Regenerative Medicine Market - Forecasts from 2023 to 2028

The worldwide regenerative medicine market is anticipated to achieve a compound annual growth rate of 25.36% throughout the forecast period, reaching a value of US$122.381 billion by 2028, up from US$25.149 billion in 2021.

Regenerative medicines are making significant progress in the field of medicine due to advances in technology, research, and clinical trials. There are several technologies for regenerative medicines, including stem cell therapies, that have the unique ability to differentiate into many different types of cells in the body. Stem cell therapies involve the transplantation of stem cells into damaged tissues, where they can differentiate into the specific cell types needed for repair and regeneration. Gene therapies involve the delivery of genetic material to cells to correct or replace defective genes. Tissue engineering involves the creation of artificial tissues using cells, scaffolds, and other materials.

Regenerative medicines offer the potential for personalized medicine, where treatments are tailored to individual patients based on their unique genetic and medical profiles. This can lead to more effective and targeted treatments, with fewer side effects.

Regenerative Medicine used in a broad range of Applications.

Further, regenerative medicine has a broad range of applications across various medical fields. They are being investigated for treating heart disease, a leading cause of death worldwide, in neurological disorders, such as Alzheimer's disease, Parkinson's disease, and multiple sclerosis. Stem cell therapies, for example, have shown promise in repairing damaged heart tissue and improving heart function in patients with heart failure. For instance, CRISPR/Cas9 is a gene-editing technology that enables regenerative medicine 2.0 by directing cell fate. The CRISPR/Cas9 system exploits the concerted action of Cas9 nuclease and programmable single guide RNA (sgRNA) and has been widely used for genome editing. Researchers are using CRISPR/Cas9 to protect transplanted cells from the patient's immune system by ex vivo editing. CRISPR/Cas9-based gene therapy has been used to correct hereditary tyrosinemia, a rare metabolic disorder. Researchers at the University of Massachusetts, the Massachusetts Institute of Technology (MIT), and Oregon Health Sciences University (OHSU) succeeded recently in CRISPR-Cas9-based gene therapy.

Additionally, the field of regenerative medicine is rapidly growing, with many different segments and subfields experiencing significant progress and innovation. The driving force behind the development of regenerative medicines includes the increasing prevalence of chronic diseases, the aging population, and the limitations of current treatments for tissue damage and degenerative conditions. Regenerative medicines have the potential to offer more effective and long-lasting solutions for these conditions. The technology used to develop and manufacture regenerative medicnes includes biotechnology, cell culture, gene editing, and nanotechnology. These technologies enable the precise manipulation of cells and genetic material to create customized regenerative therapies.

Scientific and technological advancements in the healthcare sector

The growing need for regenerative medicines in the healthcare sector is mainly due to scientific advancements. Recent advancements in stem cell research have led to the development of new therapies for a wide range of diseases, including heart disease, Parkinson's disease, and diabetes. This is in turn driving the growth of regenerative medicines.  For instance, in 2020, Novartis received approval from the European Medicines Agency for its gene therapy Zolgensma, which is used to treat spinal muscular atrophy. Zolgensma is the world's most expensive medicine, with a list price of $2.1 million per dose.

Moreover, tissue engineering involves the use of biomaterials, cells, and other components to create artificial tissues and organs. Advances in tissue engineering techniques, such as 3D printing and biomaterials development, have led to the creation of functional tissues and organs, such as heart tissue, liver tissue, and skin. For instance, BlueRock Therapeutics, a company focused on developing cell-based therapies for neurological disorders, announced positive preclinical data for its Parkinson's disease program in 2020. The data demonstrated that BlueRock's cell-based therapy improved motor function in animal models of Parkinson's disease.

Additionally, research of disease mechanisms at the molecular and cellular levels has led to the identification of new therapeutic targets and the development of more targeted therapies. This understanding has also led to the identification of biomarkers that can be used to diagnose diseases and monitor treatment effectiveness. Gene editing technologies, such as CRISPR-Cas9, allow researchers to precisely edit and modify genes, which have significant potential for the development of new therapies. For example, gene editing can be used to correct genetic mutations that cause inherited diseases or to enhance the immune system to fight cancer.

Furthermore, government support and funding for regenerative medicine research and development is also a key driver of the regenerative medicine market. Governments around the world are investing in regenerative medicine research and providing funding for clinical trials, which is helping to advance the field and bring new therapies to market. For instance, ana Biotechnology, a company focused on developing cell-based therapies, raised US$700 million in funding in 2020. The funding will be used to advance Sana's pipeline of cell-based therapies, including treatments for cancer and genetic diseases.

