Author Archives: Eric S. Langer

Biopharmaceutical Growth in China: Bioprocessing Challenges Are Creating CMO Opportunities

In the past decade, the world has seen rapid growth of more than 15% in China’s biopharmaceutical market (1). According to the second edition of BioPlan’s Advances in Biopharmaceutical Technology in China, the most populous country in the world — with the largest patient groups — has a growing economy with its GDP second only to that of the United States. Rapid urbanization and greater access to national healthcare insurance puts China in second place after the United States for…

China’s Focus on Innovation: Investment in Product and Process Development — Innovative Technologies from China Are Coming

Eric Langer, managing partner, BioPlan Associates China is a probable center of concentration for the next generation of biotechnology. However, Langer believes that the country will fail in its goal of achieving that if it cannot innovate. He said that forecasters need to understand the complex elements associated with development of biotechnology centers other than those for biogenerics and biosimilars. How is China going to develop the necessary innovation capability? Driving the industry are the 7,500 cancer deaths every day…

China Looks Inward and Outward: Investments in US and EU Biopharmaceutical Companies Are on the Rise

The growth momentum of China’s biopharmaceutical industry continues, with the China Industry Research Institute projecting that the country’s biological therapeutics market could reach 300 billion Chinese yuan (~US$50 billion) in 2019. According to the second edition of our report on advances in Chinese biopharmaceutical technology, this robust growth is boosted by continuing investment into the sector (1). A clear strategic indicator of the country’s intentions in biotherapeutics and biologics has been government investment in bioindustrial hubs, which by next year…

China Can Be Ignored No Longer: Long-Term Biopharmaceutical Opportunities Based on Near-Term Demonstrated Growth

China has long served as “the world’s factory,” but many experts in the biopharmaceutical industry have assumed that making consumer electronics, clothing, and toys for a global consumer base does not translate well to making complex biologics on the global stage. However, according to a newly released report, the biopharmaceutical market in China reached a value over US$9 billion in 2018, with the domestic monoclonal antibody (MAb) market there making up a very large percentage of that (1). Much of…

Worldwide Biopharmaceutical CMO Capacity Analysis

Contract manufacturing organizations (CMOs) are a core part of the biopharmaceutical industry, with commercial manufacturing making up about a third of marketed products. Here we examine worldwide CMO biopharmaceutical manufacturing (bioprocessing) capacity, concentrating on “mainstream” CMOs — defined as those providing primarily mammalian cell culture or microbial fermentation services for manufacture at any scale of proteins and antibodies. This analysis follows our recent article examining worldwide bioprocessing capacity status and trends (1). Survey Methodology The 2018 15th Annual Report and…

Worldwide Biopharmaceutical Manufacturing Capacity Analysis: Growth Continues Across the Board

While the growth in biopharmaceutical manufacturing capacity in developed, major market countries is continuing its slow and steady climb, developing regions often are seeing double that growth rate. Over the past eight years, as detailed in the “About the Data” box, our company’s index of the top 1,000 biomanufacturing facilities (1) has tracked and ranked bioprocessing facilities worldwide in terms of known or estimated bioprocessing capacity (cumulative onsite bioreactor volume) number of biological products manufactured at clinical scale commercial scale…

China’s Biopharmaceutical Companies Target Global Markets

Global perspectives of China as a major biopharmaceutical supplier have changed over the past decade. In 2008, BioPlan Associates completed its first analysis and directory of the top 60 biopharmaceutical facilities in China (1). Based on findings from our study titled Advances in Biopharmaceutical Technology in China (2), we found that China clearly held the image of a low quality manufacturer of biogeneric products almost exclusively for its domestic market. Further, concerns over intellectual property protection, contracting problems, and management…

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…

Outsourcing of Buffer Preparation Activity Is Increasing

The major fluid products used in bioprocessing — culture media and buffers — are classically prepared in-house by rehydrating (dissolving and mixing) powders purchased from suppliers. Most bioprocessing facilities consider in-house preparation of these fluids to be a core bioprocessing task. However, some companies are outsourcing the work either by purchasing preprepared materials from vendors or hiring contract manufacturing organizations (CMOs) to prepare them. Buffer fluid preparation is one area of downstream production operations that are seeing an increase in…

Deciding Between Single-Use and Stainless Steel Strategies

A BPI Theater Roundtable at Interphex 2016 On Tuesday, 26 April 2016, Eric S. Langer (managing partner of BioPlan Associates) chaired a morning roundtable titled “Deciding on Single-Use vs. Stainless Steel Strategy: What the CMOs Know That Biopharma Needs” as a follow-up to a similar discussion held last year. Langer brought together a panel of four contract manufacturing organization (CMO) industry experts: Daniel Vellom (senior director of global technology innovation at Sanofi Pasteur) Sue Behrens (senior director of process technology…