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Why 2025 Marks a Turning Point for Isomorphic Polymerase Enzyme Manufacturing: Game-Changing Advances, Booming Demand, and What Experts Predict for the Next 5 Years

ByCozy Naylor

May 18, 2025
Why 2025 Marks a Turning Point for Isomorphic Polymerase Enzyme Manufacturing: Game-Changing Advances, Booming Demand, and What Experts Predict for the Next 5 Years

Isomorphic Polymerase Enzyme Manufacturing: 2025’s Breakout Market & Innovation Hotspots Revealed

Table of Contents

The isomorphic polymerase enzyme manufacturing sector is experiencing a period of dynamic growth and innovation as it enters 2025. Demand is being propelled by the rapid expansion of molecular diagnostics, synthetic biology, and next-generation sequencing applications, all of which rely on high-fidelity and specialized polymerase enzymes. Isomorphic polymerases—engineered enzymes designed to mimic or surpass the function of natural DNA polymerases—are increasingly valued for their enhanced performance in challenging amplification conditions, resistance to inhibitors, and compatibility with novel nucleic acid analogs. These attributes are positioning isomorphic polymerases at the forefront of advanced biotechnological applications.

Major manufacturers and biotechnology firms are investing in both process optimization and scale-up capabilities to meet surging market needs. In 2024, New England Biolabs expanded its enzyme production facilities and launched new product lines specifically tailored for high-throughput and robust performance in clinical and research-grade workflows. Similarly, Thermo Fisher Scientific introduced next-generation isomorphic polymerases featuring improved resistance to common PCR inhibitors, enabling more reliable diagnostics from complex biological samples. These developments illustrate the sector’s ongoing shift toward application-specific enzyme engineering, supported by continuous advancements in protein design and directed evolution.

A key trend for 2025 is the integration of automated, continuous bioprocessing systems to increase enzyme yield, purity, and batch-to-batch consistency. Promega Corporation reported the implementation of single-use bioreactor technology in its enzyme manufacturing pipelines, resulting in reduced production times and greater scalability. This trend is expected to accelerate, as manufacturers seek to supply not only the research and clinical sectors but also the emerging fields of point-of-care diagnostics and decentralized testing platforms.

Looking ahead, the sector is poised for further innovation. The launch of next-generation isomorphic polymerases compatible with novel nucleic acid analogs and digital PCR platforms is anticipated from industry leaders. Strategic collaborations between enzyme manufacturers and diagnostic device companies are likely to grow, as both sectors recognize the value of custom enzyme solutions optimized for specific instrumentation and workflows. Regulatory harmonization and quality assurance, guided by organizations such as the International Society for Pharmaceutical Engineering, will remain a focus as manufacturers scale up to meet global demand.

In summary, 2025 marks a pivotal year for isomorphic polymerase enzyme manufacturing, characterized by robust demand, technological innovation, and a strong outlook for continued expansion across diverse biotechnological domains.

Market Size & Growth Forecast (2025–2030)

The isomorphic polymerase enzyme manufacturing sector is poised for significant expansion from 2025 through 2030, propelled by increasing demand in clinical diagnostics, molecular biology research, and the rise of point-of-care testing technologies. As of early 2025, leading enzyme producers are scaling up production capacities to address both surging global requirements and the growing diversity of downstream applications.

Major industry participants like Thermo Fisher Scientific Inc. and New England Biolabs report robust year-on-year growth in their nucleic acid amplification product lines, reflecting strong demand from biotechnology, pharmaceutical, and academic sectors. These trends are supported by the ongoing expansion of molecular diagnostics, with isomorphic polymerase enzymes playing a crucial role in isothermal amplification techniques such as LAMP and RPA, which are increasingly preferred for their speed, sensitivity, and field-deployability.

The market’s expansion is further catalyzed by investments in process optimization and scale-up technologies. Companies such as Finnzymes (a subsidiary of Thermo Fisher Scientific) continue to innovate in fermentation and purification methods, improving enzyme yields, purity, and stability. Such advancements are essential for meeting the stringent quality standards required by clinical and industrial applications.

From a quantitative perspective, several enzyme manufacturers have publicly announced capacity increases and facility expansions slated for completion by 2026–2027, with expected output growth ranging from 20% to 40% over current levels. For instance, QIAGEN announced plans to expand its enzyme production infrastructure to address both the rising volume and the variety of polymerase enzymes required for next-generation sequencing and diagnostic assays.

