The combination of inhalable drug and device technologies has become a significant advancement in drug delivery. Pharmosa Biopharm recently stated at the "Drug-Device Combination" New Drug Future Forum that the market for PH-ILD (Pulmonary Hypertension-Interstitial Lung Disease) drugs is expected to grow to three to four times the size of the PAH (Pulmonary Arterial Hypertension) market, making it a highly competitive field. Pharmosa aims to be the first to penetrate the European market, building competitive barriers, and strives to become the first company in Europe to launch a PAH/PH-ILD drug. Meanwhile, Delta Electronics revealed its focus on the contract development and manufacturing (OdM) of nebulizers, and confirmed that it is one of Pharmosa's development partners, currently collaborating on a drug-device combination product.
The global drug-device combination market is vast, valued at $270 billion, with the inhalable drug-device segment growing the fastest, becoming a key focus in drug delivery. Diseases like asthma and pulmonary conditions are driving this growth. Min-Jing Luo, a partner at Blackwood Investment, noted that Taiwanese companies in this field include drug-centric firms like Foresee Pharmaceuticals, Pharmosa, Intech Biopharm, and Advagene Biopharma, as well as device-centric companies like HCmed Innovations and MicroBase Technology. Most of these companies focus on improving drug formulations and enhancing market entry barriers and competitiveness through integrated devices.
Pharmosa’s L606, an inhalable liposomal formulation of treprostinil, is positioned as a novel treatment in comparison to United Therapeutics' Tyvaso. Luo pointed out that the key success factors for future inhalable formulations will be long-acting and precise drug delivery. Pharmosa’s U.S. partner, Liquidia, received tentative approval for a dry powder formulation of L606 for both PAH and PH-ILD in August 2024, with a market launch expected in May 2025. Pharmosa’s partnership with Liquidia presents significant opportunities, as L606 could potentially secure approval for both PAH and PH-ILD simultaneously.
Pei Kan, CEO of Pharmosa, emphasized that high-barrier drug-device combinations require careful consideration of regulatory frameworks globally, as different countries have varying definitions for drug-device combinations. Pharmosa’s strategy is to seek highly capable partners in key markets such as the U.S., Europe, and China, with a focus on accelerating clinical development through collaboration with key opinion leaders (KOLs) and expanding into new indications. In regions like the Middle East, Japan, Korea, and Southeast Asia, Pharmosa plans to negotiate higher royalties with companies that possess unique market channels.
Kan also highlighted that the global PAH and PH-ILD market is projected to reach $12.2 billion by 2032. In 2021, Tyvasobecame the only approved treatment for PH-ILD in the U.S., and the market is expected to grow to three to four times the size of the PAH market. Bloomberg analysts project annual sales to reach $2.3 billion by 2027. Kan noted that Pharmosa’s focus is on securing early market entry in Europe, leveraging the drug-device combination to create competitive barriers and striving to become the first PAH/PH-ILD drug approved in the region.
Kevin Wang, General Manager of Delta Electronics’ Biomedical Business Unit (BMBU), mentioned that the unit, established this year, is Delta’s ninth business segment, with strong R&D and production capacity. Its business model focuses on Contract Development and Manufacturing Services (CDMO), collaborating with pharmaceutical companies to develop devices paired with branded or generic drugs.
In terms of drug-device combination products, Delta’s first development is a nebulizer for the treatment of pulmonary diseases, with the market estimated to grow to $150 billion by 2033, at a compound annual growth rate (CAGR) of 4.8%. The potential for this market is enormous, and Delta’s goal is to secure at least two pharmaceutical contracts annually. Wang also disclosed that Pharmosa is one of Delta’s development partners, and the two companies are already working together on a drug-device combination product.
Resource (mandarin): 國邑*、台達電攜手拉高競爭壁壘，搶食吸入式藥械組合龐大商機
