Insulin Drug Market

A US pharmacy buyer restocking mealtime insulin can now order a vial of Lilly’s Insulin Lispro at a USD 25 list price, set when Eli Lilly announced 70% cuts to Humalog and Humulin on 1 March 2023 (Eli Lilly). Insulin drugs are human and analogue insulins injected to replace or top up the hormone in type 1 diabetes and type 2 diabetes. The insulin drug market covers long-acting, rapid-acting, premix and human insulins sold as vials, prefilled pens and cartridges, counted at manufacturer net prices. Douglas Insights sizes the insulin drug market at USD 22.32 billion in 2025 and USD 28.46 billion in 2035, a revenue CAGR of 2.46%, because 42.8 million insulin patient-years at an average net USD 521.4 each equal USD 22.32 billion. Readers of our pharmaceuticals research will find the full build traced to the Douglas Insights research methodology.

Why is insulin drug demand still rising while incretin prescriptions surge?

Insulin patient-years grow 3.10% a year to 2035 in our model, because diabetes prevalence keeps climbing, half of type 2 patients who need insulin still go without, and weekly basal insulin widens the pool. Douglas Insights splits that insulin drug volume leg into four contributions measured in percentage points.

Prevalence adds 1.43 points. The International Diabetes Federation (IDF) counted 589 million adults with diabetes in its 2025 atlas and projects 853 million by 2050, which works out to 1.43% a year. Insulin need follows that curve with a lag, because insulin is usually a later step in type 2 care. Over 90% of cases are type 2, so the type 2 pool sets the pace for insulin volume. About 252 million adults with diabetes are still undiagnosed, and every diagnosis moves a person closer to an eventual insulin start.

Closing the access gap adds 0.92 points. The World Health Organization (WHO) found that 9 million people with type 1 diabetes and more than 60 million with type 2 need insulin, yet one in two type 2 patients who need it does not get it (WHO). Three in four people with type 2 diabetes live outside North America and Europe, while those two regions take more than 60% of insulin sales revenue. Douglas Insights expects about 4.5 million extra treated patient-years by 2035 from wider public tenders, prequalified biosimilars and lower human insulin prices in Asia, Africa and Latin America.

New basal formats add 0.41 points. Novo Nordisk announced US approval of Awiqli, a once-weekly insulin icodec, on 27 March 2026, backed by four ONWARDS trials in about 2,680 adults with type 2 diabetes (Novo Nordisk Form 6-K). Awiqli is also approved in the EU and 13 other countries. One injection a week instead of 7 lowers the barrier for patients who delay starting basal insulin, and it suits clinics that titrate doses at weekly visits rather than daily.

US affordability adds 0.34 points. Before the Medicare cap, 37% of Medicare insulin fills carried cost-sharing above USD 35, and about 1.5 million beneficiaries would have saved an average of USD 501 a year (HHS ASPE). Lower out-of-pocket costs reduce rationing, and rationed vials are lost volume. Together the four parts sum to 3.10 points: 1.43 plus 0.92 plus 0.41 plus 0.34, already net of the incretin substitution discussed below.

What slows insulin drug revenue when vial list prices fall by 70%?

Price erosion of 0.62 points a year is the main restraint, holding insulin drug revenue growth at 2.46% against 3.10% volume growth. Incretin drugs that delay insulin starts, and interchangeable biosimilars that undercut originator pens, are the two forces behind that erosion.

List price cuts reset the US base. Lilly cut Humalog and Humulin list prices by 70% and priced Insulin Lispro at USD 25 a vial from 1 May 2023 (Eli Lilly). Novo Nordisk’s US insulin sales held at DKK 15.2 billion in 2025 only because of gross-to-net adjustments and payer mix, while its US volume share was 28.9% (Novo Nordisk 2025 report). Douglas Insights models the global net price per patient-year falling from USD 521.4 in 2025 to USD 490.0 by 2035.

Incretin substitution is the larger volume risk. Lilly sold USD 22.97 billion of Mounjaro in 2025, up 99%, and every glucagon-like peptide-1 (GLP-1) or dual agonist prescription postpones basal insulin for some type 2 patients. Novo Nordisk’s human insulin sales fell 21% to DKK 5.48 billion in 2025 (Novo Nordisk). Our slower case removes 1.25 volume points for this drag, cutting the leg from 3.10% to 1.85%.

