CGT Manufacturing: A Comparative Analysis of APAC, EMEA, and NA Markets

Cell and gene therapy (CGT) represents one of the most advanced and rapidly evolving fields in medicine, promising cures for diseases that were previously considered untreatable. However, the manufacturing process behind these therapies is highly complex, involving advanced biotechnological tools, stringent regulatory oversight, and significant logistical coordination. As the demand for CGT grows globally, manufacturing capabilities in different regions have become an essential focus. Here we explore the cell and gene therapy manufacturing landscape across three key markets: Asia-Pacific (APAC), Europe, the Middle East, and Africa (EMEA), and North America (NA), outlining the regional differences in capabilities, regulatory landscapes, and market dynamics.

The Manufacturing Landscape in North America (NA)

North America, specifically the United States, is the global leader in cell and gene therapy development and manufacturing. Home to some of the largest biopharmaceutical companies (such as Bluebird Bio and Thermo Fisher Scientific) and academic institutions pioneering CGT research (such as UCLA’s Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell and Stanford University’s Center for Definitive and Curative Medicine), North America’s dominance stems from its strong innovation ecosystem and robust funding mechanisms.

• Manufacturing Infrastructure: North America benefits from a mature biopharmaceutical manufacturing industry, with state-of-the-art facilities capable of producing both autologous and allogeneic therapies. Companies such as Bluebird Bio and Kite Pharma (a Gilead company) are pioneers in producing CAR-T cell therapies, gene-modified cell therapies, and gene therapies. The region has also seen a surge in contract development and manufacturing organizations (CDMOs), supporting scaling up production to meet rising demand.

• Regulatory Environment: The U.S. Food and Drug Administration (FDA) has established clear regulatory pathways for CGT products, such as the Breakthrough Therapy designation and the Regenerative Medicine Advanced Therapy (RMAT) designation. These pathways expedite the development and review of CGT products, fostering innovation while maintaining safety and efficacy standards.

• Challenges: Despite North America’s lead, the region still faces challenges in scaling up manufacturing due to the complexity of CGT production. Ensuring consistent product quality, controlling costs, and managing the supply chain, particularly for autologous therapies, remain significant hurdles. Furthermore, skilled labor shortages and high operating costs create bottlenecks in manufacturing capacity expansion.

The Manufacturing Landscape in Europe, the Middle East, and Africa (EMEA)

The EMEA region, specifically Europe, has also established itself as a major hub for cell and gene therapy innovation, with countries such as the United Kingdom, Germany, and Belgium leading in manufacturing capabilities. However, the market dynamics and regulatory environment in the EMEA region differ significantly from those in North America.

• Manufacturing Infrastructure: While Europe houses world-class manufacturing facilities, the region has historically lagged behind North America in terms of production capacity. Nonetheless, recent years have seen significant investment in expanding CGT manufacturing in Europe. For example, companies such as Lonza and Oxford Biomedica have established advanced facilities focused on viral vector production and cell therapy manufacturing. The European market is also seeing increasing participation from CDMOs, which are key in scaling production for smaller biotech firms.

• Regulatory Environment: The European Medicines Agency (EMA) has its own distinct regulatory pathways for cell and gene therapies, such as the PRIME (PRIority MEdicines) scheme. The EMA’s regulatory framework is harmonized across the European Union, simplifying market access for CGT manufacturers. However, the complex national-level pricing and reimbursement systems across different EU member states can pose challenges for companies in navigating market access and achieving commercial success.

• Challenges: One of the primary challenges in the EMEA region is the fragmented nature of the market. While there is regulatory harmonization, there are still discrepancies in national healthcare systems, pricing, and reimbursement policies. Moreover, Europe faces a similar issue as North America in terms of scaling up manufacturing, particularly with respect to maintaining cost efficiencies in a highly regulated environment.

The Manufacturing Landscape in Asia-Pacific (APAC)

The APAC region, particularly China, Japan, and South Korea, is emerging as a key player in the global CGT market. The region’s growing biotech sector, increasing government support, and large patient population make it a strategic market for cell and gene therapy development and manufacturing.

• Manufacturing Infrastructure: While APAC's CGT manufacturing infrastructure is still developing, it is rapidly expanding. Countries such as China and Japan have made significant strides in building advanced manufacturing capabilities. China, in particular, has seen a boom in the construction of CGT manufacturing facilities, with both domestic companies like WuXi AppTec and foreign companies expanding their presence in the region. Japan, with its focus on regenerative medicine, has also developed specialized manufacturing hubs, supported by initiatives such as the Japanese Regenerative Medicine Promotion Act.

