ARIKAYCE Sales Forecast, and Market Size Analysis - 2034

Key Factors Driving ARIKAYCE Growth

1. Market Share Gains and New Patient Starts

• ARIKAYCE continues to expand its share in the nontuberculous mycobacterial (NTM) lung disease market, particularly in patients with refractory Mycobacterium avium complex (MAC) lung disease who have failed standard therapy.
• Growing diagnosis rates of NTM infections and rising physician awareness are driving new patient starts across specialty pulmonary centers.
• Insmed's focused commercial strategy, including physician education and patient support programs, is accelerating ARIKAYCE adoption globally.

2. Expansion Across Key Indications

• Refractory MAC Lung Disease: ARIKAYCE is approved for adults with MAC lung disease who do not respond to conventional multidrug therapy, offering targeted delivery of amikacin directly to the lungs.
• Broader NTM Infections: Ongoing research and real-world use are exploring potential expansion into other NTM species beyond MAC.
• Earlier-Line Use Potential: Pipeline and real-world data are supporting evaluation of ARIKAYCE in earlier treatment settings and in combination regimens.

3. Geographic Expansion

• ARIKAYCE is marketed in the United States, Europe, and Japan, with continued expansion into additional global markets.
• Asia-Pacific is a key growth region, driven by increasing NTM prevalence, aging populations, and improved diagnostic infrastructure.
• Insmed is strengthening regional partnerships, reimbursement strategies, and distribution networks to accelerate uptake.

4. New Indication Approvals

• ARIKAYCE received regulatory approvals in the US, EU, and Japan for refractory MAC lung disease.
• Health authorities continue to review label expansions and post-marketing data to potentially broaden its use across additional NTM populations.

5. Strong MAC Lung Disease Volume Momentum

• MAC lung disease remains the primary growth driver, with sustained prescription growth in refractory patients.
• Insmed's recent updates highlight continued year-over-year volume growth, supported by strong real-world outcomes and adherence.
• Increasing referrals from pulmonologists and infectious disease specialists are reinforcing treatment momentum.

6. Competitive Differentiation and Market Trends

• Inhaled liposomal delivery enables high local drug concentrations in the lungs while limiting systemic exposure, differentiating ARIKAYCE from IV amikacin.
• Targeted pulmonary therapy improves tolerability and long-term treatment feasibility.
• Market trends toward precision respiratory anti-infective therapies, outpatient care, and real-world data-driven reimbursement support ARIKAYCE's positioning.
• Growing reliance on real-world evidence (RWE) is strengthening payer confidence.

ARIKAYCE Recent Developments

In October 2024, Insmed Incorporated reported financial results for the third quarter ended September 30, 2024, and provided a business update.

• ARIKAYCE global revenue grew 18% in the third quarter of 2024 compared to the third quarter of 2023, reflecting an all-time revenue high and double-digit year-over-year growth in the US, Japan, and Europe and rest of world.
• Insmed has closed screening of new patients for the ENCORE study and is now expected to exceed its target enrollment of 400 patients with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung infection who have not started antibiotics.
• The Company is scheduled to meet with the US Food and Drug Administration (FDA) during the fourth quarter to discuss the possibility of an accelerated approval to expand the label for ARIKAYCE to include all patients with MAC lung infection, based on the positive Phase III ARISE trial data. Insmed continues to expect that the full data from the ongoing ENCORE trial will be required for approval.

"ARIKAYCE Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of ARIKAYCE for approved indication like Nontuberculous mycobacterium infections; as well as potential indications like Cystic fibrosis-associated respiratory tract infections and Bronchiectasis. in the 7MM. A detailed picture of ARIKAYCE's existing usage in approved and anticipated entry and performance in potential indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 -2034 is provided in this report along with a detailed description of the ARIKAYCE for approved and potential indications. The ARIKAYCE market report provides insights about ARIKAYCE's sales forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current ARIKAYCE performance, future market assessments inclusive of the ARIKAYCE market forecast analysis for approved and potential indications in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of ARIKAYCE sales forecasts, along with factors driving its market.

