Avenbuan Bio Intelligence · Sample Brief · May 2026 Contents Executive summary Market Duopoly Pipeline Implications Sources
AVENBUAN BIO INTELLIGENCE
Pharma · Biotech · Intelligence
Report No.
ABI-CLB-2026-01
Competitive Landscape Brief

The GLP-1
Revolution

Market dynamics, pipeline threats, and the next phase of competition in obesity and Type 2 diabetes.
Date
May 2026
Classification
Public — sample for prospective clients
Sector
Cardiometabolic — GLP-1 receptor agonists
Geographies
United States · European Union · United Kingdom · Ireland
Authors
Cardiometabolic Intelligence Desk, Avenbuan Bio Intelligence
Pages
28 (excl. appendices)
AVENBUAN BIO INTELLIGENCECOMPETITIVE LANDSCAPE BRIEF · GLP-1 · MAY 2026

About this brief

This Competitive Landscape Brief is a sample deliverable prepared by Avenbuan Bio Intelligence to illustrate the depth, sourcing rigour, and strategic framing we apply to client engagements. It is not investment advice and does not constitute medical advice.

All figures cited are from primary sources — SEC filings, FDA and EMA decisions, NICE technology appraisals, peer-reviewed journals (NEJM, The Lancet), IDA Ireland inward-investment announcements, and company investor disclosures. The source index in Appendix A allows independent verification of every quantitative claim.

All clinical, regulatory, and commercial data are current as of 18 May 2026 unless otherwise indicated. Subsequent events may materially affect the conclusions presented here. Client-commissioned versions of this brief are updated on a rolling basis aligned with quarterly disclosures and the principal clinical-conference calendar.

Contents

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AVENBUAN BIO INTELLIGENCEEXECUTIVE SUMMARY

Executive summary

The GLP-1 receptor agonist market is the defining commercial story of pharma in the 2020s. Combined revenue from Novo Nordisk’s semaglutide franchise (Ozempic, Wegovy, Rybelsus) reached DKK 178.5 billion (~$25.8 billion) in FY2024.1 Eli Lilly’s tirzepatide franchise (Mounjaro, Zepbound) helped lift Lilly’s total revenue to ~$45.0 billion in the same period — a 32% year-on-year increase.2

A duopoly is forming, but it is not stable. SURMOUNT-5 — the first head-to-head trial — showed tirzepatide produced superior mean weight loss versus semaglutide (−20.2% vs −13.7% at 72 weeks).3 JPMorgan models the global incretin market at $200 billion by 2030,4 with daily oral pills, monthly injectables, and triple agonists each capable of redrawing the share map.

~$26B
Ozempic + Wegovy FY2024 sales
Novo Nordisk 20-F · Fortune, Mar 2025
+32%
Lilly FY2024 revenue YoY
Eli Lilly 10-K, FY2024
$200B
Global incretin market by 2030 (JPM)
JPMorgan Global Research, 2026
−20.2%
Tirzepatide weight loss vs −13.7% sema
SURMOUNT-5, NEJM 2025

Five findings that should shape every client’s GLP-1 strategy

  1. The cash-pay channel is now the primary battleground. Lilly cut LillyDirect Zepbound vial pricing to a $299 starter dose in December 2025; Novo Nordisk’s NovoCare Pharmacy now lists Wegovy at $349/month following the November 2025 White House framework.5
  2. Pfizer is out; eight credible challengers remain. Pfizer discontinued danuglipron on 14 April 2025 over a liver-injury signal.6 External programmes worth tracking: Amgen MariTide, Roche CT-388/CT-996, AstraZeneca AZD5004, Viking VK2735, Structure GSBR-1290, Altimmune pemvidutide, Boehringer/Zealand survodutide.
  3. Oral Wegovy was FDA-approved in December 2025 — the first oral GLP-1 for chronic weight management. This collapses one of Lilly’s remaining advantages and resets the manufacturing arms race.7
  4. The label is expanding beyond weight. Wegovy is now indicated for cardiovascular risk reduction (SELECT) and MASH with moderate-to-advanced fibrosis (ESSENCE);8 Zepbound is approved for moderate-to-severe obstructive sleep apnoea (SURMOUNT-OSA). Each indication unlocks a new payer conversation.
  5. Ireland is now strategically central to the GLP-1 supply chain. Lilly’s Kinsale and Limerick sites produce tirzepatide; Novo Nordisk announced a €432 million Athlone expansion on 2 March 2026 to manufacture oral Wegovy tablets.9
What this means for our clients

Three decisions cannot wait. First, the franchise economics of any cardiometabolic asset must be re-tested against a 25-million-patient US incretin population by 2030, not the 10 million on therapy in 2025. Second, oral and monthly administration is now table stakes — pipeline assets without a credible oral or extended-interval strategy face structural disadvantage. Third, the cash-pay channel and Medicare GLP-1 Bridge demonstration (effective 1 July 2026) materially change the access calculus for everything that follows.

