The 128,000-sq-ft GMP cell and gene therapy facility in New Jersey, expands the CDMOs U.S. capabilities in plasmid, AAV, and LVV manufacturing. < Back ProBio Opens Cell and Gene Therapy Center of Excellence in New Jersey The 128,000-sq-ft GMP cell and gene therapy facility in New Jersey, expands the CDMOs U.S. capabilities in plasmid, AAV, and LVV manufacturing. The announcement from ProBio, GenScript’s CDMO arm, that it has inaugurated a flagship Cell and Gene Therapy Center of Excellence in New Jersey is not just another ribbon-cutting; it's a strategic move with implications for the entire biotech ecosystem. The Hopewell facility, purpose-built at 128,000 square feet, offers GMP manufacturing capacity for plasmid DNA and viral vectors including AAV (adeno-associated virus) and LVV (lentiviral vector), both of which are central to the expanding pipeline of gene and cell therapy candidates. With clinical-grade AAV production slated for Q3 2025 and LVV to follow in Q1 2026, ProBio is positioning itself to support the full arc of therapeutic development, from early-stage process development to clinical readiness, all under one roof. This is a welcome and timely development. Demand for high-quality GMP vector production continues to outpace supply, particularly as more biotechs advance into IND-enabling studies. In viral vector manufacturing, the bottleneck is not always scientific, it’s infrastructural. Facilities like this don’t just add capacity; they inject flexibility, speed, and resilience into the pipeline. Allen Guo, CEO of ProBio, captured this sentiment well: “This is not just a new facility. It is a beacon of hope for patients waiting for cures.” And he's right. The center’s proximity to major research hospitals and precision medicine hubs in the Northeast will likely accelerate trial enrollment and tech transfer, giving developers a geographic and operational edge. Additionally, there is an economic impact that should be noted here. With over 110 highly skilled jobs being created, the Hopewell site anchors New Jersey even more firmly as a nexus of advanced biomanufacturing. As John Coelho from NJEDA says, “The opening of ProBio will be a significant enhancement to the cell and gene biologics development and biomanufacturing ecosystem.” As we shift from the era of biologics to the era of curative gene and cell therapies, infrastructure like ProBio’s Hopewell facility will be the backbone. The technologies are exciting, but it's the execution at scale, and under GMP, that will determine how many patients actually benefit. ProBio has laid a strong brick in that foundation. Let’s hope many more follow. Author BioFocus Newsroom Previous Next

FUJIFILM pledged major investment into Diosynth Biotechnologies manufacturing facility in Holly Springs, North Carolina, US. < Back FUJIFILM Diosynth Biotechnologies Restructures for Strategic Growth FUJIFILM pledged major investment into Diosynth Biotechnologies manufacturing facility in Holly Springs, North Carolina, US. Major expansion in North Carolina FUJIFILM Diosynth Biotechnologies is making a substantial investment of $3.2 billion to expand its biopharmaceutical manufacturing capabilities in Holly Springs, North Carolina. This expansion will create 725 new jobs and significantly increase the production capacity for advanced therapies, including gene therapies and monoclonal antibodies. The project emphasizes the importance of attracting and retaining top talent to drive innovation and operational excellence. Workforce restructuring While expanding in North Carolina, FUJIFILM Diosynth is also undergoing a restructuring plan that may result in the loss of 240 jobs in the U.S. and U.K. This aims to streamline operations and enhance efficiency across its global network. The restructuring is part of the company’s effort to optimize resources and adapt to the evolving demands of the biopharmaceutical industry. New cell culture facility In line with its expansion efforts, FUJIFILM Diosynth recently broke ground on a new state-of-the-art cell culture facility in North Carolina. This facility is a critical component of the $3.2 billion investment and is expected to further boost the company’s manufacturing capabilities, ensuring it meets the growing global demand for biopharmaceutical products. These initiatives reflect FUJIFILM Diosynth's commitment to balancing growth with efficiency, positioning itself as a leader in biopharmaceutical manufacturing. The expansion, coupled with strategic restructuring, aims to ensure the company remains at the forefront of innovation while optimizing its operations for future challenges. Author BioFocus Newsroom Previous Next

