U.S. Human Insulin Market Size, Share & COVID-19 Impact Analysis, By Type (Analog Insulin and Traditional Insulin), By Diabetes Type (Diabetes 1 and Diabetes 2), By Distribution Channel (Hospital Pharmacy and Retail & Online Pharmacy), and Regional Forecast, 2023-2030

The U.S. human insulin market size was valued at USD 7.87 billion in 2022. The market is projected to grow from USD 7.94 billion in 2023 to USD 8.67 billion by 2030, exhibiting a CAGR of 1.3% during the forecast period.

Diabetes is a chronic disease characterized by abnormally high blood glucose concentrations in the body. A rise in blood glucose stimulates the pancreatic beta cells to release basal insulin which aids in regulating food-acquired glucose for use as energy in the cells. However, insulin deficiency or peripheral tissue resistance to insulin in the body needs external medication intervention among patients.

• According to statistics published by the Diabetes Research Institute Foundation, around 34.2 million people (10.5%) in the U.S. have diabetes.

Insulin therapy is critically important in managing blood glucose concentrations and preventing further complications such as heart or kidney disorders, nerve damage, and others by diabetes. Thus, the rise in the prevalence of diabetes among the U.S. population increases the demand for human insulin. Furthermore, the rising introduction of new insulin products with potentially lower costs and increased medication access for diabetic patients are propelling the market growth.

• As per Yale University estimates, as of July 2022, more than 14.0% of population use insulin in the U.S.

COVID-19 IMPACT

Decline in Volume of Diabetes Testing and Decreased Sales Amid COVID-19 Pandemic

The COVID-19 pandemic significantly impacted the market growth during the forecast period. The pandemic led to unprecedented disruptions and the slowdown of pharmaceutical supply across the U.S. Moreover, country lockdowns imposed by government agencies further led to a decline in hospital visits for diabetes testing and therapy with a high focus on diagnosing and treating COVID-19 patients across health centers. Moreover, several major players reported a decline in insulin-based revenues owing to decreased sales in 2020.

• As per Eli Lily and Company's annual estimates, the company reported a decline in sales of Humalog insulin from USD 1,669.7 million in 2019 to USD 1,485.6 million in 2020.


• According to a study result published by Pharmaceutical Technology in March 2022, the number of insulin treatment visits in the U.S. declined from 0.49 million in 2019 to 0.27 million in 2020.

However, the relaxation in travel restrictions and revoke of lockdown measures led to a surge in the volume of diabetes testing and treatment among patients. Moreover, the rising introduction of novel drugs by key players and the re-establishment of insulin distribution among the population further elevated the growth of the market.

• In June 2020, the U.S. Food and Drug Administration (FDA) approved the Lyumjev injection by Eli Lilly and Company. The new rapid-acting insulin is indicated to improve glycemic control in adults with type 1 and type 2 diabetes.

Thus, the rise in diabetes testing among the U.S. population post COVID-19 pandemic and the surge in the introduction and new product launches by key players propelled the market growth.

LATEST TRENDS

Surge in Introduction and Access of Cost-Effective Products to Propel Market Growth

The prevalence of diabetes among the U.S. population is high and the demand for affordable medicines is increasing. Thus, several market players are introducing novel products with limited list prices against the available insulin versions. Such initiatives have made diabetes care more accessible and affordable among the uninsured or under-insured U.S. population.

• As per Novo Nordisk A/S annual report data in 2022, the company boosted access and affordability initiatives in the U.S. by limiting the insulin price to USD 25.0 per vial at national pharmacies, including Walmart and CVS.


• In January 2020, Novo Nordisk A/S launched its authorized generic insulins NovoLog and NovoLog mix at a 50.0% less list price than its brand-name versions supporting affordable care for patients.

Also, collaborations among leading players and online pharmacy platforms is anticipated to boost the distribution network of these products. Moreover, a surge in strategic initiatives by retail players in healthcare access to leverage its massive reach for new opportunities further propelled the growth.

• In August 2022, Optum, Inc., a UnitedHealth Group company, announced its collaboration with Sanofi to offer a 30-day supply of commonly used Sanofi insulins for USD 35.0 to people with diabetes without insurance through its online health services and products.


• In June 2021, Walmart announced the launch of ReliOn analogue insulin in an attempt to revolutionize diabetes care by offering patients affordable insulin products without compromising their quality.

Thus, a rise in strategic initiatives by insulin manufacturers and other industry players to introduce new insulin products and provide wide access to affordable products is expected to aid market growth.

