Pharma-Bio Firms 'Reinventing the Wheel' with 하이 로우 토토 사이트s
In this era of uncertainty, the biopharmaceutical contract development and manufacturing (하이 로우 토토 사이트) business has been on the radar of pharmaceutical and biotech companies. It will be interesting to see how the best-case scenario unfolds.
After a long and arduous drug discovery journey, pharma and biotech companies are increasingly interested in the biopharmaceutical 하이 로우 토토 사이트business because it is much less uncertain than drug development.
Biopharmaceutical 하이 로우 토토 사이트s can generate stable revenue since it is difficult to change suppliers once a contract is signed. The recent trend in global drug production favors outsourcing over in-house manufacturing due to the high cost of building facilities and the complexity of manufacturing processes, leading to promising market growth.
In particular, the 하이 로우 토토 사이트 business for biopharmaceuticals, such as antibody therapeutics and recombinant proteins, is highly profitable, with operating margins reaching 20-30%. According to the KoreaBio, the global bio 하이 로우 토토 사이트 market is expected to grow from .3 billion in 2020 to .3 billion by 2026.
An 'Unexpected Benef하이 로우 토토 사이트' of the US-China Conflict?
A new development in the highly anticipated biopharmaceutical 하이 로우 토토 사이트 market has fueled the fire. Chinese 하이 로우 토토 사이트s, which have captured a significant market share through low prices, could be forced out of the US market.
To protect 하이 로우 토토 사이트s bioindustry, the US is actively pursuing legislation, including the Biosecure Act, to restrict transactions w하이 로우 토토 사이트h Chinese biotech companies. Five Chinese companies, including Wuxi Bio and Wuxi AppTech, have been categorized as the highest-risk group. This legislation would effectively exclude them from the US market by 2032 if enacted.
Given the bill's bipartisan support in the US political arena, US biopharmaceutical companies must find alternatives as soon as possible. A recent survey by the American BioAssociation of 124 members found that nearly 80 percent rely on Chinese 하이 로우 토토 사이트s.
W하이 로우 토토 사이트h a massive backlog of orders on the shelf, there is high hope that Korean companies will benef하이 로우 토토 사이트. However, active lobbying by Chinese companies is a factor to consider. The failure to include biosecur하이 로우 토토 사이트y legislation in the National Defense Authorization Act (NDAA) amendment on June 12 (local time) may have had an impact.
Nevertheless, the prevailing view in the industry is that 하이 로우 토토 사이트 is only a matter of time before the legislation is passed, given the intensifying compet하이 로우 토토 사이트ion between the US and China for biopower. "The move by US biotechs to find new partners will be visible from now on," said one industry insider, adding that "companies that have not previously contracted w하이 로우 토토 사이트h Chinese companies will start by excluding them."
Of course, it's not all optimism. Indian 하이 로우 토토 사이트s, like their Chinese counterparts, are poised to capitalize on the situation. On June 15 (local time), Origen, a subsidiary of Indian pharmaceutical giant Dr. Reddy's, broke ground on a biopharmaceutical 하이 로우 토토 사이트 facility in Hyderabad, India. The R&D facility is operational, and the production facility is expected to be completed later this year.
Syngene, a subsidiary of another Indian pharma giant, Vikon, employs over 6,000 scientists and offers specialized services across the entire life cycle, including target selection, development, and production. In July 2023, Syngene announced that 하이 로우 토토 사이트 would invest million to convert a vaccine production facil하이 로우 토토 사이트y in Bengaluru, India, which 하이 로우 토토 사이트 acquired in July, into a plant for antibody therapeutics.
In November last year, Reuters reported, "As tensions rise between the United States and China, Western drugmakers are looking to reduce their reliance on Chinese 하이 로우 토토 사이트s." According to the report, four of India's largest 하이 로우 토토 사이트s have seen increased interest and requests from Western drugmakers (including major multinationals) this year.
Barriers to Entry as High as Prof하이 로우 토토 사이트abil하이 로우 토토 사이트y
When we set aside the US-China geopolitical influence, the high barriers to entry in the biopharmaceutical 하이 로우 토토 사이트 business become more apparent.
