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メンタルヘルスにおけるデジタルセラピューティクスの世界市場：2025年～2033年

Global Digital Therapeutics in Mental Health Market - 2025-2033

出版日
ページ情報
英文 148 Pages
納期
即日から翌営業日
カスタマイズ可能
適宜更新あり
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=143.57円
メンタルヘルスにおけるデジタルセラピューティクスの世界市場：2025年～2033年
出版日: 2025年04月10日
発行: DataM Intelligence
ページ情報: 英文 148 Pages
納期: 即日から翌営業日
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概要

世界のメンタルヘルスにおけるデジタルセラピューティクスの市場規模は、2024年に30億7,000万米ドルに達し、2033年には151億6,000万米ドルに達すると予測され、予測期間の2025年～2033年のCAGRは19.6%となる見込みです。

メンタルヘルスにおけるデジタルセラピューティクスとは、デジタル技術を通じてメンタルヘルス障害を予防、管理、治療するために設計された、エビデンスに基づくソフトウェア主導の治療介入を指します。これらのソリューションは、モバイルアプリ、ウェブベースのプラットフォーム、AI主導のツール、仮想現実（VR）、ウェアラブル、コネクテッドデバイスを通じて、個別化された臨床的に検証された治療を提供し、メンタルヘルスの転帰を改善します。一般的なウェルネスアプリやメンタルヘルスアプリとは異なり、デジタルセラピューティクスソリューションは、うつ病、不安障害、統合失調症、薬物使用障害、その他の精神障害などの治療における有効性と安全性を確保するために、厳格な臨床検証、規制当局の承認、実環境でのエビデンス試験を受けます。

デジタルメンタルヘルスソリューションへのシフトが、メンタルヘルスにおけるデジタルセラピューティクス市場の成長を大きく促進しています。

メンタルヘルスの専門家不足に加え、メンタルヘルスの問題に対する認識の高まりが、デジタルメンタルヘルスソリューションへの依存を高めています。これらのプラットフォームは、メンタルヘルスサービスに対する需要の高まりに対応するための拡張可能な方法を提供し、特に従来の対面療法に容易にアクセスできない集団に適しています。デジタルメンタルヘルスソリューションの需要が高まる中、市場関係者は精神障害治療のためのデジタルセラピューティクスの開発に注力しています。

例えば、2024年8月、Otsuka Precision Health, Inc.とClick Therapeutics, Inc.はRejoynを商業的に発売しました。Rejoynは2024年3月に米国食品医薬品局（FDA）の承認を得ており、抗うつ薬を服用している22歳以上の成人MDD患者を対象に、臨床医が管理する外来治療の補助として大うつ病性障害（MDD）の症状を治療する、最初で唯一の処方箋デジタルセラピューティクスです。

さらに、2024年6月には、メンタルヘルスを治療するゲームメーカーであるDeepWell Digital Therapeutics (DTx)が、メンタルヘルスを治療する同社初のアクション・ビデオゲーム「Zengence」を発売しました。メタゲームストアで発売されたこのゲームは、同ストアで発売されたバーチャルリアリティアプリケーションとしては初の治療用アプリケーションです。Zengenceは、特許出願中の呼吸と音のメカニズムに関する技術を使用して、プレイヤーがダーク・レイスを倒し、内なる不安を静めるという、これまでにないアクションゲームを駆動します。

デジタルセラピューティクスソリューションは、認知行動療法（CBT）、マインドフルネスに基づくストレス軽減法（MBSR）、行動活性化法（BA）など、エビデンスに基づく方法論に基づいて構築されています。これらの実績のある治療モデルは、アプリやオンラインプラットフォームを通じて提供され、患者にアクセスしやすく、しかも科学的に検証された、メンタルヘルス状態の管理と治療の方法を提供します。

データプライバシーとサイバーセキュリティの懸念は、メンタルヘルスデータの機密性とサイバー攻撃やデータ漏洩に関連するリスクの増大が主な原因となって、メンタルヘルスにおけるデジタルセラピューティクス市場の成長に大きな障壁となっています。デジタルツールの採用とともに、治療のための個別化データへの依存は、ユーザー、ヘルスケアプロバイダー、規制当局の間でセキュリティへの懸念を高めています。

健康関連データを管理するためのモバイルアプリやクラウドストレージの利用が増える中、デジタルメンタルヘルスプラットフォームはサイバー攻撃の格好の標的になっています。データ侵害は、個人情報の盗難、詐欺、関係企業への風評被害につながる可能性があり、消費者の信頼を失い、さらなる普及を妨げます。

