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세계의 바이오시밀러 인슐린 시장 기회와 임상 분석 전망

Global Biosimilar Insulin Market Opportunity & Clinical Insight Outlook 2022

리서치사 KuicK Research
발행일 2017년 02월 상품 코드 448697
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세계의 바이오시밀러 인슐린 시장 기회와 임상 분석 전망 Global Biosimilar Insulin Market Opportunity & Clinical Insight Outlook 2022
발행일 : 2017년 02월 페이지 정보 : 영문 120 Pages

세계의 바이오시밀러 인슐린(Biosimilar Insulin) 시장에 대해 조사 분석했으며, 임상/비임상 문제점에 초점을 맞추어 개요, 작용기서, 임상 파이프라인, 출시 제품, 경쟁 구도 등의 정보를 전해드립니다.

제1장 바이오시밀러 인슐린 소개

  • 인슐린 개요
  • 인슐린 발전과 개발의 경위

제2장 인슐린 분자의 이론적 설계

  • 인슐린 폴리펩티드의 구조
  • 인슐린의 생합성
  • 인슐린의 분비

제3장 당뇨병에서 인슐린의 기서

  • 인슐린의 글루코오스 대사
  • 1형 당뇨병에서 인슐린 조절 이상의 영향
  • 2형 당뇨병에서 인슐린 저항의 영향

제4장 합성 인슐린의 엔지니어링

  • 사람 인슐린의 생산
  • 인슐린의 분류와 유사물

제5장 당뇨병의 인슐린 치료제

  • 기존의 인슐린 요법
  • 유연한/집중 인슐린 요법

제6장 인슐린의 세계 경제적 측면

  • 급등하는 인슐린 요법 비용
  • 바이오시밀러의 대두

제7장 당뇨병의 세계 경제적 비용

  • 당뇨병의 금전적 부담
  • 미국
  • 유럽
  • 일본
  • 중국
  • 인도

제8장 바이오시밀러 인슐린의 세계적 측면

  • 미국
  • 유럽
  • 일본
  • 아시아(일본 제외)

제9장 세계의 바이오시밀러 인슐린 시장 개요

  • 바이오시밀러 인슐린 시장 소개
  • 바이오시밀러의 경쟁 평가

제10장 세계의 바이오시밀러 인슐린 임상 파이프라인 분석

제11장 출시된 바이오시밀러 인슐린 임상 분석 : 기업별, 적응별, 상(相)별

제12장 바이오시밀러 인슐린의 향후 표적 시장

제13장 세계의 바이오시밀러 인슐린 시장 역학

  • 성장 촉진요인
  • 주요 해결해야 할 과제

제14장 바이오시밀러 인슐린의 향후 영향

제15장 경쟁 구도

  • Biocon
  • Biogenomics
  • Eli Lilly
  • Gan&Lee Pharmaceuticals
  • Geropharm
  • Julphar Gulf Pharmaceutical Industries
  • Paras Biopharmaceuticals
  • Samsung Bioepis
  • Sedico
  • Wockhardt
KSM 17.03.08

"Global Biosimilar Insulin Market Opportunity & Clinical Insight Outlook 2022" report gives comprehensive insight on clinical and non-clinical issues involved with growth of global biosimilar insulin market. This report analyzes various aspects like rationale design of insulin molecule, mechanism of insulin in diabetes, engineering of synthetic insulin, global aspects of biosimilar insulins along with market overview, biosimilar insulin clinical pipeline insight and future trends for the development of biosimilar insulin market.

The development of biosimilar was a consequence of the financial success of the biologic therapies and their inevitable patent cliff a marked drop in sales as they near the expiration of their original patents. Biosimilar development represents a large profit potential for pharmaceutical manufacturers. Consumers and policy makers view appropriate market introduction of biosimilars as high priority because of the prospect of reduced medical costs.

The consequence of recent technological innovations, new regulations in the biopharmaceutical industry, and cost concerns, the idea of biosimilars has gathered attention towards them and their potential future market. In fact, efforts are already underway to develop a new class of follow-on biologics named biobetters or biosuperiors, which go beyond mimicking the original biologic to provide improvements through changes in chemistry, alteration in the formulation, and innovative delivery.

The potential of insulin biosimilars like Basaglar is huge in the upcoming future, the demand will significantly grow in developed market as the countries including US, Europe and Japan have shown a great enthusiasm towards biosimilar products especially Europe. The developed market somehow, with the exception of the United States, has represented the greatest biosimilars presence today. Most biosimilars manufacturers have been and remain focused on the developed markets whether it is for their historic and current opportunities (EU) or for their future market potential (United States, Japan).

