Ending COVID-19... "Next Year's Pharmaceutical Market Opportunities Are Alzheimer's and Obesity"

Expecting Follow-up New Drug Approvals Next Year After First New Drug

Hope for Dementia Treatments 'Leqembi' and 'Donanemab' After 'Aduhelm' Failure
Will 'Mounjaro' Further Boost Obesity Market Opened by 'Wegovy'?

Domestic Focus on Biosimilars
Expectations Rise with Successive Blockbuster Patent Expirations Starting with 'Humira' Next Year

[Image source=Getty Images]

[Asia Economy Reporter Lee Chun-hee] As the COVID-19 pandemic comes to an end, the pharmaceutical and biotech industries, which have achieved rapid growth during this period, are focusing on finding new growth engines. Major securities firms expect the markets for Alzheimer's dementia and obesity treatments?areas that previously lacked effective therapies?to open up in earnest. Domestically, biosimilars and FDA new drug approvals are cited as key variables.

According to the industry on the 16th, Mirae Asset Securities forecasted that "a huge market will open in the fields of Alzheimer's and obesity" in their outlook for the pharmaceutical and biotech sectors next year. Following the emergence of the first related new drugs and the subsequent release of new drugs with improved efficacy and safety, substantial market growth is expected.

Last year, Biogen and Eisai's 'Aduhelm' became the first Alzheimer's treatment to receive approval from the U.S. Food and Drug Administration (FDA). However, Aduhelm faced questions regarding its efficacy and effectively failed to commercialize. In contrast, Biogen and Eisai's 'Lecanemab' and Eli Lilly's 'Donanemab,' both aiming for FDA approval next year, have demonstrated clear efficacy in clinical trials compared to Aduhelm. The Alzheimer's treatment market, expected to grow to $58 billion (approximately 76 trillion KRW) by 2032, is anticipated to expand further. Lecanemab showed a 27% slower cognitive decline compared to placebo in Phase 3 trials, raising expectations for FDA accelerated approval on the upcoming June 6. Donanemab also plans to release Phase 3 results next year and seek FDA approval. Both drugs are expected to become blockbuster products, with annual sales projected at $3 billion (about 4 trillion KRW) and $1.9 billion (about 2.4767 trillion KRW) respectively by 2028.

Hana Kang, a researcher at Ebest Securities, stated, "When a market without existing treatments opens, the diagnostic market inevitably expands," emphasizing the dementia diagnostic field. She also noted, "Most late-stage Alzheimer's treatments are antibody drugs, which will enable co-growth with the contract development and manufacturing organization (CDMO) market." Additionally, Parkinson's disease, another central nervous system (CNS) disorder with significant unmet needs, currently only has adjunctive medications, so successful development of fundamental treatments could lead to high growth in this area.

The obesity treatment market, opened by Novo Nordisk's 'Wegovy,' is seeing Eli Lilly's 'Mounjaro' (active ingredient tirzepatide) aiming for FDA approval next year. In Phase 3 trials, it showed a 17.8% weight reduction compared to placebo, outperforming Wegovy's 12.5%. Lilly has even proposed direct comparative trials with Wegovy to confirm superiority. Furthermore, companies including Pfizer and Amgen are developing oral medications with improved convenience. If these treatments continue to be launched, the U.S. market size is expected to grow from $3.9 billion this year at an average annual rate of 29.1%, reaching $47.2 billion (approximately 62 trillion KRW) by 2032.

Domestic Market Prepares for Overseas Biosimilar Battle... Focus on Approval of 'Rekaza' and 'Riboceranib'

In the domestic industry, biosimilars (biologic drug generics) have become a hot topic. Yuanta Securities predicted, "From next year, biosimilars of Humira will begin launching in the U.S.," foreseeing intense competition among original manufacturer AbbVie, biosimilar developers Samsung Bioepis and Amgen, and Celltrion. Although other biosimilars exist, most are low-concentration formulations, so the battle will likely focus on high-concentration formulations. They added, "Patents for blockbuster antibody drugs such as Stelara, Eylea, and Prolia are set to expire by 2025," and "the biosimilar market growth rate will be very rapid."

In line with this, Celltrion Healthcare plans to start direct sales in overseas markets including the U.S. from next year. Although initial selling and administrative expenses will increase, the reduction in commissions paid to sales partners is expected to improve long-term profitability. NH Investment & Securities explained, "While the market is concerned about direct sales costs, sales personnel for direct U.S. sales can be reduced by 30-40% compared to expectations when focusing on payers," and "annual U.S. direct sales costs are expected to be at the lower end of the guidance range of 50 to 100 billion KRW."

Regarding Samsung Biologics, a traditional powerhouse, expectations are high for the full-scale operation of Plant 4, which began operations this year, and the early groundbreaking of Plant 5 is cited as a key variable. Korea Investment & Securities noted, "We focus on the strengthening order competitiveness amid continued antibody market growth," adding, "Next year will be the year when plans for the construction of the second bio campus are concretized, so attention should be paid to order contracts."

Among domestic new drugs, Yuhan Corporation's 'Rekaza' (active ingredient lazertinib) and HLB's 'Riboceranib' are attracting attention. Yuhan is expected to challenge FDA approval for Rekaza, a non-small cell lung cancer treatment, through its partner Janssen. HLB is also anticipated to seek FDA approval for Riboceranib for liver cancer in collaboration with Hansoh Pharmaceutical, which developed 'Camrelizumab,' currently undergoing combination therapy trials.

This content was produced with the assistance of AI translation services.