Regenerative Medicine 101: What You Need to Know

When you scrape your knee, break a bone, or cut yourself, the body is able to heal itself. But that’s not the case with certain conditions, like diabetes or heart disease.

Regenerative medicine, a fairly new field in which experts are looking for therapies and strategies similar to the mechanisms that help your body heal itself, is changing that.

What Is Regenerative Medicine?

Regenerative medicine first picked up steam in the 1990s when tissue engineering became popular for stem cell research and procedures like skin grafting.

The goal of regenerative medicine is to replace or reboot tissues or organs damaged because of disease, injury, age, or other issues instead of treating symptoms with medication and procedures.

Regeneration in humans happens at three levels:

Molecular. This includes small molecules that are the building blocks of your body, like DNA, fats, and carbohydrates.

Cellular. This includes cell structures like neurons or axons that are responsible for cell growth and reproduction in your body.

Tissue. This includes blood, skin, bone, or muscle.

While many forms of regenerative medicine research are still underway, some have already been put to use. One of them is stem cell therapy. This is when scientists grow specialized stem cells in a lab. Depending on the need, they can be instructed to behave like certain types of cells, such as those in your heart, blood, or nerves.

For example, if you have heart disease, these lab-made heart muscle cells may be used as transplanted tissue to help repair or replace damaged heart cells.

Several therapies and conditions including:

  • Type 1 diabetes
  • Cardiovascular tissue repair
  • Brain injury tissue repair
  • Immune system improvement
  • Cell therapy
  • Tissue engineering
  • Skin wounds
  • Certain cancers
  • Organ transplants

Regenerative medicine continues to take shape with new discoveries and advancements, but there are a few major areas.

They include:

Tissue engineering and biomaterials. This is when biomaterials -- made from three-dimensional (3D) printing using things like metals, ceramics, and polymers called scaffolds -- are put in your body where new tissue needs to grow.

Many people have been treated with this method, but research is ongoing.

Cellular therapies. All of us have millions of adult stem cells. It’s one of the ways our body repairs itself. Studies have shown that if adult stem cells are grouped and injected in areas where there is disease or tissue damage, the stem cells can help reconstruct new tissue under certain conditions.

Adult stem cells can be taken from various parts of your body, such as:

  • Blood
  • Fat
  • Bone marrow
  • Dental pulp
  • Skeletal muscle
  • Cord blood (blood found in the umbilical cord and placenta after birth)

Scientists are conducting studies to learn more about cellular therapy for tissue and organ regeneration.

Medical devices and artificial organs. If your organ is too far gone to function and needs to be replaced, doctors usually recommend organ transplant. But it can be difficult to find organ donors who are the right match, and it often takes a lot of time. Time is of the essence when you’re in need of a new kidney or a lung.

In these cases, regenerative medicine has used engineering and robotics to come up with technologies and machines to support failing organs. For example, your doctor can put a ventricular assistive device (VAD) in the body to help with circulation issues during complex transplant processes.

A lot more research and clinical trials are needed for certain therapies before they can be approved for medical use.

If you or a loved one has an ongoing condition or disease and you’re wondering if regenerative medicine is an option for you, ask your doctor about it.

Regenerative Medicine Market

The global regenerative medicine market size was valued at USD 55.03 billion in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 15.7% from 2023 to 2030. Several advancements in biological therapies have shifted the preference toward personalized medicinal strategies over traditional treatment methods. This has created significant opportunities for market players who are involved in biological therapeutics development. 

The COVID-19 outbreak has considerably impacted various markets, including the regenerative medicine and T-cell therapy manufacturing market. The SARS-CoV-2 coronavirus crisis has significantly affected the delivery of CAR T-cell therapies. 

The global T-Cell therapy market was valued at USD 2.83 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 35.33% from 2023 to 2030 (R).

This impact is not just limited to patient care but has extended to administration, logistics, and limited healthcare resources. Several universities have slowed down clinical trial enrollment and other research activities.



However, the market continues to expand as market players such as Novartis provide access to therapies such as Athersys, Inc.’s MultiStem, which is a highly relevant COVID-19 therapy.

