Published: September 2023
On Body Injector are providing a novel drug delivery approach for subcutaneous delivery of biologics in large volumes. It is changing the way biologics are traditionally infused / injected, providing convenience for the patients and life cycle management infused / injected, providing convenience for the patients and life cycle management opportunities for the drug developers. We analyzed a comprehensive list of On body injector that are currently available in the market for delivery of non-insulin drugs and other drug device combinations. In this article, discover detailed information on some of the marketed on body injector.
Wearable injectors have revolutionized the drug delivery landscape by providing a patient-centric approach to administering medication. Among these devices, on body injector has emerged as a promising alternative to traditional injection methods. These devices are designed to be worn on the body and can deliver a range of drugs, including those used in the treatment of acute myeloid leukemia, lung cancer, and sickle cell disease. One of the key advantages of on body injector is its ability to provide patients with a more convenient and comfortable drug delivery experience. Unlike traditional injections, which require patients to visit a healthcare facility or self-administer at home, on body injector can be worn discreetly and deliver medication automatically at the injection site, thereby reducing the need for frequent injections. These injectors, along with other novel drug delivery devices are allowing the development of subcutaneous biologics. The competitive landscape of wearable injectors is evolving rapidly, with new devices getting commercialized. It is worth mentioning that BD Libertas, Neulasta Onpro, and Skyrizi on body injector are some of the most popular wearable injectors that are either available in the market or likely to get approval soon. Neulasta Onpro is an on body injector that delivers pegfilgrastim and is designed to reduce the frequency of injections required by patients at injection site.
Owing to the increasing demand and adoption of wearable injectors, the product portfolio analysis reveals that wearable injectors market have witnessed a surge in the investment activity, with capital investments worth more than USD 1.5 billion in the past few years. Further, enrollment of over 35,000 patients in clinical trials and rise in patent filing activity, the wearable injectors market is expected to grow at a CAGR of 9.01% during the forecast period of 2023-2035.
Roots Analysis has conducted an exhaustive study on Wearable Injectors Market featuring the detailed analysis of key trends, recent activity, regulatory scenarios, growth drivers / challenges and market forecast analysis over a span of 12 years.
Following are some of the marketed wearable injectors:
On Body Injector Marketed as Drug Device Combinations
1. D-mine® Pump
2. Neulasta® (pegfilgrastim) OnPro™ Kit
3. Repatha® (evolocumab) Pushtronex™ System
4. SKYRIZI® On Body Injector
5. ULTOMRIS® (ravulizumab-cwvz) smartdose Injector
On Body Injector Marketed for Non Insulin Delivery
6. Quickdose
7. SmartDose® 3.5 Injector/ SmartDose Gen. I
Interested in exploring all approved and under development on body injector for insulin drug delivery, non-insulin drug delivery and drug device combinations
This article highlights the approved / marketed / commercialized on body injector / wearable injectors in 2023. These wearable injectors were identified by conducting extensive secondary and primary research. We then meticulously collated information on detailed set of parameters related to respective on body injector, as highlighted in below sections.
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The D-mine® Pump On Body Injector is a wearable infusion device with a micropump developed by Sensile Medical especially for EVER Pharma. The device received European CE certification and was launched in July 2019 in Europe. It was specifically designed to provide precise continuous subcutaneous drug delivery for Parkinson's patients in a compact, simple to use, and patient-friendly manner. The device is an example of technological advancements in self-injection devices, especially in wearable injectors, for the administration of high-viscosity and large-volume drugs at the injection site. The pump was developed by Sensile Medical for EVER Pharma.1 The latter developed the D-mine® Pump TRAINING APP in 2022 to support the training needs of healthcare professionals and caregivers. The app is an intuitive, easy-to-use simulator that enables training anytime, everywhere. D-mine Care is a support program for people with Parkinson's disease and healthcare professionals.
