Regenerative Medicine Market Size, Share & Trends Analysis Report By Product (Cell-based Immunotherapies, Gene Therapies), By Therapeutic Category, By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global regenerative medicine market size was valued at USD 25.92 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 16.8% from 2023 to 2030 Several advancements in biological therapies have shifted the preference toward personalized medicinal strategies over traditional treatment methods. This has created significant opportunities for market players who are involved in biological therapeutics development. The COVID-19 outbreak has considerably impacted various markets, including the regenerative medicine and T-cell therapy manufacturing market. The SARS-CoV-2 coronavirus crisis has significantly affected the delivery of CAR T-cell therapies. This impact is not just limited to patient care but has extended to administration, logistics, and limited healthcare resources. Several universities have slowed down clinical trial enrollment and other research activities. However, the market continues to expand as market players such as Novartis provide access to therapies such as Athersys, Inc.’s MultiStem, which is a highly relevant COVID-19 therapy.

Furthermore, regenerative medicines have been identified to have the unique ability to alter the fundamental mechanisms of diseases. Regenerative therapies in trials provide promising solutions for specific chronic indications with unmet medical needs. In December 2021, Novartis announced the introduction of T-Charge™, a next-generation CAR-T platform that would be a beneficial tool for novel investigational CAR-T cell therapies.

Significant advancements in molecular medicines have resulted in the development of gene-based therapy, which uses targeted delivery of DNA as a medicine to fight against various disorders. Gene therapy has high potential in the treatment of cancer and diabetes type 1 & 2 through restoring gene function. Currently, gene-based therapies are used in the treatment of patients suffering from cancer, oncology, infectious diseases, cardiovascular disorders, monogenic diseases, genetic disorders, ophthalmological indications, and diseases of the central nervous system. These factors have contributed to the growth of the regenerative medicine market.

Product Insights

The therapeutics segment held accounted for over 70% of the revenue share of the regenerative medicine market in 2022, owing to the rising geriatric population, coupled with higher incidence rates of age-related as well as degenerative disorders. The increased prevalence of diseases with unmet medical solutions, such as cancer, diabetes, and neurodegenerative diseases, including AMD, has encouraged researchers to develop alternative options. For instance, in April 2022, Kite, a Gilead Company, announced that it had received the U.S. FDA's authorization for its CAR T-cell therapy product, Yescarta, which could be used for the treatment of refractory or relapsed large B-cell lymphoma.

The banks segment is projected to witness considerable growth in the coming years. Considerable investment has been made to establish bio-banks, including tissue and cord blood banks, to provide the perceived research benefits. These banks comprise systematically organized and maintained cell lines for single or multi-use by researchers, healthcare providers, and other stakeholders. Stem cells and biologically engineered tissues are the most significant tools used in regenerative medicine. Thus, these banks are an important part of the regenerative medicine market.

Therapeutic category Insights

The oncology segment dominated the regenerative medicine market in 2022, capturing a revenue share of 31.41%, owing to the growing burden of cancer globally. Various government organizations along with private companies have made high investments in cancer research and the development of regenerative & advanced cell therapies. In January 2023, Calidi Biotherapeutics (CBT) and First Light Acquisition Group (FLAG) entered into a partnership agreement that aims to revolutionize oncolytic virotherapies with the help of stem cell-based platforms.

The cardiovascular segment is anticipated to witness significant growth during the forecast period. Advancements in cell-based therapies and regenerative medicines have accelerated the growth of the segment. Many key players are involved in the development of regenerative therapies to repair, restore, and revascularize damaged heart tissues. There is a growing adoption of single and mixed cells from autologous as well as allogeneic sources to study the effect on CVDs. In addition, advanced biologics, small molecules, and gene therapy are being investigated to stimulate the regeneration of damaged heart cells. These factors would further fuel the regenerative medicine market growth.

Regional Insights

The North America region dominated the regenerative medicine market, capturing a market share of 51.32% in 2022. The high market growth is attributed to the availability of government and private funding for development, the presence of advanced tech frameworks to support the rapid detection of chronic diseases, and high healthcare spending in the region. Moreover, several ongoing clinical trials for regenerative medicine by significant market players have contributed to the region’s growth. In December 2021, Bristol Myers Squibb received U.S. FDA approval for Orencia for the prevention of acute graft versus host disease in adults and pediatric patients 2 years of age and older, undertaking hematopoietic stem cell transplantation (HSCT).

