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Nontuberculous mycobacteria market to reach $4.6 billion in 7MM in 2033, forecasts GlobalData

Market expansion driven by novel pipeline drugs and rising diagnosed prevalence, but generic competition may limit uptake of branded therapies, says GlobalData

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The nontuberculous mycobacteria (NTM) market across the seven major markets (7MM*) is forecast to grow at a compound annual growth rate (CAGR) of 8.8 per cent from $2.0 billion in 2023 to $4.6 billion in 2033, according to GlobalData.

GlobalData’s latest report, “Nontuberculous Mycobacteria (NTM): Opportunity Assessment and Forecast”, reveals that market growth will primarily be driven by the launch of several novel pipeline agents, as well as the projected increase in the number of diagnosed prevalent cases of NTM.

Stephanie Kurdach, Infectious Disease Analyst at GlobalData, comments: “The NTM market is currently dominated by off-label usage of highly genericised, broad-spectrum antibiotics. There are several novel late-stage pipeline products in development specifically for the treatment of NTM infections.”

Several products are currently in Phase II-III development and are expected to launch by 2033. These include MannKind Corp’s antibiotic, MNKD-101 (clofazimine), Paratek Pharmaceuticals’ antibiotic, Nuzyra (omadacycline), and Nobelpharma’s recombinant protein, NPC-26 (sargramostim).

Kurdach continues, “The lack of effective therapeutics is one of the biggest unmet needs within the NTM market. Nearly all the drugs used to treat NTM infections are off-label. Moreover, many of these drugs are broad-spectrum antibiotics that have been repurposed for the treatment of NTM. The pipeline agents set to enter the NTM market throughout the forecast period are all novel therapies, which could address this unmet need.”

MNKD-101 is a novel formulation of clofazimine to be administered as an inhaled antibiotic. This drug is in development for refractory NTM lung disease caused by Mycobacterium avium complex (MAC). Nuzyra** is a novel tetracycline derivative, an aminomethylcycline antibiotic. This drug is in development for NTM lung disease caused by Mycobacterium abscessus complex (MABc).  NPC-26 is being developed as a novel therapy for patients with NTM caused by MAC. NPC-26 is an inhaled formulation of the recombinant protein sargramostim. Currently, there are no recombinant proteins being used to treat NTM infections within the 7MM.

Kurdach adds, “The NTM pipeline in the 7MM is rather limited, with only eight NTM pipeline products in active development across Phases I-III. Key opinion leaders (KOLs) interviewed by GlobalData have highlighted the dire need for novel, effective NTM therapeutics. KOLs, in particular, agree that the antibiotics MNKD-101 and Nuzyra appear promising.”

Despite the anticipated launch of several innovative products, generic erosion will represent a barrier to growth over the forecast period, with products such as Arikayce (nebulized amikacin), Nuzyra, and Sirturo (bedaquiline) losing patent protection and becoming vulnerable to competition from generics.

Kurdach concludes, “While the late-stage pipeline does address the need for novel, effective therapeutics, the current market domination by highly genericised antibiotics could end up limiting the uptake of these expensive, branded products.”

*7MM-US, France, Germany, Italy, Spain, UK, and Japan

**Nuzyra (omadacycline) is an antibacterial agent marketed in select geographies for the treatment of community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI)

 

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