2024-2030年全球免疫調節治療市場

針對機制的方法促進了自體免疫、腫瘤和發炎治療的創新，推動了轉化成長

本研究服務對全球免疫調節治療市場進行了全面的分析，特別是針對免疫學、胃腸道（GI）和皮膚病學中的發炎性疾病。本報告透過目的是透過抑製或壓制病理免疫反應來改變和控制免疫反應的產品來定義這個市場。本報告依方式和主要適應症對市場進行分類，並對全球免疫調節處方藥的六年收益預測以及主要市場參與企業的分析進行了分析。地理範圍涵蓋北美、歐洲、亞太地區（APAC）、中東和非洲（MEA）和拉丁美洲（LATAM），並最大努力原則提供依地區分類的收益佔有率預測。本報告還討論了流行和新興的經營模式，分析了免疫調節療法的市場進入和償付趨勢，並提供了競爭評估和收益佔有率分析。本報告探討了推動和抑制該行業成長的因素，並提供了對藥物開發趨勢、夥伴關係和投資環境的見解。報告重點介紹了在有效疾病管理方面開創顛覆性虛擬護理技術和輔助性治療的關鍵公司。報告基於臨床需求、技術進步、經營模式和競爭動態，識別了市場參與者和相關人員應充分利用的該領域新興成長機會。基準年為2024年，預測期間為2025年至2030年。

收益和預測

預計2024年基準年收益為 930億美元，2024-2030年研究期間內年複合成長率為 9.0%。

分析範圍

• 本研究服務提供了針對免疫學、胃腸道（GI）和皮膚病發炎疾病的全球免疫調節治療市場的詳細概述。
• 在本報告中，市場由目的是透過修改（阻斷或抑制）和調節現有病理免疫反應來治療疾病的產品定義，並根據方式和主要適應症進一步細分。
• 它預測了全球免疫調節劑處方藥市場的潛在收益，並提供了六年的收益預測，包括對行業參與企業的分析。
• 本研究最大努力原則估算了北美、歐洲、亞太地區（APAC）、中東和非洲（MEA）以及拉丁美洲（LATAM）各地區的整體市場收益佔有率。
• 本報告涵蓋了免疫調節療法最受歡迎和新興的經營模式、市場進入和償付趨勢，還涵蓋了收益佔有率分析和競爭評估，突出了關鍵的市場趨勢。
• 本報告涵蓋了關鍵市場促進因素和影響市場成長的促進因素、藥物開發趨勢、夥伴關係、投資和整合活動。
• 它簡要介紹了開發顛覆性虛擬護理技術和疾病管理輔助性治療的開創性公司。
• 根據臨床需求、技術趨勢、經營模式和競爭前景，為產業參與者確定新的成長機會。

三大策略問題對免疫調節治療產業的影響

顛覆性技術

• 背景：自體免疫疾病的發生率日益上升，尤其是在女性族群。現有的治療方法有其局限性，需要更有針對性的治療方案。
• Frost觀點：以小分子、生物製藥和細胞/基因療法的藥物類別（JAK1、IL、Calcineurin、TNF、TYK2、PDE4），利用多種作用機制進行聯合治療的趨勢將日益明顯，以實現更好的臨床結果。

內部挑戰

• 背景：隨著Humira和Stelara等收益重磅藥物失去獨佔權，導致收益損失和生物相似藥競爭加劇，迫切需要擴大產品線並加大研發投入。研發資源需求可能會對預算造成壓力，尤其對於規模較小的生技公司。
• Frost 的觀點：企業可能會擴大尋求策略夥伴關係，以分擔成本和風險，並透過合作研發促進創新。在此類聯盟中強調獨特價值提案的企業可能更有能力進入市場並制定合理的價格，例如JAK抑制劑或女性專用療法。付款人將仔細審查臨床成本和患者療效，以確保平衡且永續的償付模式能夠反映特定適應症的需求，提高患者可負擔性。

轉型大趨勢

• 背景：醫療保健系統面臨控制當前和未來支出的壓力。隨著政府考慮美國2022年降低通膨法案（IRA）及其相關降價措施的影響，醫療保健計劃發起人考慮下一步。
• Frost 的觀點：製藥公司將投資於用於證據生成的自適應試驗設計，以加快核准MoA 的新型標靶治療的核准，並推動未來的精準醫療。製藥公司將利用診斷交付服務來改善患者可近性，並透過與遠端保健/人工智慧支援的症狀監測平台（例如 Ada Health）合作，致力於新興市場的擴大策略。致力於藥物和數位療法的預測性整合，有望實現醫療保健的個人化，並改善體驗和療效。

主要競爭對手

• 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

促進因素

自體免疫和發炎性疾病的盛行率不斷上升

狼瘡、類風濕性關節炎、克隆氏症和乾癬等疾病的發生率不斷上升，推動了對免疫調節劑的需求，例如腫瘤壞死因子（TNF）抑制劑（例如Humira和Remicade）和 JAK 抑制劑（例如Xeljanz）。快速老化使人們更容易患上慢性自體免疫疾病，這進一步增加了對老年人客製化治療的需求，包括耐受性更好的生物製藥。

生物技術進步

生物技術平台和先進治療方法的創新，包括CGT、雙特異性抗體和RNA療法，增強免疫調節劑的療效和安全性，並促進下一代標靶治療的開發。 Carisma Therapeutics Inc.和Moderna, Inc.合作，利用Carisma專有的CAR-M技術和Moderna的mRNA/脂質奈米顆粒（LNP）平台，開發用於治療自體免疫疾病的巨噬細胞工程方法。

增加研發投入

公共和私人資金的增加加速研發工作，以發現新的治療方法並改善現有的治療方法。美國國立衛生研究院已撥出大量資金用於免疫調節療法的研究，以刺激創新。併購活動的增加表明大型製藥企業對免疫學的關注度有所提高。

腫瘤學領域的成功及應用範圍的擴大

免疫療法在腫瘤學中的成功提高了人們對治療自體免疫和發炎性疾病的類似方法的認知和接受度：例如，Roche公司的Gazyva/Gazyvaro（Obinutuzumab）已在 100個國家/地區核准用於治療多種淋巴瘤，並且針對狼瘡性腎炎進行 III 期 REGISTRY 試驗的研究。

成長抑制因素

免疫調節療法：成長阻礙因素，全球，2025-2030

嚴格的監管流程：全球範圍內，針對免疫調節療法的核准和新型作用機制的開發，都面臨嚴格的監管流程，這可能導致製藥公司進入市場的延遲和更高的開發成本。此外，全球範圍內的償付和保險覆蓋不足，也阻礙了該類藥物的大規模應用，尤其是在公共醫療體系和醫療資源有限的地區。高成本新藥的保險覆蓋率低，增加了長期疾病管理的成本，進而影響患者的依從性和市場成長。

潛在的副作用和安全隱患：免疫調節藥物可能產生嚴重的副作用，包括增加感染疾病和自體免疫反應的風險。例如，在自體免疫疾病中使用查核點抑制劑可能會產生免疫相關的副作用，必須謹慎處理。不良反應和安全風險可能導致監管行動，例如市場撤回、處方限制以及患者信心下降，使市場推廣更加困難。

專利到期：重磅藥物的專利到期導致生物相似藥和學名藥的出現，加劇了市場競爭，導致價格下滑，並造成品牌藥銷售收入損失。例如，AbbVie的重磅藥物Humira核准用於治療多種自體免疫疾病，包括RA、牛皮癬、克隆氏症和僵直性脊椎炎，該藥物於2023年開始面臨生物相似藥的競爭。

病人不便：生物技術的進步促進了有效生物製藥的開發，但治療需要頻繁注射或輸液，使患者難以堅持治療方法。這可能會影響患者的整體滿意度，並導致患者停止治療。

目錄

成長機會研究範圍

• 分析範圍
• 區隔

生長環境免疫調節療法的革命

• 為何成長變得越來越困難？
• The Strategic Imperative 8（TM）
• 三大策略問題對免疫調節治療產業的影響

免疫調節治療生態系統

• 流行趨勢
• 經濟負擔
• 藥物開發趨勢 - I&I
• 藥物開發趨勢
• 臨床實驗狀態
• 臨床試驗設計趨勢
• 區域監理趨勢與舉措
• 推動市場成長的趨勢
• 護理連續體中的技術解決方案
• 研發和商業化的數位解決方案
• 經營模式
• 併購評估
• 創投估值
• 競爭環境
• 主要競爭對手

免疫調節治療中的成長要素

• 成長指標
• 促進因素
• 成長阻礙因素
• 調查方法與流程
• 預測相關考察
• 預測考察和限制

收益和預測

• 收益和預測分析
• 依產品的收益預測
• 依產品的收益預測分析
• 依技術的收益預測
• 依應用的收益預測
• 依地區的收益預測
• 依地區的預測分析
• 市場進入和償付趨勢
• 價格趨勢及預測分析
• 收益佔有率
• 收益佔有率分析
• 特色公司

成長動力：技術與應用

• 成長指標
• 依技術的收益預測
• 依應用的收益預測
• 依技術的收益分析
• 依應用的收益分析

成長動力：傳統模式

• 成長指標
• 收益預測
• 依子類型的收益預測
• 預測分析

成長動力：生物技術模式

• 成長指標
• 收益預測
• 依子類型的收益預測
• 預測分析

成長動力：免疫適應

• 成長指標
• 收益預測
• 依地區的收益預測
• 依地區的預測分析
• 依子類型的收益預測
• 依子類型的預測分析

成長動力：發炎適應症

• 成長指標
• 收益預測
• 依地區的收益預測
• 依地區的預測分析
• 依子類型的收益預測
• 依子類型的預測分析

免疫調節治療領域的成長機會

• 成長機會1：針對免疫和免疫疾病的抗體療法
• 成長機會2：致力於女性的自體免疫療法
• 成長機會3：新興市場的生物相似藥
• 成長機會4：疾病管理與依從性的補充解決方案

附錄與後續步驟

• 成長機會的益處和影響
• 後續步驟
• 附件列表
• 免責聲明

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