VYNDAQEL MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2025-2032)

Global Vyndaqel Market Size and Forecast – 2025 to 2032

The global Vyndaqel market is estimated to be valued at USD 8.37 Bn in 2025 and is expected to reach USD 19.81 Bn by 2032, exhibiting a compound annual growth rate (CAGR) of 13.1% from 2025 to 2032. This significant growth underscores the increasing demand for innovative treatments targeting transthyretin amyloidosis, with expanding awareness and advancements in pharmaceutical research driving the market expansion during this forecast period.

Key Takeaways of the Global Vyndaqel Market

• In terms of indication, wild-type transthyretin-mediated amyloidosis cardiomyopathy (ATTR-CM, wild-type) segment is expected to lead the global Vyndaqel market, accounting for 52.1% share in 2025.
• The 20 mg segment is estimated to hold the largest share in the global Vyndaqel market with 60.5% share in 2025.
• The public segment is projected to dominate the market, capturing 45.8% of the market share in 2025.
• North America is expected to lead the market, holding a share of 39.3% in 2025. Asia Pacific is anticipated to be the fastest-growing region, with an estimated market share of 25.3% in 2025.

Market Overview

Market trends indicate a robust shift towards precision medicine and targeted therapies, positioning Vyndaqel as a key player in addressing rare cardiac and neurological disorders. The rise in patient diagnosis rates coupled with regulatory approvals and strategic collaborations among pharmaceutical companies fueling research innovations are further propelling the market. Additionally, increasing healthcare investments in emerging economies and growing patient support programs are anticipated to enhance the market penetration and improve treatment accessibility globally.

Currents Events and Its Impact

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Segmental Insights

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Vyndaqel Market Insights, By Indication - Wild-Type Transthyretin-Mediated Amyloidosis Cardiomyopathy (ATTR-CM, Wild-type) Dominance in the Market is Driven by Rising Diagnosis and Treatment Advancements

By indication, the wild-type transthyretin-mediated amyloidosis cardiomyopathy (ATTR-CM, wild-type) command the largest portion of the Vyndaqel market in 2025 at 52.1% share. The increased development of wild-type ATTR-CM, particularly in old age, mainly contributes to the growth of this segment. With the growing population of older people around the world especially in developed countries where life expectancy is high, the prevalence of this non-inherited cardiomyopathy increases significantly.

Wild-type ATTR-CM is a condition where misfolded Transthyretin protein is deposited in the heart tissue causing heart failure and arrhythmias. The strategies on disease recognition have improved with innovation in the fields of diagnostic methods like non-invasive imaging and discovery of biomarkers that have helped to enhance patient diagnosis and uptake of the treatment.

Vyndaqel Market Insights, By Strength - Predominance of 20 mg Segment Driven by Optimized Therapeutic Efficacy and Patient Compliance

The 20 mg segment is projected to account for 60.5% of the market share in 2025, highlighting the need to have an effective and well-tolerated therapy that meets the demands of the patients. This strength is normally given as daily dosage in treating transthyretin amyloidosis disorders especially in patients with wild type ATTR-CM.

Widespread use of the 20 mg strength is informed by clinical trial information and real life evidence to confirm its safety and effect profile which has made it the standard of care in many treatment regimens across the globe.

Vyndaqel Market Insights, By Payer - Public Leading Market Share Owing to Expanding Healthcare Coverage and Policy Support

The public segment is expected to capture 45.8% of the global Vyndaqel market share in 2025, this highlights the critical role of government funded healthcare in the provision of treatment. Public payers include national and regional health insurance which have subsidized or full coverage to necessary medicines, including new medicine to rare diseases like transthyretin amyloidosis.

Market contribution by the public payers is high due to increased commitment by governments across the world to fund orphan diseases treatment and ensure better care delivery to the patient with threatening illnesses.

Regional Pricing & Reimbursement Overview on Vyndaqel Market

• Vyndaqel's pricing and reimbursement vary across regions. In the U.S., the drug is priced at around USD 225,000 per year, with reimbursement dependent on insurer agreements, making it costly for some patients. However, in January 2024, the Inflation Reduction Act (IRA) led to an 86% increase in claims, driven by Medicare patients benefiting from USD 0 cost-sharing, significantly lowering patient costs. This change resulted in a revenue boost of USD 800 million for vyndamax and Vyndaqel, reflecting the IRA's positive impact on specialty drug utilization.
• In the EU5 (U.K., Germany, France, Italy, Spain), Vyndaqel is approved but faces rigorous cost-effectiveness evaluations, with prices ranging from USD 151.2 million to USD 199.8 million. per year (approximately USD 150 million to USD 200 million per year), and access often restricted to managed access programs. In Japan, Vyndaqel is listed under national insurance but at a lower price of about USD 93.6 million annually, with pricing subject to government revisions. In China, the price is significantly discounted, as the government enforces major price reductions for imported orphan drugs, making access challenging but possible through negotiations.

