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Updated: Jun 17, 2026

Applying an eMASS Customization Program as a Research Tool to Evaluate Consumer Benefits
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Applying an eMASS Customization Program as a Research Tool to Evaluate Consumer Benefits

Published on: September 27, 2019

mAbs: a business perspective.

Pablo A Scolnik1

  • 1The Scolnik Group Biotechnology Consultants, LLC, Hillsborough, NC 27278, USA. ps@scolnikgroup.com

Mabs
|January 12, 2010
PubMed
Summary

Monoclonal antibodies (mAbs) dominate biotechnology sales, offering significant therapeutic potential. However, high costs and payer reimbursement challenges may limit future growth for these advanced biological therapies.

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Area of Science:

  • Biotechnology
  • Pharmacology
  • Drug Development

Background:

  • Monoclonal antibodies (mAbs) represent a significant portion of top therapeutic biotechnology sales.
  • Eight top-selling mAbs achieved over $1 billion in annual sales, with rapid development cycles and favorable FDA programs.
  • mAbs are the leading class of biological therapies in development due to protein engineering advances and low generic competition.

Purpose of the Study:

  • To analyze the market dynamics and future outlook of monoclonal antibodies in the U.S. therapeutic landscape.
  • To identify key factors influencing the growth and commercial success of mAb-based therapies.
  • To assess the challenges and opportunities for companies developing new mAb products.

Main Methods:

  • Analysis of 2007 U.S. therapeutic biotechnology sales data for top-selling products.
  • Review of development timelines, regulatory pathways (FDA programs), and reimbursement policies for leading mAbs.
  • Assessment of market trends, including advancements in protein engineering and the absence of generic competition.

Main Results:

  • Monoclonal antibodies captured nearly half of the top 20 U.S. therapeutic biotechnology sales in 2007.
  • High-cost mAbs with liberal payer reimbursement have driven market growth.
  • Despite advancements, payer reimbursement is identified as the primary constraint for future mAb market expansion.

Conclusions:

  • Advancements in mAb engineering promise more effective therapies and broader indications.
  • Biomarker development is crucial for cost-effective patient stratification and treatment.
  • Navigating a challenging commercial environment requires strategic adaptation for new mAb product development.

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Last Updated: Jun 17, 2026

Applying an eMASS Customization Program as a Research Tool to Evaluate Consumer Benefits
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Published on: September 27, 2019