Biosimilar and tender pressure is the third restraint. China’s volume-based procurement (VBP) and national reimbursement list renewals keep insulin prices low there, and WHO notes biosimilar insulin can sell more than 25% below the originator. Douglas Insights nets about 0.48 points of annual price decline from these two sources inside the -0.62% price leg.

Which insulin class makes the money: basal analogues, mealtime analogues, premix or human insulin?

Long-acting insulin analogues make the money, with 44.6% of 2025 insulin drug value, or USD 9.95 billion. Basal insulin is the first injectable step for most type 2 patients, so glargine, degludec and now icodec carry the largest and fastest-growing share of revenue.

Long-acting insulin analogues grow fastest at 3.21% a year to USD 13.65 billion, because weekly icodec adds a premium product while basal starts keep pace with type 2 prevalence. Rapid-acting insulin analogues hold USD 6.90 billion, a 30.9% share, and grow at 2.27% to USD 8.63 billion; mealtime dosing is essential in type 1 diabetes, yet interchangeable aspart and lispro copies cap price. Premix insulins account for USD 3.08 billion, or 13.8%, and grow 1.38% a year, since premix remains common in China and India but loses ground to basal-plus regimens. Human insulin contributes USD 2.39 billion, a 10.7% share, and grows slowest at 0.84%, as Novo Nordisk’s 21% decline in human insulin sales in 2025 shows.

Delivery format matters for value. In our model, prefilled pens carry most analogue value in Europe and North America, while vials carry most human insulin volume bought through tenders. Cartridges for reusable pens sit between the two on price.

Where do insulin drug sales concentrate, and why does Asia Pacific grow fastest?

North America leads insulin drug sales with USD 9.19 billion in 2025, 41.2% of value, because US net prices remain the highest in the world. Asia Pacific grows fastest at 3.88% a year, as treated patients in China, India and Southeast Asia rise faster than prices fall.

North America moves from USD 9.19 billion to USD 10.80 billion at only 1.62%, because list price cuts and the USD 35 cap trade price for volume. Europe grows from USD 4.89 billion to USD 5.93 billion at 1.95%, held down by tender pricing and biosimilar glargine. Asia Pacific rises from USD 5.89 billion to USD 8.62 billion; Novo Nordisk alone booked DKK 9.90 billion of insulin in Region China in 2025, up 1% (Novo Nordisk). Latin America climbs from USD 1.29 billion to USD 1.75 billion at 3.04% as public payers widen analogue lists. The Middle East and Africa reaches USD 1.36 billion from USD 1.05 billion at 2.67%.

The wildcard is Africa’s access gap. WHO prequalification of biosimilar insulin opened donor and tender channels, and a faster rollout there would add treated patients at USD 362 a year, the regional average in our insulin model.

Which companies supply most of the world’s insulin, and how concentrated is competition?

Novo Nordisk leads with 42.7% of global insulin volume in 2025, and Douglas Insights estimates a 36.0% share of insulin drug value. Novo, Eli Lilly and Sanofi together hold about 74.0% of value, below the more than 90% WHO reported for three firms in 2021.

The three originators

Novo Nordisk reported DKK 53.1 billion of insulin sales for 2025, down 4% in kroner, with long-acting insulin at DKK 18.8 billion and fast-acting at DKK 18.6 billion (Novo Nordisk 2025 report). At Novo’s average rate of DKK 662 per USD 100, that is about USD 8.03 billion, and its volume share slipped from 44.2%. Sanofi sold EUR 1.73 billion of Lantus, EUR 1.35 billion of Toujeo and EUR 282 million of Soliqua in 2025, and Lantus gained in the US while rival supply was short. Eli Lilly built its insulin position on Humalog, Humulin and Basaglar; its 2025 revenue of USD 65.18 billion is now led by incretins, and its earnings release no longer lists insulin lines separately, so Douglas Insights models Lilly at 19.6% of insulin value and Sanofi at 18.4%.

Biosimilar challengers

Biocon Biologics won FDA approval for Kirsty, the first interchangeable biosimilar to NovoLog, on 15 July 2025, after its Semglee glargine became the first interchangeable insulin (Biocon Biologics). Biocon says it has supplied over 9.2 billion insulin doses and serves 5.8 million patients a year in more than 120 countries, and it cites US insulin aspart sales of about USD 1.9 billion in 2024. Sandoz added Ondibta, a Lantus biosimilar, with EU authorisation in January 2026. Civica, a non-profit with a plant in Petersburg, Virginia, lists a US launch of long-acting insulin glargine for January 2026. Biosimilar makers and Chinese and Indian producers share the remaining 26.0% in our estimate.

