타파미디스 약물 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the tafamidis drug market size is projected to expand from USD 4.71 billion in 2025 and USD 5.12 billion in 2026 to USD 7.77 billion by 2031, registering a CAGR of 8.71% between 2026 to 2031.

This report is Segmented by Product Type (Tafamidis Meglumine, Tafamidis Free Acid, Generic), Application (ATTR-CM, HATTR Polyneuropathy, FAP, Mixed Phenotype ATTR), Distribution Channel (Hospital, Specialty, Retail, Online Pharmacies, Others), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Tafamidis Drug Market Trends and Insights

Rising Diagnosis Of ATTR-CM Through Advanced Cardiac Imaging

Non-invasive diagnosis using 99mTc-PYP and related bone scintigraphy has changed the way ATTR-CM is found in the tafamidis drug market. The 2025 epidemiology review showed rising incidence and prevalence across the United States and Europe, with especially strong growth among men older than 65 in countries with established scintigraphy use. U.S. incidence reached 44.3 per 100,000 person-years, which reflected better detection rather than a sudden change in underlying disease burden. This matters for the tafamidis drug market because imaging identifies more patients before advanced functional decline, which supports earlier treatment start. Earlier initiation tends to capture more NYHA Class I and II patients, and this group has been the clearest clinical fit for tafamidis use. The result is that the tafamidis drug market gains both a larger diagnosed base and a longer treatment window per patient.

Aging Patient Pool And Higher ATTR-CM Prevalence In Older Populations

The tafamidis drug market is closely tied to aging because wild-type ATTR-CM is concentrated in older adults. A 2024 international study showed that prevalence in high-risk HFpEF populations above age 85 reached or exceeded 40%, which confirms how strongly age drives case finding. Population aging across North America, Western Europe, and East Asia is therefore enlarging the diagnosis pool and sustaining demand for treatment. Japan stands out with documented ATTR-CM prevalence of 100 per million per year, and that disease burden has not yet been fully matched by prescription volumes because earlier eligibility rules were stricter. The 2025 revision of Japan's Heart Failure Clinical Guidelines gave tafamidis a Class I, Evidence Level A recommendation for NYHA Class I and II ATTR-CM patients, which now supports wider use. This guideline shift should keep the tafamidis drug market on a firmer growth path in Japan over the medium term.

High Annual Therapy Cost And Payer Prior Authorization Requirements

High cost remains a direct limit on the tafamidis drug market even after recent access improvements. Tafamidis carries a U.S. list price of USD 234,900 per year, which places it among the most expensive cardiovascular therapies. Major payers require diagnosis confirmation, cardiology attestation, and functional assessment before they approve dispensing, and each plan has its own utilization rules. The 2025 Medicare Part D cap reduced patient financial burden, but some Medicare Advantage plans still placed Vyndamax in non-preferred specialty tiers, which kept plan-level friction in place. That means access barriers in the tafamidis drug market now come less from direct patient affordability and more from administrative delay, formulary placement, and documentation requirements. Appeals channels still exist for medically necessary treatment, but the prescriber burden remains significant and slows faster uptake.

Other drivers and restraints analyzed in the detailed report include:

1. Broader Cardiology Adoption Of Disease-Modifying Therapies
2. Earlier Referral From Heart Failure Clinics To Amyloidosis Centers
3. Competitive Pressure From RNA-Silencing And Next-Generation Therapies

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Tafamidis free acid held 61.53% of the tafamidis drug market share in 2025, which reflected the commercial strength of Pfizer's once-daily Vyndamax and related brands in other countries. The single-capsule regimen offered a practical adherence advantage over the older four-capsule tafamidis meglumine presentation. Pfizer's decision to discontinue Vyndaqel 20 mg in the U.S. by the end of 2025 further concentrated branded revenue around the free acid format. Tafamidis meglumine still retains relevance in markets where the free acid version has not secured local approval or where legacy patient cohorts remain established on older treatment protocols. A 2025 post-approval study in China showed that tafamidis free acid 61 mg delivered safety and efficacy findings consistent with international Phase 3 evidence, which supported confidence in markets absent from the original ATTR-ACT enrollment base.

