Organ Transplantation Market

Organ Transplantation Market Research Report By Type Of Organ (Heart, Kidney, Others), By Products (Organ Preservation Solutions, Transplant Diagnostics, Tissue Products), By Type Of Transplant (Autograft, Allograft And Others), By Treatment (Analgesic, Immunosuppressant And Other), By End Users (Hospitals, Transplant Centers And Other) - Forecast Till 2035
ID: MRFR/Pharma/0410-HCR
80 Pages
Rahul Gotadki
Last Updated: June 24, 2026
Organ Transplantation Market
Market Size
Forecast Period2025 - 2035
CAGR (2025 - 2035)8.33%
2024 Market Size$ 7.99 Billion
2025 Market Size$ 8.66 Billion
2035 Market Size$ 19.27 Billion
Key Players
Companies such as United Therapeutics Corporation
AbbVie Inc.
Astellas Pharma Inc.
Novartis AG
 Pfizer Inc.
Bristol-Myers Squibb Company
Opportunities
  • Government Initiatives and Funding
  • Increasing Incidence of Organ Failure
  • Rising Public Awareness of Organ Donation

Organ Transplantation Market Summary

The Global Organ Transplantation Market size was valued at USD 7.99 Billion in 2024, and the market is projected to grow from USD 8.656 Billion in 2025 to USD 19.27 Billion by 2035, registering a CAGR of 8.3% during the forecast period 2025–2035. North America led the market in 2024 with over 45.06% share, generating around USD 3.6 Billion in revenue.
 
The increasing prevalence of chronic diseases such as diabetes, cardiovascular disorders, and kidney diseases is driving demand for organ transplantation worldwide. Growing patient populations requiring life-saving transplant procedures, combined with advancements in transplant technologies and post-operative care, continue to accelerate market expansion.
 
According to the WHO, chronic diseases account for approximately 41 million deaths annually, representing nearly 74% of global deaths. The growing burden of noncommunicable diseases continues to increase the need for organ replacement therapies, supporting long-term growth in organ transplantation procedures worldwide.

Key Market Trends & Highlights

The Organ Transplantation Market is poised for growth driven by technological advancements and increasing public awareness.

  • Chronic diseases cause 41 million deaths annually, significantly increasing demand for organ replacement therapies worldwide.
  • The market is projected to grow from USD 8.656 billion in 2025 to USD 19.27 billion by 2035, at 8.3% CAGR.
  • North America led the global market in 2024 with 45.03% revenue share.
  • Europe generated USD 16.39 billion in 2024, accounting for approximately 30% of global market revenue.

Market Size & Forecast

2024 Market Size 7.99 (USD Billion)
2035 Market Size 19.27 (USD Billion)
CAGR (2025 - 2035) 8.33%

Major Players

Companies such as United Therapeutics Corporation (US), AbbVie Inc. (US), Astellas Pharma Inc. (JP), Novartis AG (CH), Pfizer Inc. (US), Bristol-Myers Squibb Company (US), Hoffmann-La Roche Ltd (CH), Medtronic plc (IE), TransMedics Group, Inc. (US) are some of the major participants in the global market.

Our Impact
Enabled $4.3B Revenue Impact for Fortune 500 and Leading Multinationals
Partnering with 2000+ Global Organizations Each Year
30K+ Citations by Top-Tier Firms in the Industry

Organ Transplantation Market Drivers

Government Initiatives and Funding

Government initiatives aimed at improving organ donation rates and transplantation services are playing a pivotal role in shaping the Organ Transplantation Market. Various countries are implementing policies that promote organ donation, including financial incentives for donors and their families. Additionally, increased funding for transplantation research and infrastructure development is enhancing the capabilities of healthcare systems to perform more transplants.
 
For instance, some governments have allocated millions in funding to support organ transplant programs, which has led to improved outcomes and increased transplant volumes. These initiatives not only bolster the Organ Transplantation Market but also ensure that more patients receive the life-saving transplants they need.
 

  • According to World Bank Health Data, global health expenditure exceeds USD 9 trillion annually, reflecting strong government commitment toward healthcare infrastructure and advanced treatment programs. Increased public funding for transplant centers, donor awareness initiatives, and transplantation research continues to improve patient access and strengthen organ transplantation capabilities worldwide.

