arying country-specific regulatory and reimbursement requirements, divergent legal frameworks, and inconsistent interpretation of the international guidelines create a fragmented regulatory approval process for advanced therapy medicinal products (ATMPs). The fragmentation also exists for achieving ATMP access, particularly in emerging markets (EM), where affordability constraints and limited reimbursement capacity magnify access barriers. The time for emerging markets to join the decision table and the efforts to increase access to these therapies across the world has arrived. Increasingly today, new alliances emerge among countries that share a forward-looking mindset and a willingness to collaborate and improve patient outcomes. This includes, as a crucial element, the willingness to maintain a high level of public health protection while facilitating and smoothing the path for ATMPs to reach the patients who need them across the globe, especially in EM settings.

Current State of Global ATMP Development

The world today features local and geopolitical forces that increasingly shape how medicines are developed, approved, and distributed. Meanwhile, scientific advances in cell and gene therapy are transforming our fundamental understanding of medicine and changing our ability to treat previously incurable diseases. However, they also highlight global inequities in access to therapies. These inequities are significantly amplified in EM due to affordability limitations and constrained health budgets.

The statement “Innovation can happen anywhere” is no longer aspirational; today, it is a reality. The Asia Pacific region, and China in particular, has become a major source of biotech innovation. In 2024, roughly one-third of global business development deals involved Chinese biotechnology companies, and in 2025, that number is approaching 45%. Out of the current global pipeline for ATMP development, half of the products are being developed in China.

Most biopharmaceutical companies today aim for global commercialization for their ATMP portfolios, making the specific clinical trial site locations less important. One of the key ATMP development challenges results from inconsistent interpretation of international regulatory requirements and guidelines. Furthermore, the existing differences in classification, terminology, and standards for manufacturing of ATMPs in different regions across the globe lead to great diversity in requirements, which in turn require significant effort for developers to address.

At the same time, global regulators struggle with significant challenges when reviewing ATMP submissions because of the often-limited safety and efficacy data present at the time of marketing authorization submission. These challenges are further compounded when considering the need for long-term follow-up data. In addition, the high costs of these therapies contribute to payer reluctance to broadly adopt these new therapies, thereby restricting timely patient access, and resulting in lower access to therapies by patients around the globe who need them. In summary, scientific uncertainties, varying country-specific regulatory and reimbursement requirements, divergent legal frameworks, and inconsistent interpretation of the international guidelines create a fragmented approval process and result in delays for patients accessing these life-saving therapies.

Current State of ATMP Development for Emerging Markets

Emerging markets across the globe, especially in countries with very large populations (like China, Brazil, and India) as well as in countries where certain rare disorders are more prevalent (Saudi Arabia, Egypt, Nigeria, etc.), would certainly benefit from access to ATMPs manufactured and approved in the US, Europe, Japan, Australia, and elsewhere. To satisfy current global patient needs, advanced biotechnology companies from countries like China, Saudi Arabia, and Brazil have an important role to play in the manufacture, product development, and overall patient access to innovative therapies. Bilateral partnerships between certain pairs of countries (e.g., China and Brazil) can play an important role as well.

EM regulatory systems are changing and quickly maturing to address the needs of their growing populations. Regarding their role on the global stage, they are already making significant steps forward by considering important collaborative alliances in addition to utilizing regulatory reliance whenever possible. This is particularly important as the developers of some of these APAC- and China-originated innovations may choose not to seek US or EU approval due to commercial strategy or market prioritization rather than scientific or quality-related reasons. This creates a gap in traditional regulatory reliance models that depend almost exclusively on US FDA or EMA approvals.

While global harmonization of regulatory requirements is arguably a lofty goal, regulatory convergence is not only attainable but to a certain degree an important necessity as a lever to move the ATMP field forward. Regulatory convergence—focused on alignment of scientific standards, CMC expectations, and risk-based approaches—offers a practical pathway to reduce redundancies and strengthen global regulatory capacity. It can serve patients better, allowing more people across the world to access life-saving treatments.

