Life Science Leader Magazine

NOV 2014

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BIO INNOVATION NOTES REPORT LIFESCIENCELEADER.COM NOVEMBER 2014 22 Survey Methodology: The 2014 Eleventh Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production yields a composite view and trend analysis from 238 responsible individuals at biopharmaceutical manufac- turers and contract manufacturing organizations (CMOs) in 31 countries. The methodology also included over 173 direct suppliers of materials, services, and equipment to this industry. This year's study covers such issues as: new product needs, facility budget changes, current capacity, future capacity constraints, expansions, use of disposables, trends and budgets in disposables, trends in downstream purifi cation, quality management and control, hiring issues, and employment. The quantitative trend analysis provides details and comparisons of production by biotherapeutic developers and CMOs. It also evaluates trends over time and assesses differences in the world's major markets in the U.S. and Europe. Biosimilars Will Be A Boon For CMOs: CMOs are among the major beneficiaries of the new wave of biosimilars and biobet- ters, with many already seeing increased demand across a range of activities, from bioprocess development to scale-up and manufacture of preclinical and clinical supplies. Some CMOs are reporting over- all business increases of 15 percent due to biosimilars contracts. These opportuni- ties will continue for CMOs. Established drug innovators will prefer to devote lim- ited in-house capacity to newer, higher- profit products. CMOs will manufacture their biosimilars and biobetter products. Analyses contained in our 11th Annual Report and Survey of Biopharmaceutical Manufacturers suggest that 40 percent or more of biosimilars and biobetters could be manufactured by CMOs. The New Wave Of Biosimilars Will Spur Innovation: To remain competi- tive as biosimilars and biobetters evolve, product developers and manufacturers will need better ways to cut down on time to market and streamline the overall test- ing process. The industry is demanding higher productivity and lower manufac- turing costs, and many players are look- ing to industry suppliers for the inno- vations to advance analytical studies, clinical testing, and other technologies needed to support biosimilar approvals and production. Cost-Effective Biomanufacturing: Biosimilars developers will need to adopt the most cost-effective manufac- turing technologies just to be able to compete. Expect widespread adoption of newer, advanced expression systems and improved disposable upstream and downstream bioprocessing systems. In general, developers are not looking to reverse-engineer and mirror reference products' legacy manufacturing methods developed decades ago. Rather, biosimi- lars developers are already using some of the newest and most improved biopro- cessing methods. These are expected to improve processing and lower manufac- turing costs. SUMMARY These trends toward production effi- ciency will also affect manufacturers of future reference products. As better production technologies emerge, they will first improve new biological product manufacturing. That is, advanced bio- processing technologies will first provide advantages to makers of these newer follow-on products, As such, we can expect biosimilars and biobetters to be factors in the pioneering of many new technologies, such as better analyti- cal methods, improved expression sys- tems, single-use systems, alternatives to Protein A, and other conventional chro- matography processing. In a recent survey among BioPlan's Biotechnology Industry Council™, our 425 global subject matter experts identi- fied the following micro-trends in the biosimilars market: Expect more models and analytical methods for demonstrating biosimilarity and biochemical or biophysical charac- terization; If you want to learn more about the report, please go to bioplanassociates.com U.S. Biosimilars Launchable Dates 2012-2013, By Current Reference Product Sales ($Million) Figure1 Expect more established regulations, definitions, and standards for biosimilars and "biosimilarity"; Expect bioprocess tweaks allowing for fine-tuning of biosimilars to match inno- vator biologics; and Expect more quality by design (QbD) and design of experiments (DoE) for all products including biosimilars. To those trends we also add that many current developers face challenges in the short term. Many companies are already far ahead, and the competition will be fierce as many seek to market the same product to a limited pool. Overall, the coming wave of biosimilars and biobet- ters will bring big changes to the market, enhancing the role of the CMO, expand- ing the number of players in the global market, and spurring breakthrough new technologies. Our upcoming studies will provide global subject matter review of these trends and their impact on global biopharmaceutical markets. L THE BIOSIMILARS OPPORTUNITY: 4 YEARS OF WAITING By E. Langer Source: 11th Annual Report and Survey of Biopharmaceutical Manufacturers, April 2014, www.bioplanassociates.com/11th Bars represent the total dollar estimated sales ($millions) by year for all U.S. reference biologics potentially producible as biosimilars. This data implies total market potential for biosimilars, based on when specif c U.S. biololgics become available for biosimilar production. $30,000 $25,000 $20,000 $15,000 $10,000 $5,000 $0 2013 2017 2015 2019 2021 2014 2018 2016 2020 ≤2022 ≤2012 17,757 10,255 22,653 10,483 11,997 6,764 9,645 2,372 3,691 13,172 27,870

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