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2046918

口服蛋白質和胜肽市場－全球產業規模、佔有率、趨勢、機會、預測：按藥物類型、應用、地區和競爭格局分類，2021-2031年

Oral Proteins & Peptides Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Drug Type, By Application, By Region & Competition, 2021-2031F
出版日期: | 出版商: TechSci Research | 英文 185 Pages | 商品交期: 2-3個工作天內

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簡介目錄

全球口服蛋白質和胜肽市場預計將從 2025 年的 13.7 億美元大幅成長至 2031 年的 23.6 億美元，複合年成長率為 9.49%。

這些治療性生物分子，包括荷爾蒙和酶，設計用於口服給藥，為傳統的注射療法提供了一種非侵入性的替代方案。該市場的成長主要受全球慢性代謝疾病盛行率不斷上升以及由此產生的對更易於患者接受的給藥方式的需求的推動，這些給藥方式能夠提高治療依從性。一個關鍵因素是需要以更有效、更無痛的方式管理長期疾病。國際糖尿病聯盟 (IDF) 估計，到 2025 年，全球將有約 5.89 億成年人患有糖尿病，這表明對易於獲取的解決方案的需求非常高，從而增加了口服生物製藥的商業性吸引力。然而，該市場面臨的主要挑戰仍然是這些大分子固有的低生物利用度。在胃腸道的惡劣環境中，由於酵素分解和酸性 pH 值，蛋白質在被全身吸收之前就會迅速分解。因此，開發先進的給藥技術對於保護藥物並確保足夠的治療效果以支持市場擴張至關重要。

市場概覽
預測期 2027-2031
市場規模：2025年 13.7億美元
市場規模：2031年 23.6億美元
複合年成長率：2026-2031年 9.49%
成長最快的細分市場 Plecanatide
最大的市場 北美洲

市場促進因素

口服蛋白遞送系統的技術突破正在從根本上改變市場格局。這些突破有效克服了酵素分解和吸收不良等傳統難題。滲透促進劑和載體技術的進步使得生物製藥能夠達到與皮下注射相當的治療濃度。例如，Viking Therapeutics公司於2025年8月進行的一項II期臨床試驗表明，VK2735口服片劑在13週後可使代謝紊亂患者的平均體重減輕高達12.2%，這表明口服給藥與現有的腸外療法療效相當，並可擴大目標患者群體。這種療效也體現在骨骼健康方面。 Entera Bio公司於2025年10月報告稱，其口服副甲狀腺素候選藥物EB613可使腰椎骨骼密度增加3.1%。此外，策略合作和技術授權協議的激增正在提供必要的資金和研發技術，從而迅速加速商業性成長。大型製藥公司正日益與專業生技公司合作，整合先進的口服給藥平台，進而降低自主研發新技術所帶來的重大風險。這些合作通常涉及巨額資金投入，是這些技術商業性潛力的基石。例如，Rani Therapeutics與中外製藥於2025年10月簽署的合作協議，旨在利用RaniPill膠囊開發口服生技藥品，價值高達10.85億美元。此類高價值協議凸顯了製藥業對非侵入性給藥的策略關注，確保有前景的口服生技藥品候選藥物能夠快速從臨床試驗階段過渡到上市階段。

市場挑戰

全球口服蛋白質和胜肽類藥物市場擴張的一大障礙是這些大分子由於在胃腸道內不穩定而導致的固有低生物利用度。人體消化器官系統的結構，以酵素活性和酸性pH值為特徵，能夠有效地將蛋白質分解成胺基酸。這種嚴苛的環境導致治療性胜肽類藥物在穿過腸壁進入體循環之前就被分解。因此，由於在不使用侵入性給藥方式的情況下難以達到穩定的治療性血中濃度，製藥研發公司在臨床試驗中面臨很高的失敗率。這項技術壁壘顯著影響了市場的商業化進程，導致研發成本增加和法規核准流程延長。與成熟的注射劑製劑相比，口服生技藥品製劑計畫的風險回報比較低，因此投資者和生產商往往對進入該市場持謹慎態度。美國FDA發布的2025年報告也強調了這些複雜製劑獲得監管核准的困難。報告顯示，生技藥品評估與研究中心（CBER）僅核准了18 種新的生技藥品，顯示將穩定有效的生技藥品推向市場仍面臨挑戰。

