하이드록시 프로게스테론 카프로에이트 주사제 시장 보고서 : 동향, 예측 및 경쟁 분석(-2031년)
Hydroxyprogesterone Caproate Injection Market Report: Trends, Forecast and Competitive Analysis to 2031
상품코드 : 1881995
리서치사 : Lucintel
발행일 : 2025년 12월
페이지 정보 : 영문 150 Pages
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한글목차

세계 하이드록시프로게스테론 카프론산 주사제 시장은 조산 예방 및 호르몬 대체 요법 시장에서의 기회를 배경으로 미래가 유망할 것으로 예측됩니다. 세계 하이드록시프로게스테론 카프론산 주사제 시장은 2025-2031년 연평균 복합 성장률(CAGR) 6.2%를 보일 것으로 예측됩니다. 이 시장의 주요 촉진요인은 조산 사례 증가, 모성 건강 요법에 대한 수요 증가, 산전 관리 솔루션에 대한 관심 확대 등입니다.

하이드록시프로게스테론 카프론산 주사제 시장의 새로운 트렌드

현재 하이드록시프로게스테론 카프론산 주사제 시장은 임상적 유효성에 대한 재평가로 인해 큰 불확실성과 위축의 시기를 맞이하고 있습니다. 새로운 트렌드는 성장보다는 이 약물로부터의 근본적인 전환에 초점을 맞추고 있으며, 조산 예방을 위한 보다 효과적인 대안적 개입 방법을 모색하는 데 초점을 맞추었습니다.

하이드록시프로게스테론카프론산 시장의 새로운 추세는 성장 추세가 아니라 오히려 축소 추세입니다. 그 비효율성과 잠재적 위험성을 강조하는 규제 조치와 과학적 발견으로 인해 시장은 재편되고 있으며, 보다 안전하고 효과적인 대안으로 근본적인 전환과 모성 건강 조사의 새로운 시대로 나아가고 있습니다.

하이드록시프로게스테론 카프론산 주사제 시장의 최근 동향

하이드록시프로게스테론 카프론산 주사제 시장은 이 약물의 수년간의 사용에 의문을 제기하는 규제 조치에 의해 크게 정의되는 최근 중요한 추세를 경험했습니다. 이러한 추세는 주요 시장에서 약품의 철수로 이어져 조산 예방 치료 전략의 재평가를 요구하고 있습니다.

최근 하이드록시프로게스테론 카프론산 주사제 시장 동향은 세계 주요 시장에서의 철수를 중심으로 압도적으로 부정적으로 나타나고 있습니다. 이러한 움직임은 조산 예방의 치료 패러다임에 근본적인 변화를 가져오고 있으며, 의료계는 보다 효과적이고 안전한 대체 요법의 탐색과 검증을 서둘러야 할 필요성에 직면해 있습니다.

목차

제1장 주요 요약

제2장 시장 개요

제3장 시장 동향과 예측 분석

제4장 세계의 하이드록시 프로게스테론 카프로에이트 주사제 시장 : 제품 유형별

제5장 세계의 하이드록시 프로게스테론 카프로에이트 주사제 시장 : 유통 채널별

제6장 세계의 하이드록시 프로게스테론 카프로에이트 주사제 시장 : 용도별

제7장 지역 분석

제8장 북미의 하이드록시 프로게스테론 카프로에이트 주사제 시장

제9장 유럽의 하이드록시 프로게스테론 카프로에이트 주사제 시장

제10장 아시아태평양의 하이드록시 프로게스테론 카프로에이트 주사제 시장

제11장 기타 지역(ROW)의 하이드록시 프로게스테론 카프로에이트 주사제 시장

제12장 경쟁 분석

제13장 기회와 전략 분석

제14장 밸류체인 주요 기업 개요

제15장 부록

LSH
영문 목차

영문목차

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.

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.

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.

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.

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-

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]:

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

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

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.

Features of the Global 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:

Table of Contents

1. Executive Summary

2. Market Overview

3. Market Trends & Forecast Analysis

4. Global Hydroxyprogesterone Caproate Injection Market by Product Type

5. Global Hydroxyprogesterone Caproate Injection Market by Distribution Channel

6. Global Hydroxyprogesterone Caproate Injection Market by Application

7. Regional Analysis

8. North American Hydroxyprogesterone Caproate Injection Market

9. European Hydroxyprogesterone Caproate Injection Market

10. APAC Hydroxyprogesterone Caproate Injection Market

11. ROW Hydroxyprogesterone Caproate Injection Market

12. Competitor Analysis

13. Opportunities & Strategic Analysis

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

15. Appendix

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