How much do payers and patients pay per insulin vial, pen and patient-year?

A year of insulin therapy earned manufacturers about USD 521.4 on average in 2025, by Douglas Insights estimate. The band runs from about USD 298 in Asia Pacific to USD 1,135 in North America. Patients in US Medicare pay no more than USD 35 a month.

List prices are the visible layer. Lilly priced Insulin Lispro at USD 25 a vial and capped commercial out-of-pocket insulin costs at USD 35 a month at participating pharmacies (Eli Lilly). In 2019 the average out-of-pocket cost per insulin fill in the US was USD 58, with USD 123 for the uninsured and USD 6 under Medicaid (ASPE). WHO reports that analogue insulins cost at least 1.5 times as much as human insulin, and up to three times as much in some countries.

Realised insulin drug revenue per patient-year in our model is about USD 1,135 in North America, USD 619 in Europe, USD 362 in the Middle East and Africa, USD 316 in Latin America and USD 298 in Asia Pacific. The weekly basal launch is priced in 2026; Novo has not disclosed an Awiqli US price, so Douglas Insights assumes parity per patient-year with daily basal analogues.

What does once-weekly insulin icodec change for basal insulin after the Awiqli approval?

Once-weekly insulin icodec cuts basal injections from 365 to 52 a year, and Douglas Insights expects weekly basal insulin to reach 9.8% of long-acting analogue value by 2035, about USD 1.34 billion. Novo Nordisk calls it the first and only once-weekly basal insulin.

Awiqli 700 units/mL is approved for adults with type 2 diabetes, dosed on the same day each week through the FlexTouch pen, with a nationwide US launch expected in the second half of 2026 (Novo Nordisk). The four ONWARDS trials met their HbA1c endpoints with a safety profile consistent with daily basal insulin. For pen and needle demand, see our Disposable Syringes Market report; fewer weekly injections mean fewer needles per patient.

Type 1 diabetes stays mostly on daily basal and mealtime insulin, often through pumps covered in the Insulin Pumps Market study. Hypoglycaemia monitoring with sensors, sized in the Continuous Glucose Monitoring Sensor Manufacturing Market report, gives prescribers the glucose data that weekly titration needs.

What if incretin uptake or biosimilar insulin entry moves the 2035 outlook?

Our base case reaches USD 28.46 billion in 2035, with a slower path at USD 23.28 billion and a faster one at USD 34.18 billion. The spread depends on how many type 2 patients incretins keep off insulin, and on how fast access widens in Asia and Africa.

The slower case assumes incretins delay insulin starts sharply and interchangeable biosimilars spread through US pharmacy benefit formularies: volume grows 1.85% and price falls 1.40%. The faster case assumes weekly basal insulin wins wide use after the Awiqli approval of 27 March 2026 (Novo Nordisk) and WHO-backed access halves the treatment gap: volume 4.20% and price 0.15%.

One extra point of patient-year growth lifts the 2035 insulin drug value by USD 2.88 billion. Published forecasts span 1.4% to 6.0% a year; our 2.46% sits in the lower half because it starts from reported insulin sales that are falling in kroner.

How do the USD 35 cap, interchangeability rules and WHO insulin policy shape supply?

Three policies shape insulin drug supply: the Inflation Reduction Act (IRA) cap of USD 35 a month in Medicare, US interchangeability for biosimilar insulin, and WHO prequalification. Each one moves price or access for millions of patients.

The IRA cap took effect for Medicare Part D on 1 January 2023 and for insulin used in Part B pumps on 1 July 2023, with the Low-Income Subsidy widened from 135% to 150% of the poverty line on 1 January 2024 (ASPE). ASPE estimated that 1,519,856 beneficiaries would have saved USD 761 million in 2020 under the cap.

Interchangeable status for biosimilar insulin widened when Kirsty for aspart joined Semglee for glargine on 15 July 2025 (Biocon Biologics). WHO launched insulin prequalification on 13 November 2019, and its 2021 report found three companies controlled more than 90% of the insulin market (WHO).