DRIVING FACTORS

Rising Initiatives to Provide Insulin For Low-Income Population to Boost Market Expansion

The costs associated with new technologically advanced insulin analogs are rising in the U.S., obstructing diabetes care among the low-income population. Moreover, diabetes prevalence and associated complications are rising among the U.S. population. Thus, government agencies are boosting efforts to implement solutions to limit the high expenses of these products and enhance diabetes care among patients.

• In July 2021, most states in the U.S., signed a legislation limiting out-of-pocket insulin costs to USD 100per month for all patients suffering from diabetes. As per law, every diabetic person, including uninsured patients, will not pay more than USD 100for a month’s supply of insulin.


• As per American Diabetes Association (ADA) statistics, almost 67.3% cost of diabetes care in the U.S. is provided by government insurance (including Medicare, Medicaid, and the military).

Moreover, leading players enhanced their inorganic strategies to provide a no-cost insulin supply to patients in the U.S. under certain government policy standards.

• According to Nordisk A/S annual report data in 2022, the company offered a ‘Patient Assistance Program’ by providing 50,000 Americans free insulin annually in 2021. The program offered free diabetes medication to patients who met certain eligibility criteria, including annual household income at or below 400.0% of the government-defined poverty level.        

Therefore, rising initiatives by the government and key players to provide low-cost vials to the middle and low-income population in the U.S. will further augment the market growth.

RESTRAINING FACTORS

Adverse Effects of Insulin Therapy to Limit the Market Growth

Insulin is a primary medication for treating and managing diabetes mellitus type 1 and type 2. However, prolonged insulin therapy in a diabetic patient may pose certain complications and adverse effects. The common side effects reported among patients are hypoglycemia and obesity, among others, caused by the drug itself or by the specific route of administration.

• As per data published by Drugs.com in October 2022, hypoglycemia is the most common and severe side effect of insulin in approximately 16.0% of type 1 and 10.0% of type II diabetis patients.


• According to an article published by MedicineNet, Inc., in July 2022, the frequency of hypoglycemia as a severe side effect of regular insulin therapy is more than 40.0% compared to 33.0% with weight gain in diabetic patients.

Moreover, certain modified insulin therapies with allergic pharmaceutical molecules such as protamine, zinc, or meta cresol may develop hypersensitivity and other complications among diabetic patients. Also, the rising adverse effects of these products with several drug interactions may further obliterate the diabetic patient's condition.

• According to ScienceDirect estimates, in December 2021, insulin allergy affected 0.1% to 3.0% of insulin-treated diabetic patients, with symptoms ranging from a localized rash to life-threatening anaphylaxis.


• As per MedicineNet, Inc., interaction or consumption of beta-blockers such as propranolol and atenolol, among others, with insulin can prolong hypoglycemia among diabetic patients.

Thus, the rising production of modified or recombinant human insulin products and complications associated with insulin therapy among diabetic patients will restrain the U.S. human insulin market growth.

SEGMENTATION

By Type Analysis

Rising Adoption of Analog Insulin Among U.S. Population to Augment Segment Growth

Based on type, the market is segmented into analog and traditional insulin.

Analog insulin accounted for the highest market share during the forecast period. The highest share was attributable to the rising production and introduction of new analog products by key players and high adoption over traditional insulin owing to several advantages such as high potency and predictable duration of action, among others. Moreover, the high demand and sales of analog insulin among the U.S. population further propelled the segment share.

For instance, in September 2022, Novo Nordisk A/S launched Tresiba (long acting insulin) biologic analog insulin to expand its existing portfolio of insulin products.

• According to Eli Lily and Company's annual report 2021, the company stated that its Humalog (Insulin lispro) fast-acting analog insulin reported sales of USD 1,320.7 million in 2021.

The traditional insulin segment is expected to register a substantial CAGR during the forecast period. The segment growth is attributed to traditional insulin's low production and cost-effectiveness over other products. Moreover, the better potential outcomes in patients with insulin resistance further propelled segment growth.

• According to Diabetes.co.uk, in January 2023, analog insulins cost the National Health Service (NHS) over twice as much as non-analog human insulin products.

By Diabetes Type Analysis:

High Prevalence of Type 1 Diabetes to Propel Market Progress

In terms of diabetes type, the market is segmented into diabetes type 1 and type 2.

