内臓リーシュマニア症治療の世界市場-2023年～2030年

概要

世界の内臓リーシュマニア症治療市場は、そのダイナミクスに影響を与える様々な要因によって、長年にわたり大きな成長と変貌を遂げてきました。カラアザールとして知られる内臓リーシュマニア症（VL）は、未治療の場合95％以上が致命的です。不規則な発熱発作、体重減少、脾臓および肝臓の肥大、貧血によって区別されます。ブラジル、東アフリカ、インドが感染者の大半を占めています。

特に新興経済諸国では、政府による投資や研究開発により、先進的な製品や治療法の利用が引き続き促進され、内臓リーシュマニア症治療市場の世界の拡大が見込まれます。それぞれの革新的な製品には、より良い管理のための五価アンチモニアルなどの新しい治療法の使用が含まれます。

市場促進要因：市場抑制要因

共同研究および政府のイニシアチブの拡大

新興経済諸国は、高額の投資、所得水準、インフラ整備を原動力として、ヘルスケア分野の改善において急速な成長を遂げています。いくつかの国々では、研究の成果が高く評価され、内臓リーシュマニア症治療に対する大きな需要が生じています。各国における製品上市のための様々な規制上の承認は、市場の成長を促進する重要な要因です。

2023年1月26日、世界保健機関（WHO）とギリアド・サイエンシズ社との間で結ばれていた契約は、内臓リーシュマニア症に罹患している国々へのアムビソーム（リポソーム型アムホテリシンB注射剤）304,700バイアルの供給契約により、2025年まで延長されました。

この新しい3年契約（2023-2025年）には、1,130万米ドルの費用が見込まれており、内臓リーシュマニア症に罹患している地域社会に対するより良いカバー率、アクセス、治療のための財政支援も含まれています。

さらに、α-1抗トリプシン欠乏症の管理に対する新規治療や薬剤の利用が増加しています。人々の意識の高まりと革新的な製品開発のための研究の増加は、内臓リーシュマニア症治療薬市場の成長を促進する主な要因です。

薬剤に関連する副作用

発疹、高血糖、低マグネシウム血症、低カリウム血症、下痢、嘔吐、吐き気、貧血、アルカリホスファターゼの上昇、血中尿素窒素濃度の上昇、悪寒、クレアチニンの上昇、不眠症、呼吸困難が最も頻繁に報告される副作用であり、すべての試験においてアムビゾームの発現率は20％を超えています。悪寒・嘔気、発熱、嘔吐、頻脈、高血圧、呼吸困難、低酸素症は輸液に関連した反応の一つです。

アムビゾームの投与は、顔面紅潮、胸部圧迫感に関係なく背中の不快感、胸痛のいくつかの例と関連しています。これらの徴候が観察された場合、点滴開始直後に反応が生じ、点滴を中止するとすぐに収まっています。点滴の頻度を下げると、これらの症状は通常、連続投与で再発することはなく、投与ごとに起こることもないです。

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
    • 共同研究や政府のイニシアティブの高まり
    • 技術的進歩と開発の高まり
  • 抑制要因
    • 薬剤に伴う副作用
  • 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
• SWOT分析
• 特許分析
• ロシア・ウクライナ戦争の影響分析
• DMI意見

第6章 COVID-19分析

第7章 薬剤タイプ別

• 五価アンチモニアル
  • スチボグルコン酸ナトリウム（ペントスタム）
  • メグルミンアンチモニアート（グルカンチム）
• 抗菌薬
  • パロモマイシン
  • ミルテフォシン
• 抗真菌薬
  • アムホテリシンBリポソーム

第8章 投与経路別

• 経口
• 静脈内投与
• その他

第9章 エンドユーザー別

• 病院
• 外来手術センター
• 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地域
• 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

• Merck KGaA
  • 会社概要
  • 製品ポートフォリオと説明
  • 財務概要
  • 主な発展
• PRG Pharma
• LEXICARE PHARMA PVT. LTD.
• SanMak Pharmaceuticals Private Limited
• Pfizer Inc.
• Avet Pharmaceuticals Inc.
• Profounda Pharmaceuticals
• Knight Therapeutics Inc.
• Sun Pharmaceutical Industries Ltd.
• Gilead Sciences, Inc.

第13章 付録

Overview

The global visceral leishmaniasis treatment market has witnessed significant growth and transformations over the years, with various factors influencing its dynamics. Over 95% of cases of visceral leishmaniasis (VL), often known as kala-azar, are fatal if untreated. It is distinguished by irregular fever attacks, weight loss, spleen and liver enlargement, and anemia. Brazil, east Africa, and India account for the majority of instances.

