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市場調查報告書

Teriparatide:生物相似藥的洞察(2020年)

Teriparatide- Biosimilar Insight, 2020

出版商 DelveInsight Business Research LLP 商品編碼 973903
出版日期 按訂單生產 內容資訊 英文 60 Pages
商品交期: 10個工作天內
價格
Teriparatide:生物相似藥的洞察(2020年) Teriparatide- Biosimilar Insight, 2020
出版日期: 按訂單生產內容資訊: 英文 60 Pages
簡介

本報告提供生物相似藥:Teriparatide的相關調查,提供10家公司以上的企業和10項產品以上的成藥及開發平台藥物相關全面的洞察,含臨床、非臨床階段的產品的市售及開發平台的藥物簡介,各產品類型、階段、給藥途徑、分子類型的治療方法的評估,市場成長要素和障礙,競爭情形等資訊。

本報告記載的主要企業

  • Pfenex
  • CinnaGen
  • Corium International
  • Rhein Minapharm Biogenetics
  • Stada Arzneimittel
  • Biosidus
  • Amega Biotech
  • Azelon Pharmaceuticals
  • IGI
  • Shanghai Fudan-Zhangjiang Bio-Pharmaceutical
  • Stelis Biopharma
  • Asahi Kasei Pharma
  • Intas Pharmaceuticals
  • Alkermes
  • Alkem Laboratories
  • Paras Biopharmaceuticals
  • Gedeon Richter
  • Zydus Cadila
  • Mochida Pharmaceutical
  • USV

本報告刊載主要的產品

  • BONSITY
  • CinnoPar
  • hPTH(1-34)
  • Modified PTH
  • Movymia
  • Osteofortil
  • Parathyroid hormone biosimilar
  • Recombinant parathyroid hormone biosimilar
  • rhPTH (1-34)
  • SBL 001
  • Teribone
  • Terifrac
  • Teriparatide AIR
  • Terrosa
  • IFNα-2b
  • PF708

目錄

第1章 主要洞察

第2章 概述

第3章 摘要整理

  • 概要
  • 生技藥品的基礎
  • 學名藥和生物相似藥
  • 生物相似藥的經濟學:低價格的承諾,實際的費用
  • 患者需要了解哪些有關生物相似藥的訊息

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 Teriparatide(參考產品:Forteo)

  • 藥物簡介
  • 產品概要
  • 法規當局的認證和推出
  • 適應症
  • 作用機制
  • 投藥和管理
  • 劑量與強度
  • 用量變更
  • 合成途徑
  • 藥理學
  • 藥效學
  • 藥物動力學
  • 副作用
  • 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 Forteo生物相似藥:新機會

第8章 Teriparatide:生物相似藥的評估

  • 各產品類型的評估
  • 各給藥途徑的評估
  • 各分子類型的評估
  • 各銷售的評估

第9章 企業簡介

    • Pfenex
    • Biosidus

第10章 比較形勢:各企業

第11章 競爭情形

    • 概要
    • 市場佔有率分析
    • 競爭模式

第12章 市場成長要素

第13章 市場障礙

第14章 SWOT分析

第15章 附錄

  • 調查手法

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, "Teriparatide- Biosimilar Insight, 2020," report provides comprehensive insights about 10+ companies and 10+ marketed and pipeline drugs in Teriparatide 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

Teriparatide Understanding

Teriparatide: Overview

Teriparatide (recombinant human parathyroid hormone) is a potent anabolic agent used in the treatment of osteoporosis. It is manufactured and marketed by Eli Lilly and Company. For the treatment of osteoporosis in men and postmenopausal women who are at high risk for having a fracture. Also used to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture. Teriparatide is the portion of human parathyroid hormone (PTH), amino acid sequence 1 through 34 of the complete molecule which contains amino acid sequence 1 to 84. Endogenous PTH is the primary regulator of calcium and phosphate metabolism in bone and kidney. Daily injections of teriparatide stimulates new bone formation leading to increased bone mineral density.

Teriparatide Biosimilars: Drugs Chapters

This segment of the Teriparatide 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.

Teriparatide Biosimilars: Marketed Drugs

  • Bonsity: Pfenex

Bonsity (teriparatide) is a parathyroid hormone analog (PTH 1-34) indicated for the treatment of osteoporosis in certain patients at high risk for fracture. Bonsity is approved in the U.S. under the 505(b) regulatory pathway, with Forteo (teriparatide injection) as the reference drug. Bonsity is indicated for:

  • Treatment of postmenopausal women with osteoporosis at high risk for fracture
  • Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture
  • Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture.

Further product details are provided in the report:

Teriparatide: Therapeutic Assessment

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

Major Players in Teriparatide

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

  • 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

Teriparatide 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.

Teriparatide: Pipeline Development Activities

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

Report Highlights:

  • The companies and academics are working to assess challenges and seek opportunities that could influence Teriparatide R&D. The therapies under development are focused on novel approaches to treat/improve Teriparatide.
  • In June 2020, Pfenex announced that its commercialization partner, Alvogen, has launched Teriparatide Injection in the United States. Teriparatide Injection (also referred to as PF708 and Bonsity) is a prescription medicine approved for several uses, including in postmenopausal women with osteoporosis who are at high risk for having bone fractures.
  • In August 2019, Gedeon Richter announced that it has launched its biosimilar teriparatide, Terrosa in Europe. The product is approved in adults for the same indications as Eli Lilly's Forsteo, i.e. used for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture and treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non vertebral fractures but not hip fractures has been demonstrated.

Teriparatide Biosimilars Report Insights

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

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

Key Players

  • Pfenex
  • CinnaGen
  • Corium International
  • Rhein Minapharm Biogenetics
  • Stada Arzneimittel
  • Biosidus
  • Amega Biotech
  • Azelon Pharmaceuticals
  • IGI
  • Shanghai Fudan-Zhangjiang Bio-Pharmaceutical
  • Stelis Biopharma
  • Asahi Kasei Pharma
  • Intas Pharmaceuticals
  • Alkermes
  • Alkem Laboratories
  • Paras Biopharmaceuticals
  • Gedeon Richter
  • Zydus Cadila
  • Mochida Pharmaceutical
  • USV

Key Products

  • BONSITY
  • CinnoPar
  • hPTH(1-34)
  • Modified PTH
  • Movymia
  • Osteofortil
  • Parathyroid hormone biosimilar
  • Recombinant parathyroid hormone biosimilar
  • rhPTH (1-34)
  • SBL 001
  • Teribone
  • Terifrac
  • Teriparatide AIR
  • Terrosa
  • IFNα-2b
  • PF708

Table of Contents

1. Key Insights

2. Teriparatide 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. Teriparatide (Reference Product: Forteo)

  • 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. Forteo Biosimilar: Emerging Opportunities

8. Teriparatide: 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. Teriparatide Biosimilars Profiles: By Company

    • 9.1.1. Pfenex
      • 9.1.1.1. BONSITY: Pfenex
      • 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. Biosidus
      • 9.1.2.1. Osteofortil: Biosidus
      • 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. Teriparatide Biosimilars: Comparative Landscape: By Company

11. Teriparatide 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 Teriparatide
  • 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 Teriparatide
  • 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