扩大东盟生物制药生态系统：结构性驱动因素、监管、生态系统准备度与协作增长

'Advancing ASEAN Biopharma: Strategic Drivers for Growth and Collaboration'

“推进东盟生物制药：增长与合作的战略驱动因素”

ASEAN is often described as a high-growth biopharma region. From your perspective, what are the key structural drivers behind this growth today?

东盟常被描述为高增长的生物制药区域。从您的角度来看，当今这一增长背后的关键结构性驱动因素是什么？

ASEAN’s biopharma growth is underpinned by strong demand fundamentals - a growing population, expanding healthcare needs and access, rising chronic disease prevalence, and sustained investment in biologics. However,

东盟生物制药的增长得益于强劲的需求基本面——人口增长、医疗需求和获取的扩大、慢性病患病率的上升，以及对生物制品的持续投资。然而，

Cytiva’s Global Biopharma Index

Cytiva全球生物制药指数

cautions that growth alone is not enough. While industry revenues are increasing globally, many companies are struggling to convert innovation into clinical and commercial outcomes. Persistent gaps remain in time-to-market, CMC expertise, process scalability, and profitability.

警告说，仅靠增长是不够的。尽管全球行业收入正在增加，但许多公司仍在努力将创新转化为临床和商业成果。上市时间、CMC专业知识、工艺可扩展性和盈利能力方面仍然存在持续的差距。

For ASEAN, the real long-term growth driver will be the strength of its ecosystem foundations. This includes talent availability, predictable and innovation

对于东盟来说，长期增长的真正驱动力将是其生态系统基础的实力。这包括人才的可用性、可预测性和创新性。

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ready regulatory frameworks, manufacturing agility, and supply-chain resilience - so innovation can scale reliably and translate into meaningful impact for patient while delivering sustainable commercial outcomes.

准备好监管框架、制造敏捷性和供应链弹性——使创新能够可靠地扩大规模，并在为患者带来有意义的影响的同时实现可持续的商业成果。

Growth across ASEAN is not uniform—how would you compare more advanced ecosystems like Singapore with emerging markets such as Thailand, Vietnam, or Indonesia in terms of biopharma readiness?

东盟各国的增长并不均衡——你会如何比较新加坡等较先进的生态系统与泰国、越南或印尼等新兴市场在生物制药准备方面的差异？

ASEAN’s biopharma readiness varies significantly across the region. The Index ranks Singapore 6th globally (score 6.29), reflecting strengths across talent, manufacturing capability, and regulatory maturity, while Thailand ranks 17th (score 5.59), although it has made notable progress in talent development and supply chain readiness.

东盟地区的生物制药准备程度差异显著。指数排名中，新加坡全球排名第6（得分6.29），反映了其在人才、制造能力和监管成熟度方面的优势，而泰国排名第17（得分5.59），尽管其在人才发展和供应链准备方面取得了显著进展。

Importantly, the Index also shows that economic strength is becoming a weaker predictor of biopharma success. Countries are increasingly able to improve performance by making targeting ecosystem investments rather than relying on scale alone. This suggests that emerging ASEAN markets can accelerate their progress by prioritizing workforce development, regulatory reform, and manufacturing capability, even if they start from a lower base than more established hubs like Singapore. .

重要的是，该指数还表明，经济实力正成为生物制药成功的一个较弱的预测因素。各国越来越能够通过有针对性地投资生态系统来提升表现，而不是仅仅依靠规模。这表明，即使是起点低于新加坡等更成熟的中心，新兴的东盟市场也可以通过优先考虑劳动力发展、监管改革和制造能力来加速其进展。

That said, regulatory clarity remains a critical differentiator. Biopharmaceuticals must be regulated in the markets where they are administered to patients. While regulatory frameworks in markets like Singapore are well

也就是说，监管清晰度仍然是一个关键的区别因素。生物制药必须在它们被用于患者的市场受到监管。像新加坡这样的市场的监管框架非常完善。

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established, greater standardization and predictability across the rest of ASEAN will be essential.

要实现这一目标，东盟其他地区的标准化和可预测性将至关重要。

Cytiva’s Global Biopharma Index highlights gaps in areas like talent, manufacturing agility, and regulatory consistency. Which of these are currently the biggest constraints to ASEAN’s growth?

