Autologous Stem Cell & Non-stem Cell Therapies Market: Growth, Size, Share, and Trends

Market Growth Outlook Summary

The global autologous stem cell & non-stem cell therapies market growth forecasted to transform from USD 5.5 billion in 2024 to USD 22.2 billion by 2029, driven by a CAGR of 32.3%. The major factors driving the growth of this market are the rising regulatory approvals for autologous CAR T cell therapies, increasing R&D investments in autologous therapeutics, and growing demand for personalized medicines.

Autologous Stem Cell & Non-stem Cell Therapies Market Trends

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Attractive Opportunities in Autologous Stem Cell & Non-Stem Cell Therapies Market

Global Autologous Stem Cell & Non-Stem Cell Therapies Market Dynamics

Driver: Rising Approvals for CAR T cell therapies

The growing regulatory approvals for various autologous CAR T cell therapies for the treatment of various forms of cancers such as multiple myeloma and lymphoma is a major driving factor for the growth of this market. There has been a consistent growth in the number of regulatory approvals received for these drugs. For instance, the October 2023 approval of NexCAR 19, an autologous CAR T cell therapy developed by an Indian biopharmaceutical startup, ImmunoACT highlighted the ongoing developments in the field of autologous non-stem cell-based therapies. A strong clinical pipeline exists for these drugs, with multiple autologous CAR T cell-based therapeutic products being developed for other diseases such as autoimmune and chronic diseases.

Restraint: Uptake of allogeneic cell-based therapies as substitutes

Allogenic cell-based therapies involve the use of health donor-derived cells for the development of cell-based therapies rather than using the patient’s cells. These therapies offer various advantages such as an improved quality of sourced cells selected from health donors, leading to a more robust and predictable manufacturing process. Additionally, allogenic cell-based therapies can be developed on a large scale in a single batch, allowing for scaled-up business processes and lower production costs. These therapies also offer “off-the-shelf treatments” eliminating the need for modification of patients’ cells at central manufacturing facilities or point-of-care facilities. These advantages offered by allogenic therapies are hindering the widespread adoption of autologous stem cell & non-stem cell therapies.

Opportunity: Rising outsourcing of manufacturing activities

Challenges associated with in-house manufacturing such as cost and complexities associated with building and maintaining specialized facilities, equipment, and expertise pose a significant financial burden, especially for early-stage companies. In recent years there has been an increase in outsourcing manufacturing activities for therapy development. Outsourcing offers various benefits such as reduced cost and complexities of development. These organizations also offer support for navigating the regulatory landscape associated with autologous stem cell & non-stem cell therapies. In 2023, Bristol-Myers Squibb Company (US) entered into a manufacturing agreement with Cellares (US), an Integrated Development and Manufacturing Organization (IDMO). This agreement allowed Bristol to reserve a spot in the automated cell manufacturing units of Cellars, known as Cell Shuttle. These contract development and manufacturing organizations (CDMOs) streamline the manufacturing process expediting the therapy launches. This allows the therapy developer companies to focus on their core strengths of drug discovery and development, innovation, and therapeutic pipeline expansion. Companies like Charles River Laboratories. (US), Catalent, Inc. (US), Thermo Fisher Scientific Inc. (US), FUJIFILM Corporation (Japan), and BioCentriq, Inc. (US), among others, offer CDMO services for the development & manufacturing of cell and gene therapies.

Challenge: Stringent regulatory guidelines and reimbursement challenges

The regulatory landscape for autologous stem cell & non-stem cell therapies presents a challenging environment for developers and healthcare providers. Due to variations in regulatory frameworks across different regions, a non-tariff barrier is created hindering the entry of innovative medicines into global markets. Navigating the regulatory landscape in developing countries such as India, South Korea, and Japan is often more time-consuming and resource-intensive, and hence therapy developers often first target developed markets like the US and Europe. These markets have a higher per capita income allowing the patients to spend more for these therapies. While efforts to accelerate the approval process for innovative medicines are going on around the world, differences in regional pricing and reimbursement policies hinder the widespread accessibility of these therapies. The lack of comprehensive evidence supporting the efficacy of autologous cell therapies further complicates the reimbursement process and access.

Industry Ecosystem/Map

The Autologous Non-Stem Cell Therapies segment accounted for the largest share of the autologous stem cell & non-stem cell therapies industry in 2023.

