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Forecast Period
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2024-2028
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Market Size (2022)
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USD 14.67 Billion
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CAGR (2023-2028)
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9.45%
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Fastest Growing Segment
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Tissue Engineering
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Largest Market
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North America
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Market Overview
Global Regenerative Medicine Market has
valued at USD 14.67 Billion in 2022 and is anticipated to project robust growth
in the forecast period with a CAGR of 9.45% through 2028. Regenerative medicine
is an emerging discipline that focuses on the replacement or regeneration of
damaged human organs or tissues. This therapeutic approach utilizes stem cells
to restore function to tissues and organs that are unable to heal themselves.
Scientists anticipate that this therapy will enable the laboratory growth of
organs and tissues, which can then be safely implanted into the human body. The
demand for regenerative medicine is rapidly increasing due to its personalized
treatment approach, which provides more effective management of conditions
compared to conventional treatments. Regenerative medicine encompasses a range
of medical techniques, including artificial organs, cellular therapies, and
tissue engineering. Tissue engineering and biomaterials employ scaffolds that
are implanted in the body to facilitate the formation of new tissue. These
scaffolds attract stem cells, promoting the development of tissue with the
desired shape. Cellular therapies utilize stem cells derived from dental pulp,
fat, skeletal muscle, blood, bone marrow, and other sources to repair damaged
tissues within the body. Additionally, medical devices and artificial organs
offer support to failing organs within the body.
Key Market Drivers
Increasing
Investments in R&D Activities
Increasing investments in research and
development (R&D) activities have propelled market growth by driving
innovative product launches. This surge in investments has led to comprehensive
R&D initiatives, with numerous start-up companies receiving funding for the
development of novel therapies and products. Consequently, this has facilitated
significant collaborations, mergers, and partnerships aimed at maximizing the
mutual benefits of R&D activities. In June 2022, Galapagos, a Belgian biotech
company, announced its acquisition of Cell Point and Abound Bib. This strategic
move aims to expedite the development and commercialization of next-generation
cell therapies. With the integration of Cell Point and Abound Bio, Galapagos
will gain access to innovative, scalable, decentralized, and automated
point-of-care cell therapy supply models, as well as a cutting-edge fully human
antibody-based therapeutics platform. Together, these advancements position Galapagos
as a fully integrated biopharmaceutical company with the potential to disrupt
the CAR-T treatment paradigm. Apart from private entities, various governments
and government-funded research institutes are actively investing in this
industry to introduce effective treatment options for chronic diseases like
cancer, Parkinson's disease, diabetes, renal diseases, cardiovascular diseases,
and others. In January 2022, the Royal College of Surgeons in Ireland secured
USD 226,000 in funding from the European Commission for the development of
antioxidant-ion substituted nanoparticles for osteoporotic bone treatment.
Increasing
Prevalence of Chronic Ailments
The increasing prevalence of chronic
conditions such as heart disease, diabetes, and cancer are expected to drive
market growth. For instance, data published by the Centers for Disease Control
and Prevention reveals that 37.3 million people in the United States are living
with diabetes. Factors contributing to the rise in diabetes include shifting
lifestyles, an aging population, and a lack of physical activity. Stem cell
biology presents promising solutions for diabetes treatment, utilizing various
types of stem cells including embryonic, germline, mesenchymal, and induced
pluripotent cells.
Growing
Incidence of Genetic Disorders and Trauma Emergencies
The rise in the prevalence of diseases,
such as congestive heart failure, myocardial infarction, Parkinson’s disease,
various forms of bone loss, and Duchenne muscular dystrophy (DMD), is driving
the demand for cell therapy in the regenerative medicine market. Additionally,
the conventional reliance on heterotopic autologous grafts like the intestine,
colon, or stomach for bladder, ureter, and urethra reconstruction is fueling
market growth. Numerous companies are striving to advance cell therapy through
collaborations with other companies or research institutes. For instance, in
April 2018, Eli Lilly partnered with Sigilon Therapeutics to develop
encapsulated cell therapies for type I diabetes treatment. The development of
such cutting-edge products is expected to augment the demand for cell therapies
and subsequently boost the regenerative medicine market.
While autologous cell
therapy, allogenic cell therapy, and xenogenic cell therapy are extensively
utilized in the regenerative medicine market, only a limited number of products
have received FDA approval for commercialization. Laviv from Fibrocell Science,
Inc. is approved for the treatment of moderate-to-severe nasolabial fold
wrinkles in adults, while Carticel from Genzyme Corporation is used for the repair
of symptomatic cartilage defects in the knees. The prevalence of trauma
injuries has led to an increased adoption of regenerative medicine and organ
transplantation. The rise in accidents, burn injuries, and other trauma cases
has significantly contributed to the growth of the regenerative medicine
market. According to the Center for Disease Control and Prevention, there were
approximately 223,135 hospitalizations related to Traumatic Brain Injury (TBI)
in 2019, along with 69,473 TBI-related deaths in 2021.
These figures translate
to over 611 TBI-related hospitalizations and 176 TBI-related deaths per day in
the United States alone. This surge in accident trauma cases has driven the
global demand for regenerative medicines. Many companies have expanded their
presence in the regenerative medicine market for trauma injuries, although it
is not yet dominant and is primarily used in organ transplantation. However, as
technologies for accident care units continue to advance, the regenerative
medicine market is expected to experience rapid growth in the forecast period.
Emergence
of New Technologies
The advent of novel technologies, such
as 3-D printing, is anticipated to drive the adoption of autologous cell
therapies for life-threatening ailments. Apligraf, developed by Organogenesis,
Inc., is a notable allogenic cell-based product employed in the treatment of
venous leg ulcers and diabetic foot ulcers. Advancements in regenerative
technologies fuel the commercial applications of stem cells in the regenerative
medicine market. Promising organs like heart arteries, engineered bladders, and
other internal organs and ligaments contribute to this progress. Several stem
cell-based therapies are currently undergoing clinical trials, showcasing
tremendous potential for tissue regeneration. Market players have introduced
numerous technologies to enhance the efficiency of stem cell research and
commercial applications, thereby driving the growth of the regenerative
medicine market.
Government and private agencies' programs and investments in
R&D are expected to bolster market growth during the forecast period. However,
the high cost of regenerative medicine treatments may impede market growth in
the future. GlaxoSmithKline has developed a product for adenosine deaminase,
which causes severe combined immunodeficiency (ADA-SCID). Additionally, other
companies engaged in gene additive therapies research include GE Healthcare,
Mayo Clinic, and others. The research involves the use of nucleases like zinc
finger nucleases (ZFNs), CRISPR/Cas9, mega nucleases (MNs), and others, which
are precisely tailored to modify the human genome by targeting specific cells.
However, gene correction can lead to unintended effects, impacting cell
development and proliferation. Furthermore, the efficiency of gene correction
treatment varies depending on the targeted cells' genome, which limits its
usage.
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Key Market Challenges
Lack
of Reliable Vector Production for Cell and Gene Therapy
Current methods of vector production
often have limitations in terms of scalability. Producing enough high-quality
vectors to meet the demands of clinical trials and potential commercialization
can be challenging, especially for therapies with large patient populations. As
regenerative medicine advances, the diversity of therapeutic approaches and
vector types increases. Developing reliable vector production methods for
various vectors, including adeno-associated viruses (AAVs) and lentiviruses, is
crucial to accommodate this diversity.
High Treatment
Cost
The high costs associated with
treatments utilizing these products, coupled with the absence of reimbursement
policies, are significant factors impeding market growth. For example, most
stem cell therapies are classified as experimental or investigational drugs or
treatments, resulting in limited Medicare insurance coverage and a substantial
portion of out-of-pocket expenses. Medicare only covers treatment expenses for
FDA-approved therapies, such as allogeneic transplantation. According to an
article published by DVC Stem in July 2022, the cost of stem cell therapy
ranges from USD 5,000 to USD 50,000, varying based on multiple factors
including the type of stem cells administered, the number of cells
administered, the quality of cells, the source of stem cells, and more. As
stated in a December 2021 article from Pharmacy Times, Novartis' Zolgensma is a
one-time gene therapy administered through a single intravenous infusion for
the treatment of spinal muscular atrophy, topping the list with a one-time price
of USD 2.12 million. The lack of coverage offered by major insurance providers
leaves patients with the sole option of paying for treatment costs
out-of-pocket or relying on crowdfunding, which delays treatment and hampers
market growth. Furthermore, there is a limited number of approved therapies
available for a wide range of patients suffering from various genetic
disorders. These therapies are significantly expensive and may carry additional
side effects, further hindering their adoption and limiting market growth.
Key Market Trends
Increase
In Potential in Emerging Economies
Developing economies hold significant
potential in the regenerative medicine market, driven by the rising prevalence
of traumatic injuries and organ transplantations worldwide. Key industry
players have strategically analyzed the opportunities in tissue engineering and
regenerative medicine within these economies, leveraging various developmental
strategies such as product launches, approvals, agreements, partnerships, and
mergers. Despite ethical challenges arising from unfavorable norms, it is
anticipated that developing economies will embrace tissue-engineering and
regeneration technology.
Growth
In Need of Regenerative Medicine in Organ Transplantation
Kidney transplants are the most
sought-after procedures, with 80% of the waiting list comprised of patients in
need of kidneys. Despite proactive measures by the government to increase the
number of donors, the need for organ transplants continues to rise. Tissue
engineering and regenerative medicine offer significant potential to address
this growing demand for organ transplants on a global scale. However, there are
significant challenges that must be overcome, such as vascularization and
tissue signaling, to successfully replicate the functions of the original
organs. Exciting advancements are being made in the development phase, with the
possibility of successfully producing complex tissues and even whole organs to
meet the needs of patients requiring transplants. For example, prototypes of
human livers have already been created using tissue engineering, regeneration,
and bioprinting technologies. The commercialization of regenerative medicine
products holds great promise, given the numerous products currently in the
pipeline undergoing various phases of clinical trials, with expectations of
future commercial availability.
Segmental Insights
Therapy Insights
The tissue-engineering segment dominated
the global regenerative medicine market in 2022, accounting for the largest
market share. This can be attributed to several advantages, including the
ability to replace defective structures with fully functional living structures
and the potential for treating previously untreatable medical conditions.
Additionally, significant investments in research and development to develop
effective treatments, coupled with the continuous launch of new and innovative
products, are expected to drive the demand in the tissue engineering segment.
Application Insights
The oncology segment dominated the
regenerative medicine market in 2022 due to the increasing global burden of
cancer. Significant investments by government organizations and private
companies in cancer research and the development of regenerative and advanced
cell therapies contributed to this trend. In January 2023, Calidi
Biotherapeutics (CBT) and First Light Acquisition Group (FLAG) formed a
partnership agreement with the goal of revolutionizing oncolytic virotherapies
using stem cell-based platforms. The cardiovascular segment is expected to
experience substantial growth during the forecast period. Advancements in
cell-based therapies and regenerative medicines have accelerated progress in
this field. Key players are actively involved in developing regenerative
therapies that aim to repair, restore, and revascularize damaged heart tissues.
There is a growing adoption of single and mixed cells from autologous and
allogeneic sources to study their effects on cardiovascular diseases.
Additionally, advanced biologics, small molecules, and gene therapy are being
investigated to stimulate the regeneration of damaged heart cells. These
factors are anticipated to further drive growth in the regenerative medicine
market