세계의 의약품 의료기기 조합 제품 시장 규모는 2024년 1,657억 4,000만 달러에 달했습니다. IMARC Group은 향후 이 시장이 2033년까지 2,903억 달러에 달할 전망이며, 2025-2033년 6.4%의 연평균 복합 성장률(CAGR)로 성장할 것으로 예측했습니다. 현재 북미가 시장을 독점하고 있으며 2024년 시장 점유율은 41.7%였습니다. 이 분야의 이점은 확립된 의료 인프라, 강력한 규제 프레임워크, 연구 활동에 대한 높은 투자로 인한 것입니다. 첨단 기술 혁신, 엄청난 헬스케어 지출, 환자의 결과 개선에 대한 관심 증가는 의약품 의료기기 조합 제품 시장 점유율 확대에 더욱 기여하고 있습니다.
규제 당국은 의약품 의료기기 조합 제품의 승인과 시장 진입을 위한 명확한 경로를 서서히 제공하고 있으며, 이러한 솔루션의 창출에 대한 투자를 촉진하고 있습니다. 규제 당국이 지원적인 환경을 정비함으로써 혁신적인 제품이 보다 효과적으로 시장에 진입할 수 있게 되어 시장의 성장에 기여하고 있습니다. 또한 의약품 의료기기 조합 제품은 사용하기 쉽고 투약 과정을 단순화하는 것을 목표로 합니다. 이 사용 편의성 및 자가 투여의 편리성은 만성 질환의 장기 관리에 필수적인 요인인 치료 계획에 대한 환자의 컴플라이언스 향상을 초래합니다. 게다가, 의료기기 및 약물 전달 기술의 진보로 제제의 성능과 효율성이 향상되었습니다. 자동 주사기 및 주입 펌프를 포함한 혁신적인 약물 전달 방식은 보다 정확하고 편리하고 효과적인 치료 옵션을 제공하여 환자 만족도를 높여줍니다.
미국은 의료기기와 의약품의 지속적인 기술 진보에 힘입어 시장에서 중요한 부분이 되고 있습니다. 자동 주사기 및 주입 펌프와 같은 약물 전달 방법의 개발은 의약품 의료기기 조합 제품의 효율성 및 사용 편의성을 향상시킵니다. 예를 들어, 2025년에 FDA는 파킨슨병에 대한 최초의 피하 아포모르핀 주입 장치인 SPN-830(오냅고)을 인가하여 운동의 변동과 OFF 시간을 최소화하는 연속 투여를 가능하게 하고, 치료 옵션을 더욱 늘렸습니다. 이 밖에, 이 나라에서는 충실한 헬스케어 제도와 의학 연구에 다액의 자금이 투입되고 있기 때문에 세련된 의약품 의료기기 조합 제품이 만들어지고 있습니다.
약물 전달 시스템의 기술 진보
자동 주사기, 흡입기, 주입 펌프와 같은 새로운 약물 전달 시스템은 헬스케어 행정을 변화시켜 치료를 더욱 정확하고 편리하며 효과적으로 만듭니다. 이러한 시스템은 표적화된 약물 전달을 가능하게 하며, 환자는 부작용의 위험을 최소화하면서 원하는 치료 결과를 얻을 수 있습니다. 예를 들어, 자동 주사기는 환자 자신이 쉽고 편안하게 치료할 수 있도록 함으로써 매일 투여 관리에 혁명을 일으켜 환자의 자율성을 향상시킵니다. 또한, 흡입기 및 주입 펌프와 같은 장치는 고도로 제어되고 일관된 약물 전달을 제공하며 만성 질환 관리에 특히 중요합니다. 샌드사가 2025년에 발매한 Pyzchiva(R)는 유럽에서 시판된 최초의 우스테키누맙 바이오시밀러 자동 주사기이며, 자기 투여 강화로의 시프트를 부각하고 있습니다. 편안함과 편의성을 향상시키기 위해 고안된이 장치는 특히 만성 염증성 질환의 치료에서 환자의 충격도 향상시킵니다. 그 결과 이러한 혁신은 환자 관리의 형태를 바꿀 뿐만 아니라 의약품 의료기기 조합 제품 시장의 성장을 지원하고 있습니다.
