Global Biosimilar Insulin Market Opportunity & Clinical Insight Outlook 2022
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“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.
“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.
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
3.3 Impact of Insulin Resistance in Diabetes
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
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
3.3 Impact of Insulin Resistance in Diabetes
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
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
