Autoinjectors Market Size, Share & Industry Analysis, By Type (Disposable and Reusable), By Application (Autoimmune Disorders, Diabetes, Emergency Care, and Others), By Route of Administration (Intramuscular and Subcutaneous), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies), and Regional Forecast, 2024-2032

The global autoinjectors market size was valued at USD 120.21 billion in 2023. The market is projected to grow from USD 131.45 billion in 2024 to USD 311.33 billion by 2032, exhibiting a CAGR of 11.4% during the forecast period.

Autoinjectors are spring-loaded devices with a pre-filled syringe to self-administer a fixed dose of parenteral medicines in a patient. These devices treat selected chronic diseases, such as rheumatoid arthritis, multiple sclerosis, and emergency treatments, including anaphylactic shock and migraine attacks. The incidence rate of emergency conditions, such as anaphylactic shock and migraine attacks, is increasing due to several causative agents, such as food allergens, insect bites, or drug insensitivity, across the globe. Owing to the rising incidence, there is a substantial demand for biological therapies to treat chronic diseases.

• According to an article published by NCBI in 2022, the general prevalence of anaphylaxis ranged between 0.3% – 5.1%, with an incidence of 50–112 cases per 100,000 population per year.

Thus, pharma companies are now introducing self-administration therapies to ensure patient dose compliance and easy route of administration. Several self-injection devices, such as jet injectors, pens, autoinjectors, and pre-filled syringes are being developed by leading players for delivering medications, such as injectable vaccines and chronic disease medications.

The adoption of these devices for emergency and chronic disease therapy among the population is increasing owing to potential advantages such as easy administration and high accuracy and compliance. Thus, the rising prevalence of chronic diseases across the globe and the increasing adoption of self-injection devices among patients is expected to augment market growth over the forecast period.

MARKET DYNAMICS

Market Drivers

Rising Prevalence of Chronic Diseases to Propel Market Growth

The rising prevalence of chronic diseases, such as diabetes, rheumatoid arthritis, and multiple sclerosis is significantly boosting the demand for autoinjectors. These conditions often require regular, self-administered injections, making them an ideal solution due to their ease of use, precision, and convenience.

• According to Anaphylaxis Campaign U.K., with a rise in allergic diseases during the last 60 years, the prevalence of allergies is expected to rise to 4.0 billion by 2050. The above factors are leading to rising demand for drugs, including autoinjectors, for the treatment of anaphylaxis and other critical conditions. This demand is owed to the clinical benefits of these devices over other injectable drug delivery systems

Additionally, they help reduce dependency on healthcare facilities, allowing patients to manage their treatment at home. This improves patient compliance and also addresses the growing demand for home healthcare solutions. As chronic disease rates continue to climb globally, the autoinjector market is set for sustained growth, driven by innovation and enhanced patient self-management capabilities.

Market Restraints

Limited Availability of Adrenaline Autoinjectors across Developing Countries to Hamper Market

Adrenaline (epinephrine) is the first-line treatment for anaphylaxis by healthcare professionals. However, despite its pivotal role, the autoinjectable formulation is not readily available in most countries, thus preventing optimal management of patients with anaphylaxis. Similarly, the lack of availability of this emergency medication for immediate injection in an anaphylactic reaction increases the risk of progression to a severe episode and death.

• According to an article published by UpToDate, in February 2023, deaths reported due to anaphylaxis have annual rates of 0.21 to 0.76 per million population in the U.S.


• For instance, as per data published by the National Center for Biotechnology Information in April 2020, only 32% of the world’s 195 countries, predominantly high-income ones, have access to adrenaline autoinjectors for use in first-aid treatment.

Moreover, these devices lack extensive availability through official distribution networks, such as retail or drugstore pharmacies across the globe. Similarly, these devices are only obtained through special licensing arrangements and distribution on a named-patient basis across several developing countries.

• According to an article published by Esmon Publicidad in 2021, the availability of autoinjectors for emergency treatment of anaphylaxis was limited to 32.0% of the 195 countries globally, most of which were high-income countries.

