Ultra-Large Volume Wearable Injectors Market

Market Overview

The global ultra-large volume wearable injectors market size was valued at USD 2.3 billion in 2022. It is estimated to reach USD 6.85 billion by 2031, growing at a CAGR of 12.9% during the forecast period (2023–2031). The rise in the prevalence of chronic disorders requiring ultra-large volume wearable injectors for treatment and their advantages over conventional therapies has resulted in a surge in the adoption of these devices.

Ultra-large volume wearable injectors are advanced medical devices designed to deliver large volumes of medication or therapeutic substances subcutaneously over an extended period. These devices have gained prominence in the healthcare industry due to their potential to improve patient convenience, treatment adherence, and overall therapeutic outcomes. One of the key features of ultra-large volume wearable injectors is their ability to administer high volumes of medication, typically ranging from 10 to 100 milliliters or more. This is significantly higher than the capacity of traditional injectors, which are typically limited to smaller volumes. The larger capacity of these devices enables the administration of medications that require high dosages or infrequent dosings, such as biologics, monoclonal antibodies, and long-acting therapies.

Ultra-large volume wearable injectors are advanced medical devices that have the potential to revolutionize drug delivery in healthcare. With their ability to administer large volumes of medication in a wearable and controlled manner, these devices offer benefits in terms of patient convenience, treatment adherence, and therapeutic outcomes. As technology advances, these injectors are expected to play a more significant part in enhancing patient care and expanding treatment options for various medical conditions.

Market Dynamics

Global Ultra-large Volume Wearable Injectors Market Drivers:

Rise in the Prevalence of Chronic Disorders which Require the Use of Ultra-Large Volume Wearable Injectors for Treatment

There is an increase in the demand for ultra-large volume wearable injectors owing to the rise in the prevalence of various types of cancers across the globe. This leads to a surge in side effects caused by the use of chemotherapy drugs, which require the use of ultra-large volume wearable injectors for treatment. For instance, according to the American Cancer Society, Inc. estimate, around 1,735,350 new cancer cases were registered in the U.S. in 2018.

Furthermore, according to the National Cancer Center Japan, the projected incidence of colon cancer was around 149,500 cases and 132,800 cases of stomach cancer in Japan in 2017. In addition, according to the Cancer Index (2012), nearly 6,763,000 patients are diagnosed with cancer annually in Asia-Pacific. Therefore, the rapid surge in the prevalence of cancer across the globe contributes to the growth of the ultra-large volume wearable injectors market.

Surge in Adoption of Ultra-Large Volume Wearable Injectors Across the Globe

Ultra-large volume wearable injectors have more advantages than conventional therapies, resulting in a surge in the adoption of these devices, which boosts the market's growth. Furthermore, there has been a rise in healthcare expenditure and a surge in awareness about treating side effects caused by chemotherapy drugs, boosting the demand for ultra-large volume wearable injectors.

Moreover, the presence of many key players in the market leads to the easy availability of these devices. This increases the adoption of ultra-large volume wearable devices across the globe. The other factors include a surge in awareness about using these highly user-friendly devices.

Global Ultra-large Volume Wearable Injectors Market Restraint:

High Cost of Ultra-Large Volume Wearable Injectors

Most ultra-large volume wearable injectors work on electromechanical mechanisms, which involve incorporating electronic motors, which generate the pressure required to set the flow of drug delivery. Furthermore, these devices have an additional mechanical setup incorporated as a backup for an electronic failure. Thus, these devices are complex and expensive, which serves as a hindrance to the growth of the market. For instance, the t: slim X2 insulin pump marketed by Tandem Diabetes Care is USD 6,995, and the cost of MINIMED 640G marketed by Medtronic plc is USD 4,330. Thus, the high cost of these devices hinders the market's growth.

Global Ultra-large Volume Wearable Injectors Market Opportunities:

Presence of Products in the Development Phase

The surge in the prevalence of various chronic conditions, such as diabetes and cancer, has increased the demand for advanced treatment options. Therefore, this has led to a surge in main players' emphasis on creating new items for the market. Some of the ultra-large volume wearable injector products in the development stage include Trevyent, an ultra-large volume wearable injector developed by SteadyMed.

The FDA has accepted the review of this device for a New Drug Application, which is expected to launch during the forecast period. Furthermore, Becton, Dickinson, and Company are working on developing BD Libertas. The device is an ultra-large volume wearable injector developed to deliver various biologics and other drugs in large quantities. Thus, the launch of these products during the forecast period is expected to serve as a lucrative opportunity for the market.

Regional Analysis

Based on region, the global ultra-large volume wearable injectors market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global ultra-large volume wearable injectors market shareholder and is estimated to grow at a CAGR of 12.2% over the forecast period. The study looks at the United States, Canada, and Mexico, the three biggest countries in North America. The U.S. is the largest revenue contributor in North America and a mature market. The existence of significant key actors in the area, such as Becton, Dickinson and Company, Insulet Corporation, Tandem Diabetes Care, Amgen, West Pharmaceutical Services, and others, is a major factor that contributes toward the expansion of the ultra-large volume wearable injectors market.

