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The U.S. once-weekly insulin market through insights into patient adoption, market segmentation, pricing, reimbursement, leading companies, competitive strategies, and future growth opportunities.
The market estimate is based on the eligible patient population, the proportion likely to use once-weekly insulin, and the annual cost of treatment. U.S. healthcare data show that 24.7% of adults with diabetes received insulin treatment in 2024. Earlier insurance claims data also indicate that long-acting insulin accounted for approximately two-thirds of insulin treatment visits. These figures help establish the potential patient base for once-weekly insulin.
The analysis develops base-case, optimistic, and pessimistic scenarios for 2030 and 2035. Each scenario considers patient eligibility, new treatment uptake, switching from existing insulin products, adherence, insurance coverage, pricing, and competition. Rather than treating the entire U.S. insulin market as part of the weekly insulin segment, the estimate focuses on the additional revenue that once-weekly insulin could generate as adoption increases.
The weekly once basal insulin product category for the US has been launched commercially and is now a new subcategory of the larger basal insulin market as opposed to being just another insulin form.
There is an addressable population that can be targeted. Based on statistics provided by the CDC, 29.1 million people in the U.S. have already been diagnosed with diabetes. The majority of them, 28.8 million, are adults. Approximately 1.8 million adults have type 1 diabetes and require insulin. 90-95% of all cases of diabetes are represented by type 2 diabetes, which would mean that a larger addressable population can benefit from weekly basal insulin.
The market scope is the territory of the U.S. The sales and usage of FDA-approved basal insulins. While sizing the market, the following specifics are taken into account: new versus previous insulin usage, stage of treatment of type 2 diabetes, payment for the medication, channel of sales, the product itself, dosage of the product, and its destination.
In the United States, once-weekly insulin is initially expected to gain traction among people with type 2 diabetes who already use insulin, particularly those taking daily basal insulin. Switching from daily to weekly injections would reduce the number of basal insulin injections from around 365 to 52 per year, a reduction of 85.8%. By September 2026, the market is expected to include two approved weekly basal insulin products, with early growth likely to depend more on patients switching from existing treatments than on competition among multiple products.
While our analysis suggests that the established basal-insulin patients constitute the most immediate commercial conversion opportunity, since switching an already-existing patient involves less basic treatment start-up than convincing a non-insulin patient to go on injectables, we think that insulin-naïve type 2 patients and new insulin starters also offer an important growth opportunity. This is due to the fact that weekly treatment directly solves the problem of injections during the critical period of inertia towards starting insulin.
From our perspective, the strategic opportunity will be about more than just share capture of daily basal insulin. For companies showing strength in terms of persistence, physician comfort with weekly titration, payer coverage, and cost of annual therapy, adoption can even extend to earlier treatment phases and primary care settings.
The full report provides estimates for each segment in terms of eligible population size, penetration rate, units per year, revenues, and CAGR. The segmentation approach also allows one to evaluate the switch dynamics between basal-only, basal-plus, basal-bolus, insulin-naïve, and insulin-experienced patient pools.
The key driver of adoption is the convenience of once-weekly dosing, which reduces basal insulin injections from seven per week to one. Clinical trials have shown that both weekly insulin analogs achieved A1C reductions comparable to daily basal insulin in people with type 2 diabetes.
However, weekly dosing also presents challenges. Dose adjustments, missed doses, treatment initiation, and hypoglycemia management can be more complex than with daily insulin. The FDA label also outlines specific precautions when switching patients from daily basal insulin to weekly treatment. These factors are likely to influence prescribing decisions and patient adoption.
The pricing framework used for once-weekly insulin differs radically from traditional insulin pricing, in that the relevant cost metric is annualized cost per patient in control. With the launch of the first once-weekly insulin product in the United States, affordability schemes have made it possible for patients who qualify for these programs to purchase this treatment at as low as $35 up to a maximum of $55 per one-month prescription.
Our analysis suggests that pricing and formulary status are likely going to be key drivers of adoption for this drug class as the category moves from launch to adoption. This is because, when the once-weekly therapy directly competes with traditional basal insulin, it becomes necessary for the drug manufacturers to show value for the extra cost incurred.