例えば、HIPAAジャーナルによると、2023年8月には2,300万件のヘルスケア記録の漏洩が報告されています。過去12ヶ月間、毎月平均998万9,003件のヘルスケア記録が漏洩しています。2024年8月31日までの1年間で、500件以上のデータ漏洩が491件発生し、少なくとも5,866万8,002件が漏洩したことが判明しています。2024年の平均情報漏洩件数は11万9,487件、中央値は4,109件です。

当レポートでは、世界のメンタルヘルスにおけるデジタルセラピューティクス市場について調査し、市場の概要とともに、タイプ別、用途別、地域別動向、競合情勢、および市場に参入する企業のプロファイルなどを提供しています。

目次

第1章 市場のイントロダクションと範囲

第2章 経営者の洞察と重要なポイント

第3章 市場力学

  • 影響要因
    • 促進要因
    • 抑制要因
    • 機会
    • 影響分析

第4章 戦略的洞察と業界見通し

  • 市場のリーダーとパイオニア
  • 最新の開発とブレークスルー
  • 規制と償還の情勢
  • ポーターのファイブフォース分析
  • サプライチェーン分析
  • 特許分析
  • SWOT分析
  • アンメットニーズとギャップ
  • 市場参入と拡大のための推奨戦略
  • シナリオ分析ベストケース、ベースケース、ワーストケースの予測
  • 価格分析と価格動向
  • キーオピニオンリーダー

第5章 メンタルヘルスにおけるデジタルセラピューティクス市場（タイプ別）

  • ソフトウェアベースのデジタルセラピューティクス
  • ハードウェア統合型デジタルセラピューティクス
  • センサーベースのデジタルセラピューティクス

第6章 メンタルヘルスにおけるデジタルセラピューティクス市場（用途別）

  • うつ病と気分障害
  • 不安障害
  • 心的外傷後ストレス障害
  • 強迫性障害（OCD）
  • 統合失調症および精神病
  • 睡眠障害と不眠症
  • 物質使用障害
  • 注意欠陥・多動性障害（ADHD）
  • その他

第7章 メンタルヘルスにおけるデジタルセラピューティクス市場、地域別市場分析と成長機会

  • 北米
    • 米国
    • カナダ
  • 欧州
    • ドイツ
    • 英国
    • フランス
    • スペイン
    • イタリア
    • その他
  • ラテンアメリカ
    • メキシコ
    • ブラジル
    • アルゼンチン
    • その他
  • アジア太平洋
    • 中国
    • インド
    • 日本
    • 韓国
    • その他
  • 中東・アフリカ

第8章 競合情勢と市場ポジショニング

  • 競合状況の概要と主要市場参入企業
  • 市場シェア分析とポジショニングマトリックス
  • 戦略的パートナーシップ、合併・買収
  • 製品ポートフォリオとイノベーションにおける主な発展
  • 企業ベンチマーク

第9章 企業プロファイル

  • FBigHealth
    • 会社概要
    • 製品ポートフォリオ
    • 財務概要
    • 主な発展
    • SWOT分析
  • Click Therapeutics, Inc.
  • Welldoc, Inc.
  • 2Morrow Inc.
  • Mindscapes
  • Calm.com, Inc.
  • MoodMission Pty Ltd
  • Boehringer Ingelheim Pharmaceuticals, Inc.
  • Headspace Inc.
  • Happify, Inc.

第10章 仮定と調査手法

第11章 付録

目次
Product Code: HCIT9444

The global digital therapeutics in mental health market size reached US$ 3.07 billion in 2024 and is expected to reach US$ 15.16 billion by 2033, growing at a CAGR of 19.6% during the forecast period 2025-2033.

Digital therapeutics in mental health refers to evidence-based, software-driven therapeutic interventions designed to prevent, manage, or treat mental health disorders through digital technology. These solutions deliver personalized, clinically validated treatments via mobile apps, web-based platforms, AI-driven tools, virtual reality (VR), wearables, and connected devices to improve mental health outcomes. Unlike general wellness or mental health apps, digital therapeutics solutions undergo rigorous clinical validation, regulatory approvals, and real-world evidence trials to ensure efficacy and safety in treating conditions such as depression, anxiety, schizophrenia, substance use disorders, and other mental disorders.

