메살라진(Mesalazine) 시장 보고서 : 동향, 예측 및 경쟁 분석(-2031년)

The future of the global mesalazine market looks promising with opportunities in the tablet, capsule, pellet & granule, suppository, and enema markets. The global mesalazine market is expected to grow with a CAGR of 3.7% from 2025 to 2031. The major drivers for this market are the increasing prevalence of inflammatory bowel diseases, the rising demand for effective ulcerative colitis treatments, and the growing awareness about mesalazine's therapeutic benefits.

• Lucintel forecasts that, within the type category, above 99% is expected to witness the highest growth over the forecast period.
• Within the application category, tablet is expected to witness the highest growth.
• In terms of region, APAC is expected to witness the highest growth over the forecast period.

Emerging Trends in the Mesalazine Market

The mesalazine market is evolving with emerging trends focused on improving efficacy and patient experience. These developments are not only strengthening mesalazine's role as a first-line therapy but also addressing long-standing challenges related to patient adherence and drug delivery. The trends are reshaping the market landscape by introducing innovative solutions for a chronic condition.

• Novel Drug Delivery Systems: The market is seeing a trend toward innovative drug delivery systems. New formulations like multi-matrix system (MMX) tablets and extended-release granules are designed to ensure targeted release of the drug throughout the colon. This improves local anti-inflammatory effects while minimizing systemic absorption and side effects, enhancing efficacy.
• Increased Generic Competition: A significant trend is the rise of generic competition. As patents for blockbuster mesalazine products expire, generic manufacturers are entering the market with more affordable alternatives. This is increasing market access, particularly in price-sensitive regions, and putting downward pressure on the prices of branded products.
• Focus on Combination Therapies: There is an emerging trend toward combination therapies, where mesalazine is used in conjunction with other IBD treatments, such as biologics or immunomodulators. This approach aims to provide a more comprehensive treatment regimen, targeting multiple inflammatory pathways for better disease control and long-term remission, especially in complex cases.
• Patient-Centric Formulations: The market is shifting towards patient-centric formulations that improve convenience and compliance. This includes the development of once-daily dosing options and easy-to-swallow capsules and granules. These formulations are designed to reduce the burden of frequent medication schedules, which is a common cause of poor adherence.
• Growing Role of Digital Health: Digital health solutions are becoming an important trend in IBD management. Mobile apps for medication reminders, symptom tracking, and telemedicine platforms are being integrated into care models. These tools help patients better manage their condition, improve adherence to mesalazine therapy, and provide valuable data for healthcare providers.

These trends are fundamentally reshaping the mesalazine market by improving access, enhancing treatment efficacy, and focusing on patient needs. The combination of innovative formulations, generic availability, and digital health integration is making mesalazine a more versatile and effective therapy for IBD, thereby solidifying its position in the treatment paradigm.

Recent Developments in the Mesalazine Market

The mesalazine market has seen several key developments, driven by a need for improved treatment outcomes and patient convenience. These advancements include the proliferation of new formulations with enhanced drug delivery, the entry of generic competitors, and a renewed focus on long-term disease management, all of which are impacting the market's trajectory.

• Launch of Extended-Release Formulations: A major development is the introduction of advanced extended-release oral formulations. These products, such as MMX technology tablets, are designed to release mesalazine consistently throughout the colon. This ensures maximum drug concentration at the site of inflammation, improving efficacy and allowing for more convenient once-daily dosing.
• Increased Generic Approvals: The market has witnessed an increase in generic versions of mesalazine products gaining regulatory approval. The entry of these generics is driving down prices and making mesalazine more accessible to a wider patient population, particularly in developing countries. This is also intensifying the competition among manufacturers.
• Development of Combination Products: There is a recent development in the form of fixed-dose combination products. Although not a widespread trend yet, some research is exploring combining mesalazine with other active ingredients. This approach could offer synergistic benefits and simplify the treatment regimen, addressing the complexity of managing IBD.
• Focus on Rectal Formulations: Recent developments highlight a renewed focus on rectal formulations like foams and suppositories. These are particularly effective for treating distal ulcerative colitis. The development of new formulations with improved retention and patient comfort is a key trend, addressing a specific clinical need and improving local efficacy.
• Strategic Acquisitions and Collaborations: The market has seen strategic acquisitions and collaborations aimed at expanding product portfolios and geographical reach. For example, a company acquiring a mesalazine suppository form in China. These moves are designed to consolidate market share, streamline supply chains, and gain a competitive edge in key regions.

The recent developments in the mesalazine market are enhancing its value proposition through improved delivery, increased affordability, and a more patient-friendly approach. These changes are strengthening mesalazine's role as a foundational therapy for IBD, ensuring it remains relevant despite the rise of more expensive biologic drugs.

Strategic Growth Opportunities in the Mesalazine Market

The mesalazine market offers significant strategic growth opportunities driven by the rising prevalence of IBD and the demand for cost-effective treatments. These opportunities lie in innovative formulation development, geographical expansion, and a focus on patient-centric applications that enhance treatment adherence and overall patient outcomes.

• Novel Oral Formulations: A key growth opportunity is the development of next-generation oral formulations. By creating products with superior drug delivery mechanisms that ensure higher concentration in the colon and allow for once-daily dosing, companies can differentiate their products. This application caters to the patient's desire for convenience and improved efficacy.
• Rectal Applications: There is a strategic opportunity to innovate within the rectal application segment. Developing new suppositories, enemas, and foams with improved patient comfort, higher retention rates, and better local drug distribution can capture a significant portion of the market, particularly for patients with proctitis or left-sided colitis.
• Geographical Expansion into Emerging Markets: Expanding into emerging markets, especially in Asia and Latin America, is a major growth opportunity. As diagnosis rates for IBD increase in these regions and healthcare infrastructure improves, there is a growing need for affordable and effective treatments. Strategic market entry and localized pricing are key to success.
• Pediatric Formulations: The development of mesalazine formulations specifically for pediatric patients represents a crucial growth opportunity. This application addresses a significant unmet need. Formulations that are easy for children to take, such as granules or smaller tablets, can improve treatment compliance and provide a competitive advantage.
• Combination Therapy for Severe IBD: A strategic opportunity lies in exploring the use of mesalazine as a foundational therapy in combination with biologics for severe IBD. By demonstrating that mesalazine can improve the effectiveness or reduce the dose of more expensive biologics, companies can carve out a new application and strengthen their product's value proposition.

Strategic growth opportunities in the mesalazine market are centered on improving the drug's delivery and expanding its reach. By focusing on novel formulations, new applications, and untapped geographies, companies can drive market growth while providing more effective and accessible treatment options for a growing global population of IBD patients.

Mesalazine Market Driver and Challenges

The mesalazine market is shaped by a complex interplay of major drivers and challenges. The market's growth is propelled by an increasing global incidence of inflammatory bowel diseases, technological advancements in drug delivery, and a growing emphasis on long-term maintenance therapy. However, it is also constrained by key economic and regulatory factors.

The factors responsible for driving the mesalazine market include:

1. Increasing IBD Prevalence: The rising global incidence of inflammatory bowel diseases, such as ulcerative colitis, is a primary driver. This trend, particularly in Western countries and increasingly in emerging economies, creates a large and expanding patient population requiring chronic and acute treatment, for which mesalazine is a first-line option.

2. Technological Advancements in Formulations: Ongoing technological innovations in drug delivery systems are a key driver. The development of pH-dependent, time-dependent, and multi-matrix formulations ensures targeted release of the drug in the colon. This improves therapeutic efficacy, reduces systemic side effects, and enhances patient adherence.

3. Favorable Safety Profile: Mesalazine's well-established safety and tolerability profile is a major driver. Compared to corticosteroids and immunomodulators, mesalazine has a lower risk of severe side effects, making it a preferred choice for long-term maintenance therapy and for patients with mild to moderate disease.

4. Role in Maintenance Therapy: The recognition of mesalazine's critical role in maintaining remission and preventing disease relapse is a significant driver. Healthcare guidelines recommend its long-term use, ensuring a consistent and sustained demand for the drug as a foundational treatment for IBD.

5. Cost-Effectiveness: Compared to expensive biologic therapies, mesalazine is a highly cost-effective treatment. This makes it a preferred option for both patients and healthcare systems, especially in resource-constrained environments, ensuring its continued relevance as a first-line therapy.

Challenges in the mesalazine market are:

1. Generic Competition and Pricing Pressure: The expiration of key patents has led to intense generic competition, which is a major challenge for branded manufacturers. This is creating significant pricing pressure and can erode profit margins, potentially reducing the incentive for new formulation development.

2. Limited Efficacy in Severe Disease: Mesalazine's efficacy is largely limited to mild to moderate IBD. For severe cases, patients often require more potent and expensive biologic therapies. This limitation poses a challenge as it restricts mesalazine's use in a significant portion of the IBD patient population.

3. Patient Adherence Issues: Despite new formulations, patient non-adherence remains a significant challenge, particularly with oral dosing. Missing doses can lead to disease flare-ups. This issue highlights the need for continuous innovation in drug delivery and patient support to ensure treatment success.