The remainder of this brief sets out the evidence. Section 1 sizes the market. Section 2 profiles the duopoly. Section 3 ranks the eight pipeline challengers by probability-adjusted threat. Sections 4–6 cover clinical, regulatory, and manufacturing terrain. Section 7 distils five strategic imperatives. Section 8 sets out our 2030 base, bull, and bear cases.

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AVENBUAN BIO INTELLIGENCE1 — MARKET IN CONTEXT

1. Market in context

GLP-1 receptor agonists have moved in less than a decade from a third-line Type 2 diabetes option to one of the largest drug categories in pharmaceutical history.

The transformation has been driven by three forces: clinical efficacy at thresholds previously associated with bariatric surgery; the demonstration of cardiovascular and metabolic benefits beyond weight; and a willingness among US payers, employers, and self-pay consumers to absorb list prices above $1,000 per month.

1.1 Current market scale

In FY2024 the two leading franchises generated combined revenue of approximately $26 billion from Ozempic and Wegovy alone,10 alongside the meaningful contribution of Lilly’s tirzepatide franchise to its $45 billion total. By Q3 2025, Lilly’s tirzepatide products were reporting quarterly worldwide revenue of $6.52 billion (Mounjaro) and $3.57 billion (Zepbound US) — annualised run-rates of $26 billion and $14 billion respectively.11

1.2 Forecasts to 2030 — comparative view

Forecasts diverge by a factor of more than two, reflecting genuine uncertainty about three drivers: government reimbursement, oral-formulation conversion rates, and persistence beyond year two of therapy.

Forecaster2030/2035 forecastNotes
JPMorgan Global Research$200B (2030)Global incretin market; 25M Americans on therapy by 20304
Goldman Sachs Research$95B (2030)Anti-obesity only; US peak revised down to $70B; orals ~25% share12
Morgan Stanley$190B (2035)T2D + obesity combined; +$40B upward revision13
BMO Capital Markets~$150B (early 2030s)Obesity only14
EvaluatePharma>$100B (2030)Ozempic + Mounjaro + Wegovy + Zepbound + CagriSema15
IQVIA~$130B (2034)Global anti-obesity medications; 13–15% CAGR16

1.3 The four hinge variables

1.4 Geographic mix

The United States remains the demand engine, contributing the majority of branded-GLP-1 revenue across both franchises. Europe is volume-constrained by reimbursement and HTA process rather than by underlying prevalence: NHS England moved to phased rollout of tirzepatide in March 2025 following NICE TA1026;18 HSE Ireland was not yet reimbursing Wegovy as of October 2025, with the Health Minister signalling an end-2025 target.19

Implication for Avenbuan Bio clients

Strategic plans built against a 2023-vintage TAM are now materially under-scoped. Any cardiometabolic strategy assessed today against pre-Wegovy market sizing will under-invest in three of the four hinge variables above. We recommend re-running base/bull/bear scenarios at the franchise level whenever a payer event, oral pivotal, or HTA decision moves the underlying assumption set.

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AVENBUAN BIO INTELLIGENCE2 — THE DUOPOLY

2. The duopoly: Novo Nordisk and Eli Lilly

Two companies — neither headquartered in the United States — account for the overwhelming majority of GLP-1 receptor-agonist revenue worldwide. Their competitive trajectories diverge in three respects: portfolio breadth, manufacturing strategy, and willingness to use direct-to-patient cash channels.

Novo Nordisk A/S

Bagsværd, Denmark · NYSE: NVO · Founded 1923

Franchise economics — FY2024

  • Total sales DKK 290.4B (~$41B), +26% CER20
  • Ozempic DKK 120.3B (+26%)
  • Wegovy DKK 58.2B (~$8.4B), +86% YoY
  • Obesity care (Wegovy + Saxenda) DKK 65.1B, +57% CER21

2025 trajectory

  • Q1 2025 revenue DKK 78.1B (+18%); Wegovy DKK 17.4B (+83% CER)22
  • Q2 2025 net sales DKK 76.9B23
  • FY2025 guidance narrowed to 13–21% growth (from 16–24%)

Key 2024–26 product moves

  • Wegovy CV indication (Mar 2024) based on SELECT
  • Wegovy MASH approval (Apr 2025) based on ESSENCE
  • Oral Wegovy 25 mg approved 22 Dec 2025 — first oral GLP-1 for weight management7
  • CagriSema NDA filed Dec 2025 — GLP-1 + amylin

Eli Lilly and Co.

Indianapolis, USA · NYSE: LLY · Founded 1876

Franchise economics — FY2024

  • Total revenue ~$45B, +32% YoY2
  • Mounjaro + Trulicity + Zepbound = 48% of revenue
  • Tirzepatide franchise is largest growth driver

2025 trajectory

  • Q1 2025 Mounjaro WW $3.84B (+113%); US Zepbound $2.31B vs $517M Q1 202424
  • Q2 2025 Mounjaro WW $5.20B (+68%); US Zepbound $3.38B (+172%)25
  • Q3 2025 Mounjaro WW $6.52B (+109%); US Zepbound $3.57B (+184%)11

Key 2024–26 product moves

  • Zepbound OSA approval (Dec 2024) — first ever drug for OSA26
  • Retatrutide TRIUMPH-4 P3: −28.7% weight at 12 mg, 68 wk27
  • Orforglipron ATTAIN-1 P3 in obesity readout Aug 202528
  • LillyDirect Zepbound vials repriced to $299 starter (Dec 2025)29
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AVENBUAN BIO INTELLIGENCE2 — THE DUOPOLY (CONT.)

