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市場調查報告書

Insulin Glargine、生物相似藥:全球市場的洞察 (2020年)

Insulin Glargine - Biosimilar Insight, 2020

出版商 DelveInsight Business Research LLP 商品編碼 955880
出版日期 內容資訊 英文 90 Pages
商品交期: 最快1-2個工作天內
價格
Insulin Glargine、生物相似藥:全球市場的洞察 (2020年) Insulin Glargine - Biosimilar Insight, 2020
出版日期: 2020年08月01日內容資訊: 英文 90 Pages
簡介

本報告提供全球各國Insulin Glargine的生物相似藥的疫情趨勢與今後預測相關分析,市場基本結構和最新形勢,整體臨床實驗的進展 (各階段的產品數等),主要的已上市/開發中產品 (10種以上)的特徵和臨床實驗情形,主要企業 (10家公司以上)的簡介的主力商品,主要的治療藥的評估 (各產品種類、各臨床實驗階段、各給藥途徑、各分子類型)等資訊彙整,為您概述為以下內容。

目錄

第1章 主要洞察

第2章 Insulin Glargine的生物相似藥:概述

第3章 摘要整理

  • 概況
  • 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 生物相似藥法規的展望

  • 北美
    • 美國
    • 加拿大
  • 歐洲
  • 亞太地區
    • 中國
    • 印度
    • 日本
    • 韓國
    • 澳洲
  • 其他的國家 (RoW)
    • 巴西
    • 墨西哥
    • 阿根廷
    • 沙烏地阿拉伯

第5章 Insulin Glargine (參照產品:Lantus)

  • 藥物簡介
  • 產品概要
  • 法規核准、上市
  • 適應症
  • 作用機制
  • 投藥和管理
  • 劑量和含量
  • 劑量的調整
  • 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 (R&D)

  • 臨床實驗資訊
  • 安全性和有效性

第7章 Lantus的生物相似藥:新機會

第8章 Insulin Glargine:生物相似藥的評估

  • 各產品種類的評估
  • 各給藥途徑的評估
  • 各分子類型的評估
  • 銷售量的評估

第9章 Insulin Glargine、生物相似藥的簡介:各企業

  • Mylan
  • Polus BioPharm
  • Biocon
  • Wockhardt

第10章 Insulin Glargine、生物相似藥:競爭情形比較,各企業

第11章 Insulin Glargine、生物相似藥: 競爭情形

  • 概況
  • 市場佔有率分析
  • 競爭模式

第12章 推動市場要素

第13章 阻礙市場要素

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
Product Code: DIBI000008

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

Insulin Glargine Understanding

Insulin Glargine: Overview

Insulin glargine, marketed under the names Lantus among others, is a long-acting insulin, used in the management of type I and type II diabetes. It is typically the recommended long acting insulin in the United Kingdom. It is used once a day as an injection just under the skin. Insulin glargine is produced by recombinant DNA technology using a non-pathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from endogenous human insulin by the replacement of an asparagine residue at position A21 of the A-chain with glycine and addition of two arginines to the C-terminus (positions B31 and 32) of the B-chain. The resulting protein is soluble at pH 4 and forms microprecipitates at physiological pH 7.4 allowing for the slow release of small amounts of insulin glargine, giving the drug a long duration of action and no pronounced peak concentration.

Insulin Glargine Biosimilars: Drugs Chapters

This segment of the Insulin Glargine 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.

Insulin Glargine Biosimilars: Marketed Drugs

  • Semglee: Mylan/Biocon

Semglee contains insulin glargine. This is a modified insulin, very similar to human insulin. Semglee is used to treat diabetes mellitus in adults, adolescents and children aged 2 years and above. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar.

  • Abasaglar: Eli Lilly

Insulin glargine biosimilar (Abasaglar) is licensed for the treatment of diabetes mellitus in adults, young people and children over 2 years. Abasaglar is a basal insulin for once daily use and is bioequivalent to insulin glargine (Lantus). Basaglar is not approved for use by anyone younger than 6 years old, and should not be used to treat type 2 diabetes in a child of any age.

