Latest news with #Duopharma
Focus Malaysia
7 days ago
- Business
- Focus Malaysia
Southeast Asia pharma market set to outgrow global average
SOUTHASIA Asia (SEA) presents a substantial future prospect for the pharmaceutical market. Its projected growth rate significantly outpaces the global average and other major established markets. As of calendar year 2024 (CY24), global total market size for pharmaceuticals is estimated at USD1.5 tri. In comparison, SEA's total market size is estimated at USD27 bil. The significant growth for SEA indicates that ASEAN is a prime growth engine for the global pharmaceutical industry. This makes it an attractive destination for investment and market expansion. The Philippines and Malaysia show steady growth in a biosimilar export potential, reaching USD 111 mil and USD 70 mil respectively by 2027. Malaysia's growth, though robust, is relatively smaller in absolute terms compared to Thailand, Vietnam, and Indonesia. However, companies like Duopharma and Pharmaniaga are actively developing Halal-certified biosimilars. Overall, biosimilars is an untapped potential due to increasing healthcare demands and cost pressure. 'We believe that investing in local manufacturing of biosimilars can open avenues for SEA countries to export,' said MBSB Research. Countries that prioritise and invest in local biosimilar production are likely to become stronger exporters in this field. This aligns with the broader trends of high pharmaceutical market growth in SEA driven by demographics, NCDs, and the increasing sophistication of healthcare systems, all of which necessitate tailored and creative market strategies. Malaysia's pharmaceutical sector boasts a strong and strategically recognized local manufacturing base that significantly contributes to medicine security, especially for generics and essential medicines. While Malaysia demonstrates capabilities in exporting to highly regulated markets like the USA, it remains heavily reliant on imports for patented drugs, biologics, vaccines, and key APIs. The main challenge for Malaysia lies in bridging this gap by further boosting local R&D, attracting more sophisticated manufacturing capabilities, and strengthening its position in the global pharmaceutical value chain beyond just generics. 79% of total volume of generic medicines and 47% of items listed in National Essential Medicines List (NEML) are locally produced. However, most drugs, notably patented medicaments, immunoglobulins, human vaccines and insulins, are still dependent on imports. Malaysia consistently shows widening trade deficit underscores Malaysia's high reliance on imported pharmaceuticals. While local production is strong in generics, the country still depends heavily on foreign sources for innovative, patented, and specialised medicines. This reinforces the government's strategic focus on local manufacturing and technology transfer to enhance medicine security and reduce import dependency in the long run. The overall trend in the regional and local pharmaceutical market suggests that both domestic and foreign investors will see growing opportunities in Malaysia. The 51% FDI / 49% DDI ratio suggests a healthy balance between local commitment, and global capital and expertise. FDI indicates that Malaysia is highly attractive to foreign pharmaceutical companies, bringing in capital, technology, and global best practices, while DDI signifies robust local entrepreneurship and investment from Malaysian companies, demonstrating confidence in the domestic market and capabilities. We opine that the untapped drug manufacturing ecosystem will continue to follow the megatrend of new innovative drugs – including biologics, biosimilars and cell & gene therapy drugs – and open more opportunities for Malaysia to be a major healthcare hub in the region. While direct pharmaceutical exports from Malaysia to the US might face immediate headwinds from tariffs, the broader impact on Malaysia's healthcare subsector could come from indirect effects on global pharmaceutical supply chains and procurement costs. This would affect the affordability and availability of medicines within Malaysia for all citizens and healthcare providers. The Malaysian government and industry players are already responding by prioritizing supply chain diversification and exploring domestic production enhancements to mitigate these risks. Meanwhile, we believe a multi-pronged approach involving government action, industry adaptation, and consumer awareness will be crucial. Overall, we maintain positive on the healthcare sector. The pharmaceutical market is fundamentally driven by robust demographic trends, which naturally increases the demand for healthcare services and medicines. —July 23, 2025 Main image: Daily Sabah
The Sun
03-06-2025
- Business
- The Sun
Duopharma Biotech secures halal certification for biosimilar anaemia treatment
KUALA LUMPUR: Duopharma Biotech Bhd has achieved another milestone in the halal pharmaceutical sector with the halal certification of a biosimilar product used to treat anaemia in patients with chronic renal failure. The certification, awarded by the Department of Islamic Development Malaysia (JAKIM), strengthens Duopharma's position at the forefront of Malaysia's halal pharmaceutical sector. Group Managing Director Leonard Ariff Abdul Shatar said the product is used in adult and paediatric patients undergoing haemodialysis or the predialysis stage. It is currently supplied to both public and private healthcare facilities nationwide. 'This certification marks a key advancement in the company's biologics journey and will further motivate our efforts to provide consumers and patients with access to medicines and therapies that are assured safe and effective, high in quality, hygienic and halal from the start,' Leonard Ariff said referring to the product which is manufactured at Duopharma's plant in Klang. He added that the certification is timely, given the rising number of dialysis patients in Malaysia. The Ministry of Health projects that over 106,000 Malaysians may require dialysis by 2040, with more than 10,000 new cases annually if current trends persist. Duopharma has been a pioneer in the biologics, having launched Malaysia's first Phase 3 clinical trial for an Epoetin Alfa biosimilar in 2014 with South Korea's Pangen Biotech Inc. In 2018, it became the first Malaysian company to install a biologic pre-filled syringe production line. The company also promotes the halal pharmaceutical agenda globally through the annual Halal Pharmaceuticals Symposium, which it has hosted since 2016, bringing together global experts, regulators and industry leaders to advance halal integration in the healthcare system.