Increasing Incidence of Organ Failure

The rising prevalence of chronic diseases such as diabetes and hypertension contributes significantly to the increasing incidence of organ failure. This trend is likely to drive the demand for organ transplantation procedures. According to recent statistics, the number of patients awaiting organ transplants continues to grow, with estimates suggesting that over 100,000 individuals are on waiting lists in various regions.
 
This situation underscores the urgent need for effective solutions within the Organ Transplantation Market, as healthcare systems strive to address the gap between organ supply and demand. As the population ages and lifestyle-related health issues become more common, the Organ Transplantation Market is poised for expansion, necessitating innovative approaches to organ procurement and transplantation.
 

  • According to IHME, chronic kidney disease affected more than 850 million people globally in recent assessments. The growing prevalence of kidney failure and other chronic conditions continues to expand transplant waiting lists, creating sustained demand for organ transplantation services and supporting long-term market growth.

Rising Public Awareness of Organ Donation

Public awareness campaigns regarding the importance of organ donation are gaining momentum, positively impacting the Organ Transplantation Market. Educational initiatives aimed at dispelling myths and misconceptions about organ donation are fostering a more informed public. As a result, there has been a noticeable increase in the number of registered organ donors.
 
Reports indicate that countries with robust awareness programs have seen donor registration rates rise by as much as 30%. This surge in donor registrations is crucial for addressing the organ shortage crisis and is likely to enhance the operational dynamics of the Organ Transplantation Market. The growing acceptance of organ donation as a life-saving measure is expected to further stimulate market growth.

Advancements in Transplantation Technology

Technological innovations in the field of organ transplantation are transforming the landscape of the Organ Transplantation Market. Developments such as improved organ preservation techniques, enhanced surgical methods, and the use of artificial organs are becoming increasingly prevalent. For instance, the introduction of machine perfusion technology has shown promise in extending the viability of donor organs, thereby increasing the number of successful transplants.
 
Furthermore, the integration of artificial intelligence in matching donors with recipients is streamlining the transplantation process. These advancements not only enhance patient outcomes but also contribute to the overall growth of the Organ Transplantation Market, as they facilitate more efficient and effective transplant procedures.

Ethical Considerations and Regulatory Frameworks

The evolving ethical considerations surrounding organ transplantation are influencing the regulatory frameworks that govern the Organ Transplantation Market. As the demand for organs rises, regulatory bodies are tasked with ensuring that organ procurement and transplantation processes are conducted ethically and transparently. This includes establishing guidelines for donor consent and equitable distribution of organs.
 
The implementation of stringent regulations is likely to enhance public trust in the organ transplantation system, thereby encouraging more individuals to consider becoming donors. As ethical standards continue to evolve, they will shape the operational landscape of the Organ Transplantation Market, ensuring that it remains aligned with societal values and expectations.

Market Segment Insights

By Product: Immunosuppressive Drugs (Largest) vs. Preservation Solutions (Fastest-Growing)

In the Organ Transplantation Market, the distribution of market share among different product segments is critical for understanding industry dynamics. Immunosuppressive drugs hold the largest market share of 49% due to their essential role in preventing organ rejection after transplantation. Tissue products also contribute significantly, followed by preservation solutions, which are gaining traction. This segment is bolstered by innovations in preservation technologies that ensure organ viability, reflecting shifting preferences among transplant centers who are keen on maximizing transplant success rates. The growth trends in this market indicate that while immunosuppressive drugs remain the dominant choice, preservation solutions are emerging as the fastest-growing segment. Increased awareness about improved preservation methods has motivated investment in research and development, bringing forth novel solutions that promise enhanced organ preservation techniques. The rise in transplant procedures globally also fuels the growth of both product segments, with a gradual shift toward adopting advanced preservation methods as a standard practice.

Novartis AG continues supporting transplant care through immunosuppressive therapies used across thousands of transplant recipients globally. Continuous innovation in anti-rejection medications has significantly improved long-term graft survival rates, reinforcing the dominant position of immunosuppressive drugs within the organ transplantation market.

