Steroid Hormone API Market Top Innovators
- Pfizer CentreOne
- Merck KGaA
- Novartis AG
- Sanofi S.A.
- GlaxoSmithKline plc
- Teva Pharmaceutical Industries Ltd.
- Bayer AG
- Sun Pharmaceutical Industries Ltd.
- Cipla Ltd.
- Lupin Pharmaceuticals
- Torrent Pharmaceuticals
- Zhejiang Xianju Pharmaceutical Co., Ltd.
- Wuhan Yuancheng Gongchuang Technology Co., Ltd.
- Tianjin Tianyao Pharmaceuticals
- Symbiotec Pharmalab Pvt. Ltd.
- Aspen Pharmacare
- Hikma Pharmaceuticals PLC
- AdvaCare Pharma
- Shandong Xinhua Pharmaceutical Co., Ltd.
Market Growth
The global steroid hormone API market size is calculated at US$ 3.54 billion in 2024, grew to US$ 3.74 billion in 2025, and is projected to reach around US$ 6.06 billion by 2034. The market is expanding at a CAGR of 5.54% between 2025 and 2034.
What are the Trends in the Steroid Hormone API Market?
- Active Efforts Taken by Market Players: Pharmaceutical businesses continue to depend on strategic alliances with API makers to guarantee a steady and superior supply of steroidal components as they work to maximise their manufacturing capacity.
- In June 2025, Gujarat may be able to overtake China, which now holds a near stranglehold in the $400 million hormonal active pharmaceutical ingredient (API) industry in India. The necessary World Health Organisation (WHO) Good Manufacturing Practices (GMP) accreditation has been granted to be the first one in Gujarat and the second facility of India devoted to producing hormonal API. The primary component of any medication that really has an effect is the API.
- In June 2025, according to persons acquainted with the situation, Symbiotec Pharmalab, a world leader in the production of corticosteroid and hormone active pharmaceutical ingredients (APIs), plans to go public in the next year at a target valuation of around $1 billion.
Steroid Hormone API Market Value Chain Analysis
R&D
A complicated, multi-stage research and development procedure subject to stringent regulatory regulations is needed to develop an Active Pharmaceutical Ingredient (API) for steroid hormones. The process, which is frequently based on biotechnology or chemical synthesis, moves from preliminary route exploration and optimisation to validation of full-scale manufacture.
Companies: Lupin Ltd., Aurobindo Pharma, Symbiotec Pharma, Axplora, and Brichem Sciences
Clinical Trials and Regulatory Approvals
Instead of requiring independent clinical studies for the Active Pharmaceutical Ingredients (APIs) used in steroid hormone medication formulations, regulatory requirements concentrate on manufacturing quality and site approval. To obtain regulatory clearance, the manufacturing method and quality of the API must be demonstrated to be dependable, even though clinical studies are carried out on the finished therapeutic product.
Companies: Lupin Ltd., Aurobindo Pharma, Symbiotec Pharma, Axplora, and Brichem Sciences
Patient Support and Services
The process of offering steroid hormone treatment, patient assistance, and services is complex and includes everything from initial education to ongoing monitoring. Comprehensive patient education, individualised medication management, side effect monitoring and treatment, lifestyle support, and ongoing communication between the patient and their healthcare team are all crucial components.
Latest Announcements by Industry Leaders
In October 2024, the FDA approved Estradiol Gel, 0.06% of ANI Pharmaceuticals, and it went on sale. We are happy to introduce another limited-competition product to the market and make sure that customers and patients in need have ready access with the FDA approval and commercialisation of Estradiol Gel, 0.06%, said Nikhil Lalwani, President and CEO of ANI.
Recent Developments in the Steroid Hormone API Market
- In November 2024, in honour of National Testosterone Awareness Day, a new nonprofit organisation called The Testosterone Project was established by top authorities on testosterone therapy and overall metabolic health.
- In October 2024, the first generic version of the corticosteroid Prednisolone Acetate Ophthalmic Suspension was introduced in the US, according to Lupin. It is prescribed to treat steroid-responsive inflammation of the cornea, anterior region of the globe, and palpebral and bulbar conjunctiva.
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