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市場調查報告書

商品編碼

1410147

細胞銀行外包市場：2023年至2028年預測

Cell Banking Outsourcing Market - Forecasts from 2023 to 2028

出版日期: 2023年12月19日 | 出版商:

Knowledge Sourcing Intelligence | 英文 148 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

預計細胞銀行外包市場在預測期內將以 12.65% 的複合年成長率成長。

細胞庫外包包括多種服務，其中包括細胞、細胞株和組織的儲存、收集、表徵和測試等關鍵活動。我們為研發和生物製藥製造提供細胞株、細胞和組織。細胞庫的目標是提供最大功效並最大程度地減少不利事件。細胞銀行外包市場主要是由生物技術產業的快速成長和細胞治療方法的日益採用所推動的。

新興的生技產業正在推動細胞銀行外包市場的擴張。

細胞庫涉及在受控環境中處理和儲存細胞（通常是幹細胞），以供將來用於各種治療和研究應用。對細胞銀行的有利投資可以顯著促進細胞銀行外包市場的成長。例如，2021 年 9 月，領先的幹細胞銀行和生殖檢測服務提供商 LifeCell International 從 OrbiMed Asia Partners 獲得了 225 億盧比的股權融資。籌集的資金將支持公司各部門的成長策略，並幫助擴大其在基因組學領域的測試範圍。

細胞治療方法的興起將推動細胞銀行外包市場的擴張。

細胞庫外包正在細胞療法中得到利用，以滿足對特徵明確且可靠的細胞株不斷成長的需求，這對於先進再生和個人化醫療。基於細胞的療法擴大被採用，因為它們有潛力解決未滿足的醫療需求，提供個體化的治療選擇，並為各種疾病和病症提供有前途的解決方案，從而導致未滿足的關鍵字市場正在推動顯著的成長。根據美國基因細胞治療學會預測，到2022年，基因、細胞和階段，將呈現7%的顯著成長。

監理合規推動細胞銀行外包市場的成長。

細胞庫產業受到嚴格的監管要求的管理，旨在確保藥品製造中使用的生物材料的安全性、有效性和可追溯性。這就是為什麼信譽良好的細胞銀行外包提供者強調嚴格的品質和遵守監管標準。透過保持嚴格的合規性和健全的流程，這些提供者為製藥公司提供了對其細胞庫服務的可靠性和完整性的信心，並幫助推動製藥業的研發和製造活動。我們建立重要且值得信賴的合作夥伴關係。

亞太地區可望成為市場領導

由於政府投資的改善以及旨在促進該地區生物技術產業和推廣細胞療法的舉措，亞太地區將在細胞銀行外包市場中佔據重要佔有率。因此，亞太國家正在為生物技術公司的蓬勃發展創造有利的環境，提供大量的財政支持和支持性政策，從而推動對專業細胞銀行服務的需求。 2023年2月，印度政府宣布了製藥PLI，涵蓋細胞和基因療法藥物等一系列產品，以促進高價值藥品、關鍵原料藥和高階醫療設備的國內製造。已宣布根據該計劃提供16.6 億盧比的獎勵。

保密問題限制了細胞銀行外包市場的成長。

生技公司不願意外包細胞銀行業務是因為擔心與外部合作夥伴共用敏感資訊或專有知識。這種猶豫是細胞銀行外包市場成長的主要抑制因素，因為公司優先考慮保護智慧財產權和管理關鍵生物資產。透過強力的資料保護措施解決這些保密和安全問題，並與外包供應商建立值得信賴的合作夥伴關係，將增強人們對外包流程的信心，並最大限度地發揮細胞銀行外包市場的潛力，這對於退出來說極為重要。

公司產品

符合 cGMP 的細胞庫服務GBI 提供全面的符合 cGMP 的細胞庫服務，包括研究細胞庫、主細胞庫和工作細胞庫（RCB、MCB、WCB）。這些庫是使用受控速率冷凍系統精心準備的，並安全地儲存在低溫液態氮儲存室中。每個細胞庫都根據行業最新的「考慮要點」進行嚴格的測試，以確保寶貴細胞資源的儲存和保存具有最高的品質和法規合規性。

Cell banking outsourcing consists of a diverse array of services that encompass essential activities like the storage, collection, characterization, and testing of cells, cell lines, and tissues. It offers cell lines, cells, and tissues for research and development, as well as biopharmaceutical production. Cell banks aim to provide maximum efficacy and minimize adverse events. The cell banking outsourcing market is primarily driven by the rapid growth of biotech industries and the increasing adoption of cell-based therapies.