D-mine® Pump On Body Injector Specifications
| S. No. | Parameters | Details |
| 1 | Device Name | D-mine® Pump |
| 2 | Developer | EVER Pharma |
| 3 | Launch Date | July 2019 |
| 4 | Type of Device | Infusion Pump |
| 5 | Type of Dose | Bolus and Basal |
| 6 | Container Volume | Up to 20 ml |
| 7 | Usability | Reusable (Disposable Components) |
| 8 | Mode of Injection | Needle |
| 9 | Injection Time | NA |
| 10 | Mechanism of Action / Driving Force | Rotary Pump |
| 11 | Target Indication | Parkinson’s Disease |
| 12 | Route of Administration | Subcutaneous |
| 13 | Price | $5,400 |
| 14 | Type of Technology | Micro-rotation pump technology |
| 15 | Drugs under Evaluation / Approved for use | Apomorphine |
| 16 | Compatible Drug Class | Dopamine Agonists |
| 17 | Type of Compatible Drug | Small Molecules |
| 18 | Dose of drug | NA |
| 19 | Type of Drug Container | Vial |
| 20 | Mode of Drug Filling | Prefilled |
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Amgen's Neulasta® (pegfilgrastim) OnPro™ Kit is an FDA-approved product that helps reduce the risk of infection in individuals with certain types of cancer (non-myeloid) who receive chemotherapy that can cause fever and low white blood cell count. The OnPro Kit comprises a single-use prefilled syringe and an on body injector, which is specially designed to deliver pegfilgrastim around 27 hours after application. The Neulasta medication works by increasing the production of white blood cells, which helps the body fight infections. The OnPro Kit simplifies the process of administering Neulasta®, making it more convenient for patients and healthcare providers. Although approved in 2014, the drug-device combination was launched in the US in 2015.2
Companies are also aiming to develop pegfigrastim on body injector biosimilar. One such player, Coherus Biosciences is nearing approval for its UDENCYA on body injector. In September 2023, the company received a CRL from the FDA, stating on-going inspections at a third party filler site.3
Neulasta® (pegfilgrastim) OnPro™ Kit On Body Injector Specifications
| S. No. | Parameters | Details |
| 1 | Device Name | Neulasta® (pegfilgrastim) OnPro™ Kit |
| 2 | Developer | Amgen |
| 3 | Approval Date | 2014 (FDA) |
| 4 | Type of Device | Patch Pump |
| 5 | Type of Dose | Basal |
| 6 | Container Volume | NA |
| 7 | Usability | Disposable |
| 8 | Mode of Injection | Needle |
| 9 | Injection Time | 3 Min. |
| 10 | Mechanism of Action / Driving Force | NA |
| 11 | Target Indication | Cancer |
| 12 | Route of Administration | Non-Myeloid Cancer |
| 13 | Price | $6,000-$8,000 |
| 14 | Type of Technology | Insulet's Omnipod® Technology |
| 15 | Drugs under Evaluation / Approved for use | Pegfilgratism |
| 16 | Compatible Drug Class | Protein |
| 17 | Type of Compatible Drug | Biologics |
| 18 | Dose of drug | 6 mg / 0.6 ml |
| 19 | Type of Drug Container | NA |
| 20 | Mode of Drug Filling | NA |
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Repatha® (evolocumab) is a monoclonal antibody that inhibits PCSK9 (proprotein convertase subtilisin kexin type 9). It is used to help lower the risk of stroke, heart attack, or other heart complications in people with heart or blood vessel problems caused by plaque build-up or hardening in the arteries. The Pushtronex® system is an on body injector delivery option for Repatha® that was approved by the FDA in 2016. It is a single-dose on body injector with a prefilled cartridge that delivers a 420 mg/3.5 mL subcutaneous injection. The system consists of a Repatha (evolocumab) injection that is co-packaged with an on body injector that securely adheres to the body for hands-free administration while patients perform activities requiring moderate exertion. It is worth mentioning that Pushtronex® on body injector has a hidden 29-gauge needle. Patients can administer Repatha® with either the Pushtronex® system or 3 autoinjectors for the once-monthly regimen. The drug delivery device is uses West Pharmaceutical’s SmartDose® technology.4
In addition to this on body injector the patients have an option of either taking 3 X 1ml injection each month or use three SureClick autoinjectors. As such, the Pushtronex system provides advantage over the traditional delivery devices.
Repatha® (evolocumab) Pushtronex™ System On Body Injector Specifications
| S. No. | Parameters | Details |
| 1 | Device Name | Repatha® (evolocumab) Pushtronex™ System |
| 2 | Developer | Amgen |
| 3 | Launch Date | July 2016 |
| 4 | Type of Device | Patch Pump |
| 5 | Type of Dose | Basal |
| 6 | Container Volume | 3.5 ml |
| 7 | Usability | Disposable |
| 8 | Mode of Injection | Needle |
| 9 | Injection Time | 9 Minutes |
| 10 | Mechanism of Action / Driving Force | Electromechanical System |
| 11 | Target Indication | Hyperlipidemia (Including hypercholesterolemia) |
| 12 | Route of Administration | Subcutaneous |
| 13 | Price | $14,100 (Annual) |
| 14 | Type of Technology | SmartDose Drug Delivery Platform |
| 15 | Drugs under Evaluation / Approved for use | Repatha® / evolocumab |
| 16 | Compatible Drug Class | Monoclonal Antibody |
| 17 | Type of Compatible Drug | Biologics |
| 18 | Dose of drug | 420 mg |
| 19 | Type of Drug Container | Cartridge |
| 20 | Mode of Drug Filling | Prefilled |
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SKYRIZI® is a medication developed by AbbVie, a global biopharmaceutical company, to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. In addition to treating plaque psoriasis and psoriatic arthritis, SKYRIZI® is also used to treat a certain bowel condition called Crohn's disease. For Crohn's disease patients, SKYRIZI® is supplied in a 600mg/10mL single-dose vial for IV infusion during the induction period, which is administered by a healthcare provider. For maintenance treatment, a 360mg/2.4mL single-dose prefilled cartridge is used with the on body injector for subcutaneous injection. Patients may self-inject after receiving proper training from a healthcare provider. It is worth mentioning that a 180 mg self-administered maintenance dose is currently under review by the FDA.
