Tacrolimus Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

The tacrolimus market is segmented by Product Type (Tablets and Capsules, Injections, and Others), Application (Immunosuppression, Dermatitis, and Others), End Users (Hospitals, Clinics, and Other End Users), and Geography (North America, Europe, Asia-Pacific, Middle East, and Africa, and South America). The report offers the value (in USD million) for the above segments.

Market Snapshot

Tacrolimus Market Size
Study Period: 2019-2027
Base Year: 2021
Fastest Growing Market: Asia-Pacific
Largest Market: North America
CAGR: 5.2 %
Tacrolimus Market Key Players

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Market Overview

The tacrolimus market is expected to register a CAGR of 5.2% over the forecast period, 2022-2027.

The COVID-19 pandemic has had a significant impact on the growth of the tacrolimus market. Due to stricter lockdowns and stringent social distancing norms, most of the patient population was restricted from undergoing organ transplant procedures globally. This greatly reduced the overall adoption rate of tacrolimus medications worldwide since most of the surgeries and transplantations were either postponed or delayed. For instance, as per the article titled "Kidney Transplantation in COVID Pandemic-A Review of Guidelines" published in the National Library of Medicine, in June 2021, the COVID-19 infection has had a severe impact on transplantation protocols and programs. In 2020, the number of transplants had significantly decreased. Likewise, another article titled "Organ procurement and transplantation during the COVID-19 pandemic" published in the same journal stated that the surge in COVID-19 infections and a startling decline in overall solid-organ transplantation procedures were found to have a clear temporal correlation, according to the researchers. There have been 90.6 percent fewer transplants using deceased donors in France and 51.1 percent fewer in the United States since the COVID-19 epidemic. This decrease was mostly caused by kidney transplantation in both France and the United States, but there was also a sizable impact on heart, lung, and liver transplants as well. In addition, as per the data published by the Global Observatory on Donation and Transplantation, in 2020, there were approximately 17.6% fewer transplants in 2020 as compared with the previous year, that is 2019. Thus, the COVID-19 outbreak affected the market's growth adversely in its preliminary phase; however, owing to treatment guidelines and precautionary measures released by several organizations and regulatory bodies for combatting COVID-19 in these procedures, the market is anticipated to gain traction over the coming years.

In addition, the increasing number of transplants worldwide and the surge in research and development activities for immunosuppression are likely to have a positive impact on the growth of the studied market.

Tacrolimus is administered in the management of allograft recipients receiving immunosuppressive drug therapy; thus, it plays a vital role in organ transplantation procedures. According to the data published by the Global Observatory on Donation and Transplantation, in 2020 there were a total of 1,29,681 organ transplants performed worldwide. Similarly, according to Australian and New Zealand Organ Donor Registry (ANZOD) data, in 2021, 657 kidney transplants, 253 liver transplants, 171 lung transplants, and 152 other organ transplant procedures were performed in Australia alone. Such an increase in the number of transplant procedures is expected to boost the acceptance of tacrolimus medications, in turn, driving the market growth over the forecast period.

Moreover, a surge in research and development activities, product launches, and approvals is anticipated to augment the growth of the market over the coming years. For instance, in July 2021, the enrolment for the Phase 1 clinical study for Tacrolimus Inhalation Powder was completed by TFF Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on creating and marketing cutting-edge medical products.

Therefore, owing to the aforementioned factors, the studied market is anticipated to witness growth over the analysis period. However, the side effects of the tacrolimus drugs are likely to impede the market growth.

Scope of the Report

As per the scope of the report, tacrolimus is a member of the class of drugs referred to as immunosuppressants. In order to reduce allergic reactions and prevent organ transplant rejection, the drug is used to effectively suppress the immune system. The tacrolimus market is segmented by Product Type (Tablets and Capsules, Injections, and Others), Application (Immunosuppression, Dermatitis, and Others), End Users (Hospitals, Clinics, and Other End Users), and Geography (North America, Europe, Asia-Pacific, Middle East, and Africa, and South America). The report offers the value (in USD million) for the above segments. The report offers the value (in USD million) for the above segments. The market report also covers the estimated market sizes and trends for 17 different countries across major regions, globally.

