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1755919

濾泡刺激素市場預測（至 2032 年）：按產品類型、給藥途徑、分銷管道、應用、最終用戶和地區進行的全球分析

Follicle Stimulating Hormone Market Forecasts to 2032 - Global Analysis By Product Type (Recombinant FSH and Urinary FSH), Route of Administration, Distribution Channel, Application, End User and By Geography
出版日期: | 出版商: Stratistics Market Research Consulting | 英文 200+ Pages | 商品交期: 2-3個工作天內

價格

根據 Stratistics MRC 的數據，全球濾泡刺激素市場預計在 2025 年達到 26 億美元，到 2032 年將達到 39 億美元，預測期內的複合年成長率為 6%。

濾泡刺激素(FSH) 是由腦下垂體前葉產生的一種糖蛋白激素。它透過調節女性卵巢和男性睪丸的生長、發育和功能，在生殖健康中發揮重要作用。它刺激女性卵泡成熟，促進男性精子發生。 FSH 水平通常用於評估生育能力、月經或腦下垂體功能。

根據世界衛生組織 (WHO) 2023 年 4 月更新的數據，不孕症影響全球整體約六分之一的成年人。

提高對生育治療的認知與接受度

全球不孕症的上升，以及人們對體外受精（IVF）等先進生殖技術的認知度的提高，推動了對有效不孕症治療方法的需求。此外，包括生育診所和專科中心在內的醫療基礎設施的擴張，也促進了FSH治療的可近性。這種認知促使更多患者接受治療，從而推動了市場的成長。此外，FSH生產和輸送方法的技術進步也改善了治療效果，從而推動了市場的擴張。

副作用和安全問題

FSH治療相關的副作用和安全問題對市場成長構成挑戰。有些患者會出現卵巢過度刺激症候群 (OHSS)、過敏反應和荷爾蒙失衡等副作用，這些副作用可能會阻礙治療的實施。此外，包括FSH治療在內的不孕症治療費用高昂，限制了人們的可近性，尤其是在沒有醫療保險的低收入地區。這些安全和經濟問題限制了患者接受FSH不孕症治療的意願和能力，從而抑制了整體市場的擴張。

產品創新和生物相似藥

重組FSH製劑採用先進的重組DNA技術開發，與尿源激素相比，其純度和一致性更高，從而提高了療效和安全性。生物相似藥的出現降低了治療成本，使不孕症治療更經濟實惠，並惠及更多人。此外，預填充式注射器和筆式注射器等給藥系統的創新提高了患者的便利性和依從性，進一步刺激了市場的成長。

倫理和宗教問題

倫理和宗教方面的擔憂對FSH市場構成了重大威脅。涉及使用FSH的輔助生殖技術（ART）通常會面臨與胚胎操作、儲存和基因檢測相關的審查，從而引發道德和文化爭議。這些擔憂影響了公眾認知，並導致某些地區推出限制性監管政策，限制了市場滲透。

COVID-19的影響：

新冠疫情擾亂了促卵泡激素市場，主要原因是非緊急生育治療（包括試管嬰兒）中斷，導致許多國家的平均治療延遲近兩個月。旅行限制也限制了患者前往生育診所就診，尤其是醫療旅遊。疫情期間的心理壓力進一步影響了生育治療的效果。此外，供應鏈中斷也延遲了藥物的供應。然而，診所透過實施安全通訊協定和提供遠距諮詢等措施進行了調整，隨著限制措施的放鬆和治療的恢復，需求也逐漸恢復。

重組 FSH 市場預計將成為預測期內最大的市場

重組FSH預計將在預測期內佔據最大的市場佔有率，這得益於其透過使用基因工程細胞株的重組DNA技術實現了卓越的純度、一致性和生物活性。此方法最大限度地減少了尿液來源FSH中的雜質，從而提高了安全性和療效。全球輔助生殖技術和不孕症治療的日益普及進一步推動了該細分市場的成長。此外，正在進行的研發工作不斷改進重組FSH配方，鞏固了其作為不孕症治療首選方案的地位，並有助於其佔據最大的市場佔有率。

