表紙
市場調查報告書
商品編碼
973898

Darbepoetin Alfa - 生物相似藥考察:2020年

Darbepoetin alfa- Biosimilar Insight, 2020

出版日期: 按訂單生產 | 出版商: DelveInsight Business Research LLP | 英文 60 Pages | 商品交期: 2-10個工作天內

價格
  • 全貌
  • 簡介
  • 目錄
簡介

本報告提供Darbepoetin Alfa 生物相似藥形勢調查分析,10家以上的企業,10個以上的上市藥、開發平台藥物為對象,醫藥品簡介,評估等相關的系統性資訊。

目錄

第1章 主要考察

第2章 Darbepoetin Alfa 生物相似藥:概述

第3章 摘要整理

第4章 生物相似藥的法規預測

  • 北美
    • 美國
    • 加拿大
  • 歐洲
  • 亞太地區
    • 中國
    • 印度
    • 日本
    • 韓國
    • 澳洲
  • 其他地區
    • 巴西
    • 墨西哥
    • 阿根廷
    • 沙烏地阿拉伯

第5章 Darbepoetin Alfa (商品名:Aranesp)

  • 醫藥品簡介
  • 產品概要
  • 法規核准與發售
  • 適應症
  • 作用機制
  • 用量與管理
  • 用量和優勢
  • 用量變更
  • 合成途徑
  • 藥理學
  • 藥效學
  • 藥物動力學
  • 有害反應
  • 產品概述
  • 開發里程碑

第6章 研究開發

  • 臨床試驗資訊
  • 安全性和有效性

第7章 Aranesp生物相似藥:新興機會

第8章 Darbepoetin Alfa :生物相似藥的評估

  • 評估:各產品類型
  • 評估:各給藥途徑
  • 評估:各分子類型
  • 銷售評估

第9章 Darbepoetin Alfa 生物相似藥簡介:各企業

  • Torrent Pharmaceuticals
  • Reliance Life Sciences
  • CJ Healthcare

第10章 Darbepoetin Alfa 生物相似藥比較形勢:各企業

第11章 Darbepoetin Alfa 生物相似藥:競爭情形

  • 概要
  • 市場佔有率分析
  • 競爭模式

第12章 推動市場要素

第13章 市場障礙

第14章 SWOT分析

第15章 附錄

第16章 參考文件

第17章 DelveInsight的服務內容

第18章 免責聲明

第19章 關於DelveInsight

目錄

DelveInsight's, "Darbepoetin alfa- Biosimilar Insight, 2020," report provides comprehensive insights about 10+ companies and 10+ marketed and pipeline drugs in Darbepoetin alfa Biosimilars landscape. It covers the marketed and pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered:

  • Global coverage

Darbepoetin alfa Understanding

Darbepoetin alfa: Overview

Human erythropoietin with 2 aa substitutions to enhance glycosylation (5 N-linked chains), 165 residues (MW=37 kD). Produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. Erythropoietin interacts with progenitor stem cells to increase red cell production. Binding of erythropoietin to the erythropoietin receptor leads to receptor dimerization, which facilitates activation of JAK-STAT signaling pathways within the cytosol. Activated STAT (signal transducers and activators of transcription) proteins are then translocated to the nucleus where they serve as transcription factors which regulate the activation of specific genes involved in cell division or differentiation.

Darbepoetin alfa Biosimilars: Drugs Chapters

This segment of the Darbepoetin alfa report encloses its detailed analysis of various drugs in different stages of clinical development, including marketed, phase III, II, I and preclinical. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Darbepoetin alfa Biosimilars: Marketed Drugs

  • Darbatitor: Torrent Pharmaceuticals

Darbatitor 40mcg Injection is used in the treatment of anemia that may have occurred due to chronic kidney disease or chemotherapy. It works by stimulating the bone marrow to produce more red blood cells.

Further product details are provided in the report:

Darbepoetin alfa Biosimilars: Emerging Drugs

  • CJ-40001: HK inno.N

HK inno.N is developing CJ-40001 for the treatment of Anaemia.

