ESTIMATING MARKET POTENTIAL FOR BIOSIMILAR INTRODUCTION

Author(s)

Paglia R*1;Bache G2, Rossi C3 1PAREXEL Consulting, East Brunswick, NJ, USA, 2PAREXEL Consulting, Uxbridge, United Kingdom, 3PAREXEL INTERNATIONAL, Uxbridge, United Kingdom

OBJECTIVES: The global biopharmaceutical industry is facing a biologics “patent cliff” between 2013 and 2020, which will leave approximately $54 billion in drug revenue, without patent protection. In order to achieve success with these biosimilar agents, it is critical that manufacturers/marketers target the highest potential global markets. The objective of this research is to provide a framework for identifying the markets with the highest potential for biosimilar adoption and utilization. METHODS: A review of literature, research reports, and review articles was conducted, along with a panel discussion of industry thought leaders in biosimilars. Key indicators of biosimilar market potential were identified, evaluated, and prioritized. A systematic approach was developed to score each key indicator, and a mathematical approach adopted to aggregate the market scores. A series of 20 country markets were evaluated and ranked in order of biosimilar market potential. RESULTS: Key indicators of biosimilar market potential were separated into three categories: 1.) Originator-drug indicators including originator sales, reimbursement level, and reimbursement status. 2.) Market indicators including rate of uptake of currently available biosimilars, payer cost-containment mechanisms, and future biosimilar outlook. 3.) Regulatory indicators including barriers to marketing authorization based on the complexity of required data packages, and the risks associated with the development of clinical programs. Secondary research of public domain information was conducted on each of 20 countries, in order to obtain the data to populate the key indicators for market potential. Each country achieved a score based on the data, and was ranked based on biosimilar market potential. CONCLUSIONS: The process demonstrates a rational approach to identifying and sequencing of biosimilar market potential, which can be used to inform clinical-development and market-access plans. Also, in practical application for a manufacturer/marketer, “resource indicators” of market-specific assets should be included.

Conference/Value in Health Info

2013-11, ISPOR Europe 2013, The Convention Centre Dublin

Value in Health, Vol. 16, No. 7 (November 2013)

Code

PHP115

Topic

Health Service Delivery & Process of Care

Topic Subcategory

Hospital and Clinical Practices

Disease

Multiple Diseases

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