Novotech | Top Analytical Services Company 2022
Pharma Tech Outlook

Pharma Tech Outlook

Novotech
Providing Comprehensive Clinical Development Services

Novotech: Providing Comprehensive Clinical Development Services

Andy Liu, General Manager, NovotechAndy Liu, General Manager
Since establishing its first bioanalytical laboratory in Taiwan in 1997, Novotech has been at the forefront of assisting customers in every stage of their molecule development. The company has acquired three additional bioanalytical laboratories, in Xuzhou, Jiangsu Province, Shanghai, in China and Seoul, South Korea. They also operate a central laboratory, which was established in Taiwan in 2002 and is accredited by The College of American Pathologists.

Novotech provides clinical development services across all clinical trial phases and therapeutic areas. The company’s laboratory solutions span small and large molecule clinical sample analysis, biostorage, biologistics, and kit supply.

“We have a group of dedicated employees with a wide range of capabilities—from method development to data analysis-for customers from a clinical and registration perspective,” says Andy Liu, General Manager, China at Novotech. “As a global lab CRO, we have been operating according to the “one lab” standard, which is more conducive to test consistency and repeatability.”

Liu has extensive operational experience in the Asian CRO market. Prior to joining Novotech Health Holdings, he was the General Manager of Covance Central Laboratory (Asia Pacific), managing a multi-functional team of approximately 500 employees across multiple regions. This experience allows him to instill a global perspective into every Novotech project.

For Novotech, quality assurance and control are the basis of all lab testing. The company’s laboratories are inspected by multiple global regulatory authorities, including the FDA. More importantly, Novotech’s lab successfully passed the inspection of the NMPA ADC qualification in 2021. Its laboratory information management system is access-controlled with high-security systems and a complete audit trail to ensure holistic data security. Novotech has also obtained several other target ADC MRCT projects. They can successfully handle bio-A of mAb, BsAbs, ADC, CGT, and different drug modalities in the PPC lab.

As a global company, Novotech is a great place to build a career. They are very focused on providing a motivating work environment with an inclusive culture, flexible workplace, and very high levels of transparency. All these factors have earned Novotech the trust of a large number of customers.


We have a group of dedicated employees with a wide range of capabilities—from method development to data analysis-for customers from a clinical and registration perspective

What propels Novotech forward even more is the company’s global perspective on the progress of drug development in different markets. They regularly work with clinical CRO colleagues, customers, and other personnel and researchers from different verticals to design effective solutions.

“As a clinical CRO company with full-service capability, we are focused on global biotech as well as global MRCT strategies for China mainland and abroad customers,” states Liu.

With a comprehensive clinical development services portfolio, Novotech will continue to invest and develop its lab capabilities across the region to serve global clients in the future.

Novotech News

Novotech Awarded Cell & Gene Therapy CRO Excellence 2023

SINGAPORE - Novotech, the leading Asia Pacific centred biotech CRO with global execution capabilities has just been awarded for the second consecutive year the Best CRO for Cell & Gene Therapy 2023 at the Asia Pacific Cell & Gene Therapy Excellence Awards.

Novotech’s Vice President, Clinical Services Dr. Yooni Kim accepted the award at the 7th Cell & Gene Therapy World Asia conference last week in Singapore.

Novotech is also the recipient of the Best CRO for Cell & Gene Therapy2022 award.

Accepting the award, Dr. Kim thanked the organizers IMAPAC and stated “Novotech is proud to be recognised as an exceptional cell & gene therapy (CGT) CRO leader that facilitates rapid advancement in these new therapies.”

“One of the biggest challenges in CGT trials is managing regulatory approvals, especially for multi-country studies. This is where Novotech excels. With our considerable experience in the Asia Pacific since 1997, and in recent years in the US and Europe, we navigate the complexities of regulatory processes, ensuring seamless progress for our clients,” she remarked.

Dr. Kim also indicated the success of CGT trials also hinges on patient acceptance and understanding cultural nuances. “This means that a patient centric approach in carer engagement is vital for success. Novotech is committed to fostering this engagement throughout the entire clinical trial process.”

She remarked “according to our latest CGT clinical trial landscape report the global CGT market is projected to hit $93.78 billion by 2030 and FDA approvals for gene therapy in H2 2022 surpassed the combined total for the previous five years.”

