2024-2030年全球免疫调节治疗市场

针对机制的方法促进了自体免疫、肿瘤和发炎治疗的创新，推动了转化成长

该研究服务对全球免疫调节治疗市场进行了全面的分析，特别是针对免疫学、胃肠道 (GI) 和皮肤病学中的发炎性疾病。该报告透过旨在透过抑製或压制病理免疫反应来改变和控制免疫反应的产品来定义这个市场。该报告按方式和主要适应症对市场进行分类，并对全球免疫调节处方药的六年收益预测以及主要市场参与企业的分析进行了分析。地理范围涵盖北美、欧洲、亚太地区 (APAC)、中东和非洲 (MEA) 和拉丁美洲 (LATAM)，并最大努力原则提供按地区分類的收益占有率预测。该报告还讨论了流行和新兴的经营模式，分析了免疫调节疗法的市场进入和报销趋势，并提供了竞争评估和收益占有率分析。该报告探讨了推动和抑制该行业成长的因素，并提供了对药物开发趋势、伙伴关係和投资环境的见解。报告重点介绍了在有效疾病管理方面开创颠覆性虚拟护理技术和辅助性治疗的关键公司。报告基于临床需求、技术进步、经营模式和竞争动态，识别了市场参与者和相关人员应充分利用的该领域新兴成长机会。基准年为2024年，预测期间为2025年至2030年。

收益和预测

预计 2024 年基准年收益为 930 亿美元，2024-2030 年研究期间内复合年增长率为 9.0%。

分析范围

• 该研究服务提供了针对免疫学、胃肠道 (GI) 和皮肤病发炎疾病的全球免疫调节治疗市场的详细概述。
• 在本报告中，市场由旨在透过修改（阻断或抑制）和调节现有病理免疫反应来治疗疾病的产品定义，并根据方式和主要适应症进一步细分。
• 它预测了全球免疫调节剂处方药市场的潜在收益，并提供了六年的收益预测，包括对行业参与企业的分析。
• 该研究最大努力原则估算了北美、欧洲、亚太地区 (APAC)、中东和非洲 (MEA) 以及拉丁美洲 (LATAM) 各地区的整体市场收益占有率。
• 该报告涵盖了免疫调节疗法最受欢迎和新兴的经营模式、市场进入和报销趋势，还涵盖了收益占有率分析和竞争评估，突出了关键的市场趋势。
• 该报告涵盖了关键市场驱动因素和影响市场成长的驱动因素、药物开发趋势、伙伴关係、投资和整合活动。
• 它简要介绍了开发颠覆性虚拟护理技术和疾病管理辅助性治疗的开创性公司。
• 根据临床需求、技术趋势、经营模式和竞争前景，为产业参与者确定新的成长机会。

三大策略问题对免疫调节治疗产业的影响

颠覆性技术

• 背景：自体免疫疾病的发生率日益上升，尤其是在女性族群。现有的治疗方法有其局限性，需要更有针对性的治疗方案。
• Frost观点：以小分子、生物製药和细胞/基因疗法的药物类别（JAK1、IL、Calcineurin、TNF、TYK2、PDE4），利用多种作用机制进行联合治疗的趋势将日益明显，以实现更好的临床结果。

内部挑战

• 背景：随着Humira）和思泰乐（Stelara）等收益重磅药物失去独占权，导致收益损失和生物相似药竞争加剧，迫切需要扩大产品线并加大研发投入。研发资源需求可能会对预算造成压力，尤其对于规模较小的生技公司。
• Frost 的观点：企业可能会越来越多地寻求策略伙伴关係，以分担成本和风险，并透过合作研发促进创新。在此类联盟中强调独特价值提案的企业可能更有能力进入市场并制定合理的价格，例如JAK抑制剂或女性专用疗法。付款人将仔细审查临床成本和患者疗效，以确保平衡且永续的报销模式能够反映特定适应症的需求，从而提高患者可负担性。

