APAC’s Dynamic Growth in R&D and Cell Therapy

July 1, 2025 | Opinion | By Dr Manbeena Chawla

Cell and gene therapy (CGT) represents a significant leap in medical treatments, directly targeting the root causes of diseases at the cellular or genetic level. GlobalData predicts the CGT market will reach $76 billion by 2030, with North America capturing the highest revenue share in 2024. To gain insights into the new developments in the CGT sector, particularly in the United States, BioSpectrum Asia spoke with Amy C Hay, Chief Business Officer of the Cell Therapy Manufacturing Center (CTMC).

Current Developments at CTMC

CTMC, a joint venture between Resilience and MD Anderson Cancer Center, was founded in 2022 to accelerate life-saving cell therapies. In just three years, CTMC has expanded its pipeline, supporting both MD Anderson investigators and biotech companies in advancing novel cell therapies through Investigational New Drug (IND)-enabling studies and FDA interactions.

CTMC’s portfolio has grown from five to 13 partners, with a mix of 65% biotechs and 35% academic institutions. The center has submitted and cleared eight INDs, all on or ahead of schedule. Notable products include Obsidian Therapeutics’ novel tumour-infiltrating lymphocyte (TIL) therapy, OBX-115, and Invectys’ lead engineered human leukocyte antigen A (HLA-G) targeting chimeric antigen receptor (CAR) T cell therapy for solid tumours.

CTMC has also collaborated with several companies to evaluate and utilize new technologies. Current collaborators include Ori Biotech (automated cell therapy manufacturing) and Syenex (enhanced gene delivery systems).

On a global scale, CTMC has developed the Network Alliance programme to democratize access to cell therapy through international partnerships and regional manufacturing enablement. The center has been awarded $9.1 million from the Cancer Prevention & Research Institute of Texas (CPRIT) and an additional $1.3 million in May 2025.

Future Plans for CTMC

Over the next five years, CTMC is focused on accelerating access to cell therapy through digital innovation, expanded manufacturing capabilities, and a growing global alliance network. The center is on track to have a fully integrated digital process by the end of 2025, enabling seamless data capture, analytics, and process control. This digital backbone will increase efficiency and support global partners to scale faster.

CTMC is expanding its current facility to support pivotal trials and commercial launch. Expanding capabilities reduces the risks and delays of tech transfer and gives partners a faster path to market. The personal goal of Amy C Hay is to develop the Network Alliance, an ecosystem of cell therapy developers, manufacturers, and academic partners across Latin America, Asia-Pacific, Canada, and Europe.

Strengthening Presence in Asia-Pacific

The Asia-Pacific region is dynamic and rapidly evolving, with tremendous growth in research and development and attractive market conditions. Amy C Hay anticipates the Asia-Pacific region to be a global leader in cell and gene therapies in the next few years due to increased funding, strategic investment, and expanding clinical trial infrastructure.

On the capital front, the Chapter 18A listing rule on the Hong Kong stock exchange allows pre-revenue biotech companies to go public. More than 70 early-stage biotech companies have used this mechanism to fund development. The main stock market index in Hong Kong has risen 15.94% since the beginning of 2025, driven by China’s biotech rise and internationalization.

On the development front, growing investment in cell therapy is seen in China, Japan, South Korea, and Australia from both the private and public sectors. Countries like Japan offer regulatory incentives such as expedited approvals or Fast Track designation to attract innovation. China now has the highest number of active cell therapy clinical trials in the world.

CTMC has two areas of focus for the Asia-Pacific market: identifying promising cell therapy biotech companies in the region for co-development and deploying clinical trials in the United States, and expanding the Global Network Alliance programme within Asia-Pacific to provide tools, training, and support for regional manufacturing capabilities.

Focus on Other Diseases

CTMC is primarily focused on oncology indications and those adjacent to oncology. Most of its development and manufacturing customers are focused on CAR-T or TIL therapy assets. The center has developed proprietary platforms and reagents in TIL manufacturing to support its customers.

As of 1Q25, the American Society of Gene and Cell Therapy reported 33 approved gene therapies globally, including genetically modified cell therapies. Of these, 18 (55%) target oncology indications. Additionally, there were 71 non-genetically engineered modified cell therapies, primarily focused on oncology and rare diseases. From a pipeline perspective, 2,154 gene and genetically modified cell therapies are currently in trials, with 49% targeting cancer. CAR-T remains the dominant platform, accounting for 50% of all genetically modified therapies, with 97% of CAR-T developments focused on oncology.

Role of New Technologies

In the next few years, automation and robotics will play a pivotal role in improving scalability and cost-efficiency as the demand for advanced therapies continues to grow. Equally exciting is the opportunity to incorporate artificial intelligence (AI) and machine learning into the overall continuum of cell therapy, starting with patient selection. Innovations that allow a better understanding of who will respond to cell therapy, how they will respond, and the likely outcomes of the treatment will position the industry to demonstrate the value of predictive intelligence.

Utilizing digital biomarkers during cell therapy and into survivorship will provide real-world evidence to consistently evaluate the body’s response to cell therapy, thereby providing an opportunity to develop early interventions. Ultimately, these advancements will shift the cost curve and take another step toward preventive medicine.

Clear Takeaway

The Asia-Pacific region is poised to become a global leader in cell and gene therapy, driven by robust R&D, strategic investments, and expanding clinical trial infrastructure. CTMC's innovative approaches and global alliances will play a crucial role in accelerating the development and accessibility of life-saving cell therapies.