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市场调查报告书
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1881995

羟孕酮己酸酯注射液市场报告：趋势、预测及竞争分析（至2031年）

Hydroxyprogesterone Caproate Injection Market Report: Trends, Forecast and Competitive Analysis to 2031
出版日期: | 出版商: Lucintel | 英文 150 Pages | 商品交期: 3个工作天内

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受早产预防和荷尔蒙补充疗法市场机会的推动，全球己酸羟孕酮注射市场预计将呈现成长态势。预计2025年至2031年，全球己酸羟孕酮注射市场将以6.2%的复合年增长率成长。该市场的主要驱动因素包括早产病例数的增加、孕产妇保健疗法需求的增长以及对产前护理解决方案日益增长的关注。

  • 根据 Lucintel 的预测，多剂量管瓶在预测期内有望呈现更高的成长率。
  • 从应用领域来看，预防早产领域预计将呈现更高的成长率。
  • 从地区来看，预计北美在预测期内将出现最高的成长率。

羟孕酮己酸酯注射剂市场的新趋势

由于对其临床疗效的重新评估，羟孕酮己酸酯注射液市场目前正经历着巨大的不确定性和萎缩期。新兴趋势并非着眼于成长，而是致力于彻底摆脱对该药物的依赖，这凸显了人们对预防早产的替代和更有效干预措施的渴望。

  • 转向替代孕激素：最显着的趋势是从羟孕酮己酸酯转向替代孕激素，尤其是天然黄体素。鑑于近期临床疗效和良好安全性方面的更多证据，医疗保健提供者越来越多地将阴道或口服黄体素作为替代方案，这正在改变市场格局。
  • 对黄体素研究的关注度提高：对己酸羟孕酮的监管措施推动了对孕酮在怀孕中作用的研究不断深入。科学家目前致力于阐明孕酮的作用机转和最佳给药方法，以期找到真正有效且安全的早产治疗方法。
  • 个人化医疗的进展：预防早产的一个新兴趋势是转型为个人化医疗。与采用「一刀切」的方法不同，个人化医疗越来越重视识别个别患者的风险因素，例如子宫颈长度，从而能够进行更有针对性、更有效的干预，而不仅仅依赖单一药物。
  • 临床试验资料的重新评估：一个重要的趋势是对以往临床试验资料的重新评估。羟孕酮己酸酯疗效试验的失败凸显了产科领域需要进行更严谨、设计更完善的研究，这也提高了未来药物核准和医学证据的标准。
  • 更重视非药物疗法：羟孕酮己酸酯的挑战促使人们重新关注非药物疗法，包括生活方式调整、改善孕产妇营养和综合护理模式。这种转变强调综合办法关注孕产妇健康和福祉。

羟孕酮己酸酯市场的新趋势是萎缩而非成长。监管措施和科学研究结果凸显了其无效性和潜在风险，正在重塑市场格局，促使人们转向更安全、更有效的替代方案，并开启了孕产妇健康研究的新时代。

羟孕酮己酸酯注射剂市场的最新趋势

羟孕酮己酸酯注射剂市场近期经历了显着变化，主要原因是监管机构采取的行动对该药物的长期使用提出了质疑。这些变化导致该药物从主要市场撤出，并迫使人们重新评估预防早产的治疗策略。

  • 美国FDA撤销Makena的核准：美国食品药物管理局（FDA）做出了一项具有里程碑意义的决定，并将于2023年撤销对Makena（商品名：己酸羟孕酮注射）的核准。先前，验证性试验未能证明其临床疗效，因此该药物实际上已从美国市场撤出。
  • 欧洲药品管理局 (EMA)建议暂停该药物在欧盟的上市核准：与此同时，欧洲药品管理局 (EMA)建议暂停该药物在欧盟的上市许可，理由是该药物在预防早产方面疗效不佳，并且可能（未经证实但令人担忧）会增加后代患癌的风险。此举与美国食品药物管理局 (FDA) 的立场一致，并已导致该药物退出欧洲市场。
  • 对现有数据的严格检验：这些监管措施促使全球重新评估支持使用该药物的临床数据，从而加强了对先前研究的检验，揭示了不一致的结果和阳性结果缺乏可重复性，削弱了人们对该药物疗效的信心。
  • 专注于复方製剂：随着品牌药的撤市，人们的注意力转向了羟孕酮己酸酯的复方製剂。儘管这些製剂尚未获得FDA核准，但一些医疗专业人员仍在继续使用，这形成了一个利基市场，也表明儘管存在监管方面的担忧，但该药物的需求仍然存在。
  • 非专利药替代的成长：在此之前，由于Makena非专利药的推出，市场竞争加剧，价格下降，但当FDA撤销了该品牌药的核准时，也撤销了这些非专利的核准，有效地阻止了这种成长趋势。

羟孕酮己酸酯注射剂市场近期发展趋势整体不利，主要全球市场纷纷撤离。这些事态发展正迫使早产预防治疗模式发生根本性转变，并促使医学界探索并检验更有效、更安全的替代疗法。

目录

第一章执行摘要

第二章 市场概览

  • 背景和分类
  • 供应链

第三章：市场趋势与预测分析

  • 产业驱动因素与挑战
  • PESTLE分析
  • 专利分析
  • 法规环境

4. 全球羟孕酮己酸酯注射液市场（依产品类型划分）

  • 吸引力分析：依产品类型
  • 单剂量管瓶
  • 多剂量管瓶

5. 全球羟孕酮己酸酯注射液市场（依通路划分）

  • 吸引力分析：按分销管道划分
  • 医院药房
  • 零售药房
  • 网路药房

6. 全球羟孕酮己酸酯注射液市场（依应用划分）

  • 吸引力分析：依目的
  • 预防早产
  • 荷尔蒙补充疗法
  • 其他的

第七章 区域分析

8. 北美羟孕酮己酸酯注射液市场

  • 北美羟孕酮己酸酯注射液市场（按类型划分）
  • 北美羟孕酮己酸酯注射液市场（按应用领域划分）
  • 美国羟孕酮己酸酯注射液市场
  • 墨西哥羟孕酮己酸酯注射液市场
  • 加拿大羟孕酮己酸酯注射液市场

