임신중 약제 시장 : 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the pregnancy medication market size was valued at USD 49.58 billion in 2025 and is estimated to grow from USD 51.98 billion in 2026 to reach USD 71.22 billion by 2031, at a CAGR of 6.5% during the forecast period (2026-2031).

This report is Segmented by Drug Class (Antiemetics, Antihypertensives, Antidiabetics, and More), Indication (Nausea & Vomiting of Pregnancy, Hypertensive Disorders of Pregnancy, Rh Immunoprophylaxis, and More), Route of Administration (Oral, and More), Distribution Channel (Hospital Pharmacies, and More), and Geography (North America, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Pregnancy Medication Market Trends and Insights

High Prevalence Of Nausea And Vomiting Of Pregnancy

Between 70% and 80% of pregnant women experience nausea and vomiting of pregnancy, with a smaller subset progressing to hyperemesis gravidarum that requires hospital care. Doxylamine succinate combined with pyridoxine hydrochloride has extensive safety data without a teratogenic signal across very large exposed cohorts, which supports its first-line role in guidance updates. The entry of approved generics, including the Health Canada authorization of delayed-release doxylamine-pyridoxine 10 mg/10 mg by Apotex, adds price competition and can expand access in cost-sensitive settings. The delayed-release pharmacokinetic profile that peaks after several hours enables evening dosing and better alignment with morning-predominant symptoms, which helps adherence in outpatient care. These factors keep antiemetics central to first-line management and sustain the foundation of the pregnancy medication market.

Persistent Global Burden Of Preterm Birth And Need For Tocolysis And Antenatal Corticosteroids

Preterm birth remains a leading driver of neonatal morbidity and mortality, and global standards have converged on time-limited tocolysis that creates a 48-hour window to administer antenatal corticosteroids and transfer mothers to higher-acuity centers. WHO guidance specifies evidence-backed steroid regimens, including betamethasone 12 mg intramuscularly in two doses 24 hours apart or dexamethasone 6 mg intramuscularly in four doses 12 hours apart, for women between 24 and 34 weeks when preterm delivery appears likely within seven days. Maintenance tocolysis is discouraged due to limited neonatal benefit and higher maternal risk, which restrains chronic tocolytic use in outpatient settings and focuses utilization on periods of clear neonatal benefit. The United States withdrawal of 17-hydroxyprogesterone caproate in 2023 removed the previously approved option for recurrent preterm birth risk reduction and shifted practice toward off-label alternatives or closer surveillance. Acute tocolysis often centers on short courses of nifedipine or indomethacin consistent with time-limited protocols, which aligns procurement with the inpatient windows that deliver the greatest impact on neonatal outcomes.

FDA Withdrawal Of 17-OHPC (Makena) Curtails Progesterone Use For Recurrent PTB Prevention

The U.S. Food and Drug Administration finalized the withdrawal of Makena (17-hydroxyprogesterone caproate) and its generics in April 2023, which removed the only drug that had been approved in the United States for reducing the risk of recurrent preterm birth in women with a prior spontaneous preterm birth and a current singleton pregnancy. This decision erased a mature subcategory within the pregnancy medication market and led clinicians to rely on off-label alternatives or closer surveillance for high-risk patients. The change also signaled that pregnancy medications cleared on surrogate endpoints face ongoing regulatory scrutiny that can result in post-approval reversal if confirmatory evidence does not show clinical benefit, which may influence future development and payer reviews. The resulting coverage uncertainty for off-label progesterone formulations has limited scaled substitution, which leaves a therapeutic gap for recurrent preterm birth risk reduction. As health systems adapt, utilization has shifted toward evidence-supported acute protocols like time-limited tocolysis and antenatal corticosteroids for imminent preterm delivery, which constrains the longer-duration progesterone corridor within the pregnancy medication market.

Other drivers and restraints analyzed in the detailed report include:

1. Rising Hyperglycemia In Pregnancy Driving Insulin And Antidiabetic Use
2. Guideline-Backed Low-Dose Aspirin Prophylaxis In High-Risk Pregnancies
3. Rh(D) Immune Globulin Shortages Constrain Prophylaxis Availability

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Antiemetics held 22.45% of the pregnancy medication market share in 2025, while antidiabetics are projected to grow at a 9.03% CAGR to 2031, outpacing the overall pregnancy medication market as metabolic complications rise with maternal age and obesity. Kaiser Permanente's June 2025 guidance designated insulin glargine as the preferred basal insulin and moved metformin toward extended-release dosing twice daily, which improves adherence and aligns with formulary shifts in integrated health systems. Professional recommendations that advise against glyburide as first line have consolidated treatment around insulin and metformin, creating a more predictable uptake trajectory within the pregnancy medication market. Antihypertensives remain a durable and mature corridor anchored by labetalol and nifedipine, with use rising in the third trimester as preeclampsia prevalence increases and as targets tighten in inpatient settings. Tocolytics, in contrast, face restricted indications due to WHO guidance limiting use to a 48-hour window, which curbs maintenance therapy and aligns utilization with the periods of proven neonatal benefit.

