한글목차

NPLATE(로미프로스팀)는 코르티코스테로이드, 면역글로불린, 비장절제술로 충분한 효과를 얻지 못한 성인 만성 ITP 환자의 혈소판 수 감소를 치료하기 위해 다른 특정 약물이나 비장절제술로 충분한 효과를 얻지 못한 경우에 사용되는 합성 단백질 제제입니다.

N-Plate는 혈소판 수를 약 50,000/μL로 유지하여 출혈의 위험을 낮춥니다. NPLATE는 혈소판 수치를 정상화하는 데 사용되지 않으며, 18세 미만 환자에서 NPLATE의 안전성과 유효성은 알려지지 않았습니다. NPLATE는 TPO 수용체에 결합하여 활성화시킴으로써 혈소판 생성을 증가시키는데, 그 기전은 내인성 TPO와 유사합니다. 일본에서는 중증 재생불량성 빈혈 환자의 치료제로도 승인되었습니다.

면역성 혈소판 감소증(ITP) 환자에게는 주 1회 1mcg/kg을 피하 주사합니다. 혈소판 반응에 따라 용량을 조절합니다. NPLATE는 내인성 TPO와 유사한 기전인 TPO 수용체에 결합하여 활성화시킴으로써 혈소판 생성을 증가시킵니다.

주요 7개국의 NPLATE 시장에 대해 조사했으며, 시장의 개요와 2023-2032년 판매 예측 데이터, 경쟁 구도 및 국가별 동향 등을 제공하고 있습니다.

목차

제1장 리포트의 서론

제2장 ITP에 대한 NPLATE의 개요

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

제3장 경쟁 구도(출시 치료법)

제4장 경쟁 구도(후기 단계 신규 치료법)

제5장 NPLATE 시장 평가

• ITP에 대한 NPLATE의 시장 전망
• 주요 7개국 시장 분석
  • 주요 7개국에서 ITP에 대한 NPLATE의 시장 규모
• 국가별 시장 분석
  • 미국
  • 독일
  • 영국

제6장 SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight 소개

제12장 리포트 구입 옵션

영문목차

“"NPLATE Drug Insight and Market Forecast - 2032" ” report provides comprehensive insights about NPLATE for immune thrombocytopenic purpura (ITP) in the seven major markets. A detailed picture of the NPLATE for ITP 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 NPLATE for ITP. 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 NPLATE market forecast analysis for ITP in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in ITP.

Drug Summary:

NPLATE (romiplostim) is a synthetic protein medicine used when certain other medicines, or surgery to remove the spleen, have not worked well enough to treat low blood platelet counts in adults with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

NPLATE keeps the platelet count at about 50,000/µL to lower the risk of bleeding. NPLATE is not used to normalize the platelet count. The safety and efficacy of NPLATE are not known in people under the age of 18. NPLATE increases platelet production by binding and activating the TPO receptor, whose mechanism is analogous to endogenous TPO. In Japan, this drug is also approved for the treatment of patients with severe aplastic anemia.

Dosage

For patients with ITP ¬ the recommended initial dose is 1 mcg/kg once weekly as a subcutaneous injection. Adjust dose based on platelet response.

Mechanism of action

NPLATE increases platelet production by binding and activating the TPO receptor, a mechanism analogous to endogenous TPO.

Scope of the Report:

The report provides insights into:

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

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.

NPLATE Analytical Perspective by DelveInsight

In-depth NPLATE Market Assessment

This report provides a detailed market assessment of NPLATE for immune thrombocytopenic purpura (ITP) 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 2023 to 2032.

NPLATE Clinical Assessment

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

Report Highlights:

• In the coming years, the market scenario for immune thrombocytopenic purpura (ITP) 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 NPLATE dominance.
• Other emerging products for ITP are expected to give tough market competition to NPLATE 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 NPLATE in ITP.
• Our in-depth analysis of the forecasted sales data of NPLATE from 2023 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the NPLATE in ITP.

Key Questions:

• What is the product type, route of administration and mechanism of action of NPLATE?
• What is the clinical trial status of the study related to NPLATE in immune thrombocytopenic purpura (ITP) and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the NPLATE development?
• What are the key designations that have been granted to NPLATE for ITP?
• What is the forecasted market scenario of NPLATE for ITP?
• What are the forecasted sales of NPLATE 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 NPLATE for ITP?
• Which are the late-stage emerging therapies under development for the treatment of ITP?

Table of Contents

1. Report Introduction

2. NPLATE Overview in ITP

• 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 Milestone
• 2.4. Other Developmental Activities
• 2.5. Product Profile

3. Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Therapies)

5. NPLATE Market Assessment

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

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