• Regulatory Environment: One of the distinctive features of the APAC market is its relatively fast regulatory approvals for CGT products. China’s National Medical Products Administration (NMPA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) have implemented expedited regulatory pathways for regenerative medicine products. In Japan, for example, the “conditional time-limited approval” system allows early market access for promising therapies with provisional approval based on limited clinical data.

• Challenges: Despite its rapid growth, the APAC region faces several challenges in CGT manufacturing. A lack of standardized regulations across the region creates difficulties for multinational companies seeking to enter multiple APAC markets. Additionally, the high cost of manufacturing and ensuring supply chain integrity remain significant issues. While China and Japan have made considerable strides, other APAC countries still face infrastructure gaps in terms of manufacturing capacity and expertise.

Key Differences and Comparative Insights

• Regulatory Frameworks: The regulatory landscape is one of the most distinct differences between these regions. While North America has a well-defined and streamlined regulatory process, EMEA’s market is more fragmented (despite efforts aimed at harmonization). In contrast, APAC has shown remarkable flexibility in expediting approvals, though regulatory standards vary widely across countries, making cross-border commercial strategies complex.

• Manufacturing Capacity and Expertise: North America leads in terms of established manufacturing infrastructure and expertise. However, Europe is quickly catching up, particularly with the increase in CDMO activities. APAC, while growing rapidly, still faces a gap in manufacturing infrastructure, especially outside of major markets like China and Japan.

• Market Dynamics: North America remains the largest market for CGT products, driven by a strong investment landscape and extensive healthcare reimbursement systems. Europe, while advanced in scientific innovation, struggles with market access due to complex pricing and reimbursement processes. The APAC region, with its large patient population and increasing government support, offers significant growth potential but remains fragmented in terms of market access and regulatory consistency.

Market leaders

Based on 2023 end of year figures, the top cell and gene therapy companies as judged by single therapy revenue is as follows:

1. Kite, a Gilead Company (USA)

Yescarta (axicabtagene ciloleucel) is a CAR-T cell therapy developed by Kite Pharma, a subsidiary of Gilead Sciences. It was one of the first CAR-T therapies to gain approval and represents a significant advancement in cancer treatment, specifically for certain types of blood cancers.

2023 revenue: $1.5 billion

2. Novartis (Switzerland)

Zolgensma (onasemnogene abeparvovec) is a groundbreaking gene therapy developed by Novartis for the treatment of spinal muscular atrophy (SMA), a rare genetic disorder that affects motor neurons, leading to muscle weakness and loss of movement. It is the first and only gene therapy approved to treat this condition.

2023 revenue: $1.2 billion

3. Novartis (Switzerland)

Kymriah (tisagenlecleucel) is a pioneering CAR-T cell therapy developed by Novartis for the treatment of certain blood cancers. It was the first CAR-T therapy to receive FDA approval and has since been a landmark in the field of personalized cancer treatments.

2023 revenue: $508 million

4. Janssen Biotech, Johnson & Johnson (USA), and Legend Biotech (USA)

Carvykti (ciltacabtagene autoleucel) is a CAR-T cell therapy co-developed by Legend Biotech and Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) for the treatment of relapsed or refractory multiple myeloma. It is an innovative therapy that offers a personalized treatment approach for patients with advanced stages of this blood cancer.

2023 revenue: $500 million

5. Bristol Myers Squibb (USA) and 2seventy bio (USA)

Abecma (idecabtagene vicleucel) is a CAR-T cell therapy developed by Bristol Myers Squibb and 2seventy bio for the treatment of relapsed or refractory multiple myeloma. It is the first FDA-approved CAR-T therapy specifically targeting this form of cancer, providing a new treatment option for patients who have exhausted other therapies.

2023 revenue: $472 million

Conclusion

Cell and gene therapy manufacturing is a complex and evolving field, with significant regional differences in terms of infrastructure, regulatory oversight, and market dynamics. While North America currently dominates CGT manufacturing, EMEA and APAC are quickly advancing, each with unique strengths and challenges. As the global CGT market continues to expand, manufacturers will need to navigate these regional distinctions to optimize production and market access strategies, ensuring that life-saving therapies reach patients worldwide.