The progesterone corridor contracted sharply after the 2023 United States withdrawal of hydroxyprogesterone caproate, which left off-label alternatives without consistent payer coverage and reduced scaled substitution in the pregnancy medication industry. Immunoglobulins, especially anti-D products, remain under supply strain due to donor demographics and concentrated manufacturing, which has accelerated targeted prophylaxis strategies using non-invasive fetal RhD genotyping to avoid unnecessary administration. Antenatal corticosteroids such as betamethasone and dexamethasone continue to track preterm birth exposures and are guided by WHO protocols that permit a single repeat course under specific conditions, which keeps demand stable in tertiary centers. Anticoagulants and anti-infectives focus on defined risk cohorts, and while they contribute steady baseline demand, they do not alter the aggregate growth profile of the pregnancy medication market in the current cycle.

Nausea and vomiting of pregnancy accounted for a 24.32% share of the pregnancy medication market size in 2025, which reflects widespread prevalence and the entrenched first-line role of antiemetics in outpatient care. Gestational diabetes management is advancing at an 8.53% projected CAGR to 2031 on rising maternal BMI and delayed childbearing, and it benefits from clearer preferences that center on insulin glargine and extended-release metformin. The Australasian Diabetes in Pregnancy Society's 2025 consensus refined screening and diagnostic thresholds to improve case identification while seeking to avoid overdiagnosis, but the prevalence trends in high-risk populations maintain upward pressure on treatment volumes. Hypertensive disorders of pregnancy continue to command significant pharmacologic attention, with biomarker-integrated triage in several European systems enabling earlier identification of cases that will benefit from antihypertensives and magnesium sulfate prophylaxis.

Rh immunoprophylaxis remains essential to prevent alloimmunization, but use is now being targeted through non-invasive fetal RhD genotyping in several European countries, which cuts unnecessary injections and helps steward supply. Preterm labor management revolves around tighter, evidence-based prescribing of tocolytics and antenatal corticosteroids, which shifts exposure into windows of highest neonatal benefit and contains maintenance use. Infection-related care such as Group B Streptococcus prophylaxis follows stable protocols and contributes steady baseline utilization with low volatility. Smaller indications such as threatened miscarriage and venous thromboembolism address focused risk cohorts, and while clinically important, they hold limited influence on the overall trajectory of the pregnancy medication market.

Geography Analysis

North America captured 32.45% of 2025 revenues on the strength of high per-capita pharmaceutical spending, comprehensive prenatal screening, and broad access to guideline-based therapies within the pregnancy medication market. European systems continue to integrate biomarker-led triage for preeclampsia, which supports earlier targeted treatment and reduces unnecessary admissions in high-volume centers. Donor constraints for plasma-derived anti-D in Europe have driven prioritization guidance and a fresh interest in recombinant alternatives to build long-run supply resilience for obstetric care. Provider networks in the United States emphasize rapid-control hypertension protocols and magnesium sulfate prophylaxis, which sustain hospital pharmacy demand and align with tightened targets for maternal safety. Retail channels in both regions continue to anchor outpatient antiemetics, antihypertensives, and antidiabetics and maintain the largest distribution share in the pregnancy medication market.

Asia-Pacific is projected to expand at a 7.69% CAGR to 2031, led by rising gestational diabetes prevalence, improved maternal health infrastructure, and broader coverage for advanced diagnostics and therapies. National policies that back non-invasive prenatal testing and maternal screening build a foundation for earlier identification and targeted pharmacology in high-risk pregnancies, which supports steady class growth in the pregnancy medication market. Australia's support for publicly funded fetal RhD genotyping illustrates a precision approach to maternal-fetal medicine and provides a model for resource stewardship in countries with similar payer structures. Southeast Asian health systems are adding diabetes and hypertension management capacity in ambulatory clinics and tertiary centers, which expands demand for antidiabetics, antihypertensives, and diagnostics. As coverage expands and clinical pathways standardize, the pregnancy medication market in the region is likely to sustain above-trend growth through 2031.

