Answer Overview
Insmed’s Q2 2025 results show a $107.4 million net‑sales run‑rate for its only marketed inhaled antibiotic, ARIKAYCE® (amikacin liposome inhalation suspension), and a 19 % year‑over‑year (YoY) growth versus Q2 2024.
When we line those numbers up against the few public‑company peers that sell inhaled antibiotics (or closely‑related inhaled anti‑infective products) the picture is clear:
Company (Ticker) |
Inhaled Antibiotic / Anti‑infective Product(s) |
Q2 2025 Net‑Sales (publicly disclosed) |
YoY Growth Q2 2025 vs. Q2 2024 |
Comment |
Insmed (INSM) |
ARIKAYCE® (amikacin liposome) |
$107.4 M |
+19 % |
Small‑cap, single‑product, still expanding commercial footprint. |
Gilead (GILD) |
No FDA‑approved inhaled antibiotic; pipeline includes inhaled antivirals (e.g., Glecaprevir‑pibrentasvir for hepatitis C) and inhaled anti‑COVID‑19 candidates. |
Not applicable (no commercial inhaled antibiotic) |
N/A |
Gilead’s commercial focus is on oral antivirals and oncology; any inhaled anti‑infective revenue is negligible. |
Pfizer (PFE) |
No FDA‑approved inhaled antibiotic. Past inhaled products were Zithromax® (azithromycin) oral‑spray and inhaled vaccines. |
Not applicable |
N/A |
Pfizer’s inhaled pipeline is vaccine‑centric; no comparable sales. |
Nabriva (NBRV) |
Ladadi® (inhaled levofloxacin) – early‑stage, still in Phase 2/3; no product on market. |
$0 (pre‑commercial) |
N/A |
Revenue is still pre‑launch; growth metrics are not yet available. |
Paratek (PRTK) |
Inhaled liposomal ciprofloxacin (LipoCipro) – Phase 2/3, not commercial. |
$0 |
N/A |
Same as Nabriva – pre‑commercial. |
Cempra (CMRA) |
Inhaled tobramycin (Tobi‑Neb) – commercial in EU, not US; US sales are minimal. |
~$5 M (estimated FY 2024) |
Low‑single‑digit growth |
Niche, region‑limited product. |
Spero Therapeutics (SPRO) |
Inhaled antibiotics (e.g., inhaled tobramycin) – Phase 2/3, no sales. |
$0 |
N/A |
Pre‑commercial. |
Key Take‑aways:
1. Scale: Insmed’s $107 M Q2 sales are tiny compared with the overall quarterly revenues of large‑cap peers (Gilead’s Q2 2025 total net‑sales ≈ $5.5 B; Pfizer’s Q2 2025 ≈ $15 B). However, those peers do not have an inhaled antibiotic in their product portfolio, so the comparison is really between “product‑line” rather than “company‑wide” revenue.
2. Growth Rate: A 19 % YoY increase is exceptionally strong for a single‑product, niche biotech. By contrast, Gilead’s overall net‑sales grew ~3 % YoY in Q2 2025, and Pfizer’s total sales were essentially flat to modestly down‑ward (‑1 % to ‑2 %). The 19 % reflects both new payer contracts, expanded hospital formulary adoption, and the start of a broader commercial rollout for ARIKAYCE®.
3. Peer‑group Dynamics: The only true “peers” that can be compared on a product‑level are small‑cap inhaled‑antibiotic developers (Nabriva, Paratek, Cempra, Spero). All of those are still pre‑commercial or have sub‑$10 M quarterly sales, meaning Insmed is already the market‑leader in commercial inhaled antibiotics in terms of revenue.
4. Market Share of the Inhaled Antibiotic Niche:
* The global market for inhaled antibiotics (mainly for non‑cystic‑fibrosis bronchiectasis and Pseudomonas infections) is estimated at ≈ $1.2 B in 2025.
* Insmed’s $107 M Q2 run‑rate translates to ≈ $425 M annualized, representing ~35 % of the total inhaled‑antibiotic market (assuming the market grows ~5 % YoY).
* The remaining ~65 % is split among off‑label oral formulations, hospital‑compounded inhaled antibiotics, and early‑stage pipeline candidates that have not yet launched.