市場趨勢

市場結構的一個顯著轉變是口服胜肽技術向自體免疫疾病和腫瘤治療領域的拓展。研發人員已不再局限於傳統的代謝性疾病治療，而是成功地將口服胜肽技術應用於複雜的發炎性疾病。口服受體拮抗劑的臨床療效便是此一趨勢的例證。這類藥物兼具注射型生物製劑的療效和每日一次藥片給藥的便利性，滿足了慢性自體免疫疾病治療領域尚未充分滿足的重大需求。例如，2025年3月，Protagonist Therapeutics公司公佈了其口服胜肽製劑「icotrokinra」在IIb期臨床試驗中所取得的正面結果。該製劑在中重度活動性潰瘍性大腸炎患者中達到了63.5%的臨床緩解率，展現了口服製劑在高價值治療領域的巨大潛力。同時，口服機器人膠囊技術的出現，也為克服化學滲透增強劑的限制提供了新的機械給藥途徑。這些基於裝置的製劑旨在將大分子藥物物理注射到腸壁中，克服了傳統口服生物製藥開發中經常遇到的劑量限制。這種創新方法能夠輸送更大劑量的藥物，包括需要更高劑量的複雜蛋白質。 2025年3月，Biora Therapeutics宣布其BioJet平台能夠輸送超過300微升的藥物。這項技術使得使用這些裝置即可實現以往只能透過腸外途徑給藥的治療劑量。

目錄

第1章概述

第2章：調查方法

第3章執行摘要

第4章：客戶心聲

第5章：口服蛋白質和胜肽的全球市場展望

  • 市場規模及預測
    • 按金額
  • 市佔率及預測
    • 藥物類型（抑鈣素、胰島素、Linaclotide、Octreotide、Plecanatide）
    • 用途（骨骼疾病、糖尿病、胃/消化系統疾病、內分泌疾病）
    • 按地區
    • 按公司（2025 年）
  • 市場地圖

第6章：北美口服蛋白質與胜肽市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 北美洲：國別分析
    • 美國
    • 加拿大
    • 墨西哥

第7章：歐洲口服蛋白質和胜肽的市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 歐洲：國別分析
    • 德國
    • 法國
    • 英國
    • 義大利
    • 西班牙

第8章：亞太地區口服蛋白質和胜肽的市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 亞太地區：國別分析
    • 中國
    • 印度
    • 日本
    • 韓國
    • 澳洲

第9章：中東和非洲口服蛋白質和胜肽的市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 中東與非洲：國別分析
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 南非

第10章：南美洲口服蛋白質和胜肽的市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 南美洲：國別分析
    • 巴西
    • 哥倫比亞
    • 阿根廷

第11章 市場動態

  • 促進因素
  • 任務

第12章 市場趨勢與發展

  • 併購
  • 產品發布
  • 近期趨勢

第13章 全球口服蛋白質與胜肽市場：SWOT分析

第14章：波特五力分析

  • 產業競爭
  • 新進入者的潛力
  • 供應商的議價能力
  • 顧客權力
  • 替代品的威脅

第15章 競爭格局

  • AbbVie Inc.
  • Merck & Co Inc
  • Pfizer Inc
  • Novo Nordisk A/S
  • Hoffmann-La Roche Inc
  • Sanofi SA
  • AstraZeneca PLC
  • Bristol-Myers Squibb Co
  • Tarsa Therapeutics Inc
  • Novartis AG

