The gene therapy market is on track to reach an estimated $36.55 billion by 2032, driven by increasing demand for advanced treatments targeting genetic diseases at their core. Recent approvals by the U.S. Food and Drug Administration (FDA), including three significant cell therapies in December 2025, signal a pivotal shift from experimental approaches to commercial viability. This evolving landscape is influencing the strategic directions of several key biotech firms, notably Avant Technologies Inc., Vertex Pharmaceuticals Incorporated, CRISPR Therapeutics, Prime Medicine, Inc., and Madrigal Pharmaceuticals, Inc..
Market Growth and Technological Advances
The cell and gene therapy sector is expected to expand further, with projections indicating a market size of $39.61 billion by 2034, growing at a compound annual growth rate of 17.98%. This growth is attributed to precision therapies addressing previously untreatable genetic disorders. Innovations in manufacturing, particularly in viral vector delivery systems, are facilitating scalable production and attracting significant investment as stakeholders seek functional cures instead of lifelong symptom management.
Avant Technologies Inc. is pioneering cell-based therapies for conditions such as diabetes and aging, utilizing a proprietary encapsulation technology to prevent immune rejection of genetically modified therapeutic cells. The company operates through two strategic joint ventures aimed at addressing large global health challenges.
The first, Insulinova, Inc., in collaboration with SGAustria Pte. Ltd., focuses on developing treatments for type 1 and insulin-dependent type 2 diabetes. Their innovative cell encapsulation technology allows modified insulin-producing cells to survive long-term in the body without being attacked by the immune system, eliminating the need for patients to take lifelong immunosuppressive drugs.
“Cell encapsulation is a game-changer in the field of regenerative medicine,” said Chris Winter, CEO of Avant Technologies. “By partnering with SGAustria, we’re ensuring that any genetically modified insulin-producing cells that we develop together can thrive in the body long-term and offer the potential of restoring natural glucose control.”
Joint Ventures and Research Developments
The diabetes market presents a substantial opportunity, with the International Diabetes Federation reporting that 589 million people globally live with type 1 and insulin-dependent type 2 diabetes, a figure expected to rise to 853 million by 2050. SGAustria’s patented Cell-in-a-Box® technology creates a protective barrier around genetically modified cells, allowing nutrients and insulin to pass freely while shielding against immune responses.
Avant’s second joint venture, Klothonova, in partnership with Austrianova, is developing anti-aging treatments aimed at restoring circulating α-Klotho levels using genetically modified human cells that overexpress the Klotho protein. Research from the Mayo Clinic links declining α-Klotho levels to various age-related ailments, including arterial stiffness and cardiovascular issues. Both joint ventures leverage decades of research, supported by over 50 publications.
The potential market impact is significant, as the global Alzheimer’s market is projected to reach $32.8 billion by 2033, with cardiovascular disease recognized as the leading cause of death worldwide. Additionally, kidney disease affects an estimated 850 million people globally.
In related developments, Vertex Pharmaceuticals presented groundbreaking data on CASGEVY for children aged 5-11 with severe sickle cell disease at a recent conference. In the Phase 3 CLIMB-151 study, all four patients with adequate follow-up achieved a minimum of 12 months free from vaso-occlusive crises, with some patients remaining crisis-free for nearly two years. The company plans to initiate global regulatory submissions for this age group in the first half of 2026.
CRISPR Therapeutics has also reported positive outcomes from its ongoing clinical trial for CTX310, a gene-editing therapy targeting ANGPTL3. The treatment demonstrated significant, dose-dependent reductions in circulating ANGPTL3 and lipid levels, indicating promising results for managing cardiovascular health.
Madrigal Pharmaceuticals showcased new data at the American Association for the Study of Liver Diseases meeting, highlighting the efficacy of Rezdiffra in improving liver health among patients with compensated MASH cirrhosis. The company is advancing its Phase 3 MAESTRO-NASH OUTCOMES trial, aiming to bring effective therapies to a market with pressing needs.
Meanwhile, Prime Medicine recently published Phase 1/2 clinical data for its investigational therapy, PM359, demonstrating safety and efficacy in patients with chronic granulomatous disease. These results underscore the potential of next-generation genetic therapies to deliver significant patient benefits while minimizing associated risks.
The gene therapy landscape is rapidly evolving, with advancements in technology and an increasing focus on curative treatments paving the way for significant breakthroughs in the healthcare sector.