Market Dynamics: Drivers & Restraints

The shift towards digital mental health solutions is significantly driving the digital therapeutics in the mental health market growth

The growing recognition of mental health issues, alongside the shortage of mental health professionals, is leading to an increased reliance on digital mental health solutions. These platforms provide a scalable way to address the rising demand for mental health services, particularly for populations that may not have easy access to traditional in-person therapy. As the demand for digital mental health solutions rises, the market players are focusing on the development of digital therapeutics for the treatment of mental disorders.

For instance, in August 2024, Otsuka Precision Health, Inc. and Click Therapeutics, Inc. commercially launched Rejoyn. Rejoyn was cleared by the U.S. Food and Drug Administration (FDA) in March 2024 and is the first and only prescription digital therapeutic for the treatment of major depressive disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD aged 22 years and older who are on antidepressant medication.

Additionally, in June 2024, DeepWell Digital Therapeutics (DTx), a maker of games to treat mental health, launched Zengence, its first action video game treating mental health. Launched in the Meta Game Store, DeepWell bills the game as the first therapeutic application released in the store for virtual reality applications. Zengence uses patent-pending technology for breath and sound mechanics to drive the first-of-its-kind action game, where players defeat Dark Wraiths and silence their inner anxieties.

Digital therapeutics solutions are built on evidence-based methodologies such as Cognitive Behavioral Therapy (CBT), Mindfulness-based Stress Reduction (MBSR), and Behavioral Activation (BA). These proven therapeutic models are delivered through apps and online platforms, offering patients an accessible, yet scientifically validated, way to manage and treat mental health conditions.

Data privacy & cybersecurity concerns hampering the market growth

Data privacy and cybersecurity concerns pose significant barriers to the growth of digital therapeutics in the mental health market, primarily due to the sensitive nature of mental health data and the increasing risks associated with cyberattacks and data breaches. The reliance on personalized data for treatment, along with the adoption of digital tools, raises security concerns among users, healthcare providers, and regulators.

With the increasing use of mobile apps and cloud storage to manage health-related data, digital mental health platforms are becoming prime targets for cyberattacks. A data breach could lead to identity theft, fraud, or reputational damage to the companies involved, causing a loss of consumer confidence and halting further adoption.

For instance, according to the HIPAA Journal, in August 2023, 23 million breached healthcare records were reported. Over the past 12 months, an average of 9,989,003 healthcare records were breached each month. In the year to August 31, 2024, there have been 491 data breaches of 500 or more records, and at least 58,668,002 records are known to have been breached. The average breach size in 2024 is currently 119,487 records, and the median breach size is 4,109 records.

Segment Analysis

The global digital therapeutics in mental health market is segmented based on type, application and region.

Type:

The software-based digital therapeutics segment is expected to dominate the digital therapeutics in mental health market with the highest market share

Software-based solutions, which include mobile apps, online platforms, and AI-driven interventions, have rapidly gained popularity because they can be widely adopted and personalized to cater to a large number of patients with mental health conditions. Software-based solutions are highly scalable, meaning they can reach large numbers of users simultaneously without the need for extensive physical infrastructure. These solutions are available 24/7, making mental health support more accessible for users around the globe. Thus, software solutions, especially mental health apps, are gaining traction.

For instance, in September 2024, Magellan Health, Inc., a leader in behavioral health and related services, launched a Teen Mental Wellbeing app to support the mental and emotional well-being of teenagers and young adults ages 13-22. Powered by BeMe Health's advanced digital health platform, the app helps promote self-understanding, builds resilience, and supports the journey to mental well-being through science-backed digital tools and evidence-based approaches.

Additionally, in June 2024, Talkspace, a leading online behavioral health care company, announced it will join forces with FitOn, the No. 1 fitness app and digital health and wellness platform, to provide a holistic mental health and fitness solution to employers, and showcase the power of bringing together physical and mental fitness into an everyday setting. Employers and organizations can now turn to Talkspace for its comprehensive suite of mental health services, including its core virtual therapy offering, and have the option to add FitOn within the same engagement.

Geographical Analysis

North America is expected to hold a significant position in the global digital therapeutics in mental health market with the highest market share

North America, particularly the U.S., has one of the most advanced healthcare systems globally. This includes widespread internet access, high smartphone penetration, and a tech-savvy population, all of which facilitate the adoption of digital health solutions, including digital therapeutics. The region has one of the highest adoption rates of smartphones and health-focused apps, which is a key factor in the dominance of software-based digital therapeutics in mental health.