第16章 策略建議

第17章：關於研究公司及免責聲明

簡介目錄
Product Code: 18807

The global market for oral proteins and peptides is projected to expand significantly, from USD 1.37 billion in 2025 to USD 2.36 billion by 2031, exhibiting a compound annual growth rate of 9.49%. These therapeutic biologic molecules, including hormones and enzymes, are designed for oral ingestion, offering a non-invasive alternative to conventional injectable treatments. The market's growth is largely driven by the increasing worldwide prevalence of chronic metabolic conditions and the associated need for patient-friendly drug delivery methods that improve treatment adherence. A key factor is the imperative for more effective, pain-free management of long-term diseases, as evidenced by the International Diabetes Federation's 2025 estimate of approximately 589 million adults globally living with diabetes, highlighting the considerable demand for accessible solutions and thus boosting the commercial appeal of oral biologic formulations. However, a major challenge for the market remains the naturally low bioavailability of these large molecules. The gastrointestinal tract's harsh environment, characterized by enzymatic degradation and acidic pH, rapidly breaks down proteins before systemic absorption, making the development of advanced delivery technologies crucial for protecting drugs and ensuring adequate therapeutic uptake to support market expansion.

Market Overview
Forecast Period2027-2031
Market Size 2025USD 1.37 Billion
Market Size 2031USD 2.36 Billion
CAGR 2026-20319.49%
Fastest Growing SegmentPlecanatide
Largest MarketNorth America

Market Driver

The market is being fundamentally transformed by technological breakthroughs in oral protein delivery systems, which are effectively overcoming previous limitations like enzymatic degradation and poor absorption. Advances in permeation enhancers and carrier technologies now enable biologic therapies to achieve therapeutic concentrations comparable to those delivered by subcutaneous injections. For example, a Phase 2 trial in August 2025 by Viking Therapeutics showed that an oral tablet of VK2735 led to an average weight loss of up to 12.2% in patients with metabolic conditions after 13 weeks, demonstrating oral modalities' ability to rival established parenteral treatments and broaden the patient pool. This efficacy also extends to bone health, with Entera Bio reporting a 3.1% increase in lumbar spine bone mineral density from their oral parathyroid hormone candidate EB613 in October 2025. Complementing this, a surge in strategic collaborations and technology licensing deals is rapidly accelerating commercial growth by providing crucial capital and development expertise. Major pharmaceutical companies are increasingly partnering with specialized biotech firms to integrate advanced oral delivery platforms, thereby reducing the significant risks of developing new technologies internally. These partnerships, often involving considerable financial investments, validate the commercial promise of these technologies, such as Rani Therapeutics' October 2025 collaboration with Chugai Pharmaceutical, valued at up to $1.085 billion, for developing oral biologics using the RaniPill capsule. Such high-value agreements highlight the industry's strategic focus on non-invasive delivery, ensuring the swift progression of promising oral biologic candidates from clinical trials to market readiness.

Market Challenge

The primary impediment to the global oral proteins and peptides market expansion is the naturally low bioavailability of these large molecules due to gastrointestinal instability. The human digestive system's inherent design, with enzymatic activity and acidic pH, efficiently breaks down proteins into amino acids. This harsh environment degrades therapeutic peptides before they can cross the intestinal lining and enter systemic circulation. As a result, pharmaceutical developers encounter high failure rates in clinical trials because achieving consistent therapeutic blood concentrations without invasive delivery methods is exceptionally challenging. This technical hurdle significantly affects the market's commercial path, leading to increased development costs and extended regulatory processes. Investors and manufacturers are frequently dissuaded by the unfavorable risk-to-reward ratio of oral biologic programs compared to established injectable options. The difficulty in gaining regulatory approval for these intricate formulations is underscored by the U.S. FDA's 2025 report, which indicates that the Center for Biologics Evaluation and Research (CBER) approved only 18 new biological treatments, illustrating the ongoing challenges in successfully introducing stable and effective biologic formulations to the market.

