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表紙：肥満細胞症治療の世界市場-2023年～2030年
市場調査レポート
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1374827

肥満細胞症治療の世界市場-2023年～2030年

Global Mastocytosis Treatment Market - 2023-2030
出版日: | 発行: DataM Intelligence | ページ情報: 英文 186 Pages | 納期: 約2営業日

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肥満細胞症治療の世界市場-2023年～2030年
出版日: 2023年11月01日
発行: DataM Intelligence
ページ情報: 英文 186 Pages
納期: 約2営業日
ご注意事項 :
本レポートは最新情報反映のため適宜更新し、内容構成変更を行う場合があります。ご検討の際はお問い合わせください。
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  • 概要
  • 目次
概要

概要

肥満細胞症は遺伝性の免疫疾患で、肥満細胞と呼ばれる特定の免疫細胞が皮膚の下や骨、腸、その他の臓器に蓄積します。この肥満細胞の異常増殖は、皮膚のかゆみを伴う隆起、下痢などの消化管（GI）障害、骨の痛みなど、さまざまな症状を引き起こします。また、患者が特定の環境誘因に遭遇した場合、アナフィラキシー（重篤なアレルギー反応）のリスクを高めることもあります。場合によっては、肥満細胞症が進行し、放置すると死に至ることもあります。肥満細胞症は感染しません。

肥満細胞症には、皮膚型と全身型の2種類があります。基本的に、肥満細胞症を治療する方法はありませんが、治療によって症状を管理し、最小限に抑えることができます。抗ヒスタミン薬、ロイコトリエン調整薬、肥満細胞安定化薬、コルチコステロイドクリームは、かゆみを伴う皮膚病変などのアレルギー反応の症状を緩和することができます。アナフィラキシーショックの場合は、エピネフリン注射が一般的に使用されます。侵攻性全身性肥満細胞症の治療には、クラドリビンなどの化学療法が用いられます。侵攻性全身性肥満細胞症の患者の一部は、同種造血幹細胞移植（骨髄移植とも呼ばれる）を受けることがあります。

市場力学：促進要因

新規治療薬の採用増加

新規治療薬の採用が増加していることが、予測期間中の市場を牽引すると予想されます。肥満細胞症には治療法がないため、治療によって症状を最小限に抑えることができます。新規治療薬の開発と採用は、より良い患者の転帰のために、より高度な承認済み治療薬を提供することで、肥満細胞症の管理に関連する医療上のアンメットニーズに対処することを目的としています。

例えば、2023年1月23日、Blueprint Medicines Corporationは、成人の低悪性度全身性肥満細胞症（SM）治療薬AYVAKIT（アバプリチニブ）の承認申請が米国食品医薬品局（FDA）により認可されたと発表しました。

さらに、肥満細胞症の管理においてより良い結果を示す新規治療薬の開発に向けて、多くの臨床試験が進行中です。規制当局の承認は、新規治療薬の開発と採用に対する患者の信頼を高めています。

例えば、2023年9月11日、患者に焦点を当てたバイオ医薬品会社であるHoth Therapeutics, Inc.は、米国食品医薬品局（FDA）に対し、進行性全身性肥満細胞症（AdvSM）治療のための新規分子実体であるHT-KITの医薬品開発プログラム案について、治験前新薬（IND）会議を公表しました。HT-KITは、mRNAのフレームシフトを誘導することによりがん原遺伝子cKITを標的とするアンチセンスオリゴヌクレオチドであり、すでにFDAから希少疾病用医薬品の指定を受けています。

さらに、現在進行中の研究開発努力は、新たな治療法の発見と革新的な医薬品の開発につながっています。肥満細胞症の分子・細胞レベルでの理解が進むにつれて、標的作用機序を持つ新規治療薬が同定・開発される可能性があります。

さらに、肥満細胞症の有病率の増加、FDA承認の増加、臨床試験の増加、肥満細胞症や利用可能な治療法に関する認知度の向上、新薬や新興国治療の開発における進歩は、予測期間にわたって市場を牽引すると予想されます。

抑制要因

肥満細胞症の治療に使用される様々な薬剤に関連する合併症、局所コルチコステロイドに関連する副作用、肥満細胞症の治療にかかる高額な費用、限られた承認された治療法の利用可能性、適切な治療法の欠如などの要因が市場の妨げになると予想されます。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

  • 影響要因
    • 促進要因
      • 新規治療薬への採用の増加
    • 抑制要因
      • 治療に伴う合併症
    • 機会
    • 影響分析

