North America Self-Injections Market Segmentation, By Product Type (Self-Injection Devices and Self-Injection Formulation), Dosage Form (Single Dose and Multi-Dose), Route of Administration (Subcutaneous, Intra muscular and Others), Application (Autoimmune Diseases, Pain Management, Emergency Drugs, Oncology, Hormonal Disorders and Others), Age Group (Adult, Geriatric and Pediatric), Gender (Male and Female), Distribution Channel (Direct Tender, Hospital Pharmacy, Online Pharmacy and others) – Industry Trends and Forecast to 2031
Self-Injections Market Analysis
North America self-injections market is driven by rising prevalence of chronic disease, technological advancement in self-injections, increase in patient autonomy and rise in mobile health applications. The market is characterized by the presence of key players, ongoing research and development, and strategic collaborations. The market's expansion is also supported by favorable regulatory environments and increasing healthcare expenditure. Self-injection devices, including auto-injectors, pen injectors, and wearable injectors, are becoming more popular due to their convenience, ease of use, and ability to enhance patient compliance by allowing individuals to administer their own medication at home, reducing the need for frequent healthcare visits. Technological innovations, such as connected devices that track and monitor patient adherence, are further fueling market growth.
Self-Injections Market Size
North America self-injections market size was valued at USD 19.52 billion in 2023 and is projected to reach USD 41.75 billion by 2031, with a CAGR of 10.2% during the forecast period of 2024 to 2031. In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include in-depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.
Self-Injections Market Trends
“Rise in Focus on User-Friendly and Disposable Devices”
A key trend in the North America self-injection market is the increasing demand for user-friendly and disposable devices. As more patients manage chronic conditions like diabetes, rheumatoid arthritis, and multiple sclerosis, there is a growing need for easy-to-use, self-administration systems. Self-injection devices such as auto-injectors and prefilled syringes are designed to improve patient compliance by simplifying the injection process. This trend aligns with a broader shift towards home-based care, where patients are encouraged to take more control over their treatment regimens, reducing the need for frequent visits to healthcare facilities.
Also, technological advancements are driving innovation in this market. Manufacturers are incorporating smart features, such as dose tracking and real-time feedback, into self-injection devices. These features are especially beneficial for patients who require frequent injections, as they enhance precision and reduce the risk of under- or overdosing. The combination of enhanced safety, convenience, and digital integration is likely to accelerate the adoption of self-injection devices in North America, particularly in regions with growing patient populations and increasing healthcare awareness.
Report Scope and Self-Injections Market Segmentation
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Attributes
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Self-Injections Key Market Insights
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Segments Covered
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Countries Covered
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U.S., Canada, and Mexico
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Key Market Players
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Bayer AG (Germany), UCB Pharma (Belgium), Ipsen Biopharmaceuticals, Inc. (France), Teva Pharmaceuticals Industries Ltd (Israel), Recipharm AB (Sweden), SCHOTT Pharma (Germany), Lilly (U.S.), AstraZeneca (U.K.), Takeda Pharmaceuticals Company Limited (Japan), Novartis AG (Switzerland), Pfizer Inc. (U.S.), Sanofi (France), AbbVie (U.S.), Biogen (U.S.), YPSOMED (Switzerland), Bausch Health Companies Inc. (Canada), Merck & Co. (U.S.), Amgen Inc. (U.S.), Johnson & Johnson Services, Inc. (U.S.), Penjet (U.S.), PharmaJet (U.S.), Societe Industrielle de Sonceboz SA (Switzerland), Terumo Corporation (Japan), Haselmeier (Germany), Owen Mumford (U.K.), Midas Pharma GmbH (Germany), BD (U.S.), Phillips-Medisize (U.S.), West Pharmaceutical Services (U.S.), Gerresheimer AG (Germany), Enable Injections (U.S.), Credence Medsystems, Inc. (U.S.), Nemera (France), Oval Medical Technologies Ltd. (SMC Limited) (U.K.), SHL Medical AG (Switzerland), Novo Nordisk A/S (Denmark), AptarGroup, Inc. (U.S.), Boehringer Ingelheim International GmbH (Germany), F. Hoffmann-La Roche Ltd (Switzerland), and GSK plc (U.K.) among others
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Market Opportunities
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Value Added Data Infosets
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In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include in-depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.
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Self-Injections Market Definition
The North America self-injections market refers to the industry that focuses on the development, manufacturing, and distribution of devices and technologies enabling patients to self-administer medications without requiring the direct involvement of healthcare professionals. These devices, such as auto-injectors, prefilled syringes, pen injectors, and wearable injectors, are designed to deliver a wide range of treatments, including biologics, insulin, hormones, and therapies for chronic conditions like diabetes, rheumatoid arthritis, and multiple sclerosis. The market is driven by several factors, including the increasing prevalence of chronic diseases, a growing preference for home-based healthcare, the rising demand for biologics and personalized medicine, and advancements in drug delivery technology that emphasize user-friendly designs, safety, and reliability.
Self-Injections Market Dynamics
Drivers
- Rising Prevalence of Chronic Disease
The growing prevalence of chronic diseases, including diabetes, arthritis, and multiple sclerosis, is a key driver for the self-injection market. Patients with these conditions frequently require ongoing medication, making self-injection devices both convenient and essential. As the global population ages, the demand for effective at-home treatment options continues to rise. Self-injection systems empower patients to manage their conditions independently, significantly reducing the need for hospital visits. This shift not only improves patient adherence and quality of life but also eases the burden on healthcare systems, driving further market growth. The increasing focus on personalized healthcare solutions supports the expansion of self-injection technologies, catering to the needs of a diverse patient population seeking greater autonomy in their treatment regimens.
For instance,
In January 2024, according to the article published in NCBI, Chronic diseases such as diabetes and heart disease are leading causes of global morbidity and mortality, with costs projected to reach USD 47 trillion by 2030.So, prevalence of chronic diseases like diabetes act as driver for the market.
- Technological Advancement in Self Injections
Recent innovations in medical technology have resulted in the creation of advanced self-injection devices that prioritize user-friendliness and efficiency. Features like auto-injectors, pre-filled syringes, and smart devices integrated with mobile applications significantly enhance the user experience by offering real-time feedback and reminders. These improvements increase the accuracy of medication delivery and reduce the likelihood of errors, making self-injection more attractive to patients. As healthcare increasingly shifts toward a patient-centric model, the demand for these technologically advanced solutions is expected to rise. This trend is likely to propel the self-injection market forward, catering to patients seeking greater autonomy and improved management of their health conditions. Such innovations not only enhance patient satisfaction but also contribute to better health outcomes overall.
For instance,
In October 2023, according to the article published in Frederick Furness Publishing, It explores innovative solutions to address the challenges of injecting high-viscosity medications, which are often difficult to deliver with traditional devices. By highlighting technological advancements, it discusses how improved syringe designs and automated delivery systems enhance the ease and effectiveness of self-injection, which act as driver in the market growth.
Opportunities
- Government Initiatives to Self-Injections
Government initiatives promoting self-injection therapies present significant opportunities in the global self-injections market. Many governments are focused on enhancing patient-centric healthcare and reducing the strain on overburdened healthcare systems. To achieve this, several national healthcare bodies are actively encouraging self-administration practices by offering educational programs, subsidies, and regulatory support for self-injection devices. These initiatives aim to empower patients to manage chronic diseases at home, improving access to treatment in rural or underserved areas and reducing hospital visits. Also, favorable reimbursement policies for self-injection devices and medications further incentivize both patients and manufacturers. Government support in the form of funding for research and development of innovative self-injection technologies, alongside the streamlining of regulatory approval processes, accelerates the availability of safer, more user-friendly devices. This growing governmental backing facilitates market expansion by creating a conducive environment for the adoption of self-injections, ultimately fostering increased growth potential for manufacturers and healthcare providers alike.
For instance,
In October 2023, according to the information published by UNFPA (United Nations Population Fund), UNFPA is a United Nations agency that works to improve reproductive health and maternal health worldwide promotes the incorporation of Injection Depot MedroxyProgesterone Acetate - Subcutaneous (DMPA-SC) as a self-injection contraceptive option into India’s national Family Planning Programme represents a promising and well-timed timely opportunity and plays a crucial role in addressing the unmet need of contraception among women particularly those from vulnerable communities who encounter numerous barriers to accessing contraceptives. Self-injection plays a vital role in enhancing and diversifying choices, promoting self-care practices.
- Increased Research and Development for Self-injection
Increased research and development (R&D) in self-injection technologies serve as a key opportunity in the global self-injections market by driving innovation that meets the evolving needs of patients and healthcare systems. Emerging advancements are focused on creating more intuitive, user-friendly devices that improve safety, convenience, and patient compliance. These innovations include the development of smart injectors with digital health capabilities, needle-free systems, and auto-injectors designed for easier handling and reduced pain. Also, R&D is expanding the range of injectable drugs that can be self-administered, particularly in areas such as biologics, insulin, and cancer therapies, which increases the market potential. The integration of connectivity features, enabling patients to share real-time data with healthcare providers, further enhances the personalized treatment experience and aligns with the global shift toward patient-centered care. As pharmaceutical companies and device manufacturers invest in cutting-edge technologies, these advancements not only broaden the application of self-injection devices but also drive adoption and open new growth avenues in the global market.
