세계의 오피오이드 유발성 변비 시장 : 시장 점유율 분석, 산업 동향, 통계, 성장 예측(2025-2030년)

The opioid-induced constipation treatment market was valued at USD 3.06 billion in 2025 and is expected to reach USD 3.99 billion by 2030, advancing at a 6.7% CAGR.

The sustained growth reflects the need to manage constipation in 40-80% of patients who rely on opioids for chronic or cancer-related pain. Rising opioid prescriptions, regulatory approvals for novel peripherally acting µ-opioid receptor antagonists (PAMORAs), and growing adoption of digital adherence tools are core demand drivers. North America dominates due to high opioid consumption, yet Asia Pacific records the fastest expansion as Japan, China, and India harmonize guidelines and broaden access to proven therapies. Label extensions into pediatric populations and hospital stewardship mandates institutionalize prophylactic bowel regimens, while pipeline products with improved safety profiles strengthen the opioid-induced constipation treatment market's long-term outlook.

Global Opioid Induced Constipation Market Trends and Insights

Rising Opioid Prescriptions for Chronic Pain Management

Steady reliance on opioids for legitimate pain control sustains product demand despite broader efforts to curb misuse. A 2025 Japanese cohort study found 30% opioid-induced constipation (OIC) incidence among non-cancer patients using weak opioids, climbing to 49.2% by day 14 of therapy.Cancer cohorts reported 56% cumulative incidence within two weeks of opioid initiation, underlining the inevitability of bowel dysfunction when analgesia is opioid-based. Many U.S. hospitals now require prophylactic laxatives within 24 hours of the first opioid dose, formalizing treatment as a default component of pain care.

Label Expansions & Launches of Novel PAMORAs

Regulators are broadening indications to underserved populations. FDA clearance of linaclotide for children aged 6-17 in May 2024 established the first U.S. pediatric option. The European Medicines Agency accepted AstraZeneca's naloxegol dossier in June 2024, signaling alignment with U.S. standards. Conversely, the FDA withdrew ENTEREG (alvimopan) in August 2024, highlighting close scrutiny. Pipeline assets such as PF614-MPAR, which combines opioid analgesia with built-in overdose protection, widen the competitive field.

Next-Generation Non-Opioid Analgesics

The FDA approved suzetrigine in January 2025. It offers strong acute analgesia with no opioid receptor action, removing the risk of constipation. Although priced at USD 15.50 per pill, hospital formularies may adopt it for postsurgical pain, trimming future OIC cases. Academic teams are also advancing gut-selective oxytocin mimetics that calm visceral pain without systemic absorption.

Other drivers and restraints analyzed in the detailed report include:

1. High Prevalence of Chronic Non-Cancer & Cancer Pain
2. Digital-Therapeutic Co-Prescription Boosting Adherence
3. Patient Reluctance Due to Adverse-Event Awareness

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

Segment Analysis

PAMORAs contributed USD 2.24 billion in 2024, equal to 73.3% of the opioid-induced constipation treatment market size, as their gut-restricted receptor blockade preserves central analgesia. The class retains physician confidence despite the FDA withdrawal of alvimopan because alternatives such as naldemedine yield 81-90% spontaneous bowel movement response in Japanese trials. Looking ahead, guanylate cyclase-C agonists are forecast to post the highest 11.6% CAGR, underpinned by pediatric label extensions. Sustained investment in combination opioid-PAMORA pills promises to defend the opioid-induced constipation treatment market share of peripherally acting agents amid mounting class competition.

Manufacturers hedge risk by diversifying their mode of action. 5-HT4 receptor agonists with improved cardiac safety, hemp-derived motility enhancers, and gut-selective peptides are now in Phase II. These entrants could capture niche cohorts intolerant of diarrhea or abdominal cramping. Nonetheless, prescribers may prefer well-established PAMORAs until head-to-head outcomes trials confirm equivalence, ensuring the opioid-induced constipation treatment market remains dominated by incumbents through most of the outlook period.

Prescription products represented 91.2% of 2024 revenue, confirming clinician oversight remains essential when manipulating µ-opioid receptors. The opioid-induced constipation treatment market size for OTC formulations was modest but is predicted to grow as consumer familiarity rises. Regulatory bodies continue to debate switching select PAMORAs to pharmacist-guided status once post-marketing surveillance demonstrates low misuse risk.

Advocates believe successful Rx-to-OTC switches could reduce emergency visits caused by chronic laxative misuse. Yet the mechanistic complexity of opioid antagonism and potential for precipitated withdrawal keep most molecules in prescription channels for now. Digital prescription platforms may blur lines: validated bowel-tracking apps bundled with drug coupons offer semi-automated follow-up, gradually shifting portions of the opioid-induced constipation treatment industry toward a self-management paradigm.

The Opioid-Induced Constipation Market is Segmented by Drug Class (Chloride-Channel-2 Activators, and More), Prescription Type (Prescription and More), Route of Administration (Oral and More), Patient Group (Cancer-Pain Patients and More), Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and More), and Geography (North America, Europe, and More). The Market Sizes and Forecasts are Provided in Terms of Value (USD).

