Report Overview

North America Human Insulin Drugs Market - Industry Trends & Forecast Report, 2029

North America human insulin drugs market size was estimated at USD 8.58 billion in 2022. During the forecast period between 2023 and 2029, the size of North America human insulin drugs market is projected to grow at CAGR of 2.71% reaching a value of USD 10.27 billion by 2029. Major growth drivers for North America human insulin drugs market include increasing prevalence of diabetes in the region, as well as the rising demand for advanced treatments for the disease. The market is also influenced by factors, such as the aging population, changing lifestyles, and increasing awareness about diabetes and its management. The incidence of type 2 diabetes and other forms of diabetes were found to be higher in individuals with Covid-19 in North America. Even individuals without a history of diabetes who recovered from SARS-CoV-2 infections showed insulin resistance and impaired insulin secretion. Thus, it has been suggested that the diagnosis and treatment of post-Covid syndrome require an integrated approach rather than a disease-specific one. Due to a sedentary lifestyle and the introduction of new drugs in the region, North America has a high prevalence of diabetes, resulting in its dominance of the global insulin therapeutics market. The United States, in particular, is expected to experience significant growth during the forecast period due to factors such as high obesity rates and increasing awareness of diabetes care. Therefore, taking into account the aforementioned factors, the analyzed market is expected to experience growth over the study period.

North America Human Insulin Drugs Market – Overview

The beta cells in the pancreas produce insulin, which is a hormone that plays a crucial role in regulating glucose levels by controlling the body's systems and facilitating the uptake of amino acids by cells. Its function is to assist in the absorption of glucose from the blood. When an individual experiences high blood glucose levels, it is considered a polygenic disorder or a medical condition that damages the tissues in the body and can lead to severe health complications such as diabetic nephropathy and diabetic retinopathy. Type 1 diabetes is a condition in which the body does not produce enough insulin to regulate glucose levels, necessitating daily insulin injections.

North America Human Insulin Drugs Market

Growth Drivers

Increase in Prevalence of Type 2 diabetes cases

The market growth for Type 2 Diabetes Mellitus is expected to be driven by an increasing number of R&D activities focused on insulin. One such example is the collaboration between Cleveland Clinic, a non-profit academic medical center, and Novo Nordisk A/S, a global healthcare company, which began research in September 2020. The research aims to evaluate whether therapy with once-weekly subcutaneous semaglutide in combination with once-daily insulin degludec, a basal insulin, can maintain or improve glycemic control in patients with Type 2 Diabetes Mellitus who have adequate glycemic control (≤7.5%) by replacing multiple daily injections of insulin. The study is currently in Phase IV of clinical trials and is expected to be completed by June 2023.

Restraints

High Costs Associated with Manufacturing of Insulin Drugs

The growth of the human insulin drug market is likely to be hindered due to the increasing prices of insulin. This can be attributed to the fact that the cost of insulin has significantly increased over time, leading to a doubling of out-of-pocket prescription costs for patients. As a result, diabetic patients are finding it challenging to afford insulin drugs, which are necessary to regulate their blood sugar levels. Apart from this, other factors also contribute to the excessive cost of insulin drugs, including research and development expenses, manufacturing costs, and distribution expenses. Moreover, pharmaceutical companies may set high prices for their insulin products to recover the costs associated with research and development and bringing the medication to the market.

Impact of COVID-19 on North America Human Insulin Drugs Market

COVID-19 pandemic had a detrimental impact on the North America human insulin drugs market. The pandemic disrupted the global supply chain, including the manufacturing and distribution of insulin drugs. It has resulted in shortages of insulin drugs in some regions, leading to challenges in accessing critical medication for diabetic patients. Also, the pandemic also led to changes in healthcare delivery systems, with an increased focus on telemedicine and virtual consultations. This shift impacted the way patients access and receive insulin treatment. Patients may find it challenging to visit healthcare facilities for routine check-ups and may rely more on telemedicine consultations to receive their insulin prescriptions. The economic impact of the pandemic has led to financial strains on individuals and healthcare systems, affecting their ability to afford insulin drugs. The high cost of insulin drugs coupled with job losses and economic uncertainty may lead to patients rationing or skipping doses, leading to poor health outcomes. However, COVID-19 triggered increased awareness of the importance of managing chronic conditions, such as diabetes, leading to a greater emphasis on preventative measures and early intervention. This could potentially drive demand for insulin drugs in the long run.