We believe that payer strategy may turn out to be more effective at distinguishing companies from each other than pricing per se. A favorable formulary position, predictable cost to patients, and a proven benefit in terms of reduced burden of treatment would help to drive switching amongst existing users of basal insulin products, while restrictive coverage or higher net prices may seriously limit switching even though weekly dosing would represent a convenient factor for patients. As a result, we believe there is potential for competition via value-based contracts, affordability programs, and reimbursement strategy.
The comprehensive report analyses list price, net price, gross-to-net conversion, cost to patients, payer cost, treatment costs per year, reimbursement, formulary position, and price elasticity of demand. The comparison of weekly insulin vs. daily basal products and models of premium, parity, or discount is also presented in the report.
Once-weekly insulin differs from conventional basal insulin because it uses highly concentrated, long-acting formulations. The first weekly insulin approved in the U.S. has a concentration of 700 units/mL and is available in 1.0 mL, 1.5 mL, and 3.0 mL presentations. These specifications require specialized drug manufacturing, fill-finish processes, pen devices, and dose-delivery systems.
The report charts the pathway from manufacture of the recombinant insulin and molecular modification to the formulation process, high-concentration fill-finish process, pen assembly, cold chain logistics, wholesalers, pharmacies and patients.
The critical limitation in the supply of this novel treatment will likely not be the insulin drug substance but commercial-scale manufacture, pen systems, quality systems and reliable pharmacy distribution. The first product launch is targeted at more than 70,000 pharmacies throughout the U.S.
The concept of insulin technology is related to molecular engineering. This approach makes it possible to prolong the action of insulin in the body by one week or more. There are two variations of this technology. The first variant prolongs the action of insulin by binding to albumin molecules. The second variant is based on the modification of the insulin molecule by adding fragments of antibodies.
Clinical trials of weekly insulin preparations revealed differences in the results of their use in patients with type 1 and type 2 diabetes. In patients with type 2 diabetes, once-weekly basal insulin was shown to be effective. In patients with type 1 diabetes, the safety and efficacy are not confirmed. Moreover, there was some evidence of a high risk of developing severe hypoglycemia. Therefore, the first drug approved in the United States is intended for patients with type 2 diabetes. The second drug is contraindicated in patients with type 1 diabetes due to a high risk of severe hypoglycemia.
This study aims to consider engineering, the duration of action of insulin, the conversion of doses of various insulins, and the adjustment of the dose regimen during the use of insulin pens, which are justified by clinical trials, regulatory decisions, and prospects for the use of these drugs in the future.
The competitive environment is highly concentrated. Novo Nordisk introduced the category into the US market with Awiqli (insulin icodec-abae), approved on March 26, 2026, and launched nationwide in August. Eli Lilly followed up with Onswik (insulin efsitora alfa-gobe), approved on September 24, 2026. Therefore, the two drugs would form the primary competitive set entering the fourth quarter of 2026.
Strategically, the competition will be important because both companies already have strong diabetes franchises, relationships with physicians and payers, as well as production capacities to make insulin. Consequently, weekly insulin could serve not just as a single drug but also as a gateway into the patient journey within broader diabetes management pathways.
Commercial excellence will be one of the most important competitive differences. The first entrant has the advantage of being the first mover, as well as existing in pharmacies, while the challenger launches its product with robust Phase 3 evidence in terms of naïve and experienced patients with type 2 diabetes. The QWINT program included over 3,400 adults in five phase 3 trials, while the pivotal program of the first entrant comprised around 2,680 adults with type 2 diabetes.