第5章 産業分析

  • 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
  • 価格分析
  • 規制分析
  • パイプライン分析
  • アンメットニーズ
  • 特許分析
  • ボリューム分析
  • DMIオピニオン

第6章 COVID-19分析

第7章 疾患タイプ別

  • 皮膚肥満細胞症
    • 斑状皮膚肥満細胞症（色素性じんま疹）
    • びまん性皮膚肥満細胞症
    • 皮膚肥満細胞腫（孤立性肥満細胞腫）
    • 突発性黄斑毛細血管拡張症
  • 全身性肥満細胞症
    • 遅発性全身性肥満細胞症
    • くすぶり型全身性肥満細胞症
    • 他の血液疾患または骨髄疾患を伴う全身性肥満細胞症
    • 進行性全身性肥満細胞症
    • 肥満細胞白血病

第8章 治療タイプ別

  • 抗ヒスタミン薬
    • H1抗ヒスタミン薬
    • H2抗ヒスタミン薬
  • ロイコトリエン調節薬
  • 肥満細胞安定剤
    • クロモリンナトリウム
    • ケトチフェン
  • 局所副腎皮質ステロイド
  • 経口ステロイド
  • ビスフォスフォネート
  • エピネフリン注射剤
  • 化学療法
    • クラドリビン
    • イマチニブ
    • その他
  • 同種造血幹細胞移植（骨髄移植）
  • 骨粗鬆症治療
  • その他

第9章 販売チャネル別

  • 販売チャネル
    • 病院薬局
    • 小売薬局
    • オンライン薬局
  • エンドユーザー
    • 病院
    • 専門クリニック
    • 皮膚科クリニック
    • 研究・学術センター
    • その他

第10章 地域別

  • 北米
    • 米国
    • カナダ
    • メキシコ
  • 欧州
    • ドイツ
    • 英国
    • フランス
    • イタリア
    • スペイン
    • その他欧州
  • 南米
    • ブラジル
    • アルゼンチン
    • その他南米
  • アジア太平洋
    • 中国
    • インド
    • 日本
    • オーストラリア
    • その他アジア太平洋
  • 中東・アフリカ

第11章 競合情勢

  • 競合シナリオ
  • 市況/シェア分析
  • M&A分析

第12章 企業プロファイル

  • Novartis AG
    • 会社概要
    • 製品ポートフォリオと説明
    • 財務概要
    • 主な動向
  • Mylan N.V.
  • Apotex Inc.
  • Blueprint Medicines Corporation
  • CStone Pharmaceuticals
  • Viatris Inc.
  • Cigna HealthCare
  • Ralington Pharma
  • Enzo Life Sciences, Inc.
  • Genentech USA, Inc.

第13章 付録

目次
Product Code: PH7345

Overview

Mastocytosis is a genetic immune disorder, in which certain immune cells, called mast cells, build up under the skin and in the bones, intestines and other organs. This abnormal growth of mast cells causes a range of symptoms, including itchy bumps on the skin, gastrointestinal (GI) issues such as diarrhea, and bone pain. It can increase the risk of anaphylaxis (a severe allergic response) when patients come across certain environmental triggers. In some cases, the mastocytosis can be aggressive and lead to death if left untreated. Mastocytosis is not contagious.

There are two types of mastocytosis, cutaneous and systemic types. Basically, there is no cure for mastocytosis, but treatment can help to manage and minimize the symptoms. Antihistamines, leukotriene modifiers, mast cell stabilizers and corticosteroid creams can relieve the symptoms of an allergic reaction, such as itchy skin lesions. In case of anaphylactic shock, an epinephrine injection is commonly used. Chemotherapy such as cladribine is used to treat aggressive systemic mastocytosis. Some patients with aggressive systemic mastocytosis may undergo an allogeneic hematopoietic stem cell transplant (also called a bone marrow transplant).

Market Dynamics: Drivers

Increasing adoption of novel therapeutics

The increasing adoption of novel therapeutics is expected to drive the market over the forecast period. As there is no cure for mastocytosis, the treatment helps to minimize the symptoms. The development and adoption of novel therapeutics aim to address the unmet medical needs associated with the management of mastocytosis by providing more advanced approved therapeutics for better patient outcomes.

For instance, on January 23, 2023, Blueprint Medicines Corporation cleared the U.S. Food and Drug Administration (FDA) acceptance of the company's supplemental new drug application for AYVAKIT (avapritinib) for the treatment of adults with indolent systemic mastocytosis (SM).

