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Last Updated: December 23, 2024

TRILOSTANE - Generic Drug Details


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

Trilostane is the generic ingredient in one branded drug marketed by Bioenvision and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for trilostane.

Summary for TRILOSTANE
Recent Clinical Trials for TRILOSTANE

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

SponsorPhase
The University of Hong KongPhase 2
Karolinska InstitutetPhase 2
Kristina Gemzell DanielssonPhase 2

See all TRILOSTANE clinical trials

US Patents and Regulatory Information for TRILOSTANE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bioenvision MODRASTANE trilostane CAPSULE;ORAL 018719-001 Dec 31, 1984 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bioenvision MODRASTANE trilostane CAPSULE;ORAL 018719-002 Dec 31, 1984 DISCN No No ⤷  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

TRILOSTANE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Trilostane

Introduction

Trilostane, a steroidogenesis inhibitor, is a crucial drug in the treatment of various endocrine disorders, particularly Cushing's syndrome in dogs and, in some cases, humans. The market for trilostane has been experiencing significant growth, driven by several key factors. Here, we delve into the market dynamics and financial trajectory of trilostane.

Market Size and Growth Projections

The trilostane API market is anticipated to exhibit robust growth over the forecast period from 2024 to 2031. According to recent market research, the market is expected to develop revenue at a remarkable Compound Annual Growth Rate (CAGR) during this period[1].

Segmentation of the Trilostane API Market

The market is segmented based on several criteria:

  • Type: Trilostane API is categorized into two types: ≥99% purity and <99% purity. The ≥99% purity segment is expected to dominate due to its higher demand in pharmaceutical applications.
  • Application: The primary applications are in veterinary drugs and human drugs. The veterinary segment is currently the largest, driven by the widespread use of trilostane in treating Cushing's syndrome in dogs.
  • Geography: The market is divided into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. North America and Europe are significant markets due to advanced healthcare infrastructure and higher awareness of adrenal diseases[1].

Drivers of Market Growth

Several factors are driving the growth of the trilostane market:

  • Increasing Healthcare Awareness: Growing awareness about adrenal diseases and the importance of early diagnosis and treatment is boosting the demand for trilostane[4].
  • Advancements in Pharmaceuticals: Continuous advancements in pharmaceutical technology and the development of more effective formulations of trilostane are contributing to market growth.
  • Growing Incidences of Adrenal Diseases: The rising incidence of Cushing's syndrome and other adrenal disorders in both humans and animals is a significant driver of the market[4].

Challenges and Restraints

Despite the positive growth trajectory, the trilostane market faces several challenges:

  • Side Effects and Complications: Medical management using trilostane can sometimes accelerate pituitary tumor growth, adding to the risk of compressive effects on surrounding tissues. This necessitates careful monitoring and can limit its use in some cases[5].
  • Regulatory Scrutiny: Pharmaceutical products, including trilostane, are subject to stringent regulatory requirements. Compliance with these regulations can be a significant challenge for manufacturers.
  • Competition: The market for trilostane is competitive, with several established and emerging players. This competition can lead to pricing pressures and market share battles[1].

Competitive Landscape

The trilostane API market is characterized by a mix of established and emerging players. Key companies profiled in the market include Junye Pharmaceutical, Tianjin Collabrate Chemtech, Taizhou Creating Bio-pharm, Guangzhou Topwork Chemical, and Tianjin Pharmaceutical Innovation. These companies are investing heavily in research and development to improve product quality and expand their market presence[1].

Financial Outlook

The financial trajectory of the trilostane API market is promising, with significant revenue growth anticipated over the forecast period. The market size is measured in USD million, and projections indicate a substantial increase in revenue from 2024 to 2031. The thorough segmentation of the market and detailed analysis of market dynamics, including drivers, restraints, opportunities, and challenges, provide a comprehensive outlook on the financial health of the market[1].

