Clascoterone, also known as Winlevi, is an antiandrogen medication used topically to treat acne. It is also being developed in a higher concentration under the brand name Breezula for the treatment of androgen-dependent scalp hair loss. The cream-like medication is applied to the skin, such as the face and scalp. Clascoterone is an androgen receptor (AR) antagonist or antiandrogen. Androgens such as testosterone and dihydrotestosterone have a biological target in the AR. It has very little systemic absorption when applied to the skin.This growth is primarily driven by Growing Hair Loss and Acne Problems has Been Driving the Market Growth..
|Value Unit||USD (Million)|
|Key Companies in Study||Sun Pharmaceutical Industries Ltd. (India), Symbiotec (India), Aspen Pharmacare (South Africa), Teva Pharmaceuticals (Israel), Curia (United States), Bulat Pharmaceutical (India), Farmabios (Italy), SEQENS SAS (France), Shandong Sihuan Pharmaceutical (China) and Cosmo Pharmaceuticals (Ireland)|
|Customization Scope||Avail customization with purchase of this report. Add or modify country, region & or narrow down segments in the final scope subject to feasibility|
The Pharmaceuticals sector in the region has been increasing at a sustainable rate and further growth is expected to be witnessed over the forecast period, owing to the robust investments and expansion in production facilities in the region.
Major Players, such as Sun Pharmaceutical Industries Ltd. (India), Symbiotec (India), Aspen Pharmacare (South Africa), Teva Pharmaceuticals (Israel), Curia (United States), Bulat Pharmaceutical (India), Farmabios (Italy), SEQENS SAS (France), Shandong Sihuan Pharmaceutical (China) and Cosmo Pharmaceuticals (Ireland), etc have either set up their manufacturing facilities or are planning to start new provision in the dominated region in the upcoming years.
Key Developments in the Market:
Sun Pharmaceutical Industries Limited received the certified copy of the order passed by the National Company Law Tribunal, Ahmedabad Bench in August 2021, approving the Scheme of Amalgamation and Merger of Sun Pharma Global FZE (Transferor Company), an indirect wholly-owned subsidiary of the Company with the company (Transferee Company), and their respective members and creditors (Scheme), for the merger of the Transferor Company with the Transferee Company.
The first-in-class topical treatment for acne vulgaris, clascoterone (Winlevi, Sun Pharmaceuticals) cream 1%, has officially launched in the United States. The topical androgen receptor inhibitor was first approved by the FDA in August 2020 to treat patients 12 years and older who have acne vulgaris. The cream launched in November 2021 in the United States.To entice more end users, market players are focusing on providing clascoterone of higher quality while adhering to all regulatory standards. In the global clascoterone market, there are numerous large providers. They are also concentrating on the implementation of numerous advanced technologies in drug manufacturing and R&D. Furthermore, the numerous industry profits have led to the entry of new players, raising the level of rivalry in an already competitive market. The clascoterone market is currently expanding due to the rapid advancement of technology in pharmaceuticals. Some of the key players in this market follow strategies, which include new product offerings, product approvals, partnerships and alliances, mergers and acquisitions, and business expansions.
PART 320 - BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS Subpart B - Procedures for Determining the Bioavailability or Bioequivalence of Drug Products Sec. 320.21 Requirements for submission of bioavailability and bioequivalence data. (a) Any person submitting a full new drug application to the Food and Drug Administration (FDA) shall include in the application either: (1) Evidence measuring the in vivo bioavailability of the drug product that is the subject of the application; or (2) Information to permit FDA to waive the submission of evidence measuring in vivo bioavailability.
Clascoterone Market Dynamics:
- Growing Hair Loss and Acne Problems has Been Driving the Market Growth.
- Rise in Acne and Hair Loss at Young Age.
- Known Side Effects of Drug will be Hindering the Market Growth.
|Road Blocks / Challenges|
- Regulations for Approval and Approval Process will be challenging for Market Growth.
|Gaps & Opportunities|
- Investments in R&D and Product Development will be Bringing More Opportunities in Market.
AMA Research follows a focused and realistic research framework that provides the ability to study the crucial market dynamics in several regions across the world. Moreover, an in-depth assessment is mainly conducted by our analysts on geographical regions to provide clients and businesses the opportunity to dominate in niche markets and expand in emerging markets across the globe. This market research study also showcases the spontaneously changing Players landscape impacting the market's growth. Furthermore, our market researchers extensively analyze the products and services offered by multiple players competing to increase their market share and presence.
Data Sources of Clascoterone Market Study
Primary Collection: InMail, LinkedIn Groups, Survey Monkey, Google, and Other professional Forums are some of the medium utilized to gather primary data through key industry participants and appointees, subject-matter experts, C-level executives of Clascoterone Industry, among others including independent industry consultants, experts, to obtain and verify critical qualitative commentary and opinion and quantitative statistics, to assess future market prospects.The primary interviews and data collected as per the below protocols:
By Designation: C-Level, D-Level, Others
By Company Type: Tier 1, Tier 2, Tier 3
Secondary Data Sources such as Annual reports, Press releases, Analyst meetings, Conference calls, Investor presentations, Management statements, SEC filings of Clascoterone players along with Regulatory Sites, Association, World bank, etc were used as sources secondary set of data.
Customization in the Report
AMA Research features not only specific market forecasts but also includes significant value-added commentary on:
- Market Trends
- Technological Trends and Innovations
- Market Maturity Indicators
- Growth Drivers and Constraints
- New Entrants into the Market & Entry/Exit Barriers
- To Seize Powerful Market Opportunities
- Identify Key Business Segments, Market Proposition & Gap Analysis
Against this Challenging Backdrop, Clascoterone Study Sheds Light on
The Clascoterone Market status quo and key characteristics. To end this, Analysts at AMA organize and took surveys of the Clascoterone industry Players. The resultant snapshot serves as a basis for understanding why and how the industry can be expected to change.
Where Clascoterone industry is heading and what are the top priorities. Insights are drawn from financial analysis, the survey, and interviews with key executives and industry experts.
How every company in this diverse set of Players can best navigate the emerging competition landscape and follow a strategy that helps them position to hold the value they currently claim or capture the new addressable opportunity.