Organ Transplant Immunosuppressant Drugs Market Analysis

Organ transplantation is a procedure, wherein a healthy organ is transferred from a living or deceased body into another individual’s body. It is the primary treatment option for an end-stage organ failure. The process can also involve transplantation of more than one organ at a time. Demand for organ transplant immunosuppressant drugs is rising due to increase in the number of people registering for organ transplant worldwide.

The global organ transplant immunosuppressant drugs market is estimated to be valued at US$ 4,862.0 million in 2021 and is expected to exhibit a CAGR of 3.1 % over the forecast period (2021-2028).

Recent Developments:

In July 2021, the U.S. Food and Drug Administration has approved a new use for Prograf (tacrolimus) based on a non-interventional (observational) study providing real-world evidence (RWE) of effectiveness. FDA approved Prograf for use in combination with other immunosuppressant drugs to prevent organ rejection in adult and pediatric patients receiving lung transplantation. 

In December 2020, Lupin Limited has launched Mycophenolate Mofetil Tablets USP, 500 mg, after Lupin’s alliance partner Concord Biotech Limited (Concord) received an approval for its ANDA from the United States Food and Drug Administration.

In April 2020, Lupin Limited has launched Mycophenolic acid delayed release tablets USP, 180 mg and 360 mg. Mycophenolic acid delayed-release tablets USP, 180 mg and 360 mg, is the generic equivalent of Myfortic delayed-release tablets, 180 mg and 360 mg, of Novartis Pharmaceuticals Corporation, and are indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant and use in combination with cyclosporine and corticosteroids.

North America held dominant position in the global organ transplant immunosuppressant drugs market in 2020, accounting for 46.9% share in terms of volume, followed by Europe and Asia Pacific, respectively. Dominance of North America region can be attributed to growing organ transplantation cases with rising prevalence of chronic diseases, better healthcare infrastructure, and favorable reimbursement scenario. 

Figure 1. Global Organ Transplant Immunosuppressant Drugs Market Value (US$ Mn), by Region, 2020

Global Organ Transplant Immunosuppressant Drugs Market: Drivers

Increasing incidences of chronic diseases is expected to propel growth of the global organ transplant immunosuppressant drugs market over the forecast period. For instance, according to the American Cancer Society, in 2019, there will be an estimated 1,762,450 new cancer cases diagnosed and 606,880 cancer deaths in the U.S.

Moreover, increasing geriatric population is also expected to boost demand for organ transplant immunosuppressant drugs. For instance, according to the U.S. Census Bureau, the U.S. geriatric population is expected to reach 77 million by 2034.         

Organ Transplant Immunosuppressant Drugs Market Report Coverage

Report Coverage	Details
Base Year:	2020	Market Size in 2021:	US$ 4,734.8 Mn
Historical Data for:	2017 to 2020	Forecast Period:	2021 to 2028
Forecast Period 2021 to 2028 CAGR:	3.1%	2028 Value Projection:	US$ 6,007.6 Mn
Geographies covered:	North America: U.S. and Canada Latin America: Brazil, Argentina, Mexico, and Rest of Latin America Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific Middle East: GCC Countries, Israel, and Rest of Middle East Africa: South Africa, North Africa, and Central Africa
Segments covered:	By Drug Class: Calcineurin Inhibitors, Antiproliferative Agents, mTOR Inhibitor, Steroids, Antibodies By Transplant Type: Kidney, Liver, Heart, Lung, Pancreas, Others By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Online Pharmacies
Companies covered:	Astellas Pharma, Genzyme Corporation, Accord Healthcare Ltd., Watson Pharmaceuticals, Inc., Novartis AG, Mylan Laboratories, Inc., GlaxoSmithKline plc., Belcher Pharmaceuticals LLC, Leo Pharma As, Glenmark Pharmaceuticals Ltd., TFF Pharmaceuticals, Inc., TolerogenixX GmbH, Veloxis Pharmaceuticals Inc., Dr. Reddy’s Laboratories Ltd., Panacea Biotec Ltd., Strides Pharma Global Pte Ltd., and Hoffman La Roche
Growth Drivers:	Increasing incidences of chronic diseases Increasing geriatric population
Restraints & Challenges:	High cost of procedure Lack of donor organs

Global Organ Transplant Immunosuppressant Drugs Market: Opportunities 

R&D in organ transplant immunosuppressant drugs is expected to offer lucrative growth opportunities for players in the global organ transplant immunosuppressant drugs market. For instance, in November 2018, Temple University, in collaboration with Veloxis Pharmaceuticals, initiated phase 4 clinical trial for Tacrolimus Extended Release Oral Tablet to evaluate dosing strategies for de novo once-daily extended release tacrolimus (LCPT) in kidney transplant recipients.

