Short-Acting Insulin Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Drugs (Apidra, Novolog, Humalog, Novolin, Others), By Application (Type 1 Diabetes, Type 2 Diabetes), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 8.16 Billion
CAGR (2026-2031)	4.27%
Fastest Growing Segment	Apidra
Largest Market	North America
Market Size (2031)	USD 10.49 Billion

Market Overview

The Global Short-Acting Insulin Market will grow from USD 8.16 Billion in 2025 to USD 10.49 Billion by 2031 at a 4.27% CAGR. Short-acting insulin is a prandial hormone replacement therapy designed to regulate blood glucose levels by mimicking the body's natural insulin release shortly after food ingestion. The market is primarily propelled by the escalating global incidence of diabetes mellitus and the concurrent rise in obesity rates, which necessitate effective glycemic control management to mitigate health complications. According to the International Diabetes Federation, in 2024, approximately 589 million adults between the ages of 20 and 79 are living with diabetes worldwide. This expanding patient demographic creates a sustained and urgent demand for reliable therapeutic interventions.

However, a significant challenge impeding market expansion is the prohibitive cost of insulin manufacturing combined with stringent regulatory requirements for product approval. These economic and legislative hurdles often lead to inequitable access and affordability issues in low-to-middle-income regions, effectively restricting widespread treatment adoption and negatively impacting patient adherence rates across critical growth markets.

Key Market Drivers

The Introduction and Adoption of Cost-Effective Biosimilar Insulins is a primary driver reshaping the Global Short-Acting Insulin Market. As patents for originator biologics expire, the entry of biosimilar insulins drives price competition and expands patient access in both developed and price-sensitive emerging economies. This shift not only alleviates the financial burden on healthcare systems but also accelerates volume uptake among patient populations previously limited by affordability barriers. Highlighting this trend, according to Biocon Biologics, October 2024, in the 'Q2 FY25 Earnings Update', revenue from the company's biosimilars portfolio, which includes key insulin assets, increased by 19% year-over-year, underscoring the rapid market penetration and commercial viability of these affordable therapeutic alternatives.

Advancements in Insulin Delivery Devices and Technology further propel market growth by enhancing the precision and convenience of short-acting insulin administration. The integration of smart insulin pens and automated insulin delivery (AID) systems improves patient adherence and glycemic outcomes, thereby securing consistent demand for compatible fast-acting insulin formulations used within these sophisticated mechanisms. This technological synergy is evident in recent financial performances; according to Insulet Corporation, November 2024, in the 'Third Quarter 2024 Financial Results', revenue reached $543.9 million, a 25.7% increase driven largely by the adoption of their tubeless pump technology. Furthermore, reinforcing the continued expansion of the underlying therapeutic market, according to Novo Nordisk, November 2024, in the 'Financial Report for the Period 1 January 2024 to 30 September 2024', sales of insulin products grew by 10% in the first nine months of the year, reflecting sustained global usage.

Download Free Sample Report

Key Market Challenges

The prohibitive cost of insulin manufacturing combined with stringent regulatory requirements acts as a substantial restraint on the global short-acting insulin market. Developing insulin products involves complex, capital-intensive biological processes that demand strict adherence to safety protocols and quality standards established by international health authorities. These rigorous compliance obligations necessitate significant investment in specialized facilities and technical expertise, which sustains high unit production costs. Manufacturers effectively face a price floor that prevents them from aggressively lowering costs to capture volume in price-sensitive developing regions without compromising financial sustainability.

Consequently, these economic and legislative barriers directly restrict patient access and limit the market's realizable revenue in critical growth territories. The resulting high retail prices often exceed the financial capacity of healthcare systems and individuals in low-to-middle-income countries, leading to poor treatment uptake. According to the World Health Organization, in 2024, more than 50% of people living with diabetes worldwide were not receiving treatment, a significant gap largely attributed to the lack of access to affordable insulin and essential care in lower-income settings. This widespread affordability crisis reduces patient adherence and prevents the market from capitalizing on the full volume of the expanding patient population.

Key Market Trends

Advancements in Inhalable Short-Acting Insulin Solutions are creating a significant market shift by offering a non-invasive alternative to traditional prandial injections. This trend focuses on improving patient quality of life and compliance through pulmonary delivery systems that utilize specialized particle engineering to provide ultra-rapid absorption kinetics comparable to physiological insulin secretion. The commercial traction of such innovative formulations is evident in recent financial disclosures, reflecting a dedicated user base seeking needle-free administration. According to MannKind Corporation, November 2024, in the 'Third Quarter 2024 Financial Results', net revenue for their flagship inhalable insulin product, Afrezza, increased by 12% year-over-year to reach $15 million, signaling a persistent and growing demand for alternative therapeutic options among the diabetes patient population.

