A MARKET PROFILE AND FORECAST OF ALBUMIN DEMAND IN
THE UNITED STATES THROUGH THE YEAR 2015

REPORT COMPLETE
JUNE 2011

Introduction

 The U.S. market for 5% and 25% human albumin recently rebounded from a sharp decline a decade ago, when severe shortages, high prices and safety concerns reduced the U.S. demand, reaching an all time low in 2000 with sales of about 6 million vials (12.5 grams). By 2009, U.S. albumin demand reached 10.3 million vials, the 25% concentration product accounting for more than 60% of this volume.

 A number of factors have contributed to this resurgence in albumin demand, which are analyzed in our new report.

 Evolving clinical practice patterns as well as larger economic and health insurance-related considerations have altered albumin usage patterns, which in turn impact on the future demand for albumin and synthetic colloids.

 The Marketing Research Bureau has conducted primary and secondary market research to characterize albumin and synthetic colloid usage and usage trends for these products in the U.S. and developed a forecast of the U.S. albumin demand in 2015.

 

Objectives

1. Albumin market segmentation and product mix by clinical use.  Estimates of the respective albumin market share contributions and 5%-25% usage mix have been developed for the five leading clinical use categories, including

√ Surgical blood volume replacement,

√ Cardiac surgery-related extracorporeal circuit priming and blood volume replacement,

√ Other conditions associated with acute and chronic severe hypoalbuminemia (e.g. cirrhosis with paracentesis, hepatorenal syndrome),

√ Hypotension in hemodialysis, and

√ Therapeutic plasma exchange;

2. Albumin and synthetic colloid demand trends by clinical category.  The recent three-year trends in usage for the five leading clinical categories (surgical blood volume replacement, cardiac surgery, other acute and chronic severe hypoalbuminemia, hypotension in hemodialysis, and therapeutic plasma exchange) have been characterized.

3. Emerging practice trends in the U.S. Emerging trends in clinical practice standards affecting 5% and 25% albumin and synthetic colloid usage in the U.S. have been identified.

4. Projected U.S. albumin markets through 2015.  The projected demand for 5% and 25% albumin and growth rates for conventional 6% hetastarch and low molecular weight hetastarch products from 2010 through 2015 have been forecasted.

Methodology

1) Structured interviews. Over 25 structured interviews of U.S. specialists and clinical thought leaders were conducted by telephone with anesthesiologists and critical care specialists.

2) Customized Mail Surveys were sent out to general and cardiac anesthesiologists and critical care specialists.

3) Comprehensive literature search and analysis. The clinical literature and other available published materials were extensively reviewed to identify significant studies and other recent information that directly addressed and/or advanced efforts to meet the project objectives.

4) Other information sources as identified. Albumin usage data and other information were used from other sources.


 

ALBUMIN
2015

 

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Executive Summary

 

Albumin:  Clinical Uses and Unsettled Controversies

Market Stability Following a Tumultuous Decade

The Current U.S. Albumin Market:  Product Mix

U.S. Hetastarch Sales Trends and Product Mix

Survey Focus:  General and Cardiac Anesthesiologists and
Critical Care Specialists

Surgical (Non-Cardiac) Volume Expander Usage:
Survey of General Anesthesiologists

Volume Expander Usage in Cardiopulmonary Bypass Surgery:
Survey of Cardiac Anesthesiologists

Albumin Usage in Critical Care: Survey of Specialists

The U.S. Albumin Market: 2010 and Projection to 2015

Caveat: 2015 Demand Projections Assume Price Stability

Septic Shock: Wild Card in 2015 Demand Forecast

 

Appendix 1:  Surgical Blood Volume Replacement Survey

Appendix 1a: Comments – Surgical Volume Replacement Survey

Appendix 2: Cardiac Surgery Blood Volume Replacement Survey

Appendix 2a: Comments — Cardiac Surgery Survey

Appendix 3: Survey: Albumin Usage in Critical Care Patients

Appendix 3a: Comments — Critical Care – Albumin Usage Survey