Diabetes Artificial Pancreas Omnipod 5 Sells Over $2 Billion in a Single Quarter Overseas, Files IPO Prospectus

In 2022, the landscape of the overseas insulin pump market was being reshaped.

Insulin pumps are continuous subcutaneous insulin infusion devices used to control insulin delivery in the treatment of type 1 and type 2 diabetes patients requiring insulin therapy. Insulet, a global leader in patch-style insulin pumps, announced that its third-quarter revenue reached $340 million, with the primary growth driven by the Omnipod 5, which was launched this August.

Insulet’s CEO stated, “Market enthusiasm for Omnipod 5 has exceeded our expectations, bringing Insulet more customers than anticipated.” The company recorded a record number of new customers in the third quarter, prompting it to raise its full-year revenue forecast and sending its stock price surging.

In the past, the insulin pump market was dominated by a triopoly of medical device giants: Medtronic (flagship product: MiniMed), Tandem Diabetes Care (flagship product: t-slim), and Insulet. The products from Medtronic and Tandem are both tubed insulin pumps.

Prior to the launch of Insulet’s Omnipod 5, the t:slim was the fastest-growing product in the insulin pump market. However, in the third-quarter competition, global sales of the t:slim series amounted to $204.5 million, trailing behind Omnipod 5.

Amid Omnipod 5’s strong market push, Medtronic and Tandem have also been continuously optimizing their products and recently announced product updates. Medtronic has extended the wear time of its MiniMed 600 and 700 insulin pumps to seven days. Tandem recently announced the results of a prospective, multicenter, single-arm study involving adult patients with type 2 diabetes, which demonstrated improvements across all clinical endpoints for those using the t-slim X2 insulin pump with Control-IQ technology.

Continuous glucose monitors (CGMs) and insulin pumps are the two core products in the blood glucose management market. However, the market size for insulin pumps has consistently remained smaller than that of CGMs. The global insulin pump market was estimated to reach $5.6 billion in 2020, whereas Abbott alone generated $3.7 billion in sales from its CGM products in 2021.

Previously, industry insiders stated that market demand for insulin pumps includes intelligence, simplicity, and closed-loop management, but there is currently a lack of a flagship product that can perfectly meet these needs.

Omnipod 5’s Strong Sales: What Innovations Does the Product Offer? Can the Insulin Pump Market Continue to Grow in the Future? VCBeat (WeChat ID: vcbeat) Provides an Overview.

Insulet Corporation listed the world’s first tubeless insulin pump, Omnipod, in the United States in 2003, and it remains the only fully disposable tubeless insulin pump globally to date.

Omnipod 5 is the latest-generation product. This device has received FDA Breakthrough Device designation, and its core competency lies in its compatibility with Dexcom’s G6 continuous glucose monitoring (CGM) system, forming a tubeless closed-loop artificial pancreas system. Omnipod 5 and G6 integrate both the hardware insulin pump and the continuous glucose monitor, with built-in algorithms enabling direct communication between the two to create an intelligent closed-loop insulin delivery system. Based on glucose readings from the Dexcom G6 CGM, Omnipod 5 automatically increases, decreases, or suspends insulin delivery every five minutes to maintain blood glucose levels within a preset range. Currently, Omnipod 5 is approved in the United States for use in patients aged six years and older with type 1 diabetes (T1D) and is available by prescription through accredited specialty pharmacies (ASPN) in the U.S.

Several artificial pancreas systems have already been launched in the U.S. market. A major innovation of the Omnipod 5 is its tubeless design. What makes this tubeless approach innovative?

Tubed insulin pumps and tubeless patch-style insulin pumps are the two main types of insulin pumps. Tubed pumps are equipped with an infusion pump and an insulin reservoir, delivering insulin through a long tube to an infusion set worn on the body, allowing for the setting of basal insulin infusion rates. Traditional tubed insulin pumps are typically larger in size and feature bolus buttons, enabling users to correct blood glucose levels by administering bolus insulin doses during meals or when blood glucose is elevated.

Patch pumps are wirelessly controlled by a separate device, allowing users to adjust the basal infusion rate and insulin bolus doses of the tubeless patch pump based on meals and other activities. Patch pumps eliminate the inconvenience associated with the external tubing required by traditional tubed pumps and reduce the risk of treatment disruption caused by tubing kinks, bends, or dislodgement. In terms of size, patch pump devices are more compact, portable, and discreet. However, patch insulin pumps entail higher usage costs; in Europe, the average daily cost for patients using Omnipod is approximately $10 to $15, whereas the average daily cost for patients using traditional insulin syringes does not exceed $2.