Further product details are provided in the report:

Darbepoetin alfa: Therapeutic Assessment

This segment of the report provides insights about the different Darbepoetin alfa biosimilars segregated based on following parameters that define the scope of the report, such as:

  • Major Players in Darbepoetin alfa

There are approx. 10+ key companies which are developing the therapies for Darbepoetin alfa.

  • Phases

DelveInsight's report covers around 10+ products under different phases of clinical development like:

  • Marketed stage products
  • Late stage products (BLA Filed and Phase III)
  • Mid-stage products (Phase II and
  • Early-stage products (Phase I) along with the details of
  • Pre-clinical and Discovery stage candidates
  • Discontinued & Inactive candidates
  • Route of Administration

Darbepoetin alfa pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as:

  • Subcutaneous
  • Intravenous
  • Molecule Type

Products have been categorized under various Molecule types such as:

  • Monoclonal antibodies
  • Peptide
  • Protein
  • Small molecule
  • Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Darbepoetin alfa: Pipeline Development Activities

The report provides insights into different therapeutic candidates in marketed, phase III, II, I and preclinical stage. It also analyses Darbepoetin alfa biosimilars drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Darbepoetin alfa biosimilar drugs.

Report Highlights:

  • The companies and academics are working to assess challenges and seek opportunities that could influence Darbepoetin alfa R&D. The therapies under development are focused on novel approaches to treat/improve Darbepoetin alfa.
  • In March 2020, CJ Healthcare, a subsidiary of Kolmar Korea, announced that it has changed the company name to HK inno.N on the occasion of its 36th anniversary.

Darbepoetin alfa Biosimilars Report Insights

  • Darbepoetin alfa Biosimilar Pipeline Analysis
  • Therapeutic Assessment
  • Sales Assessment
  • Unmet Needs
  • Impact of Drugs

Darbepoetin alfa Biosimilar Report Assessment

  • Marketed Product profiles
  • Pipeline Product Profiles
  • Therapeutic Assessment
  • Pipeline Assessment
  • Sales Assessment
  • Inactive drugs assessment
  • Unmet Needs

Key Questions:

Current Treatment Scenario and Emerging Therapies:

  • How many companies are developing Darbepoetin alfa Biosimilars?
  • How many Darbepoetin alfa biosimilars are developed by each company?
  • How many emerging biosimilars are in mid-stage, and late-stage?
  • What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Darbepoetin alfa biosimilars therapeutics?
  • What are the clinical studies going on for Darbepoetin alfa biosimilars and their status?
  • What are the key designations that have been granted to the emerging drugs?

Key Players

  • Torrent Pharmaceuticals
  • Reliance Life Sciences
  • Nichi-Iko Pharmaceutical
  • Kyowa Kirin
  • Kissei Pharmaceutical
  • Dr Reddy's
  • Dong-A ST
  • CJ Healthcare
  • Cipla
  • Chong Kun Dang Pharmaceutical
  • Biocad
  • Avesthagen Pharma
  • 3SBio

Key Products

  • Darbatitor
  • DarbeRel
  • AP 032
  • Darbepoetin Alfa Injection Syringe
  • JR-131
  • Cresp
  • DA-3880
  • CJ-40001
  • Actorise
  • CKD-11101
  • BCD 066
  • Avdesp
  • NuPIAO

Table of Contents

1. Key Insights

2. Darbepoetin alfa Biosimilars: Snapshot

3. Executive Summary

  • 3.1. Overview
  • 3.2. The Basics of Biologics.
  • 3.3. Biosimilars are not the Same as Generic Drugs
  • 3.4. Economics of Biosimilars - the Promise of Lower Prices, but at What Cost?
  • 3.5. What Patients Need to Know About Biosimilars

4. Regulatory Outlook For Biosimilars

  • 4.1. North America
    • 4.1.1. US
    • 4.1.2. Canada
  • 4.2. Europe
  • 4.3. Asia Pacific
    • 4.3.1. China
    • 4.3.2. India
    • 4.3.3. Japan
    • 4.3.4. South Korea
    • 4.3.5. Australia
  • 4.4. Rest Of The World
    • 4.4.1. Brazil
    • 4.4.2. Mexico
    • 4.4.3. Argentina
    • 4.4.4. Saudi Arabia