For instance,
In May 2023, according to the article published in Springer, the SMARTCLIC/CLICWISE injection device, an electromechanical auto injector developed by PHC Corporation (Tokyo, Japan), was recently introduced for subcutaneous administration of biologic therapies. The research and development program for this device was strategically designed to create a user-friendly, multi-use auto injector specifically for single-patient applications. This innovation aims to offer patients and caregivers an advanced administration option, expanding beyond traditional self-injection methods such as vials with empty syringes, prefilled pens or syringes, and earlier auto injector models.
Restraints/Challenges
- High Cost of Self Injectors
The high cost of self-injectors acts as a significant restraint in the global self-injections market by limiting accessibility for many patients and healthcare providers. Despite their convenience and potential to reduce hospital visits, the premium pricing of advanced self-injection devices, such as auto-injectors and wearable systems, makes them unaffordable for a large portion of the population, particularly in low-income regions or for those without comprehensive insurance coverage. This financial barrier often leads to reduced patient adherence to prescribed treatments, as many cannot afford the necessary devices for long-term use. Also, healthcare systems may be hesitant to invest in these high-cost solutions, which further slows their adoption and market penetration. Addressing the issue of affordability is therefore essential to broadening the reach and effectiveness of self-injection technologies.
For instance,
In July 2022, according to the article published in NCBI, for patients at risk of anaphylaxis, the high cost of epinephrine auto-injectors poses a significant barrier to accessing this life-saving treatment. Between 2014 and 2020, the list price of the leading auto-injector, the branded EpiPen, tripled, while annual out-of-pocket expenses for privately insured individuals doubled. In 2019, median out-of-pocket costs per two-pack were USD 736 for Auvi-Q, USD 63 for branded EpiPen, and just USD 10 for non-branded alternatives. Overall, in 2019, the annual out-of-pocket spending on epinephrine auto-injectors was USD 200 for 96,073 patients (50.8%), while it exceeded USD 500 for 11,863 patients (9.5%). This high cost of self-injection significantly impacts patient access and adherence to necessary treatment.
- Regulatory Hurdles and Need for Proper Training for Self-Injection Devices
Regulatory hurdles and the need for proper training act as significant restraints in the global self-injections market, slowing down both product availability and adoption. Stringent regulations and varying approval processes across different countries can delay the launch of innovative self-injection devices, as manufacturers must navigate complex and time-consuming approval pathways. This not only hampers innovation but also restricts the global reach of these products. Also, even after regulatory approval, the need for proper training becomes a barrier. Self-injection devices require patients and healthcare providers to be well-versed in their use to ensure safety and efficacy. Without comprehensive training programs, patients may misuse the devices, leading to improper dosing, health risks, and reduced treatment adherence. Healthcare providers must also invest time and resources into educating patients, which can be a burden in already stretched healthcare systems. The lack of widespread training infrastructure, especially in developing regions, further limits the potential growth of the self-injection market. Therefore, both regulatory complexities and the demand for patient education are key factors holding back the market's expansion.
For instance,
In December 2022, according to the article published in NCBI, the design of pen injectors is subject to strict regulations from various government bodies, including the US Food and Drug Administration, and must adhere to industry standards such as ISO 11608 and ISO 60601. These regulations require extensive testing to ensure that the delivered dose matches the set dose, especially for multidose pen injectors. In addition, manufacturers must conduct biocompatibility testing for all components of the device and the formulation, assessing potential leachables or extractables and their impact on the insulin formulation. Other regulatory considerations include shelf-life stability, the effects of environmental conditions on device performance, sterilization, usability testing, and visual inspection capabilities. For smart pens with electronic components, testing must also account for performance under various environmental conditions, such as heat and humidity, to ensure safety and accuracy.
This market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.
Self-Injections Market Scope
The market is segmented on the basis of product type, dosage form, route of administration, application, age group, gender and distribution channel. The growth amongst these segments will help you analyze meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.
Product Type
- Self-Injection Devices
- Auto Injectors
- Disposable
- Reusable
- Pen Injectors
- Disposable
- Reusable
- Wearable Injectors
- Disposable
- Reusable
- Needle-Free Injectors
- Disposable
- Reusable
- Auto Injectors
- Self-Injection Formulation
Dosage Form
- Single Dose
- Multi-Dose
Route of Administration
- Subcutaneous
- Intra muscular
- Others
Application
- Autoimmune Diseases
- Diabetes
- Psoriasis
- Multiple Sclerosis
- Others
- Pain Management
- Emergency Drugs
- Respiratory Therapy
- Migraine
- Anaphylactic Shock
- Others
- Oncology
- Hormonal Disorders
- Osteoporosis
- Hypogonadism
- Adrenal Insufficiency
- Others
- Others
Age Group
- Adult
- Geriatric
- Pediatric
Gender
- Male
- Female
Distribution Channel
- Direct Tender
- Hospital Pharmacy
- Online Pharmacy
- Others
Self-Injections Market Regional Analysis
The market is analyzed and market size insights and trends are provided by country, product type, dosage form, route of administration, application, age group, gender and distribution channel as referenced above.