Based on type the autologous stem cell & non-stem cell therapies market is divided into autologous stem cell therapies and autologous non-stem cell therapies. In 2023, the autologous non-stem cell therapies segment held the largest share of the autologous stem cell & non-stem cell therapies market. The major factors driving the growth of this segment are the increasing number of regulatory approvals for autologous non-stem cell therapies, specifically CAR T cell therapies for the treatment of various forms of cancer such as multiple myeloma and lymphoma, and growing research on the development of autologous cell therapies against other indications such as solid tumors, and autoimmune disorders, that affect a larger patient population. Growing awareness about alternative therapies and the potential of autologous cell-based therapeutic drugs to treat diseases that were previously deemed untreatable are other factors that propel the market of autologous non-stem cell therapies.

The cancer indication segment dominated the autologous stem cell & non-stem cell therapies industry in 2023.

Based on indication, the autologous stem cell & non-stem cell therapies market is segmented into cancer indications, musculoskeletal, dermatological, and other indications. In 2023, the cancer indication segment held the largest market share in the global autologous stem cell & non-stem cell therapies market owing to the increasing approval for autologous non-stem cell therapies such as CAR T cell-based therapies and Tumor Infiltrating Lymphocyte (TIL) therapies for the treatment of various cancers. The focus of the industry leaders to expand the use of autologous cell therapies to other forms of cancers such as solid tumors will further propel the market of autologous stem cell & non-stem cell therapies.

North America was the largest regional market for autologous stem cell & non-stem cell therapies industry in 2023.

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The global autologous stem cell & non-stem cell therapies market is segmented into six major regions—North America, Europe, the Asia Pacific, Latin America, the Middle East, and Africa. North America was the largest segment in 2023 in the autologous stem cell & non-stem cell therapies market, followed by Asia Pacific and Europe region. North America, comprising the US and Canada, is the largest regional segment in the autologous stem cell & non-stem cell therapies market. This regional segment is projected to grow at the highest CAGR during the forecast period. The increasing R&D investments in the field of autologous cell therapies and the growing focus on developing personalized therapeutics for various diseases are major factors supporting the large share of this market. The presence of a large number of major players in this region such as Gilead Sciences, Inc. (US), Bristol-Myers Squibb Company (US), Johnson & Johnson (US), Iovance Biotherapeutics, Inc. (US), Vericel Corporation (US) among others, is another key factor contributing to the large share of this market segment.

Key players in the market include Gilead Sciences, Inc. (US), Bristol-Myers Squibb Company (US), Johnson & Johnson (US), Vericel Corporation (US), Novartis AG (Switzerland), JW (Cayman) Therapeutics Co. Ltd (China), Iovance Biotherapeutics, Inc. (US), APAC Biotech (India), Regrow Biosciences Pvt Ltd. (India), healiva SA (Switzerland), Tegoscience (South Korea), ImmunoACT (India), CARsgen Therapeutics Holdings Limited (China), IASO Biotherapeutics (China), Pharmicell Co., Ltd (South Korea), Anterogen.Co., Ltd. (South Korea), Green Cross Holdings Co., Ltd. (GC Cell) (Republic of Korea)), Sanpower Group Co., Ltd. (Dendreon Pharmaceuticals Llc. (China)

Scope of the Autologous Stem Cell & Non-stem Cell Therapies Industry

This report categorizes the autologous stem cell & non-stem cell therapies market to forecast revenue and analyze trends in each of the following submarkets:

By Type

• Autologous Stem Cell Therapies
• Autologous Non-Stem Cell Therapies
  • Car T Cell Therapies
  • Tumor Infiltrating Lymphocyte

By Indication

• Cancer Indications
• Musculoskeletal Indications
• Dermatological Indications
• Other Indications

By Source

• T-Cells
• Mesenchymal Stem Cells

By End User

• Hospitals & Clinics
• Long-term Care Facilities
• Specialty Care Centers

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East
  • GCC
    • Saudi Arabia
    • United Arab Emirates
    • Rest of GCC
  • Rest of the Middle East
• Africa

Recent Developments of the Autologous Stem Cell & Non-Stem Cell Therapies Industry:

• In April 2024, Bristol-Myers Squibb Company (US) entered into a worldwide capacity reservation and supply agreement with Cellares (US) for the manufacturing of CAR T-cell therapies using Cellares’s automated & high-throughput manufacturing platform called Cell Shuttle.
• In October 2023, Kite Pharma a subsidiary of Gilead Sciences, Inc. (US) collaborated with Epicrispr Biotechnologies, Inc. (US) for the uptake of regulation technology for the development of next-generation cancer cell therapies, with the enhancement of CAR T cell functionality.

Frequently Asked Questions (FAQ):