US Biosimilar Insulin Market Opportunity & Clinical Trials Insight 2026
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“US Biosimilar Insulin Market Opportunity & Clinical Trials Insight 2026” Report Highlights:
Previously, some of the products such as Basaglar and Admelog were approved as a biosimilars of insulin but FDA rejected the biosimilar designation as there are slight differences in the method of production. Therefore, FDA acts as a strict governing body for the insulin biosimilars, which acts as a major reason for the restricted availability of insulin biosimilars in US. Approval of Semglee as first interchangeable insulin biosimilar is believed to act as revolutionary step for the US insulin biosimilar market, which simplifies the path of approval for other investigational biosimilars. During the next 4-5 years, new insulin biosimilars are expected to get approval in US, which took this market segment to the next level.
The respective field associated with US insulin biosimilars market has grown at an accelerated speed over the past few decades and is estimated to be represented as one of the most innovative and exciting approach of biomedical sector and biotech space, which will overtake major share of the insulin market. In the past few years, the volume of research, publications and number of clinical trials have increased significantly for the field as patents of most of the leading insulin are about to get expire very soon. The biosimilars of insulin aspart and insulin lispro is most likely to get market authorisation by the end of year 2023 while some of the combinational insulins are also believed to get approval in US.
Further, low price of biosimilar insulin for diabetes treatment along with the therapeutic equivalent nature is believed to open new opportunities of growth of the US insulin biosimilar market. Along with this, the availability of several advanced delivery devices are also assisting the US biosimilar market and more innovative devices will enter the US market in near future for enabling less painful and self-delivery of insulin biosimilars. Along with this, increased investment by government as well as private sector on the research and development activities related to insulin biosimilars is encouraging the pharmaceutical sector to work in this segment and provide ample scope of development for the market. The presence of leading pharmaceutical companies in US insulin biosimilar market is indicating towards the competition in this segment.
The US Insulin Biosimilar Market Report involves in-depth analysis of the various parameters related to this segment along with the analysis of current as well as future market opportunity. The report also involves the comparative price analysis along with the clinical trends, market drivers and possible challenges related to US insulin biosimilar market. It is forecasted that the US insulin biosimilar market will overtake a major share of insulin market of US and the future of this segment is full of opportunities.
“US Biosimilar Insulin Market Opportunity & Clinical Trials Insight 2026” Report Highlights:
- US Diabetic Drug Market Opportunity: > US$ 35 Billion
- US Insulin Market Opportunity > US$ 10 Billion
- US Biosimilar Insulin Market Opportunity > US$ 1 Billion
- US Biosimilar Insulin Market Cost Comparison Analysis
- First FDA Approved Interchangeable Biosimilar Insulin Cost & Dosage Insight
Previously, some of the products such as Basaglar and Admelog were approved as a biosimilars of insulin but FDA rejected the biosimilar designation as there are slight differences in the method of production. Therefore, FDA acts as a strict governing body for the insulin biosimilars, which acts as a major reason for the restricted availability of insulin biosimilars in US. Approval of Semglee as first interchangeable insulin biosimilar is believed to act as revolutionary step for the US insulin biosimilar market, which simplifies the path of approval for other investigational biosimilars. During the next 4-5 years, new insulin biosimilars are expected to get approval in US, which took this market segment to the next level.
The respective field associated with US insulin biosimilars market has grown at an accelerated speed over the past few decades and is estimated to be represented as one of the most innovative and exciting approach of biomedical sector and biotech space, which will overtake major share of the insulin market. In the past few years, the volume of research, publications and number of clinical trials have increased significantly for the field as patents of most of the leading insulin are about to get expire very soon. The biosimilars of insulin aspart and insulin lispro is most likely to get market authorisation by the end of year 2023 while some of the combinational insulins are also believed to get approval in US.
Further, low price of biosimilar insulin for diabetes treatment along with the therapeutic equivalent nature is believed to open new opportunities of growth of the US insulin biosimilar market. Along with this, the availability of several advanced delivery devices are also assisting the US biosimilar market and more innovative devices will enter the US market in near future for enabling less painful and self-delivery of insulin biosimilars. Along with this, increased investment by government as well as private sector on the research and development activities related to insulin biosimilars is encouraging the pharmaceutical sector to work in this segment and provide ample scope of development for the market. The presence of leading pharmaceutical companies in US insulin biosimilar market is indicating towards the competition in this segment.