The Middle East is experiencing faster utilization growth in gestational diabetes therapy with clear recognition of elevated baseline risk, though reimbursement and formulary structures vary by country and payer mix. South America continues to adopt first-line obstetric pharmacology, while currency volatility challenges imported biologics procurement and nudges systems to support local manufacturing of essential oral therapies. Sub-Saharan Africa carries the highest preterm birth burden, and WHO guidance emphasizes that antenatal corticosteroids should be used where accurate gestational age dating and neonatal support are available to ensure net benefit. As infrastructure and workforce training improve, demand for time-sensitive maternal medications and monitoring is expected to grow in regional referral centers, reinforcing evidence-based pathways within the pregnancy medication market.

1. Abbott Laboratories
2. Bayer
3. Besins Healthcare Monaco S.A.M
4. Biocon
5. CSL Behring
6. Duchesnay USA
7. Exeltis UK ltd.
8. Ferring
9. Fresenius
10. Galen Limited.
11. Grifols
12. Hikma Pharmaceuticals
13. Kedrion
14. Eli Lilly and Company
15. Marlex Pharmaceuticals, Inc.
16. Novo Nordisk
17. Pfizer
18. Sanofi
19. Teva Pharmaceutical Industries

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 High Prevalence of Nausea and Vomiting of Pregnancy
  • 4.2.2 Persistent Global Burden of Preterm Birth and Need For Tocolysis and Antenatal Corticosteroids
  • 4.2.3 Rising Hyperglycaemia in Pregnancy Driving Insulin and Antidiabetic Use
  • 4.2.4 Guideline-Backed Low-Dose Aspirin Prophylaxis in High-Risk Pregnancies
  • 4.2.5 Growing Use of Antihypertensives in Hypertensive Disorders of Pregnancy
  • 4.2.6 Biomarker-Led Triage Enabling Earlier Pharmacologic Intervention
• 4.3 Market Restraints
  • 4.3.1 FDA Withdrawal of 17-OHPC (Makena) Curtails Progesterone Use for Recurrent PTB Prevention
  • 4.3.2 Rh(D) Immune Globulin Shortages Constrain Prophylaxis Availability
  • 4.3.3 Non-Invasive Fetal RhD Genotyping Reducing Unnecessary Anti-D Administration
  • 4.3.4 Who Limits On Maintenance Tocolysis and Restricted Indications Temper Utilization
• 4.4 Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porters Five Forces
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Industry Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Drug Class
  • 5.1.1 Antiemetics
  • 5.1.2 Antihypertensives
  • 5.1.3 Antidiabetics
  • 5.1.4 Anticoagulants
  • 5.1.5 Tocolytics
  • 5.1.6 Progesterone therapies
  • 5.1.7 Immunoglobulins
  • 5.1.8 Corticosteroids
  • 5.1.9 Others (Anti-infectives, Hematological Agents)
• 5.2 By Indication
  • 5.2.1 Nausea & Vomiting of Pregnancy (NVP)
  • 5.2.2 Hypertensive Disorders of Pregnancy
  • 5.2.3 Rh Immunoprophylaxis (Anti-D)
  • 5.2.4 Preterm Labor Management
  • 5.2.5 Gestational Diabetes Management
  • 5.2.6 Infection Management
  • 5.2.7 Others (Threatened Miscarriage, Venous Thromboembolism)
• 5.3 By Route of Administration
  • 5.3.1 Oral
  • 5.3.2 Parenteral (IV/IM/Subcutaneous)
  • 5.3.3 Vaginal
  • 5.3.4 Other Route of Administrations
• 5.4 By Distribution Channel
  • 5.4.1 Hospital Pharmacies
  • 5.4.2 Retail Pharmacies
  • 5.4.3 Online Pharmacies
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 India
    • 5.5.3.3 Japan
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles {(includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)}
  • 6.3.1 Abbott Laboratories
  • 6.3.2 Bayer AG
  • 6.3.3 Besins Healthcare Monaco S.A.M
  • 6.3.4 Biocon
  • 6.3.5 CSL
  • 6.3.6 Duchesnay USA
  • 6.3.7 Exeltis UK ltd.
  • 6.3.8 Ferring
  • 6.3.9 Fresenius Kabi AG
  • 6.3.10 Galen Limited.
  • 6.3.11 Grifols, S.A.
  • 6.3.12 Hikma Pharmaceuticals PLC
  • 6.3.13 Kedrion
  • 6.3.14 Lilly
  • 6.3.15 Marlex Pharmaceuticals, Inc.
  • 6.3.16 Novo Nordisk A/S
  • 6.3.17 Pfizer Inc.,
  • 6.3.18 Sanofi
  • 6.3.19 Teva Pharmaceutical Industries Ltd.

7 Market Opportunities & Future Outlook

• 7.1 White-space & unmet-need assessment