BIO 2024 Showcases the Emergence of Taiwan’s Biotech CDMO Market

BIO International Convention (BIO 2024) is currently underway in San Diego, California from June 3 to 6. Following the successful experience of previous editions, the Biotechnology and Biotechnology and Pharmaceutical Industries Promotion Office (BPIPO) continues to organize the Taiwan delegation and set up the Taiwan Pavilion to showcase Taiwan’s cutting-edge technologies and products in the international arena, and to strive for cross-border technological or commercial partnerships.

The global biopharma industry has been witnessing explosive growth in the 21st century and business models have become highly diversified and specialized. As a result, “contract development and manufacturing organizations (CDMO)”, which involve outsourcing drug development and manufacturing to other companies, have become increasingly prevalent. According to a report by Grand View Research, the global pharmaceutical CDMO market is estimated to reach $155.5 billion in 2024 and grow to $235.5 billion in 2030, with a compound annual growth rate of about 7.2%.

Taiwan’s biotech industry has also embraced the CDMO boom in recent years, investing in developing CDMO facilities and pursuing R&D and manufacturing orders from domestic and global pharma companies. The Taiwanese government is also taking the lead in investing in related enterprises and including CDMO in its biotech policies. In the Taiwan Pavilion at BIO 2024, there will be a CDMO Zone in the pavilion featuring 10 representative companies in the three major areas of “small molecule drugs”, “biologics”, and “novel biopharma (including nucleic acid drugs as well as cell and gene therapies)” (refer to the table below).

Related article: BIO 2024 Sets the Stage for Taiwan’s Biotech Industry to Shine

Bora Leads Taiwan’s CDMO Market with Proactive M&A Activities

As the leading biotech CDMO company in Taiwan, Bora Group has acquired 8 domestic and international biotech companies since 2013 to strengthen its CDMO business, including the most recent $210 million purchase of Upsher-Smith Laboratories in January 2024 which marked Bora’s entry into the U.S. market. 

In BIO 2024, Bora Pharmaceuticals and Bora Biologics welcome pharma developers and manufacturers to visit their booths at the Taiwan Pavilion and the Bioprocessing Zone (#1817 and #5651) to learn more about their global CDMO services, including clinical and commercial manufacturing, formulation development, analytical services, and so on.

Notably, Bora currently has 9 cGMP-compliant manufacturing facilities in Taiwan, the U.S., and Canada, with comprehensive chemical manufacturing and control (CMC) development and commercialization capabilities for small molecule drugs and biologics (including monoclonal antibodies, Fc fusion proteins, ADCs, etc.). Its pipelines cover small molecules, protein drugs, and generic drugs, and its products have reached over 100 markets worldwide. 

Related article: Bora Pharmaceutical Makes First U.S. Acquisition to Buy Upsher-Smith for $210 Million

KriSan Biotech Enters ADC CDMO Field and Aims to Serve Global Clients

KriSan Biotech is another biotech company that specializes in CDMO service among the exhibitors in BIO 2024 Taiwan Pavilion (Booth #1817). With multiple PIC/S GMP-compliant production lines and a strong team of experts, KriSan is capable of manufacturing a wide range of products such as complex small molecules, lipid nanoparticles (LNPs), peptides, and oligonucleotides. In addition, KriSan’s production line for antibody-drug conjugates (ADCs) commenced operation earlier this year. 

Leveraging its strategic partnerships established across the biopharma sector globally, KriSan has successfully delivered over 100 molecules, catering to the needs of more than 50 clients spanning regions including the U.S., Europe, Asia-Pacific, Australia, and Taiwan. Apart from process development, drug development and GMP manufacturing, KriSan’s CDMO services cover process optimization and scale-up, analytical method development, drug validation and stability testing, CMC document preparation, and regulatory consulting. Through its presence at BIO 2024, KriSan seeks opportunities to accelerate the drug development programs of potential clients worldwide.

Tanvex Expands CDMO Business with Taiwan and U.S. Facilities

With a strong focus on the development and production of biologics and biosimilars, Tanvex BioPharma has been establishing its presence in the CDMO market since 2022. Its Taiwan subsidiary has extensive experience in non-GMP pre-clinical pilot production development, while its U.S. branch has passed FDA factory inspections for its GMP process and cGMP drug manufacturing capability. Nowadays, Tanvex BioPharma USA can offer a full suite of CDMO services such as mammalian and microbial GMP manufacturing, drug substance optimization, formulation development and drug product testing. 

BIO 2024 is Tanvex’s first participation as an exhibitor at this largest global biotech event of the year (Booth #911). Under the brand “Tanvex CDMO”, the company aspires to showcase its one-stop CDMO solutions to international visitors. Henry Chen, Chairman of Tanvex Biopharma, pointed out that with Tanvex’s rich experience in developing cancer therapeutics and related antibody drugs, coupled with strategic partnerships in the U.S, Tanvex CDMO looks forward to serving its clients with a comprehensive service chain ranging from preclinical R&D, IND enabling steps, commercial mass production, to downstream packaging, amongst which, the popular ADC CDMO service is also included.

Furthermore, after BIO 2024, BPIPO and the Industrial Development Administration, MOEA will organize a corporate visit to Tanvex BioPharma’s facility in San Diego on June 7. The delegation expects the visit to help Taiwanese biopharma companies pursue global business opportunities in the R&D and production of biologics and biosimilars.

Taimed’s CDMO Operations Expect Growth with cGMP-compliant Facility

With a strong focus on developing and commercializing novel HIV therapies, Taimed Biologics also offers protein drug CDMO services to meet global demands. Equipped with cutting-edge equipment and technologies, Taimed’s cGMP-compliant facility in Zhubei City already passed FDA inspections in 2022 and 2023, having the ability to provide cost-effective and versatile services to global clients such as GMP manufacturing, upstream and downstream process development, analytical method development and validation, formulation development, and stability testing of monoclonal antibody drug substances. 

In BIO 2024, Taimed showcases its state-of-the-art monoclonal antibody (mAb) solutions that hold promise for transforming HIV therapies, including a commercialized product Trogarzo, a clinical-stage long-acting combination therapy, together with an innovative ADC therapy in development. Besides, located at booth #5643, Taimed welcomes potential clients and collaborators to visit and explore how Taimed can assist biopharma companies in bringing their antibody products from bench to market.

TBMC Partners with National Resilience to Compete in Global CDMO Markets

Taiwan Bio-Manufacturing Corporation (TBMC), through a joint effort by the Ministry of Economic Affairs (MOEA), Industrial Technology Research Institute (ITRI), and the Development Center for Biotechnology (DCB), was established in May 2023. TBMC’s first process development laboratory in Taipei Bioinnovation Park is expected to be operational in Q3 of 2024, while its GMP-compliant manufacturing facility in Zhubei is planned to begin operation by the end of 2026. In the future, TBMC will not only focus on mRNA vaccine production, but will also enter the fields of nucleic acid drugs, biologics, viral vectors, as well as cell and gene therapies. It will adopt the “TSMC model” to pursue development and manufacturing orders from biopharma companies around the world and aspires to provide comprehensive CDMO services to the global market.

Notably, in February 2024, TBMC entered a strategic alliance with National Resilience, a technology-focused biomanufacturing company. As part of the agreement, Resilience will license certain manufacturing technology platforms in biologics, cell and gene therapy, vaccines and nucleic acids. Besides, TBMC will receive support in designing and constructing cGMP-compliant facilities and process development laboratories for the joint venture, expediting the development and production of innovative medicines to meet global demands.

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Author

Richard Chau