With the increasing global population, the incidence rates of several chronic disease indications, such as diabetes, heart disorders, neurological disorders and oncological disorders, are on the rise; this, in turn, has led to a growth in demand for effective treatment options for patients. Further, in order to improve the quality life of patients, companies have developed novel devices capable of delivering a variety of formulations of different drugs / therapies in an efficient and relatively simpler manner. Most of the devices that have been developed and commercialized in recent years allow self-administration of drugs. Such devices offer various advantages, including accurate dose delivery and improved patient compliance. In the pursuit of creating patient-centric healthcare solutions, the medical industry has witnessed a groundbreaking advancement in drug delivery with the emergence of large volume wearable injectors. These medical devices are designed to administer drug subcutaneously. These devices have capability to hold and deliver precise dosages of drugs ranging from a few milliliters to several milliliters. Unlike traditional syringes, these are compact, portable, and can be worn directly on the body, providing patients with a discreet and user-friendly experience. These devices have potential to offer enhanced convenience, improved medication adherence and empowering patients to take control of their treatment regimens. The global wearable injectors market is anticipated to grow at a CAGR of around 9%, till 2035. Driven by the growing demand for drug delivery devices, the wearable injectors market is anticipated to grow at a steady rate in the coming decade.
OVERVIEW OF WEARABLE INJECTORS
A wearable injector is a medical device designed to deliver drugs or other medications subcutaneously in a controlled manner. It can be worn on the body like a patch or a small pump, providing a convenient and discreet method of drug administration. These devices have been engineered to streamline the process of administering injectable medications, particularly those requiring higher volumes, for patients dealing with chronic conditions. They are designed to hold substantial volumes and are delivered to the patient subcutaneously in controlled manner. The discreet and compact nature of these injectors provides convenience by minimizing disruptions to the patient. Large volume wearable injectors are integrated with smart technology that allows for programmable dosing schedules. Patients get alert about low medication levels or potential issues, granting them a sense of control and enabling timely interventions. This enables healthcare professionals to remotely monitor patient adherence, dosing patterns, and overall treatment progress, leading to better management and personalized care.
ADVANTAGES OF WEARABLE INJECTORS
Various advantages associated with wearable injectors are described below:
- High drug delivery volume: Large Volume Wearable Injectors have the capacity to deliver higher volumes of drugs in a single administration. This is particularly beneficial for patients who require frequent dosing of high volumes of medication, as it reduces the number of injections they need to endure.
- Convenience and portability: These injectors empower patients by providing them with the freedom to administer medication outside of clinical settings. This freedom allows individuals to continue their daily routines without interruption, leading to better treatment adherence and improved health outcomes.
- Improved patient compliance: With reduced injection frequency and simplified administration, these large volume wearable injectors can lead to better patient adherence to prescribed treatments. Patients are more likely to comply with their medication schedules when the process is less cumbersome and requires fewer interactions.
- Precise Dosing and Monitoring: These injectors are equipped with sophisticated software that enables precise dosing and medication scheduling. This level of control ensures that patients receive the right amount of medication at the right time, thereby reducing the risk of adverse reactions and enhancing treatment efficacy.
- Enhanced safety and reliability: The devices are designed with safety features, such as dose limiting and error detection mechanisms, which can reduce the risk of medication errors and enhance overall treatment safety.
- Reduced Healthcare Burdens: With large volume wearable injectors, healthcare providers can minimize the need for frequent visits, particularly for patients requiring long-term therapies. This not only eases the burden on healthcare facilities but also optimizes the allocation of medical resources.
DRIVING FACTORS FOR WEARABLE INJECTORS
Over the past few years, there has been an evident shift towards the self-administration of drugs / therapies. This is largely attributed to the availability of various self-injection devices that offer a number of advantages, such as dosing related flexibilities, reduced need to frequently visit clinics and enhanced adherence to therapy. Some of the major factors that we believe are likely to impact the adoption of self-administration devices have been described below:
- Rising Burden of Chronic Diseases: Around 50% all adults in the US are currently suffering from one or more chronic conditions. Further, the total spending on such patients is estimated to be close to USD 3.2 trillion, accounting for 86% of the overall global healthcare expenditure. Factors that have been identified to contribute to the growing socioeconomic and financial burden associated with chronic diseases include frequent visits to hospitals, lack of adherence to prescribed medication regimens, expenses incurred in detecting and treating the side-effects of drugs, and the inability to detect signs of such diseases at an early stage.
- Healthcare Cost Savings: The emerging trend of self-injection has been dubbed as a win-win scenario for both patients and healthcare professionals. In addition to being user-friendly and convenient for patients, it saves on healthcare resources and costs by facilitating a lower-cost method to administer medicines, making self-injection system much more cost effective.
- Need for Immediate Treatment in Emergency Situations: The need for self-administration is evident in emergency situations, for life-threatening indications, and in conditions where immediate pain relief is required, such as for wounded military personnel during wartime. Such critical situations demand immediate and rapid treatment options.
- Growing Injectable Drugs Market: Over the past several years, the rapid growth of the biologics and biosimilars market has spurred significant demand for self-injection devices for the treatment of chronic disease indications. Biologics or biological drugs are defined as substances that are derived from living organisms or their by-products. Therefore, self-administration devices are best suited for this class of therapeutics due to the inherent advantages they offer in terms of convenience and safe handling.
REGULATORY CONSIDERATIONS
The USFDA classifies medical devices according to the level of associated risks and regulatory control required to ensure safety and efficiency of such devices. This classification system is briefly described below:
- Class I devices are used for less critical medication purposes and pose low risk to the patients. Their approval requires relatively less regulatory proceedings and controls. For example, dental floss is considered as a Class I device.
- Class II devices pose greater risk to patients’ health and safety, compared to Class I devices. Therefore, these require greater regulatory controls to ensure that the device is safe and effective before they are made commercially available. Pen-injectors and other related devices fall under this category.
- Class III devices are considered as the highest risk devices that have the potential to cause serious injuries (or even death under certain circumstances) to the patient, when not used properly. Devices that are used to support or sustain life and are used for critical treatment purposes are classified under this category. Such devices are therefore, subjected to the highest level of regulatory control. These typically require USFDA approval before they can be made commercially available.
In order to gain marketing approval, or continue the marketing, for a high-risk class III medical device, a pre-market approval (PMA) application is required to be submitted to the USFDA. The approval is granted on the basis of scientific evidence provided by the manufacturer elucidating the safety and effectiveness of the devices. Under this, the USFDA conducts a comprehensive review of the manufacturing processes, an inspection of the manufacturing facility, as well as a detailed review of the premarket data. If the USFDA finds the product to be unsafe and ineffective, it may not get marketing approval.
FUTURE PERSPECTIVES
Device developers are actively making efforts to introduce safety mechanisms in self-injecting devices in order to make them safe for use and disposal. In all injector devices, such as large volume wearable injectors, the syringe and needle are usually hidden from view. The needle can be released at the time of administration at the press of a button. In compliance with laws and legislation for the prevention of needlestick injuries, most large volume wearable injectors have an integrated safety device. The industry is constantly evolving in the space of drug delivery, with emergence of more convenient and patient compliant systems. As the number of commercially available biologics increases, the need for novel delivery devices is also expected to elevate. The historical trends of existing delivery devices, such as prefilled syringes, autoinjectors and insulin pumps, suggest a strong demand in the market. The large volume wearable injectors market is expected to follow a similar growth trend as more patients shift from conventional to user-friendly drug delivery alternatives.
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