Devoted regulatory pathways set the foundation for stringent, abbreviated approval processes which, in turn, have nourished investor interest. Biosimilars adoption in developed markets has been primarily payer-driven, especially in European markets, given payers' urgent, unmet need to contain public health care expenditures. Thus similar hopes are confined with the biosimilar insulins. In contrary to the developed world, developing countries tends to believe more in biosimilar versions of essential drugs. Like India and China are developing biosimilar versions of insulin from past several years but did not gained popularity due to the lack of biosimilar regulatory framework. However, in contrasting emerging markets with developed markets, the limited patient access to affordable biologics and the openness of physicians to low cost therapies offers potentially significant opportunities.

Certainly the future for biosimilar insulin is brightened by the increasing prevalence of diabetes, high cost of branded insulins and the patent cliff scenarios. The expected entry of biosimilars onto the insulin market could significantly change the insulin landscape in the coming years. These products could have a notable impact on diabetes treatment costs, accessibility of insulin, insulin market competition, and the number of insulin choices available to patients. However, biosimilar companies will face major challenges on regulatory, commercial, and competitive fronts as they seek to enter this market.

Table of Contents

1. Prologue to Insulin Biosimilars

  • 1.1 Outline Towards Insulin
  • 1.2 Trail of Insulin Evolution & Development

2. Rationale Design of Insulin Molecule

  • 2.1 Structure of Insulin Polypeptide
  • 2.2 Biosynthesis of Insulin
  • 2.3 Secretion of Insulin

3. Mechanism of Insulin in Diabetics

  • 3.1 Glucose Metabolism of Insulin
  • 3.2 Impact of Insulin Dysregulation in Diabetes 1
  • 3.3 Impact of Insulin Resistance in Diabetes 2

4. Engineering of Synthetic Insulin

  • 4.1 Production of Human Insulin
  • 4.2 Categorization of Insulin & Its Analogues
    • 4.2.1 Rapid Acting Insulins
    • 4.2.2 Short Acting Insulins
    • 4.2.3 Intermediate Insulin
    • 4.2.4 Long Lasting Insulins

5. Insulinotherapeutics in Diabetes

  • 5.1 Conventional Insulinotherapy
  • 5.2 Flexible or Intensive Insulinotherapy

6. Global Economic Aspects of Insulin

  • 6.1 Skyrocketing Cost of Insulin Therapies
  • 6.2 Emergence of Biosimilar

7. Global Economic Cost of Diabetes

  • 7.1 Monetary Burden of Diabetes
  • 7.2 US
  • 7.3 Europe
  • 7.4 Japan
  • 7.5 China
  • 7.6 India

8. Global Aspects of Biosimilar Insulins

  • 8.1 US
  • 8.2 Europe
  • 8.3 Japan
  • 8.4 Asia (Excluding Japan)

9. Global Biosimilar Insulin Market Overview

  • 9.1 Preface to Biosimilar Insulin Market
  • 9.2 Biosimilar Competition Assessment

10. Global Biosimilar Insulin Clinical Pipeline Insight

11. Marketed Biosimilar Insulin Clinical Insight by Company, Indication & Phase

  • 11.1 Insulin Biosimilar (Wosulin-R)
  • 11.2 Insulin Glargine Biosimilar (Glaritus, Glaritus Cart, Glaritus DispoPen)
  • 11.3 Insulin Glargine Biosimilar (Abasaglar, Abasria & Basalgar)
  • 11.4 Insulin Suspension Isophane/Insulin Biosimilar (Jusline 30/70)
  • 11.5 Insulin Glargine Biosimilar (Basalog & GALACTUS)
  • 11.6 Insulin Suspension Isophane Biosimilar (Jusline N)
  • 11.7 Insulin Suspension Isophane/Insulin Biosimilar (Insulin H Mix)
  • 11.8 Insulin Suspension Isophane Biosimilar (Insulin Hbio NPH)
  • 11.9 Insulin Biosimilar (Insulin Hbio R)
  • 11.10 Insulin Glargine Biosimilar (Basalin)
  • 11.11 Insulin/Insulin Suspension Isophane Biosimilar (Wosulin 30/70, 50/50)
  • 11.12 Insulin Suspension Isophane Biosimilar (Wosulin-N)
  • 11.13 Insulin Biosimilar (Jusline R)
  • 11.14 Insulin Glargine Biosimilar (Basugine)
  • 11.15 Insulin Biosimilar (Insugen)