Cytiva的全球生物制药指数突显了在人才、生产敏捷性和监管一致性等领域的差距。其中哪些是目前对东盟增长最大的制约因素？

High capital intensity, long validation timelines, and the need for mature quality systems continue to pose significant barriers- particularly for small and mid-sized manufacturers. The Index shows that ASEAN’s constraints mirror global pressures, with persistent talent shortages across R&D and translational ecosystem, spanning both traditional biologics and advanced modalities.

高资本密集度、漫长的验证周期以及对成熟质量系统的需要，继续构成显著的障碍——尤其是对中小型制造商而言。该指数显示，东盟的限制反映了全球压力，在研发和转化生态系统中，传统生物制品和先进模式都存在持续的人才短缺问题。

Globally, 38% of biopharma executives report severe shortages in specialist skills for areas such as cell and gene therapy and mRNA, alongside continued gaps in manufacturing (27%), digital (29%), and sustainability (34%) capabilities - all of which are essential for scaling next-generation biomanufacturing. .

全球范围内，38%的生物制药业高管表示，在细胞和基因治疗以及mRNA等领域严重缺乏专业技能，同时在生产（27%）、数字化（29%）和可持续发展（34%）能力方面仍然存在缺口——而这些能力对于扩大下一代生物制造规模都至关重要。

Regulatory inconsistency is another major friction point. Many executives cite unpredictable policy environments and regulatory processes that are not yet fit for advancing new therapies. While manufacturing capacity across the region is expanding, the Index makes clear that agility - rapid scale-up, quality, and standardization - remains a limiting factor.

监管不一致是另一个主要摩擦点。许多高管指出，政策环境不可预测，监管流程尚不适合推进新疗法。尽管整个地区的生产能力正在扩大，但指数明确显示，敏捷性——快速扩展、质量和标准化——仍然是一个限制因素。

Challenges are deeply interconnected and must be addressed together. Globally, we are also seeing a growing emphasis on national strategies focused on self-sufficiency and risk mitigation, as reflected in markets such as the UK, China, the United States, and India. The fastest progress occurs when governments, academia, biopharma innovators, technology transfer partners, and end manufacturers work together to align incentives, share data, and scale solutions that are fit for local market / country needs. .

挑战是深度互联的，必须共同应对。在全球范围内，我们还看到各国越来越重视以自力更生和风险缓解为重点的国家战略，这在英国、中国、美国和印度等市场中得到了体现。当政府、学术界、生物制药创新者、技术转让合作伙伴和最终制造商共同努力，协调激励措施、共享数据并规模化适合本地市场/国家需求的解决方案时，进展最为迅速。

Within ASEAN, regulatory systems play a pivotal enabling role. While important regional frameworks such as the ASEAN Common Technical Dossier (ACTD) and ASEAN Common Technical Requirements (ACTR) are in place, implementation remains uneven. Member states differ in their depth of ICH guideline adoption, use of reliance mechanism, post.

在东盟内部，监管体系发挥着关键的推动作用。尽管已经建立了重要的区域框架，如东盟通用技术文件（ACTD）和东盟通用技术要求（ACTR），但实施情况仍然参差不齐。各成员国在采用ICH指南的深度、依赖机制的使用以及后续方面存在差异。

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approval change management, and lifecycle oversight, resulting in duplicative submissions and added compliance burdens. At the same time, ongoing PIC/S expansion, WHO maturity benchmarking, and broader acceptance of reliance mechanisms are steadily improving regulatory predictability and supporting deeper integration of ASEAN manufacturing into global supply chains..

审批变更管理和生命周期监督，导致重复提交和合规负担增加。同时，PIC/S的持续扩展、WHO成熟度基准评估以及对依赖机制更广泛的接受正在稳步提高监管的可预测性，并支持东盟制造业更深入地融入全球供应链。

To what extent will local manufacturing capacity determine whether ASEAN can move from being a high-demand market to a true biopharma production hub?

本地生产能力在多大程度上决定东盟能否从高需求市场转变为真正的生物医药生产中心？

According to Cytiva’s Global biopharma Index, 56% of biopharma leaders agree that domestic manufacturing of biologics is set to increase dramatically over the next three years, up from 50% who said this in 2023. Local manufacturing will be critical for ASEAN’s evolution; however, there is an important distinction between capacity and agility. .