The Sun
03-06-2025
- Business
- The Sun
Duopharma Biotech secures halal cert for anaemia treatment
KUALA LUMPUR: Duopharma Biotech Bhd has achieved another milestone in the halal pharmaceutical sector with the halal certification of a biosimilar product used to treat anaemia in patients with chronic renal failure. The certification, awarded by the Department of Islamic Development Malaysia (JAKIM), strengthens Duopharma's position at the forefront of Malaysia's halal pharmaceutical sector. Group Managing Director Leonard Ariff Abdul Shatar said the product is used in adult and paediatric patients undergoing haemodialysis or the predialysis stage. It is currently supplied to both public and private healthcare facilities nationwide. 'This certification marks a key advancement in the company's biologics journey and will further motivate our efforts to provide consumers and patients with access to medicines and therapies that are assured safe and effective, high in quality, hygienic and halal from the start,' Leonard Ariff said referring to the product which is manufactured at Duopharma's plant in Klang. He added that the certification is timely, given the rising number of dialysis patients in Malaysia. The Ministry of Health projects that over 106,000 Malaysians may require dialysis by 2040, with more than 10,000 new cases annually if current trends persist. Duopharma has been a pioneer in the biologics, having launched Malaysia's first Phase 3 clinical trial for an Epoetin Alfa biosimilar in 2014 with South Korea's Pangen Biotech Inc. In 2018, it became the first Malaysian company to install a biologic pre-filled syringe production line. The company also promotes the halal pharmaceutical agenda globally through the annual Halal Pharmaceuticals Symposium, which it has hosted since 2016, bringing together global experts, regulators and industry leaders to advance halal integration in the healthcare system.
The Star
22-05-2025
- Business
- The Star
Duopharma aiming for big govt insulin tender
Duopharma group managing director Leonard Ariff Abdul Shatar. KLANG: Duopharma Biotech Bhd is hoping to secure a sizeable contract to supply insulin to the Health Ministry (MoH) in the near term, which will help propel its growth. 'The significant jump (in contract value) has already occurred based on the announcements we made. I think we've announced all the significant jumps that we can foresee (for now). 'The next significant one will be the results of the insulin tender. That will be sizeable enough for us to make an announcement,' said group managing director Leonard Ariff Abdul Shatar. 'Our extension goes on till the end of October. While the tender (process) started (in May), I must caution that MoH traditionally for insulin always gives the contract to two parties. 'If only one party bids, MoH will wait until there's capability for a second party to bid,' he told reporters after the company's AGM yesterday. Its wholly-owned subsidiary, Duopharma Marketing Sdn Bhd, and India Biocon Ltd's local unit, Biocon Sdn Bhd, recently secured a six-month contract extension from MoH for the supply of insulin to public hospitals. Duopharma said the latest extended agreement is effective from April 29 until Oct 28, 2025. While the contract value was not disclosed in the filing, Leonard Ariff estimated the value of the six-month extension to be worth between RM30mil and RM35mil, about half of the annualised value of RM60mil to RM70mil. Duopharma, in which Yayasan Pelaburan Bumiputra holds a 44.11% stake, was awarded contracts totalling RM684.15mil to supply a combined total of 100 pharmaceutical and non-pharmaceutical products to healthcare facilities operated by the government, until Dec 31, 2026. The contracts are for products listed under the MoH's Approved Products Purchase List. Meanwhile, Leonard Ariff aims to increase the company's export business, which accounted for around 8% of its revenue in 2024, focusing on Asean countries mainly due to familiarity with regulatory environments and sizable markets. The company operates in about 30 markets, but its primary focus remains on Asean, as countries like Indonesia, the Philippines, Vietnam, Singapore, Brunei, and Thailand represent a significant portion of the global market, he explained. He added that Duopharma has made inroads into Timor-Leste, having won a government tender to supply halal pharmaceuticals. However, he expects higher demand for halal pharmaceuticals from Indonesia compared to Qatar and other Middle Eastern markets, which are still in the early stages. He said Indonesia is moving towards implementing a law, originally slated for 2022 or 2023, that mandates halal certification for over-the-counter pharmaceutical products. 