Regional Insights

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North America Vyndaqel Market Analysis and Trends

The well-established healthcare infrastructure with share of 39.3% in 2025, high pharmaceutical research and development, and excellent patient awareness drives the dominance in global Vyndaqel market in North America. A large number of pharmaceutical firms like Pfizer, Inc. and Akcea Therapeutics have been a great reinforcement of the market with so much clinical research and strong marketing plans.

Moreover, North America has an advantage of high rate of adoption of sophisticated treatments and high rate of cover of health insurance, which allows more patients to access Vyndaqel (tafamidis). The developed ecosystem of the market of rare diseases, coupled with the continued spending on research, makes North America an overpowering region.

For instance, in October 2025, the NIH awarded USD 26 million to the Rare Diseases Clinical Research Network (RDCRN) to support 21 consortia studying rare diseases. New consortia, such as the Advancing Craniosynostosis Treatment Consortium, led by Children's Hospital of Philadelphia, aim to expand research. The RDCRN's work has contributed to FDA approvals, including for treatments like Vyndaqel for transthyretin-mediated amyloidosis.

Asia Pacific Vyndaqel Market Analysis and Trends

The global Vyndaqel market is experiencing the highest growth in Asia Pacific region with share of 25.3% in 2025, due to the growing healthcare awareness, growing healthcare infrastructure, and increasing incidences of transthyretin amyloidosis in the aging population. Other countries such as Japan, China and South Korea are also experiencing improved government involvement in the management of rare diseases such as expediting approval procedures and inclusion of orphan drugs in national reimbursement lists.

The increasing industrial foundation of pharmaceutical firms including Takeda Pharmaceutical Company and Eisai Co., Ltd. has synergistic partnership with multinational pharmaceutical firms to hasten their availability in terms of partnership and licensing. There is also increasing patient advocacy and improved diagnostic functions, which also contribute to the uptake of the market.

Global Vyndaqel Market Outlook for Key Countries

U.S. Vyndaqel Market Trends

Vyndaqel has a very developed market in the U.S. that is backed by a well-advanced healthcare system and substantial investments in research and development. Plays such as Pfizer and Akcea Therapeutics have embarked on massive education programs to create awareness among patients and physicians of transthyretin amyloidosis. Patient access is high with a good regulatory environment provided by the FDA, and intensive insurance plans that cover specialty drugs. The high-quality clinical research in the country is still a source of innovation and label expansion, making the U.S. a major growth region of Vyndaqel.

For instance, in May 2023, Pfizer Malaysia called for increased awareness of transthyretin amyloid cardiomyopathy (ATTR-CM), a rare, life-threatening disease. ATTR-CM leads to heart failure as amyloid deposits cause the heart muscle to stiffen. Pfizer emphasized the importance of early detection, as late diagnosis delays treatment and worsens patient outcomes.

Japan Vyndaqel Market Trends

Japan is one of the key market in the Asia Pacific region, and treatment of rare diseases is increasingly getting popular. Japan has incorporated Vyndaqel into reimbursement systems comparatively quickly with such companies as Eisai and Takeda in a leading role. Government policy favoring the orphan drug development and patient-focused healthcare have enhanced the penetration in the market. Also, strong networks of diagnostic, and a high incidence of amyloidosis in geriatric groups supports stable market demand. The economy is also advantaged by the presence of great domestic production as well as a collaborative relationship amongst academia and industry.

For instance, in May 2025, Japan's Orphan Drug Designation (ODD) program celebrated 25 years of success in rare disease treatments. The program, which offers regulatory incentives, has accelerated the approval of hundreds of therapies, making Japan a global leader in orphan drug development.

Germany Vyndaqel Market Trends

The healthcare industry and the reimbursement climate in Germany is very strong, thus making it a strategic market in Europe. There are active players in the market such as Pfizer, Novartis, and Alnylam Pharmaceuticals that assist patients in accessing and educating them about Vyndaqel. The centralized drug approval system and extensive health insurance system in the country facilitate the mass adoption. Moreover, the research centers in Germany are engaged in conducting clinical research on the transthyretin amyloidosis, which assists in optimizing the treatment guidelines and pushing the demand.