转型大趋势

• 背景：医疗保健系统面临控制当前和未来支出的压力。随着政府考虑美国2022年《通货膨胀控制法案》（IRA）及其相关降价措施的影响，医疗保健计划发起人正在考虑下一步。
• Frost 的观点：製药公司将投资于用于证据生成的自适应试验设计，以加快核准MoA 的新型标靶治疗的审批，并推动未来的精准医疗。製药公司将利用诊断交付服务来改善患者可近性，并透过与远端保健/人工智慧支援的症状监测平台（例如 Ada Health）合作，专注于新兴市场的扩大策略。专注于药物和数位疗法的预测性整合，有望实现医疗保健的个人化，并改善体验和疗效。

主要竞争对手

• ABBVIE
• J&J
• ELI LILLY
• ASTRAZENECA
• MERCK & CO
• SANOFI
• NOVARTIS
• AMGEN
• PFIZER
• GSK
• UCB
• BRISTOL MYERS SQUIBB
• ROCHE
• BOEHRINGER INGELHEIM
• ARGENX
• REGENERON PHARMACEUTICALS
• NOVO NORDISK
• REPERTOIRE IMMUNE MEDICINES
• INCYTE
• MALLINCKRODT PHARMACEUTICALS
• ASAHI KASEI
• AFIBBIDY
• SWEDISH ORPHAN BIovitrum
• ANH PHARMACEUTICALS
• VERA THERAPEUTICS
• RIGEL PHARMACEUTICALS
• ASTELLAS PHARMA
• TAKEDA
• CHUGAI PHARMA
• MITSUBISHI CHEMICAL
• SUN PHARMACEUTICAL INDUSTRIES
• SHANGHAI PHARMACEUTICALS HOLDING
• ZAI LAB
• INNOVENT BIOLOGICS
• KISSEI PHARMACEUTICAL
• BIOCON
• OTSUKA PHARMA
• SUMITOMO PHARMA
• CELLTRION
• 3BIO
• TEVA PHARMA
• KYOWA KIRIN
• DR REDDY'S LAB
• JIANGSHENG HENGHUI PHARMACEUTICALS
• HIKMA PHARMACEUTICALS ALS
• INTAS PHARMACEUTICALS LTD
• LABORATORIO ELEA PHOENIX SA
• IMMUNICORE HOLDINGS PLC
• SUNSHINE GUOJIAN PHARMACEUTICAL

驱动程式

自体免疫和发炎性疾病的盛行率不断上升

狼疮、类风湿性关节炎、克隆氏症和干癣等疾病的发生率不断上升，推动了对免疫调节剂的需求，例如肿瘤坏死因子 (TNF) 抑制剂（例如Humira和Remicade）和 JAK 抑制剂（例如Xeljanz）。快速老化使人们更容易患上慢性自体免疫疾病，这进一步增加了对老年人定制治疗的需求，包括耐受性更好的生物製药。

生物技术进步

生物技术平台和先进治疗方法的创新，包括CGT、双特异性抗体和RNA疗法，正在增强免疫调节剂的疗效和安全性，并促进下一代标靶治疗的开发。 Carisma Therapeutics Inc.和Moderna, Inc.正在合作，利用Carisma专有的CAR-M技术和Moderna的mRNA/脂质奈米颗粒(LNP)平台，开发用于治疗自体免疫疾病的巨噬细胞工程方法。

增加研发投入

公共和私人资金的增加正在加速研发工作，以发现新的治疗方法并改善现有的治疗方法。美国国立卫生研究院已拨出大量资金用于免疫调节疗法的研究，以刺激创新。併购活动的增加表明大型製药企业对免疫学的关注度有所提高。

肿瘤学领域的成功及应用范围的扩大

免疫疗法在肿瘤学中的成功提高了人们对治疗自体免疫和发炎性疾病的类似方法的认识和接受度：例如，罗氏公司的 Gazyva/Gazyvaro（Obinutuzumab）已在 100 个国家/地区核准用于治疗多种淋巴瘤，并且正在针对狼疮性肾炎进行 III 期 REGISTRY 试验的研究。

成长抑制因素

免疫调节疗法：成长阻碍因素，全球，2025-2030

严格的监管流程：全球范围内，针对免疫调节疗法的核准和新型作用机制的开发，都面临严格的监管流程，这可能导致製药公司进入市场的延迟和更高的开发成本。此外，全球范围内的报销和保险覆盖不足，也阻碍了该类药物的大规模应用，尤其是在公共医疗体系和医疗资源有限的地区。高成本新药的保险覆盖率低，增加了长期疾病管理的成本，进而影响患者的依从性和市场成长。