By Application: Organ Transplantation (Largest) vs. Tissue Transplantation (Fastest-Growing)

The organ transplantation market is primarily dominated by organ transplantation applications, which significantly overshadow tissue transplantation, accounting for the largest market share of 72%. This dominance can be attributed to the higher demand for organ transplants such as kidneys, livers, and hearts, which are critical for lifesaving treatment. While both segments play a crucial role in patient care, organ transplantation leads the way due to established protocols and societal awareness regarding the need for organ donation, thus securing a larger market share within the sector. On the other hand, tissue transplantation, while smaller in market share, is emerging rapidly, driven by increasing occurrences of soft tissue injuries and the expanding use of tissue grafts in surgical procedures. Factors such as improved technology for tissue preservation and processing are fueling this growth. As medical professionals become more adept at utilizing tissue transplants effectively, this segment is expected to witness significant advancement in the coming years, attracting a broader patient demographic and healthcare investments.

Pfizer Inc. supports transplant medicine through therapies that assist post-transplant patient management. Globally, more than 150,000 organ transplants are performed annually, highlighting the substantial demand for organ transplantation procedures and supporting the segment's leading market position.

By End User: Hospitals (Largest) vs. Transplant Centers (Fastest-Growing)

In the Organ Transplantation Market, hospitals have established themselves as the largest end-user segment, accounting for 61%, owing to their comprehensive capabilities in handling complex transplant procedures and patient care. This dominance is supported by an extensive network providing surgical services and post-operative care, catering to a broad patient demographic. Meanwhile, transplant centers are gaining traction with their specialized focus, which appeals to a defined segment of patients requiring targeted transplantation services. Their contribution to the overall market share is gradually increasing as they gain recognition for their advanced methodologies and successful transplant outcomes.

Hoffmann-La Roche Ltd continues supporting transplant diagnostics and monitoring technologies used by major healthcare institutions worldwide. Hospitals perform the majority of complex transplant procedures due to comprehensive surgical infrastructure, multidisciplinary care teams, and advanced post-operative monitoring capabilities, reinforcing their leadership position in market demand.

Get more detailed insights about Organ Transplantation Market

Regional Insights

North America : Leading Market for Transplants

North America is the largest market for organ transplantation, accounting for approximately 45% of the global market share. The region benefits from advanced healthcare infrastructure, high demand for organ transplants, and supportive regulatory frameworks. The increasing prevalence of chronic diseases and the aging population are significant growth drivers, alongside initiatives to improve organ donation rates.

  • According to CDC data, approximately 38.4 million Americans are living with diabetes, a major contributor to kidney failure and transplant demand. The growing chronic disease burden continues to support organ transplantation volumes, while advanced healthcare infrastructure strengthens patient access to transplant procedures across North America.

The United States is the primary contributor, with a robust network of transplant centers and a high number of transplant procedures performed annually. Key players such as United Therapeutics Corporation and AbbVie Inc. are actively involved in research and development, enhancing treatment options. The competitive landscape is characterized by innovation and collaboration among leading pharmaceutical companies, ensuring a steady supply of organ transplant solutions.

  • Bristol Myers Squibb Company invests billions of dollars annually in research and development, supporting innovation across complex therapeutic areas. Continued investment in advanced healthcare solutions, combined with strong clinical research infrastructure, reinforces North America's leadership position in transplantation innovation and patient care.

Europe : Emerging Market Dynamics

Europe is witnessing a growing organ transplantation market, holding approximately 30% of the global share. The region's growth is driven by increasing awareness of organ donation, advancements in transplant technologies, and supportive government policies. Countries like Germany and the UK are leading in transplant procedures, with regulatory bodies promoting organ donation initiatives to address the rising demand. Germany stands out as a leader in organ transplantation, supported by a well-established healthcare system and a network of transplant centers.

The competitive landscape includes major players like Novartis AG and Astellas Pharma Inc., which are focusing on innovative therapies and improving patient outcomes. The European market is characterized by collaboration among healthcare providers, regulatory agencies, and pharmaceutical companies to enhance organ transplant success rates.

  • The European Medicines Agency (EMA) supports medicines regulation for over 450 million citizens across the European Union. Its robust regulatory framework facilitates the introduction of innovative therapies, strengthens patient safety standards, and supports continued advancement in transplantation treatment across Europe.

Asia-Pacific : Rapidly Growing Market

Asia-Pacific is rapidly emerging as a significant player in the organ transplantation market, accounting for about 20% of the global share. The region's growth is fueled by increasing healthcare investments, rising awareness of organ donation, and advancements in medical technology. Countries like Japan and Australia are at the forefront, implementing policies to enhance organ donation rates and improve transplant outcomes.

Japan is particularly notable for its advanced healthcare system and innovative transplant procedures. The competitive landscape features key players such as Pfizer Inc. and Bristol-Myers Squibb Company, which are investing in research to develop new therapies. The presence of a growing number of transplant centers and collaborations among healthcare providers are further driving market growth in this region.

Middle East and Africa : Emerging Market Potential

The Middle East and Africa region is gradually developing its organ transplantation market, currently holding about 5% of the global share. The growth is driven by increasing healthcare investments, rising awareness of organ donation, and government initiatives to improve healthcare infrastructure. Countries like South Africa and the UAE are leading efforts to enhance organ transplant programs and address the growing demand for transplants.

South Africa is a key player in the region, with established transplant centers and a focus on improving organ donation rates. The competitive landscape includes local and international players, with a growing emphasis on collaboration to enhance transplant success. The region's potential for growth is significant, as healthcare systems continue to evolve and adapt to meet the needs of patients requiring organ transplants.

Organ Transplantation Market Regional Image

Key Players and Competitive Insights

The Organ Transplantation Market is characterized by a complex interplay of competitive dynamics, driven by increasing demand for organ transplants and advancements in medical technology. Key players such as United Therapeutics Corporation (US), AbbVie Inc. (US), and Novartis AG (CH) are strategically positioned to leverage innovation and partnerships to enhance their market presence. United Therapeutics Corporation (US) focuses on developing novel therapies for organ transplantation, while AbbVie Inc. (US) emphasizes its robust pipeline of immunosuppressive drugs.
 
Novartis AG (CH) is actively pursuing collaborations to expand its reach in the transplantation sector, indicating a collective strategy among these companies to shape a competitive environment that prioritizes innovation and patient outcomes. In terms of business tactics, companies are increasingly localizing manufacturing and optimizing supply chains to enhance efficiency and responsiveness to market demands. The competitive structure of the Organ Transplantation Market appears moderately fragmented, with several key players exerting influence over various segments.
 
This fragmentation allows for diverse strategies, as companies seek to differentiate themselves through specialized offerings and targeted regional expansions. In August 2025, United Therapeutics Corporation (US) announced a groundbreaking partnership with a leading biotechnology firm to develop a new class of organ preservation solutions. This strategic move is likely to enhance the viability of transplanted organs, potentially increasing transplant success rates and expanding the donor pool. Such innovations could significantly alter the landscape of organ transplantation, positioning United Therapeutics as a leader in this critical area.
 
In September 2025, AbbVie Inc. (US) launched a new immunosuppressive therapy specifically designed for kidney transplant patients. This product introduction not only strengthens AbbVie’s portfolio but also reflects its commitment to addressing unmet medical needs in transplantation. The strategic importance of this launch lies in its potential to improve patient outcomes and reduce the incidence of organ rejection, thereby solidifying AbbVie’s competitive edge in the market. In July 2025, Novartis AG (CH) entered into a strategic alliance with a prominent research institution to explore gene therapy applications in organ transplantation.
 
This collaboration signifies a forward-thinking approach, as gene therapy could revolutionize the way organ rejection is managed. The implications of this partnership may extend beyond immediate market gains, potentially leading to groundbreaking advancements in transplantation science. As of October 2025, current trends in the Organ Transplantation Market are increasingly defined by digitalization, sustainability, and the integration of artificial intelligence. Strategic alliances among key players are shaping the landscape, fostering innovation and enhancing operational efficiencies.
 
Looking ahead, competitive differentiation is likely to evolve from traditional price-based competition to a focus on technological advancements, innovative therapies, and reliable supply chains. This shift underscores the importance of adaptability and forward-thinking strategies in navigating the complexities of the organ transplantation market.