Furthermore, regenerative medicines have been identified to have the unique ability to alter the fundamental mechanisms of diseases. Regenerative therapies in trials provide promising solutions for specific chronic indications with unmet medical needs. In December 2021, Novartis announced the introduction of T-Charge™, a next-generation CAR-T platform that would be a beneficial tool for novel investigational CAR-T cell therapies.

Significant advancements in molecular medicines have resulted in the development of gene-based therapy, which uses targeted delivery of DNA as a medicine to fight against various disorders. Gene therapy has high potential in the treatment of cancer and diabetes type 1 & 2 through restoring gene function. 

The global gene therapy market size was estimated at USD 8.67 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 19.5% from 2024 to 2030. (R)

Currently, gene-based therapies are used in the treatment of patients suffering from cancer, oncology, infectious diseases, cardiovascular disorders, monogenic diseases, genetic disorders, ophthalmological indications, and diseases of the central nervous system. These factors have contributed to the growth of the regenerative medicine market.

Related: Gendicine (Ad-p53), The First Approved Gene Therapy Product for Cancer

Product Insights

The therapeutics segment held a 69.1% revenue share of the regenerative medicine market in 2022, owing to the rising geriatric population, coupled with higher incidence rates of age-related as well as degenerative disorders. The increased prevalence of diseases with unmet medical solutions, such as cancer, diabetes, and neurodegenerative diseases, including AMD, has encouraged researchers to develop alternative options. For instance, in April 2022, Kite, a Gilead Company, announced that it had received the U.S. FDA's authorization for its CAR T-cell therapy product, Yescarta, which could be used for the treatment of refractory or relapsed large B-cell lymphoma.

The banks segment is projected to witness considerable growth in the coming years. Considerable investment has been made to establish bio-banks, including tissue and cord blood banks, to provide the perceived research benefits. These banks comprise systematically organized and maintained cell lines for single or multi-use by researchers, healthcare providers, and other stakeholders. Stem cells and biologically engineered tissues are the most significant tools used in regenerative medicine. Thus, these banks are an important part of the regenerative medicine market.

Therapeutic category Insights

The oncology segment dominated the regenerative medicine market in 2022, capturing a revenue share of 32.3%, owing to the growing burden of cancer globally. Various government organizations along with private companies have made high investments in cancer research and the development of regenerative & advanced cell therapies. In January 2023, Calidi Biotherapeutics (CBT) and First Light Acquisition Group (FLAG) entered into a partnership agreement that aims to revolutionize oncolytic virotherapies with the help of stem cell-based platforms.

The cardiovascular segment is anticipated to witness significant growth during the forecast period. Advancements in cell-based therapies and regenerative medicines have accelerated the growth of the segment. Many key players are involved in the development of regenerative therapies to repair, restore, and revascularize damaged heart tissues. There is a growing adoption of single and mixed cells from autologous as well as allogeneic sources to study the effect on CVDs. In addition, advanced biologics, small molecules, and gene therapy are being investigated to stimulate the regeneration of damaged heart cells. These factors would further fuel the regenerative medicine market growth.


Regional Insights

The North America region dominated the regenerative medicine market, capturing a market share of 51.32% in 2022. The high market growth is attributed to the availability of government and private funding for development, the presence of advanced tech frameworks to support the rapid detection of chronic diseases, and high healthcare spending in the region. Moreover, several ongoing clinical trials for regenerative medicine by significant market players have contributed to the region’s growth. In December 2021, Bristol Myers Squibb received U.S. FDA approval for Orencia for the prevention of acute graft versus host disease in adults and pediatric patients 2 years of age and older, undertaking hematopoietic stem cell transplantation (HSCT).

Key Companies

Major players operating in the regenerative medicine market are focused on strategic partnerships, collaborations, and regional expansions in favorable regions. For instance, in September 2021, AstraZeneca PLC planned to invest USD 360 million in an advanced manufacturing facility in Ireland. This initiative was expected to transform the development and commercialization of novel medicines. In December 2021, Pfizer, Inc. invested USD 68.5 million in a new state-of-the-art facility in Durham to expand its capabilities in gene therapies. This initiative was expected to help strengthen the company’s presence in the U.S.


Sources and References: 

https://www.webmd.com/a-to-z-guides/what-is-regenerative-medicine

https://stemcell.aestheticsadvisor.com/2023/03/regenerative-medicine-market-2023.html

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