The diabetic neuropathic pain (DNP) market is expected to grow from sales of $1.7bn in 2021 to $3.0bn in 2031, at a compound annual growth rate (CAGR) of 6.0% across the seven major markets (7MM: US, 5EU [France, Germany, Italy, Spain, and UK], and Japan), according to GlobalData’s recently published Diabetic Neuropathic Pain: Seven-Market Drug Forecast and Market Analysis report. This growth will primarily be due to the market release of four pipeline products: Helixsmith’s Engensis (VM202), Glenmark Pharmaceutical’s ISC-17536, Lexicon’s LX-9211, and Novaremed’s NRD135S.E1 (NRD.E1).

The pharmacological management of DNP is based on the use of indicated and off-label drugs of the following main drug classes: tricyclic antidepressants (TCAs), serotonin and norepinephrine reuptake inhibitors (SNRIs), gabapentinoids, and sodium channel blockers. The four pipeline products act via novel mechanisms of action (MOAs). Engensis targets the hepatocyte growth factor gene. ISC-17536 inhibits transient receptor potential ankyrin 1. LX-9211 is an adaptor protein complex 2-associated protein kinase 1 inhibitor. NRD.E1 is a tyrosine-protein kinase inhibitor. Key opinion leaders interviewed by GlobalData noted that a product with a novel MOA that better targets the underlying pathophysiology of DNP could provide a more superior efficacy and safety profile than the currently marketed treatments.

The launch of these four pipeline products will be the main driver of growth over the forecast period. These pipeline products are all expected to have significantly higher costs of therapy when compared with the off-patent oral analgesics that are predominantly used. Therefore, late-stage pipeline products are expected to capture a significant portion of the DNP market, accounting for 48.3% of global sales in 2031.

Figure 1 summarises the DNP market growth across the 7MM from 2021 to 2031.

The US was the largest market for DNP treatments in 2021, and consequently the highest single contributing market in the 7MM, representing 51.4% of global sales. This is mainly due to the large prevalent population of patients with DNP, the high cost of drugs, and the number of drugs marketed exclusively in the US compared to the rest of the 7MM. The US market will continue to dominate the DNP market throughout the forecast period, increasing its proportion of global sales to 71.7%. By 2031, the US is expected to have grown at a CAGR of 9.6%, contributing sales of $2.2bn to the global DNP market.

Although the DNP market is projected to grow in the 7MM during the forecast period, limited growth is anticipated in the 5EU and Japan. ISC-17536 is the only late-stage pipeline product set to launch in the 5EU. Furthermore, none of the four late-stage pipeline products are anticipated to launch in Japan by 2031.

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By GlobalData

As the DNP market is crowded with inexpensive generic products for pain relief, the high use of these products is expected to continue throughout the forecast period. GlobalData believes that this can create a major barrier to growth in the DNP market during the forecast period. As such, a considerable opportunity remains for players looking to enter the DNP market in the future, particularly in markets outside of the US.