Looking ahead to 2030, the market outlook remains optimistic. Key growth drivers include the integration of isomorphic polymerase enzymes into decentralized diagnostic platforms, the adoption of synthetic biology for custom enzyme development, and increased governmental and private funding for pandemic preparedness and surveillance. Additionally, the Asia-Pacific region is expected to witness the fastest market growth due to expanding biotech manufacturing capabilities and supportive regulatory environments.

Overall, the isomorphic polymerase enzyme manufacturing market is expected to sustain a robust growth trajectory through 2030, underpinned by technological innovation, capacity investments, and the expanding spectrum of life science and healthcare applications.

Emerging Technologies & Process Innovations

The manufacturing of isomorphic polymerase enzymes is undergoing significant transformation in 2025, driven by the integration of advanced bioprocessing technologies and digital innovation. Isomorphic polymerases, engineered for enhanced fidelity, processivity, or substrate range, are increasingly vital for next-generation molecular diagnostics, synthetic biology, and DNA data storage applications. Leading enzyme manufacturers are investing in both upstream strain engineering and downstream purification process improvements to meet rising demands for quality, yield, and regulatory compliance.

  • Automated High-Throughput Screening and Strain Engineering: Adoption of AI-driven high-throughput screening platforms is accelerating the discovery and optimization of microbial strains that express isomorphic polymerases at high levels. Companies such as New England Biolabs are leveraging machine learning to predict beneficial mutations and streamline enzyme engineering, shortening development cycles and enhancing performance characteristics.
  • Continuous Manufacturing and Intensification: In 2025, continuous fermentation and integrated bioprocessing are gaining traction for enzyme production. Thermo Fisher Scientific is deploying intensified bioprocessing platforms that combine upstream fermentation with real-time product capture and purification, leading to higher volumetric productivity and reduced batch-to-batch variability. This approach also enables flexible manufacturing, allowing rapid scale-up in response to market needs.
  • Enzyme Stabilization and Formulation: Recent innovations focus on the stabilization of isomorphic polymerases for robust performance under challenging assay and storage conditions. Promega Corporation has introduced proprietary formulation technologies that extend enzyme shelf life and activity, supporting decentralized molecular testing and point-of-care diagnostics.
  • Green Chemistry and Sustainable Production: Environmental sustainability is a growing priority. Manufacturers like QIAGEN are adopting greener synthesis routes, minimizing solvent use, and implementing closed-loop water systems in enzyme manufacturing facilities to reduce environmental footprints and align with global sustainability targets.

Looking ahead, the isomorphic polymerase enzyme sector is expected to see further integration of digital twins, real-time analytics, and robotics in manufacturing processes, enabling predictive maintenance, quality assurance, and regulatory compliance. Partnerships between enzyme suppliers and synthetic biology companies are anticipated to accelerate, driving co-development of custom polymerases tailored for emerging genomic and diagnostic platforms. As regulatory expectations for enzyme quality and traceability increase, manufacturers are investing in advanced QC systems and blockchain-based batch tracking, setting new standards for transparency and reliability in the field.

Key Players and Strategic Initiatives (Official Sources Only)

The isomorphic polymerase enzyme manufacturing sector in 2025 is characterized by a rapidly evolving landscape, with established biotechnology companies and emerging innovators actively investing in research, production capacity, and strategic collaborations. Key players are leveraging advanced enzyme engineering, precision fermentation, and continuous manufacturing to enhance production efficiency and product quality, targeting applications in diagnostics, synthetic biology, and next-generation sequencing.

Among the most prominent manufacturers, Thermo Fisher Scientific continues to expand its enzyme portfolio, focusing on high-fidelity and isothermal polymerases. Their recent investments in scalable enzyme expression and purification platforms reflect a commitment to supporting growing global demand for specialty polymerases in molecular diagnostics and point-of-care testing. Similarly, New England Biolabs (NEB) remains a key innovator, developing proprietary isothermal amplification enzymes and offering custom manufacturing services to meet the requirements of industrial and academic partners.

