한글목차

약제 요약

인슐린 유사 성장인자 1 수용체 억제제(IGF-1R)인 테프로툼맙은 중국 햄스터 난소(CHO-DG44) 세포에서 생산되는 완전 인간 IgG1 단클론 항체로서 분자량은 약 148KD입니다.

테프로툼맙의 대사는 완전히 밝혀지지 않았지만, 단백질 분해에 의한 대사가 예상됩니다. 주사용 TEPEZZA는 무균, 무방부제, 백색 또는 회색의 동결건조 분말로 공급되며 정맥주사에 사용됩니다. 각 1회분 바이알에는 테프로툼맙 500mg, L-히스티딘(7.45mg), L-히스티딘 염산염 일수화물(31.8mg), 폴리솔베이트 20(1mg) 및 트레할로스 이수화합물(946mg)이 포함되어 있으며, 멸균된 주사용수(USP) 10mL로 재구성한 후 최종 농도는 47.6mg/mL, pH는 5.5입니다.

주요 7 시장(미국·독일·프랑스·이탈리아·스페인·영국·일본)의 그레이브스 안병증용 TEPEZZA에 대해 조사분석했으며, 작용기서, 용법과 용량, 연구개발 활동에 관한 인사이트, 매출의 예측 등을 제공하고 있습니다.

목차

제1장 리포트의 서론

제2장 그레이브스 안병증에서의 TEPEZZA 개요

• 제품의 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 신치료법)

제5장 TEPEZZA 시장 평가

• 그레이브스 안병증에서 TEPEZZA의 시장 전망
• 주요 7 시장 분석
  • 주요 7 시장 그레이브스 안병증용 TEPEZZA의 시장 규모
• 시장 분석 : 국가별
  • 미국의 그레이브스 안병증용 TEPEZZA의 시장 규모
  • 독일의 그레이브스 안병증용 TEPEZZA의 시장 규모
  • 영국의 그레이브스 안병증용 TEPEZZA의 시장 규모

제6장 SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight 소개

제12장 리포트 구입 옵션

영문목차

"TEPEZZA Market Size, Forecast, and Market Insight - 2032" report provides comprehensive insights about TEPEZZA for Graves' Ophthalmopathy in the seven major markets. A detailed picture of the TEPEZZA for Graves' Ophthalmopathy 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 TEPEZZA for Graves' Ophthalmopathy. 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 TEPEZZA market forecast analysis for Graves' Ophthalmopathy in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in Graves' Ophthalmopathy.

Drug Summary:

Teprotumumab, an insulin-like growth factor-1 receptor inhibitor (IGF-1R), is a fully human IgG1 monoclonal antibody produced in Chinese hamster ovary (CHO-DG44) cells with a molecular weight of approximately 148 KD.

The metabolism of teprotumumab has not been fully characterized; however, it is expected to undergo metabolism via proteolysis. TEPEZZA for injection is supplied as a sterile, preservative-free, and white to off-white, lyophilized powder for IV infusions. Each single-dose vial contains 500 mg of teprotumumab, L-histidine (7.45 mg), L-histidine hydrochloride monohydrate (31.8 mg), polysorbate 20 (1 mg), and trehalose dihydrate (946 mg). After reconstitution with 10 mL of sterile water for injection, USP, the final concentration is 47.6 mg/mL with a pH of 5.5.

• Dosage and administration

The recommended dose of TEPEZZA is an IV infusion of 10 mg/kg for the initial dose, followed by an IV infusion of 20 mg/kg every 3 weeks for seven additional infusions.

• Mechanism of action

Teprotumumab's mechanism of action in patients with Graves' Ophthalmopathy has not been fully characterized. It binds to IGF-1R and blocks its activation and signaling.

Scope of the Report:

The report provides insights into:

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

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.

TEPEZZA Analytical Perspective by DelveInsight

• In-depth TEPEZZA Market Assessment

This report provides a detailed market assessment of TEPEZZA for Graves' Ophthalmopathy 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.

• TEPEZZA Clinical Assessment

The report provides the clinical trials information of TEPEZZA for Graves' Ophthalmopathy covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights:

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

Key Questions:

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

Table of Contents

1. Report Introduction

2. TEPEZZA Overview in Graves' Ophthalmopathy

• 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. TEPEZZA Market Assessment

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

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