Many of you know my passion for drug, device, and diagnostic development and my commitment to the patient experience and patient diversity to ensure efficacy and safety for everyone. With that said, I wanted to share my personal experience as I just returned from my first (but not last) trip to Japan where I met with colleagues from Japan, China, Taiwan, Korea, and Singapore. Working globally with biopharma companies over the years, I have met numerous talented people from many cultural backgrounds. I was particularly impressed with all of the Linical colleagues I met along my journey to Japan, both personally and professionally.
In today’s blog I thought I would share some notes from my experience, with input from my respective country representatives and overall statistics of what is happening throughout Asia. While, Linical is a global CRO, I am going to focus on key countries including Japan, China, Korea, Taiwan, and Singapore. Linical has a strong presence in these countries based on their local expertise, commitment to quality, and successful project delivery.
In 2022, the Asia clinical trial market is estimated reach over $4 Billion USD and by 2027 estimated to be $6.3 Billion USD. Between 2017 and 2025, the CAGR growth rate of Asia is 12%. In 2020, Asia has a 45.3% share of global clinical trial activity and is not only growing rapidly but is a highly sought-after area for key therapeutic areas like, Oncology, Neurology, Infectious Disease, Rare Disease and Metabolic.
Asia has the ICH and GCP trained personnel and necessary experience to conduct global trials. The quality is extremely good with oversight and robust regulations that support and promote successful EMEA and FDA submissions. My expert country heads at Linical have shared many benefits in outsourcing clinical trials to Asia including countries like Japan, China, Korea, Taiwan, and Singapore:
Japan
- World’s 4th largest pharmaceutical market
- Patient access
- Quality sites
- Quality data
- Extensive therapeutic area experience
- Regulatory & licensing support
China
- Large treatment-naïve patient populations
- Quality sites
- Data collected is accepted at the US FDA (Food and Drug Administration) and EMA (European Medicines Agency) for regulatory submissions
- Experienced KOLs
- High international compliance to standards
- Cost-effective
South Korea
- A global top 10 country for the number of clinical trials conducted
- Patient availability - Major university hospitals are generally larger than 1,000 beds and receive as many as 10,000 or more outpatients a day
- Global study experienced investigators & staffs - Korean investigators regularly receive intensive GCP training in these major hospitals nationwide
- Speed - 30 working days needed from MFDS-CTA application to approval and 3 weeks (on average), IRB Submission to approval
- Diverse therapeutic areas
- Cost effective
- Quality
Taiwan
- Dense populations
- Universal healthcare system
- Cost effective
- Strong clinical trial growth market
- Ability for fast study start-up
- Diverse therapeutic areas
Singapore
- Good quality
- Diverse therapeutic area
- High effectiveness
- Experience in conduct phase 1 study
- Cover regional area
Linical is a financially stable, global CRO capable of delivering one-stop services for small or large-scale projects, covering all key markets in Asia-Pacific as well as The Americas, and Europe. Services like project management, clinical monitoring, pharmacovigilance, regulatory, including IDDB and PMDA expertise, medical writing, biostatistics, and data management are carried out throughout our global locations. At Linical, we have created a company culture of quality people that love what they do and are proud to work for a caring and impactful organization.
Author:
Clareece West
Chief Commercial Officer - Linical