< Back Collaborating Across Sectors to Eliminate Cervical Cancer Uniting innovation, equity, and cross-sector collaboration to scale prevention, expand access, and turn cervical cancer into the first cancer eliminated worldwide. The elimination of cervical cancer stands as one of the greatest opportunities for public health of our time. For the first time in history, we have the tools, strategy, and collaborative momentum to eliminate a cancer entirely. Yet, currently, over 350,000 women lose their lives to this preventable disease every year, with the overwhelming majority in low- and middle-income countries. While we are within touching distance of elimination, achieving those last, challenging steps will depend on action from all sectors, including the healthcare industry. The World Health Organization’s 90-70-90 strategy provides us with a clear roadmap: 90% of girls to be vaccinated, 70% of women to receive high-performance screening, and 90% of women identified with cervical disease to receive treatment. It’s a strategy that could save as many as 14 million lives by 2070. But challenges remain. While we have the technology to meet these targets, implementing solutions at scale, and ensuring they can be accessed by some of the most marginalised populations, requires the combined effort of governments, health systems, the private sector and communities working together. None of us can succeed alone. The basis of elimination Cervical cancer elimination is possible because of three essential elements: screening, vaccination, and treatment. Together, they provide a powerful toolkit, saving individual lives and offering a path to global elimination. Screening has long been the cornerstone of cervical cancer prevention. High-income countries with established screening programmes have drastically reduced cancer rates by detecting abnormalities early, and ensuring patients receive treatment at an early stage, when it’s most effective. Vaccination has further transformed this landscape, protecting against the root cause of 99% of all cases – HPV infection. But it’s not a perfect solution. Vaccines delivered today will take decades to fully impact incidence, meaning that millions of women at risk today and the 100,000’s who will be diagnosed annually need prevention interventions now. This is why screening is essential, to change the course of the disease for women, working alongside vaccination to protect future generations. Australia offers a glimpse of what is possible when these tools are combined effectively. By integrating high vaccination coverage with accessible and innovative screening approaches and treatment, the country is on track to become the first in the world to eliminate cervical cancer as a public health problem within the next decade. Breaking down barriers to cervical screening HPV infections are common, and in most cases, the immune system controls them effectively, reducing the virus to undetectable levels without causing harm. But left untreated, HPV infections can develop into cervical cancer, making screening a vital step in preventing deaths. Yet, despite its importance, many women face barriers that stop them from accessing screening in the first place. A recent survey highlighted the emotional and practical challenges that women face when it comes to screening. Fear of pain or discomfort, embarrassment, and anxiety about test results prevent 30% of women from attending screenings. Practical barriers such as family responsibilities, work commitments, and difficulties booking appointments were also an issue cited by 22% of respondents. A lack of awareness or support further compounds the problem; only 18% of women said they had discussed their fears about screening with someone else. When women avoid screening, the entire care pathway breaks down, leaving preventable cancers undetected and untreated. Addressing these barriers is essential to achieving global elimination. Making cervical screening easier and more accessible The healthcare industry has an important role to play here. Innovative approaches to cervical screening are beginning to remove some of the key barriers that stop women from engaging with prevention. Innovations like self-sampling kits allow women to collect their own samples privately, removing concerns related to discomfort, stigma, or lack of time. Survey data reflects the potential of this approach, with 27% of millennials – the generation most likely to cancel or postpone a screening appointment – saying they would be more likely to participate in screening if self-collection were available. Other breakthrough solutions, such as menstrual blood diagnostics , are being trialled to make testing even less invasive and more accessible, particularly in low-resource settings. These innovations have the potential to revolutionise cervical cancer screening by making it easier, faster, and more inclusive. To realise their full potential, these innovations must be integrated into health systems and made widely available to the women that need them most. Enabling equity at scale Addressing systemic inequalities in cervical cancer prevention is as much about implementation as it is about innovation. While tools like these are helping break down the barriers women experience, ensuring they deliver meaningful impact requires collaboration across governments, health systems, communities, and the healthcare industry. Each stakeholder has a role to play, and the private sector’s contribution is critical – not only in driving innovation but in ensuring that these solutions are adaptable, affordable, and accessible to women everywhere. In many low-resource settings, gaps in healthcare infrastructure, from fragmented laboratory systems to insufficient diagnostic and treatment capacities, mean that even the most promising tools fail to reach women at risk. Tackling these challenges requires collaboration to build and strengthen systems capable of delivering effective care at scale. In Peru, an industry partnership with the Ministry of Health has enabled the successful introduction of HPV self-collection and molecular testing for nearly half a million underserved women – many of whom live in rural or hard-to-reach areas. By reducing the need to travel to clinics and offering the chance for women to collect their own samples privately and at their convenience, logistical barriers and cultural sensitivities have been overcome, ensuring women are not prevented from seeking care. This partnership also demonstrates how industry can work with health systems to embed innovations sustainably. By integrating HPV self-collection into Peru’s public healthcare infrastructure, the programme has created a sustainable model for cervical cancer prevention that can serve communities for years to come. Collaborating to overcome systemic barriers Achieving elimination at scale depends on partnerships that bring together governments, healthcare providers, industry, and communities to align resources, strengthen infrastructure, and ensure lasting impact. Blended financing models offer one way to support the long-term sustainability of prevention programmes. By combining public funding with private sector contributions and donor investments, governments can ensure that cervical cancer prevention becomes an enduring feature of national health strategies. In practice, this might mean a government funds and operates clinical infrastructure, such as screening centres and treatment pathways, while industry partners provide comprehensive support beyond just diagnostic technologies. Government tenders can group volumes together to lower costs and require additional services like specialised training for laboratories and education for healthcare workers. In Peru, the Ministry of Health co-ordinated the screening programme, while Roche provided the molecular testing platforms, self-collection kits, and logistical expertise required to integrate these tools into a nationwide screening strategy for remote communities. The value of this approach has been reinforced by recent roundtable discussions involving national ministries of health, healthcare professionals, and industry leaders. These discussions highlighted how aligning government priorities with multilateral efforts and private sector collaboration creates opportunities to anchor cervical cancer elimination initiatives within national health plans and insurance schemes. Such mechanisms, including multilateral procurement frameworks and cost-sharing models, provide predictable resources to sustain long-term progress and reach marginalised populations. Collaboration at the community level is also essential to driving uptake. Partnering with grassroots organisations, local leaders, and advocates ensures interventions resonate with the cultural and social contexts of women’s lives. Strong community engagement helps build trust, address stigma, and empower women to engage confidently in prevention and care. Designing programmes alongside communities ensures that solutions respond to women’s lived realities, making prevention efforts more inclusive and effective. Conclusion: turning commitment into action The elimination of cervical cancer is no longer a distant goal. With effective tools, robust strategies, and growing collaborative momentum, achieving this vision is within reach. However, success depends on how we act now. Governments must lead by embedding cervical cancer prevention into national health systems, creating long-term strategies that integrate vaccination, screening, and treatment as core services. Communities must play their part by driving awareness, building trust, and empowering women to engage with care. The private sector, meanwhile, must continue to support innovation and access while partnering with governments to deliver equitable and sustainable solutions. The WHO’s 90-70-90 strategy provides a clear path forward. But it’s only through collective action and an unwavering focus on equity that this promise can be fulfilled. Together, we can eradicate cervical cancer as a global health threat and ensure that no woman dies from this preventable disease. Now is the time to turn ambition into action and deliver one of the most profound public health achievements of our time. Author Joanna Sickler , Vice-President, Health Policy & External Affairs, Roche Diagnostics Previous Next

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< Back Digital Cognitive Therapy Delivers Striking Cognitive Gains for UK Care Home Residents A digital therapeutic designed to combat cognitive decline in people with dementia has produced remarkable improvements in cognitive and emotional outcomes in a recent UK pilot. The BioFocus team recently sat down with Devika Wood, CEO of Brain+ and a former dementia carer, to discuss the company’s field-advancing work in digital dementia care. We discussed how the Brain+ Ayla Dementia Care platform new therapeutic platform has been a vehicle for demonstrating how data, design, and compassion can reshape one of healthcare’s greatest challenges. Beyond the numbers, Devika shared the deeply human stories of residents who, for the first time in years, began to remember names, childhood moments, and emotions thought long lost, allowing them to regain dignity and connection in their later stages of life. The study, conducted by dementia technology company Brain+ in collaboration with Southcare Homes Group, demonstrated that seven weeks of digitally delivered Cognitive Stimulation Therapy (CST) via the company’s Ayla Dementia Care Platform led to a 47.8% improvement