Geography Analysis

North America contributed 44.5% of global revenue in 2024, anchored by the United States, which consumes nearly 80% of worldwide opioid volumes. Widespread payer coverage, entrenched pain management guidelines, and FDA leadership in approving innovative classes keep the region at the forefront. Hospital networks, from Cedars-Sinai to Mayo Clinic, have embedded digital stool monitors that trigger immediate laxative escalation when no bowel movement is recorded within 24 hours, underscoring an institutional commitment to proactive care. Canada mirrors U.S. dynamics ,though on a smaller scale, with national opioid stewardship frameworks adopting fixed bowel regimen bundles in tertiary hospitals. Policy reforms aimed at curbing opioid misuse steadily reduce new opioid starts, yet high chronic-user prevalence maintains a sizeable patient pool requiring constipation therapies. Consequently, the opioid-induced constipation treatment market retains robust, if maturing, growth prospects in North America.

Asia Pacific exhibits the highest 7.5% CAGR through 2030. Japan's rapid uptake of naldemedine, validated in Phase III trials reporting 81-90% response despite 88-90% adverse-event incidence, showcases clinical confidence. China's inclusion of PAMORAs in provincial reimbursement lists improves affordability, while a 2024 osteoarthritis meta-analysis confirming 3.57-fold constipation risk associated with opioids prepares policymakers for broader adoption weekly.chinacdc.cn. India's burgeoning generic manufacturing base positions domestic firms to launch cost-effective entrants once international patents lapse, enhancing treatment penetration across lower-income populations.

Europe maintains steady uptake amid payer scrutiny. The EMA's June 2024 acceptance of naloxegol and Germany's permanent reimbursement for a gastrointestinal digital therapeutic illustrate balanced innovation and cost containment. National health technology assessment bodies evaluate not just drug price but total cost of care, encouraging manufacturers to package PAMORAs with adherence-support platforms. Reimbursement claw-backs in markets such as France temper list prices, yet volume remains resilient due to aging demographics and oncologic opioid use. The opioid-induced constipation treatment market therefore shows moderate but reliable expansion across the continent.

1. AstraZeneca
2. Mallinckrodt Pharmaceuticals
3. Bausch Health
4. Merck
5. Shionogi
6. GSK plc / Theravance Biopharma
7. Takeda Pharmaceutical Co Ltd
8. Novartis
9. RedHill Biopharma
10. BioDelivery Sciences Intl (Collegium)
11. Nektar Therapeutics
12. Daiichi Sankyo Co Ltd
13. Kyowa Kirin Co Ltd
14. Purdue Pharma
15. Ferring Pharmaceuticals
16. Lupin
17. Hikma Pharmaceuticals
18. Viatris
19. Sun Pharmaceuticals Industries
20. Abbvie

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 Rising Opioid Prescriptions For Chronic Pain Management
  • 4.2.2 Label Expansions & Launches Of Novel PAMORAs
  • 4.2.3 High Prevalence Of Chronic Non-Cancer & Cancer Pain
  • 4.2.4 Digital-Therapeutic Co-Prescription Boosting Adherence
  • 4.2.5 Pipeline Combo Opioid-PAMORA Formulations
  • 4.2.6 Hospital Opioid-Stewardship Mandates For Bowel Regimens
• 4.3 Market Restraints
  • 4.3.1 Next-Generation Non-Opioid Analgesics
  • 4.3.2 Patient Reluctance Due To Adverse-Event Awareness
  • 4.3.3 European Reimbursement Claw-Backs On PAMORA Pricing
  • 4.3.4 Medical-Cannabis Substitution Lowering Opioid Doses
• 4.4 Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Bargaining Power of Suppliers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value)

• 5.1 By Drug Class
  • 5.1.1 PAMORAs
  • 5.1.2 Chloride-Channel-2 Activators
  • 5.1.3 Guanylate Cyclase-C Agonists
  • 5.1.4 Others
• 5.2 By Prescription Type
  • 5.2.1 Prescription
  • 5.2.2 Over-the-Counter (OTC)
• 5.3 By Route of Administration
  • 5.3.1 Oral
  • 5.3.2 Parenteral
• 5.4 By Patient Group
  • 5.4.1 Cancer-Pain Patients
  • 5.4.2 Non-Cancer Chronic-Pain Patients
• 5.5 By Distribution Channel
  • 5.5.1 Hospital Pharmacies
  • 5.5.2 Retail Pharmacies
  • 5.5.3 Online Pharmacies
• 5.6 Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia Pacific
    • 5.6.3.1 China
    • 5.6.3.2 Japan
    • 5.6.3.3 India
    • 5.6.3.4 South Korea
    • 5.6.3.5 Australia
    • 5.6.3.6 Rest of Asia Pacific
  • 5.6.4 Middle East & Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East & Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 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, Products & Services, Recent Developments)
  • 6.3.1 AstraZeneca plc
  • 6.3.2 Mallinckrodt Pharmaceuticals
  • 6.3.3 Bausch Health
  • 6.3.4 Merck & Co Inc
  • 6.3.5 Shionogi & Co Ltd
  • 6.3.6 GSK plc / Theravance Biopharma
  • 6.3.7 Takeda Pharmaceutical Co Ltd
  • 6.3.8 Novartis AG (Sandoz)
  • 6.3.9 RedHill Biopharma
  • 6.3.10 BioDelivery Sciences Intl (Collegium)
  • 6.3.11 Nektar Therapeutics
  • 6.3.12 Daiichi Sankyo Co Ltd
  • 6.3.13 Kyowa Kirin Co Ltd
  • 6.3.14 Purdue Pharma L.P.
  • 6.3.15 Ferring Pharmaceuticals
  • 6.3.16 Lupin Ltd
  • 6.3.17 Hikma Pharmaceuticals plc
  • 6.3.18 Viatris Inc
  • 6.3.19 Sun Pharma
  • 6.3.20 AbbVie Inc

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment