市場調查報告書

Somatotropin:生物相似藥的考察 (2020年)

Somatotropin - Biosimilar Insight, 2020

出版商 DelveInsight Business Research LLP 商品編碼 955882
出版日期 內容資訊 英文 70 Pages
商品交期: 最快1-2個工作天內
價格
Somatotropin:生物相似藥的考察 (2020年) Somatotropin - Biosimilar Insight, 2020
出版日期: 2020年08月01日內容資訊: 英文 70 Pages
簡介

本報告含括Somatotropin的生物相似藥,提供已上市及開發平台醫藥品相關全面的考察,各地區、國家法規環境,各產品類型、階段、給藥途徑、分子類型的治療藥的評估,市場成長的影響要素等分析。

目錄

第1章 主要考察

第2章 Somatotropin的生物相似藥:概述

第3章 摘要整理

  • 概要
  • 生技藥品的基礎
  • 生物相似藥與學名藥不同
  • 生物相似藥的經濟性:承諾低價格,但代價是什麼?
  • 關於生物相似藥患者應預先知道之事

第4章 生物相似藥的法規展望

  • 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 Somatotropin(參照產品:Genotropin)

  • 藥物簡介
  • 產品概要
  • 法規核准與發售
  • 適應症
  • 作用機制
  • 投藥和管理
  • 劑量和優勢
  • 劑量的變更
  • 合成途徑
  • 藥理學
  • 藥效學
  • 藥物動力學
  • 有害反應
  • 產品的概述
  • 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 Genotropin的生物相似藥:新機會

第8章 Somatotropin: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
  • 銷售額評估

第9章 Somatotropin的生物相似藥的簡介:各企業

    • Sandoz
    • Pfizer

第10章 Somatotropin的生物相似藥:比較形勢:各企業

第11章 Somatotropin的生物相似藥:競爭情形

    • 概要
    • 市場佔有率分析
    • 競爭模式

第12章 促進市場成長因素

第13章 阻礙市場成長要素

第14章 SWOT分析

第15章 附錄

  • 調查手法
    • 調查範圍
    • 2次調查

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
Product Code: DIBI000010

DelveInsight's , "Somatropin - Biosimilar Insight, 2020," report provides comprehensive insights about 10+ companies and 10+ marketed and pipeline drugs in Somatropin 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

Somatropin Understanding

Somatropin: Overview

Somatropin is used to treat growth failure in children and adults who lack natural growth hormone. This includes people with short stature due to Noonan syndrome, Turner syndrome, Prader-Willi syndrome, short stature at birth with no catch-up growth, and other causes. hGH binds to the human growth hormone receptor (GHR). Upon binding, hGH causes dimerization of GHR, activation of the GHR-associated JAK2 tyrosine kinase, and tyrosyl phosphorylation of both JAK2 and GHR. These events recruit and/or activate a variety of signaling molecules, including MAP kinases, insulin receptor substrates, phosphatidylinositol 3' phosphate kinase, diacylglycerol, protein kinase C, intracellular calcium, and Stat transcription factors. These signaling molecules contribute to the GH-induced changes in enzymatic activity, transport function, and gene expression that ultimately culminate in changes in growth and metabolism.

Somatropin Biosimilars: Drugs Chapters

This segment of the Somatropin 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.

Somatropin Biosimilars: Marketed Drugs

  • Omnitrope: Sandoz

Omnitrope (somatropin [rDNA origin] injection) is a form of human growth hormone used to treat growth failure in children and adults who lack natural growth hormone, and in those with chronic kidney failure, Noonan syndrome, Turner syndrome, short stature at birth with no catch-up growth, and other causes.

Further product details are provided in the report.

Somatropin Biosimilars: Emerging Drugs

  • Somatropin beta-1b biosimilar: Harvest Moon Pharmaceuticals

Harvest Moon Pharmaceuticals is developing Somatropin beta-1b biosimilar for the treatment of Multiple sclerosis.

Further product details are provided in the report.

Somatropin: Therapeutic Assessment

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

  • Major Players in Somatropin

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

  • 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

Somatropin 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
  • Intramuscular
  • 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.

Somatropin: Pipeline Development Activities

The report provides insights into different therapeutic candidates in marketed, phase III, II, I and preclinical stage. It also analyses Somatropin 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 Somatropin biosimilar drugs.

Report Highlights:

  • The companies and academics are working to assess challenges and seek opportunities that could influence Somatropin R&D. The therapies under development are focused on novel approaches to treat/improve Somatropin.

Somatropin Biosimilars Report Insights

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

Somatropin 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 Somatropin Biosimilars?
  • How many Somatropin 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 Somatropin biosimilars therapeutics?
  • What are the clinical studies going on for Somatropin biosimilars and their status?
  • What are the key designations that have been granted to the emerging drugs?

Key Players

  • USV
  • Sedico
  • Sandoz
  • rEVO Biologics
  • Reliance Life Sciences
  • Polus BioPharm
  • Pfizer
  • Inbiopro Solutions
  • Harvest Moon Pharmaceuticals
  • Cristalia
  • CinnaGen
  • Biosidus
  • BioPartners
  • Bio-Ker
  • AryaTinaGene
  • Amega Biotech

Key Products

  • Human growth hormone biosimilar
  • Somatropin (rDNA origin)
  • Omnitrope
  • Human growth hormone
  • R-TPR-007
  • SomatoRel
  • PDP805
  • Genotonorm
  • IBPB 003HH
  • Somatotropin biosimilar
  • r-hGH Cristalia
  • Cinnatropin
  • Growmax
  • Valtropin
  • Recombinant somatropin
  • Somatropin biosimilar
  • Recombinant human growth hormone

Table of Contents

1. Key Insights

2. Somatropin 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. Somatropin (Reference Product: Genotropin)

  • 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. Genotropin Biosimilar: Emerging Opportunities

More variants of Somatropin would be added in the final report

8. Somatropin: 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. Somatropin Biosimilars Profiles: By Company

    • 9.1.1. Sandoz
      • 9.1.1.1. Omnitrope: Sandoz
      • 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. Pfizer
      • 9.1.2.1. Genotonorm: Pfizer
      • 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

More Companies and products would be added in the final report

10. Somatropin Biosimilars: Comparative Landscape: By Company

11. Somatropin 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 Somatropin
  • 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 Somatropin
  • 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