Regenerative Medicine Market Analysis

Global Regenerative Medicine Market Overview

The Regenerative medicine Market Size was valued at USD 18.39 Billion in 2023. The Global Regenerative medicine industry is projected to grow from USD 21.99 Billion in 2024 to USD 85.36 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 16.26% during the forecast period (2024 - 2032).

Regenerative medicine refers to an area of medicine that develops methods to replace, repair, or regrow damaged or diseased tissues, organs, or cells. It includes the generation and use of tissue engineering, therapeutic stem cells, and the production of artificial organs. The global regenerative medicine market has recorded rapid growth in recent times. The market's growth is attributed to the increasing advancement in healthcare technology, increasing prevalence of chronic diseases, advanced technology in the market of regenerative medicine, and growth in stem cell technology. 

Furthermore, the growing adoption of stem cell technology and the increasing number of approvals and product launches worldwide are also anticipated to boost the market's growth over the coming years. On the other hand, the ethical concerns for the use of embryonic stem cells may impede the growth of the market over the assessment timeframe. Factors that influence the market of regenerative medicine are increasing advancement in healthcare technology, advanced technology in the market, increasing prevalence of chronic diseases, and increasing growth in stem cell technology.

COVID-19 Analysis:

The rising prevalence of COVID-19 is projected to influence market growth over the forecast period.Like most of the markets, COVID-19 has also affected the regenerative medicine market and the market players.COVID-19 has decelerated the drug development process, resulting in slashed financing by the investors. Thus, the COVID-19 has restricted the growth of the market players. Similarly, the impact of COVID-19 on the R&D of regenerative medicines is unfavorable. The worst-hit entities are the clinics that are meant to perform clinical trials. The results of these clinical trials hold great importance to the involved regenerative medicine experts and investors. Most of the clinical trials have their enrolment postponed dealing with the rising number of COVID-19 patients and keeping the already enrolled participants away from contracting COVID-19. This has brought the initiation of new clinical trials to a standstill. Moreover, the participants skipped the clinical trials owing to the factors such as fear of contracting COVID-19, travel restrictions, etc. As a result, it can be said that COVID-19 has a negative impact on R&D.

In recent years, the market for regenerative therapies has expanded rapidly around the world. The development of new medical tools, the rise of chronic diseases, the maturation of regenerative medicine, and the expansion of stem cell research are all factors fueling the expansion of this industry.

In addition, the increasing approvals and product launches throughout the globe, as well as the rising popularity of stem cell technology, are expected to fuel the market's expansion over the next few years. Increases in healthcare innovation, market innovation, the frequency of chronic diseases, and development in stem cell technology all have an impact on the regenerative medicine industry.

Autologous cell therapies for potentially fatal diseases are also anticipated to benefit from the proliferation of cutting-edge technology like 3-D printing. One such allogenic cell-based medicine that treats venous leg ulcers and diabetic foot ulcers is Apligraf, made by Organogenesis, Inc.

July 2023: The UK-based SRAM & MRAM Group has announced a joint venture with CELLAAX, a top Malaysian cellular therapy biopharmaceutical firm. This is a huge step forward in the healthcare industry. The strategic partnership has the potential to transform stem cell therapy in India and other parts of the world. The two organizations hope to enhance regenerative medicine by pooling their knowledge and resources. The formation of this partnership is a major achievement in the ongoing fight to advance healthcare and raise people's standard of living. 

Regenerative Medicine Market Trends

Market Drivers

• Increasingprevalence of chronic diseases and genetic disorders

According to the Centre for Diseases Control and Prevention in 2019, the prevalence of chronic diseases in adults was around 60% globally, and it is reportedly much higher among elderly people. It is estimated that about 70% of adults will die of one or more chronic diseases. It is reported that 84.1 million people in the US were diagnosed with prediabetes in 2019. Similarly, according to a case study by the Royal Society in 2017, the oldest scientific academy in continuous existence, over half a million people in the United Kingdom were diagnosed with a genetic disorder. Thus, the Increasing prevalence of chronic diseases and genetic disorders drives thegrowth of the global regenerative medicine market

• Growing adoption of stem cell technology


• Rising number of approvals and product launches

Market Restraints

• Ethical concerns for the use of embryonic stem cells

ethical concernsfor the use of embryonic stem cells are, including well-informed consent from the embryo donating woman or pair, consent from the donors of the gamete involved in the embryo creation, and the confidentiality of donor details. Thus, the ethical concerns for using embryonic stem cells are expected to restrict the growth of the global regenerative medicine market to a certain extent during the forecast period.

