U.S. 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 Country Forecast, 2023-2030

The U.S. transplantation market size was worth USD 3.40 billion in 2022 and is projected to grow at a CAGR of 9.1% during the forecast period.

A transplantation refers to a medical procedure in which an organ or tissue product is removed from the donor and is implanted into another part of the body or in another recipient.

In the U.S., there is a significant demand for these procedures due to increasing organ failure cases. The increasing number of organ failure cases is due to the growing prevalence of chronic disease and trauma cases among the U.S. population. The propelling demand for such procedures and the rising number of transplant centers is eventually contributing to market growth.  

• According to Donor Alliance Inc., there are more than 250 Transplant Centers in the U.S. Thus, the increasing number of specialty transplantation care institutions is propelling the market growth.

Also, the surge in initiatives by key players to launch new products through robust R&D initiatives is expected to drive the market growth. Moreover, the market is witnessing various technological advancements in organ transplant methods. Such factors are boosting the market growth during the forecast period of 2023-2030.

The COVID-19 pandemic negatively impacted the U.S. market growth due to limited procedures and hindrances in the supply chain of companies.

U.S. Transplantation Market Trends

Strategic Initiatives among Various Organizations to Augment These Procedures is a Positive Market Trend

The U.S. market has witnessed strong demand for these procedures healthcare facilities and products. The cases of organ failures and the long waiting list for transplants have contributed to an increment in strategic activities by various organizations and governments to support tissue and organ transplantation. These initiatives help reduce any financial burden, leading to an increased frequency of these procedures. The growing initiatives by various major players and organizations strongly contribute to the market expansion.

• For instance, in April 2022, The National Kidney Foundation (NKF) partnered and became a member of the American Society of Transplantation’s (AST) Living Donor Circle of Excellence (Circle of Excellence) program. The Circle of Excellence aims to enhance the number of living organ donors by recognizing employers that provide lost wages during the donors' recovery from surgery.

U.S. Transplantation Market Growth Factors

Strong Demand for these Procedures to Augment Market Growth

The prevalence of chronic diseases, such as kidney failure, cancer, chronic obstructive pulmonary disease (COPD), and lupus, frequently leading to tragic damage to tissue and organs, has increased significantly over the last few decades. Furthermore, the upsurge in the number of organ failures is one of the most common causes of these procedures in the U.S., further aiding the market growth.

• For instance, according to preliminary data from the Organ Procurement and Transplantation Network (OPTN), in 2021, about 41,354 organ transplants were performed in the U.S., with an increase of 5.9% over 2020. For the first time, the annual total exceeded 40,000. As a result, the market is expected to experience strong growth in the coming years.

According to statistics published by the International Registry on Organ Donation and Transplantation (IRODaT) in 2022, the actual number of deceased organ donors is 14,903 in the U.S. Furthermore, according to the statistics published by the IRODaT in 2022, the actual number of living organ donors is 6,462 in the U.S. Organ donation reduces the overall healthcare cost compared to the long-term medical treatments for organ failure.

RESTRAINING FACTORS

Growing Competition from Generic Immunosuppressants to Hinder Market Growth

Immunosuppressants are widely used in these procedures, but several barriers are expected to restrict the U.S. transplantation market growth. In recent years, the pharmaceutical market has witnessed dramatic growth in terms of the generic drug industry. The generic drugs cost comparatively less than their brand equivalents. Thus, they have played an essential role in terms of reducing the national expenditure on prescription drugs from what it would otherwise be far higher.

Some commonly used immunosuppressants in this market are tacrolimus, cyclosporine, mycophenolate mofetil, azathioprine, everolimus, sirolimus, and glucocorticoids (steroids). At the same time, some generic drug manufacturers are developing great competition in the U.S. transplantation market.

• In April 2020, Lupin launched generic Mycophenolic acid delayed-release tablets in the U.S. market. It is used to prevent organ rejection in patients with kidney transplantations.

U.S. Transplantation Market Segmentation Analysis

By Product Type Analysis

By product type, the market is divided into tissue products, immunosuppressive drugs, and preservation solutions.

The immunosuppressive drugs segment held the largest U.S. transplantation market share in 2022.  These drugs work to reduce the body’s ability to reject the transplanted organ. The strong usage of these drugs for transplantation procedures is expected to propel the segmental growth in the forecast period.