預計在預測期內，注射劑部分將以最高的複合年成長率成長。

注射劑廣泛應用於卵巢刺激等不孕症治療，預計在預測期內將達到最高成長率。注射劑劑量精準、生物利用度高，對於有效治療至關重要。此外，筆式注射器和預填充式注射器等注射設備的進步提高了患者的便利性和依從性。與其他給藥方式相比，注射劑的偏好提升，加上不孕症率的上升和輔助生殖技術（ART）的普及，推動了該領域市場的快速成長。

佔比最大的地區：

在預測期內，北美預計將佔據最大的市場佔有率，這得益於其先進的醫療基礎設施、對不孕症和生育治療的高度認知度，以及輔助生殖技術的優惠報銷政策。由於對生物技術和藥物研究的大量投資，該地區早期已採用創新的促卵泡激素（FSH）療法。此外，不孕症的高發病率以及生育診所和專科中心數量的不斷增加，也推動了強勁的需求。

複合年成長率最高的地區：

在預測期內，亞太地區預計將呈現最高的複合年成長率，這得益於不孕症率的上升、可支配收入的增加以及醫療基礎設施的不斷擴張。人們對生育治療的認知和接受度的不斷提高，以及政府改善生殖健康的舉措，都推動了需求的成長。該地區中階的不斷壯大和輔助生殖技術的不斷進步，將進一步推動市場的應用。

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目錄

第1章執行摘要

第2章 前言

  • 概述
  • 相關利益者
  • 研究範圍
  • 調查方法
    • 資料探勘
    • 數據分析
    • 數據檢驗
    • 研究途徑
  • 研究材料

第3章市場走勢分析

  • 驅動程式
  • 限制因素
  • 機會
  • 威脅
  • 產品分析
  • 應用分析
  • 最終用戶分析
  • 新興市場
  • COVID-19的影響

第4章 波特五力分析

  • 供應商的議價能力
  • 買家的議價能力
  • 替代品的威脅
  • 新進入者的威脅
  • 競爭對手之間的競爭

5. 全球濾泡刺激素市場（依產品類型）

  • 重組促卵泡激素
    • 純重組FSH
    • 混合重組FSH製劑
  • 尿液促卵泡激素（uFSH）

6. 全球濾泡刺激素市場（依給藥途徑分類）

  • 注射
  • 其他路線

7. 全球濾泡刺激素市場（依通路）

  • 醫院藥房
  • 零售藥局
  • 網路藥局
  • 專業藥局

8. 全球濾泡刺激素市場（依應用）

  • 輔助生殖技術（ART）
    • 體外受精（IVF）
    • 卵細胞質內單一精蟲顯微注射術（ICSI）
  • 性腺功能低下
  • 誘導排卵
  • 其他用途

9. 全球濾泡刺激素市場（依最終用戶）

  • 醫院
  • 不孕症診所/不孕症中心
  • 研究機構和學術中心
  • 其他最終用戶

第 10 章全球濾泡刺激素市場（按地區）

  • 北美洲
    • 美國
    • 加拿大
    • 墨西哥
  • 歐洲
    • 德國
    • 英國
    • 義大利
    • 法國
    • 西班牙
    • 其他歐洲國家
  • 亞太地區
    • 日本
    • 中國
    • 印度
    • 澳洲
    • 紐西蘭
    • 韓國
    • 其他亞太地區
  • 南美洲
    • 阿根廷
    • 巴西
    • 智利
    • 南美洲其他地區
  • 中東和非洲
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 卡達
    • 南非
    • 其他中東和非洲地區

第11章 重大進展

  • 協議、夥伴關係、合作和合資企業
  • 收購與合併
  • 新產品發布
  • 業務擴展
  • 其他關鍵策略

第12章 公司概況

  • Ferring Pharmaceuticals
  • Merck KGaA
  • Pfizer Inc.
  • Teva Pharmaceutical Industries Ltd.
  • Allergan plc
  • Ipsen Pharma
  • LG Chem Ltd.
  • Asarina Pharma
  • Intas Pharmaceuticals Ltd.
  • Bharat Serums and Vaccines Ltd.
  • Sun Pharmaceutical Industries Ltd.
  • Gedeon Richter Plc.
  • Sandoz International GmbH
  • BioTech Pharmacal
  • Fuji Pharma Co., Ltd.
  • Lupin Limited
  • Geneo Pharma
  • Fidia Farmaceutici SpA
Product Code: SMRC29813

