Surge in FDA Approvals as Global Pharma Companies Target the $815.8 Billion US Market

　　【Pharmaceutical Network Industry Dynamics】 With the intensification of population aging and the enhancement of people's health awareness, the global pharmaceutical market shows a continuous growth trend.
 

Trend. According to statistics from Frost & Sullivan, the global pharmaceutical market reached a total scale of US$1.58 trillion in 2023. It is projected that by 2030, the global pharmaceutical market size will reach US$2.08 trillion, with a compound annual growth rate (CAGR) of 4% from 2024 to 2030, indicating a steady expansion of the global pharmaceutical market. Among this, the United States holds a significant position in the global market, and it is expected that by 2030, the U.S. pharmaceutical market size will reach US$815.8 billion, while China's pharmaceutical market size will reach 2,624.5 billion RMB.
 

Compared with the intense competition in China, the U.S. pharmaceutical market offers an attractive space, which has also attracted pharmaceutical companies from home and abroad to actively expand in recent years, with frequent updates on FDA approvals.
 

For example, Humanwell Healthcare Group Co. Ltd. announced on the evening of May 16 that its wholly-owned subsidiary, Epic Pharma, LLC, had received approval numbers from the U.S. Food and Drug Administration (FDA) for Acetazolamide Tablets and Difluprednate Ophthalmic Emulsion. Acetazolamide Tablets are carbonic anhydrase inhibitors used to treat glaucoma, epilepsy, acute mountain sickness, periodic paralysis, idiopathic intracranial hypertension (unexplained increase in brain pressure), heart failure, and urine alkalinization. Difluprednate Ophthalmic Emulsion is used to treat postoperative local inflammation and pain in the eye.
 

On May 16, Poly Pharm announced that its wholly-owned subsidiary, Anhui POLY Pharm. Co., Ltd., had recently received the Gadoteric Acid Meglumine Injection approval from the U.S. Food and Drug Administration (FDA).Active Pharmaceutical IngredientsFirst Adequate Letter (FAL). This means that the active pharmaceutical ingredient (API) US DMF can meet the filing requirements of associated formulation customers, making the company's products more likely to be prioritized by new customers in the market due to compliance with FDA requirements. This is beneficial for seeking market opportunities and expanding the customer base. Meanwhile, the registration work for the company’s gadoterate meglumine API in other markets is also proceeding continuously.
 

Orient Gene (688298) announced on the evening of May 15 that the company and its wholly-owned subsidiary, Healgen Scientific LLC, based in the United States, have recently obtained the U.S. FDA 510(K) license for a fentanyl urine test kit (professional/self-test) and the EU IVDR certification for a drug detection analyzer. The recent FDA 510(K) approval for Healgen Scientific’s fentanyl testing product series allows for the qualitative detection of fentanyl in urine. This testing product is easy to use, provides rapid results, and is suitable for professional institution testing or home self-testing. It enriches the variety and application areas of drug detection products the company can sell in the U.S. market, meets market testing demands, and benefits the expansion of the U.S. market.
 

On May 14 local time, Eisai (Eisai/ESALY.US) and Biogen (Biogen/BIIB.US) announced that Eisai has begun submitting a rolling Biologics License Application (BLA) to the U.S. FDA for subcutaneous injection of lecanemab, intended for the treatment of patients with early Alzheimer's disease (AD) (patients in the mild cognitive impairment or mild dementia stage). If approved, this drug will bring more convenience to Alzheimer’s patients and their families.
 

In addition, recent news indicates that the FDA has granted accelerated approval to Amgen's Imdelltra (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed after platinum-based chemotherapy. The approval is based on promising response rates and duration observed in clinical trials, pending confirmatory trials. This DLL3-targeted therapy represents a significant advancement, offering hope to pretreated patients in need of innovative therapies. Lung cancer is a devastating disease with poor prognosis, underscoring the importance of this new treatment option.
 

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