Thus, scarcity of epinephrine injection devices across distribution channels at retail pharmacies, leading to less adoption of autoinjectors among patients, may hamper the market growth.

Other Prominent Restraints:

• High Costs Associated with Autoinjector Devices


• Regulatory Complexities and Product Recalls 

Market Opportunities

Technological Advancements in Device Platforms to Offer Lucrative Opportunities

The demand for autoinjectors is rising across the globe owing to increasing incidence rates of chronic diseases such as diabetes and rheumatoid arthritis. Thus, owing to the high incidence, several market players are shifting their focus toward the development of platform device technologies to support faster development and lessen device costs. Moreover, the rising focus of key players to enable high-volume delivery of a range of biosimilars and biologics for patients in home settings will drive market growth.

• In September 2021, Owen Mumford Pharmaceutical Services, a division of Owen Mumford Ltd., launched the Aidaptus autoinjector platform. Aidaptus is a 2-step, single-use autoinjector that accommodates both 1mL and 2.25 mL pre-filled glass syringes in the same base device.

Moreover, the production and introduction of reusable technologically advanced platforms supporting the emerging prioritization of sustainable drug delivery within the pharmaceutical industry are increasing. Similarly, key players are now emphasizing adding new devices to their existing product portfolio to enable self-administration by patients for larger-volume medications. The increasing launches of autoinjectors with a wide range of applications across different medical conditions, such as cancers and autoimmune disorders, will further propel the presence of these devices across developed nations.

• In May 2022, Jabil Healthcare, a division of Jabil Inc., announced the launch of the Qfinity autoinjector platform, a simple, reusable, and modular solution for subcutaneous drug self-administration at a lower cost than market alternatives.

Therefore, the rising production of self-injection devices by key players is boosting the introduction of advanced devices across the globe, further propelling market growth.

Other Prominent Opportunities:

• Expansion in Emerging Markets to Adopt the Autoinjectors

Market Challenges

Manufacturing Complexities and Quality Control Issues Pose as Growth Barriers

The autoinjector market faces significant challenges due to the complexities involved in manufacturing and stringent quality control requirements. This device need precise engineering to deliver medications accurately, which demands advanced production processes and specialized equipment. Even minor defects or malfunctions can impact dosage accuracy, compromising patient safety.

Quality control is thus paramount, but it is also time-intensive and costly. Ensuring every device meets strict regulatory standards for reliability and performance adds to production complexity. This becomes more pronounced as demand rises for devices that accommodate various medication types and viscosities.

Additionally, any recalls due to quality issues can damage brand reputation and lead to financial losses. These challenges underscore the need for rigorous quality assurance and investment in manufacturing technology to meet evolving market demands. Furthermore, maintaining sterility and usability is expected to hinder the adoption of such devices.

Other Prominent Challenges:

• Awareness and Training Requirements: Proper use of autoinjectors requires patient education and training, which can be a challenge, especially in less-developed healthcare settings.

AUTOINJECTORS MARKET TRENDS

Broad Adoption of Disposable Autoinjectors among Patients to Boost Market Growth

Healthcare professionals have utilized injection systems as convenient drug delivery devices for treating patients by subcutaneous injections. However, challenges associated with conventional injection devices, such as needle stick injury, multiple low-dose injections, and high costs associated with recurrent hospital visits, limited their preference among patients.

Thus, several market players are focused on developing and launching self-injection and wearable devices with high efficacy, patient compliance, and low cost. These products comprise accurate dosage volumes and already reconstituted drugs, with minimized chances of needle stick injuries. Such potential advantages of autoinjectors over other conventional devices drive patient adoption and adherence to these devices.

• According to an article published by INJECTABLE DRUG DELIVERY in May 2022, the annual volume of sales of disposable autoinjectors is estimated to be above 100.0 million.

In addition, supportive regulatory authorities leading to several industry players receiving regulatory approvals for disposable products for the treatment of various types of medical conditions.

• For instance, in January 2023, the European Commission granted approval for AstraZeneca’s Tezspire (tezepelumab) used for the treatment of asthma.

