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Last Updated: December 28, 2024

CYSTEAMINE HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for cysteamine hydrochloride and what is the scope of freedom to operate?

Cysteamine hydrochloride is the generic ingredient in two branded drugs marketed by Recordati Rare and Leadiant Biosci Inc, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for CYSTEAMINE HYDROCHLORIDE
US Patents:0
Tradenames:2
Applicants:2
NDAs:2
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 119
Clinical Trials: 29
Patent Applications: 1,424
What excipients (inactive ingredients) are in CYSTEAMINE HYDROCHLORIDE?CYSTEAMINE HYDROCHLORIDE excipients list
DailyMed Link:CYSTEAMINE HYDROCHLORIDE at DailyMed
Recent Clinical Trials for CYSTEAMINE HYDROCHLORIDE

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

SponsorPhase
Nacuity Pharmaceuticals, Inc.Phase 1/Phase 2
Thiogenesis Therapeutics, Inc.Phase 2
EmeraMedPhase 2/Phase 3

See all CYSTEAMINE HYDROCHLORIDE clinical trials

Pharmacology for CYSTEAMINE HYDROCHLORIDE

US Patents and Regulatory Information for CYSTEAMINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Leadiant Biosci Inc CYSTARAN cysteamine hydrochloride SOLUTION/DROPS;OPHTHALMIC 200740-001 Oct 2, 2012 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Recordati Rare CYSTADROPS cysteamine hydrochloride SOLUTION/DROPS;OPHTHALMIC 211302-001 Aug 19, 2020 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

CYSTEAMINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cysteamine Hydrochloride

Introduction

Cysteamine hydrochloride, a compound with the CAS number 156-57-0, has been gaining significant attention in various industrial and pharmaceutical sectors. This article delves into the market dynamics, financial trajectory, and key factors influencing the cysteamine hydrochloride market.

Market Size and Growth Projections

The cysteamine hydrochloride market has experienced rapid growth in recent years and is anticipated to continue this trend. By 2023, the market had reached a substantial value, and projections indicate it will attain even higher values by the end of 2031[1][3][4].

Segmentation

The market is segmented based on several key factors:

  • Type: The market is categorized by purity levels, including purity ≥ 98% and purity < 98% for cysteamine hydrochloride, and purity levels of 97%, 98%, and 99% for dimethyl cysteamine hydrochloride[1][3].
  • Application: The primary applications include pharmaceuticals, cosmetics, chemical raw materials, and pharmaceutical intermediates[1][3].
  • Geography: The market is analyzed across regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[1][3][4].

Market Drivers

Several factors are driving the growth of the cysteamine hydrochloride market:

  • Increasing Demand in Pharmaceuticals: Cysteamine hydrochloride is used in the treatment of various diseases, including cystinosis, a rare genetic disorder. The growing need for effective treatments in the pharmaceutical sector is a significant driver[1][3].
  • Expanding Cosmetic Industry: The compound is also used in cosmetic products due to its antioxidant and skin-protective properties, contributing to market growth[1].
  • Advancements in Chemical Synthesis: Improvements in synthesis techniques and the availability of high-purity cysteamine hydrochloride have enhanced its appeal in various industrial applications[2].

Market Restraints

Despite the positive growth trajectory, there are several restraints to consider:

  • Regulatory Challenges: Strict regulatory requirements and the need for compliance can slow down market growth. Ensuring the quality and safety of cysteamine hydrochloride products is crucial but can be time-consuming and costly[1][3].
  • Raw Material Availability: The availability and cost of raw materials can fluctuate, affecting the production and pricing of cysteamine hydrochloride[2].

Market Opportunities

The market presents several opportunities for growth:

  • Emerging Markets: Regions such as Asia-Pacific and Latin America offer significant growth potential due to increasing demand for pharmaceuticals and cosmetics[1][3][4].
  • Research and Development: Continuous R&D in the use of cysteamine hydrochloride in new applications can open up additional market segments[1][3].

Competitive Landscape

The cysteamine hydrochloride market is competitive, with several key players:

  • Established Companies: Companies like Santa Cruz Biotechnology Inc., Sigma-Aldrich Corporation, Merck KGaA, and others are prominent in the market[1].
  • Emerging Players: Companies such as Shanghai TBBMed, Baoding Jiufu, and Hubei Chengyu Pharmaceutical are also making significant contributions[3].