The tafamidis drug market size for generic products is projected to expand at a 18.17% CAGR through 2031, making generic tafamidis the fastest-growing product segment. Indian manufacturers, including Dr. Reddy's Laboratories, Aurobindo Pharma, Lupin, Torrent Pharmaceuticals, Sun Pharmaceutical Industries, and Zydus Lifesciences are building active pharmaceutical ingredient capabilities ahead of the June 2031 U.S. entry date tied to Pfizer's settlements with Dexcel Pharma, Hikma Pharmaceuticals, and Cipla. Growth in this segment is expected to be uneven because some ex-U.S. markets can absorb generic tafamidis earlier under more favorable reimbursement settings, while the U.S. branded market remains protected until mid-2031. The molecule follows established organic chemistry routes, so price erosion after generic entry could be sharper than in rare-disease therapies with more complex manufacturing barriers. That outlook means the tafamidis drug market will likely see branded companies defend value through access execution, channel control, and clinical differentiation rather than formulation alone

Complete Report Scope:

• By Product Type
  • Tafamidis Meglumine
  • Tafamidis Free Acid
  • Generic Tafamidis
• By Application
  • Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
  • Hereditary Transthyretin Amyloid Polyneuropathy (ATTR-PN or hATTR-PN)
  • Familial Amyloid Polyneuropathy (FAP)
  • Mixed Phenotype ATTR Amyloidosis
• By Distribution Channel
  • Hospital Pharmacies
  • Specialty Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
  • Others
• By 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

Geography Analysis

North America held 39.37% of the tafamidis drug market share in 2025, making it the largest regional revenue base. The United States drove most of that demand because it has the deepest ATTR-CM diagnostic infrastructure, broad access to 99mTc-PYP scintigraphy, and the highest per-patient therapy spending. The 2025 Medicare Part D redesign improved patient affordability, but plan-level tiering still created friction in some Medicare Advantage settings. Canada and Mexico remain smaller contributors because reimbursement structures and specialist density are less favorable than in the United States. South America, led by Brazil and Argentina, supports demand through rare disease access programs and the presence of hereditary TTR variants in Portuguese-descended populations, which keep both ATTR-PN and ATTR-CM clinically relevant.

Europe remains the second-largest geography in the tafamidis drug market, with Germany, the United Kingdom, France, Italy, and Spain forming the core base. The European Commission approval of Beyonttra in February 2025 introduced direct TTR stabilizer competition, which will shape prescribing and pricing decisions more actively through 2031. Tafamidis still benefits from physician familiarity and from reimbursement frameworks that are already established with major health technology assessment bodies. Portugal and Sweden maintain a distinct neuropathy patient base linked to endemic TTR variants, while the rest of Europe offers incremental growth as diagnosis spreads beyond Western European specialist centers.

Asia-Pacific is the fastest-growing region in the tafamidis drug market and is forecast to expand at a 17.63% CAGR over 2026-2031. Japan has the highest documented ATTR-CM prevalence at 100 per million per year, and the 2025 guideline revision is now improving the path to broader Vynmac use in NYHA Class I and II patients. China is strengthening its position as a growth market because post-approval data in Chinese patients supported the safety and efficacy of tafamidis free acid 61 mg. India, Australia, and South Korea should grow from a smaller base as access improves, especially once pricing becomes more compatible with reimbursement expansion. The Middle East and Africa still represent a small share of the tafamidis drug market, with demand centered in GCC countries and broader regional growth dependent on stronger scintigraphy capacity and specialist diagnosis pathways

