Clinical Trials Update
Isosorbide Mononitrate in Cerebral Small Vessel Disease
A recent randomized clinical trial, the Lacunar Intervention Trial-2 (LACI-2), has provided significant insights into the use of isosorbide mononitrate (ISMN) and cilostazol in patients with symptomatic cerebral small vessel disease, particularly those who have experienced lacunar ischemic stroke.
- Trial Design and Outcomes: The trial involved 363 participants randomized to receive ISMN, cilostazol, a combination of both, or no study drug. The primary outcome was recruitment feasibility and retention at 12 months, with secondary outcomes including safety, efficacy, drug adherence, and various clinical outcomes such as recurrent stroke, dependence, cognitive impairment, and quality of life[1].
- Key Findings: ISMN reduced recurrent stroke and cognitive impairment, while cilostazol reduced dependence. The combination of ISMN and cilostazol showed a significant reduction in the composite of adverse vascular, dependence, and cognitive outcomes. The trial demonstrated good feasibility, high retention rates, and no safety concerns, suggesting that these agents could be beneficial in preventing long-term adverse outcomes in cerebral small vessel disease[1].
Implications for Future Trials
The LACI-2 trial highlights the potential of ISMN and cilostazol in managing the aftermath of lacunar ischemic stroke. The results indicate that larger phase 3 trials are warranted to confirm these findings and fully explore the therapeutic benefits of these medications.
Market Analysis
Global Isosorbide Market Size and Growth
The global isosorbide market is experiencing robust growth driven by several key factors:
- Market Size and Forecast: As of 2023, the global isosorbide market was valued at approximately USD 703.47 million and is projected to grow at a Compound Annual Growth Rate (CAGR) of 9.4% during the forecast period up to 2032. This growth is anticipated to reach a market size of USD 1,577.75 million by 2032[5].
- Driving Factors: The increasing demand for eco-friendly and sustainable products, particularly in the polymer and biotechnology industries, is a major driver. Isosorbide, derived from starch, serves as an eco-friendly alternative to synthetic polymers, which is gaining traction due to rising health and environmental concerns[2][5].
End-Use Industries and Regional Trends
- End-Use Applications: Isosorbide is widely used in various industries, including the production of polycarbonate, polyethylene, polyurethane, and polyesters succinate. The demand from these sectors, especially from the additives and resins & polymers industries, is a significant contributor to market growth[3][5].
- Regional Growth: North America is currently leading the global isosorbide market, but emerging economies such as India and China are also showing promising growth, particularly in the construction sector. For instance, India's construction sector has seen a significant growth of 16.8% in recent quarters, which is expected to drive the demand for isosorbide further[5].
Market Trends
- Rising Demand for PEIT: One of the major trends driving the isosorbide market is the increasing demand for polyethylene isosorbide terephthalate (PEIT), which is used in various applications due to its superior properties compared to traditional plastics[3][5].
- Sustainability and Legislation: Strong regulatory support for bio-based products and the continuous focus on high-quality, sustainable materials are also key trends influencing the market. The shift towards eco-friendly products is expected to continue driving the demand for isosorbide in the coming years[2][5].
Projections and Future Outlook
Market Growth Projections
- CAGR and Market Size: The global isosorbide market is expected to maintain a high growth rate, with a CAGR of 9.4% from 2023 to 2032. This growth is anticipated to result in a market size of USD 1,577.75 million by 2032[5].
- Regional Expansion: The market is expected to expand significantly in emerging economies, driven by infrastructure development and the increasing adoption of sustainable materials in various industries[5].
Opportunities and Challenges
- Opportunities: The growing demand for bio-based plastics, the expansion of the construction sector in emerging economies, and the increasing focus on sustainability present significant opportunities for the isosorbide market[5].
- Challenges: While the market is poised for growth, it may face challenges such as fluctuations in raw material prices and the need for continuous innovation to meet the evolving demands of end-use industries[3].
Key Takeaways
- Clinical Trials: Isosorbide mononitrate has shown promising results in reducing adverse outcomes in patients with cerebral small vessel disease, highlighting the need for larger phase 3 trials.
- Market Growth: The global isosorbide market is expected to grow significantly, driven by the demand for eco-friendly products and strong regulatory support.
- End-Use Applications: Isosorbide is used in various industries, including polymers, biotechnology, and construction, which are driving its market growth.
- Regional Trends: North America currently leads the market, but emerging economies are expected to contribute significantly to future growth.
FAQs
What are the primary outcomes of the LACI-2 trial involving isosorbide mononitrate?
The primary outcomes of the LACI-2 trial included recruitment feasibility and retention at 12 months, with secondary outcomes such as safety, efficacy, drug adherence, and various clinical outcomes like recurrent stroke, dependence, and cognitive impairment[1].
What is driving the growth of the global isosorbide market?
The growth of the global isosorbide market is driven by the increasing demand for eco-friendly and sustainable products, strong regulatory support for bio-based products, and the rising demand from end-use industries such as polymers and construction[2][5].
What is the projected market size of the global isosorbide market by 2032?
The global isosorbide market is expected to reach a size of USD 1,577.75 million by 2032, growing at a CAGR of 9.4% from 2023 to 2032[5].
Which regions are expected to contribute significantly to the growth of the isosorbide market?
North America is currently leading the market, but emerging economies such as India and China are expected to contribute significantly to future growth due to their expanding construction sectors and increasing adoption of sustainable materials[5].
What are the major trends influencing the isosorbide market?
Major trends include the rising demand for PEIT, increasing focus on sustainability, and strong regulatory support for bio-based products. These trends are expected to continue driving the demand for isosorbide in the coming years[3][5].
Sources
- LACI-2 Trial: "Isosorbide Mononitrate and Cilostazol Treatment in Patients With Symptomatic Cerebral Small Vessel Disease: A Randomized Clinical Trial" - JAMA Neurology[1].
- Global Isosorbide Market: "Global Isosorbide Market Anticipated to Cross $703M by 2025" - Business Wire[2].
- Isosorbide Market Report: "Research Report: Isosorbide Market (2020-2024)" - Business Wire[3].
- Hydralazine and Isosorbide Dinitrate: "Hydralazine and Isosorbide Dinitrate in Heart Failure" - ABC Heart Failure[4].
- Global Isosorbide Market Size: "Global Isosorbide Market Size, Share Analysis Report, 2024-2032" - Polaris Market Research[5].