Government investments and research, particularly in developing economies, will continue to drive utilization of advanced products or therapies and boost the global visceral leishmaniasis treatment market. The respective innovative products includes the use of novel treatments such as pentavalent antimonials for better management.

Market Dynamics: Drivers & Restraints

Growing collaborations and government initiatives

Developed economies have been witnessing rapid growth in betterment of their healthcare sectors, driven by high investments, income levels, and infrastructure development. Several countries have experienced substantial demand for visceral leishmaniasis treatment owing to the positive outcomes in research. Various regulatory approvals for product launch among different countries will be a crucial factor driving the growth of the market.

On January 26, 2023, the previous agreement between the World Health Organization (WHO) and Gilead Sciences was extended through 2025 with the signing of another contract for the supply of AmBisome (liposomal amphotericin B injection) 304,700 vials for the management of visceral leishmaniasis in nations most affected by the disease.

The new three-year agreement (2023-2025), which is expected to cost $11.3 million, also includes financial support for better coverage, access, and therapy for visceral leishmaniasis-affected communities.

Furthermore, the rising utilization of novel therapies or drugs for the management of alpha-1 antitrypsin deficiency. Rising awareness among people and increasing research for innovative product development will be a major factor driving the growth of the Visceral Leishmaniasis Treatments market.

Side effects associated with the drugs

Rashes, hyperglycemia, hypomagnesemia, hypokalemia, diarrhea, vomiting, nausea, anemia, raised alkaline phosphatase, higher levels of urea nitrogen in blood, chills, raised creatinine, insomnia, and dyspnea are the most frequently reported adverse reactions with an incidence of >20% with AmBisome across all studies. Chills/rigors, nausea, fever, vomiting, tachycardia, hypertension, dyspnea, and hypoxia are among responses connected to infusions.

The administration of AmBisome has been linked to a few instances of flushing, back discomfort regardless of chest tightness, or chest pain; on occasion, this has become severe. Where these signs were observed, a reaction arose shortly after the infusion began and quickly subsided when it was stopped. When the infusion frequency is lowered, these symptoms normally do not return with consecutive doses and do not happen with every dose.

Segment Analysis

The global visceral leishmaniasis treatment market is segmented based on drug type, route of administration, end user and region.

Amphotericin B Liposomal segment accounted for approximately 39% of market share

Ambisome Injection is a member of the 'antifungal' drug class, which is used for the treatment of severe fungal infections including leishmaniasis. A fungal infection is a condition when fungi infect the tissue and attack it. Although fungi are frequently found in nature, they typically do not cause illnesses.

Some fungi, however, may infect a human if they have a weakened immune system. Amphotericin B, an ingredient in ambisome injection, kills fungus by rupturing their outer cell membrane. Since they inhibit the escape of cell contents and the entry of undesirable substances into the cells, the fungal cell walls are crucial for their survival.

On December 15, 2021, the US FDA has given its final approval to Sun Pharmaceutical Industries Limited's wholly-owned subsidiaries for its abbreviated new drug application (ANDA) for 50 mg/vial amphotericin b liposome generic version for Injection, Single-Dose Vial. AmBisome Liposome Injection, 50 mg/vial is used as the basis for the approval of the generic product.

AmBisome Liposome Injection, 50 mg/vial is used as the basis for the approval of the generic product. The US FDA has given Sun Pharma the classification of competitive generic therapy (CGT), and as the first generic approved, the company is entitled to CGT exclusivity of 180 days for the drug.

Geographical Penetration

North America accounted for around 35% of market share in 2022

Due to the rising need for visceral leishmaniasis treatment in healthcare, manufacturers in North America have chances of increasing their operations. There are many producers and suppliers in North America and owing to the quick economic growth of the region, industrial production has expanded, driving the demand for visceral leishmaniasis treatment.

Increasing expenditure on healthcare and rising research studies, advancement of technologies and different kinds of therapies for management, and increase in pharmaceutical or biotechnology business establishment across the region are also contributing to the growth of visceral leishmaniasis treatment market share of this region. The market in this area is growing as people become more aware of various novel innovative therapies such as amphotericin b liposomal. The aforementioned elements further attest to North America's hegemonic position in the world.

North America continues to be a key player in the global visceral leishmaniasis treatment market, with United States leading the way. Government initiatives promoting infrastructure development and investment, and a focus on rising advancements have fueled the demand for visceral leishmaniasis treatment in the U.S. United States have been proactive in executing several initiatives or researches, stimulating visceral leishmaniasis treatment demand.

