Hydroxyprogesterone Caproate Injection Market Size, Share, Growth, and Industry Analysis, By Type (250mg/ml and 275mg/1.1ml), By Downstream Industry (Hospital, Clinics and Recovery Center) and Regional Forecast to 2032

HYDROXYPROGESTERONE CAPROATE INJECTION MARKET REPORT OVERVIEW

The global hydroxyprogesterone caproate injection market size was USD 265.4 million in 2024 and the market is projected to touch USD 294.46 million by 2032, exhibiting a CAGR of 1.52% during the forecast period.

Hydroxyprogesterone caproate injection is an injected drug for the therapy of females found in the antenatal period during pregnancy, as it has been proven to bring the percentage of preterm birth in females who have opened their births before. This drug is administered intramuscularly and is for women with one baby in pregnancy and who in the past could deliver premature babies. It often starts between 16 and 20 weeks of pregnancy but it may be administered every week till the 37th week of the pregnancy or the birth. Hormonal control, making the womb attempt to extend the duration of pregnancy and implementing measures to prevent early births which, as we have established, cause numerous issues.

Such tendencies may bring some side effects from the hydroxyprogesterone caproate injections, such as the development of a reaction at the site of administration and pain or swelling where the injection was administered. This means that there also lies the possibility of getting what is termed gestational diabetes. This drug was launched in the market in the 1950s, but it was withdrawn from the American market in 1999 whereby, it was re-introduced back into the American market in 2011 and is currently marketed under the name of Makena and mainly administers to prevent preterm birth. This led to the reintroduction process because the health risk was high and the associated medical expenses from preterm births were relatively high. Thus, hydroxyprogesterone caproate remains the main valuable factor when improving pregnancies among high-risk women candidates and it is greatly involved in the prevention of recurrent preterm birth.

COVID-19 Impact: Pandemic leads to a market shift with the interruption of most healthcare services

The global COVID-19 pandemic has been unprecedented and staggering, with the market experiencing lower-than-anticipated demand across all regions compared to pre-pandemic levels. The sudden market growth reflected by the rise in CAGR is attributable to market’s growth and demand returning to pre-pandemic levels.

The disruption of healthcare services has been the principal driver of change in the hydroxyprogesterone caproate injection market amid the pandemic. Due to the pandemic, most patients limited their visits to hospitals and early prenatal care, while the healthcare facilities were overwhelmed, thus finding it difficult to provide continuous and appropriate treatments to pregnant women. These disruptions affected the use of injections since many women could not go to clinics for routine appointments and elective procedures. Therefore, the market suffered a decline, which is indicative of the extent of damage that the pandemic brought to the maternal health industry particularly complications of high-risk pregnancies.

LATEST TRENDS

"Technological advancements are increasing the product's efficiency and versatility to drive the market"

Technological improvements are a key area that is improving the hydroxyprogesterone caproate injection products to increase their functionality. Technological advancements in the formulation and delivery of the drug have seen improved formulations with increased stability, bioavailability and overall effects on the patients. Advanced manufacturing processes result in increased drug purity and quality, leading to lower beer and adverse effects. Furthermore, advancement in the field of pharmacogenomics is allowing precise dosing and treatment plans according to the patient’s profile, increasing therapeutic efficacy. Self-injection systems such as auto-injectors are also being found to be easy to use and thus are also making it easier for the consumer to use them properly with less complaint. Such advancements in technology not only benefit the efficacy and the safety of the injections but also help in broadening its sphere of application to involve the management of preterm birth risks in various patient categories.

HYDROXYPROGESTERONE CAPROATE INJECTION MARKET SEGMENTATION

By Type

Based on type the global market can be categorized into 250mg/ml and 275mg/1.1ml.

