Leucine Market - Growth Drivers and Challenges
Growth Drivers
- Rising prevalence of sarcopenia among older adults: With increasing age, there is a natural loss of muscle mass and strength called sarcopenia. According to the report by NLM in June 2025, the prevalence of sarcopenia is seen in almost 10% to 16% of the elderly population around the world, thus demanding an urgent requirement for the development of prevention strategies and effective treatments that add to increasing costs for healthcare and nutrition intervention needs. Leucine appears to stimulate muscle protein synthesis, and thus its supplementation might combat the situation of sarcopenia. An increasing patient population warrants leucine-based therapies and nutritional supplements, such as the leucine market.
- Advancements in clinical nutrition and therapeutic applications: Frequent research has potentized the leucine market for clinical nutrition, especially in patients suffering from cachexia and metabolic disorders. A study published by NLM in June 2025 proved that leucine supplementation can significantly increase lean body mass, with a mean difference (MD) of 0.99 kg, body weight of 1.02 kg, and body mass index (BMI) of 0.33 kg/m2. These findings regarding the therapeutic potential of leucine have consequently prompted a significant increase in research and development investments aimed at expanding its applications across various medical conditions.
- Growing demand for functional foods and dietary supplements: With mounting awareness among consumers regarding health and wellness, the market for functional foods and dietary supplements is pushing for health and wellness claims, such as the market. According to the NIH in July 2024, sales of all kinds of dietary supplements across the U.S. were estimated at USD 55.7 billion in the last 5 years. Among the best-selling categories are also amino acids such as leucine. This trend is likely to change in the coming days, as consumers are searching for products that can enhance muscle health and weight management, together with general well-being. The spurt in personalized nutrition and preventive health care is functioning as a catalyst for innovations such as market.
Leucine-Enriched BCAA Interventions for Hepatic and Metabolic Disorders
Clinical Trials and Ongoing Studies Using Branched-Chain Amino Acids (BCAAs) in the Treatment of Liver Disease (2022)
|
Type of Study |
Intervention(s) |
Patient Population |
Sample Size |
Duration |
Primary Outcomes / Measures |
|
Multicenter RCT |
VAL, LEU, ILE |
Advanced liver cirrhosis |
232 |
6 months |
MELD, Child–Pugh (CP) score, cirrhosis-related event-free survival |
|
Double-blinded RCT |
VAL, LEU, ILE |
Advanced cirrhosis |
174 |
12 months |
CP score, total bilirubin, death or symptom deterioration |
|
Non-specified |
VAL, LEU, ILE / AAA |
Cirrhosis |
104 |
>6 months |
Cumulative survival, delayed complications (hepatic failure, GI bleeding) |
|
Non-specified |
VAL, LEU, ILE |
Cirrhosis |
211 |
≥6 months |
Hepatocellular carcinoma (HCC) occurrence, event-free survival rate |
|
Single-blinded RCT |
AXA1665 (Leu: Ile: Val) |
Child–Pugh A & B cirrhosis |
16 |
15 days |
Liver Frailty Index, lean body mass |
|
Single-blinded, Multicenter RCT |
AXA1125 (VAL, LEU, ILE, ARG, GLN) |
NAFLD ± Type 2 Diabetes |
102 |
16 weeks |
ALT, cytokeratin-18 (K18), fibro-inflammation markers (cT1, Pro-C3) |
|
RCT |
VAL, LEU, ILE |
Hepatocellular carcinoma (HCC) |
51 |
12 months |
Intrahepatic recurrence rate, event-free survival |
|
Ongoing – Triple-blinded RCT (Phase II) |
AXA1125 (VAL, LEU, ILE, ARG, GLN) |
NASH with fibrosis |
273 |
48 weeks |
Improvement in steatohepatitis, resolution of NASH/fibrosis |
|
Ongoing – RCT |
VAL, LEU, ILE |
Cirrhosis |
60 |
3 months |
Muscle mass, insulin resistance |
Source: NLM
Challenges
- Regulatory and safety concerns: While regulatory bodies view leucine as a food supplement and therapeutic agent, this consequently implies that the leucine market undergoes enforceable regulatory supervision. Varying restrictions across countries impede product approval in those territories and extensive entry in the markets, along with extended timelines and higher costs of compliance. Another issue is safety and efficacy, where high-dose leucine supplementation still presents concerns, especially when looking at long-term repercussions on kidney and liver functions.
- Market fragmentation and competition: The market is highly fragmented, with countless providers from dietary supplements to clinical nutrition formulas. Due to heavy competition, prices drop and score little loyalty-from either the final consumers or healthcare providers. Also, alternate amino acids and protein supplements claiming almost similar benefits fill up an overcrowded marketplace, where individual leucine products somehow find it difficult to differentiate themselves and take a major share of the market.
Leucine Market Size and Forecast:
|
Base Year |
2025 |
|
Forecast Year |
2026-2035 |
|
CAGR |
6.9% |
|
Base Year Market Size (2025) |
USD 2 billion |
|
Forecast Year Market Size (2035) |
USD 3.6 billion |
|
Regional Scope |
|