Market Opportunities

• Implicit guidelines by the international society for stem cell research (ISSCR) related to the extended embryo culture

In May 2021, the International Society for Stem Cell Research (ISSCR), the world's largest stem cell body, implicitly talked about the willingness to reassess the long-established restriction on laboratory efforts to cultivate and examine human embryos. Under the latest guidelines, the ISSCR also focuses upon a probable substitute for using human embryos;these guidelines may not be laws, the ISSCR might be able to fuel the discussion considering its soft power and the influence it has on the stem cell research community. These new guidelines have implicitly allowed more permissive research on human embryos. These guidelines are expected to create growth opportunities for the key entities operating in the global regenerative medicine market.

Value Chain Analysis

The global market of regenerative medicine is growing rapidly and is expected to continue growing at a steady during the study period. This is due to the growing contribution of existing players to make the product more effective. The supply chain analysis for the market comprises four major components, which start with the research and product development followed by manufacturing of the products, distribution&sales, and ends with post-sales services.

The key market players focus onthe introduction of new products to strengthen their position in the market.For instance, in February 2020,Integra Lifesciences Holding Corporation launched AmnioExcel Plus Placental Allograft Membrane,a wound care offering to support soft tissue repair.

Regenerative Medicine Market Segment Insights

The global market for regenerative medicine has been divided based ontype,material,application, and end user.

Regeerative Medicine Type Insights

• Cell Therapy

Cell therapy is the transplantation of healthy cells to repair or replace damaged cells or tissues. With the latest advancements in technologies and innovation in products, a variety of cells, such as hematopoietic stem cells (HSC), mesenchymal stem cells (MSC), skeletal muscle stem cells, dendritic cells, lymphocytes, and pancreatic islet cells, just to name a few, can be used as a part of treatment or therapy for a range of chronic diseases and disorders.

• Gene Therapy

Gene therapy entails the altering of genes within the patient's cells to cure or stop the disease. Our genes consist of our DNA which is basically the molecule that carries our genetic code, the code that controls much of our body's function and form. Faulty genes can cause one or more diseases. Gene therapy is used to replace faulty genes or add new ones to treat disease or enhance our body's ability to fight disease.

• Tissue Engineering

Tissue engineering involves the fabrication of bioartificial tissues in vitro and the in vitro alteration of cell development and function by means of transplantation of suitable cells isolated from the tissues of the donor and scaffolds. The aim of tissue engineering is to put together functioning constructs that restore, nurture, or help improve damaged tissues or entire organs.

• Small Molecule & Biologic

Small molecule drugs can be described as organic compounds with low molecular weight which can be produced by chemical synthesis. They can be administered by different kinds of routes, including orally. On the other hand, biologics include various products such as blood and blood components, somatic cells, vaccines, allergenic, tissues, gene therapy, and recombinant therapeutic proteins. 

On the basis of material, the market is bifurcated intosynthetic, genetically engineered, biologically derived, and others.The biologically derived segment accounted for the larger market share and is anticipated to register a CAGR of 21.39% from 2021 to 2027.

• Synthetic

The biomaterials used in synthetic regenerative medicines include both degradable polymers and non-degradable materials.With the advancements in bioengineering, the synthetic is expected to grow market of regenerative medicine during the forecast period.

• Genetically Engineered

Human mesenchymal stem cells (hMSCs) and human embryonic stem cell-derived cells (hESdCs) are the mainstays of the genetically engineered. These offer great potential and could offer superior treatments/therapies for chronic diseases and genetic disorders.

• Biologically Derived

Biologically derived polymeric scaffolds are used as a temporary extracellular matrix (ECM) in regenerative medicine and tissue engineering. The biologically active biomaterials and scaffolds are derived through the physical adsorption of the biomolecules lying on scaffold surface, physical capture of the biomolecules in hydrogels or polymer microspheres, and enzymatic immobilization of proteins on biomaterials or oligopeptides.

