As of April 1st, 2022, the US FDA Office of Tissues and Advanced Therapies (OTAT) has approved 23 cell and gene therapy products. (US FDA OTAT)
The Arrival of
cell & gene therapies
in the Epoch of Precision Medicine
Cell and Gene Therapy innovations are creating increasingly personalized and powerful treatments. They have the potential to transform patient care and solve previously untreatable conditions. For many of us, understanding Cell and Gene Therapy is both daunting and exciting. What makes them unique? How are they developed, and what lies ahead for the industry?
Our team is passionate about clearly communicating the most innovative areas of the life sciences. To help prepare the industry for this new therapeutic age, check out some key highlights in this infographic.
Our team is passionate about clearly communicating the most innovative areas of the life sciences. To help prepare the industry for this new therapeutic age, check out some key highlights in this infographic.
WHAT ARE CELL & GENE THERAPIES?
GENE THERAPY
Gene therapies treat genetic diseases by replacing dysfunctional genes. Genetic information is delivered to patients using “vectors,” such as adeno-associated viruses (AAVs), lentiviruses, liposomes, and beyond.
CELL THERAPY
Cell therapies treat diseases with living cells isolated from humans. These cells are commonly modified to increase target recognition and activity.
AN INSIDE LOOK AT CELL AND GENE THERAPY STRATEGIES
Unsurprisingly, not all cell and gene therapies are alike. Generally speaking, gene therapies can be categorized as either “integrating” or “non-integrating,” while cell therapies can be grouped as either “autologous” or “allogeneic.”
GENE THERAPIES
CELL THERAPIES
REAL WORLD APPLICATIONS
GENE THERAPY
Luxturna®, the first FDA approved gene therapy, used AAV vectors to replace mutant RPE65 genes to improve vision in patients with RPE65-associated blindness.
CELL THERAPIES
CAR-T Therapies (like, Yescarta®, Abecama®, and Kymriah®) use genetically modified T-cells to display CARs. CARs function as artificial T-cell receptors that target CAR-Ts to specific biomarkers associated with diseases like cancer.
That day back in 2010 when I was infused with my CAR-Ts, and my tumor cells disappeared – it meant there was a whole new treatment paradigm.
— Doug Olsen, the second CAR-T patient (STAT News)
THE DISCOVERY & DEVELOPMENT PATHWAY
Given their complexity, it truly takes a village to bring a cell or gene therapy to market. Below, we highlight some of the key steps and stakeholders that comprise the vital ecosystem creating these life-changing therapies.
CELL THERAPIES
GENE THERAPY
LOOKING AHEAD AT WHAT'S NEXT FOR CELL & GENE THERAPY
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C> Products
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Trials Ongoing
By the middle of 2021, there were nearly 1,200 organizations developing gene, cell, and tissue-based therapeutics worldwide, with over 2,600 trials ongoing, including a few hundred in Phase 3 (ARM 2021 H1 Report)
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k
Patients
Recent research estimates that about 350,000 patients will have received a cell or gene therapy by 2030, with between 30 to 60 products approved available. (Quinn, et al. Value Health 2019)
$
0
Billion
The cell and gene therapy market is expected to grow tremendously in the coming decade. Market research groups expect impressive growth—estimated between 24.1% and 33.82% annually—with the cell and gene therapy market potentially reaching up to $25 Billion in 2027 from $2.6 Billion in 2020. (Cell and Gene Therapy Global Market Report &Global Cell and Gene Therapy Market.)
0
C> Products
As of April 1st, 2022, the US FDA Office of Tissues and Advanced Therapies (OTAT) has approved 23 cell and gene therapy products. (US FDA OTAT)
0
Trials Ongoing
By the middle of 2021, there were nearly 1,200 organizations developing gene, cell, and tissue-based therapeutics worldwide, with over 2,600 trials ongoing, including a few hundred in Phase 3 (ARM 2021 H1 Report)
0
k
Patients
Recent research estimates that about 350,000 patients will have received a cell or gene therapy by 2030, with between 30 to 60 products approved available. (Quinn, et al. Value Health 2019)
$
0
Billion
The cell and gene therapy market is expected to grow tremendously in the coming decade. Market research groups expect impressive growth—estimated between 24.1% and 33.82% annually—with the cell and gene therapy market potentially reaching up to $25 Billion in 2027 from $2.6 Billion in 2020. (Cell and Gene Therapy Global Market Report &Global Cell and Gene Therapy Market.)
We hope this information was valuable to you. Let us know if we can tackle your communications challenges with our integrated capabilities for the Cell and Gene Therapy segment.