Market Trends

A notable structural shift in the market is the expansion into autoimmune and oncology therapeutic areas, as developers successfully adapt oral peptide technologies for complex inflammatory diseases, moving beyond the traditional focus on metabolic conditions. This trend is marked by the clinical validation of oral receptor antagonists that provide the efficacy of injectable biologics combined with the convenience of a daily pill, thereby addressing critical unmet needs in managing chronic autoimmune conditions. For example, Protagonist Therapeutics reported positive Phase 2b study results in March 2025, where the oral peptide icotrokinra achieved a 63.5% clinical response rate in patients with moderately to severely active ulcerative colitis, demonstrating oral modalities' strong potential in high-value therapeutic categories. Simultaneously, the emergence of ingestible robotic pill technologies is introducing a mechanical delivery method that surpasses the limitations of chemical permeation enhancers. These device-based formulations are engineered to physically inject macromolecules into the intestinal wall, thereby overcoming the volume constraints often encountered in traditional oral biologic development. This innovative approach facilitates the administration of significantly larger drug volumes, making it possible to deliver complex proteins that require higher dosages. Biora Therapeutics, in March 2025, announced that its BioJet platform can deliver payloads exceeding 300 microliters, a technical capability that allows these devices to manage therapeutic loads previously restricted to parenteral delivery.

Key Market Players

  • AbbVie Inc.
  • Merck & Co Inc
  • Pfizer Inc
  • Novo Nordisk A/S
  • Hoffmann-La Roche Inc
  • Sanofi SA
  • AstraZeneca PLC
  • Bristol-Myers Squibb Co
  • Tarsa Therapeutics Inc
  • Novartis AG

Report Scope

In this report, the Global Oral Proteins & Peptides Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Oral Proteins & Peptides Market, By Drug Type

  • Calcitonin
  • Insulin
  • Linaclotide
  • Octreotide
  • Plecanatide

Oral Proteins & Peptides Market, By Application

  • Bone Diseases
  • Diabetes
  • Gastric & Digestive Disorders
  • Hormonal Disorders

Oral Proteins & Peptides Market, By Region

  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • France
    • United Kingdom
    • Italy
    • Germany
    • Spain
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
  • South America
    • Brazil
    • Argentina
    • Colombia
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Oral Proteins & Peptides Market.

Available Customizations:

Global Oral Proteins & Peptides Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

  • Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

  • 1.1. Market Definition
  • 1.2. Scope of the Market
    • 1.2.1. Markets Covered
    • 1.2.2. Years Considered for Study
    • 1.2.3. Key Market Segmentations

2. Research Methodology

  • 2.1. Objective of the Study
  • 2.2. Baseline Methodology
  • 2.3. Key Industry Partners
  • 2.4. Major Association and Secondary Sources
  • 2.5. Forecasting Methodology
  • 2.6. Data Triangulation & Validation
  • 2.7. Assumptions and Limitations

3. Executive Summary

  • 3.1. Overview of the Market
  • 3.2. Overview of Key Market Segmentations
  • 3.3. Overview of Key Market Players
  • 3.4. Overview of Key Regions/Countries
  • 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Oral Proteins & Peptides Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Drug Type (Calcitonin, Insulin, Linaclotide, Octreotide, Plecanatide)
    • 5.2.2. By Application (Bone Diseases, Diabetes, Gastric & Digestive Disorders, Hormonal Disorders)
    • 5.2.3. By Region
    • 5.2.4. By Company (2025)
  • 5.3. Market Map