• Others

Others include umbilical cord blood (CB) and organ-on-chip (OOC)

Regeerative Medicine Application Insights

On the basis of application, musculoskeletal disorders, wound care, oncology, ocular disorders, diabetes, and others.The oncology segment accounts for the larger market share owing to the factors such as the rising product pipeline of regenerative medicine and advancements in regenerative medicine research.

• Musculoskeletal Disorders

Musculoskeletal disorders are disorders or injuries of the muscles, tendons, nerves, cartilage, joints, and spinal discs.

• Wound Care

When it comes to wound healing, regenerative medicines have been seen as a modern alternative to traditional treatments available for wound care. These regenerative medicines have great potential as their capability to regenerate, replace, and rejuvenate action can work in tandem with the body's own natural wound care processes towards promoting healing and recovery in various cases, including chronic wound treatment, aging skin repair, pain management, skin transplants, and organ transplants.

• Oncology

The regenerative medicine companies, with the help of leading oncologists around the world, have been trying to develop treatments that can cure cancer.According to Alliance for Regenerative Medicine, as of June 2019, globally, over 400 companies were developing regenerative medicine therapies that can cure cancer, with 191 of them being clinical stage. With 23 of 627 ongoing clinical trials in Phase III, over 132 products were in active development in June 2019.

• Ocular disorders

Ocular disorders primary includes age-related macular degeneration (AMD), diabetic retinopathy, amblyopia, glaucoma, strabismus, and cataract. These disorders are the leading causes of low vision and blindness. The regenerative medicine companies have been working on ocular regenerative therapies to transform the existing treatments for ocular disorders.

• Diabetes

The World Health Organization (WHO) describes diabetes as a chronic metabolic disease identified by elevated blood glucose (or blood sugar) levels. Elevated blood glucose levels lead to severe health problems over time, including serious damage to the blood vessels, nerves, heart, kidneys, and eyes. The number of diabetes cases has been rising worldwide at an alarming rate.

• Others

Others include bladder reconstruction, blood vessels (vascular grafts), trachea, eyes, and others.

Regeerative Medicine End User Insights

On the basis of end user, the market is bifurcated intohospitals, specialty centers, academic & research institutes, and others. The hospitals segment accounted for the larger market share with a value of USD 23,617.00 million in 2020; sinceadvanced treatment procedures are available in hospitals, patients usually prefer to be treated in hospitals.

• Hospitals

Hospitals are the primary locations for patients receiving consulting & treatment. Since advanced treatment procedures are available in hospitals, patients usually prefer to be treated in hospitals. Moreover, the presence of many hospitals is likely to support market growth. For instance, the US has about 6,090 active hospitals, and a well-established healthcare sector will boost the growth of the market during the forecast period.

• Specialty Centers

With the arrival of stem cell technology, the healthcare system witnessed a paradigm shift from fighting disease to restoring health. In order to establish the regulated regenerative therapies for the patients, specialized teams are being educated to guarantee valid and safe regenerative options.

• Academic and Research Institutes

Academic and research institutes are primarily responsible for the advancements in the regenerative medicine industry today. With the help of monetary resources coming from corporate partnerships, private placements, and venture financing, these institutes have researched and developed methods to treat chronic diseases and genetic disorders. In the regenerative medicine ecosystem, academic and research institutes are of utmost importance.

• Others

Others include pathology labs and biotechnology companies

July 2023: Hitachi Ltd and Brigham and Women's Hospital (BWH) have joined forces to launch a collaborative gene and cell therapy (GCT) research program with the goal of curing serious diseases by 2023. The goal of this partnership between the world-famous Mass General Brigham hospital system and the automated cell culturing and digital technology experts at Hitachi is to speed up the development of disease models and increase the practical uses of GCT across a wider range of medical diseases. Hitachi will aid in the development of cellular models for investigating diseases by working closely with experts at the Mass General Brigham Gene and Cell Therapy Institute (GCTI).

July 2023: Hitachi Ltd and Brigham and Women's Hospital (BWH) have joined forces to launch a collaborative gene and cell therapy (GCT) research program with the goal of curing serious diseases by 2023. The goal of this partnership between the world-famous Mass General Brigham hospital system and the automated cell culturing and digital technology experts at Hitachi is to speed up the development of disease models and increase the practical uses of GCT across a wider range of medical diseases. Hitachi will aid in the development of cellular models for investigating diseases by working closely with experts at the Mass General Brigham Gene and Cell Therapy Institute (GCTI).