SKYRIZI® On Body Injector Specifications
| S. No. | Parameters | Details |
| 1 | Device Name | SKYRIZI® On Body Injector |
| 2 | Developer | AbbVie |
| 3 | Launch Date | June 202 |
| 4 | Type of Device | NA |
| 5 | Type of Dose | Bolus |
| 6 | Container Volume | NA |
| 7 | Usability | Disposable |
| 8 | Mode of Injection | Needle |
| 9 | Injection Time | 5 Minutes |
| 10 | Mechanism of Action / Driving Force | Targets IL-23 to reduce inflammation |
| 11 | Target Indication | Crohn’s Disease |
| 12 | Route of Administration | Subcutaneous |
| 13 | Price | $19,734 |
| 14 | Type of Technology | Needle Injection Technology |
| 15 | Drugs under Evaluation / Approved for use | SKYRIZI® |
| 16 | Compatible Drug Class | Monoclonal Antibody |
| 17 | Type of Compatible Drug | Biologics |
| 18 | Dose of drug | 360mg/2.4mL |
| 19 | Type of Drug Container | Cartridge |
| 20 | Mode of Drug Filling | Prefilled |
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The SmartDose Injector is an on body injector used to administer ULTOMIRIS® (ravulizumab-cwvz) subcutaneously, providing an alternative to intravenous administration. It is designed to deliver a precise dose of ULTOMIRIS® (ravulizumab-cwvz) subcutaneously over a period of approximately 10 minutes, which can be more convenient for patients and healthcare providers. It is worth mentioning that SmartDose Injector is approved for use in adult patients with Paroxysmal Nocturnal Haemoglobinuria (PNH) and atypical Haemolytic Uraemic Syndrome (aHUS), and its use is intended for healthcare professionals only. By offering a subcutaneous administration option for ULTOMIRIS®, the SmartDose® platform can improve patient convenience and adherence to treatment.
ULTOMIRIS® (ravulizumab-cwvz) SmartDose On Body Injector Specifications
| S. No. | Parameters | Details |
| 1 | Device Name | ULTOMIRIS® (ravulizumab-cwvz) SmartDose Injector |
| 2 | Developer | West Pharmaceutical Services |
| 3 | Launch Date | 2010 |
| 4 | Type of Device | Patch Pump |
| 5 | Type of Dose | Basal |
| 6 | Container Volume | Up to 3.5 ml |
| 7 | Usability | Disposable |
| 8 | Mode of Injection | Needle |
| 9 | Injection Time | 10 Min. |
| 10 | Mechanism of Action / Driving Force | Electromechanical System |
| 11 | Target Indication | Paroxysmal Nocturnal Haemoglobinuria (PNH) and atypical Haemolytic Uraemic Syndrome (aHUS) |
| 12 | Route of Administration | Subcutaneous |
| 13 | Price | NA |
| 14 | Type of Technology | SmartDose Drug Delivery Platform |
| 15 | Drugs under Evaluation / Approved for use | ULTOMIRIS® (ravulizumab-cwvz) |
| 16 | Compatible Drug Class | Monoclonal Antibody |
| 17 | Type of Compatible Drug | Biologics |
| 18 | Dose of drug | NA |
| 19 | Type of Drug Container | Cartridge |
| 20 | Mode of Drug Filling | Prefilled |
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The FDA has approved the first combination product that utilizes the SmartDose® 3.5 on body delivery system (OBDS). This drug delivery system is composed of a wearable on body injector that is battery-powered and a separate, pre-fillable cartridge made of polymer that contains the drug product. The SmartDose® 3.5 OBDS has undergone human factors and usability testing to ensure that it provides a patient-centric approach to self-administration. With this approval, patients can benefit from a more convenient and user-friendly drug delivery system that incorporates advanced technology.