• 250mg/ml: The 250mg/ml formulation of hydroxyprogesterone caproate is preferred commonly due to its simplicity of use and efficiency. Given at weekly intervals from 16-20 through to 37 weeks of pregnancy as required, it is available as a single dose vial or pre-filled syringe to ensure the right dose is delivered consistently. This formulation is preferred by healthcare personnel to avoid preterm birth in women with high-risk factors ranging from poor pregnancy history, genetics, environmental issues and other complications, thus offering a reliable and consistent dosage form.
• 275mg/1.1ml: In clinical use, 1ml hydroxyprogesterone caproate formulation provides a greater concentration than the 250mg/ml type with applications where a larger dose is needed or where fewer injections are preferred. Given once weekly from 16-20 weeks to 37 weeks of pregnancy, the injection is now available in pre-filled syringes for precise dosing.

By Downstream Industry

Based on downstream industry the global market can be categorized into Hospital, Clinics and Recovery Center.

• Hospitals: Hydroxyprogesterone caproate is usually administered through injections which are prescribed mostly by hospitals that provide prenatal care, particularly to patients with complicated pregnancies. They dominate the market due to specialized professionals, advanced facilities and rigorous monitoring. Hospitals do ensure proper handling, storing as well as administration of the said medication since protocols are set. Their role in patient education and regular monitoring further drives market growth, emphasizing the importance of consistent treatment to prevent preterm birth.
• Clinics: Outpatient clinics especially the obstetrics and gynaecology clinics play a crucial role in administering the hydroxyprogesterone caproate injections. They offer convenient, accessible care for pregnant women not need hospital services. This segment is growing as healthcare providers increasingly use these injections to prevent preterm birth. Clinics, with strong hospital ties, can refer to complex cases and the rise of specialized maternal-fetal medicine clinics boosts this growth.
• Recovery Center: Hydroxyprogesterone caproate injections are administered by recovery centres such as skilled nursing and long-term care facilities for high-risk pregnant women who require extended care. Although this segment is less compared to hospitals and clinics it is growing quickly because of the focus on the patient-centric approach. These centres collaborate closely with hospitals to ensure seamless, specialized support, enhancing outcomes for high-risk pregnancies.

DRIVING FACTORS

"Rising prevalence of preterm birth and to prevention of serious obstetric complications propel the market"

The global hydroxyprogesterone caproate injection market growth is propelling mainly due to the increasing number of pre-term deliveries and lack of adequate preventive measures. This condition being a major factor in neonatal morbidity/mortality, tenacious intervention measures should be mounted to counter the health risks they expose the newborns to. In high-risk women, hydroxyprogesterone caproate has been identified the one of the most important therapeutic agents recommended by the clinical body of knowledge to prevent recurrent preterm births. The increasing identification of the long-term health consequences of preterm births and the related healthcare costs has fueled this demand. Therefore, there is increased demand for the injections that is occasioned by a shifting perception towards early intervention in maternal and neonatal care by the medical fraternity.

"Increasing accessibility by manufacturers' efforts to enhance availability and implementation to expand the market"

A factor contributing to the expansion of this market is the availability of the hydroxyprogesterone caproate injection as more manufacturers strive to make this injection more accessible and incorporate patient support programs. Multinational pharmaceutical corporations have engaged in the effort to change the channel of distribution and facilitate market access so that the injections could effectively reach the hands of healthcare professionals and pregnant women with preterm birth risk factors. Such efforts include awareness creation, provision of funds to the needy and collaboration with healthcare institutions to provide access to medicine. Due to better supplies and support services, manufacturers have significantly lowered access hurdles to this preventative intervention and more pregnant women have been able to benefit. They have not only helped to build the markets but have also contributed greatly to the betterment of maternal and neonatal health.

RESTRAINING FACTORS

"Lack of awareness of both healthcare providers and patients regarding products and services hinders the market"

The limitations are that the availability and benefits of this hydroxyprogesterone caproate injection remain overlooked or unnoticed even by the healthcare providers and the patients themselves. Despite the availability of clinical trials and FDA widespread approval in confirming the effectiveness of this treatment in avoiding early childbirth, there remains a probability that the larger population of healthcare providers and expectant women may not be aware of this therapy. These gaps of knowledge are more so seen in some sub-areas and healthcare settings due to less emphasis on education and training programs. Consequently, some patients may not benefit from the intervention when they are eligible to receive it, whereas providers may not even consider the injections in patient management. To overcome this barrier, there is a need to improve the level of awareness through increasing educational and communication initiatives so that more women at risk of preterm birth can benefit from the injections.

