Notable Players in the APAC Cell Therapy Manufacturing Space
- Key drivers such as fund and regulatory support from the government, improved market access and healthcare infrastructure and more are currently fueling growth in APAC’s cell therapy market.
- The enactment of the Act on the Safety and Support of Advanced Regenerative Medical Treatment and Medicine in August 2020, the increased market access can be expected to enhance clinical studies, approvals of regenerative medicine and drive further growth.
- Biotechs such as PT Biofarma, Kymia Pharma, Austrianova and more are coming onto the scene due to the untapped opportunities in this space.
- The Covid-19 pandemic and other viral infections have sought possible treatment with the use of cell therapies.
APAC’s cell therapy market has been forecasted to reach USD 2.9 billion by 2028 and expand at a CAGR of 14.9% from 2021 to 2028. This can be largely attributed to the regenerative medicine ecosystems that have been developing in countries like China, Japan, South Korea and Australia. Key drivers such as fund and regulatory support from the government, improved market access and healthcare infrastructure and more fuel this growth and capitalization on the untapped opportunities in the APAC cell therapy industry.
With companies such as SCM Life Sciences, Kolon Life Sciences, Medipost and more, at the helm of South Korea’s cell-based therapies, the country has seen significant development especially in stem cell treatments. In addition, with the enactment of the Act on the Safety and Support of Advanced Regenerative Medical Treatment and Medicine in August 2020, the increased market access can be expected to enhance clinical studies, approvals of regenerative medicine and drive further growth.
In China, an estimated 60 million people are suffering from genetic diseases, making China’s addressable patient population significant. Coupled with the rising affluence of those in Shanghai, Beijing, Guangzhou and Shenzhen, the regenerative medicine market in the country is lucrative.
In the rest of Asia, we see more biopharmaceutical companies expanding into the cell therapy space and new regenerative medicine-focused biopharmas popping up. In Indonesia, PT Biofarma, a sister company of PT Kalbe Farma, focuses on allogenic Umbilical Cord Mesenchymal Stem Cells (UCMSC) for osteoarthritis and it is the only product in clinical trials. It is under the review of a conditional approval from Indonesian FDA and in 2021, the company plans to move to Phase III clinical trials, which are to be performed in Japan. Meanwhile, Kymia Pharma, a part of the Indonesian government, manufactures cell therapies for hospitals and is seeking approval by the Indonesian FDA.
In Thailand, Austrianova focuses extensively on cell encapsulation technology and Genepeutic on end-to-end GMP certified manufacturing. Also, in 2020, KMUTT ATK (an automatic tissue culture facility) began its cleanroom construction.
In Singapore, the development of new modalities, such as stem cells, their derivatives and CAR T-cells for cell therapy, or gene therapy delivery by Adeno-associated virus (AAV) and virus-like particles, are considered growth drivers. Intending to establish itself as a regional manufacturing hub in this area, the government has earmarked $80 million to this sector.
In addition, the Covid-19 pandemic has opened doors to the possibility of cell therapies against the novel coronavirus. Singapore-based Duke-NUS medical school’s emerging infectious diseases research program demonstrated some success in the utility of these therapies in treating patients with COVID-19 infection. Similar research has been proposed for the use of T cells against chronic viral infections such as HIV and hepatitis B. This is expected to drive the market in Asian countries. Likewise, in April 2021, a team of researchers from Japan researched the use of induced pluripotent stem cells (iPS) to find drugs to effectively inhibit the coronavirus and other RNA viruses.
Bearing in mind the regulatory framework, market access, domestic clinical development activities, sales and marketing requirements, supply chain considerations and manufacturing infrastructure, the market for cell therapies in the APAC region could be promising for international regenerative medicine-focused biotechnology companies. There is a shift in Asia’s regulatory environment to harmonize their framework with that of the E.U. and USA. Doing so will make way for cross-country development and manufacturing.
This article is brought to you by IMAPAC’s market research team. For more on the details of the APAC Bioprocessing sector, check our Market Reports or Dashboards.