COVID-19 Impact Analysis

The outbreak of the COVID-19 pandemic in late 2019 created unprecedented challenges for industries worldwide, including the global visceral leishmaniasis treatment market. As countries grappled with lockdowns, supply chain disruptions and reduced economic activity, the pharmaceutical sector, with a significant consumer of various device designs, was significantly impacted. Several efforts all throughout the world were impacted by the pandemic's broad lockdowns and limitations that started in early 2020.

Major medical device industries came to a standstill and shifted their attention towards the management of COVID-19, leading to a slump in demand for visceral leishmaniasis treatment. Now several research studies have been initiated and companies have again started trial for their products safety and efficacy. Overall, the impact of the pandemic on the global visceral leishmaniasis treatment market is expected to be relatively moderate, with the market continuing to grow steadily due to the ongoing need and research for novel therapies, like antimicrobials and other programs for management of leishmaniasis.

Key Developments

• On March 30, 2023, for the purpose of treating cryptococcal meningitis and visceral leishmaniasis in low- and middle-income nations, Gilead Sciences, Inc. will recalculate the no-profit cost of AmBisome (amphotericin B liposome for injection 50mg/vial) for governments and other non-governmental health organizations serving the public sector. This modification is being made by Gilead to guarantee the long-term viability of the AmBisome supply for the firm's global access initiative in these nations.
• On September 29, 2022, The Drugs for Neglected Diseases initiative (DNDi), a non-profit medical research organization, and its collaborators conducted a trial in Eastern Africa that demonstrated the efficacy of a shorter, less toxic treatment for persons with visceral leishmaniasis. The novel therapy combines paromomycin (PM), an injectable antibiotic, with miltefosine (MF), the only oral medication available to treat leishmaniasis.

Competitive Landscape

The major global players in the market include: Merck KGaA, PRG Pharma, LEXICARE PHARMA PVT. LTD., SanMak Pharmaceuticals Private Limited, Pfizer Inc., Avet Pharmaceuticals Inc., Profounda Pharmaceuticals,Knight Therapeutics Inc., Sun Pharmaceutical Industries Ltd. And Gilead Sciences, Inc..

Why Purchase the Report?

• To visualize the global visceral leishmaniasis treatment market segmentation based on drug type, route of administration, end user 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 visceral leishmaniasis 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 visceral leishmaniasis treatment market report would provide approximately 61 tables, 57 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 Drug Type
• 3.2. Snippet by Route of Administration
• 3.3. Snippet by End User
• 3.4. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Growing collaborations and government initiatives
    • 4.1.1.2. Rising technological advancements and developments
  • 4.1.2. Restraints
    • 4.1.2.1. Side effects associated with the drugs
  • 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. SWOT Analysis
• 5.6. Patent Analysis
• 5.7. Russia-Ukraine War Impact Analysis
• 5.8. 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 Pandemic
• 6.5. Manufacturers Strategic Initiatives
• 6.6. Conclusion

7. By Drug Type

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Type
  • 7.1.2. Market Attractiveness Index, By Drug Type
• 7.2. Pentavalent Antimonials*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.2.3. Sodium Stibogluconate (Pentostam)
  • 7.2.4. Meglumine Antimoniate (Glucantim)
• 7.3. Antimicrobials
  • 7.3.1. Paromomycin
  • 7.3.2. Miltefosine
• 7.4. Antifungal
  • 7.4.1. Amphotericin B Liposomal

8. By Route of Administration

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 8.1.2. Market Attractiveness Index, By Route of Administration
• 8.2. Oral *
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Intravenous
• 8.4. Others

9. By End User

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 9.1.2. Market Attractiveness Index, By End User
• 9.2. Hospitals*
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Ambulatory Surgical Centers
• 9.4. 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 Drug Type
  • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 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 Drug Type
  • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 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 Drug Type
  • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 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 Drug Type
  • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 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 Drug Type
  • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User

11. Competitive Landscape

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

12. Company Profiles

• 12.1. Merck KGaA*
  • 12.1.1. Company Overview
  • 12.1.2. Product Portfolio and Description
  • 12.1.3. Financial Overview
  • 12.1.4. Key Developments
• 12.2. PRG Pharma
• 12.3. LEXICARE PHARMA PVT. LTD.
• 12.4. SanMak Pharmaceuticals Private Limited
• 12.5. Pfizer Inc.
• 12.6. Avet Pharmaceuticals Inc.
• 12.7. Profounda Pharmaceuticals
• 12.8. Knight Therapeutics Inc.
• 12.9. Sun Pharmaceutical Industries Ltd.
• 12.10. Gilead Sciences, Inc.

LIST NOT EXHAUSTIVE

13. Appendix

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