North America Human Insulin Drugs Market

Segmental Coverage

North America Human Insulin Drugs Market – By Product

Based on product, North America human insulin drugs market is segmented into Human Insulin, Basal Insulin, Bolus Insulin, Insulin Combinations, and Biosimilar Insulins. The basal insulin segment holds the highest market share in the North American region, primarily because several pharmaceutical companies have launched new products. One example is Novo Nordisk, which recently introduced unbranded versions of Tresiba analogue insulin. This development is expected to increase patients access to more affordable insulin options. Tresiba is a type of ultralong-acting basal insulin analogue called insulin degludec, which was approved by the US Food and Drug Administration (FDA) in July of 2022.

North America Human Insulin Drugs Market – By Application

Based on application, North America human insulin drugs market is bifurcated into Product I Diabetes and Product II Diabetes segments. The product I diabetes segment holds a higher market share. Type 1 diabetes is considered a more severe condition than type 2 diabetes. The global prevalence of type 2 diabetes is high, making it a faster growing segment in the market. According to the International Diabetes Federation's 2021 report, the prevalence of type 2 diabetes was approximately 405.6 million, projected to increase to 510.8 million across the globe by 2030. Various companies are investing in the R&D of oral insulin. Presently, only two oral insulin delivery systems, Oramed’s ORMD-0801 and Diasome’s HDV-I, have received FDA approval. ORMD-0801 is currently under Phase III clinical trial, and its approval would provide an add-on option to insulin injections for patients.

North America Human Insulin Drugs Market – By Region

The report on North America human insulin drugs market covers major countries in the region: United States and Canada. The United States dominates the North America Human Insulin Drugs Market, accounting for approximately 94% of the total market share. This is primarily due to the high prevalence of diabetes in the country, with the United States recording the highest healthcare expenditure in the world and adopting more advanced therapeutic treatments. Lantus, the long-acting insulin, has the highest sales across the North America region and is the most administered basal insulin globally, making the United States a crucial market for diabetes drug manufacturing companies to improve global sales. In addition, Humalog is also widely used in the United States for the treatment of diabetes, with over 56% of the market share. The drug is available in different varieties, including Humalog Mix 75/25, Humalog U-100, Humalog U-200, and Humalog Mix 50/50. Due to these factors, the North America Human Insulin Drugs Market is expected to grow in the region.

Competitive Landscape

Major players operating in North America human insulin drugs market Novo Nordisk A/S, Sanofi S.A., Eli Lilly and Company, Biocon Limited, Pfizer Inc., Wockhardt, Julphar, and Sedico. To further enhance their market share, these companies employ various strategies, including mergers and acquisitions, partnerships, joint ventures, license agreements, and new product launches.

Recent Development

• In December 2022 - Eli Lilly and Company, a pharmaceutical company based in the United States, formed a collaboration with Eva Pharma to provide a steady and cost-effective supply of human and analogue insulin to one million individuals living with type 1 and type 2 diabetes in low- to middle-income countries (LMICs), such as those in Africa.

• In December 2022 - Amalgam Rx, a company that connects healthcare providers and life sciences firms through a SaaS-enabled digital marketplace and product platform, announced its partnership with Novo Nordisk, a pharmaceutical company, for the commercialization of Dose Check. Dose Check is a digital app developed by Amalgam Rx for insulin initiation and titration, which is intended to assist people with type 2 diabetes who use basal insulin.

