세계의 오피오이드 유발성 변비 시장 - 인사이트, 역학, 예측(2034년)

Key Highlights:

• Opioid-induced constipation (OIC) is a common and burdensome side effect of chronic opioid therapy, arising from opioid-mediated inhibition of gastrointestinal motility and secretion via peripheral µ-opioid receptors.
• Opioid-induced constipation affects 40-60% of patients on chronic opioid therapy, with higher prevalence in women, older adults, and cancer pain populations.
• The treatment of opioid-induced constipation focuses on alleviating symptoms without compromising pain control. Conventional approaches, such as lifestyle modifications and over-the-counter laxatives, often provide limited relief, as they do not target the underlying opioid-receptor mechanism.
• To address the treatment gap, several peripherally acting µ-opioid receptor antagonists (PAMORAs) have been FDA-approved. These include RELISTOR (methylnaltrexone), MOVANTIK (naloxegol), and SYMPROIC (naldemedine), each designed to block opioid action in the gut without affecting central analgesia. Additionally, AMITIZA (lubiprostone), a chloride channel activator, is approved for opioid-induced constipation in adults with chronic non-cancer pain.
• The development landscape for opioid-induced constipation remains limited, with BGP345A representing one of the few investigational candidates. While its advancement underscores recognition of the unmet need in patients unresponsive to current PAMORAs.
• A key unmet need in opioid-induced constipation is the lack of consistent, durable relief in patients who remain symptomatic despite treatment with available PAMORAs, highlighting the necessity for therapies that can address refractory cases while minimizing gastrointestinal side effects. This underscores that while current therapies have advanced opioid-induced constipation management, persistent gaps in long-term efficacy and refractory patient care leave room for more differentiated solutions, sustaining opportunities for innovation even in a mature market.

DelveInsight's comprehensive report titled "Opioid-Induced Constipation - Market Insights, Epidemiology, and Market Forecast - 2034" offers a detailed analysis of opioid-induced constipation. The report presents historical and projected epidemiological data covering Total Diagnosed Prevalent Cases of Opioid-Induced Constipation, Age-Specific Cases of Opioid-Induced Constipation, Gender-Specific Cases of Opioid-Induced Constipation, Cancer and Non-Cancer Pain-Associated Cases of Opioid-Induced Constipation, and Treated Cases of Opioid-Induced Constipation. In addition to epidemiology, the market report encompasses various aspects related to the patient population. These aspects include the diagnosis process, prescription patterns, physician perspectives, market accessibility, treatment options, and prospective developments in the market across seven major markets: the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, spanning from 2020 to 2034.

The report analyzes the existing treatment practices and unmet medical requirements in opioid-induced constipation. It evaluates the market potential and identifies potential business prospects for enhancing therapies or interventions. This valuable information enables stakeholders to make well-informed decisions regarding product development and strategic planning for the market.

Opioid-Induced Constipation Overview

Opioid-induced constipation (OIC) is one of the most common and persistent adverse effects of chronic opioid therapy, affecting up to 40-60% of patients receiving opioids for pain management. Unlike other opioid-related side effects such as nausea or sedation, which often diminish with tolerance, opioid-induced constipation typically persists throughout treatment and can significantly impair quality of life, adherence to pain therapy, and overall clinical outcomes. It results from opioid binding to µ-receptors in the gastrointestinal tract, leading to reduced bowel motility, increased fluid absorption, and harder stools. Given its high prevalence and impact, opioid-induced constipation has emerged as a major clinical concern, necessitating targeted therapeutic strategies beyond traditional laxatives.

Opioid-induced constipation Diagnosis and Treatment Algorithm

The diagnosis of opioid-induced constipation is primarily clinical, based on the onset or worsening of constipation after initiating opioid therapy and supported by Rome IV criteria, which include symptoms such as straining, hard stools, sensation of incomplete evacuation, or fewer than three spontaneous bowel movements per week. Secondary causes, including diet, immobility, or other medications, should be excluded.