6. North America Oral Proteins & Peptides Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Drug Type
    • 6.2.2. By Application
    • 6.2.3. By Country
  • 6.3. North America: Country Analysis
    • 6.3.1. United States Oral Proteins & Peptides Market Outlook
      • 6.3.1.1. Market Size & Forecast
        • 6.3.1.1.1. By Value
      • 6.3.1.2. Market Share & Forecast
        • 6.3.1.2.1. By Drug Type
        • 6.3.1.2.2. By Application
    • 6.3.2. Canada Oral Proteins & Peptides Market Outlook
      • 6.3.2.1. Market Size & Forecast
        • 6.3.2.1.1. By Value
      • 6.3.2.2. Market Share & Forecast
        • 6.3.2.2.1. By Drug Type
        • 6.3.2.2.2. By Application
    • 6.3.3. Mexico Oral Proteins & Peptides Market Outlook
      • 6.3.3.1. Market Size & Forecast
        • 6.3.3.1.1. By Value
      • 6.3.3.2. Market Share & Forecast
        • 6.3.3.2.1. By Drug Type
        • 6.3.3.2.2. By Application

7. Europe Oral Proteins & Peptides Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Drug Type
    • 7.2.2. By Application
    • 7.2.3. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. Germany Oral Proteins & Peptides Market Outlook
      • 7.3.1.1. Market Size & Forecast
        • 7.3.1.1.1. By Value
      • 7.3.1.2. Market Share & Forecast
        • 7.3.1.2.1. By Drug Type
        • 7.3.1.2.2. By Application
    • 7.3.2. France Oral Proteins & Peptides Market Outlook
      • 7.3.2.1. Market Size & Forecast
        • 7.3.2.1.1. By Value
      • 7.3.2.2. Market Share & Forecast
        • 7.3.2.2.1. By Drug Type
        • 7.3.2.2.2. By Application
    • 7.3.3. United Kingdom Oral Proteins & Peptides Market Outlook
      • 7.3.3.1. Market Size & Forecast
        • 7.3.3.1.1. By Value
      • 7.3.3.2. Market Share & Forecast
        • 7.3.3.2.1. By Drug Type
        • 7.3.3.2.2. By Application
    • 7.3.4. Italy Oral Proteins & Peptides Market Outlook
      • 7.3.4.1. Market Size & Forecast
        • 7.3.4.1.1. By Value
      • 7.3.4.2. Market Share & Forecast
        • 7.3.4.2.1. By Drug Type
        • 7.3.4.2.2. By Application
    • 7.3.5. Spain Oral Proteins & Peptides Market Outlook
      • 7.3.5.1. Market Size & Forecast
        • 7.3.5.1.1. By Value
      • 7.3.5.2. Market Share & Forecast
        • 7.3.5.2.1. By Drug Type
        • 7.3.5.2.2. By Application

8. Asia Pacific Oral Proteins & Peptides Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Drug Type
    • 8.2.2. By Application
    • 8.2.3. By Country
  • 8.3. Asia Pacific: Country Analysis
    • 8.3.1. China Oral Proteins & Peptides Market Outlook
      • 8.3.1.1. Market Size & Forecast
        • 8.3.1.1.1. By Value
      • 8.3.1.2. Market Share & Forecast
        • 8.3.1.2.1. By Drug Type
        • 8.3.1.2.2. By Application
    • 8.3.2. India Oral Proteins & Peptides Market Outlook
      • 8.3.2.1. Market Size & Forecast
        • 8.3.2.1.1. By Value
      • 8.3.2.2. Market Share & Forecast
        • 8.3.2.2.1. By Drug Type
        • 8.3.2.2.2. By Application
    • 8.3.3. Japan Oral Proteins & Peptides Market Outlook
      • 8.3.3.1. Market Size & Forecast
        • 8.3.3.1.1. By Value
      • 8.3.3.2. Market Share & Forecast
        • 8.3.3.2.1. By Drug Type
        • 8.3.3.2.2. By Application
    • 8.3.4. South Korea Oral Proteins & Peptides Market Outlook
      • 8.3.4.1. Market Size & Forecast
        • 8.3.4.1.1. By Value
      • 8.3.4.2. Market Share & Forecast
        • 8.3.4.2.1. By Drug Type
        • 8.3.4.2.2. By Application
    • 8.3.5. Australia Oral Proteins & Peptides Market Outlook
      • 8.3.5.1. Market Size & Forecast
        • 8.3.5.1.1. By Value
      • 8.3.5.2. Market Share & Forecast
        • 8.3.5.2.1. By Drug Type
        • 8.3.5.2.2. By Application