Moreover, there is an increase in the prevalence of chronic diseases such as diabetes, cancer, Parkinson’s disease, and others, an increase in demand for ultra-large volume wearable injectors, the presence of advanced healthcare facilities, and a higher number of R&D activities to develop the innovative device, thereby contributing toward the growth of the North America market. For example, according to the American Cancer Society, nearly 1.7 million new cancer cases are anticipated to be registered in the U.S. in 2018. Cancer is a major worldwide concern and the second leading cause of death in the United States. In addition, higher demand for advanced therapies, high disposable income, supportive reimbursement policies, and higher awareness associated with ultra-large volume wearable injectors support the market growth in North America.

Europe is anticipated to exhibit a CAGR of 13% over the forecast period. The five major countries of Europe considered in the report include Germany, France, the UK, Italy, Spain, and the rest of Europe. The second-largest market share was in Europe of the global ultra-large volume wearable injectors market in 2022. The ultra-large volume wearable injectors market in European countries is projected to grow steadily during the forecast period. The rise in demand for ultra-large volume wearable injectors, the strong presence of key players such as Medtronic Plc., Gerresheimer AG, and Ypsomed Holding, and the increase in adoption of ultra-large volume wearable injectors influence the growth of the market in Europe.

Moreover, the rise in chronic disease prevalence, the presence of developed infrastructure in the pharmaceutical and medical device industry, the availability of technologically advanced devices, and the increase in the target population are other key growth drivers in Europe.

Asia-Pacific is forecasted to exhibit the fastest market growth during the anticipated period owing to improvements in healthcare infrastructure, an increase in demand for ultra-large volume wearable injectors, and development in healthcare infrastructure. In addition, Growth opportunities in the market are made possible by the main manufacturers' increased focus on increasing their geographic presence in developing Asia-Pacific nations. Moreover, China is anticipated to grow at the fastest CAGR during the anticipated period, owing to the presence of the highest population, a significant surge in demand for advanced medical facilities, and a rise in R&D activities to develop innovative devices, further contributing toward market growth.

LAMEA is an emerging market expected to provide lucrative growth opportunities for the key players, owing to an increase in several target populations, the surge in demand for advanced therapies to treat chronic disease, and improvement in healthcare infrastructure. Additionally, the increased chronic disease prevalence in LAMEA fuels the adoption of ultra-large volume wearable injectors, driving market growth.

Segmental Analysis

The global ultra-large volume wearable injectors market is bifurcated into product type and application.

Based on product type, the global ultra-large volume wearable injectors market is bifurcated into electromechanical wearable injectors and others. 

The electromechanical wearable injectors segment dominates the global market and is projected to exhibit a CAGR of 12.2% over the forecast period. Electromechanical wearable injectors are specially designed to deliver drugs over an extended period through a subcutaneous route. These injectors function with the help of an electric drive motor, which controls the injection and generates the required high force. These high-pressure mechanisms prevent injections from exceeding the preset volume, flow rate, and pressure.

Furthermore, there is also a mechanical stop in the device, which is responsible for physically limiting the injection volume to a preset amount. Thus, in the case of an electrical malfunction, the drug administration would be limited by the mechanical system of the device. In addition, these devices are designed to deliver the drug at a constant delivery rate regardless of tissue back pressure. Some of the electromechanical wearable injectors available in the market include YpsoDose, marketed by Ypsomed AG; SmartDose Gen. I 3.5mL, marketed by West Pharmaceutical Services, Inc.; Omnipod, by Insulet Corporation; and others. Furthermore, various electromechanical wearable injectors are currently under development and are expected to be introduced in the market during the forecast period. For instance, (FDA) has accepted for review the New Drug Application for Trevyent, an ultra-large volume wearable injector developed by SteadyMed.

Based on application, the global ultra-large volume wearable injectors market is bifurcated into Diabetes, Cancer, and Others. 

The diabetes segment dominates the global market and is projected to exhibit a CAGR of 12.6% over the forecast period. Diabetes is an endocrine disorder associated with the presence of high blood sugar. Furthermore, if left untreated, the disorder causes severe side effects, including heart attack, stroke, renal damage, and nerve damage. In addition, insulin is a hormone secreted by the pancreas responsible for regulating human blood glucose. Therefore, insulin is the most common medication used to treat diabetes. The insulin used in the management of diabetes requires chronic administration via injections.

However, this leads to a surge in risk associated with needlestick injuries and lower patient compliance. Thus, ultra-large volume wearable injectors deliver insulin to the patient over an extended period. These devices offer many benefits; for instance, these devices are wearable due to adhesive back and require fewer needle insertions than injections. In addition, these devices deliver basal insulin constantly, eliminating the need to inject insulin at specific times of the day. Furthermore, ultra-large volume wearable injectors are user-friendly, increasing patient compliance.

Recent Developments

• March 2023- Becton Dickinson and Company (BD) announced the launch of its new ultra-large volume wearable injector, the BD Ultra-Fine Pen. The BD Ultra-Fine Pen is designed to deliver high-volume, high-viscosity drugs, such as insulin, to patients with diabetes. The pen is easy to use and can be worn by patients continuously.

• February 2023- Valeritas, Inc. announced the FDA approval of its V-Go Wearable Insulin Delivery System. The V-Go is a continuous subcutaneous insulin infusion (CSII) system designed to be worn by patients with diabetes. The V-Go is a small, lightweight device that can be worn on the body and delivers insulin through a thin, flexible tube.