Scope of the Report

By Product

• Human Insulin

• Basal Insulin

• Bolus Insulin

• Insulin Combinations

• Biosimilar Insulins

By Application

• Product I Diabetes

• Product II Diabetes

By Country

• United States

• Canada

1. Research Framework
   1. Research Objective
   2. Product Overview
   3. Market Segmentation
2. Executive Summary
3. North America Human Insulin Drugs Market Insights
   1. Industry Value Chain Analysis
   2. DROC Analysis
      1. Growth Drivers
         1. Increase in Prevalence of Type 2 Diabetes Cases
         2. Changing Lifestyle
      2. Restraints
         1. High Cost Associated with the Manufacturing of Insulin Drugs
      3. Opportunities
         1. Advancement in New Product Design
      4. Challenges
         1. Stringent Regulations for the Launch of Healthcare Products
   3. Technology Advancements/Recent Developments
   4. Regulatory Framework
   5. Porter’s Five Forces Analysis
      1. Bargaining Power of Suppliers
      2. Bargaining Power of Buyers
      3. Threat of New Entrants
      4. Threat of Substitutes
      5. Intensity of Rivalry
4. North America Human Insulin Drugs Market Overview
   1. Market Size & Forecast, 2019–2029
      1. By Value (USD Million)
   2. Market Share & Forecast
      1. By Product
         1. Human Insulin
         2. Basal Insulin
         3. Bolus Insulin
         4. Insulin Combinations
         5. Biosimilar Insulins
      2. By Application
         1. Product I Diabetes
         2. Product II Diabetes
      3. By Country
         1. United States
         2. Canada
5. United States Human Insulin Drugs Market Overview
   1. Market Size & Forecast, 2019–2029
      1. By Value (USD Million)
   2. Market Share & Forecast
   3. By Product
   4. By Application
6. Canada Human Insulin Drugs Market Overview
   1. Market Size & Forecast, 2019–2029
      1. By Value (USD Million)
   2. Market Share & Forecast
   3. By Product
   4. By Application
7. Competitive Landscape
   1. List of Key Players and Their Offerings
   2. North America Human Insulin Drugs Company Market Share Analysis, 2022
   3. Competitive Benchmarking, By Operating Parameters
   4. Key Strategic Developments (Mergers, Acquisitions, Partnerships, etc.)
8. Impact of Covid-19 on North America Human Insulin Drugs Market
9. Company Profile (Company Overview, Financial Matrix, Competitive Landscape, Key Personnel, Key Competitors, Contact Address, Strategic Outlook, SWOT Analysis)
   1. Novo Nordisk A/S
   2. Sanofi S.A.
   3. Eli Lilly and Company
   4. Biocon Limited
   5. Pfizer Inc.
   6. Wockhardt
   7. Julphar
   8. Sedico
   9. Other Prominent Players
10. Key Strategic Recommendations
11. Research Methodology
    1.   Qualitative Research
       1.  Primary & Secondary Research
    2.   Quantitative Research
    3.   Market Breakdown & Data Triangulation
       1.  Secondary Research
       2.  Primary Research
    4.   Breakdown of Primary Research Respondents, By Region
    5.   Assumptions & Limitations

*Financial information of case of non-listed companies can be provided as per availability.

**The segmentation and the companies are subject to modifications based on in-depth secondary research for the final deliverable

List of Figures

Figure 1       North America Human Insulin Drugs Segmentation

Figure 2       North America Human Insulin Drugs Market Value Chain Analysis

Figure 3       Company Market Share Analysis, 2022

Figure 4       North America Human Insulin Drugs Market Size, By Value (USD Million), 2019–2029

Figure 5       North America Human Insulin Drugs Market Share, By Product, By Value, 2019–2029

Figure 6       North America Human Insulin Drugs Market Share, By Application, By Value, 2019–2029

Figure 7       North America Human Insulin Drugs Market Share, By Country, By Value, 2019–2029

Figure 8       United States Human Insulin Drugs Market Size, By Value (USD Million), 2019–2029

Figure 9       United States Human Insulin Drugs Market Share, By Product, By Value, 2019–2029

Figure 10     United States Human Insulin Drugs Market Share, By Application, By Value, 2019–2029

Figure 11     Canada Human Insulin Drugs Market Size, By Value (USD Million), 2019–2029

Figure 12     Canada Human Insulin Drugs Market Share, By Product, By Value, 2019–2029

Figure 13     Canada Human Insulin Drugs Market Share, By Application, By Value, 2019–2029

List of Tables

Table 1        North America Human Insulin Drugs Market Size, By Value (USD Million), 2019–2029

Table 2        North America Human Insulin Drugs Market Size, By Product, By Value, 2019–2029

Table 3        North America Human Insulin Drugs Market Size, By Application, By Value, 2019–2029

Table 4        North America Human Insulin Drugs Market Size, By Country, By Value, 2019–2029

Table 5        United States Human Insulin Drugs Market Size, By Value (USD Million), 2019–2029

Table 6        United States Human Insulin Drugs Market Size, By Product, By Value, 2019–2029

Table 7        United States Human Insulin Drugs Market Size, By Application, By Value, 2019–2029

Table 8        Canada Human Insulin Drugs Market Size, By Value (USD Million), 2019–2029

Table 9        Canada Human Insulin Drugs Market Size, By Product, By Value, 2019–2029

Table 10      Canada Human Insulin Drugs Market Size, By Application, By Value, 2019–2029

Table 11      Novo Nordisk A/S Company Overview

Table 12      Novo Nordisk A/S Financial Overview

Table 13      Sanofi S.A. Company Overview

Table 14      Sanofi S.A. Financial Overview

Table 15      Eli Lilly and Company Overview

Table 16      Eli Lilly and Company Financial Overview

Table 17      Biocon Limited Company Overview

Table 18      Biocon Limited Financial Overview

Table 19      Pfizer Inc. Company Overview

Table 20      Pfizer Inc. Financial Overview

Table 21      Wockhardt Company Overview

Table 22      Wockhardt Financial Overview

Table 23      Julphar Company Overview

Table 24      Julphar Financial Overview

Table 25      Sedico Company Overview

Table 26      Sedico Financial Overview