The tissue products segment held the second-largest market share in 2022. Rising trauma and injury cases are significantly increasing product demand. The growing initiatives by several market players to launch new products are expected to drive the growth of the segment during 2023-2030.

• For instance, in December 2021, Paragon 28 launched the ParaDerm NF Dermal Matrix to provide a structural allograft for applications beneath the skin in cases where an additional structural value is desired.

By Application Analysis

By application, the market is divided into organ transplantation and tissue transplantation.

The tissue transplantation segment dominated the market in terms of revenue share in 2022. Some of the key factors attributable to the remarkable growth of the segment are the surge in the number of tissue procedures due to the presence of ample facilities, such as advanced preservation systems and favorable reimbursement policies in the U.S.

• For instance, according to the American Association of Tissue Banks (AATB) data for 2022, an estimated 2,500,000 tissue procedures are performed, and approximately 3,300,000 allografts are distributed annually in the U.S.

The organ segment holds a prominent place in the market as the number of transplant operations owing to the demand for organs, increases due to the rise in the various chronic conditions such as cancer, kidney failure, COPD, and lupus.

By End-user Analysis

Based on end user, the market is segmented into hospitals, transplantation centers, and others.

The hospitals segment held a major share in 2022. The well-developed hospital infrastructure, the presence of trained healthcare providers, and the presence of services, such as multi-organ transplant operation theatres and transplant ICUs for liver, kidney, and heart surgeries, are propelling the segment’s growth.

Also, the increasing number of these procedures and efforts to decline the waiting list are favoring segmental growth.

• As per the data from the centers with the quickest transplant rates from deceased donors between January and December 31, 2021, the UF Health Shands Hospital in Gainesville, Florida, held the highest rank with 158 transplants.

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’s growth.

List of Key Companies in U.S. Transplantation Market

The market depicts a highly fragmented competitive landscape, with various biotechnology and medical device companies as market players in each segment, such as tissue products, immunosuppressive drugs, and preservation solutions. Zimmer Biomet is one of the dominant players in tissue products due to its robust product offerings. Similarly, Astellas dominated the market due to its robust sales of key immunosuppressive drug called PROGRAF (tacrolimus).

• For instance, PROGRAF recorded sales of USD 1,840.5 in FY 2022 and a 9.0% year-on-year growth rate compared to 2021.

Regarding preservation solutions, BioLife Solutions is considered a market player due to its expanded biopreservation media products. Moreover, numerous players are entering and expanding into the market through strategic activities such as partnerships and mergers, and product launches in the U.S.

LIST OF KEY COMPANIES PROFILED:

• Novartis AG (Switzerland)


• Teva Pharmaceutical Industries Ltd. (Israel)


• Arthrex, Inc. (U.S.)


• F. Hoffmann-La Roche Ltd (Switzerland)


• Zimmer Biomet (U.S.)


• Astellas Pharma Inc. (Japan)


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


• BioLife Solutions (U.S.)


• TransMedics (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• January 2023 – Zimmer Biomet Holdings, Inc. underwent a definitive agreement to acquire Embody, Inc. This acquisition includes Embody's complete portfolio of collagen-based biointegrative solutions, including the TAPESTRY, a biointegrative implant for tendon healing, and TAPESTRY RC, one of the first arthroscopic implant systems for rotator cuff repair.


• July 2021 – TransMedics Group, Inc. received 510(k) clearance from the regulatory body U.S. Food and Drug Administration for OCS Lung Solution for use in transplants using cold storage techniques.


• December 2020 – Biocon launched Tacrolimus capsules in the U.S. It is a calcineurin inhibitor used in organ transplant patients and helps to reduce the body’s ability to reject a transplanted organ.

REPORT COVERAGE

The U.S. transplantation market report provides a comprehensive analysis of the market, including the number of organ transplants, key industry developments, product launches, regulatory scenarios, key trends, and the impact of the COVID-19 pandemic on the U.S. market. It includes a complete U.S. transplantation market forecast for the study period 2019-2030 of the segments, including product type, application, and end-user. Furthermore, the market analysis report provides insights into key market players' profiles, dynamics, and other contributing factors to the market’s growth.

Report Scope & Segmentation