Emerging biotech industries drive the cell banking outsourcing market expansion.

Cell banking processes and preserves cells, typically stem cells, in controlled environments for future use in various medical treatments and research applications. Favorable Investments in cell banking can significantly boost the growth of the cell banking outsourcing market. For instance, in September 2021, LifeCell International, a leading provider of stem cell banking and reproductive testing services, secured Rs 225 crore in equity funding from OrbiMed Asia Partners. The raised capital would be instrumental in supporting the company's growth strategy for its various divisions, as well as expanding its range of tests in the genomic sector.

Increasing cell-based therapies drives the cell banking outsourcing market expansion.

Cell banking outsourcing is utilized in cell-based therapies to meet the growing demand for well-characterized and reliable cell lines, which are crucial for the development of advanced regenerative and personalized medicines. The expanding adoption of cell-based therapies stems from their potential to address unmet medical needs, provide personalized treatment options, and offer promising solutions for various diseases and conditions, driving significant growth in the cell banking outsourcing market. According to the American Society of Gene Cell Therapy, In the year 2022, the pipeline of gene, cell, and RNA therapies witnessed a notable growth of 7%, encompassing preclinical to pre-registration stages.

Regulatory compliance drive cell banking outsourcing market growth.

The cell banking industry is governed by stringent regulatory requirements aimed at guaranteeing the safety, efficacy, and traceability of biological materials utilized in pharmaceutical production. As a result, reputable cell banking outsourcing providers place great emphasis on adhering to rigorous quality and regulatory standards. By maintaining strict compliance and implementing robust processes, these providers instill confidence in pharmaceutical companies regarding the reliability and integrity of their cell banking services, thus fostering a trustworthy partnership that is essential for advancing research, development, and manufacturing activities in the pharmaceutical sector.

Asia-Pacific is expected to be the market leader

Asia Pacific will hold a significant share of the cell banking outsourcing market due to the improved government investments and initiatives aimed at fostering biotech industries and advancing cell-based therapies in the region. Hence, with substantial financial support and supportive policies, Asian-Pacific countries have cultivated a conducive environment for biotech companies to flourish, thereby increasing the demand for specialized cell banking services. In Feb 2023, to boost domestic production of high-value formulations, critical APIs (Active Pharmaceutical Ingredients), and high-end medical devices, the government of India released Rs. 166 Crores in incentives under the PLI scheme for Pharmaceuticals encompassing various products, including cell-based or gene-therapy drugs.

Confidentiality concerns restrain the cell banking outsourcing market growth.

The reluctance of biotech companies to engage in cell banking outsourcing stems from their concerns about sharing sensitive information and proprietary knowledge with external partners, primarily due to the perceived risk of data breaches or breaches of confidentiality. This hesitancy can act as a significant restraint for the cell banking outsourcing market growth, as companies prioritize safeguarding their intellectual property and maintaining control over critical biological assets. Addressing these confidentiality and security concerns through robust data protection measures and building trusted partnerships with outsourcing providers is crucial to fostering greater confidence in the outsourcing process and unlocking the full potential of the cell banking outsourcing market.

