Last updated: July 29, 2025
Introduction
Glecaprevir and pibrentasvir constitute a combination regimen highly effective in the treatment of chronic hepatitis C virus (HCV) infection. Marketed primarily under the brand name Mavyret by AbbVie, this fixed-dose combination therapies has gained significant prominence globally owing to its efficacy, safety profile, and shorter treatment duration. Ensuring a reliable supply chain of both active pharmaceutical ingredients (APIs) and finished formulations is essential for healthcare providers, pharmaceutical companies, and policymakers aiming to meet global demand, especially in regions with high HCV prevalence.
This article analyzes the primary suppliers and manufacturing landscape for glecaprevir and pibrentasvir, highlighting the key players, manufacturing capacities, and supply chain strategies. Understanding the global sourcing dynamics offers strategic insights into drug availability, affordability, and potential market risks.
Manufacturing Landscape and Key Suppliers
Active Pharmaceutical Ingredient (API) Suppliers
The cornerstone of drug production involves sourcing high-quality APIs. The APIs for glecaprevir and pibrentasvir are complex molecules which necessitate advanced synthetic processes, stringent quality controls, and robust supply chains.
Major API Manufacturers
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AbbVie Inc.
As the originator company, AbbVie is heavily involved in the synthesis and manufacturing of the APIs for glecaprevir and pibrentasvir. The company possesses proprietary manufacturing facilities primarily located in the United States and Ireland, ensuring control over the supply chain. AbbVie's in-house API production guarantees high-quality standards but also limits dependency on external sources for these APIs.
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Contract Manufacturing Organizations (CMOs)
Given the surge in demand and the complexity of synthesis, Abbott, and other pharmaceutical companies, have outsourced API production to specialized CMOs globally. These organizations often operate in regions with cost-efficient manufacturing capabilities, including:
- China: Several API manufacturers based in China have achieved regulatory compliance for hepatitis C drug APIs, driven by the country's expanding pharmaceutical export sector. Notable firms include Zhejiang Hisun Pharmaceutical and Jiangsu Hengrui Medicine.
- India: Indian pharmaceutical companies, such as Divi's Laboratories and Aurobindo Pharma, possess advanced capabilities in complex API synthesis, including hepatitis C antivirals.
- South Korea and Southeast Asia: Companies rely on South Korean firms like Hanmi Pharmaceutical for high-quality APIs, leveraging their advanced R&D facilities.
- Generic Manufacturers in Developing Markets
Several generic pharmaceutical manufacturers have entered the market post-patent expiry or through licensing agreements, sourcing APIs from reputable suppliers or developing their own synthesis capabilities to produce glecaprevir and pibrentasvir.
Finished Formulation Manufacturers
The final formulation of glecaprevir/pibrentasvir (e.g., Mavyret) is produced by pharmaceutical manufacturing firms with facilities complying with global Good Manufacturing Practices (GMP).
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AbbVie
AbbVie maintains a vertically integrated supply chain, producing both APIs and finished dosage forms at its own manufacturing plants, primarily in the United States and Europe.
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Authorized Generic and Contract Manufacturers
As patent protections diminished, numerous generic manufacturers have obtained approval from regulatory authorities (FDA, EMA, PMDA) to produce glecaprevir/pibrentasvir formulations. These firms often source APIs from the same global supplier network but manufacture and distribute their formulations locally or regionally.
Supply Chain Dynamics and Challenges
Global Sourcing and Geographical Concentration
The manufacturing of APIs for glecaprevir and pibrentasvir is predominantly concentrated in China and India, markets known for their extensive API production capabilities and cost advantages. This concentration introduces supply chain vulnerabilities, including risks associated with geopolitical tensions, trade policies, or pandemics disrupting manufacturing operations.
Regulatory and Quality Assurance
Manufacturers must meet stringent regulatory standards, including those of the FDA, EMA, and other national authorities. Regulatory approvals often require rigorous inspection and validation processes. Disruptions or delays in gaining—or maintaining—such certifications can impact supply continuity.