潜在的副作用和安全隐患：免疫调节药物可能产生严重的副作用，包括增加感染疾病和自体免疫反应的风险。例如，在自体免疫疾病中使用查核点抑制剂可能会产生免疫相关的副作用，必须谨慎处理。不良反应和安全风险可能导致监管行动，例如市场撤回、处方限制以及患者信心下降，使市场推广更加困难。

专利到期：重磅药物的专利到期导致生物相似药和学名药的出现，加剧了市场竞争，导致价格下滑，并造成品牌药销售收入损失。例如，艾伯维的重磅药物修美Humira ）核准用于治疗多种自体免疫疾病，包括干癣（克隆氏症）、牛皮癣、克隆氏症和僵直性脊椎炎，该药物于2023年开始面临生物相似药的竞争。

病人不便：生物技术的进步促进了有效生物製药的开发，但治疗需要频繁注射或输液，使患者难以坚持治疗方法。这可能会影响患者的整体满意度，并导致患者停止治疗。

目录

成长机会研究范围

• 分析范围
• 分割

生长环境免疫调节疗法的革命

• 为何成长变得越来越困难？
• The Strategic Imperative 8（TM）
• 三大策略问题对免疫调节治疗产业的影响

免疫调节治疗生态系统

• 流行趋势
• 经济负担
• 药物开发趋势 - I&I
• 药物开发趋势
• 临床实验状态
• 临床试验设计趋势
• 区域监理趋势与倡议
• 推动市场成长的趋势
• 护理连续体中的技术解决方案
• 研发和商业化的数位解决方案
• 经营模式
• 併购评估
• 创投估值
• 竞争环境
• 主要竞争对手

免疫调节治疗中的成长要素

• 成长指标
• 驱动程式
• 成长阻碍因素
• 调查方法与流程
• 预测考虑因素
• 预测考虑因素和限制

收益和预测

• 收益和预测分析
• 按产品分類的收益预测
• 按产品分類的收益预测分析
• 按技术分類的收益预测
• 按应用预测收益
• 各地区收益预测
• 区域预测分析
• 市场进入和报销趋势
• 价格趋势及预测分析
• 收益占有率
• 收益占有率分析
• 特色公司

成长动力：技术与应用

• 成长指标
• 按技术分類的收益预测
• 按应用预测收益
• 按技术分類的收益分析
• 按应用进行的收益分析

成长动力：传统模式

• 成长指标
• 收益预测
• 按子类型分類的收益预测
• 预测分析

成长动力：生物技术模式

• 成长指标
• 收益预测
• 按子类型分類的收益预测
• 预测分析

生长发生器：免疫适应

• 成长指标
• 收益预测
• 各地区收益预测
• 区域预测分析
• 按子类型分類的收益预测
• 依亚型进行预测分析

生长发生器：发炎适应症

• 成长指标
• 收益预测
• 各地区收益预测
• 区域预测分析
• 按子类型分類的收益预测
• 依亚型进行预测分析

免疫调节治疗领域的成长机会

• 成长机会1：针对免疫和免疫疾病的抗体疗法
• 成长机会2：专注于女性的自体免疫疗法
• 成长机会3：新兴市场的生物相似药
• 成长机会#4：疾病管理与依从性的补充解决方案

附录与后续步骤

• 成长机会的益处和影响
• 后续步骤Next steps
• 附件列表
• 免责声明

Mechanism-targeted Approaches are Driving Transformational Growth by Enabling Innovation in Autoimmune, Oncology, and Inflammatory Therapies

