The field of cell and gene therapies (CGTs) holds transformative potential, but it is not without hurdles, especially in the Asia-Pacific (APAC) region.
Here, we summarize two key access challenges that CGTs face, distinct from those encountered by traditional therapies – the challenging complexity of manufacturing and delivery, and the ultra-high price tag. We also explore the questions that these challenges raise in the APAC context.
Watch our free webinar
For a deep dive into access for cell and gene therapies within APAC
Challenge 1: Complexity of manufacturing and delivering cell and gene therapies in the Asia-Pacific region
The complexity of manufacturing and delivering CGTs poses intricate challenges even in a global setting involving high resource intensive steps such as cell harvesting and gene modification, requiring shipping patient samples to and from manufacturing sites and treatment centers. Today, manufacturing capacity for global CGT products is largely limited within APAC, as major processing centers for these products are predominantly situated outside of the region. This leads to increased costs and clinical bottlenecks, hindering widespread availability of these global therapies.
Additionally, when it comes to treatment delivery, due to the wide disparity across and within APAC markets in terms of access to infrastructure and health system maturity, local CGT value chains are also still nascent. This is especially evident in emerging APAC markets, where access to accredited treatment centers, trained personnel, and cold-chain infrastructure is limited, if not lacking. Hence, local CGT value chains still need to be developed further to achieve self-sufficiency and ensure optimal access to CGTs to patients in the APAC region.
Further, for global manufacturers, venturing into the APAC CGT landscape means going up against domestic players in the CGT sector, many of whom may possess advantages that come with pre-established networks within the local healthcare ecosystem and an understanding of local marketplace dynamics that global biopharmas may lack. Notably, local biotechs such as Legend and ImmunoACT – who have pioneered local CAR-T therapies in China and India, respectively, in recent years – are actively trying to ramp up localized production and delivery centers. Capitalizing on a local workforce and academic resources, local companies aim to offer CGTs to patients in the region at a fraction of the cost provided by their global counterparts.
There are also reports of point-of-care (POC) CGTs being made available to patients (sometimes referred to as ‘homebrew’) in markets like Thailand, Malaysia, Vietnam, and Singapore by leveraging manufacturing in major cancer and academic medical centers and hospital networks. While POC may still face hurdles around product quality concerns, regulatory compliance, and scalability, it shows promise to address concerns around costs and treatment delays by eliminating some of the challenges with centralized production models. This adds another layer of complexity as it essentially introduces a situation where global CGT products may have to compete for limited provider capacity against POC CGTs that medical centers develop in-house.
The still-emerging local CGT value chains coupled with an overreliance on global resources, against a thriving local CGT landscape, create a highly competitive, capital-intensive environment in APAC for CGT players seeking entry.
This raises some pertinent questions for global CGT manufacturers:
- What market entry model should global CGT manufacturers adopt considering logistical challenges and intense local competition in APAC?
- How is the regional APAC landscape influencing (and how will it influence) access to CGTs in the region?
- Is there a role for contract development and manufacturing organizations (CDMOs) in building and supporting local CGT value chains within the APAC region?
- How can commercial manufacturers navigate the challenge of potentially competing for limited provider capacity against POC CGTs?
For CGT manufacturers seeking entry in the APAC region, the still-emerging local value chains, overreliance on global resources, and a thriving local landscape present a highly competitive and capital-intensive environment.
Challenge 2: The barrier to access within the Asia-Pacific region caused by the ultra-high price tags associated with global cell and gene therapies
The ultra-high price tags associated with global CGTs presents a major barrier to their accessibility. Despite being commercialized as ‘one-time’ treatments, the immediate financial strain on patients is substantial, especially if they bear CGT costs primarily out-of-pocket. Today, the costs for these therapies in APAC markets are on par with global prices, at an approximate US$ 350k for global CAR Ts and well over US$ 1 million for global gene therapies. And this is prior to considering additional charges associated with pre- and post-infusion therapies, continued monitoring, and other travel costs.
In APAC – where markets already grapple with an access lag compared with other markets like the US or UK – most public payers are yet to adopt the long-term cost-effectiveness lens that is needed to evaluate these novel therapies. Consequently, only a handful of commercial CGT products have received public reimbursement in the region, and that too only in mature markets like Australia, Japan, and South Korea.
The limited reimbursement means that patients in the majority of the APAC markets can only access CGTs by covering the involved expenses out-of-pocket. And despite many APAC markets having experienced impressive economic growth in recent years, significant disparities in health equity persist. Hence, with costs of global CGTs being over 200 to 500 times the per capita GDP of markets like India and Indonesia – which account for some of the largest populations in the region – these innovative therapies remain out of reach for the majority in APAC at their current price points.
In this context, CGT stakeholders will need to consider several important questions:
- Have local innovators been successful in making CGTs more affordable in APAC?
- What sort of innovative models, including risk-sharing, outcome-based, have been implemented in APAC to manage uncertainties related to CGTs?
- Is there a role for alternative funding channels, such as commercial health insurance, in improving CGT access across APAC?
Watch our webinar for a deep dive into the competitive landscape of CGTs in APAC. Gain insights into the CGT capabilities of local biotechs, effective strategies for navigating manufacturing and affordability complexities in the region, and explore key considerations for optimizing access.
Senior Strategic Advisor
Watch our free webinar: “Exploring new horizons: Cell and gene therapy access in the Asia-Pacific region”
To learn more and explore some of the additional questions, please watch our free webinar. This describes the evolving competitive landscape of CGTs in the APAC region, offers insights for navigating the CGT complexities around manufacturing and affordability in the region, and presents key considerations for optimizing CGT access in APAC.
We also welcome your thoughts on the “questions for stakeholders” raised in this update and your perspectives on CGT considerations and access solutions specific to APAC. Please contact our policy, access, value, and evidence experts in Singapore.