Developments in Cell Therapy

Global cell therapy market revenue is expected to increase at a compound annual growth rate of 20.2% between 2015 and 2020, with more than 500 companies and research groups involved in product development in this space. Read more in this exclusive update from Frost & Sullivan.

Cell therapy, as the name indicates, is the practice of injecting live cells into a patient in an attempt to prevent or cure disease. This approach is distinctly different than taking pharmaceutical medicines, receiving vaccines or undergoing medical procedures to cure diseases. Since injected live cells have the potential to grow and integrate into the patient to treat diseased tissue, this approach is referred to as regenerative medicine. Cell therapy constitutes nearly 60% of all regenerative medicine approaches; others include tissue engineering and immune modulation.

Cell Therapy: An Established Market

Frost & Sullivan estimates that the global cell therapy market is valued at about $7.5 billion, and is poised to reach $10 billion by 2020. In a study published in 2016, Frost & Sullivan characterized cell therapy as a well-established treatment option that is already used on millions of patients, but still has the capacity for sustained market growth.

In the study, Frost & Sullivan also noted an expected subtle shift in regional market sizes between 2015 and 2020. While North America contributed nearly 50% of global market revenue in 2015 and is projected to contribute 51% in 2020, Europe is expected to cede some of its market share to the Asia-Pacific region. Because of a combination of an aging population, faster regulatory approvals and a more adventurous pharmaceutical ecosystem, Japan, China, and other Asian countries are expected to contribute more than 16% of 2020 global revenue.

Popular and Emerging Cell Therapies

One of the most popular approaches to effect regenerative medicine is through the use of stem cells. Stem cells are undifferentiated cells that have the ability to develop into specialized cells under favorable conditions. Stem cells can be harvested from certain tissues or bone marrow of adults, or from embryos. The use of embryonic stem cells is controversial and poses ethical questions, however; several countries ban or heavily regulate the harvesting of human embryonic stem cells for cell line production and their use in experimental therapies. 

The use of somatic stem cells, though, remains popular. There are several approved stem cell therapies for cardiovascular, oncological and neurological applications. Interestingly, while embryonic stem cells receive much criticism, the harvesting of stem cells from the umbilical cord during childbirth and from amniotic fluid are increasing in popularity. Several cell banks offer services related to harvesting and storing stem cells for future use. In 2010, the Vatican newspaper Osservatore Romano called amniotic stem cell therapy the “future of medicine.”

Frost & Sullivan has identified three other approaches as part of the next wave of cell therapy. The first of these, cell-based immunotherapy, uses highly specific T-cells as antigens to target cancer cells. The other two approaches are both hybrid therapies that use either genetically modified stem cells or other cells for therapies. Frost & Sullivan has identified several established and emerging companies that have developed innovative products built on cell therapy approaches.

Apligraf by Organogenesis (Canton, Mass.)

Apligraf was the first bioengineered, cell-based product to obtain U.S. Food and Drug Administration (FDA) clearance. Apligraf is supplied as a living, bi-layered skin substitute consisting of neonatal foreskin keratinocytes and fibroblasts with bovine Type I collagen. This product is widely used to treat diabetic foot ulcers and venous leg ulcers. 

ReCell Spray by Avita Medical (Cambridge, England)

Avita Medical has taken an alternative route to delivering cells for skin tissue regeneration: a spray-on product. ReCell capitalizes on Avita’s proprietary spray-on technique to facilitate rapid healing and return proper texture and pigmentation to a skin area that has been burned or scarred, or that is hypo- or hyper-pigmented. ReCell has regulatory clearance for use in Europe, Canada and Australia, and is awaiting FDA approval.

C-Cure by Celyad (Mont-Saint-Guibert, Belgium)

Celyad’s C-Cure is the first-in-class cell therapy option to treat heart failure. Stem cells are harvested from the patient’s bone marrow, treated with cardiopoietic agents (growth factors that promote differentiation of stem cells into cardiac cells), and then reinjected into the heart. C-Cure has been tested on patients in a multicenter clinical study, and 9- and 12-month milestones reveal promising results. The cells are found to differentiate into cardiac muscles that are similar in physiology and function as the infarcted muscles that contributed to the heart failure in the first place. Based on the encouraging findings, the FDA has granted a fast-track designation to the C-Cure platform; this status will help expedite regulatory processes related to the therapy’s development.

NOVOCART 3D by Aesculap Biologics (Center Valley, Pa.)

NOVOCART 3D is a cell-based product for cartilage regeneration. The product consists of autologous cartilage cells loaded on a three-dimensional, collagen-based matrix. The product is custom-developed for each patient, eliminating the possibilities of immune rejection since autologous cells are used. The product is considered to be investigational in the United States, and is expected to be market-ready by 2020.

MPC-06-ID by Mesoblast Ltd. (Melbourne, Australia)

Not surprisingly, there are no marketed cell-based products for neurological applications, considering the complications involved in accessing the target site. However, neurology remains an important research focus for many companies. In fact, neurology has the third-largest pipeline for stem cell therapies, behind cardiovascular and oncology. One technology is being developed to treat intractable back pain and spinal injuries. Under the developmental name of MPC-06-ID, it consists of a unit dose of 6 million mesenchymal precursor cells; the preparation is to be injected directly into a targeted damaged disc of the spinal cord in an outpatient procedure.  The product is in clinical trials, and may be in the market by 2021.

The Road Ahead

Global cell therapy market revenue is expected to increase at a compound annual growth rate of 20.2% between 2015 and 2020, with more than 500 companies and research groups involved in product development in this space. More than 500 clinical studies related to stem cell therapy for various indications are in progress. This healthy pipeline promises that cell therapy will disrupt the pharmaceutical and patient treatment landscape.

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