North America is home to a large number of venture capital firms and private investors, and insurers who are actively funding and insuring digital health startups. This influx of investment has accelerated the growth of the digital therapeutics market in mental health by enabling research and development, clinical trials, and scaling of innovative solutions.

For instance, in October 2024, MassMutual announced it was the first insurer in the U.S. to offer eligible policy owners free access to Wysa Assure, an AI-powered conversational mental health app created by Wysa and Swiss Re. This offering is the latest addition to MassMutual's Health and Wellness Program, which provides policy owners with knowledge about their health, empowers them to seek out appropriate interventions, and motivates healthy behaviors and lifestyles.

Competitive Landscape

Top companies in the digital therapeutics in mental health market include BigHealth, Click Therapeutics, Inc., Welldoc, Inc., 2Morrow Inc., Mindscapes, Calm.com, Inc., MoodMission Pty Ltd, Boehringer Ingelheim Pharmaceuticals, Inc., Headspace Inc., and Happify, Inc., among others.

Why Purchase the Report?

  • Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
  • Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
  • Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
  • Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
  • Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
  • Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
  • Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
  • Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
  • Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
  • Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
  • Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
  • Post-market Surveillance: Uses post-market data to enhance product safety and access.
  • Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global digital therapeutics in mental health market report delivers a detailed analysis with 54 key tables, more than 48 visually impactful figures, and 148 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2024

  • Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
  • Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
  • Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
  • Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
  • Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
  • Supply Chain: Distribution and Supply Chain Managers.
  • Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
  • Academic & Research: Academic Institutions.

Table of Contents

1. Market Introduction and Scope

  • 1.1. Objectives of the Report
  • 1.2. Report Coverage & Definitions
  • 1.3. Report Scope

2. Executive Insights and Key Takeaways

  • 2.1. Market Highlights and Strategic Takeaways
  • 2.2. Key Trends and Future Projections
  • 2.3. Snippet by Type
  • 2.4. Snippet by Application
  • 2.5. Snippet by Region

3. Dynamics

  • 3.1. Impacting Factors
    • 3.1.1. Drivers
      • 3.1.1.1. Shift Towards Digital Mental Health Solutions
      • 3.1.1.2. Rising Mental Health Crisis & Demand for Scalable Solutions
    • 3.1.2. Restraints
      • 3.1.2.1. Data Privacy & Cybersecurity Concerns
      • 3.1.2.2. Limited Regulatory Clarity & Approval Bottlenecks
    • 3.1.3. Opportunity
      • 3.1.3.1. Rising Technological Advancements
    • 3.1.4. Impact Analysis

4. Strategic Insights and Industry Outlook

  • 4.1. Market Leaders and Pioneers
    • 4.1.1. Emerging Pioneers and Prominent Players
    • 4.1.2. Established Leaders with Largest Marketing Brand
    • 4.1.3. Market Leaders with Established Products
  • 4.2. Latest Developments and Breakthroughs
  • 4.3. Regulatory and Reimbursement Landscape
    • 4.3.1. North America
    • 4.3.2. Europe
    • 4.3.3. Asia Pacific
    • 4.3.4. Latin America
    • 4.3.5. Middle East & Africa
  • 4.4. Porter's Five Forces Analysis
  • 4.5. Supply Chain Analysis
  • 4.6. Patent Analysis
  • 4.7. SWOT Analysis
  • 4.8. Unmet Needs and Gaps
  • 4.9. Recommended Strategies for Market Entry and Expansion
  • 4.10. Scenario Analysis: Best-Case, Base-Case, and Worst-Case Forecasts
  • 4.11. Pricing Analysis and Price Dynamics
  • 4.12. Key Opinion Leaders

5. Digital Therapeutics in Mental Health Market, By Type

  • 5.1. Introduction
    • 5.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
    • 5.1.2. Market Attractiveness Index, By Type
  • 5.2. Software-Based Digital Therapeutics*
    • 5.2.1. Introduction
    • 5.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
    • 5.2.3. Mobile Apps
    • 5.2.4. Web-based Programs
    • 5.2.5. AI-powered Chatbots
  • 5.3. Hardware-Integrated Digital Therapeutics
    • 5.3.1. Wearable Devices
    • 5.3.2. Virtual Reality (VR) & Augmented Reality (AR) Solutions
  • 5.4. Sensor-based Digital Therapeutics
    • 5.4.1. Biometric Sensors
    • 5.4.2. Motion Sensors for Behavioral Monitoring

