市場調查報告書
商品編碼
1372023
到 2030 年製藥器材組合產品的市場預測:按產品、用途、最終用戶和地區進行的全球分析Drug Device Combination Products Market Forecasts to 2030 - Global Analysis By Product, Application, End User and By Geography |
根據 Stratistics MRC 的數據,2023 年全球藥物器材組合產品市場規模為 1,417 億美元,預計到 2030 年將達到 2,924 億美元,預測期內年複合成長率為 10.9%。
藥物與醫療設備組合產品是指透過化學或物理性手段將醫療設備與藥物活性物質結合形成「單一實體」的醫療設備。透過精準給藥、局部給藥和客製化治療,這些解決方案有助於更安全、更有效率地管理和治療多種疾病。例子包括藥物洗脫支架、輸液幫浦、吸入器、經皮給藥系統、預充填式注射器和其他流行的藥物設備組合產品。
根據 IDF 2021 的數據,大約有 5.37 億成年人患有糖尿病,預計到 2030 年這一數字將增至 6.43 億,到 2045 年將增至 7.83 億。
由於糖尿病、癌症、慢性呼吸系統疾病和心血管疾病等慢性病的患病不斷增加,藥械組合產品的市場正在不斷擴大。例如,穿戴式生物感測器技術的頂級創新者Valencell計劃於2023年1月推出。 Valencell 專門為各種用途提供準確可靠的生理監測。 Valensel 專注於將慢性病管理解決方案推向市場,宣布計劃在數位健康產業開發自有品牌產品線。
組合藥物和醫療設備產品可能具有複雜的製造程序,需要特定的設備和專業知識。製藥和醫療設備整合通常需要複雜的組裝、品管和無菌包裝要求。然而,遵守良好生產規範 (GMP) 和品質要求可能很困難,從而導致製造成本增加和供應鏈問題。
世界各國政府正在實施各種計劃,以解決日益增加的慢性病負擔並提高病人安全。這些活動非常重要,因此,藥品和醫療設備組合產品的全球市場正在擴大。例如,2021 年 9 月,美國FDA 意識到人工智慧和機器學習在藥物開發中的重大影響。今年,結構要素人工智慧/機器學習的藥品和生物製藥申請超過100件。人工智慧和機器學習應用於藥物開發的各個階段,包括藥物研發發現、臨床研究、安全監測和製造。
藥物和醫療設備的組合產品需要遵守複雜的法規標準。獲得法規許可並確保遵守各種法規機構(包括歐洲藥品管理局 (EMA) 和美國食品藥物管理局(FDA))可能既耗時又昂貴。然而,在產品開發、臨床試驗和市場進入方面,製造商可能面臨嚴格法規和不斷變化的標準所帶來的挑戰。
自2019年12月Covid-19病毒爆發以來,該疾病已傳播到100多個國家,並於2020年1月30日被世界衛生組織(WHO)宣佈為突發公共衛生事件。然而,全球藥物器械組合產品市場受到了 COVID-19 疫情的嚴重影響。對呼吸設備的需求不斷成長以及藥物設備組合的技術創新正在塑造市場。然而,資源優先順序、製造和供應鏈中斷等問題正在出現。疫情激發了產業創新與合作,但長期影響尚待觀察。
由於需要長期治療的疾病對自我給藥藥物的需求不斷增加,預計經皮吸收貼片細分市場在預測期內將成長最高。例如,糖尿病患者需要頻繁靜脈注射胰島素。此外,與頻繁使用針頭給藥胰島素相關的疼痛和感染風險增加增加了對替代藥物傳遞方法的需求。
預計癌症治療領域在預測期內的年複合成長率最高。這些產品透過整合藥理物質和醫療設備來提高治療效果,提供了一種獨特的癌症治療方法。它可以使用植入式藥物傳輸裝置、局部放射線治療和標靶藥物傳輸。此外,結合不同的治療方法,包括化療、免疫療法和標靶治療,可以提供協同效應和個體化的治療選擇。
由於人口眾多、癌症等慢性病發病率上升以及醫療保健成本上升,預計亞太地區在預測期內將佔據最大的市場佔有率。此外,該地區的市場還受益於這些產品的優勢,例如較低的劑量給藥、藥物的定時釋放、與抗感染藥物聯合使用直接基於設備的感染緩解以及減少的全身暴露。這是醫生對其益處的認知不斷提高的結果。
由於藥物設備組合產品的採用以及該地區成熟的醫療基礎設施,預計北美在預測期內將實現盈利成長。此外,由於許多疫苗和其他治療方法都源自於這些行業,隨著公司在產品研發上投入更多資金,對組合藥物和醫療設備產品的需求可能會成長,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.