Key Companies in the Organ Transplantation Market include

Industry Developments

  • Q1 2025: Organ transplants exceeded 48,000 in 2024; a 3.3 percent increase from the transplants performed in 2023 The United States performed 48,149 organ transplants in 2024, marking a 3.3% increase over 2023 and the highest annual total ever recorded, according to preliminary OPTN data.
  • Q1 2025: U.S. Organ Procurement Organizations Recovered Record Number of Organs in 2024 While Looming Federal Policies Jeopardize Patients U.S. Organ Procurement Organizations recovered over 45,000 organs for transplantation in 2024, setting a new record and marking the 14th consecutive year of increased organ recovery.
  • Q1 2025: Organ transplants exceeded 48,000 in 2024; a 3.3 percent increase from the transplants performed in 2023 In 2024, 7,030 people became living organ donors in the U.S., including 476 donors aged 65 and older—a 14.2% increase over 2023 for this age group.
  • Q1 2025: U.S. Organ Procurement Organizations Recovered Record Number of Organs in 2024 While Looming Federal Policies Jeopardize Patients AOPO announced its goal to reach 50,000 organs transplanted in 2026, emphasizing the need for federal policy alignment to maximize transplantation of every viable donated organ.
  • Q1 2025: More than 7,000 living donor transplants in 2024 Over 7,000 living donor transplants were performed in the U.S. in 2024, with most donors providing kidneys and an increasing number donating liver segments.
  • Q1 2025: More than 17,000 deceased donors in 2024 The U.S. saw more than 17,000 deceased organ donors in 2024, contributing to a record-breaking year for organ donation and transplantation.

Future Outlook

Organ Transplantation Market Future Outlook

The Organ Transplantation Market size is projected to reach USD 1.824 Billion by 2035, growing at a CAGR of 8.33%, driven by technological advancements, increasing organ demand, and improved healthcare infrastructure.

New opportunities lie in:

  • Development of AI-driven organ matching software Expansion of telehealth services for pre- and post-transplant care Investment in bioprinting technologies for organ regeneration

By 2035, the market is expected to achieve substantial growth, enhancing global organ transplantation capabilities.

Market Segmentation

Organ Transplantation Market Product Outlook

  • Tissue Products
  • Immunosuppressive Drugs
  • Preservation Solutions
  • Others

Organ Transplantation Market End User Outlook

  • Hospitals
  • Transplant Centers
  • Others

Organ Transplantation Market Application Outlook

  • Organ Transplantation
  • Tissue Transplantation

Report Scope

MARKET SIZE 2024 7.99(USD Billion)
MARKET SIZE 2025 8.656(USD Billion)
MARKET SIZE 2035 19.27(USD Billion)
COMPOUND ANNUAL GROWTH RATE (CAGR) 8.33% (2025 - 2035)
REPORT COVERAGE Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
BASE YEAR 2024
Market Forecast Period 2025 - 2035
Historical Data 2019 - 2024
Market Forecast Units USD Billion
Key Companies Profiled United Therapeutics Corporation (US), AbbVie Inc. (US), Astellas Pharma Inc. (JP), Novartis AG (CH), Pfizer Inc. (US), Bristol-Myers Squibb Company (US), Hoffmann-La Roche Ltd (CH), Medtronic plc (IE), TransMedics Group, Inc. (US)
Segments Covered Type Of Organ, Products, Type Of Transplant, Treatment, End Users
Key Market Opportunities Advancements in organ preservation techniques enhance transplant success rates and expand donor organ viability.
Key Market Dynamics Technological advancements and regulatory changes are reshaping the competitive landscape of the organ transplantation market.
Countries Covered North America, Europe, APAC, South America, MEA

FAQs

What is the projected market valuation of the Organ Transplantation Market by 2035?

The Organ Transplantation Market is projected to reach a valuation of 19.27 USD Billion by 2035.

What was the market valuation of the Organ Transplantation Market in 2024?

In 2024, the Organ Transplantation Market was valued at 7.99 USD Billion.

What is the expected CAGR for the Organ Transplantation Market during the forecast period 2025 - 2035?

The expected CAGR for the Organ Transplantation Market during the forecast period 2025 - 2035 is 8.33%.

Which segments are included in the Organ Transplantation Market analysis?

The Organ Transplantation Market analysis includes segments such as Tissue Products, Immunosuppressive Drugs, Preservation Solutions, and others.

What are the projected values for Immunosuppressive Drugs in the Organ Transplantation Market?

The projected values for Immunosuppressive Drugs range from 3.0 USD Billion to 7.0 USD Billion.

Who are the key players in the Organ Transplantation Market?

Key players in the Organ Transplantation Market include United Therapeutics Corporation, AbbVie Inc., and Novartis AG, among others.

