Global Market for Cell Therapy & Tissue Engineering 2019

Global Market for Cell Therapy & Tissue Engineering 2019

EXECUTIVE SUMMARY – Market for Cell Therapy and Tissue Engineering

This report contains analysis of developments across the rapidly evolving fields of cell therapy (CT) and tissue engineering (TE), with a focus on competitive dynamics and commercial successes and failures. Cell therapy is the utilization of living cells for the treatment or potential cure of human disease or injury. Tissue engineering (TE) is a field of medicine that is focused on restoring, maintaining, improving, or replacing damaged tissues and organs through the combination of scaffolds, cells, and biologically active molecules. This report highlights important issues across these interrelated fields, including market challenges, economic evaluation, policy improvements, pricing and reimbursement, and rates of global adoption. Because several of the developments in cell therapy and regenerative medicine (RM) are closely related, the report also gives an overview of the regenerative medicine industry.

One of the earliest examples of cell therapy was the transplantation of hematopoietic stem cells (HSCs) in the 1950s from a donor to a recipient to create a bone marrow transplant, which today represents a well-established type of cell therapy practiced worldwide. Newer forms of cell therapy involve the delivery of other cell types to a patients, including CAR-T and CAR-NK cells, mesenchymal stem cells (MSCs), neural stem cells (NSCs), and to a lesser degree, induced pluripotent stem cells (iPSCs), embryonic stem cells (ESCs), directly reprogrammed cells, and other pluripotent and differentiated cell types.

Because tissue engineering (TE) integrates cellular products with scaffolds, it is integral to the field of cell therapy. These scaffolds are often made using naturally occurring proteins or biocompatible synthetic polymers. Some TE products are made using a protein-based extracellular matrix (ECM) obtained from a donor. The ECM is prepared by removing the cells by a process called decellularization. Cells and growth factors are seeded on to the ECM to develop a tissue or organ.

Cell therapy, gene-modified cell therapy, gene therapy and tissue engineering are the four pillars of regenerative medicine (RM). These therapies have the potential to favorably change the quality of life and improve the health status of patients suffering from cellular defects, genetic diseases, neurodegenerative diseases, tissue malignancies, and other medical conditions. The combined efforts of research and clinical scientists in academic, translational and industry settings have led us to the development of several approved commercial firsts, such as Glybera, Kymriah, Yescarta, Holoclar, and Luxturna.

Today, the healthcare environment is under great pressure to develop therapies capable of reversing or significantly impacting the progression of serious illnesses. The arrival of regenerative medicine (RM) has been propelled by advances across the cell therapy (CT) and tissue (TE) engineering industries. Regenerative medicines have the potential to transform the healthcare landscape by providing transformative, durable and potentially curative outcomes to human injuries, diseases, and genetic disorders.

With the number of regenerative medicine firms expanding exponentially, over a thousand clinical trials ongoing worldwide (>50% in oncology), and key strategic alliances underway among industry and academic partners, the success of regenerative medicine therapies seems to be a certainty. This report reports the market for regenerative medicine (RM) products approved worldwide, including 44 approvals across the U.S., Europe, South Korea, India, China, Japan, Australia and New Zealand. Additionally, the RM sector saw venture capital investment grow from a mere $200 million in 2010 to a massive $14.6 billion in 2018. This massive investment and market growth in the RM space indicates a future with heavy competition.

Thus, the main objectives of this cell therapy (CT) and tissue engineering (TE) report are to provide the reader with the following details:

• Total global financings in cell therapy and gene-modified cell therapy space.
• Corporate partnerships in cell therapy and gene-modified cell therapy space.
• Private placements and venture financings in cell therapy and gene-modified cell therapy space.
• The history of cell therapy from 1944 to present.
• Potential applications of cell therapy.
• FDA-approved cell therapy products made from human HSCs.
• Leading induced pluripotent stem cell (iPSC) companies.
• Potential applications of iPSCs.
• Various sources of mesenchymal stem cells (MSCs).
• Various clinical applications of mesenchymal stem cells (MSCs).
• Various biologically-active substances secreted by mesenchymal stem cells (MSCs).
• The estimated consumption of MSCs in the cell therapy industry (future projections).
• Other cell types with the potential to disrupt MSC’s demand.
• Approved MSC-based cell therapy products in the global market.
• Diseases addressed by neural stem cells in clinical trials.
• Leading companies in neural stem cells space.
• Indications addressed by human embryonic stem cells (hESCs) in clinical trials.
• Leading cell therapy startups.
• Cell therapies with RMAT designation.
• Number of gene-modified cell therapy companies.
• Number of CAR-T cell therapy companies.
• Number of NK cell therapy companies in the world.
• Approved TE products in the global market.
• Number of cell therapy clinical trials.
• Diseases addressed by MSCs in clinical trials.
• Number of clinical trials using MSCs.
• Anticipated clinical events in cell therapy space.
• Number of clinical trials in gene-modified cell therapy space.
• Anticipated developments in cell therapy space in 2019.
• Number of clinical trials in Tissue Engineering (TE) space.
• Approved cell therapy products by geography.
• Approved tissue engineering (TE) products by geography.
• Cell and gene therapy manufacturing capacities in the U.S. and Europe.
• Select CMOs/CDMOs in cell and gene therapy space.
• Projected outsourcing market for the manufacture of cell and gene therapy products.
• Projected growth of cell manufacturing capacity.
• Global market for cell therapy products by geography.
• Global market for tissue-engineered products by geography.
• Profiles of companies that are developing products in cell therapy and tissue engineering spaces.

For companies involved with the commercialization of cell therapy (CT) and tissue engineering (TE) products, this report provides market size determinations, coupled with five-year forecasts and trends. It analyzes emerging market forces, highlights industry partnerships and deal-making, and captures the progression of cell therapy and tissue engineering products across various states of development. With the rapid evolution of this market sector, this global strategic report is your guide to research advances, clinical breakthroughs, and commercialized successes.