Peptide Biotherapeutics Boom: Discover the High-Growth Surprises Shaping 2025-2029

Executive Summary: Defining the New Era in Peptide Biotherapeutics
2025 Market Snapshot: Size, Growth Drivers, and Competitive Landscape
Emerging Manufacturing Technologies: From Solid-Phase Synthesis to AI-Driven Optimization
Pipeline Insights: Leading Peptide Candidates and Late-Stage Breakthroughs
Key Players and Strategic Partnerships: Company Profiles and Official Insights
Regulatory Landscape: 2025 Updates and Global Compliance Pathways
Market Forecasts Through 2029: Growth Sectors, Geographies, and Revenue Projections
Challenges in Scalability, Purity, and Cost: Solutions from Industry Leaders
Investment Trends and Funding: Where Capital Is Flowing in Peptide Production
Future Outlook: Transformative Technologies and Disruptive Opportunities Ahead
Sources & References

Executive Summary: Defining the New Era in Peptide Biotherapeutics

Peptide-based biotherapeutics are poised to redefine therapeutic paradigms in 2025 and beyond, driven by advances in synthesis, purification, and scalable manufacturing. These therapeutics, which include peptide hormones, analogs, and peptide–drug conjugates, offer high specificity, favorable safety profiles, and the ability to address previously untreatable conditions. The modern era is characterized by integration of automated solid-phase peptide synthesis (SPPS), enhanced downstream processing, and increasing regulatory harmonization, all contributing to robust, GMP-compliant production pipelines.

In 2025, leading peptide CDMOs and biopharmaceutical companies are expanding capacity and adopting innovative production technologies. Bachem Holding AG, a global leader in peptide manufacturing, has announced significant investments in large-scale SPPS reactors, automation, and green chemistry approaches to meet rising market demand for clinical and commercial peptides. Similarly, PolyPeptide Group is scaling up operations in both Europe and North America, focusing on process intensification and high-purity peptide APIs for advanced therapeutics.

Continuous manufacturing and process analytical technology (PAT) are being rapidly implemented to improve reproducibility and reduce batch-to-batch variability. Companies such as CordenPharma have invested in continuous-flow peptide synthesis and advanced purification systems, which are expected to shorten production cycles and lower costs while maintaining stringent quality standards. These advancements are essential as the complexity of peptide-based drugs increases, particularly with the advent of multi-functional peptides and conjugates.

From a regulatory perspective, harmonized guidelines from agencies such as EMA and FDA are facilitating global market access and ensuring product quality, further encouraging investment in peptide biotherapeutics. The increasing prevalence of chronic diseases, demand for personalized medicine, and a growing pipeline of peptide-based candidates underscore the sector’s robust outlook.

Looking ahead, the next few years will see further integration of digital tools, AI-driven process optimization, and sustainable manufacturing practices. The sector’s trajectory is marked by strategic collaborations, facility expansions, and a surge in late-stage clinical peptide therapeutics, positioning peptide-based biotherapeutics production as a cornerstone of innovative medicine in this new era.

2025 Market Snapshot: Size, Growth Drivers, and Competitive Landscape

The global peptide-based biotherapeutics production sector is set for robust growth in 2025, reflecting continued advancements in drug delivery systems, manufacturing technologies, and expanding clinical pipelines. Peptide therapeutics have gained significant traction due to their high specificity, efficacy, and favorable safety profiles, making them essential in areas such as oncology, metabolic disorders, and rare diseases.

A notable driver in 2025 is the accelerated development and commercialization of peptide drugs across major markets, with more than 80 peptide-based therapeutics approved worldwide and over 150 in late-stage clinical trials. Leading manufacturers such as Bachem Holding AG and Polypeptide Group are actively expanding production capacities to meet rising demand. For instance, Bachem has recently invested in large-scale GMP manufacturing facilities, aiming to increase output and support the growing number of commercial peptide APIs, while Polypeptide Group reported ongoing facility expansions in both Europe and the United States to address the surge in customer projects.