Financial Performance

The financial performance of the cysteamine hydrochloride market is robust:

  • Revenue Growth: The market is expected to see substantial revenue growth from 2023 to 2031, driven by increasing demand and expanding applications[1][3][4].
  • Production Capacity: Global production capacity has been increasing to meet the growing demand, with significant production volumes expected in regions like China and the Asia-Pacific[4].

Regional Analysis

The market performance varies across different regions:

  • North America and Europe: These regions have a well-established market with high demand for pharmaceutical and cosmetic products[1][3][4].
  • Asia-Pacific: This region is experiencing rapid growth due to increasing industrial and pharmaceutical activities[1][3][4].
  • China: China is a significant producer and consumer of cysteamine hydrochloride, with a strong focus on both domestic and international markets[4].

Production and Manufacturing

The production of cysteamine hydrochloride involves several steps:

  • Synthesis: The compound is synthesized through specific chemical reactions, often involving sodium carbonate or sodium hydrogencarbonate, and other reagents[2].
  • Purification: High-purity cysteamine hydrochloride is obtained through meticulous purification processes, ensuring the product meets stringent quality standards[2].

Market Outlook

The market outlook for cysteamine hydrochloride is positive:

  • Growth Catalysts: Increasing demand, advancements in synthesis techniques, and expanding applications are key growth catalysts[1][3].
  • Challenges: Regulatory compliance, raw material availability, and competition are challenges that need to be addressed[1][3].

Porter's 5 Forces Analysis

A Porter's 5 Forces analysis provides a comprehensive view of the market dynamics:

  • Threat of New Entrants: The threat is moderate due to the need for significant investment in R&D and compliance with regulatory standards[1][3].
  • Bargaining Power of Suppliers: Suppliers have moderate bargaining power due to the availability of raw materials and competition among suppliers[1][3].
  • Bargaining Power of Buyers: Buyers have significant bargaining power due to the availability of multiple suppliers and the competitive nature of the market[1][3].
  • Threat of Substitute Products: The threat of substitutes is low as cysteamine hydrochloride has unique properties that are difficult to replicate with other compounds[1][3].
  • Competitive Rivalry: The competitive rivalry is high due to the presence of several established and emerging players[1][3].

Key Takeaways

  • The cysteamine hydrochloride market is experiencing rapid growth driven by increasing demand in pharmaceuticals and cosmetics.
  • The market is segmented by type, application, and geography, with Asia-Pacific and emerging markets offering significant growth potential.
  • Key players are investing in R&D to expand applications and improve production efficiency.
  • Regulatory compliance and raw material availability are critical factors influencing market dynamics.

FAQs

Q: What are the primary applications of cysteamine hydrochloride? A: The primary applications include pharmaceuticals, cosmetics, chemical raw materials, and pharmaceutical intermediates[1][3].

Q: Which regions are expected to drive the growth of the cysteamine hydrochloride market? A: Asia-Pacific, particularly China, and emerging markets in Latin America are expected to drive significant growth[1][3][4].

Q: What are the key drivers of the cysteamine hydrochloride market? A: Increasing demand in pharmaceuticals, expanding cosmetic industry, and advancements in chemical synthesis are key drivers[1][3].

Q: Who are the major players in the cysteamine hydrochloride market? A: Companies like Santa Cruz Biotechnology Inc., Sigma-Aldrich Corporation, Merck KGaA, and emerging players such as Shanghai TBBMed and Baoding Jiufu are major players[1][3].

Q: What are the challenges faced by the cysteamine hydrochloride market? A: Regulatory challenges, raw material availability, and competition are significant challenges faced by the market[1][3].

Cited Sources

  1. Market Research Intellect, "Cysteamine Hydrochloride Sales Market Size, Scope And Forecast", September 2024.
  2. Ambeed.com, "[CAS No. 156-57-0] Cysteamine hydrochloride".
  3. Market Research Intellect, "Global Dimethyl Cysteamine Hydrochloride Market Size, Scope And Forecast", September 2024.
  4. OpenPR, "75% Cysteamine Hydrochloride Market Trends and Growth", July 2024.

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