Moreover, many clinical trials are going on for the development of novel therapeutics that show better results in the management of mastocytosis. The regulatory approvals increase the trust in patients about the development and adoption of novel therapeutics.

For instance, on September 11, 2023, Hoth Therapeutics, Inc., a patient-focused biopharmaceutical company, released the Pre-Investigational New Drug (IND) meeting to the U.S. Food and Drug Administration (FDA) to discuss the proposed drug development program for HT-KIT, a new molecular entity, for the treatment of advance systemic mastocytosis (AdvSM). HT-KIT is an antisense oligonucleotide that targets the proto-oncogene cKIT by inducing mRNA frameshifting and already has an Orphan Drug Designation from the FDA.

In addition, ongoing research and development efforts lead to the discovery of new therapeutics and the development of innovative drugs. As the understanding of mastocytosis at the molecular and cellular levels improves, novel therapeutics with targeted mechanisms of action may be identified and developed.

Further, the increasing prevalence of mastocytosis, rising FDA approvals, increasing clinical trials, increasing awareness about mastocytosis and available treatments and advancements in developing novel drugs and advanced therapies are expected to drive the market over the forecast period.

Restraints

Factors such as complications associated with the various drugs used in the mastocytosis treatment, adverse effects associated with the topical corticosteroids, the high cost of the treatment of mastocytosis, availability of limited approved treatments and lack of appropriate treatment are expected to hamper the market.

Segment Analysis

The global mastocytosis treatment market is segmented based on disease type, treatment type, sales channel and region.

The mast-cell stabilizers segment accounted for approximately 45.2% of the mastocytosis treatment market share

The mast-cell stabilizers segment is expected to hold the largest market share over the forecast period. Usually, there is no cure for mastocytosis, but various types of drugs, therapies and various treatment options are used to minimize the symptoms of mastocytosis. The mast cell stabilizers are the most commonly used for the treatment of mastocytosis. The mast cell stabilizers such as cromolyn sodium and ketotifen are most commonly used.

For instance, on January 5, 2022, Ritedose, a pharmaceutical manufacturer, launched a new single-unit dose generic product, Cromolyn Sodium Oral Solution, 100 mg/5 ml. The oral solution is the first of a new product line for Ritedose Pharmaceuticals which has historically offered a portfolio of generic inhalation solutions. Cromolyn Sodium is a mast cell stabilizer, primarily used to treat the symptoms of mastocytosis.

Moreover, in mastocytosis, the mast cells are overly sensitive and can release excessive amounts of mediators like histamine, prostaglandins, and leukotrienes. Mast cell stabilizers, such as cromolyn sodium and nedocromil, work by stabilizing the membranes of mast cells, preventing them from releasing these inflammatory substances.

Further, mast cell activation leads to various symptoms, including itching, flushing, abdominal pain, and in severe cases, anaphylaxis. By inhibiting the release of mast cell mediators, mast cell stabilizers help reduce the intensity and frequency of these symptoms, improving the overall quality of life for individuals with mastocytosis and their wide adoption also increases the demand for mast cell stabilizers.

Geographical Analysis

North America accounted for approximately 39.1% of the market share

North America region is expected to hold the largest market share over the forecast period owing to the strong presence of major players and advanced healthcare facilities. North America especially the United States is well-known for its strong presence of major players such as pharmaceutical companies and medical device companies developing mastocytosis treatment products. The presence of major players actively perform in clinical trials and research activities to develop novel and advanced therapeutics for the treatment of mastocytosis.

Furthermore, the region is also known for the presence of advanced healthcare infrastructure such as hospitals, specialty clinics, research and academic centers and others, which provides advanced healthcare facilities for patients in the treatment of mastocytosis by using advanced therapies for better patient outcomes. The region's advanced healthcare facilities help to early prevention of the condition with minimal risks.

Competitive Landscape

The major global players in the mastocytosis treatment market include: Novartis AG, Mylan N.V., Apotex Inc., Blueprint Medicines Corporation, Cstone Pharmaceuticals, Viatris Inc., Cigna HealthCare, Ralington Pharma, Enzo Life Sciences, Inc., Genentech USA, Inc. and among others.

COVID-19 Impact Analysis

The COVID-19 pandemic significantly impacted the global mastocytosis treatment market. The pandemic affected the initiation and conduct of clinical trials. Research efforts, including those aimed at developing new treatments for mastocytosis, are temporarily disrupted due to the redirected focus on the COVID-19 pandemic. The pandemic also disrupted the supply chain of these treatment medications globally.

