首頁 > 市場調查報告書 > 材料/化學品

塑膠

市場調查報告書

商品編碼

2026027

ENDARI：銷售預測與市場規模（2034 年）

ENDARI Sales Forecast, and Market Size Analysis - 2034

出版日期: 2026年04月01日 | 出版商:

DelveInsight | 英文 30 Pages | 商品交期: 2-10個工作天內

價格

簡介目錄圖表

推動ENDARI成長的關鍵因素

1. 一種新的 SCD 治療藥物，是近 20 年來第一種此類藥物（存在很高的未滿足需求）。

ENDARI 於 2017 年獲得美國 FDA核准，成為近 20 年來首個治療鐮狀細胞疾病 (SCD) 的新治療方法。
在此之前，羥基尿素是唯一廣泛使用的治療方法，留下了巨大的未滿足需求。

影響：

由於上市時競爭有限，該藥物迅速被廣泛採用，尤其是在現有治療方法無法充分控制病情的患者中。

2. 臨床證明，血管阻塞性發作和住院治療減少。

在一項 III 期隨機試驗（n=230）中，ENDARI 顯示出以下效果：
鐮狀細胞疾病發作減少25%
住院人數減少了33%。
累積住院天數和急性胸痛症候群發生率顯著降低。
FDA 數據也證實，與安慰劑相比，癲癇發作的中位數較低（3 次對 4 次），就醫次數也減少了。

影響：

主要終點（VOC + 住院）的顯著臨床療效將鼓勵醫生採用該療法並獲得保險公司的報銷。

3. 適用患者範圍廣泛（可用於兒童和成人）

該藥物核准用於 5 歲及以上人群，涵蓋兒童和成人患者群體。
鐮狀細胞貧血影響美國約 10 萬人和全球數百萬人。

影響：

由於其應用範圍廣泛，該藥物的目標患者群體十分廣泛，預計所有年齡層的需求都將穩定成長。

4. 良好的安全性和口服給藥的優勢

與許多新型生物製藥和基因療法不同，ENDARI 是一種口服胺基酸療法。
它具有良好的耐受性安全性，副作用大多較輕微（如噁心、便秘）。

5.柔軟性單藥治療或聯合治療

FDA 的標籤更新證實了無論是否使用羥基尿素，其臨床療效均不受影響。

影響：

它可用於以下用途：
作為輔助療法（聯合治療）
作為羥基尿素不耐受患者的替代療法

這種柔軟性將擴大其使用範圍，並有望增加長期處方量。

6. 對孤兒藥給予優惠待遇和監管支持。

ENDARI已被指定為孤兒藥，並享有以下優惠：
市場獨佔權（約2024年）
發展獎勵和監管支持

ENDARI 的最新進展

2026 年 1 月，商業化階段的生物製藥公司 Emmaus Life Sciences（鐮狀細胞疾病治療領域的領導者）授予 NeoImmuneTech Inc. (NIT) 一項獨家許可，允許其在美國、其領土和加拿大銷售和分銷 Endari（處方級 L-谷氨醯胺口服粉劑）及其學名藥藥，用於治療鐮狀細胞製藥。 NIT 將獲得一筆預付款和 NIT 產品銷售額的特許權使用費。

本報告分析了恩達瑞（ENDARI）在七個主要國家（美國、歐盟四國（德國、法國、義大利、西班牙）、英國和日本）的市場趨勢，全面深入地探討了已通過核准的適應症，例如短腸症候群和鐮狀細胞貧血，以及潛在適應症，例如地中海貧血。報告還詳細分析了恩達瑞在2020年至2034年已通過核准適應症中的當前使用情況、其在潛在適應症中的上市前景和表現、恩達瑞在已通過核准和潛在適應症中的詳細描述、恩達瑞的銷售預測、作用機制、劑量和給藥方法、研發里程碑和其他開發活動（包括適應措施相關的市場評估、未來市場評估因素、開發因素新分析、針對新市場評估（包括調整市場因素、針對未來市場評估的新治療方法觀點。

已已通過核准適應症的市場前景
對七國集團國家的分析
- 七個主要國家已通過核准適應症的市場規模
各國市場分析
- 已獲已通過核准適應症的市場規模：美國
- 已獲已通過核准適應症的市場規模：德國
- 已獲已通過核准適應症的市場規模：英國

第 6 章 ENDARI：SWOT 分析

第7章分析師觀點

第8章附錄

第9章：DelveInsight 服務

第10章免責聲明

第11章：關於 DelveInsight

第12章：報告購買選項

簡介目錄圖表

Product Code: DIDM1637

Key Factors Driving ENDARI Growth

1. First new SCD therapy in nearly two decades (high unmet need)

ENDARI was approved by the U.S. FDA in 2017, becoming the first new treatment for sickle cell disease (SCD) in almost 20 years.
Prior to this, hydroxyurea was the only widely used therapy, leaving a major unmet need.