Proposed Solutions

Aiming for regulatory convergence in the ATMP space is the way forward for EM. Today, regulatory agencies can progress in that direction by utilizing regulatory reliance. This reliance ranges from bilateral cooperation agreements to international consortia and scientific collaboration pilots; all are going to play an important role for future development of this field. Regulatory reliance mechanisms can optimize regulatory resources without supplanting sovereign decision-making, thereby reducing duplication of efforts while maintaining the necessary rigorous oversight. However, traditional reliance models anchored solely on FDA or EMA approvals need not be the only choices. As APAC and China generate high-quality data for products for which they may not seek US/EU approval, reliance frameworks must evolve to assess the scientific merit of data regardless of country of origin. This is especially critical for ATMPs, where regulatory frameworks remain heterogeneous even among ICH members.

Regulatory sandboxes, as well as platforms for data sharing for drug development, are being created to establish frameworks for healthcare innovators on how to deal with emerging health technologies. In a neutral space, these tools and the associated discussions can guide developers as they create and evolve their individual ATMP portfolio strategies, including long-term safety and efficacy databases and real-world evidence repositories.

Finally, common standardized training and expertise-sharing, ranging from exchanging materials and practices focused on manufacturing standards to teaching others how to pursue regulatory reliance, are going to become critical components for speeding up the development and regulatory approval of innovative ATMPs.

To promote wider patient access, speeding up and broadening regulatory approval is only a step in the right direction, and must be followed by appropriate reimbursement pathways. To ensure wider access to innovative therapies, especially in EM where affordability is the primary determinant of adoption, collaboration on and sharing of starting materials are both important, as it is now clear that reusable technology fundamentals can be utilized to develop multiple therapies by leveraging some of the existing information instead of starting from scratch every single time (e.g., mRNA technology, viral vectors for gene therapies, and AI platforms for drug discovery) when supported by a framework of transparent data sharing, robust standardization, and demonstrated comparability, ensuring the maintenance of high standards of quality, safety, and efficacy. It is encouraging to see the consensus being built among regulators and developers regarding the cases where these efficiencies can be achieved, as discussed during the 2025 DIA Beijing BioForum.

Additionally, careful supply chain management planning and applying reliance agreements can help avoid drug and materials shortages, while collaboration on medical device development and deployment can play a role in the successful implementation of ATMP development and regulatory approval. That is why HTAs and value assessment collaborations have to be implemented intentionally to ensure broad access to innovative therapies across the globe, as health budgets are under severe pressure everywhere.

Emerging Markets Open Global Access

The interpretation of new scientific data generated from global ATMP trials requires greater cooperation, flexible regulatory approval systems, and continued updates of the relevant regulatory science and processes that can then be adapted to the fast-evolving ATMP technologies. The diverse stakeholders from academia, government, and the private sector need to work together to address market failures caused by the high upfront cost of new therapies, the struggles to agree on reimbursement models with payers, and the logistical and manufacturing complexity needed to deliver the therapies that hinders the potential for scalability in production.

The time for EM to actively contribute to the efforts to increase global access to life-saving ATMPs has arrived. The participation of more regions outside the US, Europe, and Japan is needed to satisfy the current global unmet medical needs. That is why companies from countries like China, Saudi Arabia, and Brazil, as well as other emerging markets, are already playing important roles in this space. These countries are not only consumers of innovation but increasingly central contributors to ATMP research, manufacturing, and regulatory science. These countries’ regulatory landscapes are also changing and quickly maturing to address global patient needs. They are already making significant steps forward and forming important alliances in addition to utilizing regulatory reliance whenever possible. Although the experience, capabilities, and know-how of the traditionally strong regulatory agencies will continue to play an important leadership role, reliance frameworks must increasingly focus on the quality and merits of the data rather than the geography of the approving authority—an essential step as APAC and China continue to contribute to a rapidly growing share of global ATMP innovation.

Partnerships between countries are built on common objectives and mutual interests. Some are formed regionally, based on geography, while others are based on a shared language or cultural values. Increasingly today, new alliances emerge among countries that share a forward-looking mindset and a willingness to collaborate and improve patient outcomes. This includes, as a crucial element, the willingness to maintain a high level of public health protection, while facilitating and smoothing the path for ATMPs to reach patients who need them and maintain public trust at the same time. The current challenge/opportunity is for countries to continue participating in these evolving networks while ensuring they continue to drive international convergence and harmonization efforts.