Since the launch of the Omnipod series, it has rapidly penetrated the U.S. market, gradually capturing market share from traditional tube-based insulin pumps due to its superior ease of use. Currently, it accounts for more than 20% of the U.S. insulin pump market. According to a report by Frost & Sullivan, patch-based insulin pumps are expected to further capture market share from tube-based pumps and will experience rapid growth in markets with lower penetration rates, such as China and Europe.

In addition to being tubeless, another major innovation of the Omnipod 5 is its automated insulin delivery, which reduces manual intervention, making it a closed-loop artificial pancreas.

Artificial Pancreas System (also known as a closed-loop pump) generally refers to an intelligent insulin delivery system comprising biosensors, continuous infusion devices, and control algorithms. Currently, the most common artificial pancreas systems consist of a Continuous Glucose Monitoring System (CGMS), an insulin pump, and a closed-loop algorithm. The CGMS continuously collects patient blood glucose data; the closed-loop algorithm issues management commands to the insulin pump based on this glucose data and other relevant parameters; and the insulin pump promptly delivers insulin to the patient according to these commands, thereby completing the closed loop from monitoring to treatment. This system enables closed-loop insulin delivery, significantly improving glycemic control, enhancing patients’ quality of life, reducing complications, and lowering healthcare costs.

Omnipod 5 Successfully Designs a Truly Closed-Loop, Wearable Artificial Pancreas. Omnipod 5 achieves fully automated insulin delivery and management through accurate data collection and artificial intelligence algorithms. Leveraging SmartAdjust technology, Omnipod 5 and the Dexcom G6 CGM maintain continuous communication to enable automatic insulin adjustment. For users, this eliminates the need for tubing and reduces the burden of manual control. Users can still view their glucose data directly on their smartphones; if a user does not have a smartphone, Insulet provides a dedicated controller at no additional cost.

Omnipod 5 Product

Medtronic MiniMed 770G

Prior to the launch of Omnipod 5, the predominant closed-loop artificial pancreas systems on the market were Medtronic’s MiniMed 770G and Tandem’s Control-IQ. Both of these advanced closed-loop systems are tube-based insulin pumps, where mobile phones are used solely for glucose monitoring, while specific operational controls must be performed directly on the insulin pump.

Overall, compared with previous Omnipod series, Omnipod 5 can form an artificial pancreas system with G6 to achieve automatic infusion; compared with past artificial pancreases, Omnipod 5 is more compact and lightweight, offering a better wearing experience. These comprehensive advantages have led to strong sales of Omnipod 5 since its market launch. 

Omnipod 5 can be described as a blockbuster product in the field of artificial pancreas systems, addressing some of the shortcomings of previous generations. Currently, the global penetration rate of artificial pancreas systems is below 0.5%, and the introduction of Omnipod 5 is expected to drive expansion of the artificial pancreas market.

According to the Frost & Sullivan report, the global insulin pump market size increased from USD 4.1 billion in 2015 to USD 5.6 billion in 2020, representing a compound annual growth rate (CAGR) of 6.6% from 2015 to 2020, and is projected to reach USD 20.7 billion by 2030, with a CAGR of 14.0% from 2020 to 2030; the Chinese insulin pump market size increased from USD 58.1 million in 2015 to USD 125.4 million in 2020, representing a CAGR of 16.6% from 2015 to 2020, and is projected to reach USD 1.0 billion by 2030, with a CAGR of 23.3% from 2020 to 2030.

In the domestic market, the ceiling for insulin pumps has long been considered low due to their bulky size, high retail prices, suboptimal user experience, and the absence of truly closed-loop artificial pancreas systems. Industry insiders previously predicted that the advent of genuine patch-style closed-loop artificial pancreas systems would drive growth in the insulin pump market.

Although the current market space for insulin pumps in China is limited, the growth potential is substantial.

On the one hand, recognition of the clinical efficacy of insulin pumps is steadily increasing among both physicians and users.Recent studies will further raise awareness among diabetic patients of the favorable clinical outcomes associated with insulin pumps, thereby increasing patient willingness to adopt this technology and driving growth in the insulin pump market. Clinical results have confirmed that glycemic control achieved with insulin pumps can effectively prevent diabetic complications and slow the progression of existing ones. Robust clinical evidence has enhanced physicians’ understanding of insulin pumps. Due to the widespread recognition of their efficacy, insulin pumps have been incorporated into the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2017 Edition). As acceptance of insulin pumps continues to rise, it is expected that more patients will utilize them.

