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NCE-1 Intelligence & Market Opportunity

Leqvio

Inclisiran
Antihyperlipidemic
Subcutaneous Solution

PCSK9 antibodies proved that deep LDL lowering was achievable, but fortnightly injections and payer resistance limited their reach. Leqvio (inclisiran) changed the dosing interval dramatically.

Unlike PCSK9 antibodies that bind the circulating protein, Leqvio silences PCSK9 messenger RNA inside the liver, which is why a subcutaneous injection twice yearly suffices after two starter doses. It is approved as add-on therapy for adults with heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease.

Twice-yearly dosing lets Leqvio be administered in-office, shifting it toward a buy-and-bill model that differentiates it from self-injected competitors. It faces no generic competition, and cardiovascular outcomes data remain the key catalyst for broader guideline adoption.

Approval Date
22-Dec-21
NCE-1 Date
22-Dec-25
NCE Date
22-Dec-26
Commercial snapshot

Market performance & projections

Revenue ($M)
1,372
CAGR (%)
28.12%
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
2,030
2027
2,632
2028
3,248
2029
3,697
2030
4,100
2031
4,461
2032
4,837
Molecule profile

Details & specifications

Molecule
Inclisiran
Innovator
NOVARTIS PHARMACEUTICALS CORPORATION
Dosage Form
Subcutaneous Solution
Strength
EQ 284 mg base/1.5 mL (EQ 189 mg base/mL)
Therapeutic Category
Antihyperlipidemic
Usage
To treat heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease as an add-on therapy
Good to know

Frequently asked questions

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