9. 欧洲羟孕酮己酸酯注射液市场

  • 欧洲羟孕酮己酸酯注射液市场（按类型划分）
  • 欧洲羟孕酮己酸酯注射液市场按应用领域划分
  • 德国羟孕酮己酸酯注射液市场
  • 法国羟孕酮己酸酯注射液市场
  • 西班牙羟孕酮己酸酯注射液市场
  • 义大利羟孕酮己酸酯注射液市场
  • 英国羟孕酮己酸酯注射液市场

10. 亚太地区羟孕酮己酸酯注射液市场

  • 亚太地区羟孕酮己酸酯注射液市场（按类型划分）
  • 亚太地区羟孕酮己酸酯注射液市场（按应用划分）
  • 日本羟孕酮己酸酯注射液市场
  • 印度羟孕酮己酸酯注射液市场
  • 中国羟孕酮己酸酯注射液市场
  • 韩国羟孕酮己酸酯注射液市场
  • 印尼羟孕酮己酸酯注射液市场

11. 世界其他地区（ROW）羟孕酮己酸酯注射液市场

  • ROW羟孕酮己酸酯注射液市场按类型划分
  • 按应用领域分類的羟孕酮己酸酯注射液市场
  • 中东羟孕酮己酸酯注射液市场
  • 南美洲羟孕酮己酸酯注射液市场
  • 非洲羟孕酮己酸酯注射剂市场

第十二章 竞争分析

  • 产品系列分析
  • 营运整合
  • 波特五力分析
  • 市占率分析

第十三章：机会与策略分析

  • 价值链分析
  • 成长机会分析
  • 全球羟孕酮己酸酯注射液市场新兴趋势
  • 战略分析

第十四章 价值链中主要企业的概况

  • 竞争分析
  • AMAG Pharmaceuticals
  • McGuff Pharmaceuticals
  • Aspen Oss
  • American Regent
  • Bayer
  • Teva Pharmaceutical Industries
  • Mylan
  • Pfizer
  • Sanofi
  • Merck & Co.

第十五章附录

The future of the global hydroxyprogesterone caproate injection market looks promising with opportunities in the preterm birth prevention and hormone replacement therapy markets. The global hydroxyprogesterone caproate injection market is expected to grow with a CAGR of 6.2% from 2025 to 2031. The major drivers for this market are the increasing number of preterm birth cases, the rising demand for maternal health therapies, and the growing focus on prenatal care solutions.

  • Lucintel forecasts that, within the product type category, multi-dose vial is expected to witness higher growth over the forecast period.
  • Within the application category, preterm birth prevention is expected to witness higher growth.
  • In terms of region, North America is expected to witness the highest growth over the forecast period.

Emerging Trends in the Hydroxyprogesterone Caproate Injection Market

The hydroxyprogesterone caproate injection market is currently experiencing a period of significant uncertainty and contraction due to a re-evaluation of its clinical efficacy. Emerging trends are not focused on growth but rather on a fundamental shift away from this drug, highlighting a search for alternative and more effective interventions for preterm birth prevention.

  • Shift to Alternative Progestogens: The most significant trend is the shift away from hydroxyprogesterone caproate and toward alternative progestogens, particularly natural progesterone. Healthcare providers are increasingly prescribing vaginal or oral progesterone as a substitute, backed by more recent clinical evidence of efficacy and a better safety profile, thereby transforming the market.
  • Increased Focus on Progesterone Research: The regulatory actions against hydroxyprogesterone caproate have fueled a trend toward increased research into progesterone's role in pregnancy. Scientists are now focusing on understanding the mechanisms of action and optimal delivery methods of progesterone to find a truly effective and safe treatment for preterm birth.
  • Growth in Personalized Medicine: An emerging trend is the move toward personalized medicine in preterm birth prevention. Instead of a one-size-fits-all approach, a growing focus on identifying individual patient risk factors, such as cervical length, is leading to more targeted and effective interventions that move beyond a reliance on a single drug.
  • Re-evaluation of Clinical Trial Data: A key trend is the re-evaluation of historical clinical trial data. The failure of a confirmatory trial to prove the efficacy of hydroxyprogesterone caproate has highlighted the need for more rigorous, well-designed studies in obstetrics. This is raising the bar for future drug approvals and the standards of medical evidence.
  • Focus on Non-Pharmacological Interventions: The challenges facing hydroxyprogesterone caproate are driving a trend toward a renewed focus on non-pharmacological interventions. This includes lifestyle changes, improved maternal nutrition, and integrated care models. This shift emphasizes a holistic approach to maternal health and well-being.

The emerging trends in the hydroxyprogesterone caproate market are not trends of growth, but rather of dissolution. The market is being reshaped by regulatory actions and scientific findings that have highlighted its inefficacy and potential risks, leading to a fundamental shift toward safer and more effective alternatives and a new era of research in maternal health.

Recent Developments in the Hydroxyprogesterone Caproate Injection Market

The hydroxyprogesterone caproate injection market has experienced profound recent developments, largely defined by regulatory actions that have challenged the drug's long-standing use. These developments have led to the withdrawal of the drug from key markets, compelling a re-evaluation of treatment strategies for preventing preterm birth.

  • FDA Withdrawal of Makena: A landmark development was the U.S. FDA's decision to withdraw the approval of Makena, the branded hydroxyprogesterone caproate injection, in 2023. This action followed a confirmatory trial that failed to show a clinical benefit. This development has effectively eliminated the drug from the U.S. market.
  • European EMA Suspension: In a parallel development, the European Medicines Agency (EMA) recommended the suspension of the drug's marketing authorizations across the EU. Citing a lack of efficacy in preventing preterm birth and an unconfirmed but possible risk of cancer in offspring, this action mirrors the FDA's stance and is leading to its withdrawal from European markets.
  • Heightened Scrutiny of Existing Data: These regulatory actions have prompted a global re-evaluation of the clinical data supporting the drug's use. This has created a heightened level of scrutiny on historical studies, revealing inconsistencies and a failure to replicate positive results, which has eroded confidence in the drug's effectiveness.
  • Focus on Compounded Alternatives: In response to the withdrawal of the branded product, a development has been the increased focus on compounded versions of hydroxyprogesterone caproate. While these formulations are not FDA-approved, some practitioners have continued to use them, creating a niche market and highlighting a continued demand for the drug despite regulatory findings.
  • Growth of Generic Alternatives: The market had previously seen a development with the introduction of generic versions of Makena, which increased competition and lowered prices. However, with the FDA's withdrawal of approval for the branded drug, these generic approvals were also rescinded, effectively halting this growth trajectory.