in overall cognitive outcomes among residents with mild to moderate dementia. Measured gains were seen across several key cognitive domains: Planning and executive function: +66.3% Recognition and memory: +56.5% Task switching: +48.3% Communication and understanding: +42.3% Participants also reported higher mood and quality-of-life scores. Average mood improved from 3.7 to 4.2 out of 5, while quality-of-life ratings (spanning energy, mood, memory, and self-perception) rose from 1.98 to 2.65. Residents rated the overall experience 9.6 out of 10, and 80% said they would recommend CST to others. These results, described by Brain+ as a “transformational step” in accessible dementia care, demonstrate the feasibility of delivering evidence-based cognitive therapy at scale through digital means. Facilitating the digitalisation of archaic paper processes CST is a non-pharmacological intervention endorsed by both the World Health Organization (WHO) and the National Institute for Health and Care Excellence (NICE) for use in people with mild to moderate dementia. It is the only non-drug therapy formally recommended for NHS delivery, with clinical trials showing benefits in cognition, communication, and mood, and evidence that it can delay cognitive decline by up to six months. Traditionally, CST is delivered through structured, themed group sessions, typically five to eight participants, run by trained facilitators. However, the format has remained largely analogue since its inception, relying on laborious paper-based documentation and significant preparation time. “The CST manual looks like an encyclopedia,” said Devika Wood. “Facilitators typically spend hours designing each session in line with the handbook. We developed Ayla to digitise the entire process, essentially turning CST into a plug-and-play digital therapy that can be delivered quickly, consistently, and at scale”. Ayla, a Class I medical device (meaning it can be delivered via healthcare providers including the NHS), provides more than 180 clinically validated activities structured across 14 sessions, each designed to stimulate specific cognitive and social domains. It also integrates data capture tools to record and analyse outcomes in real time, enabling care teams to track progress and tailor therapy to individual needs. Devika compared Ayla’s role in dementia care to the way digital platforms such as SilverCloud transformed cognitive behavioural therapy for mental health. “We refer to Ayla as a means of bringing CST into the digital age”, she said. “It standardises delivery, collects measurable data, and empowers care staff to deliver best-in-class therapy even in resource-constrained environments”. Measurable benefits and the human impact While the quantitative results of the pilot were impressive, the qualitative feedback was equally compelling. At Southcare Homes’ Grasmere and Lime Tree House sites, where the pilot was conducted, staff reported visible improvements in residents’ engagement, mood, and communication within just a few sessions. Antony Noad, Activity Coordinator at Southcare Homes, recalled the transformation of one resident who had not smiled in months. “Some of the participants had real barriers around certain memories, which they could no longer access. One particular person, for example, couldn’t talk about their childhood. “There was a wonderful moment when a memory was triggered and the whole atmosphere changed: all the pretence and defensiveness went out of their voice, and you could see them connect emotionally to their past experience”. Another participant, Tom Miller, who had long been unable to discuss his early life, began recounting vivid stories from his childhood during therapy. Vicky Miller, daughter of Southcare resident Tom Miller, who took part in the pilot, said: "Dad’s short term memory is slightly better, and he remembers my son’s name. He’s also more sociable, less easily triggered, and his interactions with other residents are a lot more positive. I’m really pleased to see the progress he’s made!”. From speaking with Devika, it is clear that these personal accounts underscore the importance of the work, especially against the backdrop of her own personal experiences in caring for her nan, who suffered from the disease. Devika commented: “You just don't understand the power of it until you sit there and you see how the recipients come alive. And they deserve it. These are the people that were the cornerstones of our society. They were our parents and our grandparents. They deserve to be listened to and to be asked about their lives”. “This report doesn’t just represent numbers; it represents people and the moments of reconnection that every person living with dementia deserves,” she said. “It has been a privilege to work alongside Southcare Homes and see first-hand the difference technology can make when implemented with compassion.” Meeting a growing national challenge There are currently an estimated 982,000 people living with dementia in the UK, a figure projected to rise to 1.4 million by 2040. With as many as three in four care home residents affected, the need for scalable, cost-effective therapies is becoming critical. Devika believes that digital delivery of CST is a key part of the solution. “One of the biggest barriers to dementia care is limited workforce capacity” she explained. “By digitising therapy and training existing care staff