The Transition Toward Ultra-Rapid Acting Insulin Analogs represents a critical evolution in glycemic management, aiming to close the time lag between administration and onset of action found in standard rapid-acting products. Pharmaceutical developers are reformulating existing molecules with novel excipients to accelerate absorption, thereby allowing patients to administer dosage closer to mealtime and achieve better postprandial glucose control. This product class continues to maintain a distinct footprint in the global portfolio of major manufacturers, catering to patients requiring tighter glycemic profiles. According to Novo Nordisk, November 2024, in the 'Financial Report for the Period 1 January 2024 to 30 September 2024', sales of the ultra-rapid acting formulation Fiasp totaled 394 million Danish kroner in the third quarter, underscoring the sustained relevance of pharmacokinetically optimized insulins in modern treatment algorithms.

Segmental Insights

Within the Global Short-Acting Insulin Market, the Apidra segment is emerging as the fastest-growing category due to its distinct clinical advantages and increasing adoption rates. Manufactured by Sanofi, this rapid-acting insulin analog is favored for its ability to closely mimic natural physiological insulin responses. The segment's expansion is significantly driven by approvals from authorities such as the U.S. Food and Drug Administration, which validate its safety for use in insulin pumps and pediatric care. This regulatory support, combined with the flexibility it offers patients regarding mealtime dosing, continues to accelerate its market presence globally.

Regional Insights

North America maintains the leading position in the global short-acting insulin market, driven primarily by the rising prevalence of diabetes and established healthcare reimbursement systems. The United States significantly influences this standing through substantial healthcare expenditure and the presence of major pharmaceutical manufacturers. Additionally, the United States Food and Drug Administration facilitates market growth by regulating and approving new insulin products, ensuring availability for patients. Widespread awareness regarding diabetes management and established clinical guidelines further support the consistent adoption of short-acting insulin therapies across the region.

Recent Developments

• In July 2025, Biocon Biologics secured FDA approval for Kirsty, a biosimilar to insulin aspart, marking a major advancement in the U.S. insulin market. The product was designated as the first and only interchangeable biosimilar to NovoLog, a status that permits pharmacists to substitute the biosimilar for the reference product without requiring a new prescription from a doctor, depending on state laws. This approval underscored the company's success in developing high-quality, affordable insulin therapies and was expected to significantly enhance patient access to rapid-acting insulin options. The launch included both single-patient-use pens and multiple-dose vials.
• In February 2025, Sanofi received approval from the U.S. Food and Drug Administration (FDA) for Merilog, a biosimilar to Novo Nordisk’s rapid-acting insulin aspart, NovoLog. This regulatory milestone established the product as the first rapid-acting insulin biosimilar approved in the United States, designed to improve glycemic control in adults and pediatric patients. The approval covered both vial and prefilled pen presentations, providing a new, potentially more affordable treatment option for mealtime blood sugar management. This development allowed the company to strengthen its position in the competitive global short-acting insulin market by offering a cost-effective alternative to the reference biologic.
• In March 2024, Eli Lilly announced a temporary supply shortage affecting its short-acting insulin products, specifically the 10 mL vials of Humalog (insulin lispro) and Insulin Lispro Injection. The manufacturer attributed this disruption to brief delays in the production process, which led to stockouts at wholesalers and pharmacies. To mitigate the impact on patient care, the company advised healthcare providers to assist patients in switching to alternative delivery methods, such as prefilled insulin pens, which were not affected by the shortage. The company emphasized its commitment to restoring full inventory levels promptly to maintain consistent diabetes management for users.
• In January 2024, Novo Nordisk implemented a significant reduction in the list prices of several insulin products in the United States, specifically cutting the price of its short-acting insulin aspart, NovoLog, by 75%. This strategic pricing adjustment was executed to address the financial burden on patients and align with shifting healthcare policies regarding insulin affordability. The company also reduced the prices of unbranded biologics to match the lowered branded equivalents. This initiative aimed to ensure that essential mealtime insulin therapies remained accessible to people with diabetes, responding to long-standing public demand for lower out-of-pocket costs for life-saving medications.

Key Market Players

• Novo Nordisk AS
• Sanofi SA
• Eli Lilly & Co
• Biocon Ltd
• Wockhardt Ltd
• Boehringer Ingelheim International GmbH
• Julphar Pharma Inc
• United Laboratories International Holdings Limited
• Tonghua Dongbao Pharmaceutical Co. Ltd.

By Drugs	By Application	By Region
Apidra Novolog Humalog Novolin Others	Type 1 Diabetes Type 2 Diabetes	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Short-Acting Insulin Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Short-Acting Insulin Market, By Drugs:

• Apidra
• Novolog
• Humalog
• Novolin
• Others

• Short-Acting Insulin Market, By Application:

• Type 1 Diabetes
• Type 2 Diabetes

• Short-Acting Insulin Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE