Company-reported prevalence

Molgramostim Inhalation Solution

Overview

Field	Value
Drug	Molbreevi (molgramostim inhalation solution)
Indication	Autoimmune pulmonary alveolar proteinosis
Disease	Autoimmune pulmonary alveolar proteinosis (autoimmune PAP); some figures count all pulmonary alveolar proteinosis (PAP)
Company	Savara Inc.; no licensing partner holding rights is named in the documents searched
Documents searched	Savara website pages on autoimmune PAP, diagnosing autoimmune PAP, Molbreevi, patients, and the company (undated, read October 2026); aPAP ClearPath disease awareness website, healthcare professional and patient pages (undated, read October 2026); press releases of March 7, 2024, September 27, 2024, 2025 (refusal to file letter, NEJM publication, September 2 claims analysis, December BLA resubmission), and 2026 (regulatory update, PANTHERx Rare selection, review period extension, second-quarter results, ERS 2026 encore presentations); Form 10-K for 2025 (filed March 13, 2026); Form 10-K for 2022 (filed 2023); corporate presentation, October 7, 2026
Data as of	October 14, 2026
Prepared by	AI research agent (Claude); not yet reviewed by a person

Company statements of prevalence

United States

Prevalence (all PAP): Savara Form 10-K for 2025, March 2026

“Autoimmune PAP represents about 90% of all patients with PAP and the estimated diagnosed prevalence of PAP is six to seven cases per million people in the U.S., with similar or higher prevalence reported elsewhere in the world.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Savara Inc. (2026) Form 10-K for 2025, quoted passage highlighted — Captured from the passage on the page (opens in a new tab)

Prevalence (all PAP): Savara aPAP ClearPath website, October 2026

“In the United States, the prevalence of PAP diagnoses is about 7 in 1 million people.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Savara Inc. (2026) aPAP ClearPath website for healthcare professionals, quoted passage highlighted — Captured from the passage on the page (opens in a new tab)

Prevalence: Savara corporate presentation, October 2026

“U.S. Autoimmune PAP Addressable Patients” (opens the source at this quote in a new tab)
“16.0 patients / million” (opens the source at this quote in a new tab)
“U.S. Claims Analysis, 2025” (opens the source at this quote in a new tab)
“~5,500” (opens the source at this quote in a new tab)

Cited source: 2.5 Savara Inc. 2025

Savara Inc. (2026) corporate presentation, October 2026, quoted passage highlighted — Captured from page 33 of 48 (opens in a new tab)

Eligible population: Savara corporate presentation, October 2026

“Current U.S. TAM of autoimmune PAP patients” (opens the source at this quote in a new tab)
“~5,500” (opens the source at this quote in a new tab)
“TAM = Total addressable market” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Number diagnosed: Savara press release, September 2025

“today announced an increased estimate of autoimmune PAP diagnosed prevalence in the U.S. The updated analysis indicates an ~50% larger autoimmune PAP patient population in the U.S. than the Company’s previously estimated claims analysis from 2023 (~5,500 autoimmune PAP patients versus ~3,600).” (opens the source at this quote in a new tab)
“Autoimmune PAP prevalence rates were applied to the confirmed PAP population (i.e., those with a J84.01 code and a medical/pharmacy claim within the last two and a half years), resulting in ~5,500 autoimmune PAP patients in the U.S.” (opens the source at this quote in a new tab)

Cited source: 2.5 Savara Inc. 2025

Savara Inc. (2025) press release, September 2, 2025, quoted passage highlighted — Captured from the passage on the page (opens in a new tab)

Number diagnosed: Savara press release, March 2024

“~3,600 currently diagnosed aPAP patients and another ~1,400 potential, currently undiagnosed, aPAP patients in the U.S.” (opens the source at this quote in a new tab)

Cited source: 2.6 Savara Inc. 2023

Savara Inc. (2024) press release, March 7, 2024, quoted passage highlighted — Captured from page 1 of 5 (opens in a new tab)

Europe

Eligible population (EU4 and the United Kingdom): Savara corporate presentation, October 2026

“Europe (EU4+UK) Market Development is Underway” (opens the source at this quote in a new tab)
“Germany 11 ~1,300 UK 25 ~1,104 France 24 ~1,104 Italy 16 ~944 Spain 12 ~784 Total 88 ~5,200” (opens the source at this quote in a new tab)

Cited source: 2.5 Savara Inc. 2025

Global

No evidence found.

Other countries and regions

Prevalence (all PAP): Savara website, October 2026

“The estimated prevalence of PAP is between 6 and 7 cases per million in the U.S. and Japan, with similar or higher prevalence reported elsewhere in the world.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Savara Inc. (2026) website, autoimmune PAP page, quoted passage highlighted — Captured from the passage on the page (opens in a new tab)

Prevalence: Savara website, October 2026

“It is now estimated the prevalence in Japan could be 26 per million in that country.” (opens the source at this quote in a new tab)

Cited source: 2.4 Kitamura 2019

Prevalence (all PAP in Japan): Savara Form 10-K for 2025, March 2026

“For example, one study estimated that the diagnosed prevalence in Japan could be three to four times the estimate of six to seven cases per million.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Geography not stated

Prevalence (estimates from published literature): Savara corporate presentation, October 2026

“Published Autoimmune PAP Epidemiology Literature” (opens the source at this quote in a new tab)
“26.6 patients / million” (opens the source at this quote in a new tab)
“Kitamura, 2019” (opens the source at this quote in a new tab)
“6.2-8.5 patients / million” (opens the source at this quote in a new tab)
“Inoue, 2008” (opens the source at this quote in a new tab)
“McCarthy, 2018” (opens the source at this quote in a new tab)
“Kimura, 2025” (opens the source at this quote in a new tab)

Cited source: 2.1 Inoue 2008; 2.2 McCarthy 2018; 2.3 Kimura 2025; 2.4 Kitamura 2019

Sources the company cites

Inoue 2008

Reference as the company lists it

“Inoue, et al Am J Respir Crit Care Med Vol 177. pp 752–762, 2008” (opens the source at this quote in a new tab)

Passage carrying the figure

“Autoimmune PAP represented 89.9% of cases and had a minimum incidence and prevalence of 0.49 and 6.2 per million, respectively.” (opens the source at this quote in a new tab)

Inoue 2008, quoted passage highlighted — Captured from the passage on the page (opens in a new tab)

McCarthy 2018

Reference as the company lists it

“McCarthy, et al. Orphanet Journal of Rare Diseases (2018) 13:129” (opens the source at this quote in a new tab)

Passage carrying the nearest figure

“The annual prevalence of PAP in the general population was 6.87 ± 0.33 per million” (opens the source at this quote in a new tab)
“Using this value and 308.7 million for the US population size” (opens the source at this quote in a new tab)

McCarthy 2018, quoted passage highlighted — Captured from the passage on the page (opens in a new tab)

Kimura 2025

Reference as the company lists it

“Kimura, et al. ERJ Open Res 2025; 11: 00666-2024” (opens the source at this quote in a new tab)

Passage carrying the nearest figure

“Consequently, the prevalence (per million persons) of APAP in each year was 7.1, 8.2, 8.8 and 9.7, respectively” (opens the source at this quote in a new tab)

Kimura 2025, quoted passage highlighted — Captured from the passage on the page (opens in a new tab)

Kitamura 2019

Reference as the company lists it, corporate presentation, October 2026

“Kitamura, et al. ERJ Open Res 2019; 5: 00190-2018” (opens the source at this quote in a new tab)

Reference as the company lists it, website, autoimmune PAP page

“Read more here.” (opens the source at this quote in a new tab)

Passage carrying the figure

“Taken together, the prevalence was estimated to be 26.6 per million, indicating that the previous data for incidence and prevalence was an underestimation.” (opens the source at this quote in a new tab)

Kitamura 2019, quoted passage highlighted — Captured from the passage on the page (opens in a new tab)

Savara inc. 2025

Reference as the company lists it, corporate presentation, October 2026

“Source: Veeva Compass Patient covering dispensed prescriptions, procedures, and diagnoses from 300+ million patients from Jan. 2017 to present. Reporting Period: 2017-2025; Patient Stabilization Period (1/1/2023 to 6/30/2025), not projected up for total U.S. patient population.” (opens the source at this quote in a new tab)
“Data from 2025 U.S. Insurance Claims Analysis commissioned by Savara and extrapolated based on geographic population; TAM, Total addressable market” (opens the source at this quote in a new tab)

Reference as the company lists it, press release, September 2, 2025

“The recent analysis of health claims data was commissioned by the Company and used a different, more recent and comprehensive dataset of health claims records.” (opens the source at this quote in a new tab)

Passage carrying the figure

Not quoted: The analysis was commissioned by Savara from a proprietary claims database (Veeva Compass Patient) and is not published as a document a reader can open.

Savara inc. 2023

Reference as the company lists it

“an analysis of a health claims database that” (opens the source at this quote in a new tab)

Passage carrying the figure

Not quoted: The 2023 health claims analysis is not published; the press release names neither the database nor a report.

Overview

1Company statements of prevalence

Prevalence (all PAP): Savara Form 10-K for 2025, March 2026

Prevalence (all PAP): Savara aPAP ClearPath website, October 2026

Prevalence: Savara corporate presentation, October 2026

Eligible population: Savara corporate presentation, October 2026

Number diagnosed: Savara press release, September 2025

Number diagnosed: Savara press release, March 2024

Eligible population (EU4 and the United Kingdom): Savara corporate presentation, October 2026

Prevalence (all PAP): Savara website, October 2026

Prevalence: Savara website, October 2026

Prevalence (all PAP in Japan): Savara Form 10-K for 2025, March 2026

Prevalence (estimates from published literature): Savara corporate presentation, October 2026

2Sources the company cites

Reference as the company lists it

Passage carrying the figure

Reference as the company lists it

Passage carrying the nearest figure

Reference as the company lists it

Passage carrying the nearest figure

Reference as the company lists it, corporate presentation, October 2026

Reference as the company lists it, website, autoimmune PAP page

Passage carrying the figure

Reference as the company lists it, corporate presentation, October 2026

Reference as the company lists it, press release, September 2, 2025

Passage carrying the figure

Reference as the company lists it

Passage carrying the figure

3References

Company statements of prevalence

Sources the company cites

References