Last updated: November 8, 2025
Overview of Makena
Makena (hydroxyprogesterone caproate) is a synthetic progestin developed to prevent preterm birth in pregnant women with a history of spontaneous preterm delivery. Approved by the U.S. Food and Drug Administration (FDA) in 2011, Makena has since established itself as a pivotal product in obstetric care, particularly in the realm of preterm birth prevention. Developed by Covis Pharma, the drug is marketed as its original injectable formulation, with subsequent biosimilar efforts seeking to expand access and reduce costs.
Clinical Trials Update
Recent and Ongoing Trials
Despite its long-standing approval, Makena's clinical development pipeline has seen limited new large-scale trials. However, several studies examining the drug's efficacy, safety, and alternative administration routes continue to contribute to the body of evidence.
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Reassessment of Efficacy and Safety: The original Phase III trial (2010) by the National Institute of Child Health and Human Development indicated that weekly injections of Makena significantly reduced preterm birth risk in high-risk women. Subsequent post-marketing surveillance has focused on long-term safety profiles and alternative titration schedules to optimize outcomes.
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Biosimilar Development: A notable clinical development has been the pursuit of biosimilar versions of hydroxyprogesterone caproate. In 2020, Biocon launched clinical trials to evaluate biosimilar candidates, aiming to facilitate market competition and improve affordability [1].
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Exploratory Studies: Some observational studies and registry data analyses continue to monitor real-world outcomes, particularly focusing on adverse events, dosing protocols, and patient adherence.
Regulatory and Post-Marketing Surveillance
The FDA continues to monitor Makena's safety through post-marketing commitments. The key concern remains whether the benefits in preventing preterm birth outweigh potential risks, such as injection site reactions and rare thromboembolic events. The ongoing collection of safety data aims to refine usage guidelines.
Innovative Formulations and Routes of Delivery
Recent research explores alternative delivery mechanisms, such as intravaginal formulations, aiming to improve patient compliance and reduce systemic side effects. While these are in preclinical or early-phase trials, they signal a potential evolution in preterm birth prophylaxis strategies.
Market Analysis
Current Market Landscape
The global preterm birth prevention market, valued at approximately USD 1.8 billion in 2022, is driven by a rising incidence of preterm births and increased awareness of maternal health risks [2]. Makena's market share remains significant in the United States, but it faces challenges from biosimilar entries and newer therapeutic candidates.
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Market Share and Revenue: Covis Pharma reports Makena’s annual global revenue exceeding USD 170 million, primarily in North America. However, patent expirations and biosimilar challenges are poised to pressure pricing and market dominance.
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Pricing and Reimbursement: Makena commands high reimbursement rates due to its traditional injectable form, with costs often exceeding USD 30,000 per pregnancy course. Recent policy debates focus on reducing drug costs to enhance access.
Competitive Landscape
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Biosimilars and Generics: Biocon's biosimilar candidate aims to capture a significant portion of the market upon approval, prompted by increasing pressure from payers and healthcare providers seeking cost-effective options.
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Alternative Therapies: Other progestins like 17-alpha hydroxyprogesterone caproate and vaginal formulations of progesterone (e.g., Crinone, Pfizer) offer varying administration routes, with some studies suggesting comparable efficacy.
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Regulatory and Market Dynamics: The FDA’s recent approval of a generic version of hydroxyprogesterone caproate from Torrent Pharmaceuticals signals an impending price competition [3].
Market Growth Drivers
- Accelerating preterm birth rates globally, especially in developing countries, expand market potential.
- Increasing awareness of maternal health and routine screening programs.
- Policy initiatives to reduce maternal morbidity and mortality.
Market Challenges
- Patent expirations and biosimilar proliferation threaten to erode proprietary revenue.
- Variability in clinical practice guidelines influences prescribing behaviors.
- Concerns about safety and efficacy lead to hesitance among some practitioners.
Future Market Projections
The preterm birth prophylaxis market is expected to grow at a compound annual growth rate (CAGR) of approximately 5.5% through 2030. The entry of biosimilars and new delivery methods could accelerate growth, potentially surpassing USD 3 billion globally by 2030.
Market Projections
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Post-Biosimilar Entry: Market share for original Makena is forecasted to decline by as much as 40% within 2-3 years following biosimilar launches, assuming price discounts and expanded access.
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Increased Adoption of Alternative Formulations: Vaginal progesterone-based therapies are likely to supplement injectable formulations, creating a more diversified market landscape.
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Regional Growth: Emerging markets, such as China and India, present significant expansion opportunities, driven by increasing healthcare infrastructure and maternal health initiatives.
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Impact of Regulatory Changes: Payer policies favoring lower-cost options and broader reimbursement inclusion may further influence market dynamics.
Conclusion
While Makena currently maintains a strong foothold in preterm birth prevention, its future market positioning hinges on new clinical developments, biosimilar approvals, and healthcare policy changes. Continuous surveillance of clinical trial outcomes and market entries will be critical for stakeholders aiming to navigate this evolving landscape.
Key Takeaways
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Clinical trials for Makena primarily focus on safety, biosimilar development, and alternative delivery routes, with limited groundbreaking studies since FDA approval.
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Market dynamics are increasingly influenced by biosimilar entries, policy reforms, and the diversification of therapeutic options.
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The market for preterm birth prophylaxis is projected to grow steadily, driven by rising preterm birth incidences and expanding access in emerging economies.
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Pricing pressures and regulatory policies will continue shaping the competitive landscape, possibly favoring cost-effective biosimilars over branded formulations.
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Innovation in formulation and administration could redefine treatment paradigms, offering potential for improved compliance and outcomes.
FAQs
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What is the current status of biosimilar development for Makena?
Biocon and other pharmaceutical companies have initiated clinical trials for biosimilar versions of hydroxyprogesterone caproate. Approval timelines vary but are anticipated within the next 2-3 years, pending successful trials and regulatory reviews.
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Are there any new clinical trials investigating alternative administration routes for Makena?
Yes, preliminary studies are exploring vaginal and transdermal formulations to improve patient compliance and reduce systemic side effects. However, these are still in early phases.
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How has the market responded to biosimilar entries aimed at hydroxyprogesterone caproate?
Market response includes increased pricing competition and greater accessibility in some regions. Payers are incentivizing biosimilar adoption, which could significantly reduce Makena's market share.
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What are the primary safety concerns associated with Makena?
Long-term safety data indicate rare instances of injection site reactions and thromboembolic events. Ongoing surveillance aims to monitor and minimize these risks.
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What is the outlook for Makena's market share over the next five years?
Market share may decline due to biosimilar competition, but established safety and efficacy profiles support continued demand. Overall, steady market growth is expected, especially in regions with high preterm birth rates.
References
[1] Biocon Announces Clinical Trial Initiatives for Biosimilar Hydroxyprogesterone Caproate. (2020). Pharma Business News.
[2] Global Preterm Birth Prevention Market Report, 2022. MarketResearch.com.
[3] FDA Approves Generic Hydroxyprogesterone Caproate for Preterm Birth Prevention. (2022). FDA Press Release.