Further product details are provided in the report.

Insulin Glargine Biosimilars: Emerging Drugs

  • Insulin RinGlar: Geropharm

Insulin RinGlar is being developed by Geropharm for the treatment of Type 1 diabetes mellitus. This is the fifth insulin in the company portfolio, which will complete the Geropharm line of human recombinant insulins and analogues. RinGlar will become the first insulin glargine, which will be produced in Russia on a full cycle basis - from substance to the finished dosage form.

Further product details are provided in the report.

Insulin Glargine: Therapeutic Assessment

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

  • Major Players in Insulin Glargine

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

  • 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

Insulin Glargine 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
  • 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.

Insulin Glargine: Pipeline Development Activities

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

Report Highlights:

  • The companies and academics are working to assess challenges and seek opportunities that could influence Insulin Glargine R&D. The therapies under development are focused on novel approaches to treat/improve Insulin Glargine.
  • In June 2020, Mylan and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Semglee (insulin glargine injection), in vial and pre-filled pen presentations, to control high blood sugar in adults with type 2 diabetes and adult and pediatric patients with type 1 diabetes. Semglee has an identical amino acid sequence to Sanofi's Lantus and is approved for the same indications.
  • In July 2019, there was an official signing ceremony for the partnership agreement between GEROPHARM and NatiVita (Belarus) that stipulates a transfer of the Russian insulin production technology to the Belarussian party. This partnership between the companies is a strategy and facilitates strengthening bilateral relationship between the Russian Federation and the Republic of Belarus. Implementation of the project will make it possible to adjust highly technological production of insulins in Belarus within a short-term period of time and provide the citizens with modern, effective and affordable drugs.
  • In July 2019, GEROPHARM received marketing authorization for long-action insulin analog - glargine under RinGlar invented name. The drug in two dosage forms - 3 ml cartridges and pre-filled disposable insulin pens RinAstra II - will take part in the state procurement procedure in the autumn of 2019.

Insulin Glargine Biosimilars Report Insights

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

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

Key Players

  • Mylan
  • Polus BioPharm
  • Biocon
  • Wockhardt
  • Boehringer Ingelheim
  • Eli Lilly and Company
  • LG Chem
  • Harvest Moon Pharmaceuticals
  • GEROPHARM
  • Merck
  • Paras Biopharmaceuticals
  • GC Pharma

Key Products

  • Semglee
  • PDP808
  • Glaricon
  • Glaritus
  • Abasaglar
  • Basalog
  • Basugine
  • Insulin glargine biosimilar
  • Insulin RinGlar
  • Lusduna
  • PB (MDT)-3030
  • Glarzia

Table of Contents

1. Key Insights

2. Insulin Glargine 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. Insulin Glargine (Reference Product: Lantus)

  • 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. Lantus Biosimilar: Emerging Opportunities

8. Insulin Glargine: 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. Insulin Glargine Biosimilars Profiles: By Company

    • 9.1.1. Mylan
      • 9.1.1.1. Semglee: Mylan
      • 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. Polus BioPharm
      • 9.1.2.1. PDP808: Polus BioPharm
      • 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. Biocon
      • 9.1.3.1. Glaricon: Biocon
      • 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
    • 9.1.4. Wockhardt
      • 9.1.4.1. Glaritus: Wockhardt
      • 9.1.4.1.1. Product Information
      • 9.1.4.1.2. Research and Development
      • 9.1.4.1.3. Other Development Activities
      • 9.1.4.1.4. General Description Table

More Companies and products would be added in the final report

10. Insulin Glargine Biosimilars: Comparative Landscape: By Company

11. Insulin Glargine 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 Insulin Glargine
  • 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 Insulin Glargine
  • 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