Regenerative Medicine Market

Market Overview

The global regenerative medicine market size was valued at USD 13.4 Billion in 2022. It is expected to reach USD 72.2 Billion by 2031, growing at a CAGR of 17.6% during the forecast period (2023–2031).

Regenerative medications are used to restore, replace, and regenerate tissues and organs damaged by trauma, illness, or aging naturally. These drugs treat a variety of degenerative conditions, including dermatological and neurological illnesses, cardiology, and orthopedics, by restoring the functionality of cells and tissues. Cell therapy treats patients with cellular components like stem cells, autologous cells, xenogeneic cells, and others. Cell therapy is used in regenerative medicine to repair damaged cells, deliver treatments to specific tissues or organs, promote self-healing, and other ways. In order to treat or prevent diseases, gene therapy involves the therapeutic delivery of nucleic acid polymers or genes into a patient's cells.

Highlights

• Cell therapy dominates the type segment 
• Biologically derived dominates the material segment
• Americas is the highest contributor to the market

Market Dynamics

Global Regenerative Medicine Market Drivers

Availability of Resources and Rising R&D Expenditures

Research activity has increased due to the growing need for better treatments for diseases like cancer, diabetes, skin conditions, musculoskeletal disorders, chronic wounds, burns, and CVD. This has increased the amount of funding available for research in regenerative medicine. There is an increasing need for funding because new cell therapies, gene therapies, and tissue-engineered products are expensive to manufacture and develop. According to the Alliance for Regenerative Medicine (ARM), significant investors Amgen, Sanofi, and Gilead Sciences helped investments reach USD 22,700 million in 2021, surpassing USD 19,900 million in 2020.

Innovative Pipeline Candidates to Support Market Development

Regenerative medicine is increasingly used in oncology, cardiology, and neurology, as well as treating wounds and mending tissue. The launch of potential candidates that are still in development, which will result in the introduction of novel products and therapies in the market, is one reason why many pharmaceutical and life science companies are conducting clinical trials to establish their dominance over conventional treatment methods.

Global Regenerative Medicine Market Restraints

Ethical Issues with Embryonic Stem Cell Use

Stem cell technology holds enormous promise for understanding the fundamental process of human growth and differentiation to develop state-of-the-art therapies for chronic diseases like cancer and diabetes as well as rare genetic disorders like spinal muscular atrophy, Parkinson's disease, cystic fibrosis, etc. In addition, blood and immune system genetic diseases have been treated with adult stem cells, primarily hematopoietic stem cells and bone marrow transplants. But in the past, research on stem cell technology has frequently sparked political controversies and raised serious ethical questions.

Global Regenerative Medicine Market Opportunities

Expanding Consumer Acceptance of Cancer Immunotherapy Products

Normal cells undergo a multi-stage process that typically starts with a precancerous lesion and progresses to a malignant tumor before becoming tumor cells, which is how cancer is brought on. The interaction of a person's hereditary factors results in these changes. By 2020, cancer will be the leading cause of death worldwide, killing about 10 million people. A correct cancer diagnosis is essential for appropriate and efficient treatment because each type necessitates a different treatment strategy.

Surgery, radiotherapy, and chemotherapy are frequently used to treat cancer. Cancer immunotherapy employing regenerative medicine has the advantage of being able to do so because hematopoietic stem or higher-developed cells inherently have the ability to target and eliminate disease cells. Additionally, it enables a deeper comprehension of cancer cells, which advances the creation of efficient cures. As a result, opportunities for market expansion will be created by both rising disease prevalence and rising product demand for cancer treatment.

Regional Analysis

By region, the global regenerative medicine market is segmented into America, Europe, Asia-Pacific, and the Middle East and Africa.

Americas Dominates the Global Market

Americas is the most significant shareholder in the global regenerative medicine market and is expected to grow at a CAGR of 20.30% during the forecast period. The 21st Century Cures Act, an increase in investor funding, favorable government policies, and the establishment of organizations like the American Academy of Regenerative Medicine (AARM) and the American Board of Regenerative Medicine (ABRM) for setting regulatory standards and promoting excellence in the field of regenerative medicine all contributed to the Americas holding the lion's share of the market. The Regenerative Medicine Innovation Project (RMIP) was created by the 21st Century Cures Act. In addition, with a focus on patient safety and scientific rigor, this project supports adult stem cell research and clinical trials to advance regenerative medicine. Under the 21st Century Cures Act, the National Institutes of Health (NIH) RMIP was granted 30 million USD over four years for clinical trials and research to advance the field of regenerative medicine using adult stem cells. In addition, to put RMIP into action, the NIH has been closely collaborating with the US Food and Drug Administration (FDA). Over the past ten years, the FDA has authorized several stem cell-based therapies for clinical research, many of which have already entered clinical trials.

Europe is expected to grow at a CAGR of 21.58% during the forecast period. Europe also held a substantial market share due to the success of pan-European efforts (including CHRODIS and CHRODIS PLUS), government initiatives, public and commercial research funders, and cooperative scientific research projects in regenerative medicine. Over half a million people in the UK were diagnosed with a genetic disorder, according to a case study conducted by the Royal Society in 2017, the oldest continuously operating scientific academy. In addition, Familial hypercholesterolemia is one of these genetic disorders that is more prevalent in the UK than others. Familial hypercholesterolemia affects about 0.4% of the nation's population, or about 1 in 250 people. Even though some of these illnesses are more common than others, some are comparably more common in certain ethnic groups. For instance, Scotland has almost twice as many cystic fibrosis patients as the rest of the world. In addition, environmental factors, chromosomal damage, and gene mutations contribute to the rising prevalence, mortality, and lifetime risk of genetic disorders.

