Sirolimus Market

Market Overview

The global sirolimus market size was valued at USD 296.3 million in 2022 and is projected to reach USD 471.6 million by 2031, registering a CAGR of 5.3% during the forecast period (2023-2031). Increasing organ transplants are the primary driver of sirolimus market growth. Sirolimus is an immunosuppressant drug used to prevent organ transplant rejection. It belongs to the mTOR inhibitor class of medicines, and it operates by inhibiting the activity of the mammalian target of rapamycin (mTOR). This inhibition reduces the likelihood of rejection by suppressing the immune system's response to foreign bodies such as donated organs.

The rise in organ transplantation is a crucial factor driving the global Sirolimus Market share. An organ transplant is a surgical procedure in which a damaged or absent organ is replaced and implanted in the body of the recipient. Anti-rejection drugs, such as Sirolimus, inhibit the immune system, reducing the body's ability to reject an organ transplant. Furthermore, the growing incidence of ailments associated with modern lifestyles is a major factor driving the global Sirolimus Market. Increased healthcare investment and infrastructure improvements are also critical.

Highlights

• 5mg is a significant contributor to the market based on strength.
• Organ Transplant Rejection is the most common application in the market.
• Selective Immunosuppressants influenced the market growth by drug class.
• Injection accounts for the largest share of the market by dosage.
• Oral occupies a significant share of the market by route of administration.
• Hospitals generate the most revenue by end-use.
• North America dominates the global market.

Market Dynamics

Market Drivers:

Increasing Organ Transplantation

Globally, the number of organ transplantation surgeries has increased in recent years, owing to factors such as improved surgical techniques, increased awareness of organ donation, and developments in post-transplant care. Sirolimus is an immunosuppressant commonly used in organ transplantation to prevent rejection. With the increased number of transplants, there is a greater demand for immunosuppressive drugs such as Sirolimus. In 2022, there will be roughly 157,494 solid organ transplants, according to the Global Observatory on Donation and Transplantation (GODT). This represents a 9.1% increase over 2021, yet it still falls short of meeting less than 10% of the worldwide need. The kidney is the most commonly transplanted organ, followed by the liver and heart. Forty-six thousand six hundred thirty-two organ transplants were performed in 2023, representing an 8.7% rise over 2022 and a 12.7% increase over 2021. This year set a new high for organ transplants. More than 107,000 people in the United States were waiting for an organ transplant as of January 2023.

Furthermore, after COVID-19, India saw a comeback in organ transplant efforts in 2022, with over 15,000 transplants completed. According to the National Organ and Tissue Transplant Organization (NOTTO), 12,791 transplants were living donor transplants, most of which occurred in private facilities. As a result, the increase in organ transplant procedures directly contributes to the Sirolimus market trend. As the number of transplants increases, so does the demand for immunosuppressive treatments, which drives sales and revenue for drugs like Sirolimus.

Market Restraints:

High Cost of the Treatment

Sirolimus is a specialized drug used to suppress the immune system in organ transplant recipients and people with certain medical disorders. When compared to more popular prescriptions, specialty drugs are frequently more expensive. Both patients and healthcare systems may be concerned about the cost of Sirolimus. The expense of specialty drugs like Sirolimus may strain the financial resources of healthcare providers and payers in some regions where healthcare budgets are tight.

According to NCBI, the average cost of a 1g dose of immunosuppressants for a 70kg patient is USD 10,500, and the average cost of a 2g dose is USD 20,000. Patients routinely spend USD 15,000-USD 20,000 a month on immunosuppressive drugs, according to Lybrate. Sirolimus, or rapamycin, is a generic medicine that costs approximately USD 847.72 for a 60 mL bottle of 1 mg/mL. High treatment costs can make Sirolimus unavailable to patients, particularly those without adequate insurance coverage. This constraint has the potential to affect patient adherence to prescribed medicines as well as overall healthcare results.

Market Opportunity:

Increasing Healthcare Spending

Global trends in rising healthcare spending, particularly in emerging nations, may contribute to increased availability and use of Sirolimus. Improved healthcare infrastructure and improved insurance coverage could aid market expansion. The World Health Organization (WHO) predicts global healthcare benefit costs will grow 10% by 2023. This is greater than the 8.8% growth rate in 2022 and the 8.2% growth rate in 2021. Factors such as population growth, aging demographics, and breakthroughs in medical technology are driving this surge. Regarding healthcare, the United States is the most expensive country in the world. In 2022, the United States will have spent over 16% of its GDP on healthcare services. This is roughly double the average OECD country. 