Impact:

Being an early entrant with limited competition at launch enabled rapid initial adoption, especially in patients inadequately controlled on existing therapies.

2. Clinically validated reduction in vaso-occlusive crises and hospitalizations

In a Phase III randomized trial (n=230), ENDARI demonstrated:
25% reduction in sickle cell crises
33% reduction in hospitalizations
Significant reduction in cumulative hospital days and acute chest syndrome
FDA data further confirms lower median crises (3 vs 4) and fewer hospital visits vs placebo.

Impact:

Strong clinical benefit on hard endpoints (VOC + hospitalization) supports physician adoption and payer reimbursement.

3. Broad eligible patient population (pediatric + adult use)

Approved for patients >=5 years, covering both pediatric and adult populations.
SCD affects ~100,000 patients in the U.S. and millions globally.

Impact:

Wide label enables large addressable population, supporting steady demand growth across age groups.

4. Favorable safety profile and oral administration advantage

ENDARI is an oral amino acid therapy, unlike many newer biologics/gene therapies.
Demonstrates a well-tolerated safety profile, with mostly mild adverse events (e.g., nausea, constipation).

5. Flexibility as monotherapy or combination therapy

Updated FDA labeling confirms clinical benefit irrespective of hydroxyurea use.

Impact:

Can be used:
As add-on therapy (combination regimen)
As alternative therapy in hydroxyurea-intolerant patients

> This flexibility expands utilization and supports long-term prescription volume growth.

6. Orphan drug incentives and regulatory support

ENDARI received Orphan Drug designation, providing:
Market exclusivity (until ~2024)
Development incentives and regulatory support

ENDARI Recent Developments

In January 2026, Emmaus Life Sciences Inc., a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease, has granted NeoImmuneTech Inc. (NIT) an exclusive license to all rights to market, sell and distribute Endari (prescription grade L-glutamine oral powder) and any generic equivalents in sickle cell disease in the U.S., its territories, and Canada in exchange for a upfront payment and a royalty on NIT's product sales.

"ENDARI Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of ENDARI for approved indication like Short bowel syndrome and Sickle cell anaemia; as well as potential indication like Thalassaemia in the 7MM. A detailed picture of ENDARI's existing usage in approved and anticipated entry and performance in potential indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 -2034 is provided in this report along with a detailed description of the ENDARI for approved and potential indications. The ENDARI market report provides insights about ENDARI's sales forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current ENDARI performance, future market assessments inclusive of the ENDARI market forecast analysis for approved and potential indications in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of ENDARI sales forecasts, along with factors driving its market.

ENDARI Drug Summary

ENDARI is a prescription amino acid medication manufactured by Emmaus Medical, FDA-approved in 2017 as the first new sickle cell disease (SCD) treatment in nearly 20 years, indicated to reduce the frequency and severity of acute complications-such as vaso-occlusive pain crises-in adults and pediatric patients aged 5 years and older. The active ingredient, pharmaceutical-grade L-glutamine (5 g per packet), works by supporting antioxidant production in sickle-shaped red blood cells to mitigate oxidative stress, restore cell flexibility, and improve blood flow, though its precise mechanism remains incompletely understood. Administered orally twice daily-dosed by weight as 5 g (<30 kg), 10 g (30-65 kg), or 15 g (>65 kg), mixed in 8 oz of cold/room-temperature liquid (e.g., water, juice) or 4-6 oz of soft food (e.g., yogurt)-it is supplied in cartons of 60 single-dose packets and may cause common side effects like constipation, nausea, headache, abdominal pain, cough, and musculoskeletal pain. The report provides ENDARI's sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the ENDARI Market Report

The report provides insights into:

A comprehensive product overview including the ENDARI MoA, description, dosage and administration, research and development activities in approved indications like Short bowel syndrome and Sickle cell anaemia; as well as potential indication like Thalassaemia.
Elaborated details on ENDARI regulatory milestones and other development activities have been provided in ENDARI market report.
The report also highlights ENDARI's cost estimates and regional variations, reported and estimated sales performance, research and development activities in approved and potential indications across the United States, Europe, and Japan.
The ENDARI market report also covers the patents information, generic entry and impact on cost cut.
The ENDARI market report contains current and forecasted ENDARI sales for approved and potential indications till 2034.
Comprehensive coverage of the late-stage emerging therapies for respective indications.
The ENDARI market report also features the SWOT analysis with analyst views for ENDARI in approved and potential indications.

