Cell & gene therapy market set to grow at 44% CAGR through 2030

New Delhi: The global cell and gene therapy (CGT) market is poised for exceptional growth at a compound annual growth rate of 44%, with sales projected to rise from $8.70 billion in 2024 to $76.03 billion in 2030. Significant advancements in treatments for gastrointestinal (GI) disorders are anticipated, driven by innovations from both large and small pharma companies, says GlobalData, a leading data and analytics company.

GlobalData’s report, “Cell and Gene Therapies in Gastrointestinal Disorders – Therapeutic Analysis, Treatment Options, Pricing and Reimbursement and Future Market,” reveals that CGT market for GI disorders, as a standalone therapy area, is expected to increase from $47 million in 2023 to $187 million in 2030.

Momna Ali, Healthcare Analyst at GlobalData, comments: “The growth in this market is expected to be driven by the anticipated launch of pipeline agents that are being individually developed by a mix of both big and small pharma companies. Examples include GSK, AstraZeneca, Alnylam Pharmaceuticals, Shanghai Hexaell Biotech and Pharmicell.”

Currently, there are only two cell and gene therapies (CGTs) within the gastroenterology market. Anterogen’s Cupistem, indicated for the treatment of anal fistula in adult patients, was the first adipose tissue-derived mesenchymal stem cell asset to receive approval in the GI market in Japan, 2012.

This approval was followed by Takeda Pharmaceuticals’ Alofisel (darvadstrocel), which received approval from the European Medicines Agency in 2018 and from Japan’s Pharmaceuticals and Medical Devices Agency in 2021. However, on 13 December 2024, the EMA announced the withdrawal of Alofisel from the EU market citing lack of data that demonstrated the benefit of this therapy in Crohn’s fistulas.

Ali adds: “Although Alofisel’s recent withdrawal from the European market is a setback for the CGT space, significant opportunities remain. Currently, there are 238 CGT assets in development for various GI disorders, with development phases spanning from discovery to pre-registration stages.

“However, challenges remain. As per the key opinion leaders interviewed by GlobalData, one major challenge is the lack of specific target genes across many, if not all GI disorders due to their polygenic nature. However, companies are focused on improving patient classification, based on molecular classification that could eventually enable the identification of patient subgroups clearly suited for CGT therapies.”

Metabolic Dysfunction-Associated Steatohepatitis / Metabolic Dysfunction-Associated Steatotic liver disease (MASH/MDSLD) accounts for the most CGTs in development with 80 assets, of which 44 are antisense RNAi oligonucleotides (ASOs), followed by 15 cell therapies, 14 gene therapies, and 7 gene-modified cell therapies.

Ali concludes: “Despite the challenges such as the lack of specific targets, pricing, and access barriers, GlobalData anticipates significant growth in the global CGT market in the future. This growth is expected to be driven by two key factors: strong demand from patients seeking curative treatments for their diseases, and widespread interest among both large and small pharma and biotech companies in discovering the next breakthrough transformative drug.”