The countries covered in the market are U.S., Canada, and Mexico.
U.S. is expected to dominate the market due to its advanced healthcare infrastructure, high prevalence of chronic diseases, and strong adoption of innovative medical technologies.
The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points like down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of North America brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.
Self-Injections Market Share
The market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, North America presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to market.
Self-Injections Market Leaders Operating in the Market Are:
- Bayer AG (Germany)
- UCB Pharma (Belgium)
- Ipsen Biopharmaceuticals, Inc. (France)
- Teva Pharmaceuticals Industries Ltd (Israel)
- Recipharm AB (Sweden)
- SCHOTT Pharma (Germany)
- Lilly (U.S.)
- AstraZeneca (U.K.)
- Takeda Pharmaceuticals Company Limited (Japan)
- Novartis AG (Switzerland)
- Pfizer Inc. (U.S.)
- Sanofi (France)
- AbbVie (U.S.)
- Biogen (U.S.)
- YPSOMED (Switzerland)
- Bausch Health Companies Inc. (Canada)
- Merck & Co. (U.S.)
- Amgen Inc. (U.S.)
- Johnson & Johnson Services, Inc. (U.S.)
- Penjet (U.S.)
- PharmaJet (U.S.)
- Societe Industrielle de Sonceboz SA (Switzerland)
- Terumo Corporation (Japan)
- Haselmeier (Germany)
- Owen Mumford (U.K.)
- Midas Pharma GmbH (Germany)
- BD (U.S.)
- Phillips-Medisize (U.S.)
- West Pharmaceutical Services (U.S.)
- Gerresheimer AG (Germany)
- Enable Injections (U.S.)
- Credence Medsystems, Inc. (U.S.)
- Nemera (France)
- Oval Medical Technologies Ltd. (SMC Limited) (U.K.)
- SHL Medical AG (Switzerland)
- Novo Nordisk A/S (Denmark)
- AptarGroup, Inc. (U.S.)
- Boehringer Ingelheim International GmbH (Germany)
- F. Hoffmann-La Roche Ltd (Switzerland)
- GSK plc (U.K.)
Latest Developments in Self-Injections Market
- In September 2024, Evotec shares jumped 6% after announcing a technology development partnership with Novo Nordisk centered on cell therapy. The collaboration involves funding for development activities in Germany and Italy, along with upfront payments, potential milestone achievements, and royalty incentives. Dr. Cord Dohrmann, Evotec's Chief Scientific Officer, expressed optimism about creating innovative stem cell-based therapies through this partnership
- In September 2024, Tremfya (guselkumab) was FDA-approved for adults with moderately to severely active ulcerative colitis, in addition to its approvals for plaque psoriasis and psoriatic arthritis. It is the first dual-acting interleukin-23 inhibitor for this condition, showing significant remission rates in the QUASAR study. Administered as a 200 mg intravenous induction dose, it follows with subcutaneous maintenance doses of 100 mg every 8 weeks or 200 mg every 4 weeks. This approval highlights Johnson & Johnson's commitment to advancing treatments for inflammatory bowel disease
- In July 2024, Biogen has acquired Human Immunology Biosciences (HI-Bio), enhancing its immunology pipeline with felzartamab, a promising therapeutic candidate. The acquisition will advance felzartamab into Phase 3 trials for various indications. Positive interim results have been reported in Phase 2 studies for IgA nephropathy and antibody-mediated rejection
- In July 2024, Biogen has acquired Human Immunology Biosciences (HI-Bio), enhancing its immunology pipeline with felzartamab, a promising therapeutic candidate. The acquisition will advance felzartamab into Phase 3 trials for various indications. Positive interim results have been reported in Phase 2 studies for IgA nephropathy and antibody-mediated rejection
- In July 2024, AstraZeneca had successfully acquired Amolyt Pharma for up to USD 1.05 billion, enhancing its Alexion Rare Disease pipeline. This includes the Phase III peptide eneboparatide for hypoparathyroidism, expanding AstraZeneca's focus on rare endocrine diseases and calcium regulation treatments
- In June 2024, Aptar Digital Health partnered with SHL Medical to enhance connected device technologies by integrating its SaMD platform. This collaboration aimed to improve the patient experience during self-administration of injectable therapies, supporting better adherence and disease management for patients
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