'They have delayed its implementation to 2026 or 2027. That would be a more viable opening for Duopharma products, rather than the Middle East,' Leonard Ariff explained. The main focus for Duopharma this year will be on removing the bottleneck at its facilities in Klang and Bangi, Selangor, to cater to the needs of both the public and private sectors, ensuring its production capacity aligns with demand. 'We have more than enough capacity for the public sector. It is all about balancing (demand from the public and private sectors). We do not want to put all our eggs in one basket,' he said.
The Sun
21-05-2025
- Business
- The Sun
Duopharma eyes Indonesia for halal product growth
KLANG: Duopharma Biotech Bhd is eyeing Indonesia as a near-term growth market for its halal-certified products as the country prepares to enforce mandatory halal certification for over-the-counter (OTC) medicines by next year. Managing director Leonard Ariff Abdul Shatar said the regulation, originally scheduled to take effect in 2022 or 2023, had been postponed but is now expected to be implemented in 2026 or 2027. ''Indonesia is moving in that direction. In fact, they had a law slated to take effect in 2022 or 2023, requiring all over-the-counter products to be 100% halal. However, the implementation of that legislation has been delayed—possibly until 2026 or 2027. I see this as a viable opening for Duopharma's products. Personally, I believe we'll see more traction coming from Indonesia in the near term compared to the Middle East,' he said at a press conference after its AGM today. As at end-2024, he said the Malaysian government contracts accounted for 50% of Duopharma's revenue, the private sector 42%, and exports 8%. So there's still a fair amount of headroom (in the export segment). 'Regionally, we are seeing positive growth in the sales of consumer healthcare products, as well as generics and biosimilars, and medical devices,' he added. Leonard Ariff said the company does not want to have too much concentration in a single sector. 'So, as a result, we de-risk through access to the private sector, and we also de-risk through the export market,' he said. Furthermore, in terms of halal, he said that Duopharma Biotech has already begun supplying Timor-Leste through a direct tender. However, Qatar and other Middle Eastern markets remain challenging due to regulatory differences. 'On the one hand, you have countries that are very keen to take advantage of our halal certification process in terms of products. But you can't forget the fact that the product still remains a pharmaceutical, which means it needs to go through a registration process first before moving on to the halal certification process.' While these countries are interested in halal-certified products, he said they do not automatically accept Malaysia's Jakim halal certification. 'They actually want to conduct an audit – reviewing the dossier and related documentation – so it will take some time before we see any real traction in the Middle East,' he said. In February, Duopharma Biotech became the first Malaysian pharmaceutical company to obtain halal certification from Jakim for its erythropoiesis-stimulating agent product to treat anaemia, adding to the previous milestone of obtaining the first halal certification from Jakim for a cancer drug. Meanwhile, the company also introduced five new generics for breast cancer, heart and kidney patients in FY24. To enable more patients in overseas markets to access medicines produced by Duopharma Biotech, the company continued to pursue more international certifications for its manufacturing facilities. Following an audit by the Health Products Regulatory Authority, Ireland, Duopharma Biotech's Highly Potent Active Pharmaceutical Ingredients manufacturing plant in Glenmarie, Shah Alam was certified as meeting European Union Good Manufacturing Practice standards.