Similarly, the European Commission reports that healthcare spending in Lithuania, Latvia, Bulgaria, Malta, Czechia, and Luxembourg increased by at least 50% between 2012 and 2020. As a result, countries with expanding healthcare budgets are more likely to invest in developing and improving transplantation programs. This includes spending on transplant centers, medical infrastructure, and immunosuppressive drugs such as Sirolimus. Furthermore, as their healthcare infrastructure improves, emerging markets are seeing huge increases in healthcare spending. For example, countries such as Asia, Latin America, and the Middle East invest in healthcare systems, which may involve purchasing modern pharmaceuticals such as Sirolimus.

Regional Analysis

The global sirolimus market analysis is conducted in North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates the Global Market

North America is the most significant global sirolimus market shareholder and is estimated to grow at a CAGR of 5.2% over the forecast period. North America is predicted to hold a substantial market position in the worldwide sirolimus market due to the region's high rate of organ transplants, rising incidence of chronic diseases, and favorable reimbursement policies. According to the Disease Control and Prevention (CDC) 2021 data, the most often transplanted organs in the United States are the kidney, liver, heart, lungs, pancreas, and intestine. Every day, around 75,000 people are on the active waiting list for organ transplantation.

Additionally, technical improvements in organ transplantation, rising healthcare spending, and well-established healthcare infrastructure contribute to the overall regional market's growth. According to preliminary estimates from the United Network for Organ Sharing (UNOS), which functions as the Organ Procurement and Transplantation Network under federal contract, 42,887 organ transplants will be done in the United States in 2022, a 3.7 percent increase over 2021 and a new yearly record.

Asia-Pacific is anticipated to exhibit a CAGR of 5.5% over the forecast period. According to Sirolimus market insights, Asia-Pacific is expected to expand at the quickest CAGR throughout the projection period, owing to pharmaceutical companies' increased R&D spending. The number of research initiatives in this region will also likely increase. The regional market is dominated by Dr. Reddy's Laboratories Ltd., Torrent Pharmaceuticals Ltd., Biocon, Intas Pharmaceuticals Ltd., and Concord Biotech.

Furthermore, awareness about liver donation is growing, which is helping the Japanese market. According to the Liver Transplantation Society, 10,839 liver transplants had been performed in Japan as of December 31, 2021. This contains 718 transplants from deceased donors and 10,121 transplants from living donors. Japanese government initiatives support large-scale transplantation plans for residents suffering from such ailments. With the addition of private companies into the market, the country is poised to enjoy remarkable expansion in the liver transplant surgery tool market, potentially increasing market revenue in the years ahead. It is anticipated to drive the market.

Europe has experienced consistent growth, owing to factors such as an increase in the frequency of organ transplant surgeries, advances in medical research, and an increase in the prevalence of disorders that Sirolimus can cure. The broader healthcare landscape impacts market size, including government regulations, healthcare infrastructure, and reimbursement systems. According to the NCBI, organ donation activities in Europe have continuously expanded over the last few decades, except for specific times during the COVID-19 epidemic. However, this rise has not met the European population's transplantation needs. As a result, the market is projected to be driven by the demand for more transplants in the coming years.

Segmental Analysis

The global sirolimus market is segmented based on strength, application, drug class, dosage, route of administration, end-users, and region.

The market is further segmented by strength into 0.5mg, 1mg, 2mg, and 1mg/mL.

0.5mg is a significant contributor to the market. Sirolimus 0.5mg is a lower dosage strength often administered for patients requiring precise and controlled immunosuppression. This level is frequently appropriate for people with specific medical issues when a lesser dose is beneficial in preventing organ rejection or treating disorders like lymphangioleiomyomatosis.

The 1mg segment of Sirolimus provides a moderate dosage, a joint strength for many organ transplant patients. This dosage is designed to balance therapeutic efficacy with side effect depreciation, making it a versatile alternative for various transplant circumstances and medical causes.

The market can be bifurcated by application into Organ Transplant Rejection, Sirolimus Catheter Devices, and Sirolimus Coated Balloons.

Organ Transplant Rejection is the most common application in the market. The primary purpose of Sirolimus is to prevent organ rejection. Sirolimus is administered as part of an immunosuppressive regimen to limit the immune system's reaction, lowering the risk of the recipient's body rejecting the transplanted organ. The component provides post-transplant patient care for a broad spectrum of organ transplants, including kidney, liver, heart, and lung transplants.