만성 질환의 이환율 증가
심혈관 질환(CVDs), 당뇨병, 암 등 만성 질환의 이환율이 상승하고 있는 것이 복잡한 치료 요건에 맞게 설계된 개별화된 혁신적인 의약품 의료기기 조합 제품에 대한 요구를 높이는 주요 요인이 되고 있습니다. 업계 보고서에 따르면 미국에서는 10명 중 6명이 적어도 하나의 만성 질환을 갖고 있으며, 10명 중 4명이 2개 이상의 만성 질환을 앓고 있다고 합니다. 사망률 통계는 이러한 질병이 세계 인구에 미치는 영향의 크기를 강조합니다. 예를 들어 호주에서는 호주 보건복지연구소에 따르면 국민의 47%가 적어도 하나의 만성질환을 갖고 있으며, 20%가 2개 이상의 만성질환을 가지고 있다고 합니다. 만성 질환의 유병률 증가는 집중적이고 효과적인 치료를 제공할 수 있는 혁신적인 의료 솔루션의 필요성을 강조하고 의약품 의료기기 조합 제품 시장 수요를 견인하고 있습니다. 효율적이고 맞춤화된 치료에 대한 지속적인 요구는 의료 분야에서 이러한 진보의 중요성을 돋보이게 합니다.
노년 인구 증가
세계적인 노인 인구 증가 및 수명의 연장은 노년 의학에서 큰 장애물이 되고, 의약품 의료기기 조합 제품과 같은 정교한 의료 솔루션에 대한 요구가 증가하고 있습니다. 세계보건기구(WHO)는 2030년까지 6명 중 1명이 60세 이상이 되어 14억 명의 노인 인구가 될 전망이라고 발표하고 있습니다. 2050년에는 60세 이상의 인구가 21억 명에 달하고 80세 이상의 인구는 2020년의 3배에 해당하는 4억 2,600만 명이 될 것으로 예상되고 있습니다. 이러한 인구 역학의 변화는 노화와 관련된 문제를 해결하기 위한 보다 효율적인 치료 솔루션의 창출을 필요로 하며, 보다 우수한 치료 전달, 환자 충동 및 우수한 건강 결과를 제공하는 혁신적인 의약품 의료기기 조합 제품에 대한 필요성이 증가하고 있습니다. 그 결과, 고령화가 진행되는 세계 인구에 맞는 솔루션에 대한 수요가 증가함에 따라, 의약품 의료기기 조합 제품에 의한 제품 시장 전망은 여전히 밝습니다.
The global drug device combination products market size was valued at USD 165.74 Billion in 2024. Looking forward, IMARC Group estimates the market to reach USD 290.3 Billion by 2033, exhibiting a CAGR of 6.4% from 2025-2033. North America currently dominates the market, holding a market share of 41.7% in 2024. The dominance of the segment is attributed to its well-established healthcare infrastructure, strong regulatory frameworks, and high investment in research activities. Advanced technological innovations, significant healthcare expenditure, and a growing focus on improving patient outcomes, are further contributing to the expansion of the drug device combination products market share.
Regulatory agencies are progressively offering clear routes for the approval and market entry of drug-device combination products, promoting investment in the creation of these solutions. Supportive regulatory environments enable innovative products to access the market more effectively, contributing to the market growth. Additionally, drug-device combination products are intended to be easy to use, simplifying the process of administering medication. This user-friendliness and the convenience of self-administration result in improved patient compliance with treatment plans, an essential element for the long-term management of chronic illnesses. Furthermore, ongoing advancements in medical devices and drug delivery technologies are improving the performance and efficacy of combination products. Innovative drug delivery methods, including auto-injectors and infusion pumps, provide more accurate, convenient, and effective treatment choices, resulting in higher patient satisfaction.
