Competing Beyond the First Mover: How Late to Market Analogues Navigate Pricing and Access in Major Global Markets
Author(s)
Nikhil Taxak, PhD1, Mahesh Jaju, Masters1, Anupama Somu, Masters1, Srikanth Utukuri, Masters1, Thomas Gilboy, BA (Hons)2, Shrinivas Mukku, PhD3, Keshav Nagaraja, BEc, MBA3.
1Access Infinity Ltd, Hyderabad, India, 2Access Infinity, Whitehill, United Kingdom, 3Access Infinity Ltd, London, United Kingdom.
1Access Infinity Ltd, Hyderabad, India, 2Access Infinity, Whitehill, United Kingdom, 3Access Infinity Ltd, London, United Kingdom.
OBJECTIVES: Pharmaceutical product launches are arguably one of the most critical events in a company's lifecycle. Pharmaceutical manufacturers develop assets across a diverse set of diseases, sometimes entering competitive markets as late entrants. Given this scenario, analogues assessment was conducted to understand market access and pricing challenges, mitigation strategies, and tactical levers along with defining key success factors.
METHODS: We included a list of must have and nice to have criteria to ensure robust identification of analogues leveraging Nuro, Access Infinity’s proprietary data platform along with secondary research. The criteria included launched in last 10 years, at least 2nd to market within its therapeutic class or mechanism of action, mix of oncology and non-oncology, mix of limited differentiation vs. clear differentiation and first indication of launch. HTA, pricing outcomes and payer perceptions for ten analogues (such as Alecensa, Zejula, Rozlytrek, Eylea, Fasenra) were analysed across seven global markets (US, Germany, France, Spain, UK, Brazil, Canada).
RESULTS: Several distinct pricing strategies (discounting, parity or premium) were observed which were highly dependent on the level of clinical differentiation vs. earlier to market options. Global payers expect late to market entrants to show clinical differentiation vs. earlier in class competitors, preferably through a head to head trial, resulting in a price premium. In some cases, clinical superiority via indirect treatment comparison or communication of safety benefits led to price premium in European markets. The trade off between a broader label and a discounted pricing was also observed.
CONCLUSIONS: Analogue assessment considered clinical and other non clinical factors that impacted their pricing and access success or failure which can potentially be used as a guide for future portfolio development and optimisation. Demonstrating clinical differentiation vs. earlier entrants is the critical factor translating into positive HTA outcomes and securing a price premium.
METHODS: We included a list of must have and nice to have criteria to ensure robust identification of analogues leveraging Nuro, Access Infinity’s proprietary data platform along with secondary research. The criteria included launched in last 10 years, at least 2nd to market within its therapeutic class or mechanism of action, mix of oncology and non-oncology, mix of limited differentiation vs. clear differentiation and first indication of launch. HTA, pricing outcomes and payer perceptions for ten analogues (such as Alecensa, Zejula, Rozlytrek, Eylea, Fasenra) were analysed across seven global markets (US, Germany, France, Spain, UK, Brazil, Canada).
RESULTS: Several distinct pricing strategies (discounting, parity or premium) were observed which were highly dependent on the level of clinical differentiation vs. earlier to market options. Global payers expect late to market entrants to show clinical differentiation vs. earlier in class competitors, preferably through a head to head trial, resulting in a price premium. In some cases, clinical superiority via indirect treatment comparison or communication of safety benefits led to price premium in European markets. The trade off between a broader label and a discounted pricing was also observed.
CONCLUSIONS: Analogue assessment considered clinical and other non clinical factors that impacted their pricing and access success or failure which can potentially be used as a guide for future portfolio development and optimisation. Demonstrating clinical differentiation vs. earlier entrants is the critical factor translating into positive HTA outcomes and securing a price premium.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA85
Topic
Clinical Outcomes, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Value Frameworks & Dossier Format
Disease
Oncology, Rare & Orphan Diseases, Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory), Sensory System Disorders (Ear, Eye, Dental, Skin), Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)