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Abstract(s)
A produtividade em Inovação e Desenvolvimento (I&D) na Indústria Farmacêutica enfrentou um declínio constante entre 2010 e 2019, com o custo de desenvolver um novo medicamento a disparar para 2,3 mil milhões de dólares. Levar um novo medicamento ao mercado demora tipicamente entre 10 e 15 anos, e a realidade é implacável: mais de 96% dos projetos falham. No entanto, apesar destes obstáculos, a indústria continua a prosperar, graças à evolução dos modelos de negócio e a uma crescente adoção de estratégias de Open Innovation.
A colaboração tornou-se uma “tábua de salvação” para superar desafios de produtividade e eficiência. As empresas biofarmacêuticas recorrem cada vez mais à inovação por fontes externas para preencher lacunas científicas, aleando métodos tradicionais com novas abordagens para otimizar a I&D. Os modelos de Open Innovation — incluindo Outsourcing, parcerias estratégicas, fusões e aquisições, In-licensing e capital de risco corporativo — são agora essenciais para as empresas manterem-se competitivas e transformar ideias inovadoras em resultados em saúde.
A Biotecnologia, outrora recebida com ceticismo, evoluiu ao longo dos últimos 50 anos para se tornar uma força importante na saúde. Em 2023, os medicamentos biológicos representavam 70% dos 20 medicamentos mais vendidos no mundo, ilustrando a sinergia entre os setores de biotecnologia e farmacêutico, a qual contribuiu de forma significativa para a melhoria do desenvolvimento de medicamentos.
Inovações recentes em biofarmacêuticos abrangem o espectro de "Diagnóstico Prevenção-Tratamento", exemplificado pelo desenvolvimento de vacinas contra a COVID-19 e avanços em proteómica em contexto da descoberta de biomarcadores. Abordagens como gene-modified cell therapy, RNA therapy, e oncolytic virotherapy estão a ganhar terreno, particularmente em oncologia e neurologia, que juntas representam mais de 54% dos ensaios clínicos em 2023 e as áreas de maior investimento. A aprovação pela FDA do LEQEMBI para a doença de Alzheimer ilustra, por exemplo, o potencial das startups para desenvolver terapias inovadoras, apesar dos desafios inerentes resultando em 90% das startups acabarem por falhar, frequentemente devido a capacidades de gestão inadequadas e capital insuficiente — dois fatores críticos que influenciam o seu sucesso.
Assim, o objetivo desta tese é apresentar uma visão geral da inovação da indústria farmacêutica na saúde, examinando os papéis da Open Innovation e da biotecnologia.
R&D productivity in the pharmaceutical industry steady declined from 2010 to 2019, with the cost of developing a new drug soaring to $2.3 billion. Bringing a new medicine to market typically takes 10 to 15 years, and the reality is stark: over 96% of drug development projects fail. Yet, despite these hurdles, the industry continues to thrive, thanks to evolving business models and a growing embrace of open innovation strategies. Collaboration has become a lifeline for overcoming productivity and efficiency challenges. Biopharmaceutical companies increasingly turn to external innovation to fill scientific gaps, blending traditional methods with new approaches to streamline R&D. Open innovation models—including outsourcing, strategic partnerships, mergers and acquisitions, in licensing, and corporate venture capital—are now essential for companies looking to stay competitive and turn innovative ideas into successful health solutions. Biotechnology, once met with scepticism, has evolved over the past 50 years into a major force in healthcare. By 2023, biologics accounted for an impressive 70% of the top 20 best-selling drugs, demonstrating the synergy between biotech and pharmaceutical sectors that has significantly enhanced drug development. Recent biopharmaceuticals innovations span the "Diagnosis-Prevention-Treatment" spectrum, exemplified by the rapid development of COVID-19 vaccines and advances in proteomics for biomarker discovery. Approaches like gene-modified cell therapy, RNA therapy, and oncolytic virotherapy are gaining momentum, particularly in oncology and neurology, which together represent over 54% of clinical trials in 2023 and the areas attracting most investment. The FDA's approval of LEQEMBI for Alzheimer’s disease illustrates the potential of biotech startups to deliver groundbreaking therapies despite inherent challenges resulting in 90% of biotech startups failure, often due to inadequate management capabilities and insufficient capital—two critical factors that influence their success. Thus, the aim of this thesis is to provide an overview of pharmaceutical industry innovation in healthcare by examining the roles of open innovation and biotechnology.
R&D productivity in the pharmaceutical industry steady declined from 2010 to 2019, with the cost of developing a new drug soaring to $2.3 billion. Bringing a new medicine to market typically takes 10 to 15 years, and the reality is stark: over 96% of drug development projects fail. Yet, despite these hurdles, the industry continues to thrive, thanks to evolving business models and a growing embrace of open innovation strategies. Collaboration has become a lifeline for overcoming productivity and efficiency challenges. Biopharmaceutical companies increasingly turn to external innovation to fill scientific gaps, blending traditional methods with new approaches to streamline R&D. Open innovation models—including outsourcing, strategic partnerships, mergers and acquisitions, in licensing, and corporate venture capital—are now essential for companies looking to stay competitive and turn innovative ideas into successful health solutions. Biotechnology, once met with scepticism, has evolved over the past 50 years into a major force in healthcare. By 2023, biologics accounted for an impressive 70% of the top 20 best-selling drugs, demonstrating the synergy between biotech and pharmaceutical sectors that has significantly enhanced drug development. Recent biopharmaceuticals innovations span the "Diagnosis-Prevention-Treatment" spectrum, exemplified by the rapid development of COVID-19 vaccines and advances in proteomics for biomarker discovery. Approaches like gene-modified cell therapy, RNA therapy, and oncolytic virotherapy are gaining momentum, particularly in oncology and neurology, which together represent over 54% of clinical trials in 2023 and the areas attracting most investment. The FDA's approval of LEQEMBI for Alzheimer’s disease illustrates the potential of biotech startups to deliver groundbreaking therapies despite inherent challenges resulting in 90% of biotech startups failure, often due to inadequate management capabilities and insufficient capital—two critical factors that influence their success. Thus, the aim of this thesis is to provide an overview of pharmaceutical industry innovation in healthcare by examining the roles of open innovation and biotechnology.
Description
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, 2024, Universidade de Lisboa, Faculdade de Farmácia.
Keywords
Pharmaceutical industry Biotechnology Open innovation Healthcare Startups Mestrado integrado - 2024