The United States is a crucial segment in the market, propelled by continuous technological advancements in medical devices and pharmaceuticals. Developments in drug delivery methods, such as auto-injectors and infusion pumps, are enhancing the efficiency and ease of use of drug-device combination products. For instance, in 2025, the FDA authorized SPN-830 (Onapgo), the initial subcutaneous apomorphine infusion device for Parkinson's disease, enabling continuous delivery to minimize motor fluctuations and OFF time, further enhancing treatment choices. Besides this, the robust healthcare system and significant funding in medical research in the country are leading to the creation of sophisticated drug-device combination products.
Technological Advancements in Drug Delivery Systems
New drug delivery systems, including auto-injectors, inhalers, and infusion pumps, are transforming healthcare administration, making treatments more precise, convenient, and effective. These systems enable targeted drug delivery, allowing patients to achieve the desired therapeutic outcomes while minimizing the risk of adverse drug reactions. Auto-injectors, for instance, have revolutionized daily medication management by enabling patients to administer their own treatments easily and comfortably, thereby improving patient autonomy. Additionally, devices like inhalers and infusion pumps offer highly controlled and consistent drug delivery, which is especially critical for managing chronic conditions. The launch of Pyzchiva(R) by Sandoz in 2025, the first ustekinumab biosimilar auto-injector commercially available in Europe, highlights this shift toward enhanced self-administration. The device, designed to improve comfort and convenience, also boosts patient adherence, particularly in treating chronic inflammatory diseases. As a result, these innovations are not only reshaping patient care but also supporting the drug device combination products market growth.
Increasing Prevalence of Chronic Diseases
The rising incidence of chronic illnesses, including cardiovascular diseases (CVDs), diabetes, and cancer, is a major factor driving the need for personalized and innovative drug-device combination products designed for intricate therapeutic requirements. Industry reports indicate that 6 in 10 individuals in America have at least one chronic disease, and 4 in 10 have two or more chronic diseases. Mortality statistics emphasize the extensive influence of these conditions on populations worldwide. In Australia, for example, the Australian Institute of Health and Welfare indicates that 47% of the people have at least one chronic illness, while 20% deal with two or more chronic diseases. The increasing prevalence of chronic diseases underscores the necessity for innovative medical solutions that can provide focused, effective treatment delivery, thus driving the drug-device combination products market demand. The continuous need for efficient, customized treatments highlights the significance of these advancements in the medical field.
Rising Geriatric Population
The worldwide growth of the elderly population and the increase in life span pose major obstacles in gerontology, leading to a higher need for sophisticated medical solutions, such as drug-device combination products. The World Health Organization (WHO) states that by 2030, one out of every six people will be 60 years or older, resulting in an elderly population of 1.4 billion. By 2050, it is anticipated that the worldwide population of individuals aged 60 and older will reach 2.1 billion, while those aged 80 and above are expected to grow to 426 million, which is three times the figure noted in 2020. This change in demographics requires creating more efficient treatment solutions to address age-related issues, fostering the need for innovative drug-device combinations that provide better treatment delivery, patient adherence, and superior health outcomes. As a result, the drug-device combination products market outlook remains highly positive, driven by the growing demand for tailored solutions for the aging global population.
Transdermal patches dominate the market with 24.2%, accredited to their capacity to ensure controlled and reliable drug delivery for a prolonged duration. This approach enhances patient adherence by removing the requirement for regular dosing or invasive interventions. The non-intrusive characteristics of transdermal patches enhance patient comfort and lower the likelihood of complications linked to oral medications or injections. Moreover, transdermal patches benefit drugs that experience considerable first-pass metabolism in the liver by circumventing the gastrointestinal system, resulting in enhanced drug absorption. Their simple application and subtle nature also make them a favored option for chronic conditions, enabling patients to handle their treatment plan without interfering with everyday life. Additionally, continuous improvements in patch design and technology are increasing the adaptability and efficacy of transdermal systems. The latest drug device combination products market trends highlight a rising demand for transdermal patches, driven by their ability to provide convenient, effective, and non-invasive treatment options, particularly in the management of chronic diseases.