1. Alnylam Pharmaceuticals
2. AstraZeneca
3. Aurobindo Pharma
4. BridgeBio Pharma, Inc.
5. Cipla
6. Dexcel Pharma Technologies Ltd.
7. Dr. Reddy's Laboratories
8. Glenmark Pharmaceuticals
9. Hikma Pharmaceuticals
10. Ionis Pharmaceuticals
11. Laurus Labs Limited
12. Lupin
13. Natco Pharma Ltd.
14. Pfizer
15. Sandoz Group AG
16. Sun Pharmaceuticals Industries
17. Teva Pharmaceutical Industries
18. Torrent Pharmaceuticals Limited
19. Viatris
20. Zydus Lifesciences Limited

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Diagnosis of ATTR-CM Through Advanced Cardiac Imaging and Biomarkers
  • 4.2.2 Broader Cardiology Adoption of Disease-Modifying Therapy for Underdiagnosed Amyloidosis
  • 4.2.3 Aging Patient Pool and Higher ATTR-CM Prevalence in Older Adults
  • 4.2.4 Favorable Rare-Disease Access Pathways and Specialist Reimbursement Support
  • 4.2.5 Treatment Consolidation Around Once-Daily Oral Tafamidis in Specialty Care Pathways
  • 4.2.6 Earlier Referral From Heart Failure Clinics to Amyloidosis Centers
• 4.3 Market Restraints
  • 4.3.1 High Annual Therapy Cost and Payer Prior Authorization Pressure
  • 4.3.2 Generic Entry and Patent-Expiry Uncertainty
  • 4.3.3 Diagnostic Delay and Misclassification of ATTR-CM as Standard Heart Failure
  • 4.3.4 Competitive Pressure From RNA-Silencing and Next-Generation ATTR Therapies
• 4.4 Supply Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Product Type
  • 5.1.1 Tafamidis Meglumine
  • 5.1.2 Tafamidis Free Acid
  • 5.1.3 Generic Tafamidis
• 5.2 By Application
  • 5.2.1 Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
  • 5.2.2 Hereditary Transthyretin Amyloid Polyneuropathy (ATTR-PN or hATTR-PN)
  • 5.2.3 Familial Amyloid Polyneuropathy (FAP)
  • 5.2.4 Mixed Phenotype ATTR Amyloidosis
• 5.3 By Distribution Channel
  • 5.3.1 Hospital Pharmacies
  • 5.3.2 Specialty Pharmacies
  • 5.3.3 Retail Pharmacies
  • 5.3.4 Online Pharmacies
  • 5.3.5 Others
• 5.4 By Geography
  • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
  • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
  • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia-Pacific
  • 5.4.4 Middle East and Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East and Africa
  • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments)
  • 6.3.1 Alnylam Pharmaceuticals, Inc.
  • 6.3.2 AstraZeneca PLC
  • 6.3.3 Aurobindo Pharma Limited
  • 6.3.4 BridgeBio Pharma, Inc.
  • 6.3.5 Cipla Limited
  • 6.3.6 Dexcel Pharma Technologies Ltd.
  • 6.3.7 Dr. Reddy's Laboratories Ltd.
  • 6.3.8 Glenmark Pharmaceuticals Ltd.
  • 6.3.9 Hikma Pharmaceuticals PLC
  • 6.3.10 Ionis Pharmaceuticals, Inc.
  • 6.3.11 Laurus Labs Limited
  • 6.3.12 Lupin Limited
  • 6.3.13 Natco Pharma Ltd.
  • 6.3.14 Pfizer Inc.
  • 6.3.15 Sandoz Group AG
  • 6.3.16 Sun Pharmaceutical Industries Limited
  • 6.3.17 Teva Pharmaceutical Industries Ltd.
  • 6.3.18 Torrent Pharmaceuticals Limited
  • 6.3.19 Viatris Inc.
  • 6.3.20 Zydus Lifesciences Limited

7 Market Opportunities & Future Outlook

• 7.1 White-Space and Unmet-Need Assessment