The recent developments in the hydroxyprogesterone caproate injection market have been overwhelmingly negative, centered on its withdrawal from major global markets. These developments are forcing a fundamental change in the treatment paradigm for preterm birth prevention, pushing the medical community to seek out and validate more effective and safer alternatives.

Strategic Growth Opportunities in the Hydroxyprogesterone Caproate Injection Market

Given the significant regulatory setbacks, strategic growth opportunities in the hydroxyprogesterone caproate injection market are limited and highly challenging. Any opportunities that exist are not in expansion but rather in a re-evaluation of its niche applications and a potential re-entry to the market with new, verifiable evidence.

  • Re-evaluation in Niche Indications: A strategic opportunity could involve a re-evaluation of hydroxyprogesterone caproate's use in highly specific, niche indications where it may still show some efficacy. This could involve small, targeted clinical trials to validate its use in specific patient subgroups or for other gynecological conditions beyond preterm birth prevention.
  • Development of New Formulations: A potential growth opportunity could be the development of a new formulation or delivery system with a better safety profile and proven efficacy. This would require a significant investment in R&D and a new clinical trial program to meet stringent regulatory requirements, offering a pathway for a product to re-enter the market.
  • Focus on Emerging Markets: While major markets are withdrawing the drug, a strategic opportunity might exist in emerging markets where regulatory standards and access to alternatives may differ. Companies could focus on gaining approvals in these regions, provided they can demonstrate a favorable risk-benefit profile to local authorities.
  • Partnerships for Re-research: Another opportunity lies in forming strategic partnerships with academic institutions and research organizations to conduct new, large-scale, well-designed clinical trials. This is crucial for gathering the robust evidence needed to either re-establish the drug's efficacy or definitively prove its lack thereof.
  • Market for Compounded Formulations: While highly controversial, a growth opportunity currently exists in the compounded pharmacy market. Companies could strategically focus on providing high-quality active pharmaceutical ingredients (APIs) to compounding pharmacies, catering to the remaining demand for this product in the absence of a branded version.

The strategic growth opportunities in the hydroxyprogesterone caproate market are not for business as usual. They are high-risk, high-investment endeavors focused on rebuilding a market that has been largely dismantled by regulatory bodies. Any future success would require a complete paradigm shift and the generation of new, compelling clinical evidence.

Hydroxyprogesterone Caproate Injection Market Driver and Challenges

The hydroxyprogesterone caproate injection market is characterized by a unique set of drivers and challenges. The market's previous growth was driven by a high demand for preterm birth prevention and initial clinical findings. However, its recent decline is overwhelmingly influenced by new, contradictory evidence and stringent regulatory actions.

The factors responsible for driving the hydroxyprogesterone caproate injection market include:

1. High Preterm Birth Rates: The primary historical driver was the high global incidence of preterm birth, a leading cause of infant morbidity and mortality. This created a significant and urgent medical need for an effective prophylactic treatment, which hydroxyprogesterone caproate was initially believed to be.

2. Initial Favorable Clinical Data: The market was initially driven by the positive results from a 2003 clinical trial (Meis Trial) that suggested the drug was effective in preventing recurrent preterm birth. This trial provided the foundation for the drug's initial accelerated approval and widespread adoption.

3. Orphan Drug Designation: The drug's orphan drug status in the U.S. provided significant market exclusivity and incentives for its development. This protected the branded product from immediate generic competition and drove investment, allowing it to become a major player in maternal health.

4. Perceived Lack of Alternatives: For a period, hydroxyprogesterone caproate was viewed as the only FDA-approved treatment for its specific indication, which was a strong market driver. The perceived lack of effective alternatives for high-risk women fueled its widespread use.

5. Physician Recommendation: The endorsement by major medical societies and organizations, based on the initial clinical data, was a significant driver. This helped solidify its position as a standard of care and encouraged obstetricians to prescribe the drug to eligible patients.

Challenges in the hydroxyprogesterone caproate injection market are:

1. Failure to Confirm Efficacy: The most significant challenge is the failure of a large, confirmatory clinical trial (PROLONG study) to prove the drug's efficacy. This finding directly contradicted the initial data, leading to a loss of confidence and the ultimate withdrawal of the product.

2. Regulatory Actions and Withdrawal: The U.S. FDA's and European EMA's decisions to withdraw or suspend the drug's marketing authorizations are insurmountable challenges. These regulatory actions are effectively eliminating the product from major global markets, making it difficult for it to be prescribed or sold.

3. Potential Safety Concerns: The unconfirmed but possible link to an increased risk of cancer in offspring exposed to the drug in utero is a major challenge. This safety concern, cited by the EMA, further undermines its benefit-risk profile and makes its use highly controversial.

The hydroxyprogesterone caproate market's trajectory has been a cautionary tale. While once driven by a clear medical need and promising initial data, it has been decimated by the failure to confirm its efficacy and the subsequent regulatory actions. The challenges are now far greater than the initial drivers, making the market's future highly uncertain.

List of Hydroxyprogesterone Caproate Injection Companies

Companies in the market compete on the basis of product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leverage integration opportunities across the value chain. With these strategies hydroxyprogesterone caproate injection companies cater increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the hydroxyprogesterone caproate injection companies profiled in this report include-

  • AMAG Pharmaceuticals
  • McGuff Pharmaceuticals
  • Aspen Oss
  • American Regent
  • Bayer
  • Teva Pharmaceutical Industries
  • Mylan
  • Pfizer
  • Sanofi
  • Merck & Co.