Market Segmentation

By Disease Type

  • Cutaneous Mastocytosis
    • Maculopapular Cutaneous Mastocytosis (Urticaria Pigmentosa)
    • Diffuse Cutaneous Mastocytosis
    • Mastocytoma of Skin (Solitary Mastocytoma)
    • Telangiectasia Macularis Eruptiva Perstans
  • Systemic Mastocytosis
    • Indolent Systemic Mastocytosis
    • Smoldering Systemic Mastocytosis
    • Systemic Mastocytosis with Another Blood or Bone Marrow Disorder
    • Aggressive Systemic Mastocytosis
    • Mast Cell Leukemia

By Treatment Type

  • Antihistamines
    • H1 Antihistamines
    • H2 Antihistamines
  • Leukotriene Modifiers
  • Mast Cell Stabilizers
    • Cromolyn Sodium
    • Ketotifen
  • Topical Corticosteroids
  • Oral Steroids
  • Bisphosphonates
  • Injectable Epinephrine
  • Chemotherapy
    • Cladribine
    • Imatinib
    • Others
  • Allogeneic Hematopoietic Stem Cell Transplant (Bone Marrow Transplant)
  • Osteoporosis Therapy
  • Others

By Sales Channel

  • Distribution Channel
    • Hospital Pharmacies
    • Retail Pharmacies
    • Online Pharmacies
  • End-User
    • Hospitals
    • Specialty Clinics
    • Dermatology Clinics
    • Research and Academic Centers
    • Others

By Region

  • North America
    • U.S.
    • Canada
    • Mexico
  • Europe
    • Germany
    • U.K.
    • France
    • Spain
    • Italy
    • Rest of Europe
  • South America
    • Brazil
    • Argentina
    • Rest of South America
  • Asia-Pacific
    • China
    • India
    • Japan
    • Australia
    • Rest of Asia-Pacific
  • Middle East and Africa

Why Purchase the Report?

  • To visualize the global mastocytosis treatment market segmentation based on disease type, treatment type, sales channel and region as well as understand key commercial assets and players.
  • Identify commercial opportunities by analyzing trends and co-development
  • Excel data sheet with numerous data points of mastocytosis treatment market-level with all segments.
  • PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
  • Product mapping available as excel consisting of key products of all the major players.

The global mastocytosis treatment market report would provide approximately 61 tables, 63 figures, and 186 Pages.

Target Audience 2023

  • Manufacturers/ Buyers
  • Industry Investors/Investment Bankers
  • Research Professionals
  • Emerging Companies

Table of Contents

1. Methodology and Scope

  • 1.1. Research Methodology
  • 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

  • 3.1. Snippet by Disease Type
  • 3.2. Snippet by Treatment Type
  • 3.3. Snippet by Sales Channel
  • 3.4. Snippet by Region

4. Dynamics

  • 4.1. Impacting Factors
    • 4.1.1. Drivers
      • 4.1.1.1. Increasing Adoption for Novel Therapeutics
    • 4.1.2. Restraints
      • 4.1.2.1. Complications Associated with the Treatment
    • 4.1.3. Opportunity
    • 4.1.4. Impact Analysis

5. Industry Analysis

  • 5.1. Porter's Five Force Analysis
  • 5.2. Supply Chain Analysis
  • 5.3. Pricing Analysis
  • 5.4. Regulatory Analysis
  • 5.5. Pipeline Analysis
  • 5.6. Unmet Needs
  • 5.7. Patent Analysis
  • 5.8. Volume Analysis
  • 5.9. DMI Opinion

6. COVID-19 Analysis

  • 6.1. Analysis of COVID-19
    • 6.1.1. Scenario Before COVID
    • 6.1.2. Scenario During COVID
    • 6.1.3. Scenario Post COVID
  • 6.2. Pricing Dynamics Amid COVID-19
  • 6.3. Demand-Supply Spectrum
  • 6.4. Government Initiatives Related to the Market During the Pandemic
  • 6.5. Manufacturers Strategic Initiatives
  • 6.6. Conclusion

7. By Disease Type

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Type
    • 7.1.2. Market Attractiveness Index, By Disease Type
  • 7.2. Cutaneous Mastocytosis*
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
    • 7.2.3. Maculopapular Cutaneous Mastocytosis (Urticaria Pigmentosa)
    • 7.2.4. Diffuse Cutaneous Mastocytosis
    • 7.2.5. Mastocytoma of Skin (Solitary Mastocytoma)
    • 7.2.6. Telangiectasia Macularis Eruptiva Perstans
  • 7.3. Systemic Mastocytosis
    • 7.3.1. Indolent Systemic Mastocytosis
    • 7.3.2. Smoldering Systemic Mastocytosis
    • 7.3.3. Systemic Mastocytosis with Another Blood or Bone Marrow Disorder
    • 7.3.4. Aggressive Systemic Mastocytosis
    • 7.3.5. Mast Cell Leukemia

