CDMO – Completing Malaysia’s Biopharmaceutical Ecosystem

Contract Development and Manufacturing Organisation (CDMO) plays a central role in the production of medicines today.

CDMOs’ partnerships with pharmaceutical companies provide solutions through specialised services such as drug development, formulation, process optimisation, and manufacturing. These collaborations enable pharmaceutical companies to focus more on drug discovery and marketing, avoiding the need for substantial capital expenditures to expand manufacturing capacity. CDMOs also provide cost-effective solution for pharmaceutical companies which lack resources to invest in expensive in-house equipment or run an asset light business model. With their capital capability, CDMOs are well versed and equipped to meet regulatory and compliance requirements accelerating drug approval and commercialisation processes. CDMOs primarily produce biopharmaceutical products derived from biological sources such as vaccines, blood products, monoclonal antibodies and hormones.

Experts’ analysis estimates that the global market size for CDMOs will be worth USD238.47 billion in 2024 and can reach up to USD330.36 billion in 2029 with a Compound Annual Growth Rate (CAGR) of 6.74% from 2024 – 2029. Among the global CDMO companies are Lonza (Switzerland), Catalent (U.S.A.), GenScript Biotech (U.S.A.), WuXi Biologics (China), Recipharm (Sweden), and Samsung Biologics (South Korea).

In Malaysia, the local pharmaceutical industry is dominated by generic drugs ranging from prescription medicines, over-the-counter (OTC) medicines, traditional medicines, as well as health supplements in various forms such as tablets, liquids, capsules, and creams. Although the generic drug segment is Malaysia’s current forte, nevertheless there is a need for the Malaysian pharmaceutical ecosystem to expand, in line with the constant evolving demands of the industry, to suit the current innovations and trends. The Malaysian Government is constantly striving to advance the local pharmaceutical landscape by attracting expertise from developed economies through projects such as CDMOs.

Although Malaysia has yet to have CDMO operations, supportive policies are in place, in line with the Government’s aspirations to achieve national health security status and attain industry advancements. At present, Malaysian pharmaceutical manufacturers are facilitated to gear up and venture into the production of biopharmaceutical products as part of an upgrade to their production capability and quality of medicines. It is important to note that manufacturing operations in biopharmaceuticals require high capital investments since it often involves processes such as bioengineering ‘target cells’ or ‘genes’ which are then transferred into ‘production cells’ for mass production in bioreactors. Given the magnitude of investment and technology from CDMOs, this segment of business is identified by the Malaysian Government as an integral factor to complement and complete the Biopharmaceutical ecosystem.

CDMOs are considered to be projects with high spill-overs to the local economy specifically in terms of talent development and transfer of technology. Therefore, the Government of Malaysia through the Ministry of Investment, Trade and Industry (MITI) and MIDA alongside the Ministry of Health (MoH) and Ministry of Science, Technology and Innovation (MOSTI) are committed to ensure pro-business policies are in place for CDMOs to expand its reach into Malaysia through direct investment and ultimately complete the biopharmaceutical ecosystem. This agenda is complemented by key national policies such as the New Industrial Master Plan (NIMP) 2030 which highlights the pharmaceutical industry as a priority sector and the National Vaccine Development Roadmap (NVDR) which sets defined goals for Malaysia to become a vaccine-producing country.

Significant development plans are also being rolled out in several states within the country specifically, the states of Selangor and Negeri Sembilan to create designated ‘pharmaceutical hubs’ to house future CDMO operations. The success of the CDMO establishment allows Malaysia to be a hub for premium biopharmaceutical manufacturing, elevating our capabilities in the Asia Pacific region.

For more information, please contact MIDA Life Sciences and Medical Technology Division at https://www.mida.gov.my/staffdirectory/life-sciences-medical-technology-division/.