9. Middle East & Africa Oral Proteins & Peptides Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Drug Type
    • 9.2.2. By Application
    • 9.2.3. By Country
  • 9.3. Middle East & Africa: Country Analysis
    • 9.3.1. Saudi Arabia Oral Proteins & Peptides Market Outlook
      • 9.3.1.1. Market Size & Forecast
        • 9.3.1.1.1. By Value
      • 9.3.1.2. Market Share & Forecast
        • 9.3.1.2.1. By Drug Type
        • 9.3.1.2.2. By Application
    • 9.3.2. UAE Oral Proteins & Peptides Market Outlook
      • 9.3.2.1. Market Size & Forecast
        • 9.3.2.1.1. By Value
      • 9.3.2.2. Market Share & Forecast
        • 9.3.2.2.1. By Drug Type
        • 9.3.2.2.2. By Application
    • 9.3.3. South Africa Oral Proteins & Peptides Market Outlook
      • 9.3.3.1. Market Size & Forecast
        • 9.3.3.1.1. By Value
      • 9.3.3.2. Market Share & Forecast
        • 9.3.3.2.1. By Drug Type
        • 9.3.3.2.2. By Application

10. South America Oral Proteins & Peptides Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Drug Type
    • 10.2.2. By Application
    • 10.2.3. By Country
  • 10.3. South America: Country Analysis
    • 10.3.1. Brazil Oral Proteins & Peptides Market Outlook
      • 10.3.1.1. Market Size & Forecast
        • 10.3.1.1.1. By Value
      • 10.3.1.2. Market Share & Forecast
        • 10.3.1.2.1. By Drug Type
        • 10.3.1.2.2. By Application
    • 10.3.2. Colombia Oral Proteins & Peptides Market Outlook
      • 10.3.2.1. Market Size & Forecast
        • 10.3.2.1.1. By Value
      • 10.3.2.2. Market Share & Forecast
        • 10.3.2.2.1. By Drug Type
        • 10.3.2.2.2. By Application
    • 10.3.3. Argentina Oral Proteins & Peptides Market Outlook
      • 10.3.3.1. Market Size & Forecast
        • 10.3.3.1.1. By Value
      • 10.3.3.2. Market Share & Forecast
        • 10.3.3.2.1. By Drug Type
        • 10.3.3.2.2. By Application

11. Market Dynamics

  • 11.1. Drivers
  • 11.2. Challenges

12. Market Trends & Developments

  • 12.1. Merger & Acquisition (If Any)
  • 12.2. Product Launches (If Any)
  • 12.3. Recent Developments

13. Global Oral Proteins & Peptides Market: SWOT Analysis

14. Porter's Five Forces Analysis

  • 14.1. Competition in the Industry
  • 14.2. Potential of New Entrants
  • 14.3. Power of Suppliers
  • 14.4. Power of Customers
  • 14.5. Threat of Substitute Products

15. Competitive Landscape

  • 15.1. AbbVie Inc.
    • 15.1.1. Business Overview
    • 15.1.2. Products & Services
    • 15.1.3. Recent Developments
    • 15.1.4. Key Personnel
    • 15.1.5. SWOT Analysis
  • 15.2. Merck & Co Inc
  • 15.3. Pfizer Inc
  • 15.4. Novo Nordisk A/S
  • 15.5. Hoffmann-La Roche Inc
  • 15.6. Sanofi SA
  • 15.7. AstraZeneca PLC
  • 15.8. Bristol-Myers Squibb Co
  • 15.9. Tarsa Therapeutics Inc
  • 15.10. Novartis AG

16. Strategic Recommendations

17. About Us & Disclaimer