根据Cytiva全球生物制药指数，56%的生物制药行业领袖认为，未来三年内生物制品的本土制造将大幅增加，高于2023年持此观点的50%。本地制造对东盟的演变至关重要；然而，产能和敏捷性之间存在重要区别。

While capacity is increasing, many organizations still struggle to scale production in a timely manner. The Index shows that around one

虽然产能正在增加，但许多组织仍然难以及时扩大生产。指数显示，大约有三分之一的组织在努力应对这一挑战。

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third of biopharma companies would be slow to ramp up manufacturing for advanced modalities such as mRNA and cell and gene therapies. At the same time, the report points to a shift away from cost-driven manufacturing toward a stronger emphasis on quality, reliability, and regulatory readiness. ASEAN’s opportunity lies in building flexible, digitally enabled manufacturing models, supported by skilled talent and robust partner networks, including CDMOs.

三分之一的生物制药公司在提升如mRNA、细胞和基因疗法等先进模式的生产方面进展缓慢。与此同时，报告指出，制造业正从成本驱动型转向更加注重质量、可靠性和法规准备度。东盟的机会在于建立灵活的、数字化赋能的制造模式，并依靠熟练的人才和强大的合作伙伴网络（包括CDMO）来提供支持。

It is this combination, rather than capacity alone, that will determine whether the region can transition into a sustainable and globally competitive biopharma production hub. .

正是这种组合，而不是单一的能力，将决定该地区能否转型为一个可持续且具有全球竞争力的生物制药生产中心。

As the region grows, how can ASEAN countries ensure that innovation, particularly biologics and advanced therapies, remains accessible and affordable?

随着该地区的发展，东盟国家如何确保创新，特别是生物制品和先进疗法，仍然可及且负担得起？

Access challenges are closely tied to ecosystem efficiency. To address this, it is useful to look at innovation and manufacturing separately.

获取挑战与生态系统的效率密切相关。为了解决这个问题，分别看待创新和制造是有用的。

On the innovation side, to accelerate bringing therapy to market, we need to establish translational research centers with two clear objectives: first, to validate clinical assets that need technology transfer from other markets or academic centers; and second, to build local capability by outsourcing the process scalability to experienced solution providers like Cytiva and learning from them for subsequent clinical assets.  .

在创新方面，为了加速将治疗方案推向市场，我们需要建立转化研究中心，该中心有着两个明确的目标：一是验证那些需要从其他市场或学术中心进行技术转移的临床资产；二是通过将流程可扩展性外包给像Cytiva这样的经验丰富的解决方案提供商来构建本地能力，并向他们学习以应用于后续的临床资产。

From a manufacturing perspective, many companies in emerging markets such as Thailand, Indonesia, and Vietnam typically begin by importing drug substance and conducting fill-finish locally as a first step, before venturing into drug substance manufacturing. As healthcare access expands across the region, the demand for biosimilars is increasing significantly.

从制造的角度来看，泰国、印尼和越南等新兴市场的许多公司通常会先从进口药用物质并在当地进行灌装作为第一步，之后再涉足药用物质的生产。随着该地区医疗可及性的扩大，对生物仿制药的需求正在显著增加。

To meet this, companies will need to work closely with technology.

为了实现这一点，企业需要与技术紧密合作。

transfer partners to commence drug

转移合作伙伴以开始药物

substance manufacturing, which also plays an important role in talent development.

物质制造，这在人才培养方面也发挥着重要作用。

Ultimately, when approval pathways are predictable and production systems are resilient, innovation can reach patients faster and at more sustainable cost. In this sense, access is not separate from growth; it is a direct outcome of how effectively the ecosystem functions.

最终，当审批路径可预测且生产系统具有弹性时，创新可以更快地惠及患者，并且成本更加可持续。从这个意义上说，获取与增长并非彼此独立；它是生态系统运行效率的直接结果。

Looking ahead, what are the top one or two priorities that will determine whether ASEAN can fully realize its biopharma growth potential over the next 3–5 years?