Other Prominent Trends:

• Technological Innovations: Advanced technologies are transforming autoinjectors, making them safer, more reliable, and easier to use. Features such as connectivity enable remote monitoring, while automatic dose adjustments improve treatment precision, driving demand for smart autoinjectors.


• Personalization in Autoinjectors: Customizable designs tailored to patient needs, such as adjustable needle lengths and ergonomic grips, enhance user experience, especially for patients with dexterity issues, improving adherence and outcomes.


• Focus on Sustainability: Companies are increasingly adopting eco-friendly materials and recyclable components in autoinjector production, aligning with global environmental goals and responding to consumer demand for greener healthcare products.


• Growing Preference for Home Healthcare: Autoinjectors enable patients to self-administer treatments conveniently at home, reducing healthcare visits and supporting the broader shift toward at-home care solutions, especially for chronic conditions.

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IMPACT OF COVID-19

The COVID-19 pandemic decreased the growth of the global market in 2020 as several regions witnessed restrictions in accessing medical care and treatments due to lockdowns. Due to which, the number of patient visits to hospitals and healthcare centers limited the disease diagnosis rate and treatments. Moreover, international supply chain disruptions amid the pandemic led to shortages of critical medical devices.

• According to results published by NCBI of a cohort study in August 2022, emergency department visit volumes across an estimated 150 million hospital-based emergency departments in the U.S. declined by 18% in 2020.

However, the resurgence of routine healthcare services after the initial COVID-19 shutdown and patient visits to healthcare centers increased globally. Moreover, rising patient focus on home healthcare and remote patient management propelled the market growth. The rising production of high-efficacy devices by market players and their growing sales across developing countries further boosted the market share.

• According to Viatris annual report estimates, in 2021, the EpiPen autoinjector sales increased from USD 307.6 million in 2020 to 378.0 million in 2021.

Thus, the rebound in diagnosis and treatment of chronic diseases, post-pandemic, coupled with the high adoption of these devices, will impact its long-term implications, thereby boosting the demand and adoption of these devices.

SEGMENTATION ANALYSIS

By Type

High Emphasis of Key Players on Device Launches to Cater to Disposable Segment Growth

By type, the market is segmented into disposable and reusable.

The disposable segment accounted for the largest market share in 2023. This growth is attributed to the rising prevalence of chronic diseases across the globe, recommendation of disposable devices by healthcare professionals, and the high preference for single-use devices by patients.

• According to an article published by Sciencedirect in October 2021, among 80 autoinjector devices launched by several manufacturers, out of them 62.0% were disposable devices.

In addition, industry players' rising focus on launching innovative disposable devices and rising product approvals by regulatory agencies further propelled the segment share.

• In August 2022, Rafa Laboratories, Ltd. announced that it had received FDA approval for its 10mg Midazolam autoinjector for treating status epilepticus or prolonged seizures.

The reusable segment is estimated to register a comparatively higher CAGR over the projected period. The segment growth is driven by high potential advantages over disposable devices, such as ease of use, cost-effectiveness, and high safety. Moreover, rising emphasis by several key players on the introduction of devices to facilitate the growing market for subcutaneous injections used to treat chronic diseases such as rheumatoid arthritis, Crohn’s’ disease, and multiple sclerosis is primarily contributing to the segment growth.

• In May 2021, Phillips-Medisize, a leader in drug delivery, diagnostic, and MedTech devices, launched the Aria Smart Autoinjector platform to unlock innovation in the digital drug-delivery device market. The latest launch comprised a small, smart injection device featuring a reusable electronic drive unit to elevate patient care while reducing the environmental impact.

Several market players are focusing on the development of reusable auto-injectors as a low-waste alternative.

• For instance, in June 2022, Jabil Healthcare introduced the Qfinity autoinjector platform, which is a reusable and modular solution designed for the self-administration of subcutaneous drugs.

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By Application

Increasing Demand for Insulin Injectable Led to Diabetes Segment Growth

Based on application, the market is segmented into autoimmune disorders, diabetes, emergency care, and others.

By application, the diabetes segment accounted for the highest autoinjectors market share in 2023. The increasing demand for injectable insulin among the rising diabetes population and initiatives by leading players to develop novel products to cater to the demand for diabetes management leads to the segment’s dominance.