Management follows a stepwise approach, beginning with patient education, lifestyle modification (adequate hydration, fiber intake, and physical activity), and prophylactic use of conventional laxatives such as osmotic or stimulant agents at the time of opioid initiation. If constipation persists despite optimal laxative therapy, targeted treatments are introduced, most notably peripherally acting µ-opioid receptor antagonists (PAMORAs) such as methylnaltrexone, naloxegol, and naldemedine, which provide effective relief without compromising analgesia. In select cases, alternatives such as lubiprostone or oxycodone/naloxone formulations may be considered, while refractory patients warrant further evaluation to exclude structural or metabolic causes.

Opioid-induced constipation Epidemiology

The epidemiology section of the opioid-induced constipation market report offers information on the patient populations, including historical and projected trends for each of the seven major markets. Examining key opinion leader views from physicians or clinical experts can assist in identifying the reasons behind historical and projected trends. The diagnosed patient pool, their trends, and the underlying assumptions are all included in this section of the report.

This section also presents the data with relevant tables and graphs, offering a clear and concise view of the prevalence of opioid-induced constipation. Additionally, the report discloses the assumptions made during the analysis, ensuring data interpretation and presentation transparency. This epidemiological data is valuable for understanding the disease burden and its impact on the patient population across various regions.

• Opioid-induced constipation accounts from over 40% to 60% in patients without cancer receiving opioids.
• According to secondary findings, globally, in international studies, the prevalence of opioid-induced constipation ranges from 8.9% to 81.0%.

The epidemiology of opioid-induced constipation is expected to change during the forecast period (2025-2034).

Opioid-induced Constipation Market Outlook

The opioid-induced constipation therapeutics market is further expected to increase by the major drivers, such as the rising prevalence population, technological advancements, and upcoming therapies in the forecast period (2025-2034).

With ongoing research and continued dedication, the future holds hope for even more effective treatments and, ultimately, a cure for this challenging condition. According to DelveInsight, the opioid-induced constipation market in the 7MM is expected to change significantly during the forecast period 2025-2034.

Opioid-induced Constipation Drug Chapters

Marketed Opioid-induced Constipation Drugs

SYMPROIC (naldemedine): Shionogi

Symproic (naldemedine) is a peripherally acting µ-opioid receptor antagonist (PAMORA) approved for the treatment of opioid-induced constipation in adults with chronic non-cancer pain, including those with pain related to prior cancer or its treatment who do not require frequent opioid dose escalation. In March 2017, Shionogi, in partnership with Purdue Pharma, announced that the US FDA had granted approval for Symproic, marking an important addition to the therapeutic options for managing opioid-induced constipation.

MOVANTIK (naloxegol): RedHill Biopharma/ Astrazeneca

MOVANTIK (naloxegol) was the first FDA approved once-daily peripherally-acting mu-opioid receptor antagonist (PAMORA) specifically designed for the treatment of opioid-induced constipation in adult patients with chronic non-cancer pain. In September 2014, AstraZeneca announced that the US FDA approved MOVANTIK tablets C-II as the first once-daily oral peripherally-acting mu-opioid receptor antagonist medication for the treatment of opioid-induced constipation.

Emerging Opioid-induced Constipation Drugs

The opioid-induced constipation market is expected to evolve gradually, driven by the limited number of emerging therapies currently in development. Key players such as BGP345A, among others are showing active commitment to addressing this unmet need, with ongoing efforts to advance novel treatment options for this complex condition.

BGP345A: BioGaia Pharma

BGP345A is being developed for the treatment of constipation in patients receiving opioid therapy for prescribed pain treatment. Opioids are an essential option for chronic pain, primarily back pain, rheumatism or post-operative pain, where non-opioid multimodal drugs or physical therapy are not providing relief. Currently, it is in Phase II of its clinical development.

Opioid-induced Constipation Market Segmentation

DelveInsight's 'Opioid-induced Constipation - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a detailed outlook of the current and future opioid-induced constipation market, segmented within countries, by therapies, and by classes. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies.