Intellectual Property and Licensing
The original patents held by AbbVie have expired or are nearing expiry in multiple jurisdictions, allowing generic manufacturers to enter the market. Licensing agreements facilitate the transfer of proprietary manufacturing processes, expanding the supplier base for finished formulations but also posing potential risks of counterfeit or substandard products if verification is inadequate.
Emerging Suppliers and Market Trends
Scale-up of Asian Manufacturers
Recent trends indicate increased capacity investments by Indian and Chinese pharmaceutical firms, targeting not only domestic markets but also global exports. Companies like Zydus Cadila, Cipla, and Hetero Drugs have announced expansions into hepatitis C drug APIs and formulations, aiming to capture market shares in low- and middle-income countries.
Strategic Partnerships and Licensing
AbbVie and other originators have partnered with regional manufacturers through licensing agreements to improve access and reduce costs. These arrangements support supply chain resilience and help meet surging demand, especially in developing countries.
Implications for Stakeholders
- Pharmaceutical Companies: Need to establish diversified manufacturing networks to reduce reliance on specific regions and ensure supply security.
- Healthcare Providers: Must monitor supply chains and validate the quality of sourced APIs and finished formulations, especially from emerging markets.
- Policymakers: Should facilitate regulatory harmonization and support local manufacturing capacities to improve drug access.
Key Takeaways
- The global supply of glecaprevir and pibrentasvir relies heavily on API manufacturing in China and India, with finished formulation production concentrated among both originator and generic companies.
- Supply chain risks include geopolitical tensions, regulatory hurdles, and manufacturing disruptions, emphasizing the importance of diversified sourcing and strategic partnerships.
- The expiration of patents has catalyzed entry of generic manufacturers, expanding supplier options but necessitating vigilance over quality assurance.
- Increasing investments by Asian pharmaceutical firms are likely to enhance capacity and reduce costs, making hepatitis C treatments more accessible worldwide.
- Strategic procurement, robust quality controls, and supply chain diversification are critical for stakeholders to ensure continuous access to these vital antiviral medications.
FAQs
1. Which companies are the primary API suppliers for glecaprevir and pibrentasvir?
While AbbVie manufactures APIs in-house, several CMOs in China, India, and South Korea produce APIs for these drugs, including Zhejiang Hisun Pharmaceutical, Divi's Laboratories, and Hanmi Pharmaceutical.
2. Are generic drug manufacturers sourcing APIs from China and India?
Yes, most generic manufacturers sourcing glecaprevir and pibrentasvir APIs procure from Chinese and Indian suppliers, leveraging their established manufacturing capabilities.
3. How does patent expiration impact the supply of glecaprevir/pibrentasvir?
Patent expiry in many jurisdictions has lowered barriers for generic manufacturers, increasing the number of suppliers and improving access; however, it also requires stringent quality controls to ensure drug safety.
4. What risks threaten the supply chain for these hepatitis C drugs?
Potential risks include geopolitical trade restrictions, manufacturing downtime, quality control issues, and regulatory delays—all of which can disrupt supply continuity.
5. What strategies can stakeholders adopt to secure a reliable supply?
Diversifying supplier relationships, investing in local manufacturing, strengthening quality assurance, and maintaining strategic stockpiles are effective approaches.
References
[1] AbbVie. Mavyret (glecaprevir and pibrentasvir) Prescribing Information. 2023.
[2] World Health Organization. Global Hepatitis Report 2017.
[3] U.S. Food & Drug Administration. Drug Approvals and Registrations for GLECAPREVIR and PIBRENTASVIR.
[4] Industry Reports. "API Manufacturing in China and India: Trends and Capacities," 2022.
[5] MarketWatch. "The Rise of Generic Drugs Post-Patent Expiry," 2022.
