The nontuberculous mycobacteria (NTM) market across the seven major markets (7MM) and 5EU (US, France, Germany, Italy, Spain, UK, and Japan) is forecast to grow from $2.0bn in 2023 to $4.6bn in 2033 at a compound annual growth rate of 8.8%. The US represents the largest market for NTM, with sales of $1.2bn in 2023, equating to a market share of 62.1% across the 7MM. Japan, which is the second-largest market, was valued at $527.5m in 2023, equating to a market share of 26.2%.
Leading data and analytics company GlobalData’s 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.
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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 expected to launch across the 7MM, MNKD-101 (clofazimine); Paratek Pharmaceuticals’ antibiotic expected to launch in the US and 5EU, Nuzyra; and Nobelpharma’s recombinant protein expected to launch in Japan, NPC-26 (sargramostim).
The lack of effective NTM therapeutics is one of the biggest unmet needs within the NTM market. Nearly all of the drugs used to treat NTM infections are used 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. Nuzyra, which is an antibacterial agent already marketed in select geographies for the treatment of community-acquired bacterial pneumonia and acute skin and skin structure infections, is a novel tetracycline derivative, an aminomethylcycline antibiotic. This drug is in development for NTM lung disease caused by Mycobacterium abscessus complex. NPC-26 is an inhaled formulation of the recombinant protein sargramostim. There are currently no recombinant proteins being used to treat NTM infections within the 7MM.
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By GlobalDataThe 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. In particular, KOLs 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, Nuzyra, and Sirturo losing patent protection and becoming vulnerable to competition from generics.
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.
