BioRegions

Innovating in France’s Auvergne-Rhône-Alpes Region

  Lyonbiopole is a French “bio-cluster” based in the Auvergne-Rhône-Alpes region surrounding Lyon (Figure 1). The cluster supports ambitious projects and companies in the broad health industry, counting more than 200 members including Lyonbiopole’s four founders: Sanofi Pasteur (the vaccines division of multinational pharmaceutical company Sanofi), bioMérieux (known worldwide for in vitro diagnostics and microbiological testing), Merial (an animal-health company that merged recently with Boehringer Ingelheim), and Becton Dickinson (supplier of flow cytometers, reagents, tools, and services). The region also is…

Introduction: Tackling the Technical and Regulatory Challenges of Biosimilar Development

In a just a few years, the biopharmaceutical industry has gone from questioning the feasibility of “follow-on biologics” (around the time of BPI’s first issues) to fearing them (when we published our first supplement on the topic in 2013) to the acceptance and strategizing of today. Perhaps because of its more socialized medicine, Europe led the way in biosimilar regulation and approved its first such product nearly 10 years before the first US biosimilar launch in 2015. In between came…

Biosimilar Markets and Regulation: Which Countries Are Going All In?

The pipeline of follow-on (biosimilar and biobetter) products in development for the US, EU, and other major markets is very healthy. It includes nearly 800 biosimilars, about three-quarters of which are presumed to be targeted for major markets, and about 500 biobetters in development. Nearly 1,200 follow-on biopharmaceutical products in the development pipeline are intended to compete with more than 100 currently marketed biopharmaceuticals. This is not just an opportunity in the Western world; biosimilars development is expanding globally. But…

India’s Next Steps: Quality Improvements Target International Markets

India’s position as a global participant in small-molecule generic drugs, vaccines, and enzymes has been proven over decades. The country is one of the most populous and fastest-growing regions in the world, both economically and technically. But India’s potential as a biologics participant has not been realized. Its competence as a global biologics producer has not yet caught up. Global industry concerns regarding the country’s position in the (bio) pharmaceutical industry haven’t changed much over the past eight years since…

Collaboration Will Drive Regenerative Medicine: Toronto Development Center Will Help to Advance the Field

With support from the federal government of Canada, GE Healthcare and the Centre for Commercialization of Regenerative Medicine (CCRM) are pushing into new frontiers to advance the progress of cell therapy and regenerative medicine. When I first met Michael May, president and chief executive officer (CEO) of CCRM, both our organizations had been exploring opportunities in parallel to drive the cell therapy industry forward. CCRM’s mission is to create and sustain a global nexus for company creation, technology and cell…

Insulin in Demand: Engineering a Facility to Serve Local and International Markets

Discovered in 1922 at the University of Toronto (by Frederick Banting and John James Rickard Macleod), insulin has been produced from animal extract, primarily cattle and pigs. Following Frederick Sanger’s work on insulin sequence in 1951, Dorothy Hogkin published in 1969 the three-dimensional structure of insulin. This breakthrough led to many developments and applications of recombinant DNA for the production of insulin, human first and then analogs. The significant increase in the diabetic population — especially in BRICS countries (Brazil,…

Opportunities in Latin America Beyond the Olympics

Olympics fans aren’t the only ones turning their eyes toward Brazil. According to JLL’s fourth annual Life Sciences Outlook, the 2016 Summer Games host nation is also one of the world’s top 10 “Global Clusters to Watch,” thanks to its proven capacity for medical device manufacturing and a growing healthcare market. Increasingly, Latin America overall has been on the radar for life sciences companies seeking greater operational efficiency and opportunity, expanded market access, promising demographics, lower-cost land and labor, and…

Developing Markets Bring Opportunity But Not Without Real Estate Risk

Life-sciences markets develop in their own way, but one aspect they all have in common is the unpredictability of their growth. Not only are local economies unpredictable, but so are companies and their needs. Driven by competing pressures to seek new markets and new innovations while operating more efficiently, biopharmaceutical companies are increasingly setting their sights on new horizons abroad. Those investments are not without risks, however. Real estate is at the core of overseas expansion, and that’s where it…

Elucidation on India and China: Powerhouses of Asia 2015 Reports Assess Their Pharmaceutical Markets

In the past year, CPhI Worldwide (a division of UBM EMEA) has released reports on both the Indian and Chinese pharmaceutical markets, findings of which were presented at CPhI India in Mumbai in early December 2014 and shortly after CPhI China in August 2015. India Looking Outward to Innovate The Indian report, CPhI India Pharmaceuticals 2015: Industry Explorations, was developed by CPhI in partnership with Global Business Reports (GBR) to provide a comprehensive analysis of the country’s pharmaceutical market. Overall, Indian companies…

Can English Unite SE Asian Markets?

By 2016, the global pharmaceutical industry is expected to generate an estimated 30% of its total sales in emerging markets (1). After India and China, southeast countries such as Indonesia, Singapore, Malaysia, Vietnam, and Thailand are especially attractive markets. The Association of Southeast Asian Nations (ASEAN) Economic Community (AEC) consists of 10 countries united through regional economic cooperation: Thailand, Myanmar, Laos, Vietnam, Malaysia, Singapore, Indonesia, Philippines, Cambodia, and Brunei. The ASEAN Community 2015 (AEC 2015) initiative aims to form a…