![]() |
市场调查报告书
商品编码
1884039
免疫抑制剂市场规模、占有率、成长及全球产业分析:依类型、应用和地区划分的洞察与预测(2024-2032 年)Immunosuppressive Drugs Market Size, Share, Growth and Global Industry Analysis By Type & Application, Regional Insights and Forecast to 2024-2032 |
||||||
由于自体免疫疾病的增加、器官移植手术的增加以及新型治疗药物的问世,全球免疫抑制剂市场正经历显着增长。 2024年,该市场价值为48.3亿美元,预计到2025年将达到52亿美元。预计到2032年,该市场将进一步成长至93亿美元,在预测期内保持稳定成长,复合年增长率(CAGR)为8.7%。
市场推动因素
免疫抑制剂旨在抑製或阻断免疫系统活性,对于治疗类风湿性关节炎、银屑病和系统性红斑狼疮等自体免疫疾病以及预防器官移植后的同种异体移植排斥反应至关重要。全球自体免疫疾病的增加以及移植手术数量的成长正在推动市场扩张。
例如,预计2024年美国将进行27,759例肾臟移植手术,凸显了对用于预防器官排斥反应的免疫抑制剂日益增长的需求。移植后免疫抑制疗法的创新以及新型候选药物的研发进一步刺激了市场需求。艾伯维、辉瑞和百时美施贵宝等老牌公司正不断拓展产品线,以满足日益增长的需求。
市场限制因子
儘管有成长机会,免疫抑制剂(尤其是生物製剂)的高昂成本仍是主要阻碍因素。高昂的监管审批成本以及中低收入国家有限的保险覆盖范围阻碍了药物的可及性。例如,在澳大利亚,仅类风湿性关节炎的治疗费用预计在2022年就将达到6.373亿美元,凸显了其沉重的经济负担。
长期毒性和严重副作用(例如感染风险增加和器官毒性)也对市场扩张构成挑战。据报道,Afinitor 和 Skyrizi 等药物的副作用包括溃疡和严重的过敏反应,这会影响患者的依从性并限制其市场渗透率。
市场机会
投资开发针对特定免疫路径的下一代免疫抑制剂、局部给药系统以及用于促进移植存活的生物材料,蕴藏着巨大的成长潜力。 2024 年 12 月,Newig Therapeutics 完成了 2 亿美元的 B 轮融资,用于推动 NVG-2089 的研发。 NVG-2089 是一种用于治疗慢性发炎性脱髓鞘性多发性神经病变 (CMDNP) 和其他自体免疫疾病的药物,展现了该领域的创新势头。
市场趋势
一个值得关注的市场趋势是生物相似药的兴起,这提高了药物的可及性和可负担性。生物相似药以最小的差异复製生物製剂的结构,从而提供治疗等效性。 2021年2月,富士软片协和麒麟生物製剂与Viatris公司合作,在日本推出首个阿达木单抗生物类似药,拓展了治疗选择,并加速了市场渗透。
依药物类别划分,钙调磷酸酶抑制剂因其靶向抑制T细胞活性(对器官移植和自体免疫疾病治疗至关重要)而引领2024年的市场。例如,voclosporin于2024年9月在日本获准用于治疗狼疮性肾炎。 mTOR抑制剂、抗代谢药物、白血球介素拮抗剂和皮质类固醇也占了相当大的市场占有率,这得益于持续的产品审批和研发投入。
依适应症划分,器官移植引领市场,因为需要使用免疫抑制剂来预防移植排斥反应。包括肾臟移植和肝臟移植在内的全球移植手术数量的成长正在推动市场成长。自体免疫疾病和肿瘤适应症也是推动市场扩张的重要因素。
依给药途径划分,口服药物在2024年占主导地位,这得益于其便利性和较高的患者依从性。同时,由于起效迅速且生物利用度高,注射给药的需求也不断增加。
依分销管道划分,由于监管要求和在移植手术中的频繁使用,医院药房占最大占有率;而零售药房和线上药房则透过合作和管道的改善,正在逐步发展壮大。
北美将在2024年以19.9亿美元的市场规模引领市场,主要得益于其先进的医疗保健基础设施、庞大的器官移植量以及活跃的研发活动。欧洲紧随其后,这主要得益于自体免疫疾病的日益增加和新产品的批准。由于器官移植数量增加、自体免疫疾病病例增多以及仿製药和新型免疫抑制剂获批数量不断增加,亚太地区预计将以最高的复合年增长率增长。拉丁美洲和中东及非洲地区预计将以适度的速度成长,这得益于区域合作和政府措施推动的医疗服务可近性提高。
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