Opioid-induced Constipation Market Size by Countries

The opioid-induced constipation market size is assessed separately for various countries, including the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan. In 2024, the United States held a significant share of the overall 7MM (Seven Major Markets) opioid-induced constipation market, primarily attributed to the country's higher prevalence of the condition and the elevated cost of the available treatments. This dominance is projected to persist, especially with the potential early introduction of new products.

Opioid-induced Constipation Market Size by Therapies

Opioid-induced Constipation Market Size by Therapies is categorized into current and emerging markets for the study period 2020-2034.

Opioid-induced Constipation Drugs Uptake

This section focuses on the sales uptake of potential opioid-induced constipation drugs that have recently been launched or are anticipated to be launched in the opioid-induced constipation market between 2020 and 2034. It estimates the market penetration of opioid-induced constipation drugs for a given country, examining their impact within and across classes and segments. It also touches upon the financial and regulatory decisions contributing to the probability of success (PoS) of the drugs in the opioid-induced constipation market.

The emerging opioid-induced constipation therapies are analyzed based on various attributes such as safety and efficacy in randomized clinical trials, order of entry and other market dynamics, and the unmet need they fulfill in the opioid-induced constipation market.

Opioid-induced Constipation Market Access and Reimbursement

DelveInsight's 'Opioid-induced Constipation - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a descriptive overview of the market access and reimbursement scenario of opioid-induced constipation.

This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments.

KOL Views

To keep up with current opioid-induced constipation market trends and fill gaps in secondary findings, we interview KOLs and SMEs' working in the opioid-induced constipation domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns or opioid-induced constipation market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the opioid-induced constipation unmet needs.

Opioid-induced Constipation: KOL Insights

DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as Mercer University, US, University Hospital Tubingen, Germany, University of Barcelona, Barcelona, Spain, ellvitge-Idibell University Hospital, Barcelona, Spain, University of Leeds, Leeds, UK, and University of Occupational and Environmental Health, Japan, among others.

"Increasing dietary fiber, fluid intake, and physical exercise are the backbone to prevention therapy. All healthcare workers who prescribe opioids need to also consider prophylactic treatment for constipation. All types of laxatives can be used as initial therapy except for the bulk-forming laxatives."

"A wide range of pharmacologic approaches are available for managing opioid-induced constipation (OIC). The cornerstone of management is the initiation of a standing oral laxative regimen at the time of opioid initiation, unless contraindicated. Osmotic or stimulant laxatives are preferred, while agents such as mineral oil, castor oil, and cascara are discouraged for regular use due to safety concerns."

Competitive Intelligence Analysis

We conduct a Competitive and Market Intelligence analysis of the opioid-induced constipation market, utilizing various Competitive Intelligence tools such as SWOT analysis and Market entry strategies. The inclusion of these analyses is contingent upon data availability, ensuring a comprehensive and well-informed assessment of the market landscape and competitive dynamics.

Opioid-induced Constipation Pipeline Development Activities

The report offers an analysis of therapeutic candidates in Phase II and III stages and examines companies involved in developing targeted therapeutics for opioid-induced constipation. It provides valuable insights into the advancements and progress of potential treatments in clinical development for this condition.

Pipeline Development Activities

The report covers information on collaborations, acquisition and merger, licensing, patent details, and other information for emerging opioid-induced constipation therapies.

Opioid-induced Constipation Report Insights

• Opioid-induced Constipation Patient Population
• Therapeutic Approaches
• Opioid-induced Constipation Pipeline Analysis
• Opioid-induced Constipation Market Size and Trends
• Opioid-induced Constipation Market Opportunities
• Impact of Upcoming Therapies

Opioid-induced Constipation Report Key Strengths

• 10 Years Forecast
• The 7MM Coverage
• Opioid-induced Constipation Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Opioid-Induced Constipation Market
• Opioid-induced Constipation Drugs Uptake

Opioid-induced Constipation Report Assessment

• Opioid-induced Constipation Current Treatment Practices
• Unmet Needs
• Opioid-induced Constipation Pipeline Product Profiles
• Opioid-induced Constipation Market Attractiveness

