Biologics at Scale
Six pillars to build a competitive ecosystem
Surbhi Gupta, Principal, Healthcare & Lifesciences Growth Analytics, Frost & Sullivan
This article delineates the construction of a modern biologics ecosystem on a global scale and within the Asia-Pacific region by aligning six essential pillars: advanced manufacturing, agile and harmonised regulation, workforce development, innovation hubs, diversified funding, and public-private partnerships. It outlines practical strategies for scaling modalities from monoclonal antibodies to cell and gene therapies, while enhancing resilience, fostering innovation, and influencing future leadership in the industry.
Biologics – including monoclonal antibodies, vaccines, and advanced cell and gene therapies (CGT) – require an integrated innovation and production ecosystem. This ecosystem rests on six pillars: Manufacturing Infrastructure, Regulatory Environment, Talent and Training, Innovation Hubs, Funding s Investment, and Public-Private Partnerships. In recent years (2024–2025), global and Asia-Pacific leaders have accelerated efforts in each area. In this article we will examine how pharma executives, policymakers, investors, and academic leaders can collaboratively cultivate a robust biological ecosystem.
Manufacturing Infrastructure: Rapid Expansion and New Capacity
Robust, large-scale manufacturing is the foundation of a biologics ecosystem. The past two years have seen unprecedented expansion of global bioproduction capacity by both in- house facilities and CDMOs. For example, in 2024 Lonza agreed to acquire Genentech’s Vacaville (California) mammalian biologics plant (US$ 1.2 billion deal), adding ~330,000 liters of single-use bioreactor capacity. This will give Lonza one of the world’s largest biologics production campuses. Samsung Biologics (Korea) has also dramatically grown its Songdo campus: it is on track to finish a dedicated ADC (antibody-drug conjugate) facility by end-2024 and bring a fifth large plant online in April 2025 (adding 180 kL of additional capacity, bringing the total to 784 kL). Such moves signal a trend toward mega-factories and flexible platforms to meet surging global demand for innovative therapies.
In the Asia–Pacific region specifically, capacity is surging. Singapore’s Tuas Biomedical Park – already a global hub – continues to attract new investment. In early 2024 AbbVie broke ground on a US$223 million expansion of its Tuas site, adding 24,000 liters of biologics drug- substance capacity to serve its immunology and oncology pipelines. Novartis similarly committed US$256 million in March 2024 to expand its Singapore biopharmaceutical plant, deploying new automation for antibody production by early 2026. Also in Singapore, Pfizer opened a state-of-the-art API (active pharmaceutical ingredient) facility (2024) – an SGD 1 billion (≈US$743 million) extension covering 429,000 sq ft – to make small-molecule oncology, pain, and antibiotic APIs. This project (operational in 2024) is already producing commercial batches and supports 250 new high‑skill jobs. In May 2024 AstraZeneca announced plans to build its first-ever full-scale ADC manufacturing plant in Singapore (US$1.5 billion investment, targeted operational readiness by 2029). Meanwhile, China and India are rapidly upgrading biomanufacturing. In China, global CDMOs are expanding microbial biologics capacity: WuXi Biologics began construction in mid-2025 on a new 95,000 m² microbial drug substance/ drug product complex in Chengdu. The Chengdu site will feature a 15,000 L fermenter (80–110 batches/year) with expansion up to 60,000 L, and China’s first dual-chamber freeze-dryer enabling >10 million vials of fill/freeze product annually. In India’s Genome Valley cluster (Hyderabad), Dr. Reddy’s Aurigene (a CRDMO) opened a 70,000 sq ft biologics development facility in 2024. This laboratory and pilot plant are now fully operational for antibody process development and small-scale manufacture. These projects underscore a trend toward regional manufacturing hubs to improve supply resilience and serve local innovation pipelines.
Regulatory Environment: Speed, Convergence, and Digitalisation
A supportive regulatory system is critical for biologics. Since 2024 regulators in major markets have reformed pathways for faster approval of innovative therapies. In China, sweeping regulatory reforms have greatly accelerated review timelines for new drugs. For example, the National Medical Products Administration (NMPA) approved 24 innovative drugs in H1 2023 under the new regime (a record pace). Regulatory officials report that the average NDA-to-approval time has dropped dramatically compared to pre-2022 norms. Accelerated pathways are a key part of this push: China now has dedicated priority review routes for orphan and urgently needed drugs. Similarly, regulators across Asia (including India and South Korea) have introduced fast-track and priority-review programs for novel biologics and cell/gene therapies. Japan’s PMDA continues to emphasize its Sakigake designation (for breakthrough drugs), targeting review in just six months. These steps reduce time-to-market and encourage investment.
Regulatory convergence is another focus. Asian agencies are harmonising requirements within the region and with Western standards. The ASEAN Common Technical Dossier (ACTD) provides a unified registration format across Southeast Asia, simplifying multi- country filings. The “Access Consortium” (Australia, Canada, Singapore, Switzerland and the UK) formally works to align review requirements and share data on new drug applications. Such initiatives allow work-sharing or mutual recognition of dossiers, meaning a biologic approval in one country can enter others more easily. India too is updating its Clinical Trial Rules and GCP guidelines (effective 2025) to international norms, smoothing the way for multi-site trials.
Meanwhile, digital transformation is streamlining regulatory processes. Agencies implement modern e-submission and review platforms (eCTD and cloud-based portals). For instance, the Access Consortium is rolling out a shared digital workspace to allow joint reviews. On the ground, regulators are also providing guidance for new modalities: many have created specialized frameworks for regenerative medicines and advanced therapies.