| # | Company | Headquarters | Market Position | Core Strength | Major Applications/Segments |
| 1 | Novo Nordisk | Denmark | Direct weekly leader | Icodec, diabetes franchise | Type 2 basal insulin |
| 2 | Eli Lilly | U.S. | Direct challenger | Efsitora, diabetes franchise | Type 2 basal insulin |
| 3 | Sanofi | France | Incumbent basal-insulin leader | Basal insulin, payer reach | Type 2/type 1 |
| 4 | Biocon Biologics | India | Biosimilar challenger | Insulin manufacturing | Basal insulin |
| 5 | Sandoz | Switzerland | Biosimilar challenger | Global commercialization | Insulin |
| 6 | Amphastar Pharmaceuticals | U.S. | U.S. insulin specialist | Insulin manufacturing | Diabetes |
| 7 | Wockhardt | India | Insulin manufacturer | Recombinant insulin | Diabetes |
| 8 | Ypsomed | Switzerland | Delivery-system specialist | Injection devices | Insulin delivery |
| 9 | Embecta | U.S. | Diabetes-device specialist | Pen needles/delivery | Insulin administration |
| 10 | Terumo | Japan | Device supplier | Injection systems | Diabetes delivery |
| 11 | Medtronic | Ireland/U.S. | Diabetes technology leader | Insulin delivery/CGM | Intensified therapy |
| 12 | Dexcom | U.S. | Glucose-monitoring leader | CGM | Glucose management |
| 13 | Abbott | U.S. | Glucose-monitoring leader | CGM | Diabetes monitoring |
| 14 | Tandem Diabetes Care | U.S. | Insulin-delivery specialist | Pump technology | Insulin-treated diabetes |
| 15 | Insulet | U.S. | Tubeless pump leader | Automated insulin delivery | Insulin-treated diabetes |
| 16 | Zealand Pharma | Denmark | Emerging metabolic innovator | Long-acting metabolic therapies | Diabetes/metabolic |
| 17 | Hanmi Pharmaceutical | South Korea | Long-acting platform specialist | Long-acting biologics | Metabolic disease |
| 18 | Tonghua Dongbao | China | Insulin specialist | Human/recombinant insulin | Diabetes |
Awiqli’s current market share, approaching 100% of total commercial U.S. weekly basal-insulin sales as of the 2026 launch period, is transitional rather than sustainable market share forecasting.
This share is modeled quarter by quarter to 2030 into new scripts, switching of currently prescribed basal insulin, stopping of treatment, and payer substitution. Share of covered lives is expected to be the most important KPI of competition rather than initial prescription rate.
Key Coverage
The two direct competitors have similarly positioned weekly-treatment options that make market access, physician coverage, supply capability, clinical positioning, and price highly important KPIs of competition.
The report compares companies in terms of revenues generated from diabetes patients, number of insulin drugs in the portfolio, clinical experience with weekly insulin, manufacturing capacity, geographic presence, payer coverage, investment in R&D, delivery technology and strategic initiatives. Adjacent competitors are assessed mainly with regard to their ability to limit pricing or substitute.
A comparison of portfolios was conducted between weekly insulin, daily basal insulin, rapid-acting insulin, biosimilar insulin, incretin therapy, CGM, and insulin delivery technologies.
Strategic decisions involve the question of whether weekly insulin will be used as a standalone approach to replace daily basal insulin or will be combined with other offerings. In light of different options available to treat diabetes, companies could develop portfolios that would consist of education, monitoring, treatment innovation, and services.
The report highlights the gaps in the portfolio and the potential of specialists to compete in the race with integrated diabetes portfolios.
The technology benchmarking was carried out based on molecular design, duration of action, concentration, dose equivalent, pen technology, clinical evidence, and pipeline breadth. The presentation and conversion algorithm of Awiqli’s U-700 demonstrate the different dose architecture used by weekly insulin compared to daily insulin. The drug label includes a seven-fold conversion schedule and the first-week loading scheme in case of substitution of daily basal insulin. The weekly insulin technology portfolio is defined by the long-lasting molecular design and a phase 3 program of several stages in the treatment of type 2 diabetes.
The report analyzes company benchmarks in terms of insulin-naïve T2D patients, established basal insulin users, basal-bolus users, and high-dose patients. Regionally, the market in the US is evaluated using the regional breakdown, Medicare penetration, density of commercial insurance coverage, endocrinologist density, and pharmacy access. The launch via over 70,000 pharmacies provides physical availability, but adoption will be determined by formulary inclusion and prescribing practice.
Manufacturing analysis is conducted based on insulin substance capacity, insulin formulation capacity, high-concentration insulin production capacity, insulin pen capacity, quality capacity, and expansion capacity.
This report analyzes the potential risks of manufacturing constraints in the event of fast adoption of the category and evaluates if supply capacity can expand prior to demand.
