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The global regenerative medicine market size was valued at USD 23.65 billion in 2021. The market is projected to grow from USD 29.86 billion in 2022 to USD 153.05 billion by 2029, exhibiting a CAGR of 26.3% during the forecast period. The global COVID-19 pandemic has been unprecedented and staggering, with regenerative medicine experiencing lower-than-anticipated demand across all regions compared to pre-pandemic levels. Based on our analysis, the global market exhibited a decline of 7.2% in 2020 as compared to 2019.
Regenerative medicine is an emerging field aiming to repair, replace, or regenerate damaged tissue or organ using cells, tissues, or genetic material. It can treat and potentially cure many conditions and diseases that are intractable, chronic, and terminal, such as cancers, Parkinson's disease, Alzheimer's disease, diabetes, renal diseases, cardiovascular diseases, and others. According to the Alliance for Regenerative Medicine (ARM) 2021 report, the global financing in this market was raised to USD 22.7 billion in 2021 from USD 19.9 billion in 2020 to support 2,406 products that are under investigation. This growth is attributed to the technological advancements in the gene therapy field such as the first in vivo CRISPR therapy which has exhibited positive outcomes in 2021.
Moreover, the rising prevalence of chronic genetic disorders, coupled with increased healthcare expenditure by developed and developing countries. For instance, in July 2022, Washington University received a grant of USD 557,000 from the National Heart Lung and Blood Institute (NHLBI) to investigate the effectiveness of a novel engineered TRIM72 (ETRIM72) protein to regenerate vasculature and skeletal muscles in murine diabetic critical limb ischemia (CLI). Such growing support from government organizations through research grants, are propelling the global regenerative medicine market growth during the forecast period.
Comparatively Robust Market Performance of Cell Therapy and Gene Therapy Minimized COVID-19 Impact on the Market
The outbreak of COVID-19 impacted the global market differently as it is composed of various segments. The tissue engineering segment witnessed a significant negative decline, while the gene therapy segment witnessed robust growth due to the consistent sales of its rare disease therapeutics. Similarly, the platelet-rich plasma (PRP) segment declined in 2020, whereas the cell therapy segment generated a slightly higher growth rate in 2020.
In 2021, the market witnessed a resurgence with the ease of the pandemic restrictions leading to positive results such as an increase in the number of approvals by key regulatory agencies.
From 2022 onwards, the market is estimated to witness consistently stronger growth rates in the forecast period. As the prevalence of chronic diseases is rising, market players are focusing toward R&D initiatives to expand their pipeline candidates, which will lead to new product launches in the forecast period.
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Strategic Acquisitions by Key Market Players to Offer Growth Opportunities
One of the prevailing global regenerative medicine market trends is the incorporation of strategic acquisitions by key players to upscale their R&D capabilities. The products of this market comprise of various novel approaches derived from living cells and protein, enzymes, antibodies, antibody-drug conjugates (ADC), gene and cellular components that have produced life-saving therapies to treat various chronic diseases. However, there is a potential gap between expectations and the realities of translating these technologies into clinical practice. Some prominent players are making strategic initiatives to bridge this gap and expand research in various clinical applications by diverting their focus on acquisitions to strengthen their R&D capabilities.
The products of this market and cellular therapies are coming together to expand their clinical applications for the treatment of many incurable diseases and the improvement of patient health outcomes.
Increasing Investments in R&D Activities Leading to Innovative Product Launches to Drive Market Growth
Increasing investments in this market have initiated full-fledged research and development activities as several investors are funding start-up companies focused on the development of novel therapies and products in the market. This has also paved the way for significant mergers, research collaborations, and partnerships to share the mutual benefits of R&D activities.
Apart from private players, various government and government-funded research institutes are actively spending in this industry to introduce effective options for the treatment of various chronic diseases such as cancers, Parkinson's disease, diabetes, renal diseases, cardiovascular diseases, and others.
Innovative Pipeline Candidates to Contribute to Market Growth
Regenerative medicine is broadening its application areas from tissue repair and wound care to various fields such as cardiology, neurology, oncology, and others. Many pharmaceutical and life science companies are conducting clinical trials to establish their dominance over the traditional treatment methods citing the launch of potential candidates that are under development, leading to the introduction of novel products and therapies in the market.