The mesalazine market is driven by the growing number of IBD patients and innovations in drug delivery that enhance its safety and efficacy. However, it faces significant challenges from generic competition and its limited utility in severe cases. The market's future will depend on its ability to overcome these hurdles and solidify its role as a versatile and cost-effective treatment.

List of Mesalazine Companies

Companies in the market compete on the basis of product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leverage integration opportunities across the value chain. With these strategies mesalazine companies cater increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the mesalazine companies profiled in this report include-

• PharmaZell
• Syntese
• Cambrex Corporation
• Divis Laboratories
• Chemi
• Ipca Laboratories
• Hangzhou Brother
• Lianyungang Fengheng Biopharm
• Lasa Laboratory
• Corden Pharma Bergamo

Mesalazine Market by Segment

The study includes a forecast for the global mesalazine market by type, application, and region.

Mesalazine Market by Type [Value from 2019 to 2031]:

• Above 97%
• Above 98%
• Above 99%

Mesalazine Market by Application [Value from 2019 to 2031]:

• Tablets
• Capsules
• Pellet & Granule
• Suppository
• Enema
• Others

Country Wise Outlook for the Mesalazine Market

The mesalazine market is experiencing steady growth driven by the rising prevalence of inflammatory bowel diseases. Recent developments are focusing on improving patient compliance and convenience through innovative drug delivery systems and formulations. These advancements are solidifying mesalazine's position as a cornerstone therapy for mild to moderate ulcerative colitis and Crohn's disease.

• United States: The U.S. market has seen a surge in generic versions of mesalazine products as key patents expire. This has led to increased price competition and improved patient access. Additionally, the development of new formulations, such as once-daily extended-release tablets, is a key focus, enhancing convenience and adherence for long-term treatment.
• China: China's mesalazine market is expanding rapidly, fueled by a rising incidence of IBD and improving diagnostic capabilities. Recent developments include an increase in strategic partnerships between international and local pharmaceutical companies to expand product portfolios and market reach. The focus is on increasing awareness and access to both oral and rectal formulations.
• Germany: In Germany, mesalazine is a standard first-line treatment. The market is driven by favorable reimbursement policies and a strong emphasis on evidence-based medicine. Recent developments involve the continued use of well-established brands and a focus on improving patient adherence through specialized formulations and patient support programs.
• India: India's mesalazine market is growing but faces challenges related to affordability. Recent developments include an increase in the number of local manufacturers producing generic versions, which is helping to improve accessibility. The market is also seeing a rise in awareness campaigns for IBD, which is expected to drive diagnosis and treatment rates.
• Japan: Japan's mesalazine market is mature, with a strong emphasis on high-quality and reliable treatments. Recent developments include the approval of new formulations that offer better efficacy and fewer side effects. The market is also seeing a focus on long-term management of IBD, with a push for therapies that maintain remission and improve patient quality of life.

Features of the Global Mesalazine Market

• Market Size Estimates: Mesalazine market size estimation in terms of value ($B).
• Trend and Forecast Analysis: Market trends (2019 to 2024) and forecast (2025 to 2031) by various segments and regions.
• Segmentation Analysis: Mesalazine market size by type, application, and region in terms of value ($B).
• Regional Analysis: Mesalazine market breakdown by North America, Europe, Asia Pacific, and Rest of the World.
• Growth Opportunities: Analysis of growth opportunities in different types, applications, and regions for the mesalazine market.
• Strategic Analysis: This includes M&A, new product development, and competitive landscape of the mesalazine market.

Analysis of competitive intensity of the industry based on Porter's Five Forces model.

This report answers following 11 key questions:

• Q.1. What are some of the most promising, high-growth opportunities for the mesalazine market by type (above 97%, above 98%, and above 99%), application (tablets, capsules, pellet & granule, suppository, enema, and others), and region (North America, Europe, Asia Pacific, and the Rest of the World)?
• Q.2. Which segments will grow at a faster pace and why?
• Q.3. Which region will grow at a faster pace and why?
• Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?
• Q.5. What are the business risks and competitive threats in this market?
• Q.6. What are the emerging trends in this market and the reasons behind them?
• Q.7. What are some of the changing demands of customers in the market?
• Q.8. What are the new developments in the market? Which companies are leading these developments?
• Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?
• Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or product substitution?
• Q.11. What M&A activity has occurred in the last 5 years and what has its impact been on the industry?