The main customer segments are endocrinologists, primary care physicians, Medicare patients, commercially insured patients, health plans, PBM's, specialty pharmacies, and retail pharmacies.
The report analyzes benchmarks for direct versus pharmacy distribution, affordability, formulary strategy, patient support, and physician education. Switching barriers are also analyzed since switching an established patient may require more clinical confidence than initiating a patient on weekly insulin directly.
The most significant events have taken place in a matter of months, not years: the first approval by the U.S. regulatory authority in March, roll-out in the country in August, and second product approval in September 2026.
It significantly shifts the strategic direction of the market. Competitive focus will shift to formulary access, physician preference, patient affordability, supply assurance, and proof of persistence/reduced treatment burden.
M&A activity in the short term will likely be focused on delivery systems, glucose monitoring, digital adherence, manufacturing technology, and other metabolic approaches rather than the purchase of a mature weekly-insulin franchise. This report scans M&A and partnership activity for relevance to strategy, focusing on what deals have on access, manufacturing capability, delivery technology, or diabetes ecosystems.
Profiles provide detailed information on the 20 companies included in the universe, including even more detailed coverage of the two companies that compete directly with weekly insulin. The company evaluations include headquarters, ownership, employee count, diabetes revenue, insulin revenue, product lines, clinical pipeline, research and development, manufacturing facilities, geography, and competitive weaknesses. Profiles of weekly-insulin competitors also include patient numbers in trials, indications approval, dosage architecture, product launches, pharmacy distribution, affordability plans, and expected market share evolution.
The report identifies white spaces across:
The largest commercial white space is expected to emerge where injection burden, treatment inertia, and inadequate basal-insulin persistence intersect.
Political and legal drivers relate to pricing of the drug, Medicare reimbursement, and FDA requirements. Economic factors consist of payer budgets and costs of diabetes treatment. Social factors include injection burden and adherence. Technology relates to long-acting molecule development, CGM, and connected diabetes management. Environmental drivers are relatively less important, but include packaging, device waste, and cold chain efficiency. These drivers are evaluated on their potential influence on the adoption rate, pricing, and profitability up until 2035.
The weekly insulin market in the U.S. is highly attractive for major diabetes players and technology innovators, but moderately attractive for newcomers in the form of standalone products. This market is highly attractive because of the size of diabetes population, established patient pool for basal-insulin therapy, rationale for treatment burden, and proven clinical benefits of the product. The limitations in this market are payer bargaining power, competition from daily insulins, alternatives to diabetes therapy, safety issues, and high regulation/development barriers.
The 2030-2035 outlook is modeled around three scenarios.
Base case: Weekly insulin gets slow but steady penetration among basal-insulin patients as payer coverage improves and doctors become comfortable with dose adjustment.
Upside case: Rapid conversion is possible if weekly insulin has greater persistence, satisfaction, and ease of initiation relative to competing brands and if competitors push down pricing and coverage.
Downside case: Limited adoption is achieved if formulary restrictions, high net costs, hypoglycemia risk, or complicated mechanisms of action override the injection frequency.
Therefore, the key opportunity in the future for profit generation is not just the price of the weekly insulin. The key opportunity is the ability to convert some fraction of the current users of basal insulins and keep them on this treatment.
The competitive outlook will continue to focus on major franchises in diabetes, with future competitors differentiating by longer duration, improved safety, lower cost, better delivery, continuous glucose monitoring integration, or indication expansion.
By Patient Type
By Treatment Regimen / Insulin Use
By Product
By Dose Intensity
By Payer
By Customer / Prescriber
By Distribution / Channel
By Age / Clinical Profile
Principal Consultant
Payal Rabde is a Healthcare Market Research Analyst at Towards Healthcare Research & Consulting with 4+ years of experience in pharmaceuticals, biotechnology, medical devices, and life sciences.
Learn more about Payal Rabde
Reviewed By
Aditi Shivarkar is a seasoned professional with over 14 years of experience in healthcare market research. As a content reviewer, Aditi ensures the quality and accuracy of all market insights and data presented by the research team.
Learn more about Aditi Shivarkar