Asia Pacific is anticipated to witness the fastest growth rate in the coming years. This growth is attributed to the rapid adoption of cell-based approaches in healthcare, the rising geriatric population in the region, and the emergence of key players. In recent years, China has emerged with rapid expansion in infrastructure and facilities to accelerate stem cell research. This, in turn, is anticipated to fuel the growth of regenerative medicine in the region.

Key Companies & Market Share Insights

Major players operating in the regenerative medicine market are focused on strategic partnerships, collaborations, and regional expansions in favorable regions. For instance, in September 2021, AstraZeneca PLC planned to invest USD 360 million in an advanced manufacturing facility in Ireland. This initiative was expected to transform the development and commercialization of novel medicines. In December 2021, Pfizer, Inc. invested USD 68.5 million in a new state-of-the-art facility in Durham to expand its capabilities in gene therapies. This initiative was expected to help strengthen the company’s presence in the U.S. Some of the companies in the global regenerative medicine market are:

• AstraZeneca plc

• F. Hoffmann-La Roche Ltd.

• Integra Lifesciences Corp.

• Astellas Pharma, Inc.

• Cook Biotech, Inc.

• Bayer AG

• Pfizer, Inc.

• Merck KGaA

• Abbott

• Vericel Corp.

• Novartis AG

• GlaxoSmithKline (GSK)

• Baxter International, Inc.

• Boehringer Ingelheim

• Amgen Inc.

• Cesca Therapeutics, Inc.

• U.S. Stem Cell, Inc.

• Bristol-Myers Squibb

• Eli Lilly and Company

• NuVasive, Inc.

• Organogenesis, Inc.

• MiMedx Group, Inc.

• Takara Bio, Inc.

• Osiris Therapeutics, Inc.

• Corline Biomedical AB

Recent Developments

• In January 2022, Novartis unveiled a strategic collaboration with Alnylam to harness Alnylam's established siRNA technology in inhibiting a target identified at Novartis Institutes for BioMedical Research. By merging regenerative medicine principles with cutting-edge siRNA technology, both companies aim to create a potential treatment fostering the regrowth of functional liver cells, offering an alternative to transplantation for patients suffering from liver failure.

• In July 2022, Mogrify Limited and Astellas Pharma Inc. announced a collaborative research agreement to develop regenerative medicine approaches for sensorineural hearing loss. Astellas Gene Therapies will fund the research and provide expertise in AAV-based genetic medicine, while Mogrify will leverage its bioinformatic platform for screening and validation to identify potential therapeutic factors. Their shared goal is to transform the lives of patients with hearing loss through innovative regenerative therapies

• In October 2022, Astellas Pharma Inc. and Pantherna Therapeutics GmbH announced a technology evaluation agreement to develop mRNA-based regenerative medicine programs through direct reprogramming. Their collaborative effort aims to expand treatment options for diseases with high unmet medical needs by targeting new organs

• In November 2022, AstraZeneca disclosed its acquisition agreement with Neogene Therapeutics Inc., aiming to bolster its portfolio in the field of cell therapies targeting solid tumors. This strategic move aligns with both companies' vision to develop TCR-Ts (T cell receptor T cell therapies) capable of recognizing cancer-specific mutations and intracellular targets, thereby expanding their presence in the dynamic field of regenerative medicine

• In March 2021, Amgen Inc. acquired Rodeo Therapeutics Corporation, specializing in the 15-PGDH program for developing regenerative therapies in inflammatory diseases. By targeting 15-PGDH's role in stem cell self-renewal and epithelial barrier repair, these therapies hold promise for regenerative potential in critical inflammatory conditions. This acquisition demonstrates the potential of combining regenerative medicine principles with small-molecule therapies to improve patient outcomes in tissue regeneration and repair.

Regenerative Medicine Market Report Scope

Global Regenerative Medicine Market Segmentation

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global regenerative medicine market report based on product, therapeutic category, and region:

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Therapeutics

    • Primary cell-based therapeutics

      • Dermatology

      • Musculoskeletal

      • Surgical

      • Dental

      • Others

    • Stem Cell & Progenitor Cell-based therapeutics

      • Autologous

      • Allogenic

      • Others

    • Cell-based Immunotherapies

    • Gene Therapies

  • Tools

  • Banks

  • Services

• Therapeutic Category Outlook (Revenue, USD Million, 2018 - 2030)

  • Dermatology

  • Musculoskeletal

  • Immunology & Inflammation

  • Oncology

  • Cardiovascular

  • Ophthalmology

  • Others

• Regional  Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • China

    • India

    • Japan

    • South Korea

    • Australia

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait