U.S. Insulin Pump Market Size, Share & COVID-19 Impact Analysis, By Product Type (Pumps [Tethered Pumps, Patch Pumps, and Others] and Consumables), By Disease Indication (Type 1 Diabetes and Type 2 Diabetes), By Distribution Channel (Hospital Pharmacy and Retail & Online Pharmacy), and Regional Forecast, 2023-2030

The U.S. insulin pump market size was valued at USD 2.58 billion in 2022. The market is projected to grow from USD 2.98 billion in 2023 to USD 8.53 billion by 2030, exhibiting a CAGR of 16.2% during the forecast period.

An insulin pump is a portable medical device that helps manage blood sugar levels in a diabetic patient. It delivers continuous and customized doses of rapid-acting insulin either by a steady flow (basal) or extra portion during mealtime (bolus). The demand for insulin delivery devices is increasing due to the rise in type 1 diabetes prevalence among the U.S. population. Moreover, the rising introduction and availability of diabetes management technologies, such as pump therapy and Continuous Glucose Monitors (CGM), have made patients more independent in managing the disease. Thus, the adoption of these pumps is expected to gain momentum owing to the rising awareness and easy availability of these portable insulin devices in the U.S.

• According to an article published by the NCBI in 2022, there were an estimated 350,000 insulin pump users in the U.S., with 90% of them having type 1 diabetes and 10% suffering from type 2 diabetes.

Also, higher advantages of these pumps over conventional pens and Metered Dose Inhaler (MDI) therapies, such as high adherence and less invasive, have further enhanced adoption among the patients, further propelling the market growth

COVID-19 IMPACT

Decline in Diabetes Diagnosis and Decreased Product Sales amid COVID-19 Pandemic Hampered Market

The COVID-19 pandemic significantly impacted the market growth during the forecast period. The pandemic led to the imposition of countrywide lockdowns and the slowdown of medical devices and consumables supply across the U.S. Also, the number of diabetic patients visiting hospitals and healthcare centers for insulin therapy decreased due to healthcare professionals’ high focus on treating the COVID-19-affected population. Moreover, major market players reported a decline in insulin pump revenues due to decreased demand and sales in 2020.

• As per Ypsomed’s semi-annual report statistics in 2020, the sales of its mylife YpsoPump dropped by 13.7% as compared to 2019.

However, the withdrawal of lockdown measures led to a surge in the diagnosis of diabetes and its treatment among patients. Thus, due to the rise in diagnosis rates, patients' demand for portable insulin delivery devices and consumables increased post-pandemic. Moreover, rising approval of regulatory agencies for technologically advanced pumps and strategic collaborations for new device production further augmented the market growth.

• In November 2020, Eli Lilly and Company and Ypsomed announced a global agreement to make an automated insulin delivery system as part of Lilly’s connected diabetes solutions. Through this partnership, Eli Lilly commercialized the new system and an insulin pump developed and manufactured by Ypsomed.


• In February 2020, Abbott and Insulet Corporation announced their partnership to integrate a next-generation insulin sensing platform with automated insulin delivery technologies for optimum diabetes care.

Thus, the surge in collaborations for new product launches by key players post the COVID-19 pandemic and high adoption of pumps among the population propelled the U.S. insulin pump market growth.

LATEST TRENDS

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Surge in Launch of New Generation Pumps by Market Players to Boost Market Growth

The awareness of insulin delivery devices is high among the U.S. population, owing to the high prevalence of type 1 diabetes. This scenario has led to the high demand for and adoption of new-generation pumps among the underserved diabetic population. Moreover, growing patient preference and recommendations of health professionals for diabetes self-management might further aid in market growth.

Thus, several players are focusing on the launch and commercialization of advanced pumps in the market for diabetes monitoring and management among patients. The recent and ongoing developments in Continuous Glucose Monitoring (CGM) technology and Automated Insulin Delivery (AID) algorithms in conjunction with insulin pump therapy provide several benefits for patients suffering from insulin-dependent diabetes.

• As per data published by Sequenex in February 2023, Medtronic's newest pump model, the MiniMed 780g, is expected to receive the FDA approval and be available to the U.S. markets in 2023.


• In January 2020, Tandem Diabetes Care, Inc. announced the commercial launch of its t:slim X2 insulin pump with control-IQ technology, an advanced hybrid-closed loop system designed to help increase the time range. The system was cleared to deliver automatic correction boluses and adjust the insulin level to help prevent high and low blood sugar. The system integrates with Dexcom G6 Continuous Glucose Monitoring (CGM) for calibration or diabetes treatment decisions.

