首頁 > 市場調查報告書 > 製藥

感染疾病

市場調查報告書

商品編碼

2048042

雙性殺黴素B市場－全球產業規模、佔有率、趨勢、機會、預測：銷售管道、最終用途、地區和競爭格局分類，2021-2031年

Amphotericin B Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Sales Channel, By End Use, By Region & Competition, 2021-2031F

出版日期: 2026年05月25日 | 出版商:

TechSci Research | 英文 180 Pages | 商品交期: 2-3個工作天內

價格

簡介目錄

全球雙性殺黴素B市場預計將從2025年的5.6105億美元成長到2031年的7.3315億美元，複合年成長率為4.56%。

Amphotericin B是一種頻譜Polyenes抗真菌藥物，需靜脈注射注射，是治療嚴重危及生命的全身性真菌感染疾病（例如白黴菌症和隱球菌腦膜炎）的必需藥物。市場擴張的主要促進因素是免疫功能低下族群（包括器官移植受者和接受化療的癌症患者）侵襲性真菌感染的全球盛行率不斷上升，以及對Azole藥物免疫力缺乏的日益增強。據估計，每年有650萬人遭受危及生命的真菌感染疾病，因此對有效抗真菌治療方法的需求極為迫切。侵襲性真菌感染疾病（尤其是由多重抗藥性菌株，例如耳念珠菌引起的感染）發病率的不斷上升進一步加劇了這種需求。 2023年，美國記錄了4,514例耳念珠菌感染病例。此外，由於侵襲性麴菌症等感染疾病的存在，也存在持續的基本需求，該疾病每年在全球造成超過210萬例。然而，傳統脫氧膽酸製劑嚴重的腎毒性是市場成長的主要障礙。這促使人們使用脂質體替代製劑，雖然這些製劑安全性更高，但價格也昂貴得多，導致中低收入國家的醫療保健系統難以取得和廣泛應用。

市場概覽
預測期	2027-2031
市場規模：2025年	561,050,000 美元
市場規模：2031年	7.3315億美元
複合年成長率：2026-2031年	4.56%
成長最快的細分市場	全身性真菌感染疾病
最大的市場	北美洲

市場促進因素

侵襲性真菌感染疾病，尤其是多重抗藥性真菌感染疾病的發生率不斷上升，是推動Amphotericin B需求成長的主要因素。諸如耳念珠菌等病原體對一線Azole和棘白菌素類抗生素的抗藥性日益增強，迫使醫療專業人員重新啟用Amphotericin B，因為其具有廣譜殺菌活性且抗藥性低。免疫力缺乏患者的醫院感染病例增加進一步加劇了這一趨勢；例如，2023年美國報告了4514例多重抗藥性耳念珠菌感染的臨床病例。此外，據估計，全球每年約有210萬人罹患侵襲性麴菌症，如此龐大的患者族群支撐著市場需求。同時，脂質藥物遞送系統的進步正在重塑市場格局，直接解決了傳統製劑相關的腎毒性問題。製藥公司正積極研發新型口服和脂質奈米晶體製劑，以顯著提高藥物安全性，並增強患者用藥依從性，同時維持藥物療效。這些創新對於拓展藥物應用範圍至關重要，可將藥物應用範圍從急性護理醫院擴展到後續的過渡治療。一項同情用藥計畫就充分體現了這一點，該計畫使用口服脂質奈米晶體製劑治療了24名患有嚴重侵襲性真菌感染疾病的患者。這些技術進步對於開拓新的市場領域至關重要，並有望減輕傳統靜脈注射帶來的巨大經濟負擔。