• In July 2020, Xeris Pharmaceuticals, Inc., a pioneer in ready-to-use injectable and infusible drug formulations, announced that Gvoke HypoPen (glucagon injection). It is available by prescription in the U.S. for the treatment of severe hypoglycemia in adults and children suffering from diabetes ages two years and above. Gvoke HypoPen is the first ready-to-use glucagon in a premixed autoinjector with no visible needle.

On the other hand, the emergency care segment is projected to register a significant CAGR during the forecast period. The growth is attributable to a high incidence rate of anaphylactic episodes among the population due to specific causative agents such as food allergens, insect bites, and drug hypersensitivity and rising demand for self-injection devices for the treatment of anaphylaxis.

• As per Allergy & Asthma Network statistics, the prevalence rate of anaphylaxis in the U.S. population is between 1.6% and 5.1%. Among the causative agents, medication allergy to non-steroidal anti-inflammatories (NSAIDs) constituted the most common factor for anaphylaxis (34.0%), followed by food allergy (31.0%).

Furthermore, some of the government authorities are funding autoinjectors for emergency treatment of anaphylaxis.

• For instance, as per data provided by pharmac.govt.nz in December 2022, the government of New Zealand has decided to fund adrenaline auto-injectors from February 2023 for the emergency treatment of anaphylaxis.

By Route of Administration

High Potential Advantages of Intramuscular Administration to Boost its Adoption

On the basis of route of administration, the global market is segmented into intramuscular and subcutaneous.

The intramuscular segment held a higher share of the market in 2023 due to the high potential advantages of intramuscular products, such as rapid onset of action, convenience, and minimal pain among patients. Similarly, the high adoption of intramuscular injections among healthcare professionals for pediatric patients further boosts the segment share of the global market.

• According to a study article published by NCBI in 2021, the intramuscular injection of adrenaline autoinjectors could achieve greater results owing to its rapid action as compared to the subcutaneous route among patients.

The subcutaneous segment is set to register a relatively higher CAGR during 2024-2032, owing to increasing demand for self-administration devices among home-use patients. Similarly, the rising production of subcutaneous devices by key players and increasing regulatory approvals of autoinjectors owing to high demand further propels the segment growth.

• For instance, in February 2024, Eisai Co., Ltd. and Nippon Medac Co., Ltd. unveiled that its Metoject Subcutaneous Injection Pen received manufacturing and marketing approval in Japan by its regulatory authority.


• In February 2023, AstraZeneca and Amgen announced the launch of Tezspire (tezepelumab) subcutaneous autoinjector in the U.S. for self-administration in patients aged 12 years and older with severe asthma.

By Distribution Channel

Rising Hospital Visits for Chronic Disorders to Boost Uptake of Autoinjectors

Based on distribution channel, the market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies.

The hospital pharmacies segment accounted for the highest market share in 2023. The segment’s leading position can be credited to the rising prevalence of chronic diseases, such as diabetes and rheumatoid arthritis, among the geriatric population and increasing hospital visits for diagnosis and treatment. Moreover, rising emergency cases in hospital settings owing to several factors, such as hospital-acquired infections and drug-induced anaphylaxis, among others, also boosted the use of these devices.

• According to an article published by Anaphylaxis UK, in 2020, the NHS hospital admissions for anaphylactic shock in adults had increased from 3,751 to 4,756 from 2019 to 2020. Similar estimates showed that the number of adult patients admitted to the hospital due to allergies was 27,172 in 2020.


• According to an article published by Karger International, in 2020, approximately 1 in 3,000 hospitalized patients suffered from drug-induced anaphylaxis across the globe.

Retail pharmacies are expected to grow at a significant CAGR during the forecast period. The growth is attributable to key players' rising focus on enhancing sales and distribution networks of these devices across developing countries.

AUTOINJECTORS MARKET REGIONAL OUTLOOK 

Based on region, the market can be divided into Europe, Latin America, North America, Asia Pacific, and the Middle East & Africa.