The type 1 diabetes segment is anticipated to exhibit a strong CAGR during the forecast timeframe. The stronger CAGR is due to the rising prevalence of type 1 diabetes in the U.S., and the rising demand for human insulin to treat the rising number of patients. Moreover, rising initiatives by government agencies to provide cost-effective therapy for patients with type 1 diabetes will further augment segmental growth.

• The JDRF estimates that in 2022, around 1.45 million Americans suffer from type 1 diabetes. Also, 2.1 million people in the U.S. are expected to suffer from the same condition by 2040.

The type 2 diabetes segment is expected to grow at a slower pace than type 1. This is due to a substantial increase in insulin resistance cases in the U.S. and the moderate demand among diabetic patients in the U.S.

• According to Diabetes Technology and Therapeutics Journal estimates, almost all patients with type 2 diabetes will need insulin ahead in 10 years.

By Distribution Channel Analysis:

Rising Presence and Sales of Insulin Products Via Retail and Online Channels to Augment Segment Growth

On the basis of distribution channels, the market is segmented into hospital pharmacy and retail & online pharmacy.

The retail and online pharmacy segment accounted for the highest market share in 2022 and is expected to grow at a higher significant CAGR during the forecast period. The highest share was attributed to rising sales of insulin products at retail & online pharmacies. Also, the rising introduction and availability of cost-effective products on these platforms will further boost segmental growth.

• As per Novo Nordisk A/S estimates, in 2022, over 752,000 people in the U.S. will continue to obtain its human insulin products through retailers such as CVS and Walmart.

The hospital pharmacy segment is estimated to grow at a substantial CAGR during the forecast period. The growth is owing to the rising number of patients visiting hospitals for insulin treatment in the U.S.

• According to JAMA Network study estimates published by NCBI in October 2021, around 4.94 million patients took insulin treatment in U.S. hospitals in 2020.

KEY INDUSTRY PLAYERS

Rising Initiatives by Key Players to Develop Novel Products to Boost Market Growth

The U.S. human insulin market share is characterized by dominant players such as Novo Nordisk A/S, Eli Lily & Company, and Sanofi. The players are focusing on introducing advanced products, and emphasizing strategic partnerships and collaborations to strengthen their position in this market.

• In November 2021, in collaboration with Abbott and Biocorp, Health2Sync and Roche, Sanofi announced building a connected set of digital tools and features to support people living with diabetes and taking insulin.

Moreover, rising R&D and production of low-cost insulin by leading players to enhance their market presence will further boost the market growth.

• In December 2022, Eli Lily and Company announced the collaboration with EVA Pharma to establish local manufacturing capabilities to supply low-cost insulin to at least 1.0 million people by 2030.

LIST OF KEY COMPANIES PROFILED:

• Novo Nordisk A/S (Denmark)


• Eli Lilly and Company (U.S.)


• Sanofi (France)


• B. Braun Melsungen AG (Germany)


• WOCKHARDT (India)


• ADOCIA (France)


• Gan & Lee Pharmaceuticals USA Corp. (U.S.)


• Biocon (India)


• Merck & Co., Inc (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• February 2021: Biocon Biologics Limited partnered with the International Diabetes Federation (IDF) as the first biosimilar insulin company to promote and support IDF’s initiative to provide affordable insulin among patients.


• July 2020: Biocon Biologics Limited, a subsidiary of Biocon Ltd., and Voluntis announced a global collaboration agreement to develop and distribute innovative digital therapeutics supporting people with diabetes through biologics therapy.

REPORT COVERAGE

The market report provides a detailed market analysis. It focuses on key aspects such as the launch of new products, technological advancements, and the prevalence of diabetes. Besides this, the report offers insights into the market trends and highlights key industry developments such as mergers, partnerships, and acquisitions and the impact of COVID-19 on the market. In addition to the above-mentioned factors, the report encompasses several factors that have contributed to the market growth over recent years.

Report Scope & Segmentation

ATTRIBUTE	DETAILS
Study Period	2019-2030
Base Year	2022
Estimated Year	2023
Forecast Period	2023-2030
Historical Period	2019-2021
Growth Rate	CAGR of 1.3% from 2023-2030
Unit	Value (USD Billion)
Segmentation	By Type, Diabetes Type, and Distribution Channel
By Type	Analogue Insulin Long-acting Fast-acting Premix Traditional Human Insulin Long-acting + Intermediate Short-acting Fast-acting Premix
By Diabetes Type	Diabetes 1 Diabetes 2
By  Distribution Channel	Hospital Pharmacies Retail & Online Pharmacies