12. Biosimilar Insulin Future Targeted Market

  • 12.1 Global High Prevalence of Diabetics
  • 12.2 Global Prevalence of Obesity

13. Global Biosimilar Insulin Market Dynamics

  • 13.1 Accelerating Parameters
  • 13.2 Major Challenges of Biosimilar Insulin Market

14. Future Implications of Biosimilar Insulin

15. Competitive Landscape

  • 15.1 Biocon
  • 15.2 Biogenomics
  • 15.3 Eli Lilly
  • 15.4 Gan&Lee Pharmaceuticals
  • 15.5 Geropharm
  • 15.6 Julphar Gulf Pharmaceutical Industries
  • 15.7 Paras Biopharmaceuticals
  • 15.8 Samsung Bioepis
  • 15.9 Sedico
  • 15.10 Wockhardt

List of Figures

  • Figure 1-1: Major Historical Events in Discovering Insulin
  • Figure 2-1: Primary Structure of Insulin with Polypeptidic Chains
  • Figure 2-2: Illustration of Biosynthesis from Preproinsulin to Proinsulin
  • Figure 2-3: Mechanism of Insulin Release from the Pancreas
  • Figure 3-1: Mechanism of glucose Uptake by Insulin Molecule
  • Figure 3-2: Deficiency of Insulin Leading towards the Type I Diabetes
  • Figure 3-3: Insulin resistance Shown by the Type 2 Diabetes
  • Figure 4-1: Process of Generating Recombinant Insulin in Bacterial Cell
  • Figure 4-2: Different Types of Insulin & Their Brand Names with Time of Action
  • Figure 5-1: Relationships among Components of Insulin, Injection Times & Blood Glucose Testing
  • Figure 5-2: Insulin Release during Conventional Insulinotherapy
  • Figure 5-3: Insulin release at Intensified or Flexible Insulinotherapy
  • Figure 6-1: Representation of Rising Cost of Insulin per Unit
  • Figure 7-1: Illustration of the Total Cost Distribution of Diabetes
  • Figure 7-2: Global Estimated Total Expenditure of Diabetes (US$ Billion), 2015 & 2040
  • Figure 7-3: Top 10 Countries by Highest Spending Per Patient with Diabetes (US$)
  • Figure 7-4: Top 10 Countries by Lowest Spending Per Patient with Diabetes (US$)
  • Figure 7-5: US - Estimated Total Cost of Diabetes & Obesity (US$ Billion)
  • Figure 7-6: Representation of Cost of Insulin among Different Countries, 2016
  • Figure 7-7: Projected Cost of Diabetes in Europe
  • Figure 7-8: Estimated Prevalence of Diabetes in Japan (In Million)
  • Figure 7-9: Projected Number of Diabetic Cases in China (Million)
  • Figure 7-10: India - Increasing Prevalence of Diabetes & Future Projections (Million)
  • Figure 8-1: Demonstration Comparative Price of Lantus Insulin in US & Other Countries
  • Figure 8-2: Highest Growth in Number of Biosimilars Candidates in South East Asian Region
  • Figure 9-1: Cost savings with Biosimilars & Generics as Compared to the Branded Versions
  • Figure 9-2: Global Insulin Market Assessment (US$ Billion), 2016-2022
  • Figure 9-3: Global Market Shares of Three Leading Companies in the Insulin Market
  • Figure 9-4: Illustrations of Lantus (Insulin Glargine) Revenues by Sanofi's (Billion Euros)
  • Figure 9-5: Market Revenues of Novo Nordisk in Modern Insulin Market (DKK Billion)
  • Figure 10-1: Number of Biosimilar Insulin in Clinical Pipeline, 2017-2022
  • Figure 10-2: Biosimilar Insulin in Clinical Pipeline (%), 2017-2022
  • Figure 12-1: Top 5 Countries with High Diabetes Prevalence in Adults by 2030(in Millions)
  • Figure 12-2: Top 10 Countries by Highest Prevalence of Diabetes (%)
  • Figure 12-3: Global Increasing Prevalence of Diabetes Prevalence (In Millions)
  • Figure 12-4: Estimated Prevalence of Obesity among Various Countries (2025)
  • Figure 12-5: Increasing Relative Risk of Diabetes with Increasing BMI
  • Figure 13-1: Trends of High Cost of Insulin from 2010 till 2015 in US
  • Figure 13-2: The Major Favorable Parameters for Growth of Biosimilar Insulin Market
  • Figure 13-3: Major Barriers Encountered by the Insulin Biosimilar Market
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