On the other hand, the commercialization of innovative products is driving growth; advancements in new technologies such as continuous glucose monitoring (CGM), closed-loop artificial pancreas systems, and patch insulin pumps will continue to boost insulin pump penetration rates.CGM and patch insulin pumps have already been commercialized in China. As more companies develop and launch additional products, patch insulin pumps will become lighter and more compact, enhancing user privacy, while their functionality will become more comprehensive. Compared with traditional tubed insulin pumps, patch insulin pumps significantly improve wearing comfort and freedom of movement, thereby enhancing medication adherence. The domestic market is expected to expand once true closed-loop products are launched.

In the in-hospital market for diabetes treatment, short-term intensive insulin therapy has also begun to be widely adopted.Short-term intensive insulin therapy is a treatment approach that, on the basis of lifestyle interventions, rapidly achieves target blood glucose levels through multiple daily (3–4 times) subcutaneous insulin injections or continuous subcutaneous insulin infusion (CSII) via an insulin pump. Implementation of this regimen requires meticulous titration of insulin doses to minimize adverse hypoglycemic events.

With the release of expert guidelines and treatment protocols, short-term intensive insulin therapy has been established as an effective approach for managing patients with diabetes and is being progressively implemented in hospitals. Compared with multiple daily insulin injections, the use of insulin pumps enhances the efficiency of short-term intensive therapy. This is because insulin pumps can maximize physiological insulin secretion patterns through personalized basal rates and preprandial bolus doses, thereby achieving better glycemic control. Short-term intensive insulin therapy is particularly suitable for patients with newly diagnosed type 2 diabetes and gestational diabetes, as insulin pump therapy can reduce glycemic variability, improve adherence to glycemic targets, and shorten the time required to reach target glucose levels. Owing to superior clinical outcomes and improved patient experience, this approach can reduce hospital length of stay and lower treatment costs.

Tubing-Free Closed-Loop Artificial Pancreas Systems Are Selling Well Overseas: Who Is Poised to Replicate This Success in the Chinese Market?

It should be emphasized that making insulin pumps smaller and smarter is not a simple task.

First, regarding miniaturization, it is an industry consensus that making insulin pumps smaller and more portable enhances user convenience. However, the overall structure of insulin pumps is complex, so integrating numerous components into a smaller device (such as patch insulin pumps) poses significant technical challenges.

Another key consideration is intelligence and safety. Even industry giants like Medtronic, which have deeply cultivated the insulin pump sector, still offer products that are relatively bulky with complex user interfaces. Notably, Medtronic’s insulin pumps underwent a large-scale recall last year, underscoring the significant challenges involved in developing stable and safe insulin pumps.

Developing and manufacturing a closed-loop artificial pancreas requires integrated capabilities in three areas: continuous glucose monitoring (CGM), control algorithms, and insulin pumps.Currently, the prevailing collaboration model among international companies involves partnerships between insulin pump manufacturers and continuous glucose monitoring (CGM) companies. Overseas, both Insulet and Tandem have chosen to partner with Dexcom. Of course, the rapid development of domestic insulin pumps will also depend on whether their prices can drop significantly in the short term.

In China, collaborations between CGM manufacturers and insulin pump companies are also underway. This year, Kailian Medical, an innovator in the field of intelligent insulin delivery, signed a strategic partnership agreement with Jiunuo Medical, an innovator in continuous glucose monitoring (CGM). Leveraging their respective technological strengths in insulin pumps, CGM devices, and control algorithms, the two parties will collaborate to advance the research, development, production, and commercialization of artificial pancreas systems. Their joint effort aims to promote novel approaches to blood glucose management and improve patients’ quality of life.

Some companies are also independently developing artificial pancreas systems. MicroTech Medical has globally approved and marketed patch insulin pumps and calibration-free continuous glucose monitoring (CGM) systems, with its CGM product AiDEX G7 and patch insulin pump Equil both commercialized. According to its semi-annual report, MicroTech Medical’s revenue in the first half of 2022 reached RMB 71.82 million, a year-on-year increase of 20.9%, among which revenue from CGM sales amounted to RMB 12.9 million. MicroTech Medical is also developing a closed-loop artificial pancreas system, with its PanCares closed-loop artificial pancreas product currently in clinical trials.

The diabetes market has always held immense potential. In recent years, domestic companies have achieved multiple breakthroughs in continuous glucose monitoring (CGM) products, giving rise to several competitive enterprises. However, CGM products alone are insufficient for China’s blood glucose management market; there is an expectation for domestic companies to achieve further breakthroughs in the insulin pump market.

Reference: MicroTech Medical Prospectus

[Guidelines and Recommendations] Expert Consensus on Short-Term Intensive Insulin Therapy for Type 2 Diabetes (2021 Edition)