Key Statistics
12
HTA markets analysed
US · EU5 · JP · CN · AU · CA
$130B
Projected GLP-1 market 2030
CAGR ~32% (2024–2030)
8
Approved GLP-1 agents
Obesity + T2D indications
40+
Pipeline GLP-1 assets
Phase I through Phase III
6
Positive HTA decisions
Full/restricted reimbursement
2026
Key reimbursement reviews
NICE · HAS · G-BA · PMDA upcoming
Target Profile
| Drug Class | GLP-1 Receptor AgonistIncretin MimeticGLP-1 / GIP Dual Agonist |
|---|---|
| Mechanism | Activates GLP-1 receptors → stimulates glucose-dependent insulin secretion, suppresses glucagon, slows gastric emptying, reduces appetite via CNS hypothalamic signalling |
| Lead Approved Agents | Semaglutide (Ozempic / Wegovy) · Tirzepatide (Mounjaro / Zepbound) · Liraglutide (Victoza / Saxenda) · Dulaglutide (Trulicity) · Exenatide (Byetta / Bydureon) |
| Key Indications | Type 2 Diabetes (T2D)Obesity / OverweightCardiovascular Risk ReductionMASH / NAFLDHeart Failure (HFpEF)CKD |
| HTA Complexity | Most markets require separate HTA submissions for T2D vs obesity indications · Obesity reimbursement faces higher budget-impact scrutiny · CVD outcome data increasingly required for positive decisions |
| Key Payers | NICE (UK) · HAS (France) · G-BA (Germany) · AIFA (Italy) · AEM (Spain) · PMDA/MHLW (Japan) · CMS (US Medicare) · CADTH (Canada) · PBAC (Australia) |
| Competitive Precedent | NICE approved semaglutide 2.4mg (Wegovy) for obesity Jun 2023 with BMI ≥35 + comorbidity restriction · G-BA rated semaglutide 2.4mg as 'no proven added benefit' in T2D vs standard of care · CMS Medicare Part D coverage expansion pending legislation |
8Approved
3NDA / MAA
12Phase III
18Phase II
14Phase I
9Preclinical
Drug Landscape
| Drug Name | Company | Modality | Indication | Stage | Mechanism |
| Semaglutide 2.4mg (Wegovy) | Novo Nordisk | GLP-1 RA (SC weekly) | Obesity (BMI ≥30) | Approved | GLP-1R agonist; 15–17% body weight reduction in STEP trials; SELECT trial showed 20% CV event reduction |
| Tirzepatide (Zepbound) | Eli Lilly | GLP-1 / GIP dual agonist | Obesity / T2D | Approved | Dual GIP+GLP-1 receptor agonist; 22.5% mean weight loss in SURMOUNT-1; superior to semaglutide in SURMOUNT-5 |
| Semaglutide oral (Rybelsus) | Novo Nordisk | GLP-1 RA (oral daily) | T2D | Approved | First oral GLP-1 RA; PIONEER trials showed HbA1c reduction of 1.4%; absorption via SNAC carrier technology |
| Liraglutide (Saxenda) | Novo Nordisk | GLP-1 RA (SC daily) | Obesity | Approved | Daily SC injection; 8% weight loss vs placebo; SCALE trials; first GLP-1 approved for obesity 2014 |
| Dulaglutide (Trulicity) | Eli Lilly | GLP-1 RA (SC weekly) | T2D, CV risk | Approved | Weekly SC GLP-1 RA; REWIND trial: 12% CV event reduction; significant T2D market share globally |
| Orforglipron | Eli Lilly | Oral small molecule GLP-1 RA | Obesity / T2D | Phase III | Non-peptide oral GLP-1 RA; no food/water restrictions; ATTAIN trials show 9–10% weight loss; potential $10B+ peak sales |
| Cagrilintide + Sema (CagriSema) | Novo Nordisk | Amylin + GLP-1 RA combo | Obesity | Phase III | Amylin analogue + semaglutide fixed-dose combo; REDEFINE-1 showed 22.7% weight loss; REDEFINE-2 ongoing |
| Retatrutide | Eli Lilly | GLP-1 / GIP / glucagon triple agonist | Obesity / MASH | Phase III | Triple incretin agonist; 24.2% weight loss at 48 weeks — highest in class; MASH Phase III initiated 2024 |
| Mazdutide | Innovent / Roche | GLP-1 / glucagon dual agonist | Obesity / T2D | Phase III | IBI362; Roche licensed globally; GLORY Phase III in Chinese obesity population; NDA submission 2025 |
| Survodutide | Boehringer Ingelheim / Zealand Pharma | GLP-1 / glucagon dual agonist | Obesity / MASH | Phase III | BI 456906; MASH Phase III SYNCHRONIZE-NASH; 49% NASH resolution at 46 weeks Phase II; Boehringer licensed |
| Semaglutide oral 25mg / 50mg | Novo Nordisk | GLP-1 RA (oral, higher dose) | Obesity | Phase III | Next-gen oral sema; OASIS-1: 15.1% weight loss at 68 weeks; NDA filed 2024 for obesity indication |
| Pemvidutide (ALT-801) | Altimmune | GLP-1 / glucagon dual agonist | MASH / Obesity | Phase II | MASH Phase IIb METAVANCE; 8.7% liver fat reduction; differentiated on muscle-sparing profile vs pure GLP-1 |
| Cotadutide | AstraZeneca | GLP-1 / glucagon dual agonist | MASH / CKD | Phase II | GLP-1/glucagon balanced agonist; MASH and diabetic kidney disease trials; AZ deprioritised obesity to focus on organ protection |
| Efocipegtrutide (HM12525A) | Hanmi / Merck | GLP-1 / glucagon / GIP triple | Obesity / MASH | Phase II | Hanmi LAPSCOVERY platform; once-weekly SC; Merck licensed; MASH Phase IIb and obesity Phase II ongoing |
| Danuglipron | Pfizer | Oral small molecule GLP-1 RA | Obesity / T2D | Phase II | Twice-daily oral non-peptide GLP-1 RA; Pfizer paused programme Nov 2023 after Phase II nausea/vomiting tolerability; development status under review |
#GLP1#Semaglutide#Tirzepatide#Obesity#Type2Diabetes#MarketAccess#HTA#Reimbursement#NICE#Wegovy#Mounjaro#DrugPricing#Biopharma#AripaSolutions