市場挑戰

脂質體製劑的高成本構成了一道重大的經濟障礙，嚴重限制了全球雙性殺黴素B市場的發展，尤其是在感染負擔沉重的中低收入國家。儘管脂質複合物和脂質體製劑為傳統的腎毒性脫氧膽酸製劑提供了必要的臨床替代方案，但其高昂的價格限制了其在受侵襲性真菌感染疾病影響最嚴重地區的廣泛應用。這種價格差異造成了市場兩極化：更安全、更有價值的產品對於最需要它們的公共醫療系統而言仍然難以負擔，這實際上將目標市場限制在了富裕的已開發國家，並阻礙了收入成長。因此，臨床需求與經濟可行性之間的差距阻礙了市場從開發中國家不斷增加的病例中獲利。這種獲取途徑的匱乏與病患預後不良和商業性機會的喪失直接相關。據估計，到2025年，侵襲性真菌感染疾病將導致全球約380萬人死亡，其中死亡負擔主要集中在資源匱乏的地區。在這種環境下，高昂的採購成本使得持續獲得高品質、低毒性的抗真菌藥物變得困難。價格壓力阻礙了企業進入高需求市場，這仍然是限制全球抗真菌藥物產業發展動能的主要因素。

市場趨勢

隨著主要品牌脂質體製劑專利到期，市場競爭格局正在發生顯著變化，具成本效益的學名藥核准上市數量激增。學名藥和生物相似藥的擴張正在迅速提高對成本敏感地區的藥物可及性，使醫療系統能夠從具有腎毒性的傳統製劑過渡到學名藥，而無需承擔原廠藥的高昂費用。這一趨勢得益於強勁的銷售成長，其中某些美國製劑的銷售額年增10.1%，反映出這些非品牌替代藥物的市場滲透率不斷提高。同時，臨床治療方案正轉向單劑量、高劑量或短劑量方案，尤其是在隱球菌腦膜炎和內臟利什曼原蟲症領域，以減少住院時間和累積毒性。標準治療方案的演變正在重塑市場需求和包裝要求，促使治療模式從長期每日輸注轉向高濃度、高價值的給藥方案。然而，由於醫療服務提供者需要逐步適應這些更新的指南，因此其廣泛應用仍受慣性阻礙。近期對臨床管理實務的調查顯示，只有14%的感染疾病專家完全採用特定的單劑量脂質體兩性Amphotericin B方案（AMBITION-cm方案）。隨著專家對這種高效給藥模式的共識不斷鞏固，這預示著巨大的市場發展機會。

The Global Amphotericin B Market is forecast to grow from USD 561.05 Million in 2025 to USD 733.15 Million by 2031, exhibiting a 4.56% CAGR. Amphotericin B, a broad-spectrum polyene antifungal antibiotic administered intravenously, is vital for treating severe, life-threatening systemic fungal infections such as mucormycosis and cryptococcal meningitis. Market expansion is largely propelled by the escalating global prevalence of invasive mycoses among immunocompromised populations, including organ transplant recipients and oncology patients undergoing chemotherapy, and the increasing resistance to azole-based therapies. Approximately 6.5 million individuals are estimated to be affected annually by life-threatening fungal diseases, emphasizing the critical need for effective antifungal treatments. This demand is intensified by the rising incidence of invasive fungal infections, particularly those caused by multi-drug resistant strains like Candida auris, which recorded 4,514 cases in the U.S. in 2023, alongside a sustained baseline demand from pathologies such as the over 2.1 million annual cases of invasive aspergillosis globally. However, a major impediment to market growth is the severe nephrotoxicity associated with conventional deoxycholate formulations, necessitating the use of considerably safer but substantially more expensive lipid-based alternatives, which consequently limit accessibility and adoption in low-to-middle-income healthcare systems.

Market Overview
Forecast Period	2027-2031
Market Size 2025	USD 561.05 Million
Market Size 2031	USD 733.15 Million
CAGR 2026-2031	4.56%
Fastest Growing Segment	Systemic Fungal Infections
Largest Market	North America

Market Driver

The rising incidence of invasive fungal infections, particularly those caused by multi-drug resistant strains, is a primary catalyst propelling the demand for Amphotericin B. Pathogens like Candida auris increasingly exhibit resistance to first-line azole and echinocandin therapies, prompting healthcare providers to revert to Amphotericin B for its broad fungicidal activity and low resistance rates. This trend is intensified by the growing prevalence of hospital-acquired infections among immunocompromised groups, with, for instance, clinical cases of multi-drug resistant Candida auris in the U.S. reaching 4,514 in 2023. Additionally, the market is sustained by the sheer volume of specific fungal pathologies, with over 2.1 million people globally estimated to develop invasive aspergillosis annually. Concurrently, advancements in lipid-based drug delivery systems are reshaping the market by directly addressing the nephrotoxicity limitations of conventional formulations. Pharmaceutical developers are actively engineering novel oral and lipid-nanocrystal mechanisms to maintain the drug's efficacy while significantly improving its safety profile and patient compliance. These innovations are crucial for expanding the drug's utility beyond acute hospital settings into step-down therapies, as demonstrated by the treatment of 24 patients with severe invasive fungal infections using an oral lipid-nanocrystal formulation in a compassionate use program. These technological progressions are vital for unlocking new market segments, promising to reduce the heavy economic burden associated with hospitalization for traditional intravenous administration.

