市场调查报告书
商品编码
1372023
到 2030 年製药器材组合产品的市场预测:按产品、用途、最终用户和地区进行的全球分析Drug Device Combination Products Market Forecasts to 2030 - Global Analysis By Product, Application, End User and By Geography |
根据 Stratistics MRC 的数据,2023 年全球药物器材组合产品市场规模为 1,417 亿美元,预计到 2030 年将达到 2,924 亿美元,预测期内年复合成长率为 10.9%。
药物与医疗设备组合产品是指透过化学或物理性手段将医疗设备与药物活性物质结合形成「单一实体」的医疗设备。透过精准给药、局部给药和客製化治疗,这些解决方案有助于更安全、更有效率地管理和治疗多种疾病。例子包括药物洗脱支架、输液帮浦、吸入器、经皮给药系统、预充填式註射器和其他流行的药物设备组合产品。
根据 IDF 2021 的数据,大约有 5.37 亿成年人患有糖尿病,预计到 2030 年这一数字将增至 6.43 亿,到 2045 年将增至 7.83 亿。
由于糖尿病、癌症、慢性呼吸系统疾病和心血管疾病等慢性病的患病不断增加,药械组合产品的市场正在不断扩大。例如,穿戴式生物感测器技术的顶级创新者Valencell计划于2023年1月推出。 Valencell 专门为各种用途提供准确可靠的生理监测。 Valensel 专注于将慢性病管理解决方案推向市场,宣布计划在数位健康产业开发自有品牌产品线。
组合药物和医疗设备产品可能具有复杂的製造程序,需要特定的设备和专业知识。製药和医疗设备整合通常需要复杂的组装、品管和无菌包装要求。然而,遵守良好生产规范 (GMP) 和品质要求可能很困难,从而导致製造成本增加和供应链问题。
世界各国政府正在实施各种计划,以解决日益增加的慢性病负担并提高病人安全。这些活动非常重要,因此,药品和医疗设备组合产品的全球市场正在扩大。例如,2021 年 9 月,美国FDA 意识到人工智慧和机器学习在药物开发中的重大影响。今年,结构要素人工智慧/机器学习的药品和生物製药申请超过100件。人工智慧和机器学习应用于药物开发的各个阶段,包括药物研发发现、临床研究、安全监测和製造。
药物和医疗设备的组合产品需要遵守复杂的法规标准。获得法规许可并确保遵守各种法规机构(包括欧洲药品管理局 (EMA) 和美国食品药物管理局(FDA))可能既耗时又昂贵。然而,在产品开发、临床试验和市场进入方面,製造商可能面临严格法规和不断变化的标准所带来的挑战。
自2019年12月Covid-19病毒爆发以来,该疾病已传播到100多个国家,并于2020年1月30日被世界卫生组织(WHO)宣布为突发公共卫生事件。然而,全球药物器械组合产品市场受到了 COVID-19 疫情的严重影响。对呼吸设备的需求不断增长以及药物设备组合的技术创新正在塑造市场。然而,资源优先顺序、製造和供应链中断等问题正在出现。疫情激发了产业创新与合作,但长期影响尚待观察。
由于需要长期治疗的疾病对自我给药药物的需求不断增加,预计经皮吸收贴片细分市场在预测期内将成长最高。例如,糖尿病患者需要频繁静脉注射胰岛素。此外,与频繁使用针头给药胰岛素相关的疼痛和感染风险增加增加了对替代药物传递方法的需求。
预计癌症治疗领域在预测期内的年复合成长率最高。这些产品透过整合药理物质和医疗设备来提高治疗效果,提供了一种独特的癌症治疗方法。它可以使用植入式药物传输装置、局部放射线治疗和标靶药物传输。此外,结合不同的治疗方法,包括化疗、免疫疗法和标靶治疗,可以提供协同效应和个体化的治疗选择。
由于人口众多、癌症等慢性病发病率上升以及医疗保健成本上升,预计亚太地区在预测期内将占据最大的市场份额。此外,该地区的市场还受益于这些产品的优势,例如较低的剂量给药、药物的定时释放、与抗感染药物联合使用直接基于设备的感染缓解以及减少的全身暴露。这是医生对其益处的认识不断提高的结果。
由于药物设备组合产品的采用以及该地区成熟的医疗基础设施,预计北美在预测期内将实现盈利增长。此外,由于许多疫苗和其他治疗方法都源自于这些行业,随着公司在产品研发上投入更多资金,对组合药物和医疗设备产品的需求可能会成长,而且很高。
According to Stratistics MRC, the Global Drug Device Combination Products Market is accounted for $141.7 billion in 2023 and is expected to reach $292.4 billion by 2030 growing at a CAGR of 10.9% during the forecast period. Drug-device combination products are medical devices that combine a device and active medicinal substances to form a "single entity" by chemical or physical means. Due to precise medication delivery, local administration, and customized treatment, these solutions contribute to the safer, more efficient management and treatment of a number of illnesses. Drug-eluting stents, infusion pumps, inhalers, transdermal delivery systems, prefilled syringes, and other popular drug-device combo products are instances.
According to the IDF 2021, approximately 537 million adults are living with diabetes, and the number of people adults living with diabetes is projected to rise to 643 million by 2030 and 783 million by 2045.
The market for drug-device combination products is expanding due to the increased prevalence of chronic diseases such as diabetes, cancer, chronic respiratory diseases, and cardiovascular diseases. For instance, Valencell, a top innovator in wearable biometric sensor technology, will be available in January 2023. Valencell specializes in accurate and dependable physiological monitoring for a variety of applications. In order to concentrate its efforts on bringing solutions to market to manage chronic conditions, Valencell has announced plans to develop its own branded product line in the digital health industry.
Drug device combination products might have complicated manufacturing procedures that require specific equipment and expertise. Complex assembly, quality control, and sterile packaging requirements are frequently required for the integration of pharmaceuticals and devices. However, it can be challenging to adhere to good manufacturing practices (GMP) and quality requirements, which can raise production costs and cause supply chain issues.
Various programs are being implemented by governments all over the world to address the growing burden of chronic diseases and advance patient safety. The global market for drug device combination products is expanding as a result of these activities, which are extremely important. For instance, the US FDA acknowledged the important influence of AI and ML in medicine development in September 2021. This year, there were over 100 medication and biologic submissions with AI/ML components. Various stages of drug development, such as drug discovery, clinical research, safety surveillance, and manufacturing, all make use of AI and ML.
Drug device combination products must adhere to complicated regulatory standards. It can take a lot of time and money to obtain regulatory licenses and ensure compliance with different regulatory organizations, including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). However, manufacturers may have difficulties when it comes to product development, clinical studies, and market access due to strict restrictions and changing standards.
The disease has expanded to over 100 nations since the COVID-19 viral epidemic in December 2019, and on January 30, 2020, the World Health Organization proclaimed it a public health emergency. However, the global market for medicine-device combination products has been significantly impacted by the COVID-19 epidemic. The market is shaped by rising demand for respiratory devices and innovations in drug-device combinations. However, issues with resource prioritization, manufacturing, and supply chain interruptions have emerged. The pandemic has stimulated industry innovation and cooperation, but the long-term effects are still being witnessed.
The segment for transdermal patches is anticipated to be the largest over the course of the projection period due to the rising demand for drug self-administration in conditions where diseases demand long-term therapy. For instance, a patient with diabetes requires frequent intravenous administration of insulin. Additionally, the need for alternative drug delivery methods is growing due to the pain and increased risk of infection associated with the frequent use of needles to deliver insulin.
Cancer Treatment segment is expected to have the highest CAGR during the forecast period. By integrating pharmacological substances and medical devices to enhance treatment outcomes, these products offer a distinctive method of cancer therapy. They make it possible to use implantable medication delivery devices, localized radiation therapy, and targeted drug delivery. Additionally, these medications offer synergistic effects and individualized treatment options by combining various therapeutic methods, including chemotherapy, immunotherapy, and targeted therapy.
Due to the region's vast population, rising frequency of chronic diseases like cancer, and rising healthcare costs, the Asia-Pacific region is anticipated to hold the largest share of the market during the projected period. Moreover, the regional market is growing as a result of increasing physician awareness of the benefits of these products, which include low dosage requirements, timed medication release, direct device-centered infection mitigation using anti-infective medication in combination, and reduced systemic exposure.
Owing to the adoption of drug-device combination products along with the region's well-established healthcare infrastructure, North America is predicted to have profitable growth over the course of the projection period. Additionally, since many vaccines and other treatments are generated by these industries, there is likely to be a growth in demand for drug-device combination products as corporations invest additional funds in product research and development.
Some of the key players in Drug Device Combination Products Market include: Abbott Laboratories, Allergan plc, Boston Scientific Corporation, C.R. Bard, Medtronic Plc, Mylan N.V., Novartis AG, Stryker Corporation, Teleflex Incorporated, Terumo Corporation and W. L. Gore & Associates, Inc.
In August 2022, Terumo Corporation launched G-Lasta Subcutaneous Injection 3.6 mg BodyPod", a drug-device combination product co-developed with Kyowa Kirin Co., Ltd. The product received approval from Japan's Ministry of Health, Labour, and Welfare (MHLW).
In June 2022, Novartis acquired Kedalion Therapeutics and its AcuStream technology that facilitate precise dosing and accurate delivery of certain topical ophthalmic medications to the eye. The acquisition enhances the Novartis ophthalmics portfolio, advancing efforts to investigate transformative ophthalmic methods to address unmet patient needs in front-of-eye conditions.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.