한글목차

파륵시가(미국 외 제품명: FORXIGA)(일반명: 다파글리플로진)는 동급 최초의 1일 1회 경구용 SGLT2 억제제입니다. 연구 결과에 따르면, 포르시가는 심장, 신장, 췌장 간의 기본적인 연관성을 고려할 때 중요한 장기 보호 효과와 함께 심-신장 질환 예방 및 지연 효과를 입증했습니다.

볼록시가 10세 이상의 성인과 소아에서 식이요법과 운동요법을 보조하는 2형 당뇨병 치료제로 승인됐습니다. 또한 DAPA-HF 및 DAPA-CKD 임상 3상 시험 결과에 따라 HFrEF 및 CKD 치료제로도 승인됐습니다.

파륵시가 현재 급성 심근경색 또는 심장마비 후 2형 당뇨병이 없는 환자를 대상으로 한 최초의 레지스트리 기반 무작위 대조군 연구인 DAPA-MI 임상 3상 시험인 DAPA-MI 임상 3상 시험이 진행 중입니다.(UCR) 및 영국의 심근허혈 국가감사프로젝트(MINAP)와 공동으로 진행 중입니다.

이 회사의 2022년 3분기 보고서에 따르면, 임상 3상(DAPA-MI) 시험의 데이터 판독은 2023년 하반기에 이루어질 예정입니다. 주요 승인 신청은 2023년 이후가 될 것으로 예상됩니다.

앞으로 몇 년동안 심근경색증 시장 시나리오는 전 세계적으로 광범위한 조사와 의료비 증가로 인해 변화할 것으로 예상됩니다. 각 업체들은 질환을 치료/개선하기 위한 새로운 접근 방식에 초점을 맞춘 치료법을 개발하고, 과제를 평가하고, FARXIGA의 우위에 영향을 미칠 수 있는 기회를 모색하고 있습니다. 다른 심근경색증 치료제들도 파르시가와 치열한 시장 경쟁을 벌일 것으로 예상되며, 가까운 시일 내에 후발 주자들이 출시되면 시장에 큰 영향을 미칠 것으로 예상됩니다.

이 보고서는 주요 7개국의 심근경색증 치료제 볼키가(Volksiga) 시장에 대해 조사했으며, 시장 개요와 함께 경쟁 구도, 2032년까지 시장 규모 예측, 국가별 시장 분석 등의 정보를 전해드립니다.

목차

제1장 보고서 서론

제2장 심근경색 파륵시가 개요

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

제3장 경쟁 구도(출시 치료법)

제4장 경쟁 구도(후기 단계 신흥 치료법)

제5장 파륵시가 시장 평가

• 심근경색증 칠제 파륵시가 시장 전망
• 주요 7개국 분석
  • 주요 7개국의 심근경색증 치료제 파륵시가 시장 규모
• 국가별 시장 분석
  • 미국
  • 독일
  • 영국

제6장 SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight에 대해

제12장 보고서 구입 옵션

영문목차

"FARXIGA Market Size, Forecast, and Emerging Insight - 2032" report provides comprehensive insights about FARXIGA for myocardial infarction in the seven major markets. A detailed picture of the FARXIGA for myocardial infarction in the 7MM, i.e., the United States, 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 FARXIGA for myocardial infarction. 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 FARXIGA market forecast analysis for myocardial infarction in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in myocardial infarction.

Drug Summary:

FARXIGA (known as FORXIGA outside the US) (dapagliflozin) is a first-in-class, oral, once-daily SGLT2 inhibitor. Research has shown FARXIGA's efficacy in preventing and delaying cardiorenal disease while protecting the organs - important findings given the underlying links between the heart, kidneys, and pancreas.

FARXIGA is approved in adults and children aged 10 and above for treating insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. FARXIGA is also approved for HFrEF and CKD treatment based on the findings of the DAPA-HF and DAPA-CKD Phase III trials.

FARXIGA is currently being tested in the DAPA-MI Phase III trial, a first-of-its-kind, registry-based randomized controlled trial in patients without type 2 diabetes following an acute MI or heart attack. The DAPA-MI trial is conducted in collaboration with Uppsala Clinical Research Center (UCR) and Myocardial Ischaemia National Audit Project (MINAP) in the UK.

As per the company's Q3 2022 report, data readouts from the Phase III (DAPA-MI) trial are anticipated by 2H 2023. With an estimated key regulatory submission acceptance after 2023.

Scope of the Report:

The report provides insights into:

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

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.

FARXIGA Analytical Perspective by DelveInsight

• In-depth FARXIGA Market Assessment

This report provides a detailed market assessment of FARXIGA for myocardial infarction in the seven major markets, i.e., the United States, 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.

• FARXIGA Clinical Assessment

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

Report Highlights:

• In the coming years, the market scenario for myocardial infarction 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 FARXIGA dominance.
• Other emerging products for myocardial infarction are expected to give tough market competition to FARXIGA 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 FARXIGA in myocardial infarction.
• Our in-depth analysis of the forecasted sales data of FARXIGA from 2024 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the FARXIGA in myocardial infarction.

Key Questions:

• What is the product type, route of administration and mechanism of action of FARXIGA?
• What is the clinical trial status of the study related to FARXIGA in myocardial infarction and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the FARXIGA development?
• What are the key designations that have been granted to FARXIGA for myocardial infarction?
• What is the forecasted market scenario of FARXIGA for myocardial infarction?
• What are the forecasted sales of FARXIGA in the seven major countries, including the United States, 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 FARXIGA for myocardial infarction?
• Which are the late-stage emerging therapies under development for the treatment of myocardial infarction?

Table of Contents

1. Report Introduction

2. FARXIGA Overview in myocardial infarction

• 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. Other Developmental Activities
• 2.4. Product Profile

3. Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Therapies)

5. FARXIGA Market Assessment

• 5.1. Market Outlook of FARXIGA in myocardial infarction
• 5.2. 7MM Analysis
  • 5.2.1. Market Size of FARXIGA in the 7MM for myocardial infarction
• 5.3. Country-wise Market Analysis
  • 5.3.1. Market Size of FARXIGA in the United States for myocardial infarction
  • 5.3.2. Market Size of FARXIGA in Germany for myocardial infarction
  • 5.3.3. Market Size of FARXIGA in France for myocardial infarction
  • 5.3.4. Market Size of FARXIGA in Italy for myocardial infarction
  • 5.3.5. Market Size of FARXIGA in Spain for myocardial infarction
  • 5.3.6. Market Size of FARXIGA in the United Kingdom for myocardial infarction
  • 5.3.7. Market Size of FARXIGA in Japan for myocardial infarction

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