Product Type
Tablets and Capsules
Injections
Others (Ointments, Granules)
By Application
Immunosuppression
Dermatitis
Others (Vitiligo, Eczema)
End Users
Hospitals
Clinics
Other End Users
Geography
North America
United States
Canada
Mexico
Europe
Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East and Africa
GCC
South Africa
Rest of Middle East and Africa
South America
Brazil
Argentina
Rest of South America

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Key Market Trends

Immunosuppression Segment is Expected to Witness Growth over the Forecast Period

Tacrolimus medications are used in immunosuppression during transplant procedures that work by lowering the body’s ability to reject a transplanted organ. The immunosuppression segment is anticipated to witness significant growth over the forecast period owing to the growing number of transplants, an increase in R&D activities for immunosuppression, and a surge in the acceptance rate of tacrolimus treatments among the patient population.

According to an article titled "Clinical significance of tacrolimus intra-patient variability on kidney transplant outcomes according to pre-transplant immunological risk" published in the National Library of Medicine in June 2021, in solid organ transplantation, the immunosuppressant tacrolimus is the cornerstone of the immunosuppressive regimen to prevent organ rejection and graft loss. According to the same source, until new therapeutic drugs become available, the only way to optimize long-term graft outcomes after kidney transplantation is to adjust current immunosuppression based on immunological risk profile. Such factors are likely to have a positive impact on the segment’s growth over the analysis period.

Similarly, growth in strategic initiatives such as product launches and approvals, mergers, and acquisitions by prominent players within the market is anticipated to boost the segment’s growth. For instance, in June 2020, Sandoz, a Novartis AG company, announced the availability of generic once-daily tacrolimus capsules under the brand names Conferoport in Italy and Spain and Dailiport in Germany, the United Kingdom, the Netherlands, Finland, Sweden, Estonia, Latvia, and Slovakia. Available in dosages of 0.5 mg, 1 mg, 3 mg, and 5 mg, Dailiport/Conferoport is recommended for use in adult kidney and liver transplant patients.

Thus, owing to these abovementioned factors, the immunosuppression segment is expected to register a substantial growth rate over the analysis period.

Tacrolimus Market Trends

North America is Expected to Dominate the Tacrolimus Market

North America is expected to dominate the market owing to factors such as a surge in the number of organ transplants, increasing awareness regarding tacrolimus, and the presence of key manufacturers within the region. For instance, according to Health Resources and Services Administration estimates, more than 40,000 transplants were performed in 2021 in the United States alone. Furthermore, 90,483 people were on the organ transplant waiting list. Thus, this higher number of transplant procedures will ultimately increase the adoption of tacrolimus medications among the patient population, thereby driving the growth of the market in North America.

In addition, strategic initiatives and key product launches by pharmaceutical companies within the region are expected to bolster the market's growth. For instance, in July 2021, Astellas Pharma Inc. received approval from the United States Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for Prograf (tacrolimus) which became the first immunosuppressive drug approved in the United States. Likewise, in November 2020, Glenmark Pharmaceuticals Inc. was granted final approval by the United States Food and Drug Administration for Tacrolimus capsules USP in the strengths of 0.5 mg, 1 mg, and 5 mg. Similarly, in November 2020, Biocon Ltd. received the United States Food and Drug Administration approval for the launch of Tacrolimus capsules in the United States. 

Thus, these aforesaid factors are collectively driving the growth of the tacrolimus market in the North American region.

Tacrolimus Market Analysis

Competitive Landscape

The tacrolimus market is fragmented in nature due to the presence of several companies operating globally as well as regionally. The competitive landscape includes an analysis of a few international as well as local companies that hold the market share and are well known. Some of the prominent players within the market include GlaxoSmithKline plc, Pfizer Inc., Panacea Biotec, Astellas Pharma Inc., Dr. Reddy’s Laboratories Limited, Glenmark Pharmaceuticals Inc., Lupin Pharmaceuticals Inc., Novartis AG, and Leo Pharma A/S, among others.