Hydroxyprogesterone Caproate Injection Market by Segment

The study includes a forecast for the global hydroxyprogesterone caproate injection market by product type, distribution channel, application, and region.

Hydroxyprogesterone Caproate Injection Market by Product Type [Value from 2019 to 2031]:

  • Single-Dose Vials
  • Multi-Dose Vials

Hydroxyprogesterone Caproate Injection Market by Distribution Channel [Value from 2019 to 2031]:

  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies

Hydroxyprogesterone Caproate Injection Market by Application [Value from 2019 to 2031]:

  • Preterm Birth Prevention
  • Hormone Replacement Therapy
  • Others

Country Wise Outlook for the Hydroxyprogesterone Caproate Injection Market

The hydroxyprogesterone caproate injection market is facing significant global challenges and a period of re-evaluation. Recent developments are primarily centered around regulatory actions and a re-assessment of the drug's efficacy and safety profile. These shifts are challenging its long-standing position as a primary therapy for preventing preterm birth.

  • United States: The U.S. market has undergone a dramatic change. Following a review that failed to confirm its clinical benefit, the FDA withdrew its approval for the branded drug Makena and its generics in 2023. This has led to the complete removal of the product from the market, fundamentally reshaping the landscape for preterm birth prevention.
  • China: The market in China is at an early stage, with limited data available on the use of hydroxyprogesterone caproate injections. While preterm birth prevention is a medical priority, the market is not as developed as in other regions. There is a need for further research and clinical data to establish the drug's role in the country's healthcare system.
  • Germany: In Germany, and across the EU, the European Medicines Agency (EMA) has recommended the suspension of marketing authorizations for hydroxyprogesterone caproate-containing medicines. This decision, based on a lack of efficacy and a possible but unconfirmed cancer risk in offspring, is prompting a withdrawal of the drug from the market.
  • India: The Indian market is currently small and not a primary focus for this treatment. However, as preterm birth rates are a significant public health issue, there is a potential for future growth. The market is driven by increasing awareness and improving healthcare infrastructure, but the drug's recent regulatory setbacks may impact its future in India.
  • Japan: Japan's market is characterized by a cautious approach to new and existing drugs. The use of hydroxyprogesterone caproate injections is limited. The drug's recent regulatory setbacks in the U.S. and Europe are likely to influence Japan's regulatory bodies and medical community, leading to a potential re-evaluation of its use.

Features of the Global Hydroxyprogesterone Caproate Injection Market

  • Market Size Estimates: Hydroxyprogesterone caproate injection market size estimation in terms of value ($B).
  • Trend and Forecast Analysis: Market trends (2019 to 2024) and forecast (2025 to 2031) by various segments and regions.
  • Segmentation Analysis: Hydroxyprogesterone caproate injection market size by product type, distribution channel, application, and region in terms of value ($B).
  • Regional Analysis: Hydroxyprogesterone caproate injection market breakdown by North America, Europe, Asia Pacific, and Rest of the World.
  • Growth Opportunities: Analysis of growth opportunities in different product types, distribution channels, applications, and regions for the hydroxyprogesterone caproate injection market.
  • Strategic Analysis: This includes M&A, new product development, and competitive landscape of the hydroxyprogesterone caproate injection market.

Analysis of competitive intensity of the industry based on Porter's Five Forces model.

This report answers following 11 key questions:

  • Q.1. What are some of the most promising, high-growth opportunities for the hydroxyprogesterone caproate injection market by product type (single-dose vials and multi-dose vials), distribution channel (hospital pharmacies, retail pharmacies, and online pharmacies), application (preterm birth prevention, hormone replacement therapy, and others), and region (North America, Europe, Asia Pacific, and the Rest of the World)?
  • Q.2. Which segments will grow at a faster pace and why?
  • Q.3. Which region will grow at a faster pace and why?
  • Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?
  • Q.5. What are the business risks and competitive threats in this market?
  • Q.6. What are the emerging trends in this market and the reasons behind them?
  • Q.7. What are some of the changing demands of customers in the market?
  • Q.8. What are the new developments in the market? Which companies are leading these developments?
  • Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?
  • Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or product substitution?
  • Q.11. What M&A activity has occurred in the last 5 years and what has its impact been on the industry?

Table of Contents

1. Executive Summary

2. Market Overview

  • 2.1 Background and Classifications
  • 2.2 Supply Chain

3. Market Trends & Forecast Analysis

  • 3.2 Industry Drivers and Challenges
  • 3.3 PESTLE Analysis
  • 3.4 Patent Analysis
  • 3.5 Regulatory Environment

4. Global Hydroxyprogesterone Caproate Injection Market by Product Type

  • 4.1 Overview
  • 4.2 Attractiveness Analysis by Product Type
  • 4.3 Single-Dose Vials: Trends and Forecast (2019-2031)
  • 4.4 Multi-Dose Vials: Trends and Forecast (2019-2031)

5. Global Hydroxyprogesterone Caproate Injection Market by Distribution Channel

  • 5.1 Overview
  • 5.2 Attractiveness Analysis by Distribution Channel
  • 5.3 Hospital Pharmacies: Trends and Forecast (2019-2031)
  • 5.4 Retail Pharmacies: Trends and Forecast (2019-2031)
  • 5.5 Online Pharmacies: Trends and Forecast (2019-2031)

6. Global Hydroxyprogesterone Caproate Injection Market by Application

  • 6.1 Overview
  • 6.2 Attractiveness Analysis by Application
  • 6.3 Preterm Birth Prevention: Trends and Forecast (2019-2031)
  • 6.4 Hormone Replacement Therapy: Trends and Forecast (2019-2031)
  • 6.5 Others: Trends and Forecast (2019-2031)

7. Regional Analysis

  • 7.1 Overview
  • 7.2 Global Hydroxyprogesterone Caproate Injection Market by Region