Thus, rising awareness of insulin delivery systems among diabetic patients and the rise in approval of technologically advanced pumps and consumables in the U.S. will foster the market growth.

DRIVING FACTORS

Favorable Reimbursement Policies to Propel Product Demand

The demand for these pumps is high owing to the rising prevalence of type 1 diabetes and the need for insulin among adults and children. However, the cost of devices and consumables is rising due to new technological advancements or pharmaceutical supply constraints, thereby limiting their adoption. Thus, policymakers, health insurance companies, and regulatory agencies are initiating new policies to increase the uptake and use of new diabetes management technologies. Also, the development of new strategies to cover the cost of insulin and its delivery devices by government authorities in the U.S. will boost the adoption of these devices among diabetic patients.

• According to a Healthline article published in November 2020, as per Centers for Medicare and Medicaid (CMS) policies, Medicare reimburses around 80% of the pump cost for patients under medical insurance (part A) in the U.S.


• According to an article published by Assistant Secretary for Planning and Evaluation (ASPE) in January 2023, under the Inflation Reduction Act (IRA), out-of-pocket costs for insulin in Medicare are capped at USD 35 per month. This regulation reduced the high costs of insulin uptake in the U.S.

Moreover, new reforms in existing coverage plans by health insurers for technologically advanced pumps will further boost the population's demand for these devices.

• In December 2021, Medtronic plc announced that the U.S. Centers for Medicare & Medicaid Services (CMS) expanded the Medicare coverage for all types of continuous glucose monitors (CGMs) including adjunctive and non-adjunctive CGMs. These also included CGMs that integrate with Medtronic’s insulin pumps.

Thus, such initiatives of cost coverage through new reimbursement policies will boost the product demand among patients, further driving the market growth.

RESTRAINING FACTORS

Adverse Events Associated with Pumps May Limit Market Growth

Insulin pumps are used to monitor and manage high blood sugar levels among patients with type 1 diabetes. However, prolonged use of these pumps may lead to adverse events, such as hypoglycemia, skin infections, and electrolyte disturbances among diabetic patients. Moreover, the surge in patient adoption of these devices may lead to a rise in reports of adverse events among the population, further limiting the market growth.

• According to an article published by International ASET Inc., in 2022, the FDA Adverse Event Reporting System (FAERS) data stated that the annual adverse events attributed to pump usage increased from 111,428 in 2016 to 361,071 in 2021, which constituted an overall increase of 224% from 2016 to 2021.

Also, device failures may cause adverse reactions related to either hyperglycemia or hypoglycemia among patients. The failure of these devices can be attributed to mechanical failures, blockages within the infusion sets, infusion site complications, instability of the insulin stored within the pump, and user error.

• According to an article published by the NCBI in 2022, out of the total adverse events reported to the FDA for Tandem T:slim X2 Basal-IQ insulin pump in 2019, about 28.7% were for system malfunction, and 11.2% were for hypoglycemia.

Thus, rising adverse events associated with pumps and the system, and its negative effects on patient therapy may restrict the adoption of pumps, further hampering the market growth.

SEGMENTATION

By Product Type Analysis

Rising Adoption of Pumps Due to Their Distinct Benefits Will Augment Segment Growth

Based on product type, the market is segmented into pumps and consumables.

Pumps segment accounted for the largest market share in 2022 and mainly contains insulin reservoirs and batteries. The rising demand for these products was attributable to the growing need for and adoption of rapid-acting insulin for basal conditions among the diabetic population. Moreover, distinct advantages and increased awareness of pump therapy compared to other available insulin therapies will continue to generate demand for these devices and pump-related supplies among the U.S. population, further propelling the segment’s growth rate.

• As per annual report estimates of Tandem Diabetes Care, in 2022, an estimated 750,000 pumps were used in the U.S. by diabetes patients.

The consumables segment is expected to register a substantial CAGR during the forecast period. This segment’s growth is attributed to the rising production and introduction of new analog products by key players in the U.S. Moreover, rising partnerships among market players for developing novel products with recent technologies will further foster the segment’s growth.

• According to an article published by Medical Device Network in November 2022, Medtronic plc launched a new infusion set (insulin set insertion device), with a wear time of up to seven days, for pumps.  The company developed the new set in collaboration with Convatec Inc., which helped minimize insulin preservative loss, maintain insulin flow & stability, and double the infusion set wear time.