Asia-Pacific is regarded as important for regenerative medicine therapy due to changes in the healthcare infrastructure, international scientific research collaborations, and training of researchers and young faculty at top institutions for tissue engineering and stem cell-based research. In addition, through a combination of clinical studies, contemporary developments in human genetics, and stem cell technology, the Department of Biotechnology, part of the Ministry of Science and Technology, Government of India, implemented a joint Indo-Japan collaborative research program to address significant disorders related to brain and blood among the Indian population. The curriculum has a strong induced pluripotent stem cell (iPSC) research training component. At the Center for iPSC, research and applications (CiRA) at Kyoto University, Kyoto, Japan, researchers, and aspiring faculty members are exposed to the most recent developments in iPSC research to close the curriculum gap. 

Additionally, the prevalence of diabetes and cancer has been rising alarmingly, necessitating permanent or advanced treatments/therapies over those currently available. These elements are anticipated to increase demand for regenerative medicine-based therapies and treatments in the region, which is expected to fuel the market's expansion during the forecast period.

The Middle East and Africa have the smallest market share for regenerative medicine because of regional political unrest, which has led to a regional decline in regenerative medicine investments. In the Gulf Cooperation Council (GCC), regenerative medicine has become widely used in wound care, cardiology, neurology, orthopedics, dermatology, plastic surgery, and organ transplantation. However, regenerative medicine has largely been restricted to orthopedics, dermatology, and plastic surgery, restraining the market's expansion. 

Additionally, a sizeable proportion of the people in the area are afflicted with genetic illnesses like thalassemia and sickle cell anemia. The use of cord blood has been shown to be a successful treatment for such genetic diseases. Still, the treatment has been hampered by the region's small number of cord blood banks, limiting the market growth of regenerative medicines. Nevertheless, the region's regenerative medicine market will grow during the projected period due to improved government policies and investments from well-known companies.

Segmental Analysis

The global regenerative medicine market is segmented by type, material, and end-user.

Based on the type, the global market is bifurcated into cell therapy, gene therapy, tissue engineering, and small molecule and biologics.

The cell therapy segment is the highest contributor to the market and is expected to grow at a CAGR of 20.83% during the forecast period. During cell therapy, healthy cells are transplanted to replace or repair damaged cells or tissues. A variety of cells, including hematopoietic stem cells (HSC), mesenchymal stem cells (MSC), skeletal muscle stem cells, dendritic cells, lymphocytes, and pancreatic islet cells, to name a few, can be used as a component of therapy or treatment for a variety of chronic diseases and disorders thanks to the most recent technological advancements and product innovations. 

In addition, allogeneic and autologous stem cell transplants are the two types available. Both share similarities in the first phase, which involves removing cells from the donor's body. The sole difference between the two is the donor who provided the blood. In the case of an allogeneic transplant, the donor is someone else, typically a family member or relative, though this person could also be genetically compatible with the general population. In contrast, the patient is the donor in an autologous transplant.

Based on the material, the global market is bifurcated into synthetic, genetically engineered, and biologically derived.

The biologically derived segment owns the highest market share and is expected to grow at a CAGR of 21.49% during the forecast period. Biologically derived polymeric scaffolds in tissue engineering and regenerative medicine serve as a temporary extracellular matrix (ECM). The physical adsorption of the biomolecules on the scaffold surface, physical capture of the biomolecules in hydrogels or polymer microspheres, and enzymatic immobilization of proteins on biomaterials or oligopeptides are how the biologically active biomaterials and scaffolds are produced. These biologically active systems hold great promise for tissue engineering because they can give scaffolds bioactivity and remodel tissues, which is anticipated to fuel demand and market expansion.

Both biodegradable polymers and non-biodegradable materials are used in synthetic regenerative medicines. While degradable polymers are used to regenerate tissue function and structure, traditional non-degradable materials like metals are primarily used to replace damaged tissues. The synthetic regenerative medicine market is anticipated to expand over the forecast period as a result of advances in bioengineering.

Based on the end-user, the global market is bifurcated into hospitals, specialty centers, and academic and research institutes.

The hospital segment is the highest contributor to the market and is expected to grow at a CAGR of 22.49% during the forecast period. Patients typically consult with and receive treatment in hospitals. Patients typically prefer to be treated in hospitals because they offer cutting-edge treatment options. Additionally, the prevalence of numerous hospitals is likely to foster market expansion. For instance, the US has about 6,090 operating hospitals, and a strong healthcare industry will support market growth over the forecast period. The market for regenerative medicine is anticipated to experience significant growth opportunities due to the expanding healthcare infrastructure in developing countries.

The healthcare system underwent a paradigm shift from treating disease to restoring health with the advent of stem cell technology. Specialized teams are being educated to ensure reliable and secure regenerative options to establish regulated regenerative therapies for the patients. The regenerative approach should be more heavily stressed in the medical school curriculum. Attempts are being made to close this gap, which has resulted in the establishment of specialist facilities for regenerative medicine. In addition, although stem cell-based therapy is the cornerstone of regenerative medicine, acellular/molecular regenerative approaches and tissue engineering are being evaluated more and more. Regenerative medicine holds the key to treating chronic illnesses and genetic disorders, so there is anticipated to be a significant increase in the number of these specialty centers in the coming years, which will help the market for regenerative medicine grow.

Recent Developments

• September 2022- Exclusive Multi-Year Co-Marketing Agreement for the HipInsight Mixed Reality System for Total Hip Replacement was announced by Zimmer Biomet and Surgical Planning Associates
• December 2022- AbbVie began a strategic partnership with HotSpot Therapeutics to further develop its pipeline for immunology products.