Generative Medicine Series: Strategy and Layout of Biomedical Startups in the Clinical Application Field of Mesenchymal Stem Cells (Part 1)

Currently, the regenerative market is experiencing rapid expansion, with mesenchymal stem cells holding a significant share and being widely utilized. This article provides a comprehensive analysis of the market's entry points and strategies.

After reading this article, you will:

1. Gain knowledge about regenerative medicine, specifically focusing on MSC (Mesenchymal Stem Cells) and MSC-EV (Extracellular Vesicles).
2. Obtain a comprehensive overview of the stem cell industry chain, including identifying pain points and opportunities in the upstream, middle stream, and lower stream.
3. Acquire marketing insights for developing future strategies to enter the MSC market.

The article is divided into two parts. Part 1 consists of sections 1-4, while part 2 will cover sections 5-9.

Introduction to Mesenchymal Stem Cells (1)- MSC

First, let's take a look at the overall structure. Regenerative medicine can be divided into various categories, and within the field of cell therapy, stem cells are highly acclaimed due to their immense potential. Some scientists even believe that stem cells have the potential to cure aging. (Note: We will discuss the potential application in aging in another article) Stem cells can be classified into two categories based on their developmental process: embryonic stem cells and adult stem cells. In this part, we will introduce mesenchymal stem cells, which belong to adult stem cells.

Mesenchymal stem cells possess at least eight characteristics

1. Pluripotency and self-renewal: They can differentiate into different types of cells (such as bone cells, cartilage cells, and nerve cells) while maintaining their ability for self-replication and activity.
2. Immune regulation and immunogenicity: They regulate relevant mechanisms to reduce inflammation and has the potential to decrease the rejection rate of allogeneic transplantation.
3. Advantages in clinical trials: They are easy to isolate and expand, with various sources of isolation (such as bone marrow, adipose tissue, and umbilical cord). They are also easy to culture for therapeutic applications.
4. Good safety profile: Many clinical trials have shown relatively reliable stability and minimal side effects.
5. Secretory activity and paracrine effects: They secrete bioactive molecules that promote tissue repair and enhance tissue regeneration.

Due to these characteristics, mesenchymal stem cells are widely applied in various fields of regenerative medicine, including neurodegenerative diseases, organ tissue reconstruction, heart disease, and even COVID-19. In addition, mesenchymal stem cells themselves secrete extracellular vesicles (EVs), which include exosomes, microvesicles, and autophagosomes.

As mesenchymal stem cell-derived extracellular vesicles (MSC-EVs) possess even greater capabilities than MSCs, let us focus on their potential.

Introduction to Mesenchymal Stem Cells (2)- MSC-EVs

Extracellular vesicles, with a size ranging from 30 to 150 nanometers, have strong transmission and permeation abilities. They exhibit biological activity and can regulate cells, offering potential therapeutic effects. Through these substances, they can promote various mechanisms in the body, potentially facilitating tissue regeneration. Similar to mesenchymal stem cells, they possess similar characteristics in immune regulation, regeneration, and immunogenicity. They may even surpass mesenchymal stem cells in terms of immune regulation, safety, and other aspects. Moreover, they demonstrate storage stability and can adapt to different environments, including freezing conditions. They also have the potential for targeted delivery, which can be enhanced through modification or editing.

This lower right chart also presents the current application areas, including in organs, tissues, and bones.

Global Market Trend of Mesenchymal Stem Cells

After introducing mesenchymal stem cells and their secretome, let's understand the current market status and future predictions for mesenchymal stem cells.

The data presented here is primarily sourced from publicly available information of large listed marketing companies (listed in the chart), as well as our desk research.

Firstly, it should be noted that mesenchymal stem cells alone account for more than 50% of the stem cell market.

Secondly, in general, the compound annual growth rate (CAGR) of the mesenchymal stem cell market from 2023 to 2030 is estimated to be 12.8%, growing from 310 million USD to 720 million USD. If we divide the market into North America, Europe, Asia, Latin America, the Middle East, and Africa, we find that North America currently has the largest market share, at around 44%. This is primarily due to the presence of world-class pharmaceutical companies in this region.

However, if we look at the Asian market alone, it has the highest CAGR of 14.5%. This is mainly attributed to the large population in China.

Now that we have an understanding of the overall market potential for mesenchymal stem cells, let's delve deeper into the situation of assembling the entire industry chain. This is because the opportunities for the application of mesenchymal stem cells are hidden within this chain.

Stem Cell Therapy Value Chain- Value Chain Overview

Let's start with the upstream sector.

The upstream sector primarily involves stem cell collection and storage, including umbilical cord blood, umbilical cord, placenta, bone marrow stem cells, and more.

This area can be divided into two aspects. First is the collection process, which requires qualified personnel, technical expertise, equipment, and facilities. It needs to meet the quality management standards of stability and SOP (Standard Operating Procedures).

The storage aspect requires relevant technical equipment, including the establishment of a complete cold chain. This part is the most mature in the entire industry, as it is relatively straightforward.

Next is the midstream sector.

Here, the focus is on drug development, research and development of technologies, matching with cell banks, and managing international transportation chains. The development of technologies includes aspects such as freezing/thawing techniques, establishment of stem cell transplantation/culturing models, and ensuring stability.

Using Taiwan as an example, it is worth noting that several major pharmaceutical companies have engaged in development collaborations in this field. However, it is important to highlight that Taiwanese companies operating in this sector are generally smaller to medium-sized enterprises that rely on government support and assistance.

Lastly, the downstream sector.

This sector primarily involves clinical trials and disease treatment, providing possibilities for product commercialization in various fields, including diseases, technologies, and medical aesthetics.

To Sum up

In essence, there may be overlaps between the upstream, midstream, and downstream sectors, and it is common for many companies to integrate across the industry chain.

To accommodate the lengthy paragraph, the discussion on sections 5-9 will be continued in part 2.

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