By Disease Indication Analysis

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Rising Prevalence of Type 1 Diabetes to Boost Demand for Insulin Pumps

On the basis of disease indication, the market is segmented into type 1 diabetes and type 2 diabetes.

The type 1 diabetes segment is anticipated to exhibit a robust CAGR during the forecast timeframe. This is due to the rising demand for insulin and insulin delivery devices to treat type 1 diabetes among patients. Moreover, the rising prevalence of this disease in adults and children will further augment the segmental growth rate.

• According to an article published by the NCBI in 2021, as per the 2020 National Diabetes Statistics Report, around 1.5 million Americans were diagnosed with type 1 diabetes in 2020.

The type 2 diabetes segment is estimated to grow slower than the type 1 segment due to a substantial rise in its prevalence among the U.S. population yet moderate demand for these pumps among type 2 diabetic patients.

• As per an investor presentation by Modular Medical Inc., in 2020, around 8% of insulin-dependent patients with type 2 diabetes used an insulin pump in the U.S.

By Distribution Channel Analysis:

Growing Initiatives to Enhance Retail & Online Pharmacy Network to Augment Segment Growth

On the basis of distribution channel, the market is segmented into hospital pharmacy, and retail & online pharmacy.

The retail & online pharmacy segment is expected to record a higher CAGR during the forecast period owing to rising direct sales of insulin delivery products at these pharmacies. Also, the growing initiatives of key players to enhance their distribution network by expanding their retail pharmacy channels will further boost the segmental growth.

• In August 2022, Insulet Corporation announced that its Omnipod 5 Automated Insulin Delivery (AID) system was fully available at the U.S. retail pharmacy channels for individuals aged six years and older suffering from type 1 diabetes.


• As per Insulet Corporation's annual report estimates for 2022, 84% of its Omnipod System sales were through intermediaries. The intermediaries comprised independent distributors, wholesalers, and pharmacy channels in the U.S.

The hospital pharmacy segment is estimated to register a substantial CAGR during the forecast period. The growth is owing to the increasing rate of diabetes diagnosis in hospitals across the U.S. and rising number of patients visiting hospitals for insulin treatment.

KEY INDUSTRY PLAYERS

Major Companies Use Collaboration Strategy to Boost their Market Position

The market is characterized by dominant players, such as Medtronic, Insulet Corporation and Tandem Diabetes Care, Inc. Medtronic held a dominant market share in 2022, owing to the presence of a strong product portfolio and global distribution channel for diabetes care.

• In January 2022, Medtronic announced the FDA approval for its Minimed 770G insulin pump system with smartphone connectivity for people with type 1 diabetes in Japan.

The other significant players, such as Ypsomed AG and Insulet Corporation are now focusing on introducing advanced pumps and emphasizing strategic partnerships and collaborations to strengthen their position in this market. These factors will enhance the company’s position in the market, further propelling the U.S. insulin pump market share in the global market.

• In November 2022, Tandem Diabetes Care, Inc., a global insulin delivery and diabetes technology company, announced that it had entered a definitive agreement to acquire AMF Medical SA, a privately held Swiss developer of the Sigi Patch Pump.

LIST OF KEY COMPANIES PROFILED:

• Medtronic (Ireland)


• Tandem Diabetes Care, Inc. (U.S.)


• Insulet Corporation (U.S.)


• ViCentra B.V. (Netherlands)


• F. Hoffmann-La Roche Ltd (Switzerland)


• Modular Medical, Inc. (U.S)


• SOOIL Developments Co., Ltd (Korea)


• CeQur Simplicity (Switzerland)


• EOFLOW CO., LTD (Korea)

KEY INDUSTRY DEVELOPMENTS:

• January 2023: EOFlow Co., Ltd., a provider of wearable drug delivery systems, and Diabeloop, a pioneer in automated diabetes treatment solutions, announced their partnership to commercialize EOFlow's EOPatch system combined with automated insulin delivery technology and provide patients with convenient access to insulin pumps in the U.S.


• June 2022: SOOIL Developments Co., Ltd and Diabeloop announced their global development and commercial agreement in the insulin pump therapy market including new clinical trials and commercial launches in the U.S.

REPORT COVERAGE

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The market research report provides a detailed market analysis. It focuses on key aspects, such as the launch of new products, technological advancements, and the prevalence of diabetes. Besides this, the report offers insights into the latest market trends and highlights key industry developments, such as mergers, partnerships, and acquisitions, and the impact of COVID-19 on the market. In addition to the above-mentioned factors, the report encompasses several factors that have contributed to the market's growth in recent years.

Report Scope & Segmentation