Pricing Analysis

The pricing of trilostane API is influenced by several factors, including the cost of raw materials, manufacturing processes, and market demand. The report conducts a meticulous pricing analysis, which is crucial for understanding the current market dynamics and forecasting future trends. This analysis also considers the impact of external factors such as national GDP, industry dynamics, and consumer behavior on product pricing[1].

Regional Market Analysis

The trilostane API market varies significantly across different regions:

  • North America and Europe: These regions are expected to remain significant markets due to their advanced healthcare systems and high awareness of adrenal diseases.
  • Asia-Pacific: This region is anticipated to show rapid growth due to increasing healthcare expenditure and growing awareness about endocrine disorders.
  • South America and Middle East & Africa: These regions are also expected to contribute to the market growth, albeit at a slower pace compared to the more developed regions[1].

Key Players and Market Strategies

Key players in the trilostane API market are adopting various strategies to maintain and expand their market share:

  • Research and Development: Investing in R&D to improve product quality and develop new formulations.
  • Market Expansion: Expanding into new geographical regions to tap into emerging markets.
  • Collaborations and Partnerships: Forming alliances with other companies and research institutions to enhance product offerings and market reach[1].

Market Opportunities and Challenges

Opportunities

  • Increasing Demand for Veterinary Drugs: The growing pet care industry and increasing incidence of Cushing's syndrome in dogs present a significant opportunity for trilostane manufacturers.
  • Emerging Markets: Expanding into regions with growing healthcare expenditure and increasing awareness of endocrine disorders offers substantial growth potential.

Challenges

  • Regulatory Compliance: Ensuring compliance with stringent regulatory requirements is a continuous challenge.
  • Side Effects and Complications: Managing the potential side effects and complications associated with trilostane use is crucial for maintaining market trust and regulatory approval[1][5].

Conclusion

The trilostane API market is poised for significant growth driven by increasing healthcare awareness, advancements in pharmaceuticals, and the growing incidence of adrenal diseases. While the market faces challenges such as regulatory scrutiny and potential side effects, the overall financial trajectory is positive. Key players are focusing on research and development, market expansion, and strategic collaborations to capitalize on the growing demand.

Key Takeaways

  • The trilostane API market is expected to grow at a remarkable CAGR from 2024 to 2031.
  • The market is segmented by type, application, and geography, with the ≥99% purity segment and veterinary application dominating.
  • Increasing healthcare awareness and advancements in pharmaceuticals are key drivers of market growth.
  • Regulatory compliance and managing side effects are significant challenges.
  • Key players are investing in R&D and market expansion strategies.

FAQs

Q: What are the primary applications of trilostane? A: The primary applications of trilostane are in veterinary drugs, particularly for treating Cushing's syndrome in dogs, and in human drugs for similar endocrine disorders.

Q: Which regions are expected to dominate the trilostane API market? A: North America and Europe are currently the dominant regions due to their advanced healthcare systems and high awareness of adrenal diseases.

Q: What are the key drivers of the trilostane market growth? A: Key drivers include increasing healthcare awareness, growing incidences of adrenal diseases, and advancements in pharmaceutical technology.

Q: What challenges does the trilostane market face? A: The market faces challenges such as regulatory scrutiny, potential side effects, and competition from other pharmaceutical products.

Q: Which companies are key players in the trilostane API market? A: Key companies include Junye Pharmaceutical, Tianjin Collabrate Chemtech, Taizhou Creating Bio-pharm, Guangzhou Topwork Chemical, and Tianjin Pharmaceutical Innovation.

Sources

  1. Market Research Intellect, "Global Trilostane API Market Size, Trends and Projections".
  2. University Senate, "MS/Ph.D Reproductive Sciences - University Senate".
  3. FDA, "2018log - FDA".
  4. 360iResearch, "Trilostane Capsules Market Size & Share 2025-2030".
  5. Frontiers in Veterinary Science, "Challenges of transsphenoidal pituitary surgery in severe hypercortisolism".

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