Download Recent CGT Report here

“Asia Pacific is playing a significant role in the global CGT trials growth with an increase in percentage share from 41% in 2018 to 48% in 2022, demonstrating the region’s commitment to cutting-edge medical research. North America and Europe together had 54% in 2018 but fell to 47% in 2022,” she commented.

Dr. Kim noted mainland China and the United States, each with over 600 trials, were the leading locations in CGT trials, while over 450 CGT trials were initiated in European countries.

“From 2018-2022 the APAC region’s single country CGT trials share was 90%, North America was 69% and Europe was 35%.”

According to a recent report, China played a significant role in the APAC region, representing approximately 75% of the market share. Japan, South Korea, Taiwan, and Australia also made substantial contributions, accounting for 9%, 8%, 3%, and 2%, respectively. Other locations within the APAC region, such as India, Singapore, Malaysia, Hong Kong, New Zealand, and Thailand, collectively contributed 3% to the share of single-country CGT trials.

Novotech boasts a workforce of over 3,000 employees spread across 25 different geographical areas, with 34 office locations in places like Greater China, South Korea, Australia, New Zealand, the US, and Europe. The company offers a comprehensive range of services, spanning from early to late-phase clinical trials, and has a strong presence in the Asia Pacific region, known for its exceptional track record in delivering high-quality expedited clinical trials.

Novotech has earned recognition for its outstanding contributions to the industry, receiving prestigious awards such as the CRO Leadership Award 2023 and the Best CRO for Cell & Gene Therapy awards in 2022 and 2023. Furthermore, the company was honored with the Asia-Pacific Contract Research Organization Company of the Year Award. Its commitment to collaboration is evident through the 50 Leading Site Partnership agreements it has entered into over the past three years.

Novotech Publishes New Reports on Dyslipidaemia and Non-Small Cell Lung Cancer Global Clinical Trial Landscape

Boston, USA - Novotech, the leading Asia Pacific centred biotech CRO with global execution capabilities, today released the latest 2023 global clinical trial landscape reports on dyslipidaemia and non-small cell lung cancer (NSCLC).

The Novotech research analyst team offers these expert reports monthly at no cost.

These reports provide up-to-date information on global clinical trial activity, shedding

light on the regions that are witnessing the highest trial numbers and the reasons driving these trends. It also addresses the challenges confronting biotech companies in these specific therapeutic domains and the future directions in therapy and investment trends.

The expert report titled Dyslipidaemia - Global Clinical Trial Landscape found that since 2018, the biopharma industry has initiated over 500 dyslipidaemia clinical trials worldwide, with the majority of them occurring in the Asia-Pacific region.

Dyslipidaemia, marked by abnormal blood lipids, significantly increases ischemic heart disease risk. Over the past three decades, global dyslipidaemia rates have surged, emphasizing a pressing public health concern.

The report analysed global trial data and found:

• APAC contributed >65% of dyslipidaemia trials, notably driven by Mainland China and South Korea

• In the West, North America and Europe have also played crucial roles, conducting nearly 30% of the trials, with the US and Canada contributing 69% and 31% of trials respectively.

• In Europe, the UK, the Netherlands, and Poland stand out as the leaders in hosting dyslipidaemia trials, demonstrating the region’s dedication and advancement in this field.

• APAC has not only demonstrated considerably shorter recruitment durations but has also shown notably faster patient recruitment rates.

The report also referenced 2022 prevalence data provided by GlobalData, revealing that China and India have the highest incidence of dyslipidaemia among Asian regions. In the Asia Pacific region, Japan follows closely with more than 44 million cases, with South Korea and Australia also showing substantial numbers. In the Western countries, the United States has a significant burden with over 130 million cases, while the EU5 countries, including Germany, Spain, Italy, France, and the United Kingdom, collectively account for more than 110 million cases of dyslipidaemia.

Top 10 Analytical Services Companies - 2022

Company
Novotech

Management
Andy Liu, General Manager

Description
Since establishing its first bioanalytical laboratory in Taiwan in 1997, Novotech has been at the forefront of assisting customers in every stage of their molecule development. The company has acquired three additional bioanalytical laboratories, in Xuzhou, Jiangsu Province, Shanghai, in China and Seoul, South Korea.