Transplantation Market Size, Share & COVID-19 Impact Analysis, By Product Type (Tissue Products, Immunosuppressive Drugs, and Preservation Solutions), By Application (Organ Transplantation and Tissue Transplantation), By End-user (Hospitals, Transplantation Centers, and Others), and Regional Forecast, 2023-2030

The global transplantation market size was valued at USD 8.68 billion in 2022. The market is projected to grow from USD 11.37 billion in 2023 to USD 21.62 billion by 2030, exhibiting a CAGR of 9.6% during the forecast period.

Transplantation is a surgical procedure of taking an organ or living tissue and implanting it in another part of the body or another body. The rising demand for these procedures and the launches of novel products to prevent the failure of these procedures is one of the foremost factors contributing to transplantation market growth. Organ failure cases usually occur due to various factors, including severe trauma, blood loss, poisoning, drug abuse, leukemia, sepsis, and other acute diseases.

This has led to a vast global demand for tissue and organ transplantation, including organs such as kidneys, liver, heart, and lungs. For instance, according to the statistics published by Directorate General of Health Services,Government of India in 2023, it is estimated that about 25 to 30 thousand patients require liver transplantation in India. However, only 1,500 procedures are carried out per year in India. Such strong demand for these procedures in developing countries is anticipated to drive market growth in the forecast period.

Additionally, various non-government and government groups are helping to disseminate awareness regarding the importance of organ donation. For instance, in the U.K., the government agency National Health Service (NHS) carries out regular public awareness drives to educate and encourage individuals to register for organ donations. Such programs are expected to surge market growth.

COVID-19 IMPACT:

Reduced Patient Visits amid COVID-19 Exterted a Negative Influence on the Global Market

The COVID-19 outbreak affected the global market due to a global decline in injuries and trauma incidents. Another factor that deepened the negative impact of the COVID-19 pandemic in 2020 was the reduced patient visits to healthcare professionals owing to the coronavirus. For instance, as per data recorded by the U.S. Department of Health and Human Services (HHS), in 2021, the COVID-19 pandemic significantly impacted the number of organ transplant procedures in the U.S., with 39,036 procedures performed in the U.S. in 2020 compared to 39,719 in 2019, representing a decline of 1.7%. Thus, several procedures were adversely impacted by the reduction in patient visits.

Furthermore, the pandemic negatively impacted the global sales of products. Prominent companies in the market reported substantial sales decline in their annual revenues for FY 2020. For instance, key companies in the global market, such as the product segment of Astellas Pharma Inc. and the S.E.T segment of Zimmer Biomet, recorded substantial declines in sales performance. Additionally, the company BioLife Solutions, which has a strong presence in the global market in terms of its preservation solutions portfolio, witnessed an increase in its revenues in 2021 compared to 2020. For instance, the ‘Cell Processing’ segment witnessed an increase of 45.3% in 2021 compared to FY 2020.

However, greater adoption of technologically advanced offerings coupled with increased patient visits is expected to surge the market's growth prospects and return to its pre-pandemic scenario in 2023. Also, the increasing number of procedures is anticipated to contribute towards stable market growth during 2023-2030.

LATEST TRENDS

Collaborations between Public and Private Players and FDA Approvals for New Indications Contribute to Market Growth Prospects

The market has witnessed numerous strategic collaborations over the years. The increasing incidence of organ failure has led to an extreme necessity for these procedures. Therefore, many players are continuously focusing on building their product portfolio and are also focused on increasing the number of these procedures through collaborations. For instance, the Transplant Therapeutics Consortium (TTC) has collaborated with the transplant community, including stakeholders, such as industry, academia, professional societies, and regulatory agencies. The TTC is managed and supported by the Critical Path Institute (C-Path). It is co-founded by the American Society of Transplantation (AST) and the American Society of Transplant Surgeons (ASTS).

Further,the Sectoral Coordination of Transplants, Seville-Huelva, Spain, signed a public-private collaboration agreement with several hospitals in Seville, Spain, in 2012. The agreement aims to support the process of organ and tissue donation in the Intensive Care Unit (ICU) setting without transferring to the potential donor, thus guaranteeing that the donor can participate in this process. Also, it added to a training program for the ICU and OR staff of the private sector.

Similarly, in March 2023, The Pan American Health Organization (PAHO) signed an agreement with the Ministry of Health of the Government of Spain to strengthen organ donation and transplants in the U.S. Such market drifts are expected to sturdily contribute to the market's growth rate during the forecast period.

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DRIVING FACTORS

Rise in Demand for Transplantation Procedures Drive Market Growth

A substantial rise in these procedures globally due to organ demand will likely push the overall market growth. The rising prevalence of chronic diseases, such as cancer, kidney failure, COPD, and lupus, frequently leads to extensive tissue and organ damage. The upsurge in organ failures is one of the most crucial factors for market growth. For instance, according to data from the United Network for Organ Sharing, in 2022, 42,800 organ transplants were performed in the U.S.