2.1 Novo Nordisk — strategic posture

Novo Nordisk’s response to Lilly’s clinical lead has been to broaden formulations (oral plus injectable), broaden labels (CV, MASH), and broaden geographies (Catalent and Athlone). The bet is that a globally diversified semaglutide franchise — supplemented by CagriSema and the next-generation amycretin — can hold share against tirzepatide’s efficacy advantage.

2.2 Eli Lilly — strategic posture

Lilly is using its clinical lead to set a faster cadence than Novo can match: oral, monthly, and triple-agonist programmes are progressing in parallel, supported by what is effectively the largest cardiometabolic manufacturing build-out in industry history.

2.3 Side-by-side comparison

DimensionNovo NordiskEli Lilly
Lead moleculeSemaglutide (GLP-1)Tirzepatide (GIP/GLP-1)
Lead obesity brandWegovy (injectable + oral 25 mg)Zepbound (injectable + LillyDirect vials)
FY2024 lead-franchise sales~$25.8B Ozempic+Wegovy+RybelsusMounjaro + Zepbound, major share of $45B
Major label expansions 2024–26CV (Mar 2024); MASH (Apr 2025); Oral (Dec 2025)OSA (Dec 2024); pipeline reads in HFpEF, addiction
Pipeline lead asset(s)CagriSema (NDA Dec 2025); AmycretinRetatrutide (P3); Orforglipron (P3 P1 readouts 2025)
Manufacturing strategyCatalent fill-finish; Athlone tabletting €432mLebanon IN $9B; Feb 2025 $27B package; Kinsale/Limerick
Direct-to-patient channelNovoCare Wegovy $349/month (post Nov 2025 framework)LillyDirect Zepbound $299 starter, $399–$449 other doses
Strategic read

In a fully reimbursed market with no manufacturing constraint, tirzepatide would be the default first-line choice for obesity management. The fact that semaglutide retains comparable share globally is therefore evidence of the persistent role of supply, brand, and physician familiarity — all factors that diminish over time.

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AVENBUAN BIO INTELLIGENCE3 — PIPELINE PRESSURE

3. Pipeline pressure — the next wave

Eight late-stage challengers warrant active monitoring. Two come from inside the duopoly. The remaining six are external. We score each on six attributes — efficacy, route, expected approval window, manufacturing scalability, label-expansion potential, and current development risk — and rank by probability-adjusted commercial threat.

3.1 Probability-adjusted threat ranking

Asset (sponsor)DifferentiationThreatWatch item
Retatrutide (Lilly)Highest efficacy in class; triple GIP/GLP-1/glucagonHighTolerability profile at top doses
Orforglipron (Lilly)Oral non-peptide; scalable manufacturingHighReal-world persistence vs injectables
MariTide (Amgen)Monthly subcutaneous dosingHighPhase 3 efficacy vs Phase 2 readouts
CagriSema (Novo)GLP-1 + amylin combination; NDA filed Dec 2025Medium-HighMissed internal 25% weight-loss target
CT-388 (Roche)Strong Phase 1b SC GLP-1/GIPMediumPhase 3 launch timing
AZD5004 / Elecoglipron (AstraZeneca)Oral, well-resourced sponsorMediumADA 2026 weight-loss data drop
VK2735 (Viking)Independent dual-agonist optionMediumManufacturing scale-up
Survodutide (Boehringer/Zealand)Strong dual MASH + obesity profileMediumMASH Phase 3 readouts
GSBR-1290 (Structure)Oral small-moleculeMediumPhase 2b ACCESS readout
Pemvidutide (Altimmune)Best-in-class MASH profileNiche (MASH)Obesity P3 financing
Amycretin (Novo)Unimolecular GLP-1 + amylin; SC and oralHighPhase 3 design and timeline
Danuglipron (Pfizer)DiscontinuedPfizer redirected to GIPR antagonist
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AVENBUAN BIO INTELLIGENCE3 — PIPELINE PRESSURE (CONT.)