High Treatment Costs and Inadequate Reimbursement Policies to Hinder Market Growth
High costs of the treatment using these products and lack of reimbursement policies are key factors restraining the market growth. For instance, most stem cell therapies are experimental or investigational drugs or treatments due to which there is limited Medicare insurance coverage leading to a considerable proportion of out-of-pocket payments. It only covers expenses of treatment that have been approved by the FDA such as allogeneic transplantation.
Lack of coverage provided by the major insurance providers leaves the only options for patients is to pay the treatment cost out-of-pocket or through crowd funding, which delays the treatment and slows the growth of the market. Moreover, there are limited approved therapies for a wide range of patient population suffering from various genetic disorders which are considerably expensive and may have other side effects which restrains its adoption, limiting the market growth.
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Cell Therapy Segment to Dominate the Market Due to Increase in Product Adoption
Based on product, the global market includes cell therapy, gene therapy, tissue engineering, and platelet rich plasma.
The cell therapy segment dominated with the highest market share in 2021. The growth is driven by its rising applications in the treatment of autoimmune diseases, cancers, infectious diseases, and repairing of joint injuries which has increased the adoption of products of this segment.
The gene therapy segment is estimated to grow with the highest CAGR owing to the advantages of gene therapy over traditional treatment methods, including improved clinical results, targeting desirable sites, and others. Gene therapy has been widely used in the treatment of rare diseases including Spinal Muscular Atrophy (SMA), and other diseases.
The tissue engineering segment held the second largest market share in the global market due to increased demand for its products, such as scaffolds, bio matrixes, and others in wound care. On the other hand, the platelet rich plasma segment held the lowest market share in 2021 due to limited product offerings. However, the demand for cosmetic surgeries is increasing along with the gradual adoption of platelet rich plasma for the treatment of orthopedic diseases, which is propelling the segment’s growth during the forecast period.
Usage of the Product for the Treatment of Orthopedic Diseases to Drive Segment’s Growth
In terms of application, the global market is segmented into orthopedics, wound care, oncology, rare diseases, and others.
The orthopedics segment held the maximum global regenerative medicine market share in 2021 due to a gradual increase in the prevalence of osteoarthritis and bone related injuries. This has led to the adoption of these products for the enhancement of healing process and reduction of pain and discomfort, which is driving the segment’s growth.
The oncology segment is estimated to grow with a comparatively higher CAGR during the forecast period. Factors such as the rising prevalence of cancer, leading to significant unmet cancer patient population needs and to cater to this demand, many novel therapies have been introduced, such as CAR-T cell therapy, which showcased significant positive results. Furthermore, increasing active government support through research grants and awareness programs are contributing to the segment’s growth.
The wound care segment accounted for a considerable market value in 2021 and is estimated to grow with a substantial CAGR by the end of 2029. Introduction of advanced products that mimic the skin structure and accelerate wound healing, along with the rising prevalence of chronic wounds, is expected to fuel the segment’s growth.
The rare diseases segment is anticipated to grow with the highest CAGR during the forecast period as the number of individuals living with rare diseases is rising worldwide, and the treatment options are limited, providing a huge scope for the segment’s growth in the market.
The others segment comprises cardiovascular diseases, musculoskeletal, ophthalmology, and metabolic diseases where the R&D initiatives are limited and yet to be explored leading to slower growth of the segment due to limited product launches.
Increasing Number of Surgeries to Propel the Hospital Segment Growth
On the basis of distribution channel, the global market is classified into hospitals, clinics, and others.
Hospitals segment dominated with maximum market share in 2021 and is estimated to grow with the highest CAGR. The segment’s growth is augmented due to rising number of surgeries in hospitals coupled with increasing government support and initiatives through policy harmonization which provides impetus for major companies offering these products.
Clinics segment held the second largest market share in 2021, owing to the increased privatization of clinics to provide specialized regenerative medicine services which includes treatment for musculoskeletal conditions to relieve pain and enhance healing process. Hence, adoption of these products in these institutions is contributing to the expansion of the clinics segment.
The others segment is growing at a lower CAGR in the forecast period. Some of the factors contributing to the slower growth rate include the stringent eligibility criteria to conduct R&D activities at the academic research institutes.
North America Regenerative Medicine Market Size, 2021 (USD Billion)
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Geographically, the global market of regenerative medicine is studied across North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
The North America market size was valued at USD 10.50 billion in 2021 and is likely to remain dominant throughout the forecast period. The growth in this region is attributed to the technological advancements in the field, rapid adoption of cell and gene therapy, and new product approvals. For instance, in May 2022, FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to obecabatagene autoleucel (obe-cel), a CAR T-cell therapy developed by Autolus Therapeutics and is under clinical trial for the treatment of R/R B-acute lymphocytic leukemia.
Europe is anticipated to be the second leading region in terms of revenue, which is attributable to emerging government guidelines and reimbursement for these therapies. Moreover, the substantial presence of numerous research institutes and increasing government funding are expected to boost the market growth across Europe.
Asia Pacific is projected to grow with maximum CAGR due to the rising prevalence of chronic diseases, active government initiatives for technological advancements, and improving disposable incomes. For instance, as per an article published in November 2021 by BioSpectrum, 8.5 million people suffer from some chronic disease such as diabetes, cancer, and respiratory conditions in Asia. This rising prevalence of diseases offers a potential growth opportunity for the market growth across the region.
On the other hand, Latin America and the Middle East and Africa regions are estimated to grow at a comparatively lower CAGR due to lower healthcare expenditure per person. Furthermore, lack of awareness regarding the existence of effective treatment options in these regions is leading to a lower adoption rate and slower growth.
Novartis AG and Zimmer Biomet are Key Market Players due to Strong Sales Owing to New Product Launches and Approvals
In terms of the competitive landscape, the market is highly fragmented, with a few regenerative medicine players holding a higher proportion of the market. In terms of cell and gene therapy, Gilead Sciences Inc. and Novartis AG are dominant players in these segments on the account of their strong CAR T-cell therapy pipeline, which is anticipated to generate strong sales due to new product launches and approvals in the forecast period. Some other emerging players that are present in cell and gene therapy include Orchard Therapeutics plc through its products such as Libmeldy and Strimvelis which are approved in the European Union and bluebird bio, Inc.
In terms of tissue engineering, Stryker dominates the global market due to its acquisition of Wright Medical Group N.V., which has led to the development strong biologics portfolio for the company, while the platelet rich plasma market reflects a fragmented competitive landscape, however some key companies including Zimmer Biomet on account of its product of GPS III Platelet Concentration System, and Terumo Corporation have established its presence in the market due to its strong product offering.
An Infographic Representation of Regenerative Medicine Market
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The report provides qualitative and quantitative insights on the global market and a detailed analysis of global market size & growth rate for all possible segments in the market. Along with this, the market analysis provides elaborative insights of the global regenerative medicine market drivers and competitive landscape. Various key insights presented in the report are prevalence of chronic diseases, by key countries/regions, 2021, pipeline analysis, new product launches, key recent industry developments – mergers, acquisitions, & partnerships, technological developments and, impact of COVID-19 on the global market.
Value (USD billion)
By Product, Application, Distribution Channel, and Region
By Distribution Channel
Fortune Business Insights says that the global market size was USD 23.65 billion in 2021 and is projected to reach USD 153.05 billion by 2029.
In 2021, the North America market stood at USD 10.50 billion.
Growing at a CAGR of 26.3%, the market will exhibit steady growth in the forecast period (2022-2029).
The cell therapy segment is expected to be the leading segment in this market during the forecast period.
The increasing prevalence of blood cancers and treatment initiatives for rare diseases, coupled with the rising need for personalized treatment, are some of the major driving factors of the growth of the market.
Novartis AG, Stryker, and Bristol-Myers Squibb Company are the leading market players in the global market.
North America dominated the market in 2021.
The demand for cosmetic rejuvenation procedures, potential pipeline candidates, and a continuous increase in R&D investment for technological advancements are expected to surge the demand for these products.
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