Recent Developments

In November 2020, Lupin Limited launched Tacrolimus Capsules USP, 0.5 mg, 1 mg, and 5 mg (the generic equivalent of Astellas Pharma Prograf Capsules), after Lupin’s alliance partner Concord Biotech Limited got approval for its ANDA from the United States Food and Drug Administration.

In October 2020, Aequus Pharmaceuticals Inc. agreed to extend the terms of their promotional service agreement with Sandoz Canada Inc. for Tacrolimus immediate release until December 2021. It is a high-quality and cost-effective substitute for branded tacrolimus.

Table of Contents

  1. 1. INTRODUCTION

    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study

  2. 2. RESEARCH METHODOLOGY

  3. 3. EXECUTIVE SUMMARY

  4. 4. MARKET DYNAMICS

    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Increasing Number of Transplants Worldwide

      2. 4.2.2 Surge in Research and Development Activities for Immunosuppression

    3. 4.3 Market Restraints

      1. 4.3.1 Side Effects of the Tacrolimus

    4. 4.4 Porter's Five Force Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION (Market Size by Value - USD million)

    1. 5.1 Product Type

      1. 5.1.1 Tablets and Capsules

      2. 5.1.2 Injections

      3. 5.1.3 Others (Ointments, Granules)

    2. 5.2 By Application

      1. 5.2.1 Immunosuppression

      2. 5.2.2 Dermatitis

      3. 5.2.3 Others (Vitiligo, Eczema)

    3. 5.3 End Users

      1. 5.3.1 Hospitals

      2. 5.3.2 Clinics

      3. 5.3.3 Other End Users

    4. 5.4 Geography

      1. 5.4.1 North America

        1. 5.4.1.1 United States

        2. 5.4.1.2 Canada

        3. 5.4.1.3 Mexico

      2. 5.4.2 Europe

        1. 5.4.2.1 Germany

        2. 5.4.2.2 United Kingdom

        3. 5.4.2.3 France

        4. 5.4.2.4 Italy

        5. 5.4.2.5 Spain

        6. 5.4.2.6 Rest of Europe

      3. 5.4.3 Asia-Pacific

        1. 5.4.3.1 China

        2. 5.4.3.2 Japan

        3. 5.4.3.3 India

        4. 5.4.3.4 Australia

        5. 5.4.3.5 South Korea

        6. 5.4.3.6 Rest of Asia-Pacific

      4. 5.4.4 Middle East and Africa

        1. 5.4.4.1 GCC

        2. 5.4.4.2 South Africa

        3. 5.4.4.3 Rest of Middle East and Africa

      5. 5.4.5 South America

        1. 5.4.5.1 Brazil

        2. 5.4.5.2 Argentina

        3. 5.4.5.3 Rest of South America

  6. 6. COMPETITIVE LANDSCAPE

    1. 6.1 Company Profiles

      1. 6.1.1 Astellas Pharma Inc.

      2. 6.1.2 Pfizer Inc.

      3. 6.1.3 GlaxoSmithKline plc

      4. 6.1.4 LEO Pharma A/S

      5. 6.1.5 Dr. Reddy's Laboratories Ltd.

      6. 6.1.6 Glenmark Pharmaceuticals Inc.

      7. 6.1.7 Lupin Pharmaceuticals Inc.

      8. 6.1.8 Panacea Biotec

      9. 6.1.9 Biocon Ltd.

      10. 6.1.10 Novartis AG

    2. *List Not Exhaustive
  7. 7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Competitive Landscape covers- Business Overview, Financials, Products and Strategies and Recent Developments

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Frequently Asked Questions

The Global Tacrolimus Market market is studied from 2019 - 2027.

The Global Tacrolimus Market is growing at a CAGR of 5.2% over the next 5 years.

Asia-Pacific is growing at the highest CAGR over 2021- 2026.

North America holds highest share in 2021.

Pfizer Inc., Astellas Pharma Inc., Lupin Pharmaceuticals Inc., Glenmark Pharmaceuticals Inc., Biocon Ltd. are the major companies operating in Global Tacrolimus Market .

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