3.2 Late-stage incumbents — programme detail

Retatrutide (Eli Lilly)

Triple agonist (GIP/GLP-1/glucagon). TRIUMPH-4 Phase 3: −28.7% mean weight loss at 12 mg over 68 weeks in obesity with knee osteoarthritis, with WOMAC pain reductions of up to 4.5 points. ~5,800 patients enrolled across the TRIUMPH programme; seven additional Phase 3 readouts expected through 2026. Likely FDA submission: late 2026 or 2027.27

Orforglipron (Eli Lilly)

Oral non-peptide GLP-1. ATTAIN-1 (n=3,127): 36.0% of patients at 36 mg achieved ≥15% body-weight loss at 72 weeks versus 5.9% on placebo. ATTAIN-2 (obesity + T2D): mean 10.5% / 22.9 lb weight loss at top dose; A1C reduction of 1.8%. Global regulatory submissions for obesity initiated in 2025; published in NEJM.28

CagriSema (Novo Nordisk)

Co-formulation of cagrilintide (amylin analogue) and semaglutide. REDEFINE 1 (n=3,417, 68 wk): −22.7% mean weight loss vs −16.1% semaglutide alone vs −11.8% cagrilintide alone vs placebo. The result fell short of Novo’s internal 25% target;36 nevertheless the NDA was filed with FDA in December 2025.37

Amycretin (Novo Nordisk)

Unimolecular GLP-1 + amylin. Subcutaneous Phase 1b/2a delivered up to −22% body weight at 36 weeks (Lancet, January 2025).38 Oral Phase 1 produced −13% body weight at 12 weeks. Phase 3 in T2D begins in 2026.

3.3 External challengers — programme detail

MariTide (Amgen)

Peptide-antibody conjugate, monthly subcutaneous dosing. Phase 2 produced up to −20% mean weight loss in obesity without T2D and up to −17% in obesity with T2D (ADA 85th Scientific Sessions, June 2025).39 The Phase 3 MARITIME programme — plus dedicated Phase 3 OSA, ASCVD, and HFpEF studies — are recruiting. Monthly administration is the differentiator.

CT-388 and CT-996 (Roche, ex-Carmot)

Roche acquired Carmot Therapeutics for $2.7 billion upfront in late 2023.40 CT-388 (SC GLP-1/GIP) produced −18.8% placebo-adjusted body-weight reduction at 24 weeks in Phase 1b; CT-996 (oral small-molecule GLP-1) showed −7.3% body-weight reduction at 4 weeks in Phase 1.41

Elecoglipron / AZD5004 (AstraZeneca)

In-licensed from Eccogene November 2023 ($185 million upfront, up to $1.8 billion milestones). Phase 2b VISTA (NCT06579092) and SOLSTICE (NCT06579105) both met primary endpoints; weight-loss data held until ADA June 2026. Progressing to Phase 3.42

VK2735 (Viking Therapeutics)

Dual GLP-1/GIP. Phase 3 VANQUISH-1 (subcutaneous, ~4,650 obesity patients, 78 weeks) and VANQUISH-2 (~1,000 T2D + obesity patients) initiated Q2 2025. Oral VK2735 is in Phase 2.43

GSBR-1290 (Structure Therapeutics)

Oral small-molecule GLP-1. Phase 2a (n=64, 12 wk): −6.2% placebo-adjusted weight reduction in capsule formulation; −6.9% with tablet. Phase 2b ACCESS and ACCESS II read out Q4 2025.44

Pemvidutide (Altimmune)

GLP-1/glucagon dual. IMPACT Phase 2b in MASH: up to 59.1% MASH resolution without worsening fibrosis; up to 34.5% fibrosis improvement at 24 weeks; weight loss up to −6.2%.45

Survodutide (Boehringer Ingelheim / Zealand Pharma)

GLP-1/glucagon dual. SYNCHRONIZE-1 Phase 3 in obesity: −16.6% mean weight loss. Up to 83% of MASH Phase 2 patients achieved liver-disease improvement without worsening fibrosis. FDA Breakthrough Therapy designation in MASH (September 2024).46

Withdrawn: Danuglipron (Pfizer)

Pfizer discontinued danuglipron on 14 April 2025 following a single case of potentially drug-induced asymptomatic liver injury. Pfizer continues an oral GIPR antagonist programme but is no longer a near-term competitive threat.6

Strategic read

The single highest-probability disruption to the duopoly is a credible monthly subcutaneous agent (MariTide) or best-in-class triple agonist (retatrutide). The single highest-impact disruption is an oral programme with injectable-grade efficacy — either Lilly’s orforglipron or AstraZeneca’s elecoglipron. Whichever route wins, manufacturing scalability becomes the constraint.

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AVENBUAN BIO INTELLIGENCE4 — CLINICAL DIFFERENTIATION

4. Clinical differentiation

The clinical-trial database below records every late-stage GLP-1 readout that has shaped competitive positioning since 2021. Each row is sourced to the publishing journal or sponsor announcement.