Emerging biotech firms such as Codexis are advancing protein engineering technologies, including directed evolution, to optimize polymerase properties such as thermostability, processivity, and inhibitor resistance. In recent years, Codexis has formed strategic collaborations with major diagnostic companies to accelerate the commercialization of novel polymerase variants tailored for isothermal applications.

Asian manufacturers are also asserting their presence. Genetika, based in China, has scaled up enzyme production facilities to address surging demand for isomorphic polymerases in the Asia-Pacific region, particularly for clinical and research markets. Meanwhile, Takara Bio in Japan is investing in expanding its global distribution networks and proprietary enzyme technologies, supporting both in-house product lines and OEM partnerships.

  • In 2024, Thermo Fisher Scientific announced the integration of automation and digital process controls in its enzyme manufacturing lines, aiming to improve batch consistency and reduce time-to-market for specialized polymerases (Thermo Fisher Scientific).
  • New England Biolabs launched new isothermal amplification master mixes and expanded contract manufacturing services in late 2024, targeting decentralized testing platforms (New England Biolabs).
  • Codexis entered into a multi-year enzyme supply and development agreement with a leading global diagnostic company in early 2025, focusing on next-generation isomorphic polymerases for rapid molecular diagnostics (Codexis).
  • Takara Bio announced an increase in R&D investment for enzyme innovation and plans for new manufacturing capacity by 2026 to serve growing global markets (Takara Bio).

Looking ahead, strategic initiatives among these key players are expected to center on further process optimization, sustainability in enzyme production, and the integration of artificial intelligence for enzyme design. The sector is poised for continued growth, with collaborative efforts between manufacturers and end-users driving innovation in isomorphic polymerase enzyme technologies through 2025 and beyond.

Supply Chain & Raw Material Analysis

The supply chain for isomorphic polymerase enzyme manufacturing in 2025 is defined by a complex web of raw material sourcing, bioprocessing technologies, and global distribution networks. Enzyme production relies heavily on high-purity reagents, recombinant DNA technology, and specialized fermentation substrates, making upstream supply chain resilience a critical concern. The primary raw materials include microbial strains (often genetically engineered), nucleotides, buffer chemicals, and specialized growth media. Most leading polymerase enzyme producers, such as New England Biolabs, Thermo Fisher Scientific, and Takara Bio Inc., maintain vertically integrated supply chains to ensure quality and uninterrupted access to these inputs.

Due to the increased demand for high-fidelity and isomorphic polymerase enzymes in diagnostics, synthetic biology, and next-generation sequencing applications, manufacturers have been investing in upscaling fermentation capacities and automating purification steps. For example, QIAGEN has expanded its enzyme manufacturing facilities in Europe to address market growth and mitigate potential disruptions in raw material supply, ensuring continuity and rapid response to market needs.

A notable trend in 2025 is the strategic localization of enzyme manufacturing closer to major biotech hubs. This is partly a response to geopolitical tensions and pandemic-related disruptions observed in previous years. Companies like New England Biolabs have announced infrastructure upgrades in North America, while Thermo Fisher Scientific continues to invest in regional supply chain diversification to reduce reliance on any single geography for critical raw materials. Additionally, suppliers of key inputs such as recombinant E. coli strains and nucleotide triphosphates are increasingly entering into long-term supply agreements with enzyme producers, enhancing supply chain predictability.

Sustainability is another emerging focus, with manufacturers seeking greener production processes and more sustainable sourcing for primary feedstocks. Takara Bio Inc. has publicly committed to reducing its environmental footprint by optimizing fermentation waste management and exploring biobased alternatives for some reagents.

Looking ahead, the outlook for the isomorphic polymerase enzyme supply chain in the next few years involves further automation, enhanced digital tracking of raw material provenance, and increased collaboration between suppliers and manufacturers. These measures are expected to buffer the sector against volatility and enable rapid scale-up in response to surging demand from emerging applications in genomics and molecular diagnostics.

Regulatory Environment & Compliance Updates

The regulatory environment for isomorphic polymerase enzyme manufacturing is undergoing significant evolution in 2025, driven by advances in synthetic biology, increasing global demand for high-fidelity enzymes in diagnostics and therapeutics, and growing emphasis on safety and traceability. Regulatory agencies in key regions have begun updating guidelines to reflect the unique aspects of isomorphic enzymes—engineered or modified polymerases designed for enhanced performance or novel functionalities.

In the United States, the U.S. Food and Drug Administration (FDA) continues to refine its oversight of enzyme manufacturing for medical and research applications. The FDA’s Center for Biologics Evaluation and Research (CBER) has issued updated draft guidance addressing the characterization, quality control, and documentation requirements for recombinant and engineered polymerase enzymes, emphasizing lot-to-lot consistency and the minimization of impurities. Manufacturers such as Thermo Fisher Scientific and New England Biolabs have responded by investing in advanced analytical platforms and digital batch tracking to meet these standards.

In the European Union, the European Medicines Agency (EMA) has signaled increased scrutiny of isomorphic polymerases used in in vitro diagnostics (IVDs) and pharmaceutical manufacturing. The implementation of the In Vitro Diagnostic Regulation (IVDR) in 2022 continues to impact 2025, requiring comprehensive technical documentation, post-market surveillance, and traceability for enzyme components. European enzyme manufacturers such as QIAGEN are expanding their compliance teams and adopting automated quality management systems to address the IVDR’s ongoing requirements for performance evaluation and risk management.

In Asia, regulatory harmonization efforts are expanding. The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has begun collaborating with international bodies to align standards for recombinant enzyme manufacturing, while China’s National Medical Products Administration (NMPA) is increasing facility inspections and enforcing stricter documentation for genetically modified enzyme products. Regional players such as Takara Bio are actively engaging in dialogue with regulators to ensure new isomorphic polymerase variants can be commercialized efficiently.

Looking ahead, manufacturers anticipate further requirements for environmental impact assessments and expanded digital traceability, especially as synthetic biology tools become more prevalent. Industry leaders are advocating for greater clarity and international alignment of standards to streamline cross-border supply chains and accelerate innovation in isomorphic polymerase enzyme manufacturing.

End-Use Segments: Diagnostics, Therapeutics, and Beyond

In 2025, the manufacturing of isomorphic polymerase enzymes is increasingly tailored to address the specific requirements of diverse end-use segments, with diagnostics and therapeutics emerging as the primary drivers of innovation and market expansion. Isomorphic polymerases—engineered or synthetic enzymes that facilitate nucleic acid amplification with enhanced fidelity, robustness, or tailored substrate compatibility—are reshaping molecular diagnostics, point-of-care testing, and next-generation therapeutics.

Within the diagnostics domain, clinical laboratories and point-of-care platform developers are demanding polymerases that can operate efficiently under challenging sample conditions, tolerate inhibitors, and function at accelerated speeds. Leading enzyme manufacturers such as Thermo Fisher Scientific and New England Biolabs have expanded their portfolios of proprietary isothermal and high-fidelity polymerases, specifically marketed for rapid infectious disease testing—including for respiratory viruses, antimicrobial resistance genes, and cancer biomarkers. These enzymes are fundamental to the continued evolution of molecular diagnostic platforms, such as digital PCR and microfluidic-based assays, which require robust performance in miniaturized or multiplexed settings.

In therapeutics, isomorphic polymerase enzyme manufacturing is increasingly intersecting with the development of gene therapies, genome editing, and personalized medicine. Companies like QIAGEN are supplying custom polymerase solutions for the synthesis and amplification of therapeutic nucleic acids, including mRNA constructs and gene editing payloads. The ability to manufacture GMP-grade, highly pure, and sequence-agnostic polymerases is crucial for the scalability and regulatory compliance of these advanced therapeutic modalities.

Beyond traditional diagnostics and therapeutics, isomorphic polymerase enzymes are finding novel applications in synthetic biology, environmental monitoring, and agricultural biotechnology. For instance, tailored polymerases are enabling ultra-sensitive environmental DNA (eDNA) detection for biodiversity assessment and supporting the creation of engineered microbial systems for sustainable production of biochemicals. Manufacturers such as Promega Corporation are actively developing enzymes with unique performance features—such as resistance to environmental inhibitors or compatibility with non-standard nucleotides—to meet the needs of emerging sectors.

Looking ahead to the next several years, the outlook for isomorphic polymerase enzyme manufacturing remains robust, driven by ongoing demand for customizability, quality, and regulatory assurance across diverse end-use cases. The convergence of automation, high-throughput screening, and machine learning-guided enzyme engineering will likely accelerate the pace of innovation, enabling manufacturers to rapidly deliver specialized polymerase solutions to both established and emerging markets.

Competitive Landscape: Partnerships, M&A, and Global Expansion

The competitive landscape of isomorphic polymerase enzyme manufacturing in 2025 is characterized by strategic partnerships, targeted mergers and acquisitions (M&A), and a pronounced drive for global expansion. As demand for advanced polymerase enzymes intensifies—driven by applications in diagnostics, genomics, and synthetic biology—market leaders and emerging players are actively reshaping their operations and alliances to secure technological and commercial advantages.

A notable trend in 2025 is the consolidation of expertise through M&A activity. Established enzyme manufacturers are acquiring innovative biotech firms with proprietary isomorphic polymerase technologies to broaden their product offerings and reinforce intellectual property portfolios. For example, Thermo Fisher Scientific has continued to expand its enzyme technology assets, leveraging both in-house R&D and acquisitions to strengthen its leadership in custom and high-fidelity polymerase solutions. Similarly, QIAGEN has pursued deals to integrate next-generation polymerase technologies into its workflow automation systems, targeting clinical and research markets worldwide.

Partnerships are also pivotal, especially those facilitating co-development and co-marketing of polymerase enzyme products. New England Biolabs (NEB) has entered into collaborations with synthetic biology firms and academic research centers to accelerate isomorphic enzyme variant development, with a focus on expanding the range of isothermal amplification solutions. These agreements enable rapid scaling of novel enzyme formulations and support regulatory submissions in diverse geographies. Meanwhile, Promega Corporation has teamed with diagnostic device manufacturers to customize polymerase enzymes for point-of-care applications, capitalizing on the growing need for robust, room-temperature-stable reagents.

Global expansion remains a strategic imperative, with manufacturers investing in new production facilities and regional distribution hubs. In 2025, Merck KGaA (operating as MilliporeSigma in the US and Canada) announced the commissioning of an advanced enzyme manufacturing plant in Asia to meet surging demand from pharmaceutical and biotechnology customers. This move is complemented by localization strategies, such as establishing technical support centers in emerging markets and adapting supply chains to reduce lead times and regulatory hurdles.

Looking ahead, the competitive landscape for isomorphic polymerase enzyme manufacturing is expected to become even more dynamic over the next few years. Companies are likely to pursue further integration across the enzyme value chain, invest in digital infrastructure for enzyme discovery, and expand strategic alliances to access regional markets and cutting-edge innovation. The pace of M&A and partnership activity is set to continue, as global players seek to differentiate themselves in a rapidly evolving sector where scale, innovation, and agility are key competitive levers.

Challenges, Risks, and Mitigation Strategies

The manufacturing of isomorphic polymerase enzymes—a key class of biomolecular catalysts engineered for enhanced fidelity, processivity, and compatibility with synthetic nucleic acid analogs—faces distinct challenges and risks as commercial and clinical demand rises in 2025 and beyond. The sector’s rapid evolution, driven by applications in next-generation sequencing, diagnostics, and synthetic biology, places a premium on robust, scalable, and reproducible production processes.

  • Quality Control and Batch Consistency: Ensuring batch-to-batch consistency for isomorphic polymerases is particularly challenging due to the sensitivity of these enzymes to subtle variations in expression systems, purification protocols, and storage conditions. Leading manufacturers, such as New England Biolabs and Thermo Fisher Scientific, have highlighted the need for advanced in-process analytics and the implementation of rigorous quality assurance (QA) standards, including real-time monitoring of enzyme activity and contaminant profiles.
  • Raw Material Supply Chain Risks: The dependence on high-grade reagents, specialty resins, and custom expression systems exposes manufacturers to supply chain disruptions. In 2024 and 2025, the industry has observed increased lead times for fermentation media and chromatography materials—exacerbated by global logistics challenges and geopolitical tensions. Merck KGaA (MilliporeSigma) has responded by diversifying supplier bases and investing in dual sourcing strategies.
  • Regulatory Compliance: As isomorphic polymerases move toward more clinical and diagnostic applications, compliance with evolving regulatory standards (e.g., ISO 13485:2016 for medical devices) becomes more demanding. Manufacturers like Promega Corporation are expanding their quality management systems and investing in regulatory affairs expertise to ensure global market access.
  • Intellectual Property (IP) and Freedom to Operate: The highly innovative nature of isomorphic polymerase development leads to a crowded IP landscape, increasing the risk of infringement and litigation. Companies are responding by conducting thorough freedom-to-operate analyses and negotiating cross-licensing agreements.
  • Process Optimization and Scalability: Moving from laboratory-scale recombinant expression to industrial-scale fermentation and purification presents technical bottlenecks, such as low yields or loss of activity. QIAGEN and others are exploring continuous manufacturing and advanced bioreactor designs to mitigate scale-up risks and lower production costs.