Douglas Exclusive: the Insulin Class-by-Region Value Matrix

The Insulin Class-by-Region Value Matrix is a Douglas Insights model built from 23 inputs: 18 sourced figures from Novo Nordisk, Sanofi, WHO and IDF documents, plus 5 regional class-mix assumptions of our own. It splits the USD 22.32 billion of 2025 insulin drug value into 20 cells, four insulin classes by five regions, fitted so every row and column matches the totals above.

The finding is a split market. One cell, North American long-acting analogues at USD 4.42 billion, holds 19.8% of world insulin value. Human insulin is 19.6% of Latin American value but only 6.8% of North American value, and Asia Pacific holds USD 1.32 billion of the USD 3.08 billion premix total. Where human insulin and premix dominate, a modest price cut converts into large patient gains.

What do insulin drugs include, and which diabetes products sit outside the insulin count?

Insulin drugs include four classes and exclude devices and non-insulin medicines: long-acting, rapid-acting, premix and human insulins count, while pumps, sensors, needles and GLP-1 drugs sit outside. The exclusions apply to USD 22.32 billion in 2025 and USD 28.46 billion in 2035.

The study covers vials, prefilled pens and cartridges; patients with type 1 diabetes and type 2 diabetes; and three channels: retail pharmacies, hospital pharmacies, and mail-order and online pharmacies. Fixed-ratio basal insulin and GLP-1 combinations such as Soliqua count at their full value. Revenue is counted at manufacturer net prices. The wider medicine total is sized in our Pharmaceutical Drug Market report, where diabetes care is one large slice.

Why does US insulin revenue stall while US insulin patient numbers hold?

US insulin revenue stalls because net price per patient-year falls about as fast as volume grows: Douglas Insights puts North American insulin drug growth at 1.62% a year against a global 2.46%. More than 7 million Americans need daily insulin, according to HHS.

Novo Nordisk’s US insulin sales rose 2% at constant rates in 2025, helped by gross-to-net adjustments, even as volumes fell (Novo Nordisk). Lantus gained in the US partly because rivals were unavailable, a windfall Sanofi expects to partly subside in 2026. Volume is resilient; price is not.

Which methodology turns 42.8 million insulin patient-years into USD 22.32 billion?

The methodology multiplies 42.8 million insulin patient-years by USD 521.4 of average net revenue each, giving USD 22.32 billion for 2025. Volume then grows 3.10% a year and price falls 0.62%, which reaches USD 28.46 billion in 2035 across five regions.

Inputs: 5 regional models, 4 insulin classes, 23 matrix inputs and 5 published CAGRs read for comparison. Volume: WHO’s 9 million type 1 patients plus half of 60 million type 2 patients gives 39 million treated in 2021; scaling by IDF adult prevalence from 537 million to 589 million gives 42.8 million patient-years. Arithmetic: 42.8 million times USD 521.4 equals USD 22.32 billion. Growth: 1.0310 times 0.9938 gives 2.46% a year, and the 2026 value is USD 22.87 billion.

Cross-check one: Novo Nordisk’s USD 8.03 billion of insulin sales is 36.0% of our total against its reported 42.7% volume share, consistent with Novo’s heavy weight in lower-priced human insulin and premix. Cross-check two: North American value of USD 9.19 billion over 8.1 million patient-years gives USD 1,135 each, about 1.6 fills a month at the USD 58 average US fill cost. Cross-check three: segments sum to USD 28.41 billion in 2035, within 0.2% of the regional total.

Sources

1. Novo Nordisk / SEC Financial report for 2025 (Form 6-K) (2026)
2. Novo Nordisk / SEC US approval of once-weekly Awiqli (Form 6-K) (2026)
3. Sanofi / SEC Q4 and full-year 2025 results (Form 6-K) (2026)
4. Eli Lilly Lilly cuts insulin prices by 70% and caps patient insulin out-of-pocket costs at USD 35 (2023)
5. Eli Lilly Lilly reports fourth-quarter 2025 financial results (2026)
6. World Health Organization New WHO report maps barriers to insulin availability (2021)
7. HHS ASPE Insulin affordability and the Inflation Reduction Act (2023)
8. Biocon Biologics FDA approval of Kirsty, interchangeable insulin aspart (2025)
9. International Diabetes Federation IDF Diabetes Atlas 11th edition (2025)
10. European Medicines Agency Ondibta European public assessment report (2026)