Fibroadenoma Market Highlights
The Fibroadenoma Market is projected to reach USD 1,093.6 Million by 2030 at 6.5% CAGR during the forecast period 2022-2030.
Fibroadenomas are benign tumours of the breast which are characterized by a mixture of stromal and epithelial tissue. Fibroadenomas develop from the milk producing glands to form a solid lump. Fibroadenomas are caused due to hormone imbalances and the symptoms are painless, firm, mobile lump in the breast of a woman. According to American Cancer Society, fibroadenomas are most common in young women in their 20s and 30s, although they can be found in women of any age. The growth of these tumours is faster during pregnancy while menopause, causes them to shrink.
The market for treatment of fibroadenomas is growing due to factors such as growing use of hormonal contraceptives which increases the chances of fibroadenomas, genetic predisposition, greater screening rates, growing awareness etc. Obesity also increases the chances of developing fibroadenoma Breast. The market restraints are the non-life-threatening nature of the fibroadenomas, the self-resolving nature of Fibroadenomas etc.
However, against the backdrop of the worsening regulatory and reimbursement environment combined with the uncertainty of healthcare reforms will restrain and threaten the future market for high intensity focused ultrasound (HIFU). The U.S. food and drug administration (FDA) classifies medical devices into Class I, II, and III with regulatory control increasing from Class I to Class III, based on the need to provide reasonable assurance of its safety and effectiveness. In general, most Class I devices are exempted from premarket notification 510(k) while the situation gets more and more serious for Class II devices and most Class III devices which require premarket approval. Positive Mental Attitude (PMA) is very time and effort intensive process due to requirements of valid scientific evidence about the probable health benefits from the intended use of a device which must outweigh the probable risks. It also requires reasonable evidence to assure that the device will significantly help a large portion of the target population. Thus, regulatory uncertainty in the FDA approval process for HIFU will constrain the market.
Fibroadenoma Market Players:
The top key Fibroadenoma Market players profiled in the report are ICECURE MEDICAL, Alpinion Medical Systems Co., Ltd., SonaCare Medical, LLC, Insightec, Torrent Pharmaceuticals Ltd, Taj Pharmaceuticals Ltd., Novartis Pharmaceuticals Limited, Torrent Pharmaceuticals Limited, and others.
Segmentation:
The global fibroadenoma market is segmented on the basis of types, diagnosis, treatment, and end users. Based on types, the market has been segmented as simple fibroadenoma and complex fibroadenoma. Based on the diagnosis, the market has been segmented as physical examination, ultrasound scan, mammogram, biopsy and others. Based on the treatment, the market has been segmented as cryoablation, High Intensity Focused Ultrasound (HIFU), drugs, surgery and others. Based on the end users, the market has been segmented as hospitals and clinics, diagnostic centers and others.
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