Looking forward, the sector’s outlook depends on the successful integration of automation, advanced analytics, and supply chain resilience. Investment in digital manufacturing technologies, alongside strategic partnerships between manufacturers and suppliers, is expected to play a vital role in mitigating ongoing and emerging risks in isomorphic polymerase enzyme production.

Future Outlook: Opportunities, Disruptors, and Expert Perspectives

The landscape of isomorphic polymerase enzyme manufacturing is poised for significant evolution in 2025 and the coming years, shaped by technological innovation, emerging market opportunities, and regulatory developments. Isomorphic polymerases—engineered enzyme variants with enhanced fidelity, thermal stability, or novel substrate compatibility—are gaining traction in applications spanning clinical diagnostics, next-generation sequencing (NGS), and synthetic biology.

Opportunities in the sector are closely aligned with the growing demand for precision medicine and rapid molecular diagnostics. Companies such as New England Biolabs and Thermo Fisher Scientific are actively expanding their polymerase portfolios, investing in advanced enzyme engineering platforms and high-throughput screening. Recent data highlights increased adoption of isomorphic polymerases for direct-from-sample PCR and RNA detection, underscoring their commercial relevance in infectious disease testing and decentralized diagnostic workflows.

Synthetic biology is another key growth driver, with organizations like Twist Bioscience leveraging custom polymerases to improve DNA synthesis performance and fidelity. The intersection of machine learning and enzyme design, as pursued by Codexis, is expected to accelerate the generation of novel isomorphic polymerases tailored for specific biomanufacturing challenges—including resistance to inhibitors or compatibility with non-natural nucleotides.

However, several disruptors are shaping the future landscape. Intellectual property (IP) challenges related to proprietary polymerase variants remain prominent, especially as more players enter the field and the boundaries of enzyme engineering are tested. Regulatory scrutiny is intensifying, with agencies like the FDA and EMA signaling increased oversight on the use of engineered enzymes in clinical applications. Manufacturers are therefore prioritizing robust quality assurance, traceability, and compliance frameworks, as reflected in initiatives by QIAGEN and other leading suppliers.

Expert perspectives converge on the likelihood of continued consolidation among enzyme manufacturers, driven by the need for scale, portfolio breadth, and access to proprietary engineering technologies. Collaboration between academic groups, biotech startups, and established suppliers is projected to accelerate innovation, particularly in niche areas such as high-temperature polymerases or those enabling novel sequencing chemistries.

Looking ahead, the isomorphic polymerase enzyme manufacturing sector is expected to see robust growth, propelled by increasing adoption in decentralized diagnostics, synthetic biology, and high-throughput genomics. The interplay of technological advances, strategic alliances, and evolving regulatory frameworks will remain central to shaping competitive dynamics and unlocking new market opportunities through 2025 and beyond.

Sources & References

Unraveling the DNA Mystery Tiny Workers and Their Big Impact! 🧬

By Cozy Naylor

Cozy Naylor is a seasoned writer and thought leader in the fields of new technologies and fintech. With a Bachelor’s degree in Economics from Oxbridge University, Cozy combines academic rigor with a passion for exploring the transformative potential of emerging technologies. Their career includes significant experience at Tech Innovations, where they contributed to groundbreaking projects that bridged the gap between finance and technology. Cozy’s work focuses on the intersection of digital finance and consumer behavior, providing insightful analyses that help both industry professionals and general readers navigate the complexities of the fintech landscape. When not writing, Cozy enjoys engaging with tech communities and mentoring aspiring writers.

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Biotechnology Manufacturing Trends News Polymer Science

Why 2025 Marks a Turning Point for Isomorphic Polymerase Enzyme Manufacturing: Game-Changing Advances, Booming Demand, and What Experts Predict for the Next 5 Years

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