Key Developments

June 2023: Extracellular, a pioneering company in the cultivated meat industry, announced the launch of license-free cell banks dedicated to supporting cultivated meat research. These cell banks are equipped with primary cells specifically relevant to cultivated meat studies and have been developed through funding from InnovateUK, in collaboration with Multus. By providing access to these specialized cell resources without licensing fees, Extracellular aims to accelerate research and innovation in the field of cultivated meat, promoting sustainable and ethical alternatives to traditional meat production methods.
April 2023: AnaBios, a San Diego-based preclinical contract research organization (CRO), completed the acquisition of Cell Systems, a group specializing in human primary cells and cell culture media. This strategic deal enables AnaBios to enhance its portfolio with a broader range of human tissue and cells, further strengthening its capabilities to provide comprehensive preclinical research services.
January 2023: The Technology Partnership company introduced a spin-out entity called Cellular Origins, aimed at revolutionizing the production of cell and gene therapies with scalable and cost-effective manufacturing solutions. Cellular Origins offers a proprietary technology that tackles the challenges of manufacturing advanced therapies in later stages of development. Their adaptable automated sterile fluidic end-to-end interconnection system can seamlessly integrate into existing and future bioprocess equipment, enabling comprehensive automation across the manufacturing workflow.
June 2021: Generate Life Sciences (Generate) has recently made an acquisition of the Cell Care international cord blood banking group (Cell Care), encompassing Cell Care in Australia, along with Inspection Lifebank and Cells for Life in Canada. With this merger, Cell Care becomes a part of Generate's Cord Blood Registry, forming a global network of newborn stem cell banks dedicated to advancing collective research in regenerative medicine.

Company Products

cGMP-compliant cell banking services: GBI offers comprehensive cGMP-compliant cell banking services, encompassing research, master, and working cell banks (RCB, MCB, and WCB). These banks are meticulously prepared using a controlled-rate freezing system and securely stored in cryogenic vapor-phase liquid nitrogen storage chambers. Each cell bank undergoes rigorous testing, adhering to the latest industry Points to Consider, ensuring the highest quality and regulatory compliance for the storage and preservation of valuable cell resources.

Segmentation

By Type

Master Cell Banking
Working Cell Banking
Viral Cell Banking

By Cell

Stem Cell
Non-Stem Cell

By Phase

Bank Storage
Bank Characteristics & Testing
Bank Preparation

By Geography

North America
United States
Canada
Mexico
South America
Brazil
Argentina
Others
Europe
United Kingdom
Germany
France
Spain
Others
Middle East and Africa
Saudi Arabia
UAE
Israel
Others
Asia Pacific
Japan
China
India
South Korea
Indonesia
Thailand
Others

1. INTRODUCTION

1.1. Market Overview
1.2. Market Definition
1.3. Scope of the Study
1.4. Market Segmentation
1.5. Currency
1.6. Assumptions
1.7. Base, and Forecast Years Timeline

2. RESEARCH METHODOLOGY

2.1. Research Data
2.2. Assumptions

3. EXECUTIVE SUMMARY

3.1. Research Highlights

4. MARKET DYNAMICS

4.1. Market Drivers
4.2. Market Restraints
4.3. Porter's Five Force Analysis
- 4.3.1. Bargaining Power of Suppliers
- 4.3.2. Bargaining Power of Buyers
- 4.3.3. Threat of New Entrants
- 4.3.4. Threat of Substitutes
- 4.3.5. Competitive Rivalry in the Industry
4.4. Industry Value Chain Analysis

5. CELL BANKING OUTSOURCING MARKET, BY TYPE

5.1. Introduction
5.2. Master Cell Banking
5.3. Working Cell Banking
5.4. Viral Cell Banking

6. CELL BANKING OUTSOURCING MARKET, BY CELL

6.1. Introduction
6.2. Stem Cell
6.3. Non-stem Cell

7. CELL BANKING OUTSOURCING MARKET, BY PHASE

7.1. Introduction
7.2. Bank Storage
7.3. Bank Characteristics & Testing
7.4. Bank Preparation

8. CELL BANKING OUTSOURCING MARKET, BY GEOGRAPHY

8.1. Introduction
8.2. North America
- 8.2.1. United States
- 8.2.2. Canada
- 8.2.3. Mexico
8.3. South America
- 8.3.1. Brazil
- 8.3.2. Argentina
- 8.3.3. Others
8.4. Europe
- 8.4.1. United Kingdom
- 8.4.2. Germany
- 8.4.3. France
- 8.4.4. Spain
- 8.4.5. Others
8.5. The Middle East and Africa
- 8.5.1. Saudi Arabia
- 8.5.2. UAE
- 8.5.3. Israel
- 8.5.4. Others
8.6. Asia Pacific
- 8.6.1. Japan
- 8.6.2. China
- 8.6.3. India
- 8.6.4. South Korea
- 8.6.5. Indonesia
- 8.6.6. Thailand
- 8.6.7. Others