to deliver it, we can expand access without adding pressure to the NHS. CST is most effective when introduced early, so it belongs in primary and community care, not only in secondary services”. On the pilot study, Karim Nanji, proprietor of Southcare Homes Group, said that “ working with the Brain+ team in introducing Ayla to our team and residents has been groundbreaking. We were thrilled to be the first UK-based care home group to partner with this exceptional team, whose dedication and passion match ours. Through step-by-step training, both in person and virtual, our team has been able to learn how best to deliver the Ayla initiative in an effective, caring and person-centred manner”. Following the pilot’s success, Southcare Homes has confirmed plans to implement Ayla across its wider group of care homes. Dementia: data, doubt, and the distance still to go While the early data from the Ayla pilot are undeniably encouraging and have the potential to drastically improve patients’ lives, it must be noted that CST is a complementary therapy, not a cure. Dementia remains a progressive, neurodegenerative condition with no treatment capable of halting or reversing its underlying pathology. CST, whether delivered digitally or in person, does not alter the biological mechanisms of diseases such as Alzheimer’s or vascular dementia. Instead, it targets neuroplasticity, engagement, and quality of life, helping patients make the most of their remaining cognitive function. The Ayla pilot’s 47.8% improvement figure, though striking, should also be interpreted carefully. The study involved just 12 participants across two sites, with no placebo or control group for direct comparison. While the use of Likert-based outcome measures aligns with CST research standards, further randomised controlled trials (RCTs) and long-term follow-ups will be essential to confirm the durability of these effects and rule out potential bias. That said, the pilot represents an important proof of concept: that evidence-based, person-centred therapies can be made scalable through digital innovation. For a condition where pharmacological progress remains slow and fragmented, the potential societal impact of sustained cognitive gains is enormous. As Brain+ continues to expand its research, the hope is that digital therapeutics like Ayla can fill a vital gap between diagnosis and long-term care, bridging clinical science and human connection in one of the most pressing health challenges of our time. What's next for Brain+ For Brain+, the pilot marks only the beginning. The company has initiated a new collaboration with a GP practice participating in a dementia-led care strategy, exploring how CST can be integrated at the point of diagnosis. “Early intervention is essential,” Wood said. “We are testing delivery of CST groups in primary care settings for newly diagnosed patients and will use the outcome data to demonstrate the benefits of early, community-based therapy.” Alongside its UK expansion, Brain+ is pursuing international partnerships in Australia, Canada, and other markets, including at-home care services. “Our aim is to embed CST globally as a first-line intervention for dementia and make this the gold standard care option” Wood added. “We want to give people not only longer lives, but better lives”. About the Ayla Dementia Care Platform Ayla is a digital toolkit that replicates the structure and clinical integrity of the original CST programme while reducing preparation time by more than 50%. The platform includes a 14-session, NICE-aligned framework with over 180 evidence-based activities targeting memory, language, problem-solving, and social engagement. Co-designed with care providers and individuals living with dementia, Ayla integrates seamlessly into existing care routines, enabling care homes to deliver standardised, measurable therapy while improving staff confidence and efficiency. About Brain+ Brain+ is a Copenhagen-founded digital therapeutics company developing non-pharmacological treatments for dementia and cognitive impairment. Its mission is to make evidence-based cognitive therapies accessible at scale through digital innovation and data-driven care delivery. Author BioFocus Newsroom Previous Next

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We assess the intricate manufacturing landscapes of cell and gene therapies, highlighting the distinct capabilities, regulatory environments, and market dynamics of North America, Europe, the Middle East, Africa, and the Asia-Pacific region. < Back CGT Manufacturing: A Comparative Analysis of APAC, EMEA, and NA Markets We assess the intricate manufacturing landscapes of cell and gene therapies, highlighting the distinct capabilities, regulatory environments, and market dynamics of North America, Europe, the Middle East, Africa, and the Asia-Pacific region. 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. Author BioFocus Newsroom Previous Next

< Back 12th – 15th January, 2026 San Francisco, CA J.P. Morgan Healthcare Conference The 44th Annual Healthcare Conference will take place on January 12-15, 2026 in San Francisco, California. This premier conference is the largest and most informative healthcare investment symposium in the industry, which connects global industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community. Previous Register now Next

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