BioRegions

Biopharmaceuticals On Demand

    By 2016, five of the top 10 biopharmaceuticals are expected to be monoclonal antibodies (MAbs). Follow-on (biosimilar) versions of those blockbusters will most likely become available in later years due to patent expiry and the introduction of legislation for biosimilars around the world. Personalized therapies will drive the fractionation of the biopharmaceutical market, trending biomanufacturing toward smaller batch sizes and campaign-based production schemes. A growing need for flexible, multipurpose, and cost-effective manufacturing will significantly affect the design of…

Success Stories from the Asia–Pacific

The Asia–Pacific region is a vast geographic area with a loose definition — covering East Asia, Southeast Asia, and Oceania. It includes a variety of cultures and races and is home to both developed and developing countries. Depending on the definitions of the region, the gross domestic product (GDP) varies from $500 per capita in East Timor to $41,500 in Australia, and the populations climb from a mere 55,500 in Australian Samoa to a vast 1.3 billion in China (1).…

Expanding Emerging Market Access Through Regulatory Strategy

    The growth potential for biopharmaceutical companies in emerging markets is no secret. By 2015, up to 35% of the global biopharmaceutical market will be in China and other developing countries. Yet even though most companies have reset their research and development (R&D) and supply chain models to support global expansion, their regulatory submission strategies and capabilities often fall short. The number of regulatory requirements has grown exponentially as biopharmaceutical companies enter new and disparate markets, but efforts in…

Effect of China’s Talent Scheme on Life-Science Innovation

The impact that the migration of talent is having on life sciences companies’ ability to innovate and differentiate themselves worldwide is a topic of constant concern. Of particular interest are the increasing flows between the United States and China. China’s “1,000 Talents Scheme” and similar initiatives at the local level were specifically designed to help the country become a world leader in innovation. Such programs incentivize people who are among the top 10 practitioners in their field to return to…

China Ranked Top Potential Biopharma Outsourcing Destination

Until recently, China had not been considered a global contender for outsourced biopharmaceutical manufacturing. In fact, it’s been less than a decade since pharmaceutical contract manufacturing in China became legal (1). Yet, the industry now ranks China as the most likely biomanufacturing outsourcing location. According to our recently released study, 17% of the industry considers China as the top future offshore production destination (Figure 1). The BioPlan 2011 Eighth Annual Report and Survey of Biomanufacturing Capacity and Production shows China…

Australia

    Australia is the only Asia–Pacific country that’s home to one of the world’s top-10 biotechnology companies (in revenue): CSL Limited, a maker of drugs, vaccines, antivenoms, blood products, and diagnostics. Many companies in the West consider this country a “gateway” to the Asia–Pacific region because of its relatively familiar culture, language, laws, and infrastructure. Indeed, Australia’s proximity to Singapore, Indonesia, Malaysia, and the rest of Asia compares favorably to the rest of the English-speaking world. For cell therapies…

China’s New Five-Year Plan

    In October 2010, the Communist Party of China’s Central Committee approved its 12th Five-Year Plan for National Economic and Social Development (FYP) (2011–2015), which it ratified on 14 March 2011. During those five years, China will continue to focus on government-guided economic development, industry, and technology. The FYP outlines the government’s commitment toward reforming its economy and increasing its domestic consumption to decrease its dependence on exports for future growth of its gross domestic product (GDP). Other initiatives…

France Biotech Presents Results of Its 2010 Life-Sciences Survey

    France Biotech (the French association of life-science companies) presented the results of its “Life Science Panorama 2010” survey at the BioVision world life-sciences forum in Lyons, France, on 29 March 2011. The survey describes major trends for 2009–2010 in the life-science industry, both in France and internationally. More than 263 companies responded to the survey this year, and 211 were included in the final analysis.   Main Trends in France   Results of the latest survey attest to…

India

    India is well known as a key destination for bioprocess outsourcing and a major supplier of active pharmaceutical ingredients and raw materials. The global pharmaceuticals manufacturing outsourcing industry is expected to reach US$100 billion by 2015 (1). India has the potential to capture 8–10% of this industry by 2015 and become one of the top 10 global markets by value (2). By comparison, India’s biotechnology industry (consisting of biopharmaceuticals as well as other sectors) has gained global attention…

Japan

Japan is the third largest economy in the world. Its chemical (and classical drug) industry is fully mature, and it is a founding member and major participant in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) project. The country’s aging population represents an attractive market to outside drug companies. Some well-known vendors to the bioprocess industry are headquartered in Japan, including Tosoh Bioscience and Shimadzu Scientific Instruments. “Japanese companies have become so…