Why is "cell therapy" so high-end and precious?
A. Why is cell therapy expensive?
The emergence of any new thing has limited dissemination in a relatively small market environment.
In this budding period, it is limited by: a small audience and a lot of negative news.
There are multiple factors such as low policy intensity and high production costs.
Prices will inevitably remain high.
This is the law of the market economy, and it is also the challenge that any new thing must face and the process it must go through.
Over the past decade, a host of self-proclaimed cellular agencies have sprung up.
The cell industry is a very "heavy" industry.
"Emphasis on assets", "emphasis on talents", "emphasis on research", "emphasis on technology" and "emphasis on supervision".
However, what is out of proportion to the high cost and human investment is that the current market economy is small in scale, has a small audience, and the policies of various countries are highly binding.
This results in higher ongoing cost investment in cell machinery, and the cost of the entire industry chain of cell therapy has also increased.
B. How expensive is cell therapy?
Scientific research is valuable:
The investment in scientific research costs is huge, especially in the stages of biopharmaceutical R&D and clinical trials.
The development of every new therapy requires a large amount of experiments and data accumulation, including basic research, animal experiments, early clinical trials (Phase I and Phase II), and large-scale Phase III clinical trials.
Each step requires a significant investment of money and time, and these costs are ultimately reflected in the cost of treatment.
The most important thing is production:
The production process for cell therapies is complex and rigorous.
It needs to be performed in a sterile, strictly controlled environment.
(FDA / CPC) The construction and maintenance of production facilities and equipment are expensive, and expensive culture media, reagents and consumables are also required during the production process.
In addition, to ensure product quality and consistency, each batch of cell products needs to undergo strict quality control and official third-party testing, which further increases costs.
The most valuable thing lies in talent:
The development and implementation of cell therapy requires a highly qualified professional team, including biologists, clinicians, pharmacists, technicians, etc. The training and introduction of these professional talents is very costly.
Scientists and technicians need to undergo years of rigorous education and training to master cutting-edge scientific research methods and technologies.
Clinicians not only need to have rich medical knowledge.
It also requires a deep understanding of the principles and operating procedures of cell therapy.
To attract and retain top scientists from these countries.
Cell therapy institutions are often required to provide high salaries and good career development opportunities, which further increases the cost of the entire treatment.
The most important thing is supervision:
Every aspect of cell therapy needs to comply with strict regulatory requirements...from research and development, production to clinical application.
All need to go through a series of complex approval and certification procedures.
These procedures not only require a lot of time and manpower investment, but may also face high legal approval fees from government units.
The most important thing is personalization:
Many cell therapies are tailored to a patient's specific condition, meaning each treatment course needs to be individually designed and produced.
This personalized treatment plan is more complex and expensive than traditional "one size fits all" therapies.
To sum up, the high cost of cell therapy is not only due to investment in scientific research, production, supervision and personalization, but also due to the demand for high-quality professionals.
Only high standards are achieved in these aspects.
Global cell therapy can provide patients with cutting-edge treatment options while ensuring safety and effectiveness.
為什麼「細胞療法」這麼高端而珍貴。
A、細胞療法為什麼會貴?
任何一个新鮮事物的出現,都是在比較小范圍的市場環境中進行有限傳播的。
在這個萌芽時期,受制於:受衆人群較少,負面消息較多。
政策力度較低,生產成本較高等多重因素。
價格必然會居高不下。
這是市場經濟的法則,也是任何一個新事物要面臨的挑戰和必然要經歷的過程。
在過去的10年中,一堆自稱是細胞機構如雨後春筍一樣冒了出來。
細胞這個產業是個很「重」的產業。
「重資產」、「重人才」、「重研究」、「重技術」、「重監管」。
但與高昂的成本投入和人力投入不成正比的是,目前的市場經濟規模較小、受衆群體較少,各國政策約束力度較大。
這就造成細胞機構持續性的成本投入更高,細胞療法的整個產業鏈的成本也就水漲船高。
B、細胞療法到底貴在哪?
貴在科研:
科研成本的投入是巨大的,尤其是在生物藥劑研發和臨床試驗階段。
每一個新療法的開發都需要大量的實驗和數據積累,這包括基礎研究、動物實驗、早期臨床試驗(I期和II期),以及大規模的III期臨床試驗。
每一步都需要大量的資金和時間投入,而這些成本最终都會反映在治療費用上。
貴在生產:
細胞療法的生產過程複雜且嚴格。
需要在無菌、嚴格控制的環境下進行。
(FDA /CPC)生產設施和設備的建設和維護費用高昂,生產過程中還需要使用昂貴的培養基、試劑和耗材。
此外,為確保產品的質量和一致性,每一批次的細胞產品都需要經過嚴格的質量控制和官方第三方檢測,這進一步增加了成本。
貴在人才:
細胞療法的發展和實施需要一支高素質的專業團隊,包括生物學家、臨床醫生、藥劑師、技術人員等。這些專業人才的培養和引進成本很高。
科學家和技術人員需要經過多年嚴格的教育和培訓,掌握前沿的科研方法和技術。
而臨床醫師不僅需要具備豐富的醫學知識。
還需要對細胞療法的原理和操作流程有深刻的理解。
為了吸引和留住這些國家頂尖科學家。
細胞治療機構往往需要提供高薪酬和良好的職業發展機會,這進一步增加了整個治療的成本。
貴在監管:
細胞療法的每一個環節需要符合嚴格的監管要求⋯⋯從研發、生產到臨床應用。
都需要通過一系列複雜的審批和認證程序。
這些程序不僅需要大量的時間和人力投入,還可能面臨高昂的政府單位合格合法審批費用。
貴在個性化:
許多細胞療法是根據患者的具體情況量身定制的,這意味着每一個療程都需要單獨設計和生產。
這種個性化的治療方案比傳統的「一刀切」療法更加複雜和昂貴。
綜上所述,細胞療法的高成本不僅源於科研、生產、監管和個性化等方面的投入,還在於對高素質專業人才的需求。
只有在這些方面都達到高標準。
全球的細胞療法才能在保障安全性和有效性的基礎上,為患者提供前沿的治療方案。