8. By Treatment Type

  • 8.1. Introduction
    • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
    • 8.1.2. Market Attractiveness Index, By Treatment Type
  • 8.2. Antihistamines*
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
    • 8.2.3. H1 Antihistamines
    • 8.2.4. H2 Antihistamines
  • 8.3. Leukotriene Modifiers
  • 8.4. Mast Cell Stabilizers
    • 8.4.1. Cromolyn Sodium
    • 8.4.2. Ketotifen
  • 8.5. Topical Corticosteroids
  • 8.6. Oral Steroids
  • 8.7. Bisphosphonates
  • 8.8. Injectable Epinephrine
  • 8.9. Chemotherapy
    • 8.9.1. Cladribine
    • 8.9.2. Imatinib
    • 8.9.3. Others
  • 8.10. Allogeneic Hematopoietic Stem Cell Transplant (Bone Marrow Transplant)
  • 8.11. Osteoporosis Therapy
  • 8.12. Others

9. By Sales Channel

  • 9.1. Introduction
    • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Sales Channel
    • 9.1.2. Market Attractiveness Index, By Sales Channel
  • 9.2. Distribution Channel*
    • 9.2.1. Introduction
    • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
    • 9.2.3. Hospital Pharmacies
    • 9.2.4. Retail Pharmacies
    • 9.2.5. Online Pharmacies
  • 9.3. End-User
    • 9.3.1. Hospitals
    • 9.3.2. Specialty Clinics
    • 9.3.3. Dermatology Clinics
    • 9.3.4. Research and Academic Centers
    • 9.3.5. Others

10. By Region

  • 10.1. Introduction
    • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
    • 10.1.2. Market Attractiveness Index, By Region
  • 10.2. North America
    • 10.2.1. Introduction
    • 10.2.2. Key Region-Specific Dynamics
    • 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Type
    • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
    • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Sales Channel
    • 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 10.2.6.1. U.S.
      • 10.2.6.2. Canada
      • 10.2.6.3. Mexico
  • 10.3. Europe
    • 10.3.1. Introduction
    • 10.3.2. Key Region-Specific Dynamics
    • 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Type
    • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
    • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Sales Channel
    • 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 10.3.6.1. Germany
      • 10.3.6.2. UK
      • 10.3.6.3. France
      • 10.3.6.4. Italy
      • 10.3.6.5. Spain
      • 10.3.6.6. Rest of Europe
  • 10.4. South America
    • 10.4.1. Introduction
    • 10.4.2. Key Region-Specific Dynamics
    • 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Type
    • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
    • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Sales Channel
    • 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 10.4.6.1. Brazil
      • 10.4.6.2. Argentina
      • 10.4.6.3. Rest of South America
  • 10.5. Asia-Pacific
    • 10.5.1. Introduction
    • 10.5.2. Key Region-Specific Dynamics
    • 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Type
    • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
    • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Sales Channel
    • 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 10.5.6.1. China
      • 10.5.6.2. India
      • 10.5.6.3. Japan
      • 10.5.6.4. Australia
      • 10.5.6.5. Rest of Asia-Pacific
  • 10.6. Middle East and Africa
    • 10.6.1. Introduction
    • 10.6.2. Key Region-Specific Dynamics
    • 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Type
    • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
    • 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Sales Channel

11. Competitive Landscape

  • 11.1. Competitive Scenario
  • 11.2. Market Positioning/Share Analysis
  • 11.3. Mergers and Acquisitions Analysis

12. Company Profiles

  • 12.1. Novartis AG*
    • 12.1.1. Company Overview
    • 12.1.2. Product Portfolio and Description
    • 12.1.3. Financial Overview
    • 12.1.4. Key Developments
  • 12.2. Mylan N.V.
  • 12.3. Apotex Inc.
  • 12.4. Blueprint Medicines Corporation
  • 12.5. CStone Pharmaceuticals
  • 12.6. Viatris Inc.
  • 12.7. Cigna HealthCare
  • 12.8. Ralington Pharma
  • 12.9. Enzo Life Sciences, Inc.
  • 12.10. Genentech USA, Inc.

LIST NOT EXHAUSTIVE

13. Appendix

  • 13.1. About Us and Services
  • 13.2. Contact Us