As outlined in Cytiva’s 2023 Global Biopharma Resilience Index, economies such as Singapore, South Korea, Japan and Australia, are able to provide a whole-of-nation support to the cause by putting in place a favorable ecosystem for biotechs to set up, develop therapies and scale up manufacturing. Their contributions have made Asia Pacific the second largest region for Advanced Therapy Medicinal Product (ATMP) trials, surpassing Europe. Most other countries within the region, are at an earlier developmental stage in their journey to nurture biotech innovation – but that doesn’t mean there aren’t bright spots in the region.

Just this year, in Thailand, the research and development of cell and gene therapies, such as CAR-T cell therapies, has recently gained visibility. In late April 2023, a multi-stakeholder effort involving the Thailand Center of Excellence for Life Sciences (TCELS), the Ministry of Higher Education, Science, Research, and Innovation, the Federation of Thai Industries (FTI), the Board of Trade of Thailand, and the Office of Small and Medium Enterprises Promotion (OSMEP), have announced a combined effort to elevate the life science industry to be one of the country’s top 10 growth pillars and make Thailand a high-value medical and health hub.

In Indonesia, the pandemic catalyzed the impetus for the government to provide a clear direction for the industry while attracting stable and consistent investments. Even in the post-pandemic era, domestic and overseas funds are still actively pouring into new initiatives on vaccines, plasma and biosimilars. 

In Vietnam, there’s a strong willingness among the local pharma and healthcare providers to move forward in biologics and new modalities of therapies. However, there’s a gap in terms of clear policies and legal framework that’s hindering Vietnam’s biopharma industry from taking off.

In the Philippines, the biopharma industry is still at a nascent stage. There’s a need for more support in three areas - government policy and regulation, talent pool as well as R&D ecosystem - to attract investment into the biopharma industry. However, the industry in the Philippines, just like Vietnam, shows great potential. Just last month, there were multistakeholder talks to discuss the goal of making the Philippines the centre of excellence in clinical trials.

Challenges in creating an “Asia Champion”

The development of cell therapies as well as mRNA vaccines and therapeutics are still fraught with high complexity in supply chains, and high risks of failure. Despite their clinical successes, there are major challenges to the widespread adoption of cell therapies and mRNA therapeutics. For cell therapies, high manufacturing costs and complex logistics and supply chains are making widespread adoption difficult. Hence, to appreciate the bright spots that we see in Asia’s journey to become a global biotech hub, we can look at the funding, supply chain, scalability and talent challenges biotechs face and must overcome to become a success story or “Asia Champion”.

Funding challenges

The power of biotech startups has proven to be enormous by BioNTech, during the pandemic, when mRNA vaccines saved lives around the world. Since then, the biotechnology industry and its investors have been searching eagerly for ‘the next BioNTech’.” Between 2019 and 2021, when $35 billion venture capital flooded into startups. However, we have seen the fever cooling down since 2022. Biotech startups need more flexible solutions to secure their cash flow and talent, which are keys to their surviving and thriving. 

Since 2018, Cytiva has provided flexible access to bioprocess development, technology verification, and opportunities to collaborate alongside industry experts and institutional investors to biotech startups’ to accelerate and advance their projects from molecule to market. This initiative is called BioChallenge, and it has expanded its impact across China, South Korea, Southeast Asia, and Australia and New Zealand. 

BioChallenge is also exploring and fostering cooperation among governments, industry associates and academia institutions to mitigate the talent, resources and scalability constraints faced by early-stage biotechs. In South Korea for example, BioChallenge engaged the Korean Ministry of Health and Welfare and the Ministry of Food and Drug Safety which then joined as co-sponsors. Two participants of the first season of BioChallenge, GI Innovation and Yuhan Corporation, have since gone on to sign a million USD deal to jointly develop and commercialise a treatment of allergic diseases. 

In this year’s Southeast Asia BioChallenge, two winners – Singapore-based BetaLife and Thailand-based BGF Plantrix emerged as winners. 

In China, BioChallenge goes one step further to bridge startups and investors. In 2022, we attracted over 110 submissions, and thousands of investors. As a result, the winner, Genhouse, received $14 million in funding to develop a small molecule anti-tumor drug. 

Supply chain complexities 

Small–molecule medicines, including aspirin and other long–standing, familiar drugs you might find in your home, are easier to commoditize and offshore. Cell and gene therapy products are significantly more complex to manufacture and need to be produced close to the patient. Research from the 2023 Global Biopharma Resilience Index shows that, currently, most countries cannot meet this requirement. 

This creates a complication around the coordinating of transportation of materials that require constant freezing – including custom-made DNA templates. mRNA molecules need to be more stable. Currently, they have logistics and storage challenges as they can require down to –20⁰C or even –70⁰C storage conditions. Cytiva supports drug developers working on mRNA vaccines and therapeutics from idea to injection with our FlexFactory solutions, as well as our robotic aseptic filling workcells.

Scalability challenges

If we were to look back at an instance of success about a decade ago, Cytiva was involved in the first successful pediatric trial of CAR-T therapy in 2012. During that time, we foresaw challenges and the need for simplification and automation. Manufacturing technologies have since matured to allow for the reproducible manufacturing of cell therapies and Cytiva provides a range of flexible solutions that blend platforms and facilities with services and expertise to roll out this next generation of medicines.

Data from the 2023 Global Biopharma Resilience Index showed that manufacturing of cell and gene therapies remains plagued by a lack of streamlining and limited standardization. Many new therapies come from start-ups or academic labs that are innovative but lack the ability to scale up. 

A success story has emerged in Thailand recently, which brings our attention to what’s possible when start-ups and bigger companies work together. With Cytiva’s FlexFactory biomanufacturing platform, Genepeutic Bio, a leader in Thailand’s life sciences sector, has established the first GMP-certified cell therapy manufacturing facility in Thailand. Genepeutic Bio aims to bring chimeric antigen receptor-T (CAR T) cell therapies to a few hundred patients with relapsed and refractory blood cancers such as acute lymphoid leukemia (ALL) in Thailand and Southeast Asia by 2025. The company has also applied for Thai Food and Drug Administration (FDA) approval for this treatment and hopes to receive approval by end of 2024.

Talent shortage

The shortage of talent remains one of the factors holding back Asia’s potential to become a biotech hub – with some countries facing stiffer competition than others. The biopharma industry has long grappled with global competition for R&D talent, highly qualified biologics manufacturing talent who can work in GMP-certified facilities. Today, this is exacerbated by the need for talent who can support the digitalization of processes in the industry. 

On macro level, the hunt for talent has now intensified across Asia. Governments across Asia Pacific are now proactively implementing strategies to attract and retain talent, particularly in the biotech sector. In Singapore, a country that had scored highly on talent in the Resilience Index, has launched a one-stop resource gateway - Deep Tech Talent Central (DTTC) - to address talent shortages in emerging technology sectors to remain competitive. In India, the Department of Biotechnology has set up the National Biopharma Mission and the National Biotechnology Development Strategy to nurture the biotech ecosystem and make India a global biomanufacturing hub through a strong focus on talent and R&D development. Similarly, Australia has established the Global Business and Talent Attraction Taskforce, along with the Researcher Exchange and Development within Industry (REDI) Fellowship Program. These efforts are geared towards bridging skill gaps in advanced manufacturing, and life sciences.

At Cytiva, we do our part to meet biotech startups’ demands through talent training and development system, which is taking a high stake in their R&D budget. Compared with the well-established institutions in big biopharma companies, startups are struggling to compete for mature talents, and to train the fresh hands. 

Cytiva has established the Fast Trak Education and Training Programme, available at six centres globally – three of which are based in Asia Pacific region -- Korea, China, and India. For example, both Songdo and Shanghai centres have the capability to train more than 300 people every year for the biotechnology industry. The India centre collaborates with Bangalore BioInnovation Centre to set up a world class incubation centre to provide bioprocessing training programmes to support the startup ecosystem in India.

To nurture talent in ASEAN, Cytiva established the Experience Learning Lab (CELL) in Singapore in 2021. CELL, a learning facility that provides education and training on the latest bioprocessing and production techniques to develop advanced therapeutics, has delivered over 70 training sessions to tertiary academic and research institutes and 30 training sessions at the Centre of Excellence in Nanyang Polytechnic.

This year, Cytiva established a Customer Experience Center in Pune, which will conduct immersive trainings and technology demonstrations needed to accelerate the development of novel therapeutics and help India deliver on its Aatmanirbhar Bharat vision and mission.

We must continue the kind of collaboration in the R&D ecosystem that has brought us safe and effective vaccines in the most recent pandemic. With the reset of the biotech industry after the pandemic, emerging biotech startups developing innovative, high-impact therapeutics for patients must also be supported. And this should be the joint responsibility of industry, governments, think tanks and academia institutions. 

Sustaining the momentum

The 2023 Global Biopharma Resilience Index has found that regions that achieve cohesive domestic policies and regulatory processes with an eye to international collaboration will continue to attract investment in biopharma development. Our data shows the perceived importance of both public funds and supportive, firmly enforced policy, as well as regulatory process efficiencies will help translational and early-stage firms appeal to venture partners with access to the private capital needed at clinical-stage development. In particular, in a macroeconomic climate where venture capital may be more limited and many larger pharma firms are slimming their pipelines, both policy and regulation must come together to enable translational and clinical development of the next generation of medical technologies.

We acknowledge that governments play a critical role in laying down the policies and framework to nurture the biopharma ecosystem and put Asia Pacific in good stead to become a global biotech hub. These are evidenced in countries like Singapore, South Korea, Japan and Australia. For countries like Thailand, the Philippines, and Indonesia, for example, it will take time for their efforts to bear fruit and to realize a more research and innovation-driven biopharma industry. There’s a need to bridge the gap between emerging and developed economies. Strong areas among the cohort of less-developed countries — such as India’s efficient supply chain and China’s manufacturing agility — should be studied by other developing countries for ways in which they could emulate these successes and thereby accelerate their own progress.

Fast Trak™ and FlexFactory™ are trademarks of Global Life Sciences Solutions USA LLC or an affiliate doing business as Cytiva.