Market Challenge

The prohibitive cost of lipid-based formulations represents a critical economic barrier that severely constrains the Global Amphotericin B Market, particularly in high-burden, low-to-middle-income countries. While lipid complex and liposomal variants offer a necessary clinical alternative to the nephrotoxic conventional deoxycholate, their premium pricing structure restricts widespread adoption in regions where invasive fungal infections are most endemic. This price disparity creates a bifurcated market where the safer, higher-value products are financially inaccessible to the public healthcare systems that require them the most, effectively capping revenue growth by limiting the addressable market to wealthy developed nations. Consequently, the gap between clinical necessity and economic feasibility prevents the market from capitalizing on the rising volume of cases in developing economies. This lack of accessibility directly correlates with adverse patient outcomes and lost commercial opportunity, as invasive fungal diseases were estimated to result in approximately 3.8 million deaths globally in 2025, a mortality burden heavily concentrated in resource-limited settings where consistent access to less toxic, high-grade antifungal pharmacotherapies remains elusive due to acquisition costs. This inability to penetrate high-need markets due to pricing pressures remains a primary drag on global industry momentum.

Market Trends

Following the patent expiration of major branded liposomal products, the market is experiencing a surge in the approval and commercialization of cost-effective generic versions, significantly altering the competitive landscape. This expansion of generic and biosimilar therapeutics is rapidly increasing accessibility in cost-sensitive regions, allowing healthcare systems to transition away from nephrotoxic conventional formulations without incurring the prohibitive costs of originator brands. This trend is underscored by robust growth in sales, such as a 10.1% year-over-year increase in certain US formulation sales, reflecting rising market penetration of these non-branded alternatives. Concurrently, clinical treatment protocols are increasingly moving toward single high-dose or short-course regimens, particularly for Cryptococcal Meningitis and Visceral Leishmaniasis, to reduce hospitalization time and cumulative toxicity. This evolution in the standard of care is reshaping volume demand and packaging requirements, driving a shift from prolonged daily infusions to concentrated, high-value dosing schedules. However, widespread implementation still faces inertia as providers slowly adapt to these updated guidelines; a review of recent clinical management practices revealed that only 14% of infectious disease physicians had fully adopted a specific single-dose liposomal Amphotericin B regimen (AMBITION-cm protocol), indicating a significant opportunity for market development as professional consensus consolidates around these efficient delivery models.

Key Market Players

Gilead Sciences, Inc.
Bristol-Myers Squibb Company
Sun Pharmaceutical Industries Ltd.
Cipla Limited
Mylan N.V.
Xellia Pharmaceuticals ApS
Fresenius Kabi AG
Pfizer Inc.
Teva Pharmaceutical Industries Ltd.
Astellas Pharma Inc.

Report Scope

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

Amphotericin B Market, By Sales Channel

Direct
Indirect

Amphotericin B Market, By End Use

Systemic Fungal Infections
Candidiasis
Aspergillosis
Mucormycosis
Leishmaniasis
Others

Amphotericin B 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 Amphotericin B Market.

