerging therapies for OSA.
• The report also features the SWOT analysis with analyst views for OZAWADE in OSA.

Methodology:

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight's team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

OZAWADE Analytical Perspective by DelveInsight

• In-depth OZAWADE Market Assessment

This report provides a detailed market assessment of OZAWADE for Obstructive sleep apnea (OSA) in the six major markets, i.e., EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides forecasted sales data from 2024 to 2032.

• OZAWADE Clinical Assessment

The report provides the clinical trials information of OZAWADE for OSA covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights:

• In the coming years, the market scenario for Obstructive sleep apnea (OSA) is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence OZAWADE dominance.
• Other emerging products for OSA are expected to give tough market competition to OZAWADE and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of OZAWADE in OSA.
• Our in-depth analysis of the forecasted sales data of OZAWADE from 2024 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the OZAWADE in OSA.

Key Questions:

• What is the product type, route of administration and mechanism of action of OZAWADE?
• What is the clinical trial status of the study related to OZAWADE in Obstructive sleep apnea (OSA) and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the OZAWADE development?
• What are the key designations that have been granted to OZAWADE for OSA?
• What is the forecasted market scenario of OZAWADE for OSA?
• What are the forecasted sales of OZAWADE in the six major countries, including Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
• What are the other emerging products available and how are these giving competition to OZAWADE for OSA?
• Which are the late-stage emerging therapies under development for the treatment of OSA?

Table of Contents

1. Report Introduction

2. OZAWADE Overview in OSA

• 2.1. Product Detail
• 2.2. Clinical Development
  • 2.2.1. Clinical studies
  • 2.2.2. Clinical trials information
  • 2.2.3. Safety and efficacy
• 2.3. Regulatory Milestones
• 2.4. Other Developmental Activities
• 2.5. Product Profile

3. Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Therapies)

5. OZAWADE Market Assessment

• 5.1. Market Outlook of OZAWADE in OSA
• 5.2. 6MM Analysis
  • 5.2.1. Market Size of OZAWADE in the 6MM for OSA
• 5.3. Country-wise Market Analysis
  • 5.3.1. Market Size of OZAWADE in Germany for OSA
  • 5.3.2. Market Size of OZAWADE in France for OSA
  • 5.3.3. Market Size of OZAWADE in Italy for OSA
  • 5.3.4. Market Size of OZAWADE in Spain for OSA
  • 5.3.5. Market Size of OZAWADE in the United Kingdom for OSA
  • 5.3.6. Market Size of OZAWADE in Japan for OSA

6. SWOT Analysis

7. Analysts' Views

8. Appendix

• 8.1. Bibliography
• 8.2. Report Methodology

9. DelveInsight Capabilities

10. Disclaimer

11. About DelveInsight

12. Report Purchase Options