Tacrolimus is used in combination with other drugs to prevent rejection (attack of a transplanted organ by the recipient's immune system) in persons who have received a kidney transplant. Tacrolimus is also used in combination with other drugs to prevent rejection in recipients of a liver, lung, or heart transplant. Tacrolimus belongs to a class of drugs known as immunosuppressants. It works by suppressing the immune system's activity in order to prevent it from attacking the transplanted organ.
The global tacrolimus market is estimated to be valued at US$ 6,485.3 million in 2022 and is expected to exhibit a CAGR of 4.7% during the forecast period (2022-2030).
Figure 1.Global Tacrolimus Market Share (%) in Terms of Value, by Product Type, 2022
Increasing number of organ transplant procedures is expected to drive growth of the global tacrolimus market
The increasing number of organ transplant procedures is expected to drive the market growth over the forecast period. For instance, according to the data published by the U.S. Department of Health & Human Services, in January 2021, a total of 39,034 transplants were performed in the U.S. from both living and deceased donors in 2020.
|Base Year:||2021||Market Size in 2022:||US$ 6,485.3 Mn|
|Historical Data for:||2017 to 2020||Forecast Period:||2022 to 2030|
|Forecast Period 2022 to 2030 CAGR:||4.7%||2030 Value Projection:||US$ 9,380.2 Mn|
Novartis AG, Mylan N.V., Astellas Pharma Inc., Dr. Reddy's Laboratories Ltd., Pfizer Inc., Abbott, Senju Pharmaceutical Co. Ltd., Glenmark Pharmaceuticals Ltd., Lupin Limited, and Vibcare Pharma Pvt. Ltd.
|Restraints & Challenges:||
Figure 2.Global Tacrolimus Market Share (%), by Application, 2022
Increasing research and development activities by pharmaceutical companies are expected to drive the market growth during the forecast period.
Increasing research and development activities by key players for the development and launch of tacrolimus are expected to drive the global tacrolimus market growth over the forecast period. For instance, in June 2018, VIVUS, Inc., a biopharmaceutical company, announced positive preliminary results from a Phase 1 clinical study evaluating the pharmacokinetic (PK) profile of its VI-0106 in healthy volunteers. VIVUS is developing VI-0106, a proprietary soft capsule formulation of tacrolimus for the treatment of pulmonary arterial hypertension (PAH), a degenerative disease that makes it difficult for the heart to pump blood through the lungs to be oxygenated and may ultimately lead to heart failure.
Global Tacrolimus Market– Impact of Coronavirus (COVID-19) Pandemic
Since the COVID-19 virus outbreak in December 2019, the disease has spread to over 100 countries across the globe and the World Health Organization declared it a public health emergency on January 30, 2020.
COVID-19 can affect the economy in three main ways: by directly affecting production and demand, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to nationwide lockdowns, several countries, such as China, India, Saudi Arabia, U.A.E., Egypt, and others are facing problems with regards to the transportation of products from one place to another.
The COVID-19 pandemic had a negative effect on the tacrolimus market, owing to the decreased number of organ transplantations. For instance, according to an article published by Elsevier Inc., a global information analytics company, the transplant activities in 2020 from the date of the 100th reported cumulative COVID-19 case to December 31, 2020 were compared to the same period of time in 2019. According to the results, an overall decrease of 11,253 (−15·92%) organ transplants was observed across 22 countries.
Global Tacrolimus Market: Restraint
The major factors that hinder growth of the global tacrolimus market include side effects and presence of alternative medicine. For instance, tacrolimus may cause serious side effects including decreased urination, pain or burning on urination, pale skin, shortness of breath, fast heartbeat coma (loss of consciousness for a period of time), etc. The most common side effects of tacrolimus include headache, diarrhea, constipation, nausea, and others.
Moreover, the presence of alternative medicine for tacrolimus is expected to hamper the market growth. Nulojix is an injectable medication that works in a different way than any other anti-rejection medicines available. It was designed as a potential replacement medication for Prograf (tacrolimus). The goal of this medication is to not only prevent rejection but also avoid toxic effects on the kidney, heart, and nervous system.
Major players operating in the global tacrolimus market include Novartis AG, Mylan N.V., Astellas Pharma Inc., Dr. Reddy's Laboratories Ltd., Pfizer Inc., Abbott, Senju Pharmaceutical Co. Ltd., Glenmark Pharmaceuticals Ltd., Lupin Limited, and Vibcare Pharma Pvt. Ltd.
Tacrolimus is a calcineurin inhibitor and potent immunosuppressive drug that is primarily used to prevent cellular rejection following organ transplantation. It is also used topically to treat severe atopic dermatitis, severe refractory uveitis following bone marrow transplants, and the skin disorder vitiligo. Tacrolimus is available in capsule, granules for oral suspension (to be combined with liquid), extended-release (long acting) capsule, and extended-release tablet for oral administration. Tacrolimus immediate-release formulations, in combination with other immunosuppressants, are approved for the prevention of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants. Tacrolimus extended-release formulations are approved for the prevention of organ rejection in adult and pediatric patients having kidney transplants when combined with other immunosuppressants, and may be used in patients who have been converted from immediate-release formulations.
The increasing product launch by the key players in the market is expected to drive the market growth over the forecast period. For instance, in June 2020, Sandoz, a Novartis division and a global leader in generic pharmaceuticals and biosimilars, announced the launch of once-daily generic tacrolimus capsules known as Dailiport in Germany, the U.K., The Netherlands, Finland, Sweden, Estonia, Latvia, and Slovakia, and as Conferoport in Italy and Spain.
Moreover, key companies in the market are focusing on inorganic growth strategies such as distribution of tacrolimus products, which is expected to drive the market growth over the forecast period. For instance, in January 2022, Mayne Pharma Group Limited, an Australia-based specialty pharmaceutical company announced that it had begun distribution of tacrolimus ointment, 0.1% in the U.S. Tacrolimus ointment is a generic version of PROTOPIC, indicated for the treatment of Atopic dermatitis.
Key features of the study:
“*” marked represents similar segmentation in other categories in the respective section.