Furthermore, emerging and developed nations, including the U.S. and the U.K., are continuously increasing awareness amongst the population regarding organ donation. The emphasis on developed healthcare infrastructure and implementing favorable reimbursement policies are propelling market growth. For instance, the National Organ and Tissue Transplant Organization (NOTTO) is a national-level organization set up under the Directorate General of Health Services, Ministry of Health, and Family Welfare. It conducts coordination and networking activities to procure and distribute the Organs and Tissues Donation and Transplantation registry in India.

Technological Advancements in Tissue Products Augment Market Growth

One of the distinguishing factors expected to push market growth is the development of technologically advanced tissue products. Some emerging technologies in tissue products include autologous stem cell transplant, which has become convenient due to the advent of induced Pluripotent Stem Cells (iPSC). Scientists are trying to develop organs from human-induced pluripotent stem cells.

Furthermore, novel technologies, such as three-dimensional (3D) bioprinting, decellularization and recellularization, and interspecies organogenesis, are being utilized to overcome immunologic hurdles. Prominent players are focusing on launching novel tissue products in the market. For instance, in August 2021, AlloSource launched the AlloMend Ultra-Thick Acellular Dermal Matrix (ADM) to create innovative cellular and tissue products to help surgeons heal their patients. Therefore, integrating such unique tools will decisively boost market expansion.

RESTRAINING FACTORS

Extensive Wait Time for Transplantation Procedures in Various Countries Hinders the Market Growth

There is growing demand for organ and tissue transplant procedures. However, one of the substantial hindrances to market growth is the extensive wait times for these procedures, especially in emerging countries. For instance, as per the statistics published by the World Economic Forum (2022), in 2021, a total of 120,000 organ transplant patients were on the waiting list in the U.S. However, fewer organ donations eventually increase the waiting time for these procedures. According to an article published by BMC in 2020, the average waiting time for kidney transplants was 386.22 days in Iran. The unmet demand for these procedures is anticipated to augment the market growth.

Additionally, in developing countries, most people are unaware of the options for these procedures, and there is an abundance of inadequate reimbursement policies. According to an article published by Kidney 360 in December 2021, the median waiting time for a deceased donor kidney transplant is three years in Brazil. All the above mentioned factors could impede the market growth.

SEGMENTATION

By Product Type Analysis

Tissue Products Held Largest Market Share in 2022 Due to Significant Product Launches

The global market can be segmented based on product type into tissue products, immunosuppressive drugs, and preservation solutions.

The tissue products segment held a dominant market share due to increased R&D initiatives by various medical devices companies leading to product launches. Also, the rising trauma and injury cases significantly propel the segment’s expansion. For instance, in June 2022, Arthrex Inc. funded and granted support to a soft tissue injury research project. The project was conducted in collaboration between the Orthopedic Research and Education Foundation (OREF) and the Orthopedic Trauma Association (OTA).

The immunosuppressive drugs segment is expected to witness positive growth prospects and is the second largest segment. This is due to the benefits these drugs offer, lowering the body's ability to reject a transplanted organ.

The preservation solutions segment is expected to grow significantly during the forecast period due to increasing technological advancements in these products, making them more cost-effective and having several logistical advantages and features.

By Application Analysis

Escalating Injury Cases Favored the Tissue Transplantation Segment’s Dominance in 2022 

In terms of application, the market is divided into organ transplantation and tissue transplantation. The tissue transplantation segment captured a higher market share in revenue generation as replacing skin, cornea, bones, heart valves, tendons, nerves, and veins is among the most commonly performed procedures globally. The escalating number of burn and accident cases is also expected to propel the demand for these procedures. According to an article published by the Ministry of Health and Family Welfare in 2021, approximately 7.0 million people suffer from severe burns per year in India. These people do require advanced medical intervention, such as tissue transplants, to reconstruct the defects.

The organ segment is estimated to grip a significant position in the marketplace due to the rising number of transplant procedures due to the increased prevalence of various chronic diseases such as cancer, kidney failure, Chronic Obstructive Pulmonary Disease (COPD), and lupus. For instance, according to the National Institutes of Health (NIH), in September 2021, approximately 786,000 patients in the U.S. are suffering from End-stage Kidney Disease (ESKD); out of that, 71.0% are on dialysis and 29.0% are living with a kidney transplant.

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By End-user Analysis

Strong Procedural Volume in Hospitals to Boost Segment’s Growth 

Based on end-user, the market is fragmented into hospitals, transplantation centers, and others. The hospitals segment dominates the market and is likely to grow as hospitals are primary care centers for treatment and these procedures. Furthermore, favorable health reimbursements for these procedures and a rise in equipped hospitals are vital prospects for contributing to the hospital's segment. 

The transplantation centers segment held a prominent position in 2022. The rise in these specialized institutions in developed and developing regions is anticipated to contribute to this segment. According to Donor Alliance Inc., there are more than 250 Transplant Centers in the U.S. The other segment is expected to witness limited growth prospects due to the fewer procedures conducted in these institutions.

REGIONAL INSIGHTS

On the basis of region, the global market is fragmented into Europe, Asia Pacific, Latin America, the Middle East & Africa, and North America.

