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市場調查報告書
商品編碼
1884039
免疫抑制劑市場規模、佔有率、成長及全球產業分析:依類型、應用和地區劃分的洞察與預測(2024-2032 年)Immunosuppressive Drugs Market Size, Share, Growth and Global Industry Analysis By Type & Application, Regional Insights and Forecast to 2024-2032 |
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由於自體免疫疾病的增加、器官移植手術的增加以及新型治療藥物的問世,全球免疫抑制劑市場正經歷顯著增長。 2024年,該市場價值為48.3億美元,預計到2025年將達到52億美元。預計到2032年,該市場將進一步成長至93億美元,在預測期內保持穩定成長,複合年增長率(CAGR)為8.7%。
市場推動因素
免疫抑制劑旨在抑製或阻斷免疫系統活性,對於治療類風濕性關節炎、銀屑病和系統性紅斑狼瘡等自體免疫疾病以及預防器官移植後的同種異體移植排斥反應至關重要。全球自體免疫疾病的增加以及移植手術數量的成長正在推動市場擴張。
例如,預計2024年美國將進行27,759例腎臟移植手術,凸顯了對用於預防器官排斥反應的免疫抑制劑日益增長的需求。移植後免疫抑制療法的創新以及新型候選藥物的研發進一步刺激了市場需求。艾伯維、輝瑞和百時美施貴寶等老牌公司正不斷拓展產品線,以滿足日益增長的需求。
市場限制因子
儘管有成長機會,免疫抑制劑(尤其是生物製劑)的高昂成本仍是主要阻礙因素。高昂的監管審批成本以及中低收入國家有限的保險覆蓋範圍阻礙了藥物的可及性。例如,在澳大利亞,僅類風濕性關節炎的治療費用預計在2022年就將達到6.373億美元,凸顯了其沉重的經濟負擔。
長期毒性和嚴重副作用(例如感染風險增加和器官毒性)也對市場擴張構成挑戰。據報道,Afinitor 和 Skyrizi 等藥物的副作用包括潰瘍和嚴重的過敏反應,這會影響患者的依從性並限制其市場滲透率。
市場機會
投資開發針對特定免疫路徑的下一代免疫抑制劑、局部給藥系統以及用於促進移植存活的生物材料,蘊藏著巨大的成長潛力。 2024 年 12 月,Newig Therapeutics 完成了 2 億美元的 B 輪融資,用於推動 NVG-2089 的研發。 NVG-2089 是一種用於治療慢性發炎性脫髓鞘性多發性神經病變 (CMDNP) 和其他自體免疫疾病的藥物,展現了該領域的創新勢頭。
市場趨勢
一個值得關注的市場趨勢是生物相似藥的興起,這提高了藥物的可及性和可負擔性。生物相似藥以最小的差異複製生物製劑的結構,從而提供治療等效性。 2021年2月,富士軟片協和麒麟生物製劑與Viatris公司合作,在日本推出首個阿達木單抗生物類似藥,拓展了治療選擇,並加速了市場滲透。
依藥物類別劃分,鈣調磷酸酶抑制劑因其靶向抑制T細胞活性(對器官移植和自體免疫疾病治療至關重要)而引領2024年的市場。例如,voclosporin於2024年9月在日本獲準用於治療狼瘡性腎炎。 mTOR抑制劑、抗代謝藥物、白血球介素拮抗劑和皮質類固醇也佔了相當大的市場佔有率,這得益於持續的產品審批和研發投入。
依適應症劃分,器官移植引領市場,因為需要使用免疫抑制劑來預防移植排斥反應。包括腎臟移植和肝臟移植在內的全球移植手術數量的成長正在推動市場成長。自體免疫疾病和腫瘤適應症也是推動市場擴張的重要因素。
依給藥途徑劃分,口服藥物在2024年佔主導地位,這得益於其便利性和較高的患者依從性。同時,由於起效迅速且生物利用度高,注射給藥的需求也不斷增加。
依分銷管道劃分,由於監管要求和在移植手術中的頻繁使用,醫院藥房佔最大佔有率;而零售藥房和線上藥房則透過合作和管道的改善,正在逐步發展壯大。
北美將在2024年以19.9億美元的市場規模引領市場,主要得益於其先進的醫療保健基礎設施、龐大的器官移植量以及活躍的研發活動。歐洲緊隨其後,這主要得益於自體免疫疾病的日益增加和新產品的批准。由於器官移植數量增加、自體免疫疾病病例增多以及仿製藥和新型免疫抑制劑獲批數量不斷增加,亞太地區預計將以最高的複合年增長率增長。拉丁美洲和中東及非洲地區預計將以適度的速度成長,這得益於區域合作和政府措施推動的醫療服務可近性提高。
The global immunosuppressive drugs market is witnessing strong growth due to the rising prevalence of autoimmune diseases, increasing organ transplantation procedures, and the introduction of novel therapeutic agents. The market was valued at USD 4.83 billion in 2024, projected to reach USD 5.20 billion in 2025, and expected to expand significantly to USD 9.30 billion by 2032, reflecting a steady growth trajectory at a CAGR of 8.7% during the forecast period.