For instance, in February 2020, Pfizer announced that the European Commission approved VYNDAQEL (tafamidis) for treating transthyretin amyloid cardiomyopathy (ATTR-CM) in adults. VYNDAQEL is the first approved treatment in the EU for this rare, life-threatening disease, offering patients more than just symptom management

China Vyndaqel Market Trends

China is a fast developing market of Vyndaqel supported by growing governmental attention to rare diseases and faster regulatory conditions. The existence of partnerships between local firms and international pharmaceutical corporations, including the partnerships between Pfizer and local producers, increases the availability of drugs. The focus of the government on the advancement of the healthcare infrastructure, the quality of the diagnostic, and the rise of the healthcare spending promote the development of the market.

For example, Pfizer collaborates with Chinese firms like Shanghai Fosun Pharmaceutical to expand Vyndaqel's availability in China. These partnerships benefit from China's growing healthcare infrastructure and regulatory support for rare diseases.

End User Feedback and Unmet Needs in the Global Vyndaqel Market

End users, including healthcare providers and patients, have highlighted both satisfaction and challenges with Vyndaqel. On the positive side, many report improved patient outcomes, particularly in managing ATTR-CM, with fewer hospitalizations. However, a frequent concern is the high cost of the drug, which is often not fully covered by insurance, creating a barrier for many patients.

Key unmet needs in the market revolve around affordability and product customization. Patients struggle with high costs and complex insurance processes, while healthcare providers seek more tailored treatment options, such as extended-release formulations. Addressing these gaps could boost accessibility, improve customer retention, and foster innovation, creating new growth opportunities for manufacturers.

Market Players, Key Developments, and Competitive Intelligence

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Key Developments

• In October 2024, the Institute for Clinical and Economic Review (ICER) released a Final Evidence Report on treatments for transthyretin amyloid cardiomyopathy (ATTR-CM). The report assessed tafamidis (Vyndamax/Vyndaqel, Pfizer), acoramidis (BridgeBio Pharma), and vutrisiran (Amvuttra, Alnylam Pharmaceuticals).
• In October 2024, Pfizer's Vyndaqel (tafamidis) was recommended by the National Institute of Health and Care Excellence (NICE) for treating transthyretin amyloidosis cardiomyopathy (ATTR-CM), a rare heart disease affecting around 1,500 people in England. The drug is the first ATTR-CM therapy to be available via the NHS, specifically for adults with wild-type or hereditary forms of the disease.
• In December 2021, Pfizer Inc. announced that its VYNDAQEL/VYNDAMAX treatments reduced the risk of all-cause mortality by 41% in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) in a five-year follow-up. The results, published in Circulation: Heart Failure, showed a 53.2% five-year survival rate for patients on continuous treatment. VYNDAQEL and VYNDAMAX are the first approved treatments for wild-type and hereditary ATTR-CM. VYNDAQEL has been used in the EU since 2011 for transthyretin amyloid polyneuropathy.

Market Report Scope

Vyndaqel Market Dynamics

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Vyndaqel Market Driver - Rising Awareness and Diagnosis of Transthyretin ‑Mediated Amyloidosis

The rising recognition and enhanced diagnostic ability of the transthyretin-mediated amyloidosis (ATTR) is become an important driver of the demand of Vyndaqel worldwide. Historically, ATTR has been underdiagnosed because of its rarity and the manner in which the symptoms are complex and are intertwined with other cardiac and neurological diseases. Nevertheless, there has been improvement in diagnostic equipment such as non-invasive imaging technology and genetic tests that has increased early and accurate detection rates. The broader identification of the disease has been achieved through the increased educational efforts and the attempts of healthcare professionals to be able to identify the manifestations of the disease. Such an increase in the number of diagnoses directly affects the demand in treatment because Vyndaqel is currently one of the first-line therapeutic agents that can be used to control the progression of ATTR.

According to article published in CardioOncology journal, in October 2021, ATTR-CA is being increasingly diagnosed due to improved clinical awareness and advancements in diagnostic methods, such as non-invasive imaging and genetic testing. The World Heart Federation also supports this, noting that the global incidence of ATTR-CM is rising thanks to better utilization of these diagnostic tools.

Vyndaqel Market Opportunity - Development of Next-Generation Formulations or Oral Alternatives

Vyndaqel has a huge growth potential in the global Vyndaqel market by creating new formulations and oral substitutes. Nowadays, Vyndaqel (tafamidis) is mainly given in a capsule form, which, though effective, restricts patient convenience and compliance, particularly with groups having issues with swallowing or gastrointestinal sensitivities. Development of new formulations, orally disintegrating pills, liquid suspensions, or prolonged-release formulations can be used to improve patient compliance and increase the range of patients to be addressed. Moreover, new technologies of drug delivery may enhance its bioavailability and decrease the frequency of doses, additionally streamlining therapeutic effectiveness in transthyretin amyloidosis patients.