According to Stratistics MRC, the Global Follicle stimulating Hormone Market is accounted for $2.6 billion in 2025 and is expected to reach $3.9 billion by 2032 growing at a CAGR of 6% during the forecast period. Follicle Stimulating Hormone (FSH) is a glycoprotein hormone produced by the anterior pituitary gland. It plays a crucial role in reproductive health by regulating the growth, development, and function of the ovaries in females and the testes in males. In women, it stimulates ovarian follicle maturation; in men, it promotes spermatogenesis. FSH levels are often measured to assess fertility, menstrual irregularities, or pituitary function.

According to the World Health Organization (WHO) data updated in April 2023, approximately 1 in 6 adults globally are affected by infertility.

Market Dynamics:

Driver:

Growing awareness and acceptance of fertility treatments

Increasing infertility rates globally, coupled with enhanced knowledge about advanced reproductive technologies such as IVF, have led to a rising demand for effective fertility solutions. Additionally, expanding healthcare infrastructure, including fertility clinics and specialized centers, supports greater accessibility to FSH therapies. This awareness encourages more patients to seek treatment, driving market growth. Furthermore, technological advancements in FSH production and delivery methods improve treatment outcomes, reinforcing market expansion.

Restraint:

Adverse effects and safety concerns

Adverse effects and safety concerns related to FSH treatments pose challenges to market growth. Some patients experience side effects such as ovarian hyperstimulation syndrome (OHSS), allergic reactions, or hormonal imbalances, which can deter treatment adoption. Moreover, the high cost of fertility treatments, including FSH therapies, restricts access, especially in low-income regions lacking insurance coverage. These safety and financial concerns limit patient willingness and ability to pursue FSH-based fertility interventions, thereby restraining overall market expansion.

Opportunity:

Product innovation and biosimilars

Recombinant FSH products, developed through advanced recombinant DNA technology, provide higher purity and consistency compared to urinary-derived hormones, enhancing efficacy and safety. The emergence of biosimilars can reduce treatment costs, making fertility care more affordable and accessible to a broader population. Additionally, innovations in drug delivery systems, such as pre-filled syringes and pen injectors, improve patient convenience and compliance, further stimulating market growth.

Threat:

Ethical and religious concerns

Ethical and religious concerns present significant threats to the FSH market. Assisted reproductive technologies (ART), including the use of FSH, often face scrutiny related to embryo manipulation, storage, and genetic testing, raising moral and cultural debates. These concerns can influence public perception and lead to restrictive regulatory policies in certain regions, limiting market penetration.

Covid-19 Impact:

The COVID-19 pandemic disrupted the FSH market primarily through the suspension of non-urgent fertility treatments, including IVF, causing delays averaging nearly two months in many countries. Travel restrictions also limited patient access to fertility clinics, especially for medical tourism. Psychological stress during the pandemic further affected fertility outcomes. Additionally, supply chain interruptions delayed medication availability. However, clinics adapted by implementing safety protocols and offering remote counseling, leading to a gradual recovery in demand as restrictions eased and treatments resumed.

The recombinant FSH segment is expected to be the largest during the forecast period

The recombinant FSH segment is expected to account for the largest market share during the forecast period due to its superior purity, consistency, and bioactivity, achieved through recombinant DNA technology in genetically engineered cell lines. This method minimizes impurities found in urinary-derived FSH, enhancing safety and treatment efficacy. The segment's growth is further supported by increasing adoption of assisted reproductive technologies and infertility treatments worldwide. Moreover, ongoing research and development efforts continue to improve recombinant FSH formulations, solidifying its position as the preferred choice in fertility therapies and contributing to its largest market share.