More Countries would be added in the final report

5. Darbepoetin alfa (Reference Product: Aranesp)

  • 5.1. Drug Profile
  • 5.2. Product Overview
  • 5.3. Regulatory Approvals and Launch
  • 5.4. Indications
  • 5.5. Mechanism of Action
  • 5.6. Dosage and Administration
  • 5.7. Dosage and Strengths
  • 5.8. Dose Modification
  • 5.9. Route of Synthesis
  • 5.10. Pharmacology
  • 5.11. Pharmacodynamics
  • 5.12. Pharmacokinetics
  • 5.13. Adverse Reactions
  • 5.14. Product Snapshot
  • 5.15. Development Milestones

6. Research and Development

  • 6.1. Clinical Trials Information
  • 6.2. Safety and Efficacy

7. Aranesp Biosimilar: Emerging Opportunities

8. Darbepoetin alfa: Biosimilars Assessment

  • 8.1. Assessment by Product Type
  • 8.2. Assessment by Route of Administration
  • 8.3. Assessment by Molecule type
  • 8.4. Sales Assessment

9. Darbepoetin alfa Biosimilars Profiles: By Company

    • 9.1.1. Torrent Pharmaceuticals
      • 9.1.1.1. Darbatitor: Torrent Pharmaceuticals
      • 9.1.1.1.1. Product Information
      • 9.1.1.1.2. Research and Development
      • 9.1.1.1.3. Other Development Activities
      • 9.1.1.1.4. General Description Table
    • 9.1.2. Reliance Life Sciences
      • 9.1.2.1. DarbeRel : Reliance Life Sciences
      • 9.1.2.1.1. Product Information
      • 9.1.2.1.2. Research and Development
      • 9.1.2.1.3. Other Development Activities
      • 9.1.2.1.4. General Description Table
    • 9.1.3. CJ Healthcare
      • 9.1.3.1. CJ-40001: CJ Healthcare
      • 9.1.3.1.1. Product Information
      • 9.1.3.1.2. Research and Development
      • 9.1.3.1.3. Other Development Activities
      • 9.1.3.1.4. General Description Table

More Companies and products would be added in the final report

10. Darbepoetin alfa Biosimilars: Comparative Landscape: By Company

11. Darbepoetin alfa Biosimilars: Competitive Landscape

    • 11.1.1. Overview
    • 11.1.2. Market Share Analysis
    • 11.1.3. Competitive Scenario
      • 11.1.3.1. Product Launches and approval
      • 11.1.3.2. Partnerships, Collaborations and Agreements
      • 11.1.3.3. Acquisitions
      • 11.1.3.4. Expansions
      • 11.1.3.5. Patent Expiration of Biologics

More information would be added in the final report

12. Market Drivers

13. Market Barriers

14. SWOT Analysis

15. Appendix

  • 15.1. Research Methodology
    • 15.1.1. Coverage
    • 15.1.2. Secondary Research

16. Bibliography

17. DelveInsight Capabilities

18. Disclaimer

19. About DelveInsight

List of Tables

  • Table 1: Total Products for Darbepoetin alfa
  • Table 2: Late Stage Products
  • Table 3: Mid Stage Products
  • Table 4: Early Stage Products
  • Table 5: Pre-clinical & Discovery Stage Products
  • Table 6: Assessment by Product Type
  • Table 7: Assessment by Stage and Product Type
  • Table 8: Assessment by Route of Administration
  • Table 9: Assessment by Stage and Route of Administration
  • Table 10: Assessment by Molecule Type
  • Table 11: Assessment by Stage and Molecule Type
  • Table 12: Inactive Products

List of Figures

  • Figure 1: Total Products for Darbepoetin alfa
  • Figure 2: Late Stage Products
  • Figure 3: Mid Stage Products
  • Figure 4: Early Stage Products
  • Figure 5: Preclinical and Discovery Stage Products
  • Figure 6: Assessment by Product Type
  • Figure 7: Assessment by Stage and Product Type
  • Figure 8: Assessment by Route of Administration
  • Figure 9: Assessment by Stage and Route of Administration
  • Figure 10: Assessment by Molecule Type
  • Figure 11: Assessment by Stage and Molecule Type
  • Figure 12: Inactive Products