Summary

Overview
The global on-body drug delivery devices market reached US$ 37.9 billion in 2023 and is expected to reach US$ 73.3 billion by 2031 growing with a CAGR of 8.6% during the forecast period 2024-2031.
On-body drug delivery devices are medical devices that are designed to be worn on the body to deliver medications directly to patients or other therapeutic substances to the site of action. These devices are designed to release drugs through the skin, mucous membranes, or other body surfaces, providing a controlled and targeted delivery of medication.
These devices include various forms such as patches, pumps, and injectors, which can be attached to the body either under or over clothing. The primary purpose of these devices is to provide sustained and controlled delivery of medications, allowing for precise dosing at predetermined times or continuous infusion.
The on-body drug delivery device for the subcutaneous administration of small-molecule drugs is available for volumes up to 3 ml. It is patched onto the body. Typical applications are bolus and basal regimens over several hours. This patched-on device delivers large molecules (biologics) subcutaneously and is designed for therapies that periodically require a certain total quantity of a formulated drug. Typical applications include proteins such as monoclonal antibodies (mAbs).
Market Dynamics: Drivers
Rise in incidences of chronic diseases & patients' shift toward advanced drug delivery systems
The demand for the global on-body drug delivery devices market is driven by multiple factors. One of the key factors is the rise in incidences of chronic diseases & patients' shift toward advanced drug delivery systems.
The increasing prevalence of chronic conditions such as diabetes, arthritis, hypertension, and cancer is a major factor driving the demand for on-body drug delivery devices. These devices enable more effective management of chronic diseases by allowing for precise dosing, improved adherence, and reduced variability in treatment response.
Patients are increasingly preferring on-body drug delivery devices due to their advantages over traditional drug delivery methods. These advantages include higher precision, lower dosing increments, home-use capabilities, automatic needle insertion and retraction, occlusion detection, and the use of standard glass cartridges. The ability to accurately target specific cells or tissues while minimizing side effects and increasing therapeutic efficacy is driving the adoption of these advanced drug delivery systems.
Moreover, key players in the industry strategies such as partnerships & collaborations, and product launches & approvals would propel this market growth. For instance, in March 2023, Stevanato Group S.p.A. announced its collaboration with Thermo Fisher Scientific to bring a fully integrated on-body delivery system platform for subcutaneous administration to the market.
Also, in April 2023, Medtronic announced the U.S. Food and Drug Administration (FDA) approval of its MiniMed 780G system with the Guardian 4 sensor requiring no finger sticks while in Smart Guard technology. This milestone marks the approval of the only system with meal detection technology that provides automatic adjustments and corrections† to sugar levels every 5 minutes§ for both basal (background) and bolus (mealtime) insulin needs. The system provides insulin to help account for when users occasionally forget to bolus or underestimate the number of carbs in their meals.
Restraints
Factors such as the high costs of devices & treatment, the risk of needlestick injuries & patient discomfort, regulatory challenges, and lack of awareness among people, are expected to hamper the market.
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Segment Analysis
The global on-body drug delivery devices market is segmented based on device type, molecule type, application, distribution channels, and region.
The wearable injectors segment accounted for approximately 62.8% of the global on-body drug delivery devices market share
The wearable injectors segment is expected to hold the largest market share over the forecast period. Wearable injection systems are drug-delivery devices that adhere to the body, automatically delivering set doses to the patient at optimal times. Wearable injection systems represent the natural evolution of chronic disease management. As wearable injection systems have emerged in response to these conditions, so has a completely new set of challenges regarding device design and testing.
Moreover, key players in the industry product launches and approvals help to drive this segment growth in the market. For instance, in February 2024, LTS LOHMANN Therapie-Systeme AG launched its UDENYCA on-body injector (OBI) utilizing the LTS Sorrel wearable drug delivery platform. UDENYCA (pegfilgrastim-cbqv) is a biosimilar pegfilgrastim administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.
Also, in September 2023, Enable Injections, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the EMPAVELI Injector (enFuse) for the subcutaneous delivery of EMPAVELI (pegcetacoplan), which is commercialized in the United States by Apellis Pharmaceuticals, Inc. for adults with paroxysmal nocturnal hemoglobinuria (PNH). The EMPAVELI Injector is a compact, wearable injector designed to streamline the self-administration experience with minimal disruption to patients’ daily lives.
In addition, major players' innovative developments, investments, and mergers & acquisitions drive this segment's growth in the market. For instance, in January 2023, Eitan Medical opened a new manufacturing facility for a wearable drug delivery platform. The new manufacturing facility at its headquarters to support drug-delivery device production.
Similarly, in April 2023, LTS Lohmann acquired the Sorrel wearable injection device business headquartered in Netanya, Israel, a part of Eitan Medical Ltd.
Geographical Analysis
North America accounted for approximately 42.1% of the global on-body drug delivery devices market share
North America region is expected to hold the largest market share over the forecast period owing to the rising incidence of chronic diseases, demand for self-administration medications, and well-advanced healthcare infrastructure propelling the market growth in this region.
Moreover, a major number of key players' presence, technological advancements, and product launches & approvals drive the market growth. For instance, in February 2024, Tandem Diabetes Care, Inc. announced the United States commercial launch of its new Tandem Mobi, the world’s smallest, durable automated insulin delivery system for people living with diabetes. The company has begun taking orders and shipping to eligible customers in the United States.
Also, in October 2022, after five years and two unsuccessful attempts, scPharmaceuticals finally pushed its on-body infusor for congestive heart failure across the FDA finish line. With the approval, Furoscix becomes the first self-administered, subcutaneous loop diuretic for those with worsening HF.
The Food and Drug Administration (FDA) approved Furoscix (furosemide injection) for the treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure.
Market Segmentation
By Devices Type
• Wearable Injectors
• Infusion Pumps
• Others
By Molecules Type
• Small Molecule
• Large Molecule
By Application
• Cardiovascular Diseases
• Cancer
• Diabetes
• Auto-immune Disease
• Others
By Distribution Channel
• Hospital Pharmacies
• Online Pharmacies
• Retail Pharmacies
By Region
• North America
o U.S.
o Canada
o Mexico
• Europe
o Germany
o U.K.
o France
o Spain
o Italy
o Rest of Europe
• South America
o Brazil
o Argentina
o The rest of South America
• Asia-Pacific
o China
o India
o Japan
o South Korea
o Rest of Asia-Pacific
• Middle East and Africa
Competitive Landscape
The major global players in the on-body drug delivery devices market include Gerresheimer AG, NOVO Engineering, West Pharmaceutical Services, Inc., Enable Injections, Stevanato Group, LTS Lohmann Therapie-Systeme AG, BD, Coherus BioSciences, Inc., Tandem Diabetes Care, Inc, and Battelle among others.
Key Developments
 In January 2024, Aptar Digital Health and Gerresheimer developed an integrated cancer therapy solution. By connecting Aptar Digital Health’s proprietary SaMD platform with Gx SensAir, Gerresheimer’s on-body device for the subcutaneous delivery of large biologics molecules, this integrated solution is intended to improve overall treatment adherence and clinical outcomes.
 In December 2023, Stevanato Group introduced the new patented on-body delivery system Vertiva for several subcutaneous therapies. Designed to be adapted to different delivery profiles, the device facilitates the administration of biologics and small-molecule drugs.
Why Purchase the Report?
• To visualize the global on-body drug delivery devices market segmentation based on device type, molecule type, application, distribution channels, and region and understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of the on-body drug delivery devices market with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping is available in Excel consisting of key products of all the major players.
The global on-body drug delivery devices market report would provide approximately 70 tables, 63 figures, and 184 pages.
