VOL. XCIV, NO. 247
★ MOAT STOCKS & COMPETITIVE ADVANTAGES ★
PRICE: 5 CENTS
Tuesday, December 23, 2025
Amgen Inc.
AMGN · Nasdaq Stock Market
Weighted average of segment moat scores, combining moat strength, durability, confidence, market structure, pricing power, and market share.
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Overview
Amgen Inc. is a global biopharmaceutical company with economically distinct businesses in (1) core innovative medicines, (2) a rare-disease portfolio (boosted by the Horizon acquisition), and (3) biosimilars. The core moat mechanisms are legal exclusivity (patents and regulatory exclusivities) and the difficulty of scaling and validating biologics manufacturing at high quality. Rare-disease assets can enjoy quasi-monopoly positions when therapies are first/only approved, supporting stronger pricing, but they remain exposed to eventual competition and payer pushback. Biosimilars are structurally more competitive and price-led, with advantages leaning on manufacturing know-how, scale and supply reliability more than enduring pricing power.
Primary segment
Core Innovative Medicines
Market structure
Competitive
Market share
—
HHI: —
Coverage
3 segments · 6 tags
Updated 2025-12-22
Segments
Core Innovative Medicines
Branded biopharmaceutical therapies for common diseases (bone health, inflammation, oncology, cardiovascular and other specialty areas)
Revenue
80.1%
Structure
Competitive
Pricing
moderate
Share
—
Peers
Rare Disease Portfolio (Horizon + others)
Rare disease and ultra-rare specialty therapeutics (e.g., thyroid eye disease, chronic refractory gout, NMOSD, ANCA-associated vasculitis)
Revenue
13.3%
Structure
Quasi-Monopoly
Pricing
strong
Share
—
Peers
Biosimilars
Biosimilar biologic drugs (e.g., adalimumab, bevacizumab and other reference biologics)
Revenue
6.6%
Structure
Oligopoly
Pricing
weak
Share
—
Peers
Moat Claims
Core Innovative Medicines
Branded biopharmaceutical therapies for common diseases (bone health, inflammation, oncology, cardiovascular and other specialty areas)
Revenue_share estimated from FY2024 total revenues ($33.4B) and FY2024 biosimilars/rare disease disclosures in Amgen 2024 results press release: https://www.amgen.com/newsroom/press-releases/2025/02/amgen-reports-fourth-quarter-and-full-year-2024-financial-results
IP Choke Point
Legal
IP Choke Point
Strength: 4/5 · Durability: medium · Confidence: 4/5 · 2 evidence
Key products are protected by patent portfolios and (where applicable) regulatory exclusivity; this supports premium pricing and delays direct copies until loss of exclusivity.
Erosion risks
- Patent challenges and unfavorable litigation outcomes
- Accelerated net price declines after biosimilar/generic entry
- Regulatory or legislative changes that compress exclusivity (e.g., price controls)
Leading indicators
- Patent expiry calendar and major litigation milestones
- FDA/EMA approvals for competing biosimilars/generics
- Net selling price trend (gross-to-net) for mature brands
Counterarguments
- Many therapeutic areas are crowded with alternative mechanisms, limiting pricing even during exclusivity
- Some revenues are concentrated in mature brands already facing net price declines
Regulated Standards Pipe
Legal
Regulated Standards Pipe
Strength: 4/5 · Durability: durable · Confidence: 5/5 · 1 evidence
Drug development/manufacturing requires meeting stringent regulatory standards; the approval process and ongoing compliance raise time/cost barriers for entrants.
