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Dinâmica do mercado dos biossimilares
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Advisor(s)
Abstract(s)
Os medicamentos biológicos inovadores têm vindo a ser associados a preços galopantes que introduzem elevadas pressões nos orçamentos para a saúde. A adoção de medicamentos biossimilares, terapêuticas similares às biológicas, permite aumentar o acesso dos doentes às mesmas, oferecendo diversidade de opções de tratamento, atenuando as pressões orçamentais sobre os sistemas de saúde e libertando recursos que poderão ser investidos em outras áreas. Apesar destas vantagens, o mercado europeu dos biossimilares está longe de estar consolidado, existindo uma elevada variância de adoção entre estados-membro motivada pelo desconhecimento tido pelos vários intervenientes em relação às dinâmicas de mercado.
A presente monografia propõe-se a identificar as principais dinâmicas que regem o mercado europeu dos biossimilares, determinando a influência das mesmas na market share (quota de mercado) obtida pelos diversos produtos aprovados ao longo de 10 anos.
Realiza-se assim um estudo estatístico partindo de uma amostra de 22 países da EU para os quais são selecionadas 11 dinâmicas de mercado (variáveis independentes), cuja correlação com a market share (variável dependente) é determinada através de regressão linear múltipla, com recurso ao método estatístico análise de variância (ANOVA). São obtidos 3 modelos matemáticos que constatam a influência de 3 dinâmicas na market share de um biossimilar, nos mercados europeus.
Conclui-se que, para os mercados maturados (Epoetina, Filgrastim e Somatropina), a market share de um biossimilar aumenta 0,65% por cada -1% de variação de preço introduzida pelo biossimilar (no conjunto biossimilar e produto de referência) e diminui 12,9% por cada ano de presença de biossimilares da mesma classe, num dado país e 16,3% por cada ano de delay de entrada do biossimilar (face à AIM centralizada), num dado país.
Innovative biologic medicines have been linked to a skyrocketing cost which introduces high pressures on the already constrained national health budgets. The adoption of biosimilars (similar versions of an approved biologic reference product) allows to expand patients’ access to costly therapies, increasing the diversity of treatment options and attenuating national health budget pressures, releasing resources that can be used in other areas. Despite this advantage, biosimilars’ European market is not yet fully established and it’s common to observe high variances in biosimilars’ adoption among EU member-states due to unawareness of the dynamics that rule the market. Therefore, the present study aims to identify the most relevant dynamics of the EU biosimilars’ market and to access the influence of those in the market share obtained by these medicines in 10 years. In order to do so, it’s performed a statistical study based on a 22 EU countries’ sample for which are obtained a total of 11 market dynamics (independent variables) whose correlation with market share (dependent variable) is accessed through multiple linear regression using the statistical method ANOVA. The results achieved comprise 3 mathematical models which confirm the influence of 3 market dynamics in a biosimilars’ market share In conclusion, in what refers to European mature markets (Epoetin, Filgrastim, and Somatropin), biosimilars’ market share increases 0,65% by every -1% price variation introduced by the respective biosimilar (in the biosimilar + reference product segment) and it decreases 12,9% for every year that a biosimilar of the same class is present in the respective country and 16,3% for every year between the centralized Market Introduction Authorization approval and the national entrance of the given biosimilar.
Innovative biologic medicines have been linked to a skyrocketing cost which introduces high pressures on the already constrained national health budgets. The adoption of biosimilars (similar versions of an approved biologic reference product) allows to expand patients’ access to costly therapies, increasing the diversity of treatment options and attenuating national health budget pressures, releasing resources that can be used in other areas. Despite this advantage, biosimilars’ European market is not yet fully established and it’s common to observe high variances in biosimilars’ adoption among EU member-states due to unawareness of the dynamics that rule the market. Therefore, the present study aims to identify the most relevant dynamics of the EU biosimilars’ market and to access the influence of those in the market share obtained by these medicines in 10 years. In order to do so, it’s performed a statistical study based on a 22 EU countries’ sample for which are obtained a total of 11 market dynamics (independent variables) whose correlation with market share (dependent variable) is accessed through multiple linear regression using the statistical method ANOVA. The results achieved comprise 3 mathematical models which confirm the influence of 3 market dynamics in a biosimilars’ market share In conclusion, in what refers to European mature markets (Epoetin, Filgrastim, and Somatropin), biosimilars’ market share increases 0,65% by every -1% price variation introduced by the respective biosimilar (in the biosimilar + reference product segment) and it decreases 12,9% for every year that a biosimilar of the same class is present in the respective country and 16,3% for every year between the centralized Market Introduction Authorization approval and the national entrance of the given biosimilar.
Description
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, Universidade de Lisboa, Faculdade de Farmácia, 2016
Keywords
Biossimilares Biológicos Europa Mercado Dinâmica Market Share Preço Epoetina Filgrastim Somatropina Anti-TNF Mestrado Integrado - 2016