The injectable segment is expected to have the highest CAGR during the forecast period

Over the forecast period, the injectable segment is predicted to witness the highest growth rate, driven by their widespread use in fertility treatments such as ovarian stimulation. Injectables provide precise dosing and rapid bioavailability, which are critical for effective therapy. Additionally, advancements in injection devices, including pen injectors and pre-filled syringes, enhance patient convenience and compliance. The growing preference for injectable forms over other delivery methods, combined with rising infertility rates and expanding ART adoption, fuels this segment's rapid market growth.

Region with largest share:

During the forecast period, the North America region is expected to hold the largest market share owing to its advanced healthcare infrastructure, high awareness of infertility and fertility treatments, and favorable reimbursement policies for assisted reproductive technologies. The region benefits from significant investments in biotechnology and pharmaceutical research, resulting in early adoption of innovative FSH therapies. Moreover, a high prevalence of infertility, coupled with a growing number of fertility clinics and specialized centers, drives robust demand.

Region with highest CAGR:

Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR due to increasing infertility rates, rising disposable incomes, and expanding healthcare infrastructure. Growing awareness and acceptance of fertility treatments, along with government initiatives to improve reproductive health, contribute to rising demand. The region's expanding middle class and improvements in assisted reproductive technologies further accelerate market adoption.

Key players in the market

Some of the key players in Follicle stimulating Hormone Market include Ferring Pharmaceuticals, Merck KGaA, Pfizer Inc., Teva Pharmaceutical Industries Ltd., Allergan plc, Ipsen Pharma, LG Chem Ltd., Asarina Pharma, Intas Pharmaceuticals Ltd., Bharat Serums and Vaccines Ltd., Sun Pharmaceutical Industries Ltd., Gedeon Richter Plc., Sandoz International GmbH, BioTech Pharmacal, Fuji Pharma Co., Ltd., Lupin Limited, Geneo Pharma, and Fidia Farmaceutici S.p.A.

Key Developments:

In May 2024, The National Medical Products Administration (NMPA) in China approved Rekovelle(R), with a commercial launch planned for 2025.

In January 2020, Merck announced that the European Commission had granted Marketing Authorization for a new GONAL-f(R) (follitropin alfa) 150 IU pen. GONAL-f(R) is a recombinant human follicle-stimulating hormone (r-hFSH) used to treat anovulation and to stimulate the development of multiple follicles in women undergoing assisted reproductive technologies (ART).

Product Types Covered:

  • Recombinant FSH
  • Urinary FSH (uFSH)

Route of Administrations Covered:

  • Injectable
  • Other Routes

Distribution Channels Covered:

  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
  • Specialty Drug Stores

Applications Covered:

  • Assisted Reproductive Technology (ART)
  • Hypogonadism
  • Ovulation Induction
  • Other Applications

End Users Covered:

  • Hospitals
  • Fertility Clinics/Infertility Centers
  • Research Institutes & Academic Centers
  • Other End Users

Regions Covered:

  • North America
    • US
    • Canada
    • Mexico
  • Europe
    • Germany
    • UK
    • Italy
    • France
    • Spain
    • Rest of Europe
  • Asia Pacific
    • Japan
    • China
    • India
    • Australia
    • New Zealand
    • South Korea
    • Rest of Asia Pacific
  • South America
    • Argentina
    • Brazil
    • Chile
    • Rest of South America
  • Middle East & Africa
    • Saudi Arabia
    • UAE
    • Qatar
    • South Africa
    • Rest of Middle East & Africa

What our report offers:

  • Market share assessments for the regional and country-level segments
  • Strategic recommendations for the new entrants
  • Covers Market data for the years 2024, 2025, 2026, 2028, and 2032
  • Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
  • Strategic recommendations in key business segments based on the market estimations
  • Competitive landscaping mapping the key common trends
  • Company profiling with detailed strategies, financials, and recent developments
  • Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

  • Company Profiling
    • Comprehensive profiling of additional market players (up to 3)
    • SWOT Analysis of key players (up to 3)
  • Regional Segmentation
    • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
  • Competitive Benchmarking
    • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

