Naldemedine Tosylate Market

Naldemedine Tosylate Market Size, Share & Industry Analysis, By Source (Pharmaceutical Manufacturers (Branded & Generic), Contract Manufacturing Organizations (CMOs), Research-Grade Suppliers) By End-User (Pharmaceutical Industry, Hospitals & Clinics, Research Institutions) and Forecast, 2025-2035

The Naldemedine Tosylate market is projected to grow at a CAGR of 7.8% from 2025 to 2035, supported by the increasing global prevalence of opioid-induced constipation (OIC) and the clinical demand for peripherally acting mu-opioid receptor antagonists (PAMORAs). Naldemedine Tosylate is the tosylate salt form of Naldemedine, developed to enhance oral bioavailability and stability. It works by blocking mu-opioid receptors in the gastrointestinal tract while sparing the central nervous system, thereby relieving constipation without impairing opioid-induced analgesia.

This compound is primarily prescribed for patients on chronic opioid therapy, including those with non-cancer pain and cancer-related pain, who are at high risk for OIC. Its once-daily oral administration and strong safety profile make it a convenient and effective therapeutic option. The increasing use of opioid analgesics, particularly in aging populations, combined with heightened awareness of OIC’s impact on quality of life, continues to drive demand for Naldemedine Tosylate-based formulations.

North America holds the largest share of the Naldemedine Tosylate market, propelled by high opioid prescription volumes and proactive pain management guidelines. Europe follows, supported by regulatory approvals and increasing integration of PAMORAs in clinical care pathways. Asia-Pacific is expected to witness the fastest growth due to expanding cancer therapy access, palliative care improvements, and the gradual shift towards more comprehensive opioid management strategies, especially in Japan, where Naldemedine originated.

Seeking Comprehensive Intelligence on Different markets? Get in Touch with our Experts

Report Scope & Segmentation

  1. Introduction
  • Overview of Naldemedine Tosylate
  • Key Applications & Industry Use Cases
  • Market Scope & Study Objectives
  1. Market Overview
  • Global Market Size & Growth Trends (Historical & Forecast)
  • Market Value & Revenue Analysis
  • Demand-Supply Dynamics
  1. Segmental Outlook
  • By Source
    • Pharmaceutical Manufacturers (Branded & Generic)
    • Contract Manufacturing Organizations (CMOs)
    • Research-Grade Suppliers
  • Key End-Use Industries
    • Pharmaceutical Industry.
    • Hospitals & Clinics.
    • Research Institutions.
  1. Price Analysis
  • Current Price Trends (Per kg & Per Ton)
  • Price Fluctuation Factors (Raw Material Costs, Production, Trade Tariffs)
  • Regional Price Comparison (North America, Europe, Asia-Pacific, and Other)
  1. Production & Supply Volume
  • Global Production Capacity & Key Manufacturers
  • Production Process & Technological Developments
  • Raw Material Analysis
  1. Trade Analysis (Import & Export)
  • Major Exporting & Importing Countries
  • Trade Volume & Value Statistics
  • Impact of Trade Regulations & Policies
  1. Regional Analysis
  • North America (US and Canada)
  • Europe (UK, Germany, France, Italy, Spain, and Rest of Europe)
  • Asia-Pacific (China, Japan, South Korea, Taiwan, India, and Rest of Asia-Pacific)
  • Rest of the World (Latin America, Middle East, and Africa)
  1. Competitive Landscape
  • Top Global Manufacturers & Market Share
  • Company Profiles & Key Developments
  • Mergers, Acquisitions & Investments
  1. Regulatory & Compliance Factors
  • FDA, REACH, and Other Regulatory Frameworks
  • Environmental & Safety Considerations
  • Emerging Policies Impacting Market Growth
  1. Conclusion & Strategic Recommendations
  • Key Takeaways for Stakeholders
  • Market Entry Strategies
What is Naldemedine Tosylate?
Naldemedine Tosylate is the tosylate salt form of Naldemedine, a peripherally acting μ-opioid receptor antagonist (PAMORA) used to treat opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Like its parent compound, Naldemedine Tosylate blocks the opioid receptors in the gastrointestinal tract without affecting the central analgesic effects of opioids. This selective action enables patients on long-term opioid therapy to maintain effective pain control while reducing the discomfort and health risks associated with constipation. It is administered orally and typically prescribed once daily, offering a convenient and non-invasive therapeutic approach.
What is the market growth of Naldemedine Tosylate?
The global market for Naldemedine Tosylate is expected to grow at a CAGR of 7.8% from 2025 to 2035. Growth is being driven by the increasing number of individuals on chronic opioid therapy, coupled with heightened awareness of the side effects of opioids, particularly gastrointestinal complications like constipation.
What are the drivers of the Naldemedine Tosylate market?
The primary drivers of the Naldemedine Tosylate market include the global burden of chronic pain requiring opioid therapy, the need for safe and effective treatments for opioid-induced constipation, and growing physician and patient awareness of PAMORAs.
Who are the key players operating in the Naldemedine Tosylate market?
Leading companies in the Naldemedine Tosylate market include Shionogi & Co., Ltd., the developer of the compound, along with marketing and distribution partners such as BioDelivery Sciences International and Purdue Pharma.
Which region will exhibit the fastest growth in the Naldemedine Tosylate market?
The Asia-Pacific region is forecasted to show the fastest growth in the Naldemedine Tosylate market, fueled by rising opioid prescriptions, expanding palliative care services, and greater access to novel gastroenterological therapies.
$1800/- Single User License
$3600/- Multi User License

How can we help you?

Reach out to discuss how our team can help your business achieve real results.