Overall, regulatory regimes in 2024–2025 are faster and more aligned. Asia-Pacific countries have accelerated approval pathways (China’s drug review reform, Korea’s expedited routes, Japan’s Sakigake) and strengthened convergence initiatives (ASEAN ACTD, Access Consortium work-sharing). Combined with more digital processing, these changes improve predictability and encourage companies to file biologics locally.
Talent and Training: Building a Specialized Workforce
Biologics RCD and manufacturing demand highly skilled specialists (bioprocess engineers, cell culture scientists, QC/regulatory experts, etc.). Governments and industry worldwide are investing in workforce development to staff the growing ecosystem. In Asia–Pacific, universities are expanding biotech and bioprocessing curricula, often in partnership with companies. For example, Singapore and South Korea have launched programs linking students to internships in biomanufacturing firms. Local governments also sponsor specialized institutes and vocational training focused on biopharma.
Global organisations are stepping up as well. Notably, the WHO Biomanufacturing Workforce Training Initiative (launched in 2023) provides targeted training to low- and middle-income countries. Even established biotech hubs are formalising pipelines. In the US, for instance, the City of Boston launched the Life Sciences Workforce Development Initiative (2024), aiming to train and place 1,000 residents in life sciences roles by 2025. This involves partnerships between the city, community colleges, and biopharma employers. Across Asia, governments similarly offer scholarships, on-the-job training grants, and streamlined visas to attract biotech professionals.
Innovation Hubs: Biotech Clusters and Research Ecosystems
Breakthroughs in biologics often emerge from close-knit innovation clusters where companies, research institutes, hospitals and startups co-locate. Asia–Pacific governments are actively fostering such hubs to catalyse idea exchange and startup formation. China’s Shanghai Zhangjiang Science City (formerly Zhangjiang Hi-Tech Park) exemplifies this approach. Now covering ~95 km² (with plans to expand to 220 km² by 2025), Zhangjiang hosts a full spectrum life-sciences ecosystem. It is home to 400+ biopharma companies, numerous CROs and CDMOs, and leading research institutes (including ShanghaiTech University, CAS institutes, etc.). Seven of the world’s top ten pharma firms have Shanghai RCD centres there, and the cluster employs some 370,000 people. The Pudong government offers generous incentives (land leases, subsidies for talent, grants for labs), ensuring Zhangjiang attracts global and domestic firms.
Other Asian innovation parks are similarly emerging. India’s Genome Valley (Telangana) has long concentrated in biopharma RCD and manufacturing companies. The state government continues to upgrade it with wet labs, incubators and biomedical campuses. Singapore’s one-north and Tuas areas, as mentioned, cluster research facilities and manufacturing sites side by side. Biotech incubators (often co-funded by universities and government agencies) spring up to nurture startups – for example, enterprise incubators at NUS and A*Star in Singapore, or venture labs in Seoul and Hyderabad.
Funding Models and Public-Private Partnerships
Sustaining biologics development – from discovery through clinical trials and scale-up – demands vast investment. Accordingly, a mix of public and private financing is necessary. Governments in Asia-Pacific have greatly expanded biotech funding. China relies heavily on state-guided and sovereign funds to co-finance biotech ventures, alongside steep RCD tax incentives (e.g. 75%–100% super-deductions). India’s Biotechnology Industry Research Assistance Council (BIRAC) runs grant schemes (SBIRI, BIPP) that share costs with startups on high-risk projects. In 2024 the Indian government unveiled the BioE³ (Biotechnology for Economy, Environment and Employment) policy to invest in shared biomanufacturing infrastructure (such as biofoundry hubs) via public–private partnerships (PPP). The aim is to “empower institutions and industries” through co-funded pilot plants and tech platforms. While details are emerging, these initiatives are meant to crowd in private capital and reduce early-stage risk.
On the private side, large pharma and corporate venture arms continue to pour money into partnerships and acquisitions of biotech companies. For instance, many Chinese biotech’s have advanced thanks to licensing deals with multinational firms (providing upfront funding without equity). Some CDMOs now even offer “capacity for equity” deals, where a cash- strapped biotech receives manufacturing support in exchange for an ownership stake. Additionally, later-stage biotech’s increasingly tap public equity markets: Asia’s stock exchanges are seeing more biotech IPOs and SPACs as investor appetite rebounds post- pandemic.
PPPs bring these elements together. Well-structured PPPs – where government agencies, companies, and academic groups share funding and facilities – accelerate projects that no single party could handle alone. Examples include vaccine consortia (e.g. pandemic- response initiatives) and joint RCD centres. Such partnerships often accompany the funding models above (e.g. a state-funded pilot plant co-operated by a private CDMO).
Conclusion – Synergising Six Pillars for a Sustainable Biologics Future
Building a robust biologics ecosystem requires all six pillars to advance in concert. Recent developments (2024–2025) show it can be done with coordinated effort. For example, Singapore, South Korea, India and China have each launched biotech masterplans tying together new manufacturing sites, fast-track approvals, talent programs, cluster incentives and funding schemes. The synergy is self-reinforcing: new factory investments attract RCD projects; clear regulatory pathways encourage local trials and launches; trained scientists boost productivity and innovation; thriving clusters spawn startups; and diverse financing keeps the chain moving.
Surbhi Gupta is an Industry Principal at Frost & Sullivan with extensive experience in global pharmaceutical and biotech market research and consulting. She leads the Personalized Therapeutics program, focusing on next-generation modalities and precision medicine. Her expertise spans market analytics, forecasting, and competitive benchmarking, supporting strategic decision-making for global clients. Recognised as a trusted growth advisor, helping stakeholders navigate disruption, accelerate innovation, and capture transformative growth opportunities across the evolving biopharma landscape.