  • 2.1 Abstract
  • 2.2 Stake Holders
  • 2.3 Research Scope
  • 2.4 Research Methodology
    • 2.4.1 Data Mining
    • 2.4.2 Data Analysis
    • 2.4.3 Data Validation
    • 2.4.4 Research Approach
  • 2.5 Research Sources
    • 2.5.1 Primary Research Sources
    • 2.5.2 Secondary Research Sources
    • 2.5.3 Assumptions

3 Market Trend Analysis

  • 3.1 Introduction
  • 3.2 Drivers
  • 3.3 Restraints
  • 3.4 Opportunities
  • 3.5 Threats
  • 3.6 Product Analysis
  • 3.7 Application Analysis
  • 3.8 End User Analysis
  • 3.9 Emerging Markets
  • 3.10 Impact of Covid-19

4 Porters Five Force Analysis

  • 4.1 Bargaining power of suppliers
  • 4.2 Bargaining power of buyers
  • 4.3 Threat of substitutes
  • 4.4 Threat of new entrants
  • 4.5 Competitive rivalry

5 Global Follicle stimulating Hormone Market, By Product Type

  • 5.1 Introduction
  • 5.2 Recombinant FSH
    • 5.2.1 Pure Recombinant FSH
    • 5.2.2 Mixed Recombinant FSH Formulations
  • 5.3 Urinary FSH (uFSH)

6 Global Follicle stimulating Hormone Market, By Route of Administration

  • 6.1 Introduction
  • 6.2 Injectable
  • 6.3 Other Routes

7 Global Follicle stimulating Hormone Market, By Distribution Channel

  • 7.1 Introduction
  • 7.2 Hospital Pharmacies
  • 7.3 Retail Pharmacies
  • 7.4 Online Pharmacies
  • 7.5 Specialty Drug Stores

8 Global Follicle stimulating Hormone Market, By Application

  • 8.1 Introduction
  • 8.2 Assisted Reproductive Technology (ART)
    • 8.2.1 In Vitro Fertilization (IVF)
    • 8.2.2 Intracytoplasmic Sperm Injection (ICSI)
  • 8.3 Hypogonadism
  • 8.4 Ovulation Induction
  • 8.5 Other Applications

9 Global Follicle stimulating Hormone Market, By End User

  • 9.1 Introduction
  • 9.2 Hospitals
  • 9.3 Fertility Clinics/Infertility Centers
  • 9.4 Research Institutes & Academic Centers
  • 9.5 Other End Users

10 Global Follicle stimulating Hormone Market, By Geography

  • 10.1 Introduction
  • 10.2 North America
    • 10.2.1 US
    • 10.2.2 Canada
    • 10.2.3 Mexico
  • 10.3 Europe
    • 10.3.1 Germany
    • 10.3.2 UK
    • 10.3.3 Italy
    • 10.3.4 France
    • 10.3.5 Spain
    • 10.3.6 Rest of Europe
  • 10.4 Asia Pacific
    • 10.4.1 Japan
    • 10.4.2 China
    • 10.4.3 India
    • 10.4.4 Australia
    • 10.4.5 New Zealand
    • 10.4.6 South Korea
    • 10.4.7 Rest of Asia Pacific
  • 10.5 South America
    • 10.5.1 Argentina
    • 10.5.2 Brazil
    • 10.5.3 Chile
    • 10.5.4 Rest of South America
  • 10.6 Middle East & Africa
    • 10.6.1 Saudi Arabia
    • 10.6.2 UAE
    • 10.6.3 Qatar
    • 10.6.4 South Africa
    • 10.6.5 Rest of Middle East & Africa

11 Key Developments

  • 11.1 Agreements, Partnerships, Collaborations and Joint Ventures
  • 11.2 Acquisitions & Mergers
  • 11.3 New Product Launch
  • 11.4 Expansions
  • 11.5 Other Key Strategies