This research service offers a comprehensive analysis of the global immunomodulator therapeutics market, specifically targeting inflammatory disorders in the immunology, gastrointestinal (GI), and dermatology segments. The report defines this market through products designed to modify and regulate pathological immune responses, either by inhibiting or suppressing them. It categorizes the market by modality and key indications, providing a 6-year revenue forecast for global immunomodulator prescription drugs, alongside an analysis of key industry participants. The geographic scope encompasses North America, Europe, Asia-Pacific (APAC), the Middle East and Africa (MEA), and Latin America (LATAM), with regional revenue share estimates presented on a best-effort basis. The report also discusses prevalent and emerging business models, analyzes trends in market access and reimbursement for immunomodulator therapies, and offers competitive assessments and revenue share analyses. It examines the factors driving and restraining growth in this space, offering insights into drug development trends, partnerships, and the investment landscape. The report highlights key companies pioneering disruptive virtual care technologies and adjunctive therapies for effective disease management. Based on clinical needs, technological advancements, business models, and competitive dynamics, the report identifies the growth opportunities emerging from this space for market players and stakeholders to leverage. The base year is 2024, and the forecast period is from 2025 to 2030.

Revenue Forecast

Revenue estimate for the base year 2024 is $93 billion with a CAGR of 9.0% for the study period 2024-2030.

Scope of Analysis

• This research service provides a detailed overview of the global immunomodulator therapeutics market for immunology, gastrointestinal (GI), and dermatology inflammatory disorders.
• The report defines the market by products designed to treat diseases by modifying (inhibiting or suppressing) and regulating a pre-existing, pathological immune response. The market is further broken down by modality and key indications.
• It forecasts the potential revenue of global immunomodulator prescription drugs and provides a 6-year revenue forecast, including an analysis of industry participants.
• The research provides regional revenue share estimates of the overall market on a best-effort basis. The geographic scope includes North America, Europe, Asia-Pacific (APAC), the Middle East and Africa (MEA) and Latin America (LATAM).
• It discusses the most prevalent and emerging business models, market access, and reimbursement trends for immunomodulator therapies. It also covers revenue share analysis and competitive assessments and identifies key market trends.
• The report highlights the primary market drivers and restraints, drug development trends, partnerships, and investment and consolidation activities that affect market growth.
• It provides brief insights into game-changing companies developing disruptive virtual care technologies and adjunctive therapies for disease management.
• It identifies emerging growth opportunities for industry players based on clinical needs, technology trends, business models, and competitive outlooks.

The Impact of the Top 3 Strategic Imperatives on the Immunomodulator Therapeutics Industry

Disruptive Technologies

• Why: There is an increasing incidence of autoimmune diseases, particularly impacting women. Limitations in existing therapies demand more targeted applications.
• Frost Perspective: A new wave of drug classes (JAK1, IL, calcineurin, TNF?, TYK2, PDE4), across small molecules, biologics, and cell and gene therapies, will emerge, offering enhanced efficacy and safety profiles for treating autoimmune and inflammatory conditions. There will be a growing trend towards combination therapies that utilize multiple mechanisms of action to achieve better clinical outcomes.

Internal Challenges

• Why: The industry is moving toward an extended patent cliff, with several revenue-generating blockbuster drugs like Humira and Stelara losing their exclusivity, leading to revenue losses and increased biosimilar competition, creating an urgent need for pipeline growth, and driving increased research and development (R&D). Resource demands for R&D can strain budgets, especially for smaller biotech firms.
• Frost Perspective: Companies may increasingly seek strategic partnerships to share costs and risks, fostering innovation through collaborative R&D efforts. Companies that emphasize unique value propositions in these strategic alliances will be better positioned to access markets/fair pricing with drugs like JAK inhibitors and women-specific therapies. Payers will scrutinize clinical costs and patient outcomes to ensure balance and sustainable reimbursement models that reflect indication-specific needs and improve affordability.

Transformative Megatrends

• Why: Healthcare systems are under pressure to contain current and future spending. Healthcare plan sponsors are considering their next moves as governments contemplate the impact of the Inflation Reduction Act (IRA) 2022, and associated price cuts in the United States.
• Frost Perspective: Firms will invest in adaptive trial designs for evidence generation to expedite approvals for novel MoA-based targeted therapies, advancing precision medicine going forward. Pharma companies will utilize diagnostic delivery services to improve patient access by partnering with telehealth/AI-enabled symptom monitoring platforms (e.g., Ada Health) and focus on an emerging market-expansion strategy. Focus on predictive convergence of drugs and digital therapeutics will likely personalize medicine and improve experiences and outcomes.

Key Competitors

• ABBVIE
• J&J
• ELI LILLY
• ASTRAZENECA
• MERCK & CO
• SANOFI
• NOVARTIS
• AMGEN
• PFIZER
• GSK
• UCB
• BRISTOL MYERS SQUIBB
• ROCHE
• BOEHRINGER INGELHEIM
• ARGENX
• REGENERON PHARMACEUTICALS
• NOVO NORDISK
• BRISTOL MYERS SQUIBB
• REPERTOIRE IMMUNE MEDICINES
• ELI LILLY
• PFIZER
• ASTRAZENECA
• ROCHE
• BOEHRINGER INGELHEIM
• MERCK & CO
• SANOFI
• ARGENX
• UCB
• INCYTE
• MALLINCKRODT PHARMACEUTICALS
• ASAHI KASEI
• AFIBBIDY
• SWEDISH ORPHAN BIovitrum
• ANH PHARMACEUTICALS
• VERA THERAPEUTICS
• RIGEL PHARMACEUTICALS
• ASTELLAS PHARMA
• TAKEDA
• CHUGAI PHARMA
• MITSUBISHI CHEMICAL
• SUN PHARMACEUTICAL INDUSTRIES
• SHANGHAI PHARMACEUTICALS HOLDING
• ZAI LAB
• INNOVENT BIOLOGICS
• KISSEI PHARMACEUTICAL
• BIOCON
• OTSUKA PHARMA
• SUMITOMO PHARMA
• CELLTRION
• 3BIO
• TEVA PHARMA
• KYOWA KIRIN
• DR REDDY'S LAB
• JIANGSHENG HENGHUI PHARMACEUTICALS
• EVA PHARMA
• ROCHE
• TEVA
• ASTELLAS PHARMA
• HIKMA PHARMACEUTICALS ALS
• BOEHRINGER INGELHEIM
• SANOFI
• INTAS PHARMACEUTICALS LTD
• BIOCON
• NOVARTIS
• LABORATORIO ELEA PHOENIX S.A.
• IMMUNICORE HOLDINGS PLC
• CELLTRION
• SUNSHINE GUOJIAN PHARMACEUTICAL

Growth Drivers

Rising Prevalence of Autoimmune and Inflammatory Diseases

Increasing prevalence of diseases like lupus, RA, Crohn's disease, and psoriasis is driving demand for immunomodulators like tumor necrosis factor (TNF) inhibitors (e.g., Humira, Remicade) and JAK inhibitors (e.g., Xeljanz). The rapidly aging global population is more susceptible to chronic autoimmune conditions. It is further bolstering demand for treatments tailored to older adults, such as more tolerable biologics.

Biotech Advancements

Innovations in biotech platforms and advanced modalities such as CGT, bispecific antibodies, and RNA therapies are enhancing the efficacy and safety profiles of immunomodulators and driving the development of next-gen targeted therapies. Carisma Therapeutics Inc. and Moderna, Inc. have collaborated to use Carisma's proprietary CAR-M technology and Moderna's mRNA/lipid nanoparticles (LNP) platform to develop a macrophage engineering approach for autoimmune diseases.

Growing Investment in R&D

Increased funding from both public and private sectors is accelerating R&D efforts for discovering new therapies and improving existing ones. The NIH allocates significant funding for research on immunomodulatory therapies, fostering innovation. An increasing number of M&A deals demonstrate a growing focus on immunology by big pharma.

Success in Oncology and Expanding Applications

The success of immunotherapies in oncology has raised awareness and acceptance of similar approaches in treating autoimmune and inflammatory diseases. For example, Roche's Gazyva/Gazyvaro (obinutuzumab), approved in 100 nations for several lymphoma types, is being investigated in the Phase III REGISTRY trial for lupus nephritis.

Growth Restraints

Immunomodulator Therapeutics: Growth Restraints, Global, 2025-2030

Stringent Regulatory Processes: Stringent regulatory processes for immunomodulatory treatment approval or the development of novel mechanisms of action, globally, can cause delays in market access and raise development expenses for pharmaceutical companies. Moreover, inadequate reimbursement/insurance coverage globally may deter wide-scale adoption, especially in public health systems or regions with limited healthcare resources. Inadequate coverage of high-cost new drugs would increase the expenses of managing long-term conditions, impacting patient compliance and market growth.