TrialAssetDurationMean weight lossReference
STEP-1Semaglutide 2.4 mg68 wk−14.9% (placebo −2.4%)NEJM 202147
SURMOUNT-1Tirzepatide 15 mg72 wk−22.5% (placebo −2.4%)NEJM 202248
SELECT (CV outcomes)Semaglutide 2.4 mgmedian 39.8 moHR 0.80 MACE compositeNEJM 202349
SURMOUNT-OSATirzepatide 15 mg52 wk−20% body weight; AHI −27.4 events/hLilly 202450
SURMOUNT-5 (head-to-head)Tirzepatide vs Sema72 wk−20.2% vs −13.7% (p<0.001)NEJM 20253
ESSENCE (MASH)Semaglutide 2.4 mg72 wk63% MASH resolution vs 34% pboNEJM Apr 202551
REDEFINE 1CagriSema68 wk−22.7% vs −16.1% sema vs −2.3% pboNEJM 202536
ATTAIN-1 (oral)Orforglipron 36 mg72 wk36% achieved ≥15% loss vs 5.9% pboNEJM 202528
TRIUMPH-4Retatrutide 12 mg68 wk−28.7% weight; WOMAC pain −4.5Lilly Dec 202527

4.1 What the head-to-head data mean commercially

SURMOUNT-5 is the most consequential trial of the post-launch era. By directly comparing tirzepatide to semaglutide at maximum tolerated doses in 751 patients over 72 weeks, the study removed comparator ambiguity from physician decision-making. Tirzepatide produced 47% more relative weight loss than semaglutide (−20.2% versus −13.7%) and had a more favourable gastrointestinal adverse-event discontinuation rate (2.7% vs 5.6%).

4.2 Beyond weight — the indication map

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AVENBUAN BIO INTELLIGENCE5 — REGULATORY & REIMBURSEMENT

5. Regulatory and reimbursement

The commercial trajectory of a GLP-1 asset is now decided by reimbursement architecture as much as by clinical efficacy. The 2024–26 period has produced four reimbursement events that materially alter franchise valuation.

5.1 United States — Medicare GLP-1 Bridge demonstration

On 1 July 2026 the Centers for Medicare & Medicaid Services begins a demonstration providing Part D coverage of Wegovy and Zepbound for chronic weight management, capped at a $50 patient copay. Eligibility requires BMI ≥35 alone, or BMI ≥27 with specified clinical criteria. The demonstration runs through 31 December 2027 and does not cover the Wegovy cardiovascular indication or the Zepbound OSA indication.17

The demonstration is not a permanent statutory change. Sponsors should model the addressable Medicare population on a probability-weighted basis between (a) permanent post-demonstration extension, (b) limited extension to specific clinical sub-groups, and (c) sunset on 1 January 2028.

5.2 United Kingdom — NICE TA1026 and NHS phased rollout

NICE TA1026 (December 2024) recommends tirzepatide for obesity management in NHS England, with an estimated 3.4 million people meeting eligibility criteria. NHS England issued interim commissioning guidance in March 2025 setting a phased implementation: 90 days for existing specialist weight-management services, 180 days for high-priority populations, and up to three years for expanded population groups.18

5.3 Ireland — HSE reimbursement landscape

As of October 2025, neither Wegovy nor Mounjaro was reimbursable under HSE schemes (Medical Card, Long-Term Illness, Drug Payment Scheme). Patients pay €120–€475 per month privately. Health Minister Carroll MacNeill indicated an end-2025 target for Wegovy reimbursement.19

For Avenbuan Bio clients with Irish operations

The takeaway is binary: either reimbursement is secured by H2 2026 and brand-share dynamics align with UK/EU markets, or Ireland remains a cash-pay outlier — with corresponding implications for franchise valuation and sales-force investment.

5.4 European Union — country-level variation

There is no harmonised EU reimbursement decision for GLP-1 weight-management indications. Germany, France, and Spain operate through individual HTA bodies (G-BA, HAS, AEMPS); reimbursement status varies markedly. Eastern European markets are predominantly cash-pay. The EMA centralised approval grants market authorisation but not reimbursement, which means franchise commercial leads must navigate ~27 HTA conversations rather than one.

5.5 Compounding regulation — the post-shortage era

FDA declared the tirzepatide shortage resolved on 19 December 2024 and the semaglutide shortage resolved on 21 February 2025. Enforcement discretion for 503A pharmacies ended in February and April 2025 respectively; 503B outsourcing facilities had until 19 March and 22 May 2025. The Outsourcing Facilities Association lawsuit challenging the semaglutide delisting did not produce preliminary injunctive relief.32

5.6 Cash-pay channel — pricing dynamics

A White House framework in November 2025 produced concurrent price reductions in the direct-to-patient channel. NovoCare Pharmacy reduced Wegovy from $499 to $349 per month; LillyDirect introduced Zepbound vials at $299 (starter), $399 (5 mg), and $449 (other doses) from 1 December 2025.5,29 The channel is now a primary access route alongside payer-mediated distribution.

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AVENBUAN BIO INTELLIGENCE6 — MANUFACTURING & SUPPLY

6. Manufacturing and supply chain

The GLP-1 manufacturing arms race is the single largest capacity expansion in pharmaceutical history. Sterile fill-finish and peptide / small-molecule API capacity have both been the binding constraint, and remain so for the next-generation oral and monthly programmes.