12 Company Profiling

  • 12.1 Ferring Pharmaceuticals
  • 12.2 Merck KGaA
  • 12.3 Pfizer Inc.
  • 12.4 Teva Pharmaceutical Industries Ltd.
  • 12.5 Allergan plc
  • 12.6 Ipsen Pharma
  • 12.7 LG Chem Ltd.
  • 12.8 Asarina Pharma
  • 12.9 Intas Pharmaceuticals Ltd.
  • 12.10 Bharat Serums and Vaccines Ltd.
  • 12.11 Sun Pharmaceutical Industries Ltd.
  • 12.12 Gedeon Richter Plc.
  • 12.13 Sandoz International GmbH
  • 12.14 BioTech Pharmacal
  • 12.15 Fuji Pharma Co., Ltd.
  • 12.16 Lupin Limited
  • 12.17 Geneo Pharma
  • 12.18 Fidia Farmaceutici S.p.A.

List of Tables

  • Table 1 Global Follicle stimulating Hormone Market Outlook, By Region (2024-2032) ($MN)
  • Table 2 Global Follicle stimulating Hormone Market Outlook, By Product Type (2024-2032) ($MN)
  • Table 3 Global Follicle stimulating Hormone Market Outlook, By Recombinant FSH (2024-2032) ($MN)
  • Table 4 Global Follicle stimulating Hormone Market Outlook, By Pure Recombinant FSH (2024-2032) ($MN)
  • Table 5 Global Follicle stimulating Hormone Market Outlook, By Mixed Recombinant FSH Formulations (2024-2032) ($MN)
  • Table 6 Global Follicle stimulating Hormone Market Outlook, By Urinary FSH (uFSH) (2024-2032) ($MN)
  • Table 7 Global Follicle stimulating Hormone Market Outlook, By Route of Administration (2024-2032) ($MN)
  • Table 8 Global Follicle stimulating Hormone Market Outlook, By Injectable (2024-2032) ($MN)
  • Table 9 Global Follicle stimulating Hormone Market Outlook, By Other Routes (2024-2032) ($MN)
  • Table 10 Global Follicle stimulating Hormone Market Outlook, By Distribution Channel (2024-2032) ($MN)
  • Table 11 Global Follicle stimulating Hormone Market Outlook, By Hospital Pharmacies (2024-2032) ($MN)
  • Table 12 Global Follicle stimulating Hormone Market Outlook, By Retail Pharmacies (2024-2032) ($MN)
  • Table 13 Global Follicle stimulating Hormone Market Outlook, By Online Pharmacies (2024-2032) ($MN)
  • Table 14 Global Follicle stimulating Hormone Market Outlook, By Specialty Drug Stores (2024-2032) ($MN)
  • Table 15 Global Follicle stimulating Hormone Market Outlook, By Application (2024-2032) ($MN)
  • Table 16 Global Follicle stimulating Hormone Market Outlook, By Assisted Reproductive Technology (ART) (2024-2032) ($MN)
  • Table 17 Global Follicle stimulating Hormone Market Outlook, By In Vitro Fertilization (IVF) (2024-2032) ($MN)
  • Table 18 Global Follicle stimulating Hormone Market Outlook, By Intracytoplasmic Sperm Injection (ICSI) (2024-2032) ($MN)
  • Table 19 Global Follicle stimulating Hormone Market Outlook, By Hypogonadism (2024-2032) ($MN)
  • Table 20 Global Follicle stimulating Hormone Market Outlook, By Ovulation Induction (2024-2032) ($MN)
  • Table 21 Global Follicle stimulating Hormone Market Outlook, By Other Applications (2024-2032) ($MN)
  • Table 22 Global Follicle stimulating Hormone Market Outlook, By End User (2024-2032) ($MN)
  • Table 23 Global Follicle stimulating Hormone Market Outlook, By Hospitals (2024-2032) ($MN)
  • Table 24 Global Follicle stimulating Hormone Market Outlook, By Fertility Clinics/Infertility Centers (2024-2032) ($MN)
  • Table 25 Global Follicle stimulating Hormone Market Outlook, By Research Institutes & Academic Centers (2024-2032) ($MN)
  • Table 26 Global Follicle stimulating Hormone Market Outlook, By Other End Users (2024-2032) ($MN)

Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.