Erosion risks
- Policy changes that speed competitor approvals or expand abbreviated pathways
- Heightened enforcement actions or compliance failures
Leading indicators
- Inspection outcomes and warning letters
- Time-to-approval and label updates for key products
- Changes to FDA/EMA guidance on biosimilars and generics
Counterarguments
- Regulatory standards apply to all incumbents; they are barriers but not necessarily a differentiator versus other large pharma/biotech
Capex Knowhow Scale
Supply
Capex Knowhow Scale
Strength: 4/5 · Durability: durable · Confidence: 4/5 · 2 evidence
Large-scale biologics manufacturing requires substantial capital, specialized know-how, validation, and quality systems, which are difficult to replicate quickly.
Erosion risks
- Manufacturing disruptions, quality issues, or supply interruptions
- Technology shifts (e.g., novel modalities) that reduce relevance of existing capacity
- Greater outsourcing/CMO availability lowering entry barriers
Leading indicators
- Batch success/yield trends and supply reliability
- Capacity expansion milestones and capex cadence
- Regulatory inspection outcomes across manufacturing network
Counterarguments
- Other large biopharma firms also possess global manufacturing scale
- Some therapies can be outsourced to specialized CMOs, reducing the advantage
Brand Trust
Demand
Brand Trust
Strength: 3/5 · Durability: medium · Confidence: 3/5 · 1 evidence
In biologics, physician/patient confidence and supply reliability can support persistence versus lower-cost alternatives, particularly around switching and substitution decisions.
Erosion risks
- Payer-driven switching to lowest-cost alternatives
- Safety signals or product recalls that damage trust
- Interchangeable biosimilars enabling automatic substitution
Leading indicators
- Formulary tiering and preferred product decisions
- Share shifts following biosimilar launches
- Pharmacovigilance / safety updates
Counterarguments
- In many channels, contracting and rebates dominate brand preference
- As biosimilar familiarity rises, brand trust advantage may diminish
Rare Disease Portfolio (Horizon + others)
Rare disease and ultra-rare specialty therapeutics (e.g., thyroid eye disease, chronic refractory gout, NMOSD, ANCA-associated vasculitis)
FY2024 rare disease revenue approximated by summing TEPEZZA ($1.851B), KRYSTEXXA ($1.185B), UPLIZNA ($0.379B), TAVNEOS ($0.283B) and Ultra-Rare products ($0.758B) from Amgen's FY2024 product sales table in the 2024 results press release.
Regulated Standards Pipe
Legal
Regulated Standards Pipe
Strength: 4/5 · Durability: medium · Confidence: 4/5 · 2 evidence
Early-in-lifecycle rare-disease therapies can face limited direct therapeutic competition because regulatory approval requires specialized trials and evidence in small patient populations.
Erosion risks
- New entrants (including novel mechanisms) targeting the same indications
- Regulatory setbacks or label restrictions
- Payer utilization management and step edits
Leading indicators
- Competitive clinical trial readouts in TED, gout, NMOSD and vasculitis
- Guideline updates and specialist prescribing trends
- Coverage criteria changes by major payers
Counterarguments
- Being first/only can be temporary; competitors can enter with better efficacy/safety or new delivery modalities
IP Choke Point
Legal
IP Choke Point
Strength: 4/5 · Durability: medium · Confidence: 3/5 · 2 evidence
Patent coverage and exclusivity help defend high-value specialty indications, but durability depends on patent strength, enforcement, and eventual competitive innovation.
Erosion risks
- Patent challenges and earlier-than-expected loss of exclusivity
- Off-label substitution or new standards of care displacing branded therapy
- Safety or access controversies reducing uptake
Leading indicators
- Patent litigation filings/outcomes for key assets
- Pipeline disclosures from competitors in the same indications
- Net price and patient access trends in specialty channels
Counterarguments
- Rare disease markets can attract targeted competition due to high pricing and concentrated prescriber base
Biosimilars
Biosimilar biologic drugs (e.g., adalimumab, bevacizumab and other reference biologics)
FY2024 biosimilars revenue estimated as AMJEVITA/AMGEVITA ($0.761B) + MVASI ($0.727B) + other biosimilars ($0.725B) from Amgen's FY2024 product sales table; total biosimilars ~= $2.213B. Source: Amgen 2024 results press release (table notes state 'Biosimilars total $725 million in FY 24').
Capex Knowhow Scale
Supply
Capex Knowhow Scale
Strength: 3/5 · Durability: durable · Confidence: 4/5 · 2 evidence
Biosimilars require high-quality, validated biologics manufacturing and analytics; scale and know-how reduce unit costs and improve supply reliability versus smaller entrants.
Erosion risks
- Aggressive price competition and tender dynamics compressing returns
- Improved CMO capacity lowering entry barriers
- Interchangeability and payer mandates shifting volume to lowest-price suppliers
Leading indicators
- Biosimilar ASP/price trends by molecule
- Contract wins/losses with major payers and group purchasing organizations
- Supply reliability incidents and backorders
Counterarguments
- Biosimilars often become commoditized quickly; scale does not prevent price wars
Learning Curve Yield
Supply
Learning Curve Yield
Strength: 3/5 · Durability: durable · Confidence: 4/5 · 1 evidence
Analytical characterization, process development, and yield learning over time can lower cost and reduce comparability risk versus newer manufacturers.
Erosion risks
- Technology standardization reducing learning-curve advantages
- Regulatory convergence lowering approval friction
- Competitors with equal or greater manufacturing experience
Leading indicators
- Yield improvements / manufacturing cost trends
- Regulatory approvals and inspection outcomes for biosimilar sites
- Time-to-launch for new biosimilars versus peers
Counterarguments
- Large competitors may have similar learning curves and analytics capabilities
Brand Trust
Demand
Brand Trust
Strength: 2/5 · Durability: medium · Confidence: 3/5 · 1 evidence
Even in price-competitive biosimilars, reliability and safety perception can influence provider/payer selection among multiple similar suppliers.
Erosion risks
- Payers prioritize lowest net cost, overriding brand considerations
- Interchangeability reduces differentiation
Leading indicators
- Share stability after new biosimilar launches
- Customer complaints / recalls / shortage events
- Interchangeability designations for competing biosimilars
Counterarguments
- For many payers, price is the primary selection factor, limiting the value of brand trust
Evidence
The following table lists our outstanding material patents for the indicated product...
Shows product-by-product patent coverage and expirations that underpin exclusivity.
...new molecular entities would receive a 12 year exclusivity period in the United States...
Supports the role of regulatory exclusivities (in addition to patents) as a legal barrier.
Regulation by government authorities... is a significant factor in the development, manufacture and marketing of our products.
Highlights the breadth and centrality of regulatory requirements to compete in biopharma.
Highly specialized knowledge... is required to transform laboratory-scale processes into reproducible commercial manufacturing processes.
Supports the expertise/capability barrier in scaling biologics manufacturing.
It can take longer than five years to build, validate and license another manufacturing plant.
Supports high time-to-replicate capacity (capex + regulatory validation).
Showing 5 of 12 sources.
Risks & Indicators
Erosion risks
- Patent challenges and unfavorable litigation outcomes
- Accelerated net price declines after biosimilar/generic entry
- Regulatory or legislative changes that compress exclusivity (e.g., price controls)
- Policy changes that speed competitor approvals or expand abbreviated pathways
- Heightened enforcement actions or compliance failures
- Manufacturing disruptions, quality issues, or supply interruptions
Leading indicators
- Patent expiry calendar and major litigation milestones
- FDA/EMA approvals for competing biosimilars/generics
- Net selling price trend (gross-to-net) for mature brands
- Inspection outcomes and warning letters
- Time-to-approval and label updates for key products
- Changes to FDA/EMA guidance on biosimilars and generics
Curation & Accuracy
This directory blends AI‑assisted discovery with human curation. Entries are reviewed, edited, and organized with the goal of expanding coverage and sharpening quality over time. Your feedback helps steer improvements (because no single human can capture everything all at once).
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