HYDROXYPROGESTERONE CAPROATE INJECTION MARKET REGIONAL INSIGHTS

The market is primarily segregated into Europe, Latin America, Asia Pacific, North America, and Middle East & Africa.

"North America is expected to hold the market share due to well-developed healthcare infrastructure"

North America region is expected to dominate in the global hydroxyprogesterone caproate injection market share as it has well-established healthcare sector. The region also has well-established healthcare facilities. The region also has well-developed medical centres, a high level of medical facilities and large research work potential. These factors favour early adoption and diffusion of innovative treatment equipment such as hydroxyprogesterone caproate injections. Moreover, the well-developed healthcare policies, emphasis on maternal and childcare programs and preventive healthcare services also play a key role in growth in the market. North America has well-established leading pharmaceutical companies plus ongoing clinical trials which further promote access to products and fuel growth in the markets. Altogether, these elements contribute to the effective implementation of the injections in clinical practice, as well as the needs of high-risk pregnant women and the overall preterm birth rate.

KEY INDUSTRY PLAYERS

"Key industry players are adopting advanced technologies to expand the market"

The key industry players within this market are turning to enhance technological advancement to deliver new forms of hydroxyprogesterone caproate injections, especially about the sustained release of the hormone and the usage of customized treatment for patients via advanced approaches in precision medicine. All of these measures are intended to improve the effectiveness, safety and accessibility of the drug. Sustained-release formulations enable the drug to be released gradually so that there is no need for the drug injections for a long span in some cases and patient compliance can be enhanced. Personalized medicine strategies take into account patient characteristics to enhance the efficacy of therapeutic interventions based on genetics, propensity to certain environments and behaviour. All these technology-enhanced features not only enhance the efficacy and quality of the drug and the experience of the patient but also widen the drug’s coverage for various patients. Through the implementation of these innovative technologies, manufacturers can establish higher levels of preventive measures for preterm births hence improving the effectiveness of interventions for high-risk pregnancies.

List of Market Players Profiled

• Slayback Pharma (U.S.)
• Mylan (U.S.)
• American Regent (U.S.)
• ANI Pharmaceuticals (U.S.)
• AuroMedics (U.S.)
• AMAG (U.S.)
• Prasco (U.S.)
• PRM Life Science (India)
• SG pharm (India)
• Zydus (India)

INDUSTRIAL DEVELOPMENT

May 2024: The EY US Entrepreneur Of The Year® program identifies and celebrates the unstoppable, such as Nikhil Lalwani, CEO of ANI Pharmaceuticals, for the remarkable value delivered by EV growth at ANI Pharmaceuticals and the sustained strategic growth discipline. Receiving this prize showcases EY’s work and commitment to promoting founder success via programs such as the ‘Entrepreneurial Winning Women™’ and Entrepreneurs Access Network to assist an inclusive range of business owners.

REPORT COVERAGE

The study encompasses a comprehensive SWOT analysis and provides insights into future developments within the market. It examines various factors that contribute to the growth of the market, exploring a wide range of market categories and potential applications that may impact its trajectory in the coming years. The analysis takes into account both current trends and historical turning points, providing a holistic understanding of the market's components and identifying potential areas for growth.

The research report delves into market segmentation, utilizing both qualitative and quantitative research methods to provide a thorough analysis. It also evaluates the impact of financial and strategic perspectives on the market. Furthermore, the report presents national and regional assessments, considering the dominant forces of supply and demand that influence market growth. The competitive landscape is meticulously detailed, including market shares of significant competitors. The report incorporates novel research methodologies and player strategies tailored for the anticipated timeframe. Overall, it offers valuable and comprehensive insights into the market dynamics in a formal and easily understandable manner.