The US Insulin Biosimilar Market Report involves in-depth analysis of the various parameters related to this segment along with the analysis of current as well as future market opportunity. The report also involves the comparative price analysis along with the clinical trends, market drivers and possible challenges related to US insulin biosimilar market. It is forecasted that the US insulin biosimilar market will overtake a major share of insulin market of US and the future of this segment is full of opportunities.
1. INTRODUCTION TO US BIOSIMILAR INSULIN MARKET
1.1 Overview
1.2 Current Market Scenario
2. US BIOSIMILAR INSULIN MARKET OPPORTUNITY ASSESSMENT
2.1 Overall Market Opportunity
2.2 Opportunity by Product Type
3. SEMGLEE - FIRST FDA APPROVED INTERCHANGEABLE BIOSIMILAR INSULIN
3.1 Overview
3.2 Dosages & Price Analysis
3.3 Sales Forecast
4. US BIOSIMILAR INSULIN MARKET - COST COMPARISON
4.1 Semglee v/s Lantus
4.2 Semglee v/s Basaglar
4.3 Semglee v/s Toujeo
5. US BIOSIMILAR INSULIN MARKET - CLINICAL INSIGHT
6. US BIOSIMILAR INSULIN MARKET DYNAMICS
6.1 US Biosimilars Insulin Drivers Market
6.2 Challenges for US Biosimilar Insulin Market
7. US BIOSIMILAR INSULIN MARKET FUTURE OUTLOOK
8. COMPETITIVE LANDSCAPE
8.1 Biocon
8.2 Boehringer Ingelheim
8.3 Eli Lily
8.4 Gan & Lee Pharmaceuticals
8.5 Harvest Moon Pharmaceuticals
8.6 HEC Pharma
8.7 Mylan
8.8 Samsung Bioepis
8.9 Sanofi
8.10 Wockhardt
1.1 Overview
1.2 Current Market Scenario
2. US BIOSIMILAR INSULIN MARKET OPPORTUNITY ASSESSMENT
2.1 Overall Market Opportunity
2.2 Opportunity by Product Type
3. SEMGLEE - FIRST FDA APPROVED INTERCHANGEABLE BIOSIMILAR INSULIN
3.1 Overview
3.2 Dosages & Price Analysis
3.3 Sales Forecast
4. US BIOSIMILAR INSULIN MARKET - COST COMPARISON
4.1 Semglee v/s Lantus
4.2 Semglee v/s Basaglar
4.3 Semglee v/s Toujeo
5. US BIOSIMILAR INSULIN MARKET - CLINICAL INSIGHT
6. US BIOSIMILAR INSULIN MARKET DYNAMICS
6.1 US Biosimilars Insulin Drivers Market
6.2 Challenges for US Biosimilar Insulin Market
7. US BIOSIMILAR INSULIN MARKET FUTURE OUTLOOK
8. COMPETITIVE LANDSCAPE
8.1 Biocon
8.2 Boehringer Ingelheim
8.3 Eli Lily
8.4 Gan & Lee Pharmaceuticals
8.5 Harvest Moon Pharmaceuticals
8.6 HEC Pharma
8.7 Mylan
8.8 Samsung Bioepis
8.9 Sanofi
8.10 Wockhardt
LIST OF FIGURES
Figure 1-1: US – Estimated Diabetic Population (Million), 2019, 2025, 2030 & 2045
Figure 1-2: US – Undiagnosed & Diagnosed Diabetic Population (Million), 2019
Figure 1-3: US – Undiagnosed & Diagnosed Diabetic Population (%), 2019
Figure 1-4: US – Estimated Diabetic Prevalence Rate (%), 2019, 2025, 2030 & 2045
Figure 1-5: US – Number of Insulin Users (Million), 2020 & 2030
Figure 1-6: US – Total Diabetic Population v/s Insulin Users (Million), 2020
Figure 1-7: US – Total Diabetic Population v/s Insulin Users (%), 2020
Figure 1-8: US – Diabetes Drug Market Size by Products (US$ Billion), 2020
Figure 1-9: US – Diabetes Drug Market Size by Products (%), 2020
Figure 2-1: US – Diabetes Drug Market Opportunity (US$ Billion), 2021–2026
Figure 2-2: US – Insulin Market Opportunity (US$ Billion), 2021–2026