6. Digital Therapeutics in Mental Health Market, By Application

  • 6.1. Introduction
    • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 6.1.2. Market Attractiveness Index, By Application
  • 6.2. Depression & Mood Disorders*
    • 6.2.1. Introduction
    • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 6.3. Anxiety Disorders
  • 6.4. Post-Traumatic Stress Disorder
  • 6.5. Obsessive-Compulsive Disorder (OCD)
  • 6.6. Schizophrenia & Psychotic Disorders
  • 6.7. Sleep Disorders & Insomnia
  • 6.8. Substance Use Disorders
  • 6.9. Attention-Deficit/Hyperactivity Disorder (ADHD)
  • 6.10. Others

7. Digital Therapeutics in Mental Health Market, By Regional Market Analysis and Growth Opportunities

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
    • 7.1.2. Market Attractiveness Index, By Region
  • 7.2. North America
    • 7.2.1. Introduction
    • 7.2.2. Key Region-Specific Dynamics
    • 7.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
    • 7.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 7.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 7.2.5.1. U.S.
      • 7.2.5.2. Canada
  • 7.3. Europe
    • 7.3.1. Introduction
    • 7.3.2. Key Region-Specific Dynamics
    • 7.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
    • 7.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 7.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 7.3.5.1. Germany
      • 7.3.5.2. UK
      • 7.3.5.3. France
      • 7.3.5.4. Spain
      • 7.3.5.5. Italy
      • 7.3.5.6. Rest of Europe
  • 7.4. Latin America
    • 7.4.1. Introduction
    • 7.4.2. Key Region-Specific Dynamics
    • 7.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
    • 7.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 7.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 7.4.5.1. Mexico
      • 7.4.5.2. Brazil
      • 7.4.5.3. Argentina
      • 7.4.5.4. Rest of South America
  • 7.5. Asia-Pacific
    • 7.5.1. Introduction
    • 7.5.2. Key Region-Specific Dynamics
    • 7.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
    • 7.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 7.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 7.5.5.1. China
      • 7.5.5.2. India
      • 7.5.5.3. Japan
      • 7.5.5.4. South Korea
      • 7.5.5.5. Rest of Asia-Pacific
  • 7.6. Middle East and Africa
    • 7.6.1. Introduction
    • 7.6.2. Key Region-Specific Dynamics
    • 7.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
    • 7.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application

8. Competitive Landscape and Market Positioning

  • 8.1. Competitive Overview and Key Market Players
  • 8.2. Market Share Analysis and Positioning Matrix
  • 8.3. Strategic Partnerships, Mergers & Acquisitions
  • 8.4. Key Developments in Product Portfolios and Innovations
  • 8.5. Company Benchmarking

9. Company Profiles

  • 9.1. FBigHealth*
    • 9.1.1. Company Overview
    • 9.1.2. Product Portfolio
      • 9.1.2.1. Product Description
      • 9.1.2.2. Product Key Performance Indicators (KPIs)
      • 9.1.2.3. Historic and Forecasted Product Sales
      • 9.1.2.4. Product Sales Volume
    • 9.1.3. Financial Overview
      • 9.1.3.1. Company Revenue
      • 9.1.3.2. Geographical Revenue Shares
      • 9.1.3.3. Revenue Forecasts
    • 9.1.4. Key Developments
      • 9.1.4.1. Mergers & Acquisitions
      • 9.1.4.2. Key Product Development Activities
      • 9.1.4.3. Regulatory Approvals, etc.
    • 9.1.5. SWOT Analysis
  • 9.2. Click Therapeutics, Inc.
  • 9.3. Welldoc, Inc.
  • 9.4. 2Morrow Inc.
  • 9.5. Mindscapes
  • 9.6. Calm.com, Inc.
  • 9.7. MoodMission Pty Ltd
  • 9.8. Boehringer Ingelheim Pharmaceuticals, Inc.
  • 9.9. Headspace Inc.
  • 9.10. Happify, Inc.

LIST NOT EXHAUSTIVE

10. Assumption and Research Methodology

  • 10.1. Data Collection Methods
  • 10.2. Data Triangulation
  • 10.3. Forecasting Techniques
  • 10.4. Data Verification and Validation

11. Appendix

  • 11.1. About Us and Services
  • 11.2. Contact Us