Respiratory diseases hold the biggest market share attribute to the widespread occurrence of issues like asthma, chronic obstructive pulmonary disease (COPD), and various other chronic respiratory disorders. These conditions necessitate ongoing management, increasing the need for effective treatments that offer steady relief and enhance patients' quality of life. The intricate nature of respiratory disorders frequently requires sophisticated drug delivery methods, rendering combination products especially advantageous. The growing recognition of respiratory health, along with a heightened global burden of pollution and lifestyle influences, also leads to the higher prevalence of these conditions. As a result, healthcare practitioners are focusing on creating advanced treatments and delivery systems specifically for respiratory care, promoting improved patient results. In addition, respiratory illnesses frequently necessitate accurate and effective drug delivery, and combination products provide the benefit of targeted therapy, reinforcing their prominence in the market.
Hospitals represent the largest segment, accounting 48.7% market share, owing to their essential function in the healthcare system, where many patients with complicated conditions need urgent and specialized treatment. Hospitals feature modern medical facilities, enabling the provision of state-of-the-art therapies, such as drug-device combination products. Consistent monitoring and tailored treatment plans in hospitals encourage the implementation of innovative therapies that enhance patient outcomes. Furthermore, hospitals frequently act as centers for clinical trials, promoting the rapid incorporation of new technologies and products into clinical practice. The concentration of healthcare practitioners and resources in hospitals allows for the efficient and effective use of combination products, guaranteeing their correct administration and oversight. Additionally, with the global rise in the demand for healthcare services, hospitals remain the main setting for addressing critical conditions, reinforcing their leading role in the market for drug-device combination products.
North America leads the market with a share of 41.7%, because of its developed healthcare system, strong regulatory framework, and significant investment in research activities. The region benefits from a robust healthcare system that encourages the extensive use of advanced medical technologies. Significant healthcare expenditure facilitates the swift launch of new drug-device combination products, bolstering the region's dominance in market expansion. Moreover, North America is home to prominent pharmaceutical and medical device firms, promoting ongoing innovation and the advancement of next-generation treatments. Furthermore, investment in advanced manufacturing capabilities to support the development and commercialization of drug-device combination products is ensuring improved production efficiency. In 2024, PCI Pharma Services announced a $365 million investment in its US and EU facilities to support the clinical and commercial assembly of advanced drug delivery and drug-device combination products. Key projects included expansions in Rockford (Illinois), Philadelphia, and Dublin. These developments aimed to enhance PCI's global capabilities in injectable formats and patient-centric packaging.
United States Drug Device Combination Products Market Analysis
In North America, the market portion held by the United States is 86.80% owing to scientific advancements and the increased demand for focused therapies. Swift progress in materials science and microfabrication is paving the way for advanced delivery systems, including drug-eluting stents, inhalers, and implantable insulin pumps, which enhance dosage accuracy, patient compliance, and treatment results. Producers are increasingly utilizing biocompatible polymers, nanoparticle carriers, and intelligent sensors to develop integrated systems that enable sustained or on-demand medication delivery. Additionally, clear regulations concerning combination products are simplifying approval processes, fostering investment and innovation. Furthermore, the growing incidence of chronic illnesses like heart disease, diabetes, and cancer is catalyzing the demand for less invasive and more convenient treatment choices. As per the American Heart Association, nearly 48.6% of people in the United States experience various forms of cardiovascular disease, such as high blood pressure and coronary heart disease. The International Diabetes Federation stated that in 2024, 38.5 million people in the United States experienced diabetes. Besides this, payer systems and healthcare providers are emphasizing value-based care, promoting solutions that can reduce hospitalization rates and enhance long-term health results. Strategic alliances between pharmaceutical companies, medtech firms, and contract development organizations are accelerating product pipelines, allowing quicker market launch of combination products.