Available Customizations:

Global Amphotericin B 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:

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 Amphotericin B Market Outlook

5.1. Market Size & Forecast
- 5.1.1. By Value
5.2. Market Share & Forecast
- 5.2.1. By Sales Channel (Direct, Indirect)
- 5.2.2. By End Use (Systemic Fungal Infections, Candidiasis, Aspergillosis, Mucormycosis, Leishmaniasis, Others)
- 5.2.3. By Region
- 5.2.4. By Company (2025)
5.3. Market Map

6. North America Amphotericin B Market Outlook

6.1. Market Size & Forecast
- 6.1.1. By Value
6.2. Market Share & Forecast
- 6.2.1. By Sales Channel
- 6.2.2. By End Use
- 6.2.3. By Country
6.3. North America: Country Analysis
- 6.3.1. United States Amphotericin B 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 Sales Channel
    - 6.3.1.2.2. By End Use
- 6.3.2. Canada Amphotericin B 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 Sales Channel
    - 6.3.2.2.2. By End Use
- 6.3.3. Mexico Amphotericin B 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 Sales Channel
    - 6.3.3.2.2. By End Use

7. Europe Amphotericin B Market Outlook

7.1. Market Size & Forecast
- 7.1.1. By Value
7.2. Market Share & Forecast
- 7.2.1. By Sales Channel
- 7.2.2. By End Use
- 7.2.3. By Country
7.3. Europe: Country Analysis
- 7.3.1. Germany Amphotericin B 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 Sales Channel
    - 7.3.1.2.2. By End Use
- 7.3.2. France Amphotericin B 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 Sales Channel
    - 7.3.2.2.2. By End Use
- 7.3.3. United Kingdom Amphotericin B 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 Sales Channel
    - 7.3.3.2.2. By End Use
- 7.3.4. Italy Amphotericin B 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 Sales Channel
    - 7.3.4.2.2. By End Use
- 7.3.5. Spain Amphotericin B 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 Sales Channel
    - 7.3.5.2.2. By End Use

8. Asia Pacific Amphotericin B Market Outlook

8.1. Market Size & Forecast
- 8.1.1. By Value
8.2. Market Share & Forecast
- 8.2.1. By Sales Channel
- 8.2.2. By End Use
- 8.2.3. By Country
8.3. Asia Pacific: Country Analysis
- 8.3.1. China Amphotericin B 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 Sales Channel
    - 8.3.1.2.2. By End Use
- 8.3.2. India Amphotericin B 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 Sales Channel
    - 8.3.2.2.2. By End Use
- 8.3.3. Japan Amphotericin B 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 Sales Channel
    - 8.3.3.2.2. By End Use
- 8.3.4. South Korea Amphotericin B 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 Sales Channel
    - 8.3.4.2.2. By End Use
- 8.3.5. Australia Amphotericin B 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 Sales Channel
    - 8.3.5.2.2. By End Use

9. Middle East & Africa Amphotericin B Market Outlook

9.1. Market Size & Forecast
- 9.1.1. By Value
9.2. Market Share & Forecast
- 9.2.1. By Sales Channel
- 9.2.2. By End Use
- 9.2.3. By Country
9.3. Middle East & Africa: Country Analysis
- 9.3.1. Saudi Arabia Amphotericin B 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 Sales Channel
    - 9.3.1.2.2. By End Use
- 9.3.2. UAE Amphotericin B 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 Sales Channel
    - 9.3.2.2.2. By End Use
- 9.3.3. South Africa Amphotericin B 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 Sales Channel
    - 9.3.3.2.2. By End Use

10. South America Amphotericin B Market Outlook

10.1. Market Size & Forecast
- 10.1.1. By Value
10.2. Market Share & Forecast
- 10.2.1. By Sales Channel
- 10.2.2. By End Use
- 10.2.3. By Country
10.3. South America: Country Analysis
- 10.3.1. Brazil Amphotericin B 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 Sales Channel
    - 10.3.1.2.2. By End Use
- 10.3.2. Colombia Amphotericin B 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 Sales Channel
    - 10.3.2.2.2. By End Use
- 10.3.3. Argentina Amphotericin B 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 Sales Channel
    - 10.3.3.2.2. By End Use

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 Amphotericin B 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. Gilead Sciences, 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. Bristol-Myers Squibb Company
15.3. Sun Pharmaceutical Industries Ltd.
15.4. Cipla Limited
15.5. Mylan N.V.
15.6. Xellia Pharmaceuticals ApS
15.7. Fresenius Kabi AG
15.8. Pfizer Inc.
15.9. Teva Pharmaceutical Industries Ltd.
15.10. Astellas Pharma Inc.