6.1 Capital commitments — comparison

Sponsor / siteCommitmentPurpose
Eli Lilly — Lebanon, IN$9B (from $3.7B)Tirzepatide API; ~900 FTEs33
Eli Lilly — US package (Feb 2025)$27B (4 new plants)3 API + 1 injectables; 3,000 FTEs + 10,000 construction jobs34
Eli Lilly — Kinsale, Ireland$800M completedTirzepatide production35
Eli Lilly — Limerick, Ireland$1.0B (Sept 2024)Limerick expansion — total site investment now ~$2.0B
Eli Lilly — Concord, NC$1BNew injectable plant
Novo Holdings — Catalent$16.5B (closed Dec 2024)3 fill-finish sites to Novo Nordisk for $11B30
Novo Nordisk — Athlone, Ireland€432M (announced Mar 2026)Oral Wegovy tabletting; ~600 construction jobs9

6.2 Ireland’s strategic role

Ireland now hosts active GLP-1 manufacturing for both leading franchises and is the single most strategically central European location for the category. For clients evaluating European manufacturing footprint, Ireland offers (a) regulatory familiarity with both FDA and EMA inspections, (b) a deep contract-manufacturing ecosystem (with the residual Catalent sites now Novo Nordisk-owned), and (c) corporate-tax certainty under the OECD 15% floor.

6.3 The remaining choke point — sterile fill-finish

API capacity for semaglutide and tirzepatide has materially expanded. The constraint now sits in sterile fill-finish — auto-injector assembly, vial fill, cartridge manufacture — and in the secondary packaging supply chain (needles, prefilled-pen assemblies, glass containers). The Catalent acquisition and the Lebanon expansion explicitly addressed this constraint; competitors without a captive fill-finish footprint will pay rising prices for contract capacity through 2027.

Implication for pipeline assets

A Phase 3 asset entering the regulatory submission window in 2027 without secured fill-finish capacity will face a 12–18 month commercial launch delay regardless of approval. We recommend that emerging-biotech clients negotiate fill-finish capacity at Phase 2b — including the right of first refusal on second-source qualifications — rather than after pivotal-trial readout.

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AVENBUAN BIO INTELLIGENCE7 — STRATEGIC IMPLICATIONS

7. Strategic implications — five imperatives

The findings of Sections 1 through 6 converge on five strategic imperatives for pharma and biotech leadership teams. Each is action-oriented; the time-horizon is the next 12 to 24 months.

Imperative 1 — Re-base your TAM against a 25M-patient incretin market

JPMorgan now models 25 million Americans on GLP-1 therapy by 2030, against approximately 10 million in 2025. Any business case authored before mid-2024 likely under-states the addressable population by 2–3x. Re-run base, bull, and bear cases at the franchise level, incorporating (a) the Medicare GLP-1 Bridge demonstration window, (b) oral conversion sensitivities at 15%, 25%, and 40% of total volume, and (c) Year-2 persistence at 35%, 50%, and 65%.

Imperative 2 — Pre-secure fill-finish capacity at Phase 2b

The single most underrated constraint on the next-generation pipeline is sterile fill-finish. Innovator companies launching after 2027 without captive capacity, a long-term contract, or second-source qualifications will experience launch delays measured in quarters, not months. Treat fill-finish negotiation as a Phase 2b deliverable rather than a launch-readiness item.

Imperative 3 — Build a credible oral or monthly story, or partner for one

Oral semaglutide is now approved for weight management; orforglipron submissions are in regulatory review; AZD5004 and GSBR-1290 will read out in 2025–2026. Within five years, the injectable-only asset will have lost optionality in two of the four largest payer markets. If your portfolio does not contain a credible oral or monthly programme, partner for one — and price the optionality value of doing so against the discounted franchise revenue of remaining injectable-only.

Imperative 4 — Treat label expansion as a commercial asset

Beyond weight, the indications that meaningfully expand the payer rationale are cardiovascular event reduction (SELECT), obstructive sleep apnoea (SURMOUNT-OSA), MASH (ESSENCE), and — pending data — HFpEF, Alzheimer’s, kidney disease, and substance-use disorders. Each indication that survives a Phase 3 readout adds a defensible reimbursement conversation with payers. Price labels-in-development as commercial assets, not exploratory science.

Imperative 5 — Decide your direct-to-patient strategy explicitly

Both leading sponsors have made a structural commitment to the cash-pay channel — Wegovy at $349/month, Zepbound at $299 starter through LillyDirect. The optionality argument for direct-to-patient is no longer theoretical. Clients with cardiometabolic franchises should decide explicitly (a) whether to operate a captive direct-to-patient channel, (b) which patient cohorts are best served by cash-pay versus payer-mediated access, and (c) the tier-discount logic against PBM rebates.

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AVENBUAN BIO INTELLIGENCE8 — OUTLOOK TO 2030

8. Outlook to 2030

Avenbuan Bio Intelligence models three scenarios for the GLP-1 receptor-agonist market by 2030. Each scenario varies the four hinge variables identified in Section 1: reimbursement breadth, oral conversion, Year-2 persistence, and indication expansion.

VariableBear caseBase caseBull case
Total 2030 revenue$95B$130B$200B
US Medicare GLP-1 BridgeSunset Dec 2027; no extensionLimited extension to BMI ≥35 + CVPermanent statutory inclusion
Oral share of obesity15%25%40%
Year-2 persistence (US)35%50%65%
New approved indicationsNo further beyond MASH/OSAAdd HFpEF or kidneyAdd HFpEF + AD + addiction
Duopoly share of market55%65%70% (network effects)

The bear case is anchored to Goldman Sachs’ most recent revision of the anti-obesity-only market; the base case interpolates Morgan Stanley, EvaluatePharma, and IQVIA forecasts; the bull case follows JPMorgan’s $200 billion 2030 incretin figure. In all three scenarios, the duopoly accounts for the majority of total revenue, but the bear-case scenario sees aggressive share erosion from MariTide, retatrutide, and oral programmes outside the originator portfolios.

Signals to monitor in the next 18 months

  1. The SURMOUNT-OSA reimbursement decision in Europe.
  2. Medicare GLP-1 Bridge enrolment ramp from July 2026.
  3. Phase 3 retatrutide read-outs (TRIUMPH-1, -2, -3, -5).
  4. The SURPASS-CVOT cardiovascular outcomes read-out for tirzepatide.
  5. Phase 3 read-outs for VK2735 (VANQUISH) and AZD5004.
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AVENBUAN BIO INTELLIGENCE9 — METHODOLOGY

9. Methodology

All quantitative claims in this brief are sourced to primary documents. Forecasts cited are presented as the work of the named institution at the date of publication. Avenbuan Bio Intelligence triangulates across at least three sources before placing a figure in our base case.

9.1 Source hierarchy

9.2 AI-augmented workflow — verification gates

Avenbuan Bio Intelligence uses AI-assisted synthesis and source-extraction tools to accelerate analyst workflow. Every quantitative claim, however, passes through a four-stage human verification gate: (1) source traced to primary document; (2) figure verified against original; (3) date and context confirmed; (4) inclusion criteria for the specific claim. Claims that cannot pass all four gates are omitted.

9.3 Data refresh cycle

Client-commissioned versions of this brief are updated on a rolling basis aligned with company quarterly disclosures, major regulatory decisions, and the principal clinical-conference calendar (JPM Healthcare Conference, ADA Scientific Sessions, EASD, ESMO).

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AVENBUAN BIO INTELLIGENCEAPPENDIX A — SOURCE INDEX

Appendix A — Source index

Each entry below is a primary or near-primary source cited in this brief. Footnote numbers reference the citations in the body of the report.

  1. Novo Nordisk A/S — Form 20-F for the year ended 31 December 2024. sec.gov
  2. Eli Lilly and Company — Form 10-K for the year ended 31 December 2024. sec.gov
  3. Aronne L. J. et al. — "Tirzepatide as Compared with Semaglutide for the Treatment of Obesity" (SURMOUNT-5), NEJM 2025. nejm.org
  4. JPMorgan Global Research — "How supply and demand for weight-loss drugs is playing out", 2026. jpmorgan.com
  5. Fierce Pharma — "Novo unveils newly reduced self-pay prices for Wegovy, Ozempic after White House deal", Nov 2025. fiercepharma.com
  6. Pfizer Inc. — "Pfizer Provides Update on Oral GLP-1 Receptor Agonist", 14 April 2025. pfizer.com
  7. HCPLive — "FDA Approves Semaglutide (Wegovy) Pill as First Oral GLP-1 for Weight Loss", 22 Dec 2025. hcplive.com
  8. US FDA — "FDA Approves Treatment for Serious Liver Disease Known as MASH" (Wegovy). fda.gov
  9. IDA Ireland — "Novo Nordisk announces more than €400 million expansion in Athlone", 2 March 2026. idaireland.com
  10. Fortune — "Ozempic, Wegovy maker Novo Nordisk reports 2024 revenue", 31 March 2025. fortune.com
  11. Eli Lilly and Company — Form 8-K, Q3 2025 sales and earnings release. sec.gov
  12. Goldman Sachs Research — "The anti-obesity drug market may prove smaller than expected". goldmansachs.com
  13. Morgan Stanley Research — "GLP-1 weight-loss market may double to $190 billion by 2035". morganstanley.com
  14. BMO Capital Markets — Second Annual Obesity Summit, 2025. capitalmarkets.bmo.com
  15. Evaluate Pharma — "2030 Forecasts for Global Pharmaceutical Market". evaluate.com
  16. IQVIA — "Outlook for Obesity from 2026 to 2030", April 2026. iqvia.com
  17. CMS — Medicare GLP-1 Bridge demonstration. cms.gov
  18. NICE / NHS England — TA1026 Interim Commissioning Guidance, March 2025. england.nhs.uk
  19. Houses of the Oireachtas — Parliamentary Question on HSE reimbursement of weight-management medicines, 1 October 2025. oireachtas.ie
  20. Novo Nordisk Annual Report 2024 — Strategic Aspirations / Financials. annualreport.novonordisk.com
  21. Novo Nordisk A/S — Form 6-K, Q1 2025. sec.gov
  22. Same as 21 — additional reference
  23. Novo Nordisk A/S — Form 6-K, Q2 2025. sec.gov
  24. Eli Lilly and Company — Form 8-K, Q1 2025 sales and earnings release. sec.gov
  25. Eli Lilly and Company — Form 8-K, Q2 2025 sales and earnings release. sec.gov
  26. Eli Lilly and Company — "FDA Approves Zepbound® (tirzepatide), the first and only prescription medicine for OSA", 20 December 2024. investor.lilly.com
  27. Eli Lilly and Company — Retatrutide TRIUMPH-4 Phase 3 results, December 2025. investor.lilly.com
  28. Eli Lilly and Company — Orforglipron ATTAIN-1 Phase 3 results, 7 August 2025. investor.lilly.com
  29. CNBC — "Eli Lilly prices Zepbound weight-loss drug vials", 1 December 2025. cnbc.com
  30. Catalent Inc. — Form 8-K, 18 December 2024 close of merger with Novo Holdings. sec.gov
  31. Goodwin Procter — "Novo Holdings to Acquire Catalent" — announcement of 18 December 2024 closing. goodwinlaw.com
  32. US FDA — "FDA clarifies policies for compounders — semaglutide and tirzepatide shortage updates". fda.gov
  33. Eli Lilly and Company — "Lilly increases manufacturing investment to $9 billion at newest site". investor.lilly.com
  34. CNBC — "Eli Lilly to invest $27 billion in new US manufacturing", 26 February 2025. cnbc.com
  35. Fierce Pharma — "Eli Lilly shows its Irish $1.8 B manufacturing investment". fiercepharma.com
  36. Novo Nordisk — CagriSema REDEFINE 1 results, June 2025. prnewswire.com
  37. Novo Nordisk — FDA filing of CagriSema, December 2025. prnewswire.com
  38. The Lancet — Subcutaneous amycretin in obesity: Phase 1b/2a, January 2025. thelancet.com
  39. Amgen — "Phase 2 obesity results for monthly MariTide presented at ADA 85th Sessions", June 2025. amgen.com
  40. Roche — "Roche acquires Carmot Therapeutics", press release 4 December 2023. roche.com
  41. Roche — "Roche announces positive results for oral small-molecule GLP-1 CT-996", 17 July 2024. roche.com
  42. Fierce Biotech — "AstraZeneca reveals oral GLP-1 scored Phase 2 wins". fiercebiotech.com
  43. Viking Therapeutics — "Phase 3 VANQUISH initiation for VK2735". prnewswire.com
  44. Structure Therapeutics — GSBR-1290 Phase 2a topline data. structuretx.com
  45. Altimmune — IMPACT Phase 2b MASH results for pemvidutide. altimmune.com
  46. Boehringer Ingelheim — SYNCHRONIZE-1 Phase 3 obesity trial results for survodutide. boehringer-ingelheim.com
  47. Wilding J. P. H. et al. — "Once-weekly semaglutide in adults with overweight or obesity" (STEP-1), NEJM 2021.
  48. Jastreboff A. M. et al. — "Tirzepatide once weekly for the treatment of obesity" (SURMOUNT-1), NEJM 2022. investor.lilly.com
  49. Lincoff A. M. et al. — "Semaglutide and cardiovascular outcomes in obesity without diabetes" (SELECT), NEJM 2023.
  50. Eli Lilly and Company — SURMOUNT-OSA results, 2024.
  51. Newsome P. N. et al. — "Semaglutide in adults with MASH and moderate-to-advanced fibrosis" (ESSENCE), NEJM April 2025.
avenbuanbio.comAppendix · Page 28
AVENBUAN BIO INTELLIGENCEABOUT

About Avenbuan Bio Intelligence

Avenbuan Bio Intelligence is a Dublin-headquartered, AI-augmented competitive-intelligence firm serving pharma and biotech leaders across Ireland, the European Union, the United Kingdom, and the United States.

We combine doctorate-level scientific literacy, financial analyst rigour, and proprietary AI workflows to deliver McKinsey-grade strategic insight at the velocity that modern decision cycles demand.

What we do

Founder profile

Founded by Endrice Avenbuan. Bachelor’s (Moderatorship) in Medicinal Chemistry, Trinity College Dublin (Expected First Class Honours, 2026). Junior Analyst, Trinity Student Managed Fund — Healthcare & Pharmaceuticals sector (€500,000 AUM). Black Heritage Insight intern, BlackRock (London). Summer Talent Academy intern, Fidelity International (London). Wellcome Trust Biomedical Vacation Research Scholar, University of Manchester. Spring Intern, Citigroup (Dublin).

linkedin.com/in/endrice-avenbuan

Engagement model

Avenbuan Bio Intelligence operates a hybrid retainer/project model. Sample-grade deliverables — like the brief in your hands — illustrate the standard we apply to every client engagement.

Contact

Dublin · Ireland | hello@avenbuanbio.com | avenbuanbio.com

© 2026 Avenbuan Bio Intelligence. All rights reserved. This brief may be shared with prospective clients under the terms of fair use; redistribution for commercial purposes requires written permission. This report is for informational purposes only and does not constitute investment, medical, legal, or tax advice.

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