What is the expected growth for the Organ Transplantation application segment by 2035?
The Organ Transplantation application segment is expected to grow from 4.79 USD Billion to 11.56 USD Billion by 2035.
How do hospitals and transplant centers compare in terms of market valuation?
In 2024, hospitals were valued at 3.5 USD Billion, while transplant centers were valued at 2.5 USD Billion.
What is the projected market size for Preservation Solutions by 2035?
The projected market size for Preservation Solutions is expected to grow from 1.0 USD Billion to 2.5 USD Billion by 2035.
What trends are influencing the growth of the Organ Transplantation Market?
Trends influencing the growth of the Organ Transplantation Market include advancements in immunosuppressive drugs and increasing demand for organ transplants.
Author
Author
Author Profile
Rahul Gotadki LinkedIn
Research Manager
He holds an experience of about 9+ years in Market Research and Business Consulting, working under the spectrum of Life Sciences and Healthcare domains. Rahul conceptualizes and implements a scalable business strategy and provides strategic leadership to the clients. His expertise lies in market estimation, competitive intelligence, pipeline analysis, customer assessment, etc.
Leave a Comment

Research Approach

 

Secondary Research

The secondary research process involved comprehensive analysis of regulatory databases, peer-reviewed medical journals, clinical transplantation publications, and authoritative health organizations. Key sources included the US Food & Drug Administration (FDA) Center for Biologics Evaluation and Research, European Medicines Agency (EMA), Organ Procurement and Transplantation Network (OPTN) / United Network for Organ Sharing (UNOS), Scientific Registry of Transplant Recipients (SRTR), Eurotransplant, NHS Blood and Transplant (UK), Agence de la biomédecine (France), Global Observatory on Donation and Transplantation (GODT), International Society for Heart and Lung Transplantation (ISHLT), The Transplantation Society (TTS), American Society of Transplantation (AST), American Society of Transplant Surgeons (ASTS), National Institutes of Health (NIH/NIDDK), Centers for Medicare & Medicaid Services (CMS), World Health Organization (WHO) Global Health Observatory, EU Eurostat Health Database, and national health ministry reports from key transplant markets. These sources were used to collect transplant procedure statistics, waitlist data, regulatory approval data for immunosuppressive therapies, clinical outcomes studies, donor demographics, and market landscape analysis for organ preservation solutions, transplant diagnostics, tissue products, and immunosuppressive drugs.

 

Primary Research

In order to gather both qualitative and quantitative insights, supply-side and demand-side stakeholders were interviewed during the primary research process. CEOs, VPs of clinical development, chiefs of regulatory affairs, and commercial directors from manufacturers of organ preservation solutions, immunosuppressive drug developers, transplant diagnostic firms, and OEMs of medical devices were examples of supply-side sources. Transplant surgeons, medical directors of organ procurement organizations (OPOs), administrators of transplant centers, and procurement leads from academic medical centers, hospitals, and transplant centers were examples of demand-side sources. Primary research obtained information on clinical adoption patterns, reimbursement dynamics, and immunosuppression protocols; verified product pipeline timelines for xenotransplantation and machine perfusion technologies; and validated market segmentation across organ types (kidney, heart, liver, and lung).

Primary Respondent Breakdown:

• By Designation: C-level Primaries (38%), Director Level (25%), Others (37%)

• By Region: North America (33%), Europe (29%), Asia-Pacific (28%), Rest of World (10%)

 

Market Size Estimation

Global market valuation was derived through revenue mapping and transplant procedure volume analysis. The methodology included:

• Identification of 50+ key manufacturers and service providers across North America, Europe, Asia-Pacific, and Latin America

• Product mapping across immunosuppressive drugs, organ preservation solutions, transplant diagnostics, and tissue products

• Analysis of reported and modeled annual revenues specific to organ transplantation portfolios

• Coverage of manufacturers and service providers representing 72-78% of global market share in 2024

• Extrapolation using bottom-up (transplant procedure volume × ASP by country/organ type) and top-down (manufacturer revenue validation) approaches to derive segment-specific valuations for autograft, allograft, and xenograft applications

Download Free Sample

Kindly complete the form below to receive a free sample of this Report

Download PDF ×

We do not share your information with anyone. However, we may send you emails based on your report interest from time to time. You may contact us at any time to opt-out.