The global regenerative medicine market for stem cell therapy technology

Stem cell therapy is a rapidly growing field of regenerative medicine that involves using stem cells to repair or replace damaged tissues and organs. Stem cells are undifferentiated cells that can differentiate into different cell types in the body, which makes them ideal for treating a wide range of diseases and conditions.

The prevalence of chronic diseases such as diabetes, heart disease, and cancer are increasing worldwide, leading to a higher demand for innovative and effective treatments. Stem cell therapy offers a promising solution to treat these conditions by repairing or replacing damaged tissues and organs. The World Health Organization (WHO) estimates that there were 19.3 million new cancer cases and 10 million cancer-related deaths worldwide in 2020. This highlights the significant global burden of cancer and the need for effective treatments such as stem cell therapy. Additionally, the field of stem cell therapy has received significant investment and funding in recent years, which has led to increased research and development of new therapies. The National Institutes of Health (NIH) in the United States is one of the largest government funders of stem cell research. In 2019, the NIH invested over $1.5 billion in stem cell research, demonstrating the significant level of government support for this technology.

Moreover, advances in stem cell technology, such as induced pluripotent stem cells (iPSCs) and CRISPR gene editing, have made it easier to generate and manipulate stem cells, leading to more efficient and effective therapies.

Impact of severe ailments on the market

Furthermore, the prevalence of severe ailments like cancer, dementia, Parkinson’s, and Alzheimer’s disease also has a significant impact on the stem cell therapy segment. Stem cell therapy has the potential to be used in the treatment of various types of cancer, including blood cancers such as leukemia and lymphoma, as well as solid tumors such as breast and lung cancer. The number of cancer cases can drive demand for stem cell therapies as a potential treatment option. For example, in the case of blood cancers, stem cell transplantation is a well-established therapy that can be used to replace diseased or damaged bone marrow with healthy stem cells. As the number of cancer cases increases, the demand for stem cell transplantation is also likely to increase. In addition to being used as a treatment option, stem cell therapy is also a promising area of research for developing new cancer treatments. For example, stem cells can be genetically modified to produce anti-cancer agents or to target cancer cells specifically. This approach has shown promise in preclinical studies and is being explored in clinical trials. As such, the number of cancer cases can have an impact on the stem cell therapy segment of the regenerative medicine market by driving demand for new treatments, increasing investment in research and development, and influencing the availability of funding and resources.

USA in North America is predicted to hold the largest market share for the market

Regenerative medicine enables healthy cells and tissue generation which can replace cells that are damaged due to some major diseases or injuries. Such medicines, due to their high regenerative potential, are finding their way into gene therapies and tissue engineering.

Growing prevalence of cardiovascular and skin diseases coupled with the surge in accidental injuries has provided a positive outlook to regenerative medicines in the United States since such medicines would be used for wound healing in injuries and for replacing irreversibly damaged heart and skin tissue. According to the data provided by the Centers for Disease Control and Prevention, the number of deaths that occurred due to heat attacks in the United States stood at 6,97,000 which signified a 5.7% increase in deaths in comparison to 2019’s death figure. Also, as per the same source, the number of Americans who died due to coronary heart disease stood at 3,82,820.

Skin diseases are also one of the major diseases affecting Americans. According to the American Academy of Dermatology Association, 50 million Americans get affected by skin conditions such as atopic dermatitis, psoriasis, rosacea, and skin cancer on annual basis.

The growing emphasis on regenerative medicine development in the United States market has made various companies to establish their manufacturing facilities in the country. for instance, in April 2022, Enzyvant announced its plan to establish its manufacturing facility in North Carolina. the 25,972 square-foot facility will be focused on developing regenerative medicines for rare diseases such as congenital athymia. besides facilities establishments, the comprehensive regenerative medicine policy announced by the Food and Drug Administration (FDA) in November 2017, has also established a framework for the development of such medicine in the United States, thereby augmenting the overall market growth during the forecast period.

Market Key Developments

• In September 2022, Alkem Laboratories partnered with Stempeutics to introduce the first cell therapy medicine made in India, named "StemOne," which is designed to treat Knee Osteoarthritis. The product has been granted regulatory approval by the Drugs Controller General of India (DCGI), marking the first commercial use of an allogeneic cell therapy product in India for treating Knee OA. StemOne is composed of cultured-pooled, allogeneic mesenchymal stromal cells that are derived from bone marrow.

Segmentation:

By Technology

• Stem cell Therapy
• Gene Therapy
• Tissue Engineering
• Others

By Application

• Cardiovascular
• Oncology
• Dermatology
• Orthopedics and Musculoskeletal
• Wound Healing
• Ophthalmology
• Others

By End-User

• Hospitals
• Clinics
• Others

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