Next Generation Diabetes Therapy and Drug Delivery Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product Type (Inhalable Insulin, Oral Insulin, Insulin Patches, CGM Systems, Artificial Pancreas), By Indication (Type 1 diabetes, Type 2 diabetes), By End user (Diagnostic/Clinics, Intensive Care Units (ICUs), Home Healthcare), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 23.86 Billion
CAGR (2026-2031)	7.25%
Fastest Growing Segment	CGM Systems
Largest Market	North America
Market Size (2031)	USD 36.31 Billion

Market Overview

The Global Next Generation Diabetes Therapy and Drug Delivery Market will grow from USD 23.86 Billion in 2025 to USD 36.31 Billion by 2031 at a 7.25% CAGR. The Next Generation Diabetes Therapy and Drug Delivery market encompasses advanced pharmacological agents, such as novel insulin analogs and glucagon-like peptide-1 receptor agonists, integrated with automated administration systems like continuous glucose monitors and patch pumps to optimize glycemic regulation. The primary drivers supporting this market include the critical need for non-invasive treatment options that improve patient adherence and the rapidly increasing global burden of metabolic disorders. According to the International Diabetes Federation, in 2024, approximately 589 million adults were living with diabetes worldwide, creating a substantial demand for these enhanced therapeutic interventions.

However, a significant challenge impeding market expansion is the prohibitive cost associated with these advanced devices and biologics, which limits accessibility in price-sensitive regions and creates reimbursement hurdles. This economic barrier, combined with stringent regulatory requirements for approving complex combination products, restricts the speed at which these therapies reach the broader patient population.

Key Market Drivers

The escalating global prevalence of diabetes and obesity-related comorbidities stands as a primary catalyst propelling the adoption of advanced pharmacological interventions and integrated delivery systems. This surge in metabolic disorders drives patient reliance on next-generation therapies, particularly dual GIP and GLP-1 receptor agonists, which offer superior glycemic control and weight management benefits compared to traditional insulin regimens. The market is witnessing a direct correlation between rising disease incidence and the commercial success of these novel biologics, as healthcare providers prioritize treatments that address both glucose regulation and weight reduction. Reflecting this intense demand, according to Eli Lilly and Company, August 2024, in the 'Q2 2024 Financial Results', worldwide revenue for the novel therapy Mounjaro increased significantly to $3.09 billion in the second quarter alone, underscoring the critical role of disease burden in accelerating the uptake of innovative formulations.

Rapid advancements in automated and closed-loop insulin delivery systems further stimulate market growth by addressing the increasing patient requirement for continuous and minimally invasive monitoring solutions. Technologies that integrate real-time data analytics with automated dosing reduce the cognitive burden on patients and mitigate the risks of hypoglycemia associated with manual injections. The expansion of these sophisticated devices is essential to manage the broader metabolic crisis, especially considering that according to the World Health Organization, in 2024, more than 1 billion people worldwide were living with obesity, creating a massive need for scalable therapeutic options. Consequently, manufacturers are seeing robust adoption rates for connected devices; according to Abbott, October 2024, in the 'Third Quarter 2024 Financial Results', global sales of the FreeStyle Libre continuous glucose monitoring system reached $1.6 billion, driven by the system's ability to facilitate personalized care.

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Key Market Challenges

The prohibitive cost associated with advanced diabetes devices and biologics stands as a substantial barrier directly hampering the growth of the Global Next Generation Diabetes Therapy and Drug Delivery Market. While novel insulin analogs and automated delivery systems offer superior glycemic control, their high price points render them inaccessible to a large segment of the global population, particularly in developing regions where out-of-pocket spending is common. This economic disparity limits the addressable market size, as only affluent demographics or those with comprehensive insurance coverage can afford these next-generation interventions. Consequently, manufacturers face difficulties in scaling adoption rates beyond developed markets.

Furthermore, this financial burden intensifies scrutiny from healthcare payers and insurance providers which leads to stringent reimbursement criteria that delay market penetration. The sheer magnitude of existing costs exacerbates this issue and makes payers hesitant to approve expensive new therapies. According to the International Diabetes Federation, in 2024, diabetes was responsible for an estimated USD 1.015 trillion in global health expenditure. This immense financial strain forces healthcare systems to prioritize cost containment which restricts the widespread funding and uptake of premium therapeutic technologies.

Key Market Trends

The market is experiencing a decisive shift toward tubeless and miniaturized wearable patch pump technologies, fundamentally altering insulin delivery mechanisms. Unlike traditional durable pumps that require tubing, these discreet, waterproof devices adhere directly to the skin, offering patients greater freedom and reducing the stigma associated with visible medical equipment. This specific form factor appeals significantly to younger demographics and those with active lifestyles who previously resisted pump therapy due to the physical constraints of tubed devices. The commercial viability and rapid uptake of this segment are evident in the performance of category leaders; according to Insulet Corporation, November 2024, in the 'Third Quarter 2024 Financial Results', revenue reached $543.9 million, driven largely by the high demand for their tubeless automated insulin delivery platform.