Figure 2-3: US – Biosimilar Insulin Market Opportunity (US$ Million), 2021–2026
Figure 2-4: US – Number of Insulin Users (Million), 2020 - 2026
Figure 2-5: US – Number of Biosimilar Insulin Users by 10% of Total Insulin Users (Million), 2020 - 2026
Figure 2-6: US – Number of Biosimilar Insulin Users by 20% of Total Insulin Users (Million), 2020 - 2026
Figure 2-7: US – Number of Biosimilar Insulin Users by 30% of Total Insulin Users (Million), 2020 - 2026
Figure 2-8: US – Number of Biosimilar Insulin Users by 40% of Total Insulin Users (Million), 2020 - 2026
Figure 2-9: US – Number of Biosimilar Insulin Users by 50% of Total Insulin Users (Million), 2020 - 2026
Figure 2-10: US – Biosimilar Insulin Market Opportunity by 10% Acceptance Rate (US$ Million), 2021–2026
Figure 2-11: US – Biosimilar Insulin Market Opportunity by 20% Acceptance Rate (US$ Million), 2021–2026
Figure 2-12: US – Biosimilar Insulin Market Opportunity by 30% Acceptance Rate (US$ Billion), 2021–2026
Figure 2-13: US – Biosimilar Insulin Market Opportunity by 40% Acceptance Rate (US$ Billion), 2021–2026
Figure 2-14: US – Biosimilar Insulin Market Opportunity by 50% Acceptance Rate (US$ Billion), 2021–2026
Figure 2-15: US – Insulin Glargine Biosimilar Market Opportunity (US$ Million), 2021–2026
Figure 2-16: US – Insulin Lispro Biosimilar Market Opportunity (US$ Million), 2023–2026
Figure 2-17: US – Insulin Aspart Biosimilar Market Opportunity (US$ Million), 2023–2026
Figure 3-1: US – Semglee FDA Approval History (Year)
Figure 3-2: US – Price for 10ml Vial & Price Per ml of Semglee Subcutaneous Solution (US$), August’2021
Figure 3-3: US – Price for 5 Prefilled Pens, Single Pen & Price Per ml of Semglee Subcutaneous Solution (US$), August’2021
Figure 3-4: US – Semglee Sales Forecast (US$ Million), 2021-2026
Figure 4-1: US – Price Comparison for 10ml Vial of Lantus & Semglee (US$), August’2021
Figure 4-2: US – Price Comparison for 5 Prefilled Pens of 3ml Lantus & Semglee (US$), August’2021
Figure 4-3: US – Monthly Treatment Cost Comparison Lantus v/s Semglee (US$), August’2021
Figure 4-4: US – Price Comparison for 5 Prefilled Pens of 3ml Basaglar & Semglee (US$), August’2021
Figure 4-5: US – Monthly Treatment Cost Comparison Basaglar v/s Semglee (US$), August’2021
Figure 4-6: US – Cost per ml Comparison of Toujeo Solostar v/s Semglee (US$), August’2021
Figure 4-7: US – Cost per ml Comparison of Toujeo Max Solostar v/s Semglee (US$), August’2021
Figure 5-1: US – Number of Biosimilars in Clinical Trial by Phase
Figure 5-2: US – Number of Biosimilars in Clinical Trial by Phase
Figure 6-1: US Insulin Biosimilars Market Drivers
Figure 6-2: Challenges for US Insulin Biosimilars Market
Figure 1-1: US – Estimated Diabetic Population (Million), 2019, 2025, 2030 & 2045
Figure 1-2: US – Undiagnosed & Diagnosed Diabetic Population (Million), 2019
Figure 1-3: US – Undiagnosed & Diagnosed Diabetic Population (%), 2019
Figure 1-4: US – Estimated Diabetic Prevalence Rate (%), 2019, 2025, 2030 & 2045
Figure 1-5: US – Number of Insulin Users (Million), 2020 & 2030
Figure 1-6: US – Total Diabetic Population v/s Insulin Users (Million), 2020
Figure 1-7: US – Total Diabetic Population v/s Insulin Users (%), 2020
Figure 1-8: US – Diabetes Drug Market Size by Products (US$ Billion), 2020
Figure 1-9: US – Diabetes Drug Market Size by Products (%), 2020
Figure 2-1: US – Diabetes Drug Market Opportunity (US$ Billion), 2021–2026
Figure 2-2: US – Insulin Market Opportunity (US$ Billion), 2021–2026
Figure 2-3: US – Biosimilar Insulin Market Opportunity (US$ Million), 2021–2026
Figure 2-4: US – Number of Insulin Users (Million), 2020 - 2026
Figure 2-5: US – Number of Biosimilar Insulin Users by 10% of Total Insulin Users (Million), 2020 - 2026
Figure 2-6: US – Number of Biosimilar Insulin Users by 20% of Total Insulin Users (Million), 2020 - 2026
Figure 2-7: US – Number of Biosimilar Insulin Users by 30% of Total Insulin Users (Million), 2020 - 2026
Figure 2-8: US – Number of Biosimilar Insulin Users by 40% of Total Insulin Users (Million), 2020 - 2026
Figure 2-9: US – Number of Biosimilar Insulin Users by 50% of Total Insulin Users (Million), 2020 - 2026
Figure 2-10: US – Biosimilar Insulin Market Opportunity by 10% Acceptance Rate (US$ Million), 2021–2026
Figure 2-11: US – Biosimilar Insulin Market Opportunity by 20% Acceptance Rate (US$ Million), 2021–2026
Figure 2-12: US – Biosimilar Insulin Market Opportunity by 30% Acceptance Rate (US$ Billion), 2021–2026
Figure 2-13: US – Biosimilar Insulin Market Opportunity by 40% Acceptance Rate (US$ Billion), 2021–2026
Figure 2-14: US – Biosimilar Insulin Market Opportunity by 50% Acceptance Rate (US$ Billion), 2021–2026
Figure 2-15: US – Insulin Glargine Biosimilar Market Opportunity (US$ Million), 2021–2026
Figure 2-16: US – Insulin Lispro Biosimilar Market Opportunity (US$ Million), 2023–2026
Figure 2-17: US – Insulin Aspart Biosimilar Market Opportunity (US$ Million), 2023–2026
Figure 3-1: US – Semglee FDA Approval History (Year)
Figure 3-2: US – Price for 10ml Vial & Price Per ml of Semglee Subcutaneous Solution (US$), August’2021
Figure 3-3: US – Price for 5 Prefilled Pens, Single Pen & Price Per ml of Semglee Subcutaneous Solution (US$), August’2021
Figure 3-4: US – Semglee Sales Forecast (US$ Million), 2021-2026
Figure 4-1: US – Price Comparison for 10ml Vial of Lantus & Semglee (US$), August’2021
Figure 4-2: US – Price Comparison for 5 Prefilled Pens of 3ml Lantus & Semglee (US$), August’2021
Figure 4-3: US – Monthly Treatment Cost Comparison Lantus v/s Semglee (US$), August’2021
Figure 4-4: US – Price Comparison for 5 Prefilled Pens of 3ml Basaglar & Semglee (US$), August’2021
Figure 4-5: US – Monthly Treatment Cost Comparison Basaglar v/s Semglee (US$), August’2021
Figure 4-6: US – Cost per ml Comparison of Toujeo Solostar v/s Semglee (US$), August’2021
Figure 4-7: US – Cost per ml Comparison of Toujeo Max Solostar v/s Semglee (US$), August’2021
Figure 5-1: US – Number of Biosimilars in Clinical Trial by Phase
Figure 5-2: US – Number of Biosimilars in Clinical Trial by Phase
Figure 6-1: US Insulin Biosimilars Market Drivers
Figure 6-2: Challenges for US Insulin Biosimilars Market