ARIKAYCE Drug Summary

ARIKAYCE (amikacin liposome inhalation suspension) is a liposomal formulation of the aminoglycoside antibiotic amikacin, indicated in adults with limited or no alternative treatment options for refractory Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial regimen following >=6 months of standard multidrug therapy without culture conversion, and also approved in the EU for non-tuberculous mycobacterial (NTM) lung infections caused by MAC. Delivered via nebulization using the Lamira Nebulizer System (590 mg/8.4 mL once daily), the liposomes (composed of dipalmitoylphosphatidylcholine, cholesterol, and sodium chloride) enable targeted pulmonary delivery with a mass median aerodynamic diameter of ~4.7 μm, facilitating penetration into bacterial biofilms and macrophage phagocytosis where MAC resides; amikacin binds to the 30S ribosomal subunit, inhibiting bacterial protein synthesis and exerting bactericidal activity against intracellular and extracellular MAC while minimizing systemic exposure. Administered chronically with close monitoring for ototoxicity, nephrotoxicity, bronchospasm, and anti-drug antibodies, ARIKAYCE represents an innovative inhaled therapy for this progressive pulmonary infection affecting vulnerable patients. The report provides ARIKAYCE's sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the ARIKAYCE Market Report

The report provides insights into:

• A comprehensive product overview including the ARIKAYCE MoA, description, dosage and administration, research and development activities in approved indications like Nontuberculous mycobacterium infections; as well as potential indications like Cystic fibrosis-associated respiratory tract infections and Bronchiectasis..
• Elaborated details on ARIKAYCE regulatory milestones and other development activities have been provided in ARIKAYCE market report.
• The report also highlights ARIKAYCE's cost estimates and regional variations, reported and estimated sales performance, research and development activities in approved and potential indications across the United States, Europe, and Japan.
• The ARIKAYCE market report also covers the patents information, generic entry and impact on cost cut.
• The ARIKAYCE market report contains current and forecasted ARIKAYCE sales for approved and potential indications till 2034.
• Comprehensive coverage of the late-stage emerging therapies for respective indications.
• The ARIKAYCE market report also features the SWOT analysis with analyst views for ARIKAYCE in approved and potential indications.

Methodology:

The ARIKAYCE market report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight's team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

ARIKAYCE Analytical Perspective by DelveInsight

• In-depth ARIKAYCE Market Assessment

This ARIKAYCE sales market forecast report provides a detailed market assessment of ARIKAYCE for approved indication like Nontuberculous mycobacterium infections; as well as potential indications like Cystic fibrosis-associated respiratory tract infections and Bronchiectasis. in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides current and forecasted ARIKAYCE sales data uptil 2034.

• ARIKAYCE Clinical Assessment

The ARIKAYCE market report provides the clinical trials information of ARIKAYCE for approved and potential indications covering trial interventions, trial conditions, trial status, start and completion dates.

ARIKAYCE Competitive Landscape

The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.

ARIKAYCE Market Potential & Revenue Forecast

• Projected market size for the ARIKAYCE and its key indications
• Estimated ARIKAYCE sales potential (ARIKAYCE peak sales forecasts)
• ARIKAYCE Pricing strategies and reimbursement landscape

ARIKAYCE Competitive Intelligence

• Number of competing drugs in development (pipeline analysis)
• ARIKAYCE Market positioning compared to existing treatments
• ARIKAYCE Strengths & weaknesses relative to competitors

ARIKAYCE Regulatory & Commercial Milestones

• ARIKAYCE Key regulatory approvals & expected launch timelines
• Commercial partnerships, licensing deals, and M&A activity

ARIKAYCE Clinical Differentiation

• ARIKAYCE Efficacy & safety advantages over existing drugs
• ARIKAYCE Unique selling points

ARIKAYCE Market Report Highlights

• In the coming years, the ARIKAYCE market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
• The ARIKAYCE companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence ARIKAYCE's dominance.
• Other emerging products for Nontuberculous mycobacterium infections; as well as potential indications like Cystic fibrosis-associated respiratory tract infections and Bronchiectasis. are expected to give tough market competition to ARIKAYCE and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of ARIKAYCE in approved and potential indications.
• Analyse ARIKAYCE cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
• Our in-depth analysis of the forecasted ARIKAYCE sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of ARIKAYCE in approved and potential indications.

Key Questions:

• What is the class of therapy, route of administration and mechanism of action of ARIKAYCE? How strong is ARIKAYCE's clinical and commercial performance?
• What is ARIKAYCE's clinical trial status in each individual indications such as Nontuberculous mycobacterium infections; as well as potential indications like Cystic fibrosis-associated respiratory tract infections and Bronchiectasis. and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the ARIKAYCE Manufacturers?
• What are the key designations that have been granted to ARIKAYCE for approved and potential indications? How are they going to impact ARIKAYCE's penetration in various geographies?
• What is the current and forecasted ARIKAYCE market scenario for approved and potential indications? What are the key assumptions behind the forecast?
• What are the current and forecasted sales of ARIKAYCE in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
• What are the other emerging products available and how are these giving competition to ARIKAYCE for approved and potential indications?
• Which are the late-stage emerging therapies under development for the treatment of approved and potential indications?
• How cost-effective is ARIKAYCE? What is the duration of therapy and what are the geographical variations in cost per patient?