Moreover, implementation of favorable reimbursement scenario is also expected to boost demand for organ transplant immunosuppressant drugs. For instance, in January 2020, The Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2019 (HR 5534) extended Medicare coverage of immunosuppressive drugs for kidney transplants past the 36-month cut-off currently in place to cover the medications for the life of the transplant.

Market Trends

Increasing mortality among organ transplant patients diagnosed with COVID-19 is expected to propel growth of the global organ transplant immunosuppressant drugs market. For instance, according to the European Renal Association-European Dialysis and Transplant Association, since March 2020, 25% of kidney transplant patients diagnosed with COVID-19 in European countries have died.

The emergence of Covid-19 is expected to have significant impact on heart and lung transplant. For instance, in August 2020, researchers from University Hospital of Siena, Italy, reported that a higher percentage of lung transplant subjected that Covid-19 could have a negative impact on the outcome of their graft. Moreover, 28% of the patients declared that they were afraid to come to the hospital for routine examinations and asked to postpone.

Figure 2. Global Organ Transplant Immunosuppressant Drugs Market Share, By Drug Class, 2020

Key Takeaways of the Graph:

• Among Drug Class, the Calcineurin Inhibitors held dominant position in the market and accounted for 35.3% share in the global organ transplant immunosuppressant drugs market in 2020. The segment is expected to reach US$ 2,080.1 million in 2028.
• Better efficacy of Calcineurin, pipeline studies conducted by different research institutes, and increasing demand of cost effective options are some of the major factors responsible for the dominance of Calcineurin inhibitors segment
• Among Transplant type, the kidney segment held dominant position in the market and accounted for 53.9% share in the global organ transplant immunosuppressant drugs market in 2020. The segment is expected to reach US$ 3,262.1 million in 2028.
• Dominance of kidney segment during the forecast period can be attributed to increasing kidney transplantation, growing demand of immunosuppressant drugs, and accessibility of large number of drug options for kidney transplant immunosuppressant

Global Organ Transplant Immunosuppressant Drugs Market: Restraints

High cost of procedure is expected to hinder growth of the global organ transplant immunosuppressant drugs market. Patient non-adherence to immunosuppressive medications is related to high medication cost and patient’s inability to pay for the expensive procedures. The cost of post-transplantation care and on-going immunosuppression in several low and middle income countries present a significant barrier to the development of higher transplantation capacity. This has been a driving factor for illegal organ trafficking practiced across the world. Kidney transplant procedure costs around US$ 100,000 in the U.S., US$ 70,000 in China, and only US$ 5,000 in India.

Moreover, lack of donor organs is also expected to hinder growth of the global organ transplant immunosuppressant drugs market. Despite advances in medicine and technology and increased awareness about organ donation and transplantation, the gap between demand and supply continues to widen.

Global Organ Transplant Immunosuppressant Drugs Market: Competitive Landscape

Major player operating in the global organ transplant immunosuppressant drugs market include, Astellas Pharma, Genzyme Corporation, Accord Healthcare Ltd., Watson Pharmaceuticals, Inc., Novartis AG, Mylan Laboratories, Inc., GlaxoSmithKline plc., Belcher Pharmaceuticals LLC, Leo Pharma AS, Glenmark Pharmaceuticals Ltd., TFF Pharmaceuticals, Inc., TolerogenixX GmbH, Veloxis Pharmaceuticals Inc., Dr. Reddy’s Laboratories Ltd., Panacea Biotec Ltd., Strides Pharma Global Pte Ltd., and F-Hoffman La Roche.

Global Organ Transplant Immunosuppressant Drugs Market: Key Developments

Major players in the global organ transplant immunosuppressant drugs market are focused on R&D of new drugs to expand their product portfolio. For instance, in May 2020, TolerogenixX GmbH announced the publication of positive Phase Ib results of its lead product MIC-Lx, a cell therapy product that can induce donor-specific tolerance in kidney transplant recipients, in The Journal of Clinical Investigation.