Simultaneously, there is a rapid expansion of device interoperability and open-architecture diabetes ecosystems, allowing for the seamless integration of components from different manufacturers. This trend moves away from proprietary, single-brand systems, enabling patients to pair their preferred insulin pumps with various continuous glucose monitoring sensors to create customized management solutions. This flexibility enhances user experience and encourages broader adoption of automated therapy by removing hardware compatibility barriers that previously limited patient choice. Reflecting the financial impact of this cross-compatibility strategy, according to Tandem Diabetes Care, November 2024, in the 'Third Quarter 2024 Financial Results', worldwide sales totaled $243.5 million, bolstered by the integration of their pump platforms with multiple sensor technologies.

Segmental Insights

The Continuous Glucose Monitoring (CGM) Systems segment represents the fastest-growing category within the Global Next Generation Diabetes Therapy and Drug Delivery Market. This expansion is primarily driven by the increasing patient demand for real-time glycemic tracking, which reduces reliance on traditional manual testing methods. Furthermore, supportive regulatory actions from organizations such as the U.S. FDA have accelerated product approvals and expanded reimbursement coverage, thereby increasing accessibility. The capability of these devices to integrate with insulin delivery units to automate management strategies also significantly contributes to their heightened adoption rates globally.

Regional Insights

North America holds the leading position in the global next-generation diabetes therapy and drug delivery market, driven by a well-established healthcare infrastructure and rising disease prevalence. The dominance is largely attributed to favorable reimbursement policies that improve patient access to advanced treatment options. Additionally, the United States Food and Drug Administration (FDA) plays a critical role by granting timely approvals for novel insulin formulations and delivery devices. High adoption rates of these therapies and the presence of major industry players further consolidate the region's market leadership.

Recent Developments

• In November 2024, Vertex Pharmaceuticals announced the advancement of its stem cell-derived islet cell therapy, VX-880, into a pivotal Phase 1/2/3 clinical trial. This decision followed positive data from the ongoing study, which demonstrated that the therapy could restore endogenous insulin production and potentially eliminate the need for exogenous insulin in patients with type 1 diabetes. This development represented a critical research breakthrough in the Global Next Generation Diabetes Therapy and Drug Delivery Market, moving the industry closer to a functional cure for patients suffering from severe hypoglycemia and impaired hypoglycemic awareness.
• In August 2024, Medtronic announced a strategic global partnership with Abbott to integrate Abbott’s continuous glucose monitoring sensor technology with Medtronic’s smart dosing devices and algorithms. This collaboration aimed to develop an integrated sensor designed to work exclusively with Medtronic’s automated insulin delivery and smart insulin pen systems. The alliance represented a major consolidation in the Global Next Generation Diabetes Therapy and Drug Delivery Market, allowing Medtronic to incorporate widely used sensor technology into its ecosystem. The partnership was designed to expand user choice and enhance the performance of integrated diabetes management platforms for patients worldwide.
• In August 2024, Dexcom launched the Stelo Glucose Biosensor System in the United States, marking the availability of the first over-the-counter continuous glucose monitor. The biosensor was designed for adults with type 2 diabetes who do not use insulin, as well as for individuals with prediabetes, providing them with 24/7 glucose insights directly on a smartphone without a prescription. This product launch established a new category in the Global Next Generation Diabetes Therapy and Drug Delivery Market, significantly improving access to continuous glucose monitoring technology for a broader population focused on metabolic health and lifestyle modifications.
• In February 2024, Tandem Diabetes Care launched the Tandem Mobi insulin pump in the United States, introducing a significant advancement in the Global Next Generation Diabetes Therapy and Drug Delivery Market. The device, which is less than half the size of the company's previous pump models, is described as the world's smallest durable automated insulin delivery system. It is fully controllable through a mobile application on a compatible smartphone and features Control-IQ technology to predict and prevent high and low blood sugar levels. This launch expanded the company's portfolio, offering a new wearable option designed to provide greater discretion and convenience for people living with diabetes.

Key Market Players

• Abbott Laboratories
• Dexcom Inc.
• Eli Lilly and Company
• Enteris BioPharma Inc.
• GlySens Incorporated
• MannKind Corporation
• Medtronic plc
• Sanofi S.A.
• Senseonics, Holdings

By Product Type	By Indication	By End user	By Region
Inhalable Insulin Oral Insulin Insulin Patches CGM Systems Artificial Pancreas	Type 1 diabetes Type 2 diabetes	Diagnostic/Clinics Intensive Care Units (ICUs) Home Healthcare	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Next Generation Diabetes Therapy and Drug Delivery Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Next Generation Diabetes Therapy and Drug Delivery Market, By Product Type:

• Inhalable Insulin
• Oral Insulin
• Insulin Patches
• CGM Systems
• Artificial Pancreas

• Next Generation Diabetes Therapy and Drug Delivery Market, By Indication:

• Type 1 diabetes
• Type 2 diabetes

• Next Generation Diabetes Therapy and Drug Delivery Market, By End user:

• Diagnostic/Clinics
• Intensive Care Units (ICUs)
• Home Healthcare

• Next Generation Diabetes Therapy and Drug Delivery 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