THE MARKET FOR MONOCLONAL ANTIBODIES: TRENDS, CHALLENGES, AND OPPORTUNITIES
Author(s)
André S. Motta-Santos, PhD1, Kenya V. Noronha, PhD2, Leonardo C. Ribeiro, PhD2, Jeffrey Gow, PhD3, Korshed Alam, PhD3, Mônica V. Andrade, PhD2;
1Universidade Federal de Minas Gerais and University of Southern Queensland, PhD Candidate, Belo Horizonte, Brazil, 2Universidade Federal de Minas Gerais, Department of Economics, Belo Horizonte, Brazil, 3University of Southern Queensland, School of Business, Toowoomba, Australia
1Universidade Federal de Minas Gerais and University of Southern Queensland, PhD Candidate, Belo Horizonte, Brazil, 2Universidade Federal de Minas Gerais, Department of Economics, Belo Horizonte, Brazil, 3University of Southern Queensland, School of Business, Toowoomba, Australia
OBJECTIVES: This study examines the mAb innovation landscape through patent activity and market data.
METHODS: A dedicated dataset was constructed by linking multiple sources (Antibody Society, Orange Book, Ark Patent Intelligence, USPTO, PATSTAT, Purple Book, US Veterans Affairs, US-FDA, and ORBIS). Data analysis comprised six components: (i) a general description of the dataset, (ii) an examination of mAb patents and approval trends, (iii) an analysis of therapeutic indications, (iv) a characterization of patent holders and producers through descriptive and network analyses, (v) an assessment of shareholder influence, including common-ownership patterns, and (vi) an evaluation of mAb prices.
RESULTS: The dataset included 63 mAbs, 1,732 unique patents, 89 active pharmaceutical ingredients, 34 producers, and 214 therapeutic indications. 36.5% were single-indication while the average number of secondary indications was 3.78. The most central firms in the network analysis included Amgen, Roche, Pfizer, Celltrion, and Samsung, with shareholders such as BlackRock, UBS, the Vanguard Group, and JPMorgan Chase exerting strong market influence. Prices were extremely high, averaging US$127,430 per course or year (s=US$142,509), with 42.1% of mAbs priced above US$100,000. mAbs were approximately 250 more expensive than gold. Patent thicketing and evergreening are relevant problems in this market, contributing to the its concentration.
CONCLUSIONS: While mAbs have transformed modern medicine and improved safety and effectiveness, their persistently high prices, reinforced by market concentration and financial investor influence, raise serious concerns for social welfare. Innovation in the mAb market has been prolific, but heavily concentrated in a few companies from developed countries.
METHODS: A dedicated dataset was constructed by linking multiple sources (Antibody Society, Orange Book, Ark Patent Intelligence, USPTO, PATSTAT, Purple Book, US Veterans Affairs, US-FDA, and ORBIS). Data analysis comprised six components: (i) a general description of the dataset, (ii) an examination of mAb patents and approval trends, (iii) an analysis of therapeutic indications, (iv) a characterization of patent holders and producers through descriptive and network analyses, (v) an assessment of shareholder influence, including common-ownership patterns, and (vi) an evaluation of mAb prices.
RESULTS: The dataset included 63 mAbs, 1,732 unique patents, 89 active pharmaceutical ingredients, 34 producers, and 214 therapeutic indications. 36.5% were single-indication while the average number of secondary indications was 3.78. The most central firms in the network analysis included Amgen, Roche, Pfizer, Celltrion, and Samsung, with shareholders such as BlackRock, UBS, the Vanguard Group, and JPMorgan Chase exerting strong market influence. Prices were extremely high, averaging US$127,430 per course or year (s=US$142,509), with 42.1% of mAbs priced above US$100,000. mAbs were approximately 250 more expensive than gold. Patent thicketing and evergreening are relevant problems in this market, contributing to the its concentration.
CONCLUSIONS: While mAbs have transformed modern medicine and improved safety and effectiveness, their persistently high prices, reinforced by market concentration and financial investor influence, raise serious concerns for social welfare. Innovation in the mAb market has been prolific, but heavily concentrated in a few companies from developed countries.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
HPR35
Topic
Health Policy & Regulatory
Topic Subcategory
Health Disparities & Equity, Pricing Policy & Schemes, Reimbursement & Access Policy
Disease
STA: Biologics & Biosimilars