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The North American market size was valued at USD 3.70 billion in 2022, and the region is estimated to dominate the global market. The market is expected to maintain its dominance due to the substantial demand for novel tissue transplantation products and organ transplantation. Other factors that bolstered the development of the market are satisfactory reimbursement plans and the fast adoption of three-dimensional (3D) bioprinting across the region. Furthermore, the presence of prominent companies in the U.S. and the regulatory approvals for innovative items are some common contributing factors to market growth in North America. In July 2021, Astellas Pharma Inc. received U.S. Food and Drug Administration (FDA) approval for its supplemental New Drug Application (sNDA) for PROGRAF (tacrolimus). It prevents organ rejection in adult and pediatric lung transplant recipients.

The European market was the second-largest market in 2022. The growth can be attributed to the increase in transplantation procedures and the vital initiatives by various governments to raise awareness about organ donations in the region. As per an article published by the Nature Reviews Nephrology in 2021, a group of prominent European stakeholders is collaborating within a Thematic Network, presented with an outline of challenges to increase the rates of these procedures. It has proposed 12 critical areas along with specific measures that should be considered to promote the conduction of these procedures.

The Asia Pacific market witnessed significant growth in 2022. In Asia Pacific, the cases of organ failure are considerably high due to the rising prevalence of chronic diseases among the geriatric population.

Latin America is also expected to gain momentum during the forecast period. Many organ donation and transplantations in Mexico and Brazil could provide lucrative opportunities for leading market players. According to an article published by Serviços e Informações do Brasil in 2022, 12,000 organ transplants were performed in Brazil in 2021. The country is second in the world ranking, behind the U.S.

The Middle East and Africa are expected to witness decent growth in the projected period due to the rising government programs to increase awareness amongst the individuals of emerging countries across the region.

KEY INDUSTRY PLAYERS

Strong Portfolio and Sales of Zimmer Biomet, Astellas Pharma, and BioLife Solutions to Strengthen their Market Position

Based on the competitive landscape, the market is fragmented into several national and international players for tissue products, immunosuppressive drugs, and preservation solutions. However, new product launches and focus on strategic acquisitions are driving factors to capture a higher global transplantation market share. Regarding tissue products, Zimmer Biomet dominated the market due to its prominent portfolio of soft tissue products, including the ‘DeNovo NT Graft’ and the ‘DermaSpan Acellular Dermal Matrix,’ which have several indications for knee, hip, ankle, and shoulder. At the same time, Astellas dominates the market due to its strong sales of PROGRAF (tacrolimus) in immunosuppressive drugs. Also, some companies, such as Veloxis Pharmaceuticals, Inc., have pipeline drugs in their portfolio, supporting its growth.

In terms of preservation solutions, BioLife Solutions is one of the key market players due to its robust cell processing segment, including biopreservation media products. Furthermore, emerging companies, such as MTF Biologics, Dr. Franz Köhler Chemie GmbH, and Paragonix Technologies, are slowly gaining a significant market share owing to the technologically advanced product offerings.

LIST OF KEY COMPANIES PROFILED:

• Novartis AG (Switzerland)


• Teva Pharmaceutical Industries Ltd. (Israel)


• Arthrex, Inc. (U.S.)


• Veloxis Pharmaceuticals, Inc. (Asahi Kasei Corporation) (U.S.)


• BioLife Solutions (U.S.)


• TransMedics (U.S.)


• F. Hoffmann-La Roche Ltd (Switzerland)


• Zimmer Biomet (U.S.)


• Astellas Pharma Inc. (Japan)

KEY INDUSTRY DEVELOPMENTS:

• July 2022: Carl Zeiss Meditec partnered with Precise Bio to develop and commercialize fabricated corneal tissue for patients requiring endothelial keratoplasty and natural lenticular transplants to treat keratoconus and vision correction.


• March 2022: Zimmer Biomet entered into a multi-year agreement with Biocomposites to exclusively distribute Genex Bone Graft Substitute with its new mixing system and delivery options in the U.S.


• January 2022: Novartis AG collaborated with Alnylam, intending to explore targeted therapy to restore liver function. Alnylam’s siRNA technology is intended to promote the regrowth of functional liver cells and is an alternative for liver failure patients.


• January 2022: BioLife Solutions extended collaboration with Seattle Children's Therapeutics to optimize biopreservation and closed-system manufacturing by integrating Sexton's AF-500 cell processing tools.


• October 2021: TransMedics signed a manufacturing agreement with Dalton Pharma Services for its OCS Liver System.

REPORT COVERAGE

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The global market report includes a detailed market overview. The market forecast includes for the segments of product type, application, end-user, and geography. The analysis emphasizes crucial aspects such as dynamics of the market, key industry developments, mergers, acquisitions, partnerships, new product launches, overview of technological advancements, regulatory scenarios, number of organ transplants, key industry trends, major market players, and COVID-19 pandemic impact on the global market. Besides this, the report includes insights into the market trends and industry dynamics. Additionally, the report offers numerous factors and market statistics contributing to the market's growth.

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