Key Questions:

• How common is opioid-induced constipation?
• What are the key findings of opioid-induced constipation epidemiology across the 7MM, and which country will have the highest number of patients during the study period (2020-2034)?
• What are the currently available treatments for opioid-induced constipation?
• What are the disease risk, burden, and unmet needs of opioid-induced constipation?
• At what CAGR is the opioid-induced constipation market and its epidemiology is expected to grow in the 7MM during the forecast period (2025-2034)?
• How would the unmet needs impact the opioid-induced constipation market dynamics and subsequently influence the analysis of the related trends?
• What would be the forecasted patient pool of opioid-induced constipation in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan?
• Among EU4 and the UK, which country will have the highest number of patients during the forecast period (2025-2034)?
• How many companies are currently developing therapies for the treatment of opioid-induced constipation?

Reasons to buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the opioid-induced constipation Market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of current treatment in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Frequently Asked Questions:

1. What are the treatment goals for opioid-induced constipation?

The treatment goals for opioid-induced constipation are to restore normal bowel habits and improve stool frequency, consistency, and ease of passage. Management aims to relieve symptoms such as straining, bloating, and abdominal discomfort while minimizing complications of chronic constipation. Importantly, these goals must be achieved without compromising opioid analgesia. By doing so, overall quality of life and adherence to pain therapy can be maintained.

2. What are the challenges in managing opioid-induced constipation?

Managing opioid-induced constipation is challenging because tolerance to constipation does not develop, making symptoms persistent throughout opioid therapy. Conventional laxatives often provide inadequate relief, as they do not address the underlying opioid receptor-mediated mechanism. Patient reluctance to discuss bowel issues, variability in response to therapies, and cost or access barriers to targeted treatments like PAMORAs further complicate management.

3. What are the key factors driving the growth of the opioid-induced constipation market?

The opioid-induced constipation market is growing due to the rising use of opioids for chronic pain, leading to a larger patient pool. Increased recognition of opioid-induced constipation as a distinct condition and the limited efficacy of traditional laxatives have driven demand for targeted therapies. The launch of FDA-approved PAMORAs has expanded treatment options and improved clinical adoption. Greater focus on patient quality of life and access to innovative therapies further supports market growth.

4. How will the opioid-induced constipation Market and Epidemiology Forecast Report benefit the clients?

The Opioid-Induced Constipation Market and Epidemiology Forecast Report will benefit clients by providing a comprehensive understanding of disease burden, patient population trends, and treatment practices across key markets. It offers insights into current therapies, emerging drugs, and unmet needs, helping clients identify growth opportunities. The report also highlights competitive dynamics, market drivers, and barriers, enabling strategic decision-making.

Table of Contents

1. Key Insights

2. Report Introduction

3. Market Overview at a Glance

• 3.1. Market Share (%) Distribution by Therapies in 2024
• 3.2. Market Share (%) Distribution by Therapies in 2034

4. Epidemiology and Market Methodology

5. Executive Summary

6. Key Events

7. Disease Background and Overview

• 7.1. Introduction
• 7.2. Types
• 7.3. Causes
• 7.4. Pathophysiology
• 7.5. Symptoms
• 7.6. Risk Factor
• 7.7. Diagnosis
  • 7.7.1. Diagnostic Algorithm
  • 7.7.2. Diagnostic Guidelines
• 7.8. Treatment and Management
  • 7.8.1. Treatment Algorithm
  • 7.8.2. Treatment Guidelines