Table of Contents

1. Executive Summary

2. Market Overview

• 2.1 Background and Classifications
• 2.2 Supply Chain

3. Market Trends & Forecast Analysis

• 3.2 Industry Drivers and Challenges
• 3.3 PESTLE Analysis
• 3.4 Patent Analysis
• 3.5 Regulatory Environment

4. Global Mesalazine Market by Type

• 4.1 Overview
• 4.2 Attractiveness Analysis by Type
• 4.3 Above 97%: Trends and Forecast (2019-2031)
• 4.4 Above 98%: Trends and Forecast (2019-2031)
• 4.5 Above 99%: Trends and Forecast (2019-2031)

5. Global Mesalazine Market by Application

• 5.1 Overview
• 5.2 Attractiveness Analysis by Application
• 5.3 Tablets: Trends and Forecast (2019-2031)
• 5.4 Capsules: Trends and Forecast (2019-2031)
• 5.5 Pellet & Granule: Trends and Forecast (2019-2031)
• 5.6 Suppository: Trends and Forecast (2019-2031)
• 5.7 Enema: Trends and Forecast (2019-2031)
• 5.8 Others: Trends and Forecast (2019-2031)

6. Regional Analysis

• 6.1 Overview
• 6.2 Global Mesalazine Market by Region

7. North American Mesalazine Market

• 7.1 Overview
• 7.2 North American Mesalazine Market by Type
• 7.3 North American Mesalazine Market by Application
• 7.4 United States Mesalazine Market
• 7.5 Mexican Mesalazine Market
• 7.6 Canadian Mesalazine Market

8. European Mesalazine Market

• 8.1 Overview
• 8.2 European Mesalazine Market by Type
• 8.3 European Mesalazine Market by Application
• 8.4 German Mesalazine Market
• 8.5 French Mesalazine Market
• 8.6 Spanish Mesalazine Market
• 8.7 Italian Mesalazine Market
• 8.8 United Kingdom Mesalazine Market

9. APAC Mesalazine Market

• 9.1 Overview
• 9.2 APAC Mesalazine Market by Type
• 9.3 APAC Mesalazine Market by Application
• 9.4 Japanese Mesalazine Market
• 9.5 Indian Mesalazine Market
• 9.6 Chinese Mesalazine Market
• 9.7 South Korean Mesalazine Market
• 9.8 Indonesian Mesalazine Market

10. ROW Mesalazine Market

• 10.1 Overview
• 10.2 ROW Mesalazine Market by Type
• 10.3 ROW Mesalazine Market by Application
• 10.4 Middle Eastern Mesalazine Market
• 10.5 South American Mesalazine Market
• 10.6 African Mesalazine Market

11. Competitor Analysis

• 11.1 Product Portfolio Analysis
• 11.2 Operational Integration
• 11.3 Porter's Five Forces Analysis
  • Competitive Rivalry
  • Bargaining Power of Buyers
  • Bargaining Power of Suppliers
  • Threat of Substitutes
  • Threat of New Entrants
• 11.4 Market Share Analysis

12. Opportunities & Strategic Analysis

• 12.1 Value Chain Analysis
• 12.2 Growth Opportunity Analysis
  • 12.2.1 Growth Opportunities by Type
  • 12.2.2 Growth Opportunities by Application
• 12.3 Emerging Trends in the Global Mesalazine Market
• 12.4 Strategic Analysis
  • 12.4.1 New Product Development
  • 12.4.2 Certification and Licensing
  • 12.4.3 Mergers, Acquisitions, Agreements, Collaborations, and Joint Ventures

13. Company Profiles of the Leading Players Across the Value Chain

• 13.1 Competitive Analysis
• 13.2 PharmaZell
  • Company Overview
  • Mesalazine Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.3 Syntese
  • Company Overview
  • Mesalazine Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.4 Cambrex Corporation
  • Company Overview
  • Mesalazine Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.5 Divis Laboratories
  • Company Overview
  • Mesalazine Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.6 Chemi
  • Company Overview
  • Mesalazine Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.7 Ipca Laboratories
  • Company Overview
  • Mesalazine Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.8 Hangzhou Brother
  • Company Overview
  • Mesalazine Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.9 Lianyungang Fengheng Biopharm
  • Company Overview
  • Mesalazine Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.10 Lasa Laboratory
  • Company Overview
  • Mesalazine Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.11 Corden Pharma Bergamo
  • Company Overview
  • Mesalazine Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing

14. Appendix

• 14.1 List of Figures
• 14.2 List of Tables
• 14.3 Research Methodology
• 14.4 Disclaimer
• 14.5 Copyright
• 14.6 Abbreviations and Technical Units
• 14.7 About Us
• 14.8 Contact Us