Biosimilar & Biologics: Analytical Strategies & Market Analysis

Effective management of a current good manufacturing practice (GMP) facility requires a strict eye on all those factors. This also includes Bioanalytical methods, Formulation, Bioassay for comparability and potency testing, GMP protein analysis, LC/MS analysis for discovery, preclinical, and clinical programs. Analysis of Biosimilars and Biologics forms to be one of the most important aspects towards the Biologics and Biosimilar development process. On average, facilities outsource 32% of their analytical testing/bioassays (up from 28%) meaning that close to one-third of analytical testing is estimated to be outsourced by the industry. The market for Biosimilars follow-on-Biologics is expected to grow at an exponential rate for next decade with the expiry of most patented drugs by 2020.The market in the APAC region for Biosimilars reached $605 million in 2010 and $683 million in 2011. The market is expected to reach $1.1 billion by 2016, a CAGR of 10.3%. The market in the United States for Biosimilars reached $507 million in 2010 and $1.1 billion in 2011. The market is expected to reach $1.3 billion by 2016, a CAGR of 4.1%.

  • Biosimilar Formulation
  • Biosimilar bioanalytical methods
  • Bioassay for comparability and Potency Testing
  • Biosimilar GMP protein analysis
  • Biosimilar lc/ms analysis for discovery, preclinical, and clinical programs
  • Biosimilar Electrophoresis
  • Biosimilar multimodal techniques
  • Biosimilars companies

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