SmartDose® 3.5 Injector/ SmartDose Gen. I On Body Injector Specifications
| S. No. | Parameters | Details |
| 1 | Device Name | SmartDose® 3.5 Injector/ SmartDose Gen. I |
| 2 | Type of Technology | SmartDose Drug Delivery Platform |
| 3 | Developer | West Pharmaceutical Services |
| 4 | Type of Device | Infusion Pump |
| 5 | Type of Dose | Bolus |
| 6 | Container Volume | Up to 3.7 ml |
| 7 | Usability | Reusable (Disposable Components) |
| 8 | Mode of Injection | Needle |
| 9 | Mechanism of Action / Driving Force | Electromechanical System |
| 10 | Route of Administration | Subcutaneous |
| 11 | Viscosity Compatibility | High Viscosity |
| 12 | Type of Drug Container | Cartridge |
| 13 | Mode of Drug Filling | Preloaded |
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CCBio has developed QuickDose, a type of wearable injectors that offers patients and pharmaceutical industry partners a range of benefits. QuickDose on body injector comprises container, needle set, and the delivery unit. The container is highly flexible and customizable, while the needle set is designed for ease of use and maximum patient comfort. Further, the delivery unit incorporates advanced technologies, including WiFi, NFC, and Bluetooth connectivity, programmability, a powerful server motor, and a lithium battery.
QuickDose On Body Injector Specifications
| S. No. | Parameters | Details |
| 1 | Device Name | QuickDose |
| 2 | Developer | CCBio |
| 3 | Type of Device | Patch Pump |
| 4 | Container Volume | Up to 250 ml |
| 5 | Mode of Injection | Needle |
| 6 | Type of Drug Container | Mini-bag System |
| 7 | Mode of Drug Filling | Manually Loaded |
| 8 | Connectivity Feature | Available |
The above section features some of the approved wearable injectors from a pool of about 90 wearable injectors for insulin drug delivery, non-insulin drug delivery and drug device combinations that we have compiled. If you're interested, you can download the Sample Report on this topic by Roots Analysis. For personalized assistance in identifying the most relevant solutions based on your specific criteria, please don't hesitate to reach out to us at sales@rootsanalysis.com.
Ronit Sharma is an accomplished business resear ch and competitive intelligence professional with over six years of experience in the pharmaceutical and healthcare industry. As a team leader at Roots Analysis, he has authored numerous multidisciplinary market research reports, and led the efforts on several bespoken consulting assignments, providing valuable insights into the latest innovations in healthcare and the digital transformation of the pharmaceutical industry. Ronit's exceptional analytical skills and strategic thinking in the field contribute to the firm's intellectual capital, empowering clients to make informed decisions in the dynamic pharmaceutical landscape. With a passion for staying at the forefront of industry advancements, Ronit specializes in identifying emerging opportunities for various stakeholders, leveraging his deep understanding of market trends and technological developments. He is committed to fostering an environment of excellence, creativity, and innovation within his team, encouraging collaboration and empowering team members to bring their best ideas to the table.
Recently, Ronit's expertise has been recognized by a prestigious online news agency, where he was interviewed and featured as an emerging industry leader. Ronit holds a B. Tech degree in Biotechnology from Lovely Professional University and his research and thought leadership can be found in his professional blog and social media profiles, where he shares the latest insights and engages in meaningful discussions with industry peers. To ensure the highest ethical standards, Ronit openly declares no conflicts of interest in his work, ensuring unbiased and trustworthy contributions. His insights undergo rigorous editorial and peer-review processes, establishing his credibility as a thought leader within the pharmaceutical and healthcare domain. Ronit's exceptional analytical and strategic thinking skills, coupled with his commitment to excellence, make him a valuable asset to any organization in the pharmaceutical and healthcare industry.
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Source 1: https://www.gerresheimer.com/en/company/newsroom/corporate-news/detail/innovative-micro-infusion-pump-from-gerresheimer-subsidiary-sensile-medical-for-ever-pharma
Source 2: https://www.amgen.com/newsroom/press-releases/2017/04/amgen-launches-neulasta-pegfilgrastim-onpro-narratives
Source 3: https://www.onclive.com/view/fda-issues-crl-to-bla-for-on-body-injector-presentation-of-pegfilgrastim-cbqv
Source 4: https://www.prnewswire.com/news-releases/wests-smartdose-drug-delivery-technology-platform-selected-by-amgen-for-pushtronex-system-300296409.html#:~:text=Repatha%C2%AE%20and%20Pushtronex%E2%84%A2%20are%20registered%20trademarks%20of%20Amgen%20Inc
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