孟鲁司特原料药市场（2026—2031）
孟鲁司特原料药市场规模预计由2026年的52.9亿美元增至2031年的92.1亿美元，预测期复合年增长率为11.75%。北美是当前最大市场，亚太地区增长最快。
市场研究正文
规模、增长、细分、驱动因素与关键问题
当前质量分 100.00，审核状态 accepted。结构化字段已按 RoboInd 内容层级组织。
核心结论
孟鲁司特原料药市场规模预计由2026年的52.9亿美元增至2031年的92.1亿美元，预测期复合年增长率为11.75%。北美是当前最大市场，亚太地区增长最快。
市场走势
结构化指标
| 指标 | 年份 | 数值 | 性质 |
|---|---|---|---|
| 复合年增长率 | 2031 | 11.75% | 机构预测 |
| 市场规模 | 2026 | USD 5.29 billion | 机构预测 |
| 市场规模 | 2031 | USD 9.21 billion | 机构预测 |
细分市场份额
市场结构
| 维度 | 细分项 | 年份 | 份额 |
|---|---|---|---|
| application | Asthma | 2025 | 58.700% |
| dosage-form_compatibility | Film-Coated Tablets | 2025 | 56.400% |
| geography | North America | 2025 | 40.500% |
| product_type | Montelukast Sodium Crystalline | 2025 | 64.700% |
关键结论
- application 维度中，Asthma 在 2025 年的公开份额为 58.7%。
- dosage-form_compatibility 维度中，Film-Coated Tablets 在 2025 年的公开份额为 56.4%。
- geography 维度中，North America 在 2025 年的公开份额为 40.5%。
- product_type 维度中，Montelukast Sodium Crystalline 在 2025 年的公开份额为 64.7%。
主要参与者
- Morepen Laboratories Limited
- Dr. Reddy’s Laboratories Limited
- Teva Pharmaceutical Industries Ltd.
- Aurobindo Pharma Limited
- Sun Pharmaceutical Industries Limited
增长驱动因素
| 因素 | 影响 CAGR | 地区相关性 | 影响周期 |
|---|---|---|---|
| Rising Asthma and Allergic Rhinitis Treatment Demand | +3.500% | Global, strongest in Asia-Pacific, North America, and Europe | Long term (≥ 4 years) |
| Generic-First Payer Economics | +2.500% | North America, Europe, with growing influence in Asia-Pacific and Middle East and Africa | Medium term (2-4 years) |
| Pediatric Chewable and Granule Demand | +1.800% | Global, concentrated in North America, Europe, and South and Southeast Asia | Medium term (2-4 years) |
| Extended Allergy Seasons and Perennial Rhinitis | +1.200% | North America, Europe, and urban Asia-Pacific centers | Long term (≥ 4 years) |
| DMF-Backed Supplier Consolidation | +0.900% | Global supplier base serving FDA and EMA regulated import channels | Medium term (2-4 years) |
| Integrated Impurity-Control Documentation as a Supplier Differentiator | +0.700% | Global, with early gains in North America and European Union procurement | Short term (≤ 2 years) |
市场制约因素
| 因素 | 影响 CAGR | 地区相关性 | 影响周期 |
|---|---|---|---|
| FDA Boxed Warning and Neuropsychiatric Safety Concerns | -1.300% | North America, with secondary influence in Europe and Australia | Short term (≤ 2 years) |
| Shift Toward Inhaled Corticosteroid-Based Treatment Pathways | -0.900% | Global, most pronounced in high managed-care penetration markets | Medium term (2-4 years) |
| Mature Generic Price Erosion | -1.200% | Global | Short term (≤ 2 years) |
| Montelukast-Specific Nitrosamine and Impurity-Control Burden | -0.500% | Global supplier base, FDA and EMA regulated import channels | Medium term (2-4 years) |
报告关注的关键问题
What is the projected value of the Montelukast API market by 2031?
The Montelukast API market is projected to reach USD 9.21 billion by 2031, growing at an 11.75% CAGR from 2026 to 2031. The forecast reflects continued generic demand for oral asthma and allergy treatments, together with the need for qualified API supply in regulated markets.
Which product type has the largest share of montelukast API demand?
Montelukast Sodium Crystalline led product-type demand with a 64.70% share in 2025. Established tablet manufacturing processes, known stability characteristics, and familiar handling practices continue to support its use by high-volume formulators.
Which dosage form is expected to grow fastest through 2031?
Oral Granules are expected to record the highest forecast CAGR at 13.20% through 2031. Their format is suitable for infants and younger children who cannot use chewable tablets, creating different sourcing needs for pediatric medicine programs.
Why is amorphous montelukast sodium important for pediatric products?
Its solubility and dissolution characteristics support granules and liquid matrices used for younger patients. These products also need careful controls for particle behavior, taste masking, moisture sensitivity, and stability during manufacture and distribution.
Which application has the fastest forecast growth?
Allergic Rhinitis is projected to expand at a 13.80% CAGR from 2026 to 2031. Longer pollen exposure periods and broader demand across several regions support this rate, although the FDA warning can limit new use in some settings.
Which region is expected to grow fastest?
Asia-Pacific is forecast to grow at a 14.50% CAGR between 2026 and 2031. The Montelukast API market in the region combines expanding demand with an important supply role for regulated export markets and a growing need for pediatric formats.
市场概览
- 增长最快市场：亚太地区
- 最大市场：北美
- 市场集中度：中等
查看来源：Mordor Intelligence