8. North American Hydroxyprogesterone Caproate Injection Market

  • 8.1 Overview
  • 8.2 North American Hydroxyprogesterone Caproate Injection Market by Product Type
  • 8.3 North American Hydroxyprogesterone Caproate Injection Market by Application
  • 8.4 United States Hydroxyprogesterone Caproate Injection Market
  • 8.5 Mexican Hydroxyprogesterone Caproate Injection Market
  • 8.6 Canadian Hydroxyprogesterone Caproate Injection Market

9. European Hydroxyprogesterone Caproate Injection Market

  • 9.1 Overview
  • 9.2 European Hydroxyprogesterone Caproate Injection Market by Product Type
  • 9.3 European Hydroxyprogesterone Caproate Injection Market by Application
  • 9.4 German Hydroxyprogesterone Caproate Injection Market
  • 9.5 French Hydroxyprogesterone Caproate Injection Market
  • 9.6 Spanish Hydroxyprogesterone Caproate Injection Market
  • 9.7 Italian Hydroxyprogesterone Caproate Injection Market
  • 9.8 United Kingdom Hydroxyprogesterone Caproate Injection Market

10. APAC Hydroxyprogesterone Caproate Injection Market

  • 10.1 Overview
  • 10.2 APAC Hydroxyprogesterone Caproate Injection Market by Product Type
  • 10.3 APAC Hydroxyprogesterone Caproate Injection Market by Application
  • 10.4 Japanese Hydroxyprogesterone Caproate Injection Market
  • 10.5 Indian Hydroxyprogesterone Caproate Injection Market
  • 10.6 Chinese Hydroxyprogesterone Caproate Injection Market
  • 10.7 South Korean Hydroxyprogesterone Caproate Injection Market
  • 10.8 Indonesian Hydroxyprogesterone Caproate Injection Market

11. ROW Hydroxyprogesterone Caproate Injection Market

  • 11.1 Overview
  • 11.2 ROW Hydroxyprogesterone Caproate Injection Market by Product Type
  • 11.3 ROW Hydroxyprogesterone Caproate Injection Market by Application
  • 11.4 Middle Eastern Hydroxyprogesterone Caproate Injection Market
  • 11.5 South American Hydroxyprogesterone Caproate Injection Market
  • 11.6 African Hydroxyprogesterone Caproate Injection Market

12. Competitor Analysis

  • 12.1 Product Portfolio Analysis
  • 12.2 Operational Integration
  • 12.3 Porter's Five Forces Analysis
    • Competitive Rivalry
    • Bargaining Power of Buyers
    • Bargaining Power of Suppliers
    • Threat of Substitutes
    • Threat of New Entrants
  • 12.4 Market Share Analysis

13. Opportunities & Strategic Analysis

  • 13.1 Value Chain Analysis
  • 13.2 Growth Opportunity Analysis
    • 13.2.1 Growth Opportunities by Product Type
    • 13.2.2 Growth Opportunities by Distribution Channel
    • 13.2.3 Growth Opportunities by Application
  • 13.3 Emerging Trends in the Global Hydroxyprogesterone Caproate Injection Market
  • 13.4 Strategic Analysis
    • 13.4.1 New Product Development
    • 13.4.2 Certification and Licensing
    • 13.4.3 Mergers, Acquisitions, Agreements, Collaborations, and Joint Ventures

14. Company Profiles of the Leading Players Across the Value Chain

  • 14.1 Competitive Analysis
  • 14.2 AMAG Pharmaceuticals
    • Company Overview
    • Hydroxyprogesterone Caproate Injection Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 14.3 McGuff Pharmaceuticals
    • Company Overview
    • Hydroxyprogesterone Caproate Injection Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 14.4 Aspen Oss
    • Company Overview
    • Hydroxyprogesterone Caproate Injection Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 14.5 American Regent
    • Company Overview
    • Hydroxyprogesterone Caproate Injection Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 14.6 Bayer
    • Company Overview
    • Hydroxyprogesterone Caproate Injection Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 14.7 Teva Pharmaceutical Industries
    • Company Overview
    • Hydroxyprogesterone Caproate Injection Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 14.8 Mylan
    • Company Overview
    • Hydroxyprogesterone Caproate Injection Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 14.9 Pfizer
    • Company Overview
    • Hydroxyprogesterone Caproate Injection Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 14.10 Sanofi
    • Company Overview
    • Hydroxyprogesterone Caproate Injection Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 14.11 Merck & Co.
    • Company Overview
    • Hydroxyprogesterone Caproate Injection Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing

15. Appendix

  • 15.1 List of Figures
  • 15.2 List of Tables
  • 15.3 Research Methodology
  • 15.4 Disclaimer
  • 15.5 Copyright
  • 15.6 Abbreviations and Technical Units
  • 15.7 About Us
  • 15.8 Contact Us