In its October 2022 report, Contract Manufacturing (CMO) & New Drug Development, Kyobo Securities stated, "The biopharmaceutical CMObusiness requires a higher initial investment, certification from global regulatory agencies, and customer acquisition than the small molecule compound CMO business," adding, "The difficulty of production management is much greater, as biopharmaceuticals are produced using cells, tissues, and hormones derived from living organisms." This challenging business environment supports the profitability of the biopharmaceutical 하이 로우 토토 사이트 business.
In particular, the 'antibody therapeutics' 하이 로우 토토 사이트 business is less accessible because it requires large investments to achieve so-called 'economies of scale.' "Antibody therapeutics are a 'trillion-dollar race,'" said Mr. A, a 하이 로우 토토 사이트 executive. "Even if you secure a Series A, B, or C investment, you can't launch a typical venture with only 40-50 billion won."
SK Group's 하이 로우 토토 사이트, SK Pharmtech, hasn't entered the antibody therapeutics business. In 2022, SK Pharmtech CEO Yog Algrim said, "Our vision is cell-gene therapy (CGT), oligonucleotides, and plasmids. Antibody therapies are not on the horizon." This is because competing for production capacity at a high cost as a latecomer is burdensome.
Currently, the domestic 하이 로우 토토 사이트 market for antibody therapeutics is led by Samsung Biologics, followed by Lotte Biologics (LOTBA). By 2030, LOTBA plans to invest approximately KRW 3.73 trillion in Songdo, Incheon, to build a total capacity of 360,000 liters for antibody therapeutics. Mr. A notes, "The antibody therapeutics business requires significant investment in facilities. It’s a 'money in, money out' business. It will take some time, but it's not a business that will fail."
For smaller CGTs, a GMP (Good Manufacturing Practice) plant can be built with a facility investment of 15-20 billion won. Compared to antibody therapeutics, the profit margins are lower, and contracts are shorter. "If antibody therapeutics are worth 40 to 50 billion won per project, CGT is much less, and there is still a 'battle for position,' so the margins are slim," said Mr. B, a CGT 하이 로우 토토 사이트 business manager. "Antibody therapeutics are usually long-term contracts of 10 years because many drugs are already on the market. CGT, on the other hand, deals mainly with drugs in the clinical phase. For us, each project we win lasts two to three years at most."
CGT 하이 로우 토토 사이트s are competitive due to their lower initial investment. "Compared to 10 years ago, there are now too many CMOs and 하이 로우 토토 사이트s. Competition in sales and marketing is fierce, and many companies struggle to win orders even after 5-10 years. In particular, fewer than 10 CGT 하이 로우 토토 사이트s can successfully secure orders in Korea." "Many companies advertise their manufacturing facility capabilities, but in reality, the companies that build the facilities are rather obvious. There are only three or four major players like GC GreenShip GM. Regardless of who builds them, the quality is similar."
Traditional pharmaceutical companies with 'drug manufacturing know-how' are also entering the biopharmaceutical 하이 로우 토토 사이트 business to minimize the risk of developing new drugs by securing a stable revenue stream. Hanmi Pharmaceutical is the most prominent example at the moment.
Hanmi Pharmaceutical has been in the biopharmaceutical 하이 로우 토토 사이트 business since last year. Their role model is neither Samsung Biologics nor Celltrion, but LONZA. LONZA, the world's No. 1 biopharmaceutical 하이 로우 토토 사이트, is similar to Hanmi Pharm, focusing on 'small molecule 하이 로우 토토 사이트s.' This approach involves producing drugs by culturing microorganisms rather than animal cells, which requires relatively low facility investment and a shorter production period.
Hanmi Pharm is confident that it will excel in the 하이 로우 토토 사이트 business, given its experience in the entire drug development cycle. However, large orders are still a ways off. Hanmi Pharmaceutical's Pyeongtaek Bio Plant, a production base completed in 2018, is currently running at a deficit of 70 billion won annually.
With the microbial 하이 로우 토토 사이트 business's slow growth rate, it remains to be seen whether it can become a 'Korean LONZA.' The Center for Biotechnology Policy and Research forecasts that the microbial 하이 로우 토토 사이트 business, which accounted for 34% of the total cell line market (including microbial, animal cell, viral vector, and others) in 2020, will have the lowest growth rate among cell lines by 2026.
Yuwon Chun contributed to the ed하이 로우 토토 사이트ing of the English version of this article.