Market Drivers
Immunosuppressive drugs are designed to reduce or inhibit immune system activity, making them critical for treating autoimmune disorders such as rheumatoid arthritis, psoriasis, and lupus, as well as for preventing allograft rejection following organ transplantation. The global rise in autoimmune disorders, coupled with an increase in transplantation surgeries, has driven the market expansion.
For example, in the U.S., there were 27,759 kidney transplant surgeries reported in 2024, emphasizing the growing need for immunosuppressants to prevent organ rejection. Innovations in post-transplantation immunosuppression regimens and novel drug candidates are further stimulating market demand. Established companies like AbbVie Inc., Pfizer Inc., and Bristol-Myers Squibb Company continue to advance their product pipelines to meet these growing requirements.
Market Restraints
Despite growth opportunities, high costs associated with immunosuppressive drugs, particularly biologics, remain a major restraint. Expensive regulatory approvals and limited reimbursement in low- and middle-income countries impede accessibility. For instance, in Australia, treating rheumatoid arthritis alone accounted for USD 637.3 million in expenditure in 2022, highlighting the financial burden.
Long-term toxicity and severe adverse effects, such as increased infection risk and organ toxicity, also challenge market expansion. Drugs like AFINITOR and SKYRIZI are associated with side effects ranging from ulcers to serious allergic reactions, influencing patient adherence and limiting market adoption.
Market Opportunities
Investments in developing next-generation immunosuppressants targeting specific immune pathways, localized delivery systems, and biomaterials for transplant survival offer substantial growth potential. Nuwig Therapeutics raised USD 200 million in Series B funding in December 2024 to advance NVG-2089 for chronic inflammatory demyelinating polyneuropathy and other autoimmune disorders, demonstrating the sector's innovative momentum.
Market Trends
A notable trend in the market is the rise of biosimilars, improving accessibility and affordability. Biosimilars replicate biologic drug structures with minimal variability, providing therapeutic equivalence. In February 2021, Fujifilm Kyowa Kirin Biologics collaborated with Viatris to launch Japan's first adalimumab biosimilar, expanding treatment availability and market penetration.
By drug class, calcineurin inhibitors dominated the market in 2024 due to their targeted inhibition of T-cell activity, crucial for organ transplantation and autoimmune disease management. For instance, voclosporin received approval in Japan in September 2024 for lupus nephritis. mTOR inhibitors, antimetabolites, interleukin antagonists, and corticosteroids also hold significant shares, driven by ongoing product approvals and R&D.
By application, organ transplantation dominates due to the essential role of immunosuppressants in preventing graft rejection. Rising transplant surgeries globally, including kidney and liver transplants, support market growth. Autoimmune disorders and oncology indications also contribute to market expansion.
By route of administration, oral drugs led in 2024, favored for convenience and adherence, while parenteral drugs are gaining traction for rapid efficacy and bioavailability.
By distribution channel, hospital pharmacies hold the largest share due to regulatory requirements and frequent use in transplantation procedures, while retail and online pharmacies are gradually growing through collaborations and increased accessibility.
North America led in 2024 with USD 1.99 billion, driven by advanced healthcare infrastructure, a high volume of organ transplants, and robust R&D initiatives. Europe follows, supported by increasing autoimmune disease prevalence and novel product approvals. Asia Pacific is projected to grow at the highest CAGR due to rising transplant surgeries, autoimmune disorders, and increasing approvals of generic and novel immunosuppressants. Latin America and the Middle East & Africa are expected to expand moderately, with regional collaborations and government initiatives enhancing access.
Competitive Landscape
The market is semi-consolidated, with major players including Novartis AG, Pfizer Inc., F. Hoffmann-La Roche Ltd, GSK plc., Bristol-Myers Squibb Company, AbbVie Inc., and Astellas Pharma Inc. These companies are investing in product innovation, strategic collaborations, and acquisitions to expand global presence.
Conclusion
With a market size of USD 4.83 billion in 2024, projected to grow to USD 5.20 billion in 2025 and USD 9.30 billion by 2032, the global immunosuppressive drugs market is poised for robust growth. Rising autoimmune disease prevalence, increasing organ transplant procedures, adoption of biosimilars, and strategic investments by leading companies are driving the market toward new opportunities globally.
Segmentation By Drug Class
By Application
By Route of Administration
By Distribution Channel
By Region