展望未来，决定东盟是否能在未来3到5年内充分实现其生物制药增长潜力的首要一两个优先事项是什么？

Two priorities stand out for ASEAN over the next 3-5 years. The first is talent. Access to specialized skills remains one of the weakest pillars globally, and companies that perform well on talent acquisition and retention are more than seven times as likely to outperform commercially. This makes the need for national strategies focused on self-reliance and sufficiency through talent development, a top priority across the region. .

未来3至5年，东盟有两个优先事项尤为突出。首先是人才。获取专业技能仍然是全球最薄弱的支柱之一，而在人才招聘和留用方面表现良好的公司，其商业表现优异的可能性要高出七倍以上。这使得通过人才培养实现自力更生和自给自足的国家战略成为整个地区的首要任务。

The second priority is regulatory coherence. The Index highlights that policy inconsistency and legacy approval frameworks are increasingly misaligned with the pace of innovation, particularly for advanced therapies. Across ASEAN, regulators are strengthening harmonization through the ASEAN Pharmaceutical Regulatory Policy (APRP) and reliance mechanisms, moving from WHO Good Regulatory Practices toward deeper PIC/S and ICH alignment, albeit at differing paces. .

第二个重点是监管一致性。指数强调，政策的不一致性和过时的审批框架与创新的步伐日益脱节，尤其是在先进疗法方面。在东盟地区，监管机构正通过东盟药品监管政策（APRP）和依赖机制加强协调，从世界卫生组织的良好监管实践朝着更深层次的PIC/S和ICH对齐迈进，尽管步伐不尽相同。

Over the next three to five years, ASEAN’s ability to build skilled workforces and establish more predictable, innovation-ready regulatory environments will be decisive in determining long-term growth outcomes.

在未来三到五年内，东盟建立熟练劳动力队伍和设立更可预测、准备创新的监管环境的能力，将对决定长期增长结果起着关键作用。

ASEAN’s biopharma growth will likely depend on collaboration. What types of partnerships, whether public-private, regional, or global, are most critical to accelerate growth in this region?

东盟的生物制药增长很可能取决于合作。什么样的伙伴关系，无论是公私合作、区域合作还是全球合作，对加速该地区的增长最为关键？

The Index consistently shows that strong biopharma ecosystems are built on collaboration. Yet collaboration remains uneven. The Index shows that collaboration is a challenge across many markets, with many executives continuing to report difficulty finding high-quality partners across CROs, CDMOs, technology transfer, academia, and government institutions. .

指数始终表明，强大的生物制药生态系统是建立在协作基础上的。然而，协作仍然不平衡。指数显示，在许多市场中，协作是一个挑战，许多高管报告称，在CRO、CDMO、技术转让、学术界和政府机构等领域，仍然难以找到高质量的合作伙伴。

For ASEAN, partnerships are therefore essential to closing capability gaps quickly and sustainably. Governments are increasingly recognizing biomanufacturing as a strategic health and economic infrastructure, driving targeted incentives, public-private partnerships, and localization efforts. Public-private partnerships can also play a critical role in supporting workforce development and regulatory modernization, while manufacturing and CDMO partnerships help improve agility, quality, and speed to market.

因此，对东盟而言，伙伴关系对于迅速且可持续地缩小能力差距至关重要。各国政府日益将生物制造视为一项战略性的健康和经济基础设施，推动有针对性的激励措施、公私合作伙伴关系以及本地化努力。公私合作伙伴关系还可以在支持劳动力发展和监管现代化方面发挥关键作用，而制造和合同开发与生产组织（CDMO）的伙伴关系则有助于提高敏捷性、质量和上市速度。

Importantly, collaboration is not optional - it is a practical mechanism for strengthening ecosystem pillars and enabling countries and companies to scale innovation more effectively than they could on their own. With a population of around 700 million, ASEAN must remain focused on expanding therapeutic access.

重要的是，合作不是可选项——它是一种加强生态系统支柱的实用机制，使各国和各公司能够比独自行动更有效地扩大创新规模。东盟拥有大约7亿人口，必须继续专注于扩大治疗的可及性。

In this context and the continued evolution and approval of biosimilars, strong partnerships will be central to improving affordability and patient impact across the region..

在这种情况下，随着生物仿制药的不断演变和批准，强大的合作伙伴关系将是在整个地区提高可负担性和对患者的影响的核心。