Industry Snapshot

An Expansive and Growing Industry

The regenerative medicine industry represents a vast network of interdisciplinary companies working in biology, chemistry, engineering and physical sciences. These companies are developing some of the world’s most advanced therapies, tools and services in medicine today, and addressing many unmet medical needs.

ARM estimates there are more than 700 companies with a regenerative medicine and/or advanced therapies focus ranging from divisions of multinational corporations to smaller
organizations focused solely on the sector.

The products they are developing include several hundred cell-based therapies, biologics, tissue-engineered cells and materials and implantable devices. Additional products use cells as drug discovery or toxicity testing tools as well as clinical tools, bioprocessing tools and platforms that include equipment, consumables, reagents and storage systems.

The field also incorporates a variety of service companies specializing in clinical trial management, manufacturing, engineering and financing among others.

Regenerative Medicine Technologies Include a Variety of Therapeutic Approaches

Regenerative medicines—the spotlight of the industry—encompass an array of technologies and therapeutic approaches including cell-based therapies, small molecules and biologics as well as synthetic and bio-based materials designed to augment, repair, replace or regenerate organs and tissues, thereby targeting the root cause of disease.

Cell-Based Therapies

Living cells, a pillar of the field, are incorporated into regenerative medicines to achieve a variety of positive effects:

  • To replace damaged or diseased cells and/or tissue
  • To stimulate an endogenous response that promotes the body’s own healing such as an immune response or regeneration in diseased tissue
  • To deliver genetic or molecular therapies to targets

Gene Therapy

Gene therapy addresses defective or mutated genes needing either correction or improved regulation through the insertion of properly functioning genes into a patient’s cells. While the largest segment of gene therapies targets cancer, regenerative-focused gene therapies are being developed for several monogenic diseases such as cystic fibrosis, hemophilia, muscular dystrophy, thalassemia, and sickle-cell anemia. Additionally there is a significant effort to develop and test gene therapies to induce cell and tissue regeneration in cardiovascular, neurological, and ocular diseases through highly innovative regenerative gene therapies.

Biologics and Small Molecules

Biologics and small molecules can be defined as the use of chemicals and cellular components that are known to induce dormant,or edogenous cells to regain regenerative properties.

Tissue Engineering: Synthetic Materials, Biomaterials and Scaffolds

Synthetic and bio-based materials, cornerstones of the regenerative medicine field, are generally implanted in the body for reconstructive purposes,
such as in joint replacement, bone repair, as artificial ligaments and tendons, dental implants, heart valves and wound repair. They work in partnership with native cells to support reconstruction and healing.

Stem Cells for Drug Discovery, Toxicity Testing and Disease Modeling

Companies are increasingly learning to leverage the use of stem cells and/or living tissue constructs to create in-vitro models to study human mechanisms of disease and the effects of drugs on a variety of cell and tissue types such as human heart, liver and brain cells. These models, built predominantly using embryonic and induced pluripotent stem cells, allow for faster and safer drug development.

Biobanking

Cell and tissue banks are responsible for collecting, storing and distributing biological materials used in regenerative medicine including adipose tissue, cord blood and birth tissues, musculoskeletal tissues, pericardium, skin, bone, vascular tissue, autologous and allogeneic cells as well as other biological samples.