Target Audience 2023
• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

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Table of Contents

Table of Contents
1. Methodology and Scope
1.1. Research Methodology
1.2. Research Objective and Scope of the Report
2. Definition and Overview
3. Executive Summary
3.1. Snippet by Devices Type
3.2. Snippet by Molecule Type
3.3. Snippet by Application
3.4. Snippet by Distribution Channels
3.5. Snippet by Region
4. Dynamics
4.1. Impacting Factors
4.1.1. Drivers
4.1.1.1. Rise in Incidences of Chronic Diseases & Patients' Shift Toward Advanced Drug Delivery Systems
4.1.1.2. Increasing Demand for Biologics and Large-Volume Injections
4.1.2. Restraints
4.1.2.1. High Cost for Devices & Treatment
4.1.3. Opportunity
4.1.4. Impact Analysis
5. Industry Analysis
5.1. Porter’s Five Force Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis
6. By Devices Type
6.1. Introduction
6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Devices Type
6.1.2. Market Attractiveness Index, By Devices Type
6.2. Wearable Injectors *
6.2.1. Introduction
6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
6.3. Infusion Pumps
6.4. Others
7. By Molecule Type
7.1. Introduction
7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Molecule Type
7.1.2. Market Attractiveness Index, By Molecule Type
7.2. Small Molecule *
7.2.1. Introduction
7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Large Molecule
8. By Application
8.1. Introduction
8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application Market Attractiveness Index, By Application
8.2. Cardiovascular Diseases *
8.2.1. Introduction
8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Cancer
8.4. Diabetes
8.5. Auto-immune Disease
8.6. Others
9. By Distribution Channels
9.1. Introduction
9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channels
9.1.2. Market Attractiveness Index, By Distribution Channels
9.2. Hospital Pharmacies *
9.2.1. Introduction
9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Retail Pharmacies
9.4. Online Pharmacies
10. By Region
10.1. Introduction
10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
10.1.2. Market Attractiveness Index, By Region
10.2. North America
10.2.1. Introduction
10.2.2. Key Region-Specific Dynamics
10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Devices Type
10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Molecule Type
10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channels
10.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.2.7.1. U.S.
10.2.7.2. Canada
10.2.7.3. Mexico
10.3. Europe
10.3.1. Introduction
10.3.2. Key Region-Specific Dynamics
10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Devices Type
10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Molecule Type
10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channels
10.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.3.7.1. Germany
10.3.7.2. U.K.
10.3.7.3. France
10.3.7.4. Spain
10.3.7.5. Italy
10.3.7.6. Rest of Europe
10.4. South America
10.4.1. Introduction
10.4.2. Key Region-Specific Dynamics
10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Devices Type
10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Molecule Type
10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channels
10.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.4.7.1. Brazil
10.4.7.2. Argentina
10.4.7.3. Rest of South America
10.5. Asia-Pacific
10.5.1. Introduction
10.5.2. Key Region-Specific Dynamics
10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Devices Type
10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Molecule Type
10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channels
10.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.5.7.1. China
10.5.7.2. India
10.5.7.3. Japan
10.5.7.4. South Korea
10.5.7.5. Rest of Asia-Pacific
10.6. Middle East and Africa
10.6.1. Introduction
10.6.2. Key Region-Specific Dynamics
10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Devices Type
10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Molecule Type
10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
10.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channels
11. Competitive Landscape
11.1. Competitive Scenario
11.2. Market Positioning/Share Analysis
11.3. Mergers and Acquisitions Analysis
12. Company Profiles
12.1. Gerresheimer AG *
12.1.1. Company Overview
12.1.2. Product Portfolio and Description
12.1.3. Financial Overview
12.1.4. Key Developments
12.2. NOVO Engineering
12.3. West Pharmaceutical Services, Inc
12.4. Enable Injections
12.5. Stevanato Group
12.6. LTS Lohmann Therapie-Systeme AG
12.7. BD
12.8. Coherus BioSciences, Inc.
12.9. Tandem Diabetes Care, Inc
12.10. Battelle
LIST NOT EXHAUSTIVE
13. Appendix
13.1. About Us and Services
13.2. Contact Us