Cell Therapy in the US - Industry Research Report

New Building Blocks: Industry Operators Will Benefit from Continued R&D Efforts and Investor Interest

Cell therapy isn't a new field, but only recent tech and medical advances have made cell therapies commercially available for patients. Since the first cell therapy received FDA approval just over a decade ago, cell therapy developers have been at the forefront of life sciences innovation, with interest and investment pouring into the field. But, the current regulatory environment hasn't kept up with the rapidly evolving cell therapy field. A lack of clarity in the regulatory guidelines for cell therapies creates confusion and uncertainty for manufacturers and developers. At the same time, a lengthy approval process delays patients' access to treatments and companies' chance to earn profit. Some recent changes - like the Prescription Drug User Fee Fact - aim to resolve some regulatory hurdles. An active funding environment has led revenue to expand at a CAGR of 25.6% to an estimated $9.2 billion over the past five years, including an expected 2.0% decline in 2023.

Operators in this industry engineer human tissue via cell therapy or regenerative medicine. Tissue engineering involves the use of cell combination, engineering and materials methods and suitable biochemical and chemical factors to improve or replace biological functions. This industry includes repair or replacement of tissues such as bone, cartilage, blood vessels and skin.

This report covers the scope, size, disposition and growth of the industry including the key sensitivities and success factors. Also included are five year industry forecasts, growth rates and an analysis of the industry key players and their market shares.