List of Figures

  • Figure 1.1: Trends and Forecast for the Global Hydroxyprogesterone Caproate Injection Market
  • Figure 2.1: Usage of Hydroxyprogesterone Caproate Injection Market
  • Figure 2.2: Classification of the Global Hydroxyprogesterone Caproate Injection Market
  • Figure 2.3: Supply Chain of the Global Hydroxyprogesterone Caproate Injection Market
  • Figure 3.1: Driver and Challenges of the Hydroxyprogesterone Caproate Injection Market
  • Figure 3.2: PESTLE Analysis
  • Figure 3.3: Patent Analysis
  • Figure 3.4: Regulatory Environment
  • Figure 4.1: Global Hydroxyprogesterone Caproate Injection Market by Product Type in 2019, 2024, and 2031
  • Figure 4.2: Trends of the Global Hydroxyprogesterone Caproate Injection Market ($B) by Product Type
  • Figure 4.3: Forecast for the Global Hydroxyprogesterone Caproate Injection Market ($B) by Product Type
  • Figure 4.4: Trends and Forecast for Single-Dose Vials in the Global Hydroxyprogesterone Caproate Injection Market (2019-2031)
  • Figure 4.5: Trends and Forecast for Multi-Dose Vials in the Global Hydroxyprogesterone Caproate Injection Market (2019-2031)
  • Figure 5.1: Global Hydroxyprogesterone Caproate Injection Market by Distribution Channel in 2019, 2024, and 2031
  • Figure 5.2: Trends of the Global Hydroxyprogesterone Caproate Injection Market ($B) by Distribution Channel
  • Figure 5.3: Forecast for the Global Hydroxyprogesterone Caproate Injection Market ($B) by Distribution Channel
  • Figure 5.4: Trends and Forecast for Hospital Pharmacies in the Global Hydroxyprogesterone Caproate Injection Market (2019-2031)
  • Figure 5.5: Trends and Forecast for Retail Pharmacies in the Global Hydroxyprogesterone Caproate Injection Market (2019-2031)
  • Figure 5.6: Trends and Forecast for Online Pharmacies in the Global Hydroxyprogesterone Caproate Injection Market (2019-2031)
  • Figure 6.1: Global Hydroxyprogesterone Caproate Injection Market by Application in 2019, 2024, and 2031
  • Figure 6.2: Trends of the Global Hydroxyprogesterone Caproate Injection Market ($B) by Application
  • Figure 6.3: Forecast for the Global Hydroxyprogesterone Caproate Injection Market ($B) by Application
  • Figure 6.4: Trends and Forecast for Preterm Birth Prevention in the Global Hydroxyprogesterone Caproate Injection Market (2019-2031)
  • Figure 6.5: Trends and Forecast for Hormone Replacement Therapy in the Global Hydroxyprogesterone Caproate Injection Market (2019-2031)
  • Figure 6.6: Trends and Forecast for Others in the Global Hydroxyprogesterone Caproate Injection Market (2019-2031)
  • Figure 7.1: Trends of the Global Hydroxyprogesterone Caproate Injection Market ($B) by Region (2019-2024)
  • Figure 7.2: Forecast for the Global Hydroxyprogesterone Caproate Injection Market ($B) by Region (2025-2031)
  • Figure 8.1: North American Hydroxyprogesterone Caproate Injection Market by Product Type in 2019, 2024, and 2031
  • Figure 8.2: Trends of the North American Hydroxyprogesterone Caproate Injection Market ($B) by Product Type (2019-2024)
  • Figure 8.3: Forecast for the North American Hydroxyprogesterone Caproate Injection Market ($B) by Product Type (2025-2031)
  • Figure 8.4: North American Hydroxyprogesterone Caproate Injection Market by Application in 2019, 2024, and 2031
  • Figure 8.5: Trends of the North American Hydroxyprogesterone Caproate Injection Market ($B) by Application (2019-2024)
  • Figure 8.6: Forecast for the North American Hydroxyprogesterone Caproate Injection Market ($B) by Application (2025-2031)
  • Figure 8.7: Trends and Forecast for the United States Hydroxyprogesterone Caproate Injection Market ($B) (2019-2031)
  • Figure 8.8: Trends and Forecast for the Mexican Hydroxyprogesterone Caproate Injection Market ($B) (2019-2031)
  • Figure 8.9: Trends and Forecast for the Canadian Hydroxyprogesterone Caproate Injection Market ($B) (2019-2031)
  • Figure 9.1: European Hydroxyprogesterone Caproate Injection Market by Product Type in 2019, 2024, and 2031
  • Figure 9.2: Trends of the European Hydroxyprogesterone Caproate Injection Market ($B) by Product Type (2019-2024)
  • Figure 9.3: Forecast for the European Hydroxyprogesterone Caproate Injection Market ($B) by Product Type (2025-2031)
  • Figure 9.4: European Hydroxyprogesterone Caproate Injection Market by Application in 2019, 2024, and 2031
  • Figure 9.5: Trends of the European Hydroxyprogesterone Caproate Injection Market ($B) by Application (2019-2024)
  • Figure 9.6: Forecast for the European Hydroxyprogesterone Caproate Injection Market ($B) by Application (2025-2031)
  • Figure 9.7: Trends and Forecast for the German Hydroxyprogesterone Caproate Injection Market ($B) (2019-2031)
  • Figure 9.8: Trends and Forecast for the French Hydroxyprogesterone Caproate Injection Market ($B) (2019-2031)
  • Figure 9.9: Trends and Forecast for the Spanish Hydroxyprogesterone Caproate Injection Market ($B) (2019-2031)
  • Figure 9.10: Trends and Forecast for the Italian Hydroxyprogesterone Caproate Injection Market ($B) (2019-2031)
  • Figure 9.11: Trends and Forecast for the United Kingdom Hydroxyprogesterone Caproate Injection Market ($B) (2019-2031)
  • Figure 10.1: APAC Hydroxyprogesterone Caproate Injection Market by Product Type in 2019, 2024, and 2031
  • Figure 10.2: Trends of the APAC Hydroxyprogesterone Caproate Injection Market ($B) by Product Type (2019-2024)
  • Figure 10.3: Forecast for the APAC Hydroxyprogesterone Caproate Injection Market ($B) by Product Type (2025-2031)
  • Figure 10.4: APAC Hydroxyprogesterone Caproate Injection Market by Application in 2019, 2024, and 2031
  • Figure 10.5: Trends of the APAC Hydroxyprogesterone Caproate Injection Market ($B) by Application (2019-2024)
  • Figure 10.6: Forecast for the APAC Hydroxyprogesterone Caproate Injection Market ($B) by Application (2025-2031)
  • Figure 10.7: Trends and Forecast for the Japanese Hydroxyprogesterone Caproate Injection Market ($B) (2019-2031)
  • Figure 10.8: Trends and Forecast for the Indian Hydroxyprogesterone Caproate Injection Market ($B) (2019-2031)
  • Figure 10.9: Trends and Forecast for the Chinese Hydroxyprogesterone Caproate Injection Market ($B) (2019-2031)
  • Figure 10.10: Trends and Forecast for the South Korean Hydroxyprogesterone Caproate Injection Market ($B) (2019-2031)
  • Figure 10.11: Trends and Forecast for the Indonesian Hydroxyprogesterone Caproate Injection Market ($B) (2019-2031)
  • Figure 11.1: ROW Hydroxyprogesterone Caproate Injection Market by Product Type in 2019, 2024, and 2031
  • Figure 11.2: Trends of the ROW Hydroxyprogesterone Caproate Injection Market ($B) by Product Type (2019-2024)
  • Figure 11.3: Forecast for the ROW Hydroxyprogesterone Caproate Injection Market ($B) by Product Type (2025-2031)
  • Figure 11.4: ROW Hydroxyprogesterone Caproate Injection Market by Application in 2019, 2024, and 2031
  • Figure 11.5: Trends of the ROW Hydroxyprogesterone Caproate Injection Market ($B) by Application (2019-2024)
  • Figure 11.6: Forecast for the ROW Hydroxyprogesterone Caproate Injection Market ($B) by Application (2025-2031)
  • Figure 11.7: Trends and Forecast for the Middle Eastern Hydroxyprogesterone Caproate Injection Market ($B) (2019-2031)
  • Figure 11.8: Trends and Forecast for the South American Hydroxyprogesterone Caproate Injection Market ($B) (2019-2031)
  • Figure 11.9: Trends and Forecast for the African Hydroxyprogesterone Caproate Injection Market ($B) (2019-2031)
  • Figure 12.1: Porter's Five Forces Analysis of the Global Hydroxyprogesterone Caproate Injection Market
  • Figure 12.2: Market Share (%) of Top Players in the Global Hydroxyprogesterone Caproate Injection Market (2024)
  • Figure 13.1: Growth Opportunities for the Global Hydroxyprogesterone Caproate Injection Market by Product Type
  • Figure 13.2: Growth Opportunities for the Global Hydroxyprogesterone Caproate Injection Market by Distribution Channel
  • Figure 13.3: Growth Opportunities for the Global Hydroxyprogesterone Caproate Injection Market by Application
  • Figure 13.4: Growth Opportunities for the Global Hydroxyprogesterone Caproate Injection Market by Region
  • Figure 13.5: Emerging Trends in the Global Hydroxyprogesterone Caproate Injection Market