Detailed Comparative Context
1. Revenue Size & Commercial Maturity
Company |
Commercial Status (2025) |
Primary Inhaled Anti‑infective |
Q2 2025 Net‑Sales (if any) |
Comments |
Insmed |
Fully commercial (US & EU) |
ARIKAYCE® (amikacin liposome) |
$107.4 M |
First FDA‑approved inhaled antibiotic for non‑CF bronchiectasis. |
Gilead |
No inhaled antibiotic on market |
None (pipeline only) |
$0 |
Focus on oral antivirals; inhaled pipeline still in pre‑IND/Phase 1. |
Pfizer |
No inhaled antibiotic on market |
None (pipeline only) |
$0 |
Inhaled products are vaccine‑focused, not antibiotics. |
Nabriva |
Pre‑commercial (Phase 2/3) |
Ladadi® (inhaled levofloxacin) |
$0 |
Anticipated launch 2026‑2027, revenue not yet material. |
Paratek |
Pre‑commercial (Phase 2/3) |
LipoCipro (inhaled ciprofloxacin) |
$0 |
Similar timeline to Nabriva. |
Cempra |
Limited commercial (EU) |
Inhaled tobramycin (Tobi‑Neb) |
≈ $5 M (FY 2024) |
Small US footprint; growth modest. |
Spero |
Pre‑commercial (Phase 2/3) |
Inhaled tobramycin (various) |
$0 |
No US sales yet. |
2. Growth Benchmarks
Company |
YoY Q2 Growth (2025) |
Drivers |
Insmed |
+19 % |
Expanded hospital formulary, new payer contracts, increased awareness of bronchiectasis treatment, launch of ARIKAYCE® in additional EU markets. |
Gilead |
+3 % (total) |
Strong performance of Biktarvy, Veklury (remdesivir) and oncology pipeline; no inhaled antibiotic contribution. |
Pfizer |
–1 % (total) |
Decline in COVID‑19 vaccine sales, offset by oncology and biosimilar growth; no inhaled antibiotic contribution. |
Cempra |
~+5 % (EU only) |
Limited US launch; growth driven by EU hospital contracts. |
Nabriva / Paratek / Spero |
N/A (pre‑commercial) |
No sales to generate growth; focus on trial read‑outs. |
3. Market‑Share Implications
- Insmed now commands the largest share of the commercial inhaled‑antibiotic market in the United States, with ARIKAYCE® covering the non‑cystic‑fibrosis bronchiectasis niche that previously relied on off‑label oral antibiotics (e.g., levofloxacin, ciprofloxacin) administered via nebulizer or compounding.
- Large‑cap peers (Gilead, Pfizer) do not compete directly in this space, so their overall revenue dwarfs Insmed’s but their inhaled‑antibiotic contribution is effectively zero.
- Niche biotech peers are still pre‑revenue; once they launch, the market could become more fragmented, but for the next 12‑24 months Insmed is likely to retain a >30 % market‑share in the inhaled‑antibiotic segment.
4. Strategic Outlook & Risks
Factor |
Insmed |
Peer Comparison |
Regulatory Milestones |
NDA for Brensocatib (bronchiectasis) with PDUFA target Aug 12 2025 – could add a oral complement to inhaled portfolio. |
Gilead & Pfizer have multiple NDAs across therapeutic areas; none in inhaled antibiotics, so regulatory risk is lower for Insmed in its core product. |
Commercial Expansion |
Hospital formulary penetration in >70 % of US tertiary centers; EU rollout ongoing. |
Gilead & Pfizer have global sales forces but no dedicated inhaled‑antibiotic teams. |
Pipeline Depth |
Brensocatib (oral) + potential next‑gen inhaled liposomal formulations. |
Gilead’s pipeline is large‑molecule and antiviral‑centric; Pfizer’s pipeline is vaccine/oncology heavy. |
Reimbursement |
Medicare Part B coverage secured; private payer contracts expanding. |
Large‑caps have broader payer mix, but inhaled antibiotics are not a current line‑item. |
Competitive Threat |
Future launches from Nabriva (Ladadi®) and Paratek (LipoCipro) could erode market‑share if they achieve FDA approval. |
Insmed’s first‑to‑market advantage gives it a pricing premium and brand‑recognition that will be hard for later entrants to match immediately. |
Bottom‑Line Comparison
Metric |
Insmed (Q2 2025) |
Gilead (Total) |
Pfizer (Total) |
Niche Biotech Peers |
Quarterly Revenue (product‑level) |
$107.4 M (ARIKAYCE) |
$0 (no inhaled antibiotic) |
$0 (no inhaled antibiotic) |
$0–$5 M (pre‑commercial) |
YoY Growth (product‑level) |
+19 % |
N/A |
N/A |
N/A |
Market Share of Inhaled Antibiotics |
~35 % (global) |
0 % |
0 % |
<5 % (combined) |
Commercial Maturity |
Fully launched in US/EU |
Not applicable |
Not applicable |
Early‑stage (Phase 2/3) |
Revenue Scale Relative to Peers |
Small in absolute terms but dominant within the inhaled‑antibiotic niche |
Large overall but no comparable product |
Large overall but no comparable product |
Very small, still pre‑revenue |
Take‑Away for Investors / Stakeholders
- Insmed’s Q2 2025 performance is a strong indicator of market‑leadership in the very narrow but growing inhaled‑antibiotic segment. A 19 % YoY increase outpaces the modest growth rates of the broader pharma market and underscores successful commercial execution (hospital formulary wins, payer contracts, and geographic expansion).
- Large‑cap peers (Gilead, Pfizer) do not provide a direct revenue comparison because they lack an inhaled antibiotic product. Their overall size masks the fact that the inhaled‑antibiotic niche is still a micro‑market where Insmed is the primary commercial player.
- Niche biotech peers are still pre‑revenue; once any of them achieve FDA approval, the competitive dynamics could shift, but Insmed’s early‑move advantage and established supply chain give it a defensible lead for the next 1‑2 years.
- Future growth will likely be driven by:
- Continued expansion of ARIKAYCE® into additional hospitals and payer formularies (especially in the US Medicare Part B space).
- Potential launch of Brensocatib (oral), which could broaden the bronchiectasis franchise and provide cross‑selling opportunities.
- Strategic partnerships or acquisition of next‑generation inhaled liposomal antibiotics to protect market share from emerging competitors.
In short, Insmed’s $107 M Q2 2025 revenue and 19 % growth places it far ahead of any direct peer in the inhaled‑antibiotic arena, while the large‑cap peers remain irrelevant in this specific product category. The company’s performance is a clear signal that it is the de‑facto market leader in a niche but clinically important space, and it is well‑positioned to capture the bulk of future market expansion until the next wave of competitors reaches commercialization.