8. Epidemiology and Patient Population

• 8.1. Key Findings
• 8.2. Assumptions and Rationale: The 7MM
• 8.3. Total Diagnosed Prevalent Cases of Opioid-induced constipation in the 7MM
• 8.4. The US
  • 8.4.1. Total Diagnosed Prevalent Cases of Opioid-Induced Constipation
  • 8.4.2. Age-Specific Cases of Opioid-Induced Constipation
  • 8.4.3. Gender-Specific Cases of Opioid-Induced Constipation
  • 8.4.4. Cancer and Non-Cancer Pain-Associated Cases of Opioid-Induced Constipation
  • 8.4.5. Treated Cases of Opioid-Induced Constipation
• 8.5. EU4 and the UK
  • 8.5.1. Total Diagnosed Prevalent Cases of Opioid-Induced Constipation
  • 8.5.2. Age-Specific Cases of Opioid-Induced Constipation
  • 8.5.3. Gender-Specific Cases of Opioid-Induced Constipation
  • 8.5.4. Cancer and Non-Cancer Pain-Associated Cases of Opioid-Induced Constipation
  • 8.5.5. Treated Cases of Opioid-Induced Constipation
• 8.6. Japan
  • 8.6.1. Total Diagnosed Prevalent Cases of Opioid-Induced Constipation
  • 8.6.2. Age-Specific Cases of Opioid-Induced Constipation
  • 8.6.3. Gender-Specific Cases of Opioid-Induced Constipation
  • 8.6.4. Cancer and Non-Cancer Pain-Associated Cases of Opioid-Induced Constipation
  • 8.6.5. Treated Cases of Opioid-Induced Constipation

9. Patient Journey

10. Marketed Therapies

• 10.1. Key Cross Competition
• 10.2. SYMPROIC (naldemedine): Shionogi
  • 10.2.1. Drug Description
  • 10.2.2. Regulatory Milestones
  • 10.2.3. Other Development Activities
  • 10.2.4. Clinical Trials Information
  • 10.2.5. Safety and Efficacy
• 10.3. MOVANTIK (naloxegol): RedHill Biopharma/ Astrazeneca
  • 10.3.1. Drug Description
  • 10.3.2. Regulatory Milestones
  • 10.3.3. Other Development Activities
  • 10.3.4. Clinical Trials Information
  • 10.3.5. Safety and Efficacy

11. Emerging Therapies

• 11.1. Key Cross Competition
• 11.2. BGP345A: BioGaia Pharma
  • 11.2.1. Drug Description
  • 11.2.2. Other Development Activities
  • 11.2.3. Clinical Trials Information
  • 11.2.4. Safety and Efficacy
  • 11.2.5. Analysts' Views

12. Opioid-Induced Constipation: Seven Major Market Analysis

• 12.1. Key Findings
• 12.2. Key Market Forecast Assumptions
  • 12.2.1. Cost Assumptions and Rebates
  • 12.2.2. Pricing Trends
  • 12.2.3. Analogue Assessment
  • 12.2.4. Launch Year and Therapy Uptake
• 12.3. Market Outlook
• 12.4. Attribute Analysis
• 12.5. Total Market Size of Opioid-Induced Constipation in the 7MM
• 12.6. Market Size of Opioid-Induced Constipation by Therapies in the 7MM
• 12.7. The US Market Size
  • 12.7.1. Total Market Size of Opioid-Induced Constipation
  • 12.7.2. Market Size of Opioid-Induced Constipation by Therapies
• 12.8. Market Size of Opioid-Induced Constipation in the EU4 and the UK
  • 12.8.1. Total Market Size of Opioid-Induced Constipation
  • 12.8.2. Market Size of Opioid-Induced Constipation by Therapies
• 12.9. Japan Market Size
  • 12.9.1. Total Market Size of Opioid-Induced Constipation
  • 12.9.2. Market Size of Opioid-Induced Constipation by Therapies

13. Key Opinion Leaders' Views

14. Unmet Needs

15. SWOT Analysis

16. Opioid-Induced Constipation Market Access and Reimbursement

• 16.1. United States
  • 16.1.1. Centre for Medicare and Medicaid Services (CMS)
• 16.2. EU4 and the UK
  • 16.2.1. Germany
  • 16.2.2. France
  • 16.2.3. Italy
  • 16.2.4. Spain
  • 16.2.5. United Kingdom
• 16.3. Japan
  • 16.3.1. MHLW

17. Appendix

• 17.1. Bibliography
• 17.2. Abbreviations and Acronyms
• 17.3. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight