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Last Updated: April 18, 2025

Protein hydrolysate - Generic Drug Details


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What are the generic drug sources for protein hydrolysate and what is the scope of patent protection?

Protein hydrolysate is the generic ingredient in two branded drugs marketed by Abbvie and B Braun, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for protein hydrolysate.

Summary for protein hydrolysate
US Patents:0
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: 3
Clinical Trials: 1
DailyMed Link:protein hydrolysate at DailyMed
Recent Clinical Trials for protein hydrolysate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Baylor College of MedicinePhase 2
U.S. Department of EducationPhase 2

See all protein hydrolysate clinical trials

US Patents and Regulatory Information for protein hydrolysate

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Abbvie AMINOSOL 5% protein hydrolysate INJECTABLE;INJECTION 005932-012 Jan 31, 1985 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
B Braun HYPROTIGEN 5% protein hydrolysate INJECTABLE;INJECTION 006170-003 Jan 10, 1984 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 2 of 2 entries

Protein Hydrolysate Market Dynamics and Financial Trajectory

Market Size and Growth Projections

The protein hydrolysate market is experiencing significant growth, driven by various factors such as increasing health consciousness, a surge in demand for high-protein diets, and the need for specialized nutrition products. As of 2023, the global protein hydrolysate market was valued at USD 3,567.0 million and is projected to grow to USD 5,500.7 million by 2031, exhibiting a Compound Annual Growth Rate (CAGR) of 5.66% during the forecast period[3].

Segmentation and Key Players

The market is segmented based on source, application, and form. The sources include plant-based, animal, and microbial protein hydrolysates. Animal-derived hydrolysates, particularly milk protein hydrolysates, are gaining traction due to their superior digestibility and bioavailability. The milk protein hydrolysate market alone was valued at USD 2.9 billion in 2024 and is expected to grow at a CAGR of over 8.7% from 2025 to 2034[1].

Applications and End-Use Industries

Protein hydrolysates are widely used in various industries, including:

Infant Nutrition

Milk protein hydrolysates are particularly popular in infant nutrition due to their hypoallergenic nature and low lactose content, making them ideal for infant formulas[1].

Sports Nutrition

Whey protein hydrolysate (WPH) leads the market in sports nutrition, aiding in muscle recovery and enhancing performance due to its rapid absorption and high bioavailability of essential amino acids[1].

Medical Nutrition

There is an escalating demand for medical nutrition solutions, especially for aging populations and those with chronic diseases, further bolstering the market's expansion[1].

Functional Foods and Dietary Supplements

The demand for functional foods and dietary supplements is driving the growth of the protein hydrolysate market. Consumers are increasingly looking for products that provide targeted health benefits, including muscle recovery and immune support[3].

Technological Innovations and Production Methods

The industry is witnessing significant technological advancements, particularly in production techniques. Innovations in enzymatic hydrolysis, microbial fermentation, and ultrasonic hydrolysis are refining the production of bioactive peptides, making the process more controlled, efficient, and sustainable. These advancements are also leading to cleaner production methods and enhanced stability and delivery of hydrolysates through encapsulation technology[1].

Challenges and Regulatory Landscape

Despite the growth, the protein hydrolysate market faces several challenges:

High Production Costs

The intricate processes involved in hydrolysis, including enzymatic treatment and purification, elevate manufacturing expenses. The need for premium raw materials and rigorous quality control measures further compounds these costs[1].

Regulatory Challenges

Manufacturers must navigate stringent regulations, especially around labeling and health claims. The approval process for these claims can be time-intensive and financially burdensome. Compliance with regional regulations adds another layer of complexity, which can stifle market growth, particularly for smaller firms or newcomers[1].

Regional Analysis

The global protein hydrolysate market is geographically diverse:

North America

North America accounts for a substantial share of the market, driven by high demand in industries such as sports nutrition, healthcare, and food processing. The region's well-established fitness culture and extensive R&D activities contribute to its dominance[3].

Europe

Europe is another significant market, with a strong presence of key industry players and a high demand for premium protein supplements and fortified food products[5].

Asia-Pacific

The Asia-Pacific region is emerging as a profitable market, fueled by rising health consciousness and increasing disposable incomes, which are promoting the adoption of protein hydrolysates in functional foods and beverages[5].

Consumer Trends and Preferences

Consumers are increasingly prioritizing products that offer targeted health benefits, such as muscle recovery and immune support. There is a growing trend towards plant-based hydrolysates, driven by the vegan movement and sustainability concerns. The evolution of personalized nutrition is also shaping product development, leading to hydrolysates customized for individual health requirements[1].

Key Takeaways

  • The protein hydrolysate market is projected to grow significantly, driven by health consciousness and demand for high-protein diets.
  • Milk protein hydrolysates are particularly popular in infant and sports nutrition due to their superior digestibility and bioavailability.
  • Technological innovations in production methods are enhancing the yield and functionality of bioactive peptides.
  • High production costs and regulatory challenges are key hurdles in the market.
  • Regional markets, especially North America and Europe, are driving growth due to high demand and extensive R&D activities.

FAQs

Q: What is the projected growth rate of the global protein hydrolysate market? A: The global protein hydrolysate market is projected to grow at a CAGR of 5.66% from 2024 to 2031[3].

Q: Which segment leads the market in terms of protein hydrolysates? A: Whey protein hydrolysate (WPH) leads the market, particularly in sports nutrition and infant formulas, due to its superior digestibility and high bioavailability of essential amino acids[1].

Q: What are the main challenges facing the protein hydrolysate market? A: High production costs and regulatory challenges are the main hurdles in the protein hydrolysate market[1].

Q: How are technological innovations impacting the protein hydrolysate market? A: Innovations in enzymatic hydrolysis, microbial fermentation, and ultrasonic hydrolysis are refining production methods, making them more efficient and sustainable[1].

Q: Which regions are driving the growth of the protein hydrolysate market? A: North America and Europe are driving the growth due to high demand and extensive R&D activities, while the Asia-Pacific region is also emerging as a significant market[3][5].

Cited Sources

  1. Global Milk Protein Hydrolysate Market Size & Share, 2034 Report - GMI Insights
  2. Fish Protein Hydrolysate Market Report: Size, Trends, and Growth Projections for 2024-2031 - OpenPR
  3. Protein Hydrolysate Market Overview By 2030 - Kings Research
  4. Fish Protein Hydrolysate Market Trends, Demand, Key Players and Forecast to 2026 - eTurboNews
  5. In-Depth Industry Outlook: Fish Protein Hydrolysate Market Size, Forecast - Verified Market Research

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