North America

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North America’s market was valued at USD 71.17 billion in 2023 and is expected to lead in the forthcoming years. The region witnesses an increase in R&D and the introduction of new technologies in self-injection devices by key players to support in-patient treatment. Moreover, healthcare professionals' emphasize and recommend autoinjector prescriptions against anaphylactic episodes. Additionally, advanced healthcare and increasing chronic disease cases in the region are expected to increase demand for these drug delivery systems, thereby propelling the market size in the coming years.

• According to the Medical Device Network Statistics, the average prescription rate for epinephrine autoinjectors to peanut allergy patients in the U.S. is around 90.0%.

Europe

Europe was the second most dominated region in terms of revenue and market share in 2023. The market held a significant share due to increasing collaborations among manufacturing players to boost production, and rising approvals of new injectables. Moreover, high health expenditure, along with the increasing adoption of advanced drug delivery systems, such as self-administration delivery systems is expected to boost the region’s autoinjectors market growth.

• For instance, in January 2024, FUJIFILM Diosynth Biotechnologies signed a strategic partnership agreement with SHL Medical to enhance its autoinjector services.

Asia Pacific

In Asia Pacific, the market’s growth is driven by the growing prevalence of chronic disorders amongst the population. The region is anticipated to observe the fastest CAGR over the forecast period against the backdrop of huge demand for emergency care at home settings. Furthermore, increasing healthcare awareness, and government initiatives is expected to propel the market growth in the region.

• As per data published by Frontiers Media S.A. in October 2022, the prevalence of rheumatoid arthritis is estimated to be 0.2% – 0.3% in China, with approximately 3.0 million patients.

Latin America & the Middle East & Africa

Latin America & the Middle East & Africa is expected to grow at a significant CAGR during the forecast period. The region's growth is due to rising chronic disease prevalence amongst the population and the high adoption of these devices by patients in home care settings. Furthermore, the countries in these regions are emerging markets with a growing healthcare focus due to rising diagnosis and treatment rates of anaphylaxis, creating demand for these devices.

TRADE PROTECTIONISM AND REGULATORY LANDSCAPE

The global regulatory landscape for autoinjectors is stringent, with regional differences influencing market entry and compliance. U.S. FDA regulations enforce strict standards on safety, efficacy, and labeling, particularly through the FDA 510(k) clearance process, which requires manufacturers to demonstrate device equivalency to previously approved models. This adds complexity and time to market entry, impacting innovation speed. In Europe, the European Medical Device Regulation (MDR) imposes rigorous requirements that can be costly for smaller manufacturers, limiting their market access and increasing compliance costs.

Trade policies and protectionism further affect the autoinjector market by raising production costs through tariffs, impacting supply chain efficiency and material costs. These factors create a challenging landscape, particularly for international players. Additionally, intellectual property and patent issues play a critical role in market dynamics, as patents provide competitive advantages and create barriers for new entrants, making market entry and growth particularly difficult without significant IP assets.

RESEARCH AND DEVELOPMENT

The key players in the market are focusing on R&D in order to innovate in drug delivery precision and patient comfort. Furthermore, companies also focus on improvements in device design and patient usability. The integration of mobile applications with autoinjectors is a significant research and development. These smart devices can track, provide reminders, medication usage, and share data with doctors, enhancing patient monitoring.

• For instance, in February 2022, the U.S. Food and Drug Administration (FDA) approved a 10mg naloxone autoinjector designed for non-medically trained users to protect service members against ultra-potent opioids.

Furthermore, companies are increasing their R&D budgets to enhance device capabilities, and develop smaller and compact devices. Compact devices are easy to carry, which is convenient for patients.

FUTURE OUTLOOK AND GROWTH OPPORTUNITIES

The future outlook for the autoinjectors market is promising, with significant growth projected over the forecast period. It indicates steady revenue increases and a robust CAGR of 11.4%, driven by rising demand for at-home treatment options and chronic disease management.

Emerging markets in Asia Pacific and Latin America are expected to be key growth areas due to increasing healthcare investments and expanding access to advanced medical devices, fueling the adoption of these devices. Technological advancements are anticipated to enhance device capabilities, particularly with innovations in digital health, such as smart autoinjectors and mobile-integrated monitoring, which improve patient compliance and treatment outcomes.