The global regenerative medicine market, based on region, has been divided into the Americas, Europe, Asia-Pacific, and Middle East & Africa.

Americas:

The Americas is expected to command the largest market share due to the rising number of clinical trials, enactment of the 21st Century Cures Act, increasing monetary support by investors, favorable government policies, and establishment of institutions such as the American Academy of Regenerative Medicine (AARM) and the American Board of Regenerative Medicine (ABRM), for setting regulatory standards and promoting excellence in the area of regenerative medicine.

Europe:

Europe also accounted for a significant regenerative medicine market share owing to the success of the pan-European projects (such as CHRODIS and CHRODIS PLUS), government initiatives, public and private research funders, and collaborative scientific research projects in the field of regenerative medicine. According to a case study by the Royal Society in 2017, the oldest scientific academy in continuous existence, over half a million people in the UK were diagnosed with some kind of genetic disorder. For instance, the number of people suffering from cystic fibrosis in Scotland is almost twice the global average.

Asia-Pacific:

Asia-Pacific is estimated to be significant in regenerative medicine treatment due to transformation in healthcare infrastructure, cross-country scientific research programs, and training of researchers and young faculties at leading institutes in the field of tissue engineering and stem cell-based research. The Department of Biotechnology under the Ministry of Science and Technology, Government of India, implemented a joint Indo-Japan collaborative research program to major disorders related to brain and blood among the Indian population through a combined approach of clinical investigations, modern advancements in human genetics, and stem cell technology

Middle East & Africa:

The Middle East & Africa accounts for the minimum market share of the regenerative medicine due to regional political tensions, which have led to limited investments in the field of regenerative medicine across the region.

Regenerative Medicine Market Competitive Landscape

The global regenerative medicine market is expected to grow significantly in the coming years due to the increasing prevalence of chronic diseases and genetic disorders, growing adoption of stem cell technology, and rising product pipeline of regenerative medicine. The global market for regenerative medicine is characterized by the presence of several global and regional vendors. The market is highly competitive, with all the players trying to gain maximum market share. For instance, in February 2020, Integra Lifesciences Holding Corporation launched AmnioExcel Plus Placental Allograft Membrane. It is a wound care offering to support soft tissue repair.

List of Key Companies Covered in this report:

• Zimmer Biomet Holdings Inc. (US)


• AbbVie Inc. (US)


• Cryolife, Inc. (US)


• Stryker (US)


• Medtronic Plc (Ireland)


• Baxter International Inc. (US)


• Organogenesis Inc. (US)


• Ocata Therapeutics Inc. (US)


• Integra Lifesciences Holdings Corporation (US)


• Vericel Corporation (US)


• Reliance Life Sciences (India)

Recent Developments

Report Overview:

The study covers the existing short-term and long-term market effects, helping decision-makers to draught short-term and long-term plans for businesses by region. The report covers major regions in the Americas, Europe, Asia-Pacific, and the Middle East & Africa. The report analyzes market drivers, restraints, opportunities, challenges, Porter's Five Forces, Value Chain, and impact of COVID-19 on the market.

Regenerative Medicine Market Segmentation

Regenerative Medicine Type Outlook

• Cell Therapy


• Gene Therapy


• Tissue Engineering


• Small Molecule & Biologic

Regenerative Medicine Material Outlook

• Synthetic


• Genetically Engineered


• Biologically Derived


• Others

Regenerative Medicine Application Outlook

• Musculoskeletal Disorders


• Wound Care


• Oncology


• Ocular Disorders


• Diabetes


• Others

Regenerative Medicine End User Outlook

• Hospitals


• Specialty Centers


• Academic and Research Institutes


• Others

Regenerative Medicine Region Outlook

• Americas
  
  
  
  • North America
    
    
    
    • US
    
    
    • Canada
    
    
    
    
  
  
  • Latin America
  
  
  
  


• Europe
  
  
  
  • Western Europe
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  • Eastern Europe
  
  
  
  


• Asia-Pacific
  
  
  
  • China
  
  
  • India
  
  
  • Japan
  
  
  • Australia
  
  
  • South Korea
  
  
  • Rest of Asia-Pacific
  
  
  
  


• Middle East & Africa
  
  
  
  • Middle East
  
  
  • Africa