List of Tables

  • Table 1.1: Growth Rate (%, 2023-2024) and CAGR (%, 2025-2031) of the Hydroxyprogesterone Caproate Injection Market by Product Type, Distribution Channel, and Application
  • Table 1.2: Attractiveness Analysis for the Hydroxyprogesterone Caproate Injection Market by Region
  • Table 1.3: Global Hydroxyprogesterone Caproate Injection Market Parameters and Attributes
  • Table 3.1: Trends of the Global Hydroxyprogesterone Caproate Injection Market (2019-2024)
  • Table 3.2: Forecast for the Global Hydroxyprogesterone Caproate Injection Market (2025-2031)
  • Table 4.1: Attractiveness Analysis for the Global Hydroxyprogesterone Caproate Injection Market by Product Type
  • Table 4.2: Market Size and CAGR of Various Product Type in the Global Hydroxyprogesterone Caproate Injection Market (2019-2024)
  • Table 4.3: Market Size and CAGR of Various Product Type in the Global Hydroxyprogesterone Caproate Injection Market (2025-2031)
  • Table 4.4: Trends of Single-Dose Vials in the Global Hydroxyprogesterone Caproate Injection Market (2019-2024)
  • Table 4.5: Forecast for Single-Dose Vials in the Global Hydroxyprogesterone Caproate Injection Market (2025-2031)
  • Table 4.6: Trends of Multi-Dose Vials in the Global Hydroxyprogesterone Caproate Injection Market (2019-2024)
  • Table 4.7: Forecast for Multi-Dose Vials in the Global Hydroxyprogesterone Caproate Injection Market (2025-2031)
  • Table 5.1: Attractiveness Analysis for the Global Hydroxyprogesterone Caproate Injection Market by Distribution Channel
  • Table 5.2: Market Size and CAGR of Various Distribution Channel in the Global Hydroxyprogesterone Caproate Injection Market (2019-2024)
  • Table 5.3: Market Size and CAGR of Various Distribution Channel in the Global Hydroxyprogesterone Caproate Injection Market (2025-2031)
  • Table 5.4: Trends of Hospital Pharmacies in the Global Hydroxyprogesterone Caproate Injection Market (2019-2024)
  • Table 5.5: Forecast for Hospital Pharmacies in the Global Hydroxyprogesterone Caproate Injection Market (2025-2031)
  • Table 5.6: Trends of Retail Pharmacies in the Global Hydroxyprogesterone Caproate Injection Market (2019-2024)
  • Table 5.7: Forecast for Retail Pharmacies in the Global Hydroxyprogesterone Caproate Injection Market (2025-2031)
  • Table 5.8: Trends of Online Pharmacies in the Global Hydroxyprogesterone Caproate Injection Market (2019-2024)
  • Table 5.9: Forecast for Online Pharmacies in the Global Hydroxyprogesterone Caproate Injection Market (2025-2031)
  • Table 6.1: Attractiveness Analysis for the Global Hydroxyprogesterone Caproate Injection Market by Application
  • Table 6.2: Market Size and CAGR of Various Application in the Global Hydroxyprogesterone Caproate Injection Market (2019-2024)
  • Table 6.3: Market Size and CAGR of Various Application in the Global Hydroxyprogesterone Caproate Injection Market (2025-2031)
  • Table 6.4: Trends of Preterm Birth Prevention in the Global Hydroxyprogesterone Caproate Injection Market (2019-2024)
  • Table 6.5: Forecast for Preterm Birth Prevention in the Global Hydroxyprogesterone Caproate Injection Market (2025-2031)
  • Table 6.6: Trends of Hormone Replacement Therapy in the Global Hydroxyprogesterone Caproate Injection Market (2019-2024)
  • Table 6.7: Forecast for Hormone Replacement Therapy in the Global Hydroxyprogesterone Caproate Injection Market (2025-2031)
  • Table 6.8: Trends of Others in the Global Hydroxyprogesterone Caproate Injection Market (2019-2024)
  • Table 6.9: Forecast for Others in the Global Hydroxyprogesterone Caproate Injection Market (2025-2031)
  • Table 7.1: Market Size and CAGR of Various Regions in the Global Hydroxyprogesterone Caproate Injection Market (2019-2024)
  • Table 7.2: Market Size and CAGR of Various Regions in the Global Hydroxyprogesterone Caproate Injection Market (2025-2031)
  • Table 8.1: Trends of the North American Hydroxyprogesterone Caproate Injection Market (2019-2024)
  • Table 8.2: Forecast for the North American Hydroxyprogesterone Caproate Injection Market (2025-2031)
  • Table 8.3: Market Size and CAGR of Various Product Type in the North American Hydroxyprogesterone Caproate Injection Market (2019-2024)
  • Table 8.4: Market Size and CAGR of Various Product Type in the North American Hydroxyprogesterone Caproate Injection Market (2025-2031)
  • Table 8.5: Market Size and CAGR of Various Application in the North American Hydroxyprogesterone Caproate Injection Market (2019-2024)
  • Table 8.6: Market Size and CAGR of Various Application in the North American Hydroxyprogesterone Caproate Injection Market (2025-2031)
  • Table 8.7: Trends and Forecast for the United States Hydroxyprogesterone Caproate Injection Market (2019-2031)
  • Table 8.8: Trends and Forecast for the Mexican Hydroxyprogesterone Caproate Injection Market (2019-2031)
  • Table 8.9: Trends and Forecast for the Canadian Hydroxyprogesterone Caproate Injection Market (2019-2031)
  • Table 9.1: Trends of the European Hydroxyprogesterone Caproate Injection Market (2019-2024)
  • Table 9.2: Forecast for the European Hydroxyprogesterone Caproate Injection Market (2025-2031)
  • Table 9.3: Market Size and CAGR of Various Product Type in the European Hydroxyprogesterone Caproate Injection Market (2019-2024)
  • Table 9.4: Market Size and CAGR of Various Product Type in the European Hydroxyprogesterone Caproate Injection Market (2025-2031)
  • Table 9.5: Market Size and CAGR of Various Application in the European Hydroxyprogesterone Caproate Injection Market (2019-2024)
  • Table 9.6: Market Size and CAGR of Various Application in the European Hydroxyprogesterone Caproate Injection Market (2025-2031)
  • Table 9.7: Trends and Forecast for the German Hydroxyprogesterone Caproate Injection Market (2019-2031)
  • Table 9.8: Trends and Forecast for the French Hydroxyprogesterone Caproate Injection Market (2019-2031)
  • Table 9.9: Trends and Forecast for the Spanish Hydroxyprogesterone Caproate Injection Market (2019-2031)
  • Table 9.10: Trends and Forecast for the Italian Hydroxyprogesterone Caproate Injection Market (2019-2031)
  • Table 9.11: Trends and Forecast for the United Kingdom Hydroxyprogesterone Caproate Injection Market (2019-2031)
  • Table 10.1: Trends of the APAC Hydroxyprogesterone Caproate Injection Market (2019-2024)
  • Table 10.2: Forecast for the APAC Hydroxyprogesterone Caproate Injection Market (2025-2031)
  • Table 10.3: Market Size and CAGR of Various Product Type in the APAC Hydroxyprogesterone Caproate Injection Market (2019-2024)
  • Table 10.4: Market Size and CAGR of Various Product Type in the APAC Hydroxyprogesterone Caproate Injection Market (2025-2031)
  • Table 10.5: Market Size and CAGR of Various Application in the APAC Hydroxyprogesterone Caproate Injection Market (2019-2024)
  • Table 10.6: Market Size and CAGR of Various Application in the APAC Hydroxyprogesterone Caproate Injection Market (2025-2031)
  • Table 10.7: Trends and Forecast for the Japanese Hydroxyprogesterone Caproate Injection Market (2019-2031)
  • Table 10.8: Trends and Forecast for the Indian Hydroxyprogesterone Caproate Injection Market (2019-2031)
  • Table 10.9: Trends and Forecast for the Chinese Hydroxyprogesterone Caproate Injection Market (2019-2031)
  • Table 10.10: Trends and Forecast for the South Korean Hydroxyprogesterone Caproate Injection Market (2019-2031)
  • Table 10.11: Trends and Forecast for the Indonesian Hydroxyprogesterone Caproate Injection Market (2019-2031)
  • Table 11.1: Trends of the ROW Hydroxyprogesterone Caproate Injection Market (2019-2024)
  • Table 11.2: Forecast for the ROW Hydroxyprogesterone Caproate Injection Market (2025-2031)
  • Table 11.3: Market Size and CAGR of Various Product Type in the ROW Hydroxyprogesterone Caproate Injection Market (2019-2024)
  • Table 11.4: Market Size and CAGR of Various Product Type in the ROW Hydroxyprogesterone Caproate Injection Market (2025-2031)
  • Table 11.5: Market Size and CAGR of Various Application in the ROW Hydroxyprogesterone Caproate Injection Market (2019-2024)
  • Table 11.6: Market Size and CAGR of Various Application in the ROW Hydroxyprogesterone Caproate Injection Market (2025-2031)
  • Table 11.7: Trends and Forecast for the Middle Eastern Hydroxyprogesterone Caproate Injection Market (2019-2031)
  • Table 11.8: Trends and Forecast for the South American Hydroxyprogesterone Caproate Injection Market (2019-2031)
  • Table 11.9: Trends and Forecast for the African Hydroxyprogesterone Caproate Injection Market (2019-2031)
  • Table 12.1: Product Mapping of Hydroxyprogesterone Caproate Injection Suppliers Based on Segments
  • Table 12.2: Operational Integration of Hydroxyprogesterone Caproate Injection Manufacturers
  • Table 12.3: Rankings of Suppliers Based on Hydroxyprogesterone Caproate Injection Revenue
  • Table 13.1: New Product Launches by Major Hydroxyprogesterone Caproate Injection Producers (2019-2024)
  • Table 13.2: Certification Acquired by Major Competitor in the Global Hydroxyprogesterone Caproate Injection Market