North America Self-Injections Market Size, Share, and Trends Analysis Report – Industry Trends and Forecast to 2031

Análise de mercado de autoinjeções

O mercado norte-americano de autoinjeções é impulsionado pelo aumento da prevalência de doenças crónicas , pelo avanço tecnológico nas autoinjeções, pelo aumento da autonomia dos doentes e pelo aumento das aplicações móveis de saúde . O mercado é caracterizado pela presença de players importantes, investigação e desenvolvimento contínuos e colaborações estratégicas. A expansão do mercado é também apoiada por ambientes regulamentares favoráveis ​​e pelo aumento dos gastos em saúde. Os dispositivos de autoinjeção, incluindo autoinjetores , injetores de caneta e injetores vestíveis , estão a tornar-se mais populares devido à sua conveniência, facilidade de utilização e capacidade de melhorar a adesão dos doentes, permitindo que os indivíduos administrem os seus próprios medicamentos em casa, reduzindo a necessidade para consultas de saúde frequentes. As inovações tecnológicas, como os dispositivos conectados que rastreiam e monitorizam a adesão dos doentes, estão a alimentar ainda mais o crescimento do mercado.

Tamanho do mercado de autoinjeções

O tamanho do mercado de autoinjeções na América do Norte foi avaliado em 19,52 mil milhões de dólares em 2023 e deverá atingir os 41,75 mil milhões de dólares até 2031, com um CAGR de 10,2% durante o período de previsão de 2024 a 2031 . Além dos insights sobre cenários de mercado como como valor de mercado, taxa de crescimento, segmentação, cobertura geográfica e grandes players, os relatórios de mercado com curadoria da Data Bridge Market Research também incluem análises especializadas aprofundadas, epidemiologia de pacientes, análise de pipeline , análise de preços e enquadramento regulamentar.

Tendências do mercado das autoinjeções

“Aumente o foco em dispositivos fáceis de utilizar e descartáveis”

Uma tendência chave no mercado de autoinjeção da América do Norte é a crescente procura por dispositivos descartáveis ​​e fáceis de utilizar. À medida que mais doentes gerem condições crónicas como a diabetes, a artrite reumatoide e a esclerose múltipla, há uma necessidade crescente de sistemas de autoadministração fáceis de utilizar. Os dispositivos de autoinjeção, como os autoinjetores e as seringas pré-cheias, são concebidos para melhorar a adesão do doente, simplificando o processo de injeção. Esta tendência está alinhada com uma mudança mais ampla em direcção aos cuidados domiciliários, onde os doentes são encorajados a assumir mais controlo sobre os seus regimes de tratamento, reduzindo a necessidade de visitas frequentes aos estabelecimentos de saúde.

Além disso, os avanços tecnológicos estão a impulsionar a inovação neste mercado. Os fabricantes estão a incorporar características inteligentes, como o rastreio de dose e feedback em tempo real, nos dispositivos de autoinjeção. Estas características são especialmente benéficas para os doentes que necessitam de injeções frequentes, pois melhoram a precisão e reduzem o risco de subdosagem ou sobredosagem. A combinação de maior segurança, conveniência e integração digital irá provavelmente acelerar a adoção de dispositivos de autoinjeção na América do Norte, especialmente em regiões com populações crescentes de doentes e uma crescente consciencialização sobre os cuidados de saúde.

Âmbito do relatório e segmentação        do mercado de autoinjeções

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

O mercado está segmentado com base no tipo de produto, forma farmacêutica, via de administração, aplicação, faixa etária, sexo e canal de distribuição. O crescimento entre estes segmentos irá ajudá-lo a analisar os escassos segmentos de crescimento nas indústrias e fornecer aos utilizadores uma valiosa visão geral do mercado e insights de mercado para os ajudar a tomar decisões estratégicas para identificar as principais aplicações do mercado.

Tipo de produto

• Dispositivos de autoinjeção
  •  Injetores automáticos
    • Descartável
    • Reutilizável
  •  Injetores de caneta
    • Descartável
    • Reutilizável
  •  Injetores vestíveis
    • Descartável
    • Reutilizável
  •  Injetores sem agulha
    • Descartável
    • Reutilizável
•  Formulação de autoinjeção

Forma farmacêutica

• Dose única
• Multidose

Rota de Administração

• Subcutâneo
• Intramuscular
• Outros

Aplicação

• Doenças Autoimunes
  • Diabetes
  •  Psoríase
  •  Esclerose múltipla
  •  Outros
•  Gestão da dor
• Medicamentos de Emergência
  • Terapia Respiratória
  •  Enxaqueca
  •  Choque Anafilático
  •  Outros
•  Oncologia
•  Distúrbios hormonais
  • Osteoporose
  •  Hipogonadismo
  •  Insuficiência Adrenal
  •  Outros
•  Outros

Faixa etária

• Adulto
• Geriátrico
• Pediátrico

Género

• Macho
• Fêmea

Canal de distribuição

• Concurso Direto
• Farmácia Hospitalar
• Farmácia on-line
• Outros

Análise regional do mercado de autoinjeções

O mercado é analisado e são fornecidos insights e tendências do tamanho do mercado por país, tipo de produto, forma farmacêutica, via de administração, aplicação, faixa etária, género e canal de distribuição como mencionado acima.

Os países abrangidos no mercado são os EUA, Canadá e México.

Espera-se que os EUA dominem o mercado devido à sua infraestrutura de saúde avançada, à elevada prevalência de doenças crónicas e à forte adoção de tecnologias médicas inovadoras.

A secção do país do relatório também fornece fatores individuais de impacto no mercado e alterações na regulamentação do mercado interno que impactam as tendências atuais e futuras do mercado. Pontos de dados como a análise da cadeia de valor a jusante e a montante, tendências técnicas e análise das cinco forças de Porter, estudos de caso são alguns dos indicadores utilizados para prever o cenário de mercado para países individuais. Além disso, são considerados a presença e disponibilidade de marcas da América do Norte e os desafios enfrentados devido à grande ou escassa concorrência de marcas locais e nacionais, o impacto das tarifas domésticas e das rotas comerciais, ao mesmo tempo que se fornece uma análise de previsão dos dados do país.

Participação no mercado de autoinjeções

O cenário competitivo do mercado fornece detalhes por concorrente. Os detalhes incluídos são a visão geral da empresa, finanças da empresa, receitas geradas, potencial de mercado, investimento em investigação e desenvolvimento, novas iniciativas de mercado, presença na América do Norte, localizações e instalações de produção, capacidades de produção, pontos fortes e fracos da empresa, lançamento de produtos, largura e amplitude do produto, domínio da aplicação. Os dados acima fornecidos estão apenas relacionados com o foco das empresas em relação ao mercado.

Os líderes de mercado de autoinjeções que operam no mercado são:

• Bayer AG (Alemanha)
• UCB Pharma (Bélgica)
• Ipsen Biopharmaceuticals, Inc. (França)
• Teva Pharmaceuticals Industries Ltd (Israel)
• Recipharm AB (Suécia)
• SCHOTT Pharma (Alemanha)
• Lily (EUA)
• AstraZeneca (Reino Unido)
• Takeda Pharmaceuticals Company Limited (Japão)
• 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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