Sirolimus is used for targeted local delivery in specialized medical devices such as catheters. This application involves coating catheters with Sirolimus to prevent restenosis (blood vessel narrowing) after interventional procedures such as angioplasty. Localized distribution of Sirolimus at the site of intervention aids in preventing tissue overgrowth and maintaining blood vessel patency, especially in situations of coronary artery disease or peripheral artery disease.

Based on drug class, the market is fragmented into MTOR Inhibitors and selective Immunosuppressants.

Selective Immunosuppressants influenced the market growth. Selective Immunosuppressants are a broader class of medications that control the immune system. Unlike mTOR inhibitors, selective immunosuppressants can affect multiple immune response components. Sirolimus, a member of this class, demonstrates selectivity by blocking mTOR. Other immunosuppressive drugs that act through distinct pathways are included in the broader class, giving physicians alternatives for personalizing therapy to particular patient needs while regulating the overall immune response.

Sirolimus and other mTOR (mammalian target of rapamycin) inhibitors are immunosuppressive medications specifically targeting the mTOR pathway. Sirolimus suppresses mTOR, a transcription factor that controls cell growth and proliferation. Sirolimus lowers the immune response by interrupting this route, making it essential in preventing organ transplant rejection and treating specific disorders. The mTOR inhibitor class is a tailored strategy for immunosuppression, having applications in organ transplantation and other medical conditions.

By dosage, the market is subdivided into Injection and tablet.

Injection accounts for the largest share of the market. Sirolimus injection is intended for parenteral delivery, most often intravenously or subcutaneously. This administration mode allows the medicine to be delivered directly into the bloodstream. In clinical settings, sirolimus injections are routinely utilized, particularly in the early post-transplant period or when oral administration is impossible. The injectable form allows healthcare personnel to distribute Sirolimus in a precise and controlled manner, guaranteeing efficient absorption and dispersion throughout the body.

Sirolimus tablets are an oral dose form intended for ingestion. Tablets are a convenient and patient-friendly long-term therapy choice since they allow users to self-administer the medication at home. The oral tablet form offers a standardized and easily titratable dosage, assisting patients in adhering to treatment schedules.

The route of administration can be further bifurcated into Oral and intravenous.

Oral occupies a significant share of the market. The oral route of administration entails swallowing Sirolimus tablets or liquid preparations. This standard and practical method allows patients to self-administer medication at home, boosting treatment plan adherence. Long-term maintenance therapy, such as immunosuppressive regimens for organ transplant recipients, is frequently delivered orally. It ensures that the medicine is distributed throughout the body via the gastrointestinal tract.

Sirolimus is infused directly into the bloodstream via the intravenous (IV) route of administration. This approach is frequently used in therapeutic settings, particularly in the early post-transplant period or when rapid commencement of activity is critical. Intravenous Injection allows more quick and exact drug distribution, making it appropriate for essential circumstances of care. It can be given as injections or IV infusions, giving healthcare practitioners more options for treating immunosuppression based on patient needs and clinical concerns.

Based on end-users, the market is sub-segmented into Hospitals, Specialty Clinics, and home care.

Hospitals generate the most revenue in the market. Hospitals are an essential end-user category. These facilities offer a full range of healthcare treatments, including surgical operations such as organ transplants. Sirolimus can be given in hospitals or critical care settings immediately post-transplant. Furthermore, hospitals are essential in treating patients with lymphangioleiomyomatosis, for which Sirolimus is utilized.

Another important end-user group is specialty clinics, which focus on fields such as transplantation medicine, nephrology, cardiology, and respiratory care. These clinics frequently specialize in long-term care and managing patients suffering from certain medical diseases, such as organ transplant recipients. Specialty clinics use Sirolimus in inpatient and outpatient settings because they give a more specialized approach to patient care.

Recent Developments

• January 2024- Amneal released a complex generic fluorometholone ophthalmic suspension.
• January 2024- The FDA has accepted TIVDAK® Supplemental Biologics License Application for Patients with Recurrent or Metastatic Cervical Cancer for Priority Review.
• May 2023- The FDA accepted the TIVDAK® Supplemental Biologics License Application for Patients with Recurrent or Metastatic Cervical Cancer for Priority Review.