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市场调查报告书
商品编码
1832029
2025 年至 2033 年药物设备组合产品市场规模、份额、趋势及预测(按产品、应用、最终用户和地区)Drug Device Combination Products Market Size, Share, Trends and Forecast by Product, Application, End User, and Region, 2025-2033 |
2024年,全球药物器材组合产品市场规模达1,657.4亿美元。展望未来, IMARC Group预测,到2033年,市场规模将达到2,903亿美元,2025-2033年的复合年增长率为6.4%。北美目前占据市场主导地位,2024年的市占率将达到41.7%。该领域的主导地位归功于其完善的医疗基础设施、强大的监管框架以及对研究活动的大力投入。先进的技术创新、巨额的医疗支出以及对改善患者预后的日益关注,进一步促进了药物器械组合产品市场份额的扩大。
监管机构正逐步为药械组合产品的审批和市场准入提供清晰的途径,以促进对这些解决方案的投资。有利的监管环境使创新产品更有效地进入市场,从而促进市场成长。此外,药械组合产品旨在易于使用,简化用药流程。这种使用者友善性和自行给药的便利性提高了患者对治疗计划的依从性,这是长期管理慢性病的关键要素。此外,医疗器材和药物传输技术的不断进步正在提高组合产品的性能和疗效。包括自动注射器和输液帮浦在内的创新给药方式提供了更准确、更便利、更有效的治疗选择,从而提高了患者满意度。
美国是市场中至关重要的一部分,得益于医疗器材和药品领域持续的技术进步。自动注射器和输液帮浦等给药方式的进步,正在提升药械组合产品的效率和易用性。例如,2025年,美国食品药物管理局(FDA)批准了SPN-830(Onapgo),这是第一个用于治疗帕金森氏症的皮下阿扑吗啡输注装置,能够持续给药,最大限度地减少运动波动和「关」期,进一步丰富了治疗选择。此外,美国健全的医疗保健系统和对医学研究的大量投入,也促进了先进药械组合产品的诞生。
药物输送系统的技术进步
新型给药系统,包括自动注射器、吸入器和输液泵,正在改变医疗保健管理,使治疗更加精准、便利和有效。这些系统能够实现标靶给药,使患者能够达到预期的治疗效果,同时最大限度地降低药物不良反应的风险。例如,自动注射器彻底改变了日常用药管理,使患者能够轻鬆舒适地自行给药,从而提高了患者的自主性。此外,吸入器和输液帮浦等设备能够提供高度可控且一致的药物输送,这对于管理慢性病尤其重要。山德士将于2025年推出Pyzchiva(R),这是欧洲首款上市的乌司奴单抗生物相似药自动注射器,凸显了这种向增强自主给药的转变。该设备旨在提高舒适度和便利性,同时也提高了患者的依从性,尤其是在治疗慢性发炎性疾病方面。因此,这些创新不仅重塑了病患护理,也支持了药物器材组合产品市场的成长。
慢性病盛行率不断上升
心血管疾病 (CVD)、糖尿病和癌症等慢性疾病的发生率不断上升,是推动对复杂治疗需求而设计的个人化和创新性药械组合产品需求的主要因素。产业报告显示,美国每 10 人中就有 6 人患有至少一种慢性病,每 10 人就有 4 人患有两种或两种以上的慢性病。死亡率统计数据强调了这些疾病对全球人口的广泛影响。例如,在澳大利亚,澳洲健康与福利研究所指出,47% 的人患有至少一种慢性疾病,而 20% 的人患有两种或两种以上的慢性病。慢性病盛行率的不断上升凸显了对能够提供有针对性、有效治疗的创新医疗解决方案的必要性,从而推动了药械组合产品的市场需求。对高效、客製化治疗的持续需求凸显了这些医疗领域进步的重要性。
老年人口不断增加
全球老龄人口的增长和寿命的延长对老年医学造成了重大挑战,导致对复杂医疗解决方案(例如药械组合产品)的需求增加。世界卫生组织 (WHO) 指出,到 2030 年,每六人中就有一人年龄在 60 岁或以上,老年人口将达到 14 亿。预计到 2050 年,全球 60 岁及以上人口将达到 21 亿,而 80 岁及以上人口预计将增长到 4.26 亿,是 2020 年数字的三倍。这种人群结构的变化需要创造更有效的治疗方案来解决与年龄相关的问题,从而促进对创新药械组合的需求,以提供更好的治疗方案、患者依从性和卓越的健康结果。因此,在全球老龄化人口对客製化解决方案的需求不断增长的推动下,药械组合产品市场前景依然十分乐观。
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.