This report presents a detailed update to our 2008 publication on the tissue engineering (TE) and stem cell industry. Data are reported through mid 2011 showing an almost three-fold growth in commercial sales over the past 4 years. In addition, the number of companies selling products or offering services has increased over twofold to 106, and they are generating a remarkable $3.5 billion in sales. Overall, the TE and stem cell sector is spending $3.6 billion and employing almost 14,000 employees. These data suggest the TE and stem cell industry has stabilized and is on a path pointing toward continued success.

Introduction

The tissue engineering (TE) industry has hardly traveled a smooth path toward success, experiencing a roller coaster ride over the last quarter century. The late Michael Lysaght devoted five articles analyzing this path over time, the first reported in 1995 and the last in 2008.1–۵ Lysaght’s analyses outlined the emergence and hype, growth, downward trend, and rebound of the field and are eloquently summarized in Nerem’s article.6 Briefly, the TE industry began to develop in earnest in the 1990s and grew to 3300 full time employees (FTEs) working in over 70 companies at the end of 2000.1 By 2001, a number of TE products had reached the market, including Organogenesis’ Apligraf and Genzyme’s Carticel. Expectations and hype were high both in the science and TE business communities and in the news. In 1999, a Good Morning America report described TE as one of the greatest scientific accomplishments of the 20th century.7 Soon after the turn of the century, however, the industry entered a dark period. Private sector activity decreased 20% and the capital value of publicly traded TE companies fell a staggering 90 percent.4 This was in part due to a poor economy and the consequent decrease in investor interest, and also due to failed product launches and disappointing results from Food and Drug Administration (FDA) clinical trials. Incredibly, the industry had rebounded by our 2008 report and was back on track to meet the expectations set in the ’۹۰s.3 The capital values for public TE companies increased over 10-fold compared to 2003 and products were entering FDA clinical trials, achieving FDA-approval, and in some cases becoming profitable. Today, as the data reported here indicate, the industry is on a path pointing toward continued success.