Methodology:

The ENDARI market report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight's team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

ENDARI Analytical Perspective by DelveInsight

In-depth ENDARI Market Assessment

This ENDARI sales market forecast report provides a detailed market assessment of ENDARI for approved indication like Short bowel syndrome and Sickle cell anaemia; as well as potential indication like Thalassaemia in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides current and forecasted ENDARI sales data uptil 2034.

ENDARI Clinical Assessment

The ENDARI market report provides the clinical trials information of ENDARI for approved and potential indications covering trial interventions, trial conditions, trial status, start and completion dates.

ENDARI Competitive Landscape

The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.

ENDARI Market Potential & Revenue Forecast

Projected market size for the ENDARI and its key indications
Estimated ENDARI sales potential (ENDARI peak sales forecasts)
ENDARI Pricing strategies and reimbursement landscape

ENDARI Competitive Intelligence

Number of competing drugs in development (pipeline analysis)
ENDARI Market positioning compared to existing treatments
ENDARI Strengths & weaknesses relative to competitors

ENDARI Regulatory & Commercial Milestones

ENDARI Key regulatory approvals & expected launch timelines
Commercial partnerships, licensing deals, and M&A activity

ENDARI Clinical Differentiation

ENDARI Efficacy & safety advantages over existing drugs
ENDARI Unique selling points

ENDARI Market Report Highlights

In the coming years, the ENDARI market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
The ENDARI companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence ENDARI's dominance.
Other emerging products for Short bowel syndrome and Sickle cell anaemia; as well as potential indication like Thalassaemia are expected to give tough market competition to ENDARI and launch of late-stage emerging therapies in the near future will significantly impact the market.
A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of ENDARI in approved and potential indications.
Analyse ENDARI cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
Our in-depth analysis of the forecasted ENDARI sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of ENDARI in approved and potential indications.

Key Questions:

What is the class of therapy, route of administration and mechanism of action of ENDARI? How strong is ENDARI's clinical and commercial performance?
What is ENDARI's clinical trial status in each individual indications such as Short bowel syndrome and Sickle cell anaemia; as well as potential indication like Thalassaemia and study completion date?
What are the key collaborations, mergers and acquisitions, licensing and other activities related to the ENDARI Manufacturers?
What are the key designations that have been granted to ENDARI for approved and potential indications? How are they going to impact ENDARI's penetration in various geographies?
What is the current and forecasted ENDARI market scenario for approved and potential indications? What are the key assumptions behind the forecast?
What are the current and forecasted sales of ENDARI in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
What are the other emerging products available and how are these giving competition to ENDARI for approved and potential indications?
Which are the late-stage emerging therapies under development for the treatment of approved and potential indications?
How cost-effective is ENDARI? What is the duration of therapy and what are the geographical variations in cost per patient?

1. Report Introduction

2. ENDARI Overview in approved indications like Short bowel syndrome and Sickle cell anaemia; as well as potential indication like Thalassaemia

2.1. Product Detail
2.2. ENDARI Clinical Development
- 2.2.1. ENDARI Clinical studies
- 2.2.2. ENDARI Clinical trials information
- 2.2.3. Safety and efficacy
2.3. Other Developmental Activities
2.4. Product Profile

3. ENDARI Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging ENDARI Therapies)

5. ENDARI Market Assessment

5.1. ENDARI Market Outlook in approved and potential indications
5.2. 7MM Analysis
- 5.2.1. ENDARI Market Size in the 7MM for approved and potential indications
5.3. Country-wise Market Analysis
- 5.3.1. ENDARI Market Size in the United States for approved and potential indications
- 5.3.2. ENDARI Market Size in Germany for approved and potential indications
- 5.3.3. ENDARI Market Size in France for approved and potential indications
- 5.3.4. ENDARI Market Size in Italy for approved and potential indications
- 5.3.5. ENDARI Market Size in Spain for approved and potential indications
- 5.3.6. ENDARI Market Size in the United Kingdom for approved and potential indications
- 5.3.7. ENDARI Market Size in Japan for approved and potential indications