As an example, Adalvo is currently working on soft gel capsule formulations of tafamidis: they have already filed two Decentralized Community Procedure (DCP) applications of tafamidis meglumine 20mg and tafamidis 61mg soft gel capsules in Europe.

Analyst Opinion (Expert Opinion)

• The market of Vyndaqel expands at a very fast rate due to the invention of genetic medicine and drug delivery system. The presence of regulatory support by authorities such as U.S. FDA and EMA has increased the rate at which treatments are given approvals, and the increasing number of patients is a boost to the growth of the market. Nonetheless, there are still issues of expensive drugs and inaccessibility.
• Special events such as the Annual Amyloidosis Research Consortium Summit have played an important role in enhancing cooperation and speeding up the treatment development process. Efforts like a rare disease treatment program and expanded access schemes in Europe in the market are likely to influence the market, enhancing the outcome of patients and accelerate further.

Market Segmentation

• Indication Insights (Revenue, USD Bn, 2020 - 2032)
  • Wild-type transthyretin-mediated amyloidosis cardiomyopathy (ATTR-CM, wild-type)
  • Hereditary transthyretin-mediated amyloidosis cardiomyopathy (ATTR-CM, variant)
  • Transthyretin-mediated amyloidosis polyneuropathy (ATTR-PN/FAP)
• Strength Insights (Revenue, USD Bn, 2020 - 2032)
  • 20 mg
  • 61 mg
• Payer Insights (Revenue, USD Bn, 2020 - 2032)
  • Public
  • Private
  • Self-pay/Out-of-pocket
• Distribution Channel Insights (Revenue, USD Bn, 2020 - 2032)
  • Hospital pharmacies
  • Specialty/Online pharmacies
  • Retail pharmacies
• End User Insights (Revenue, USD Bn, 2020 - 2032)
  • Hospitals
  • Cardiac Amyloidosis Centers
  • Ambulatory Surgical Centers
  • Homecare Settings
• Age Group Insights (Revenue, USD Bn, 2020 - 2032)
  • Adults (≥18 yrs)
  • Elderly (≥65 yrs)
• Regional Insights (Revenue, USD Bn, 2020 - 2032)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • Pfizer Inc.

Sources

Primary Research Interviews

Industry Stakeholders

• Clinicians specializing in transthyretin amyloidosis
• Hospital procurement heads for rare-disease therapies

End Users

• Patient advocacy group leaders for ATTR‑CM
• Caregivers of patients on tafamidis
• Rare disease center managers
• Pharmacists in cardiology clinics

Government & International Databases

• U.S. FDA drug approval databases
• European Medicines Agency orphan designations
• WHO global health statistics
• ClinicalTrials.gov (trial registries)
• National health authority reimbursement datasets
• Canadian Agency for Drugs and Technologies reports

Trade Publications

• Pharma newsletters on rare disease therapies
• Regulatory bulletins for orphan‑drug legislation
• Healthcare procurement journals
• Pharma technology magazines
• Specialty drug pricing trade journals
• Cardiovascular therapy market insights

Academic Journals

• Studies on tafamidis in ATTR‑CM
• Systematic reviews on tafamidis therapy
• Therapeutic strategy reviews for amyloidosis
• Clinical applications of tafamidis
• Patient‑reported outcomes in ATTR amyloidosis
• Public‑private collaboration studies in rare‑disease development

Reputable Newspapers

• Business daily coverage on orphan drug access
• News reports on amyloidosis breakthroughs
• National newspapers' health sections
• Media on regulatory approvals for tafamidis
• Financial press on pharma strategies in rare diseases
• Specialist healthcare news on treatment adoption

Industry Associations

• Amyloidosis Research Consortium
• Amyloidosis Forum
• Cardiovascular imaging societies
• Rare disease patient‑advocacy federations
• Orphanet rare disease network
• Rare disease treatment access consortia

Public Domain Resources

• Open‑access clinical reviews
• Disease prevalence/incidence public datasets
• Patient registry summaries
• Conference proceedings
• Reimbursement/access maps for therapies
• Regulatory filings & briefing documents

Proprietary Elements

• CMI Data Analytics Tool: Proprietary analytics tool to analyze real-time market trends, consumer behavior, and technology adoption in market
• Proprietary CMI Existing Repository of Information for Last 8 Years