Meanwhile, a focus on sustainability and eco-friendly initiatives is driving manufacturers to adopt greener practices, such as recyclable materials and reduced waste in production. This aligns with global environmental goals and consumer demand for sustainable healthcare solutions.

COMPETITIVE LANDSCAPE

Key Market Players

Leading Companies Focus on Adoption of Various Organic and Inorganic Growth Strategies to Maintain Their Positions

The global market is majorly led by producers such as Viatris, Bristol-Myers Squibb, Teva Pharmaceutical Industries Ltd., and other prominent players. Leading market participants are concentrating on increasing investments in device production centers and rising collaborations and acquisitions owing to the huge demand for these devices globally.

• In July 2023, Viatris Inc. and Kindeva Drug Delivery L.P., a manufacturer of complex drug-delivery formats, including autoinjectors and other injectables, announced the launch of Breyna inhalation aerosol, the first generic version of AstraZeneca's Symbicort. Breyna, a drug-device combination product, is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD).

Similarly, other major market players, including Recipharm AB, ALK-Abelló A/S, and Phillips-Medisize are constantly focused on inorganic developments, such as enhancing their distribution channel across the global market through strategic partnerships and extensive product approvals. Such initiatives by key players are projected to propel the global market and register growth by 2032.

• In July 2021, ALK-Abelló A/S, a Danish allergy immunotherapy company, announced a licensing agreement with China Grand Pharmaceutical and Healthcare Holdings (Grandpharma), which registered and launched ALK’s adrenaline auto-injector (AAI) Jext in China and expanded its presence in the country.

Continuous engagements in the production of devices and a rising focus on enhancing their distribution channels through inorganic strategies to establish their footprints in emerging nations are expected to propel market expansion over the forecast period.

List of Key Autoinjectors Companies Profiled:

• Viatris Inc. (U.S.)


• Teva Pharmaceuticals, Inc. (Netherlands)


• Ypsomed AG (Switzerland)


• Recipharm AB (Sweden)


• Becton Dickinson and Company (U.S.)


• Halozyme, Inc. (U.S.)


• AstraZeneca (U.K.)


• Bristol-Myers Squibb (U.S.)


• Phillips-Medisize (U.S.)


• SHL Medical AG (Switzerland)


• Xeris Pharmaceuticals, Inc. (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• May 2023 - Boehringer Ingelheim International GmbH announced that the U.S. FDA has approved the Cyltezo Pen, an autoinjector option for Cyltezo (adalimumab), an FDA-approved interchangeable biosimilar to Humira.


• September 2023 - Ypsomed has entered a long-term partnership with Novo Nordisk to supply GLP-1 autoinjectors, meeting the high demand for Novo Nordisk’s obesity and diabetes treatments.


• May 2022 - The FDA approved Eli Lilly and Company's Mounjaro (tirzepatide) injection, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The drug is available in six dose forms and will come in a well-established autoinjector.


• April 2022 - Halozyme Therapeutics, Inc., entered into a definitive agreement to acquire Antares Pharma, Inc. The acquisition created a leading drug delivery and specialty product company in the business of autoinjector platforms.


• August 2021 - Gerresheimer AG and Midas Pharma announced a strategic partnership for developing and marketing its new generation autoinjector. The new-generation autoinjector is suitable for subcutaneous injection with up to 3ml injection volume.


• March 2021 - Ipsen Pharma announced that it invested in a new electronic autoinjector for Somatuline Autogel / Somatuline Depot (lanreotide) to deliver further innovation in the class to improve administration and the injection experience for patients.

REPORT COVERAGE

The report provides a detailed market analysis and focuses on crucial aspects such as leading players, product types, and major applications of the product. Additionally, it offers insights into market trends and key industry developments such as mergers, partnerships, and acquisitions. In addition to the factors mentioned above, the report includes the factors that have contributed to the market's growth in recent years with a regional analysis of different segments.

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Report Scope & Segmentation