Potential Adverse Effects and Safety Concerns: Immunomodulators may have serious adverse effects, such as an elevated risk of infections and autoimmune responses. For example, checkpoint inhibitor use in autoimmune disease is linked to immune-related side effects that need to be carefully managed. Adverse outcomes and safety risks may lead to regulatory actions such as market recalls, limited prescriptions, and reduced patient confidence, challenging market uptake.

Patent Expiry: Expiry of blockbuster drug patents is leading to the introduction of biosimilars and generic versions, intensifying market competition, resulting in price erosions, and leading to a loss of sales revenue for branded products. For example, AbbVie's blockbuster Humira, approved for several autoimmune conditions like RA, psoriasis, Crohn's disease, and ankylosing spondylitis, started facing biosimilar competition in 2023.

Patient Inconvenience: Biotech advancements have facilitated the development of effective biologic therapies; however, therapy administration requires frequent injections or infusions, making it challenging for patients to adhere to their treatment regimens. It may affect overall patient satisfaction and treatment discontinuation.

Table of Contents

Growth Opportunities: Research Scope

• Scope of Analysis
• Segmentation

Growth Environment: Transformation in Immunomodulator Therapeutics

• Why is it Increasingly Difficult to Grow?
• The Strategic Imperative 8™
• The Impact of the Top 3 Strategic Imperatives on the Immunomodulator Therapeutics Industry

Ecosystem in the Immunomodulator Therapeutics Sector

• Prevalence Trends
• Economic Burden
• Drug Development Trends-I&I
• Drug Development Trends
• Trial Landscape
• Clinical Trial Design Trends
• Regulatory Trends and Initiatives by Region
• Trends Advancing Market Growth
• Technology Solutions Across the Care Continuum
• Digital Solutions for R&D and Commercialization
• Business Models
• Mergers and Acquisitions M&As Assessment
• Venture Financing Assessment
• Competitive Environment
• Key Competitors

Growth Generators in Immunomodulator Therapeutics

• Growth Metrics
• Growth Drivers
• Growth Restraints
• Research Process and Methodology
• Forecast Considerations
• Forecast Considerations and Limitations

Revenue Forecast

• Revenue Forecast Analysis
• Revenue Forecast by Product
• Forecast Analysis by Product
• Revenue Forecast by Technology
• Revenue Forecast by Application
• Revenue Forecast by Region
• Forecast Analysis by Region
• Market Access and Reimbursement Trends
• Pricing Trends and Forecast Analysis
• Revenue Share
• Revenue Share Analysis
• Companies to Watch

Growth Generator: Technology & Application

• Growth Metrics
• Revenue Forecast by Technology
• Revenue Forecast by Application
• Revenue Forecast Analysis-Technology
• Revenue Forecast Analysis-Application

Growth Generator: Conventional Modality

• Growth Metrics
• Revenue Forecast
• Revenue Forecast by Sub-type
• Forecast Analysis

Growth Generator: Biotechnology Modality

• Growth Metrics
• Revenue Forecast
• Revenue Forecast by Sub-type
• Forecast Analysis

Growth Generator: Immunology Indications

• Growth Metrics
• Revenue Forecast
• Revenue Forecast by Region
• Forecast Analysis by Region
• Revenue Forecast by Sub-type
• Forecast Analysis by Sub-type

Growth Generator: Inflammation Indication

• Growth Metrics
• Revenue Forecast
• Revenue Forecast by Region
• Forecast Analysis by Region
• Revenue Forecast by Sub-type
• Forecast Analysis by Sub-type

Growth Opportunity Universe in Immunomodulator Therapeutics Sector

• Growth Opportunity 1: Antibody Therapies for I&I
• Growth Opportunity 2: Women-centric Autoimmune Therapies
• Growth Opportunity 3: Biosimilars for Emerging Markets
• Growth Opportunity 4: Adjunctive Solutions for Disease Management and Adherence

Appendix & Next Steps

• Benefits and Impacts of Growth Opportunities
• Next Steps
• List of Exhibits
• Legal Disclaimer