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Last Updated: January 5, 2025

Drugs Containing Excipient (Inactive Ingredient) ARGININE HYDROCHLORIDE


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Generic drugs containing ARGININE HYDROCHLORIDE excipient

ARGININE HYDROCHLORIDE Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Arginine Hydrochloride as a Pharmaceutical Excipient

Introduction to Arginine Hydrochloride

Arginine hydrochloride, a salt of the amino acid arginine, has emerged as a crucial excipient in the pharmaceutical industry. Its unique properties make it an essential component in various therapeutic protein formulations.

Physicochemical Properties and Applications

Arginine hydrochloride is renowned for its ability to enhance protein refolding and solubilization, suppress protein aggregation and opalescence, and reduce the viscosity of high-concentration protein formulations. These properties are particularly valuable in the development of subcutaneous administration formulations, where high protein concentrations can lead to stability and manufacturability issues[4].

Market Size and Growth

The market for arginine, including its hydrochloride form, is experiencing significant growth. The global arginine market is projected to reach 39 thousand tons by 2032, growing at a CAGR of 5.51% from 2023 to 2032. This growth is driven by increasing demand in the nutrition and supplements segment, which is the leading end-use segment for arginine[1].

High Purity L-Arginine Hydrochloride Market

The high purity L-arginine hydrochloride market, a subset of the broader arginine market, is also witnessing robust growth. In 2023, this market was valued at US$ 6 million and is expected to reach US$ 10 million by 2030, with a CAGR of 6.4% during the forecast period of 2024-2030[2].

Key Players and Market Competition

The arginine hydrochloride market is characterized by the presence of several key players. Companies such as Kyowa Hakko Bio Co., Ltd., Shijiazhuang Haitian Amino Acid, Hebei Huayang Group, Wuxi Jinghai Amino Acid, and Shaoxing King-Year Biochemical are prominent in the high purity L-arginine hydrochloride market. Other significant players in the broader arginine market include Ajinomoto Co., Inc., CJ CheilJedang Corporation, Evonik Industries AG, and Novus International, Inc.[1][2].

Regional Dominance

Asia Pacific is expected to dominate the global arginine market during the forecast period, driven by increasing demand from countries like China, Japan, and South Korea. This region's strong pharmaceutical and biotechnology sectors contribute significantly to the demand for arginine hydrochloride as an excipient[1].

Applications in Pharmaceutical Industry

Arginine hydrochloride is widely used in the pharmaceutical industry, particularly in the formulation of therapeutic proteins. It is an effective excipient in antibody formulations, helping to suppress protein aggregation and opalescence. The use of arginine hydrochloride in high-concentration protein formulations is becoming a trend, especially for subcutaneous administration, due to its ability to reduce viscosity and stabilize proteins[4].

Approved Protein Products

As of recent years, arginine hydrochloride has been incorporated into 20 approved protein injectables, with 12 of these approvals occurring in the last decade. This includes products like R-Gene 10® and Hemlibra, where arginine concentrations range from 25 to 300 mM. The increasing approval rate is driven by the booming biopharmaceutical industry's need for high-concentration formulations[4].

Financial Trajectory

The financial trajectory of the arginine hydrochloride market is positive, with significant growth projected over the next several years. Here are some key financial metrics:

  • Global Arginine Market: Expected to grow at a CAGR of 5.51% from 2023 to 2032, reaching a market size of 39 thousand tons by 2032[1].
  • High Purity L-Arginine Hydrochloride Market: Valued at US$ 6 million in 2023 and expected to reach US$ 10 million by 2030, with a CAGR of 6.4% during the forecast period[2].

Pricing and Cost Considerations

The pricing of arginine hydrochloride can vary based on purity levels and application. For instance, high purity L-arginine hydrochloride, which is often used in pharmaceutical applications, is priced accordingly due to its stringent quality requirements. The cost of production, including plant costs and licensing fees, also plays a crucial role in determining the final market price[1][2].

Competitive Landscape

The competitive landscape of the arginine hydrochloride market is characterized by a mix of established players and emerging companies. Key players focus on developing customized strategies, including sales and go-to-market strategies, to expand their market share. The market is also driven by the need for real-time pricing data and benchmarking reports to make informed decisions[1][2].

Future Trends and Outlook

The future of arginine hydrochloride in the pharmaceutical industry looks promising. As the biopharmaceutical sector continues to grow, the demand for excipients that can stabilize high-concentration protein formulations will increase. The use of arginine hydrochloride, along with other counterions like glutamate, is expected to become more prevalent to counterbalance negative effects and enhance protein stability[4].

Regulatory and Safety Considerations

Arginine hydrochloride has an acceptable safety profile and is used in various approved protein products. However, its use must be carefully managed to avoid adverse reactions. For example, in IV formulations, arginine hydrochloride can cause side effects such as nausea, vomiting, and local venous irritation. Regulatory compliance and thorough safety assessments are essential for its continued use in pharmaceutical formulations[4].

Conclusion

Arginine hydrochloride is a vital excipient in the pharmaceutical industry, particularly in the formulation of therapeutic proteins. With its unique properties and growing demand, the market for arginine hydrochloride is poised for significant expansion. Key players, regional dynamics, and financial trajectories all indicate a bright future for this market.

Key Takeaways

  • Market Growth: The global arginine market is expected to grow at a CAGR of 5.51% from 2023 to 2032.
  • High Purity Market: The high purity L-arginine hydrochloride market is projected to reach US$ 10 million by 2030, growing at a CAGR of 6.4%.
  • Applications: Arginine hydrochloride is crucial in therapeutic protein formulations, especially for subcutaneous administration.
  • Regional Dominance: Asia Pacific is expected to dominate the global arginine market.
  • Key Players: Companies like Kyowa Hakko Bio Co., Ltd. and Ajinomoto Co., Inc. are prominent in the market.

FAQs

Q1: What is the projected CAGR of the global arginine market? The global arginine market is expected to grow at a CAGR of 5.51% from 2023 to 2032[1].

Q2: Which segment is leading the global arginine market? The nutrition and supplements segment is leading the global arginine market[1].

Q3: What is the forecasted market size of the high purity L-arginine hydrochloride market by 2030? The high purity L-arginine hydrochloride market is expected to reach US$ 10 million by 2030[2].

Q4: Who are the main players in the high purity L-arginine hydrochloride market? Key players include Kyowa Hakko Bio Co., Ltd., Shijiazhuang Haitian Amino Acid, Hebei Huayang Group, Wuxi Jinghai Amino Acid, and Shaoxing King-Year Biochemical[2].

Q5: What are the primary applications of arginine hydrochloride in the pharmaceutical industry? Arginine hydrochloride is primarily used in therapeutic protein formulations to enhance protein refolding, solubilization, and stability, particularly for subcutaneous administration[4].

Sources

  1. ChemAnalyst: Arginine Market Size, Growth, Analysis & Forecast, 2032.
  2. Valuates Reports: High Purity L-Arginine Hydrochloride Market.
  3. BioSpace: Pharmaceutical Excipients Market Size USD 14.72 Billion by 2033.
  4. Oxford Academic: Effects of arginine in therapeutic protein formulations: a decade review.
  5. Market Research Intellect: Global High Purity L-Arginine Hydrochloride Market Size, Scope.

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