Europe Drug Device Combination Products Market Analysis
The expansion of the Europe drug device combination products market is primarily driven by a rising need for home healthcare and self-administration therapies, necessitating dependable and easy-to-use delivery systems. The movement towards outpatient care and initiatives to shorten hospital stays is increasing the use of wearable drug delivery devices, including infusion pumps and auto-injectors, allowing patients to handle their treatments with greater independence. Innovations in drug delivery systems, along with a growing emphasis on personalized medicine, are leading to the creation of more advanced and user-friendly combination products. Moreover, increasing awareness among healthcare professionals and patients regarding the advantages of these products, including enhanced compliance, targeted delivery, and minimized side effects, is bolstering the market growth. The regulatory landscape in Europe is adapting to these intricate products, promoting investment and innovation from companies in pharmaceuticals and medical devices. For example, in January 2025, the UK Government reintroduced the Innovative Licensing and Access Pathway (ILAP) for pharmaceuticals. The ILAP plan seeks to reduce the time to market for innovative and transformative medications and drug-device combination products by providing drug researchers with tailored and coordinated support from the ILAP Partners right from the start of clinical development.
Asia Pacific Drug Device Combination Products Market Analysis
The Asia Pacific market for drug-device combination products is growing because of swift urbanization, heightened healthcare awareness, and improved access to medical technologies in developing countries. An expanding middle-class demographic with enhanced healthcare expenditures is driving the need for innovative treatment options, such as combination products that provide convenience and effectiveness. Government efforts to enhance healthcare infrastructure and encourage local production of pharmaceuticals and medical equipment are further contributing to the market growth. Moreover, the rising prevalence of chronic illnesses like asthma, cancer, and heart diseases is generating a continuous demand for precise and effective treatments, especially those suitable for self-administration. In 2023, the Press Information Bureau (PIB) reported more than 1,400,000 cancer cases in India. The Global Asthma Report states that roughly 35 million people in India were affected by asthma in 2022. In addition, the growing use of minimally invasive treatment techniques and the incorporation of digital health technologies into drug delivery systems are improving patient outcomes and fueling innovation.
Latin America Drug Device Combination Products Market Analysis
The market for drug-device combination products in Latin America is influenced by rising investments in healthcare infrastructure and the growth of insurance coverage, enhancing patient access to innovative therapies. Increasing urbanization and shifts in lifestyle are resulting in higher cases of ailments like diabetes and respiratory conditions, driving the need for effective drug delivery methods. For example, according to the International Diabetes Federation (IDF), the count of people with diabetes in Brazil hit 16.6 million in 2024. This figure is projected to rise to 24.0 Million by 2050. Furthermore, the area is experiencing increased cooperation among pharmaceutical and medical device firms to create innovative combination products suited to regional demands. Government efforts aimed at enhancing regulatory systems and accelerating product approvals are further aiding quicker penetration across Latin America. The drug device combination products market forecast for Latin America indicates significant growth as these factors continue to shape the demand for advanced therapies and delivery systems.
Middle East and Africa Drug Device Combination Products Market Analysis
The drug device combination products market in the Middle East and Africa is seeing growth driven by rising healthcare investments and expanding government initiatives focused on enhancing healthcare infrastructure and accessibility. For example, the Saudi Arabian Government assigned SR 99,279,673 to the Ministry of Health (MoH) for FY 2025, showing a notable rise compared to FY 2024, which was SR 86,253,063. Moreover, enhancing local pharmaceutical manufacturing capabilities is improving the availability of combination products designed for regional healthcare requirements. The growing recognition of preventive healthcare and early detection is encouraging the adoption of combination treatments for chronic and lifestyle-related conditions. Additionally, collaborations between public sectors and private companies are enhancing distribution systems, guaranteeing broader access to these products, including in rural and marginalized regions.
Major participants in the drug-device combination products market are concentrating on innovation and broadening their product ranges to address the increasing need for tailored and effective treatment options. They are making significant investments in research operations to advance drug delivery systems, upgrade device capabilities, and achieve improved patient outcomes. Strategic alliances and collaborations are being established to utilize technological advancements and speed up product development. Furthermore, ensuring regulatory adherence and tackling patient safety issues continue to be key priorities. In 2025, OneSource Specialty Pharma announced that its flagship drug-device combination facility in Bangalore maintained its USFDA compliance status. Following a March 20 to 28, 2025 inspection, the USFDA issued a Form 483 with four observations, later classified as "Voluntary Action Indicated" (VAI). This classification confirms the facility's continued adherence to quality standards.