The market’s competitive landscape is marked by both established players and new entrants. Companies such as Novo Nordisk continue to lead with blockbuster peptide-based drugs like semaglutide for diabetes and obesity, which have seen record sales and prompted further investments in production infrastructure. Biotech innovators and CDMOs are also introducing novel synthesis methods, including solid-phase peptide synthesis (SPPS) and continuous manufacturing, to improve scalability and reduce costs. Lonza, for example, has announced expanded peptide manufacturing services, integrating advanced analytical tools to support faster process development and regulatory compliance.

Geographically, North America and Europe remain dominant in both R&D and commercial production, supported by a mature regulatory environment and significant investments. However, Asia-Pacific is rapidly emerging, with companies like CPC Scientific expanding manufacturing operations in China to serve both local and global pharmaceutical partners.

Looking ahead, the outlook for 2025 and the following years is highly favorable. Growth is projected to be fueled by continued approvals of innovative peptide-based drugs, expansion of contract manufacturing services, and integration of digital technologies for process optimization. The sustained commitment from key industry leaders to invest in capacity, technology, and global reach is likely to intensify competition and drive further consolidation and strategic partnerships within the sector.

Emerging Manufacturing Technologies: From Solid-Phase Synthesis to AI-Driven Optimization

The landscape of peptide-based biotherapeutics production is experiencing rapid transformation in 2025, propelled by advances in both established and emerging manufacturing technologies. Solid-phase peptide synthesis (SPPS), pioneered by Bruce Merrifield, remains a cornerstone, enabling high purity and scalability, but its limitations—such as reagent consumption and aggregation with longer sequences—have spurred innovation. Companies like Bachem and Polypeptide Group have invested substantially in automating SPPS platforms, integrating real-time monitoring and in-line analytics to minimize batch variability and improve yields. These investments cater to the rising demand for complex peptides, such as cyclic or stapled variants, used in oncology and metabolic disorders.

Continuous-flow chemistry is gaining traction as a complementary approach, particularly for large-scale or more challenging peptide assemblies. In 2025, CordenPharma has expanded its continuous manufacturing capabilities, enabling greater process control, shorter production cycles, and reduced solvent usage. Such advancements address both economic and environmental sustainability, aligning with the biopharmaceutical sector’s increasing focus on green chemistry.

Meanwhile, the integration of artificial intelligence (AI) and machine learning is redefining process development and optimization. AI algorithms are now routinely employed to predict optimal synthesis routes, reagent combinations, and purification protocols, drastically reducing experimental cycles. Lonza has reported success in using digital twins and predictive analytics to streamline the production of peptide APIs, allowing for rapid scale-up from bench to commercial manufacturing. These digital tools also facilitate proactive quality control, predicting potential failure points and enabling real-time troubleshooting.

On the analytical front, advances in high-resolution mass spectrometry and automated chromatography systems enable real-time release testing, a shift embraced by leading CDMOs to accelerate time-to-market. Thermo Fisher Scientific continues to launch instrumentation tailored for peptide analytics, supporting both characterization and regulatory compliance.

Looking forward, the convergence of these technologies is anticipated to further lower production costs, improve consistency, and allow for the rapid introduction of novel peptide modalities targeting previously “undruggable” targets. With regulatory agencies encouraging the adoption of innovative manufacturing (e.g., continuous processes and real-time analytics), the sector is poised for accelerated growth and diversification in the coming years.

Pipeline Insights: Leading Peptide Candidates and Late-Stage Breakthroughs

The peptide-based biotherapeutics pipeline is expanding rapidly in 2025, with several late-stage candidates poised to reshape the treatment landscape across oncology, metabolic disorders, and infectious diseases. Technological advancements in synthesis, purification, and formulation have enabled the development of increasingly complex peptides with enhanced stability, bioavailability, and target specificity.

Among the notable late-stage candidates, Amgen is advancing AMG 133, a multispecific peptide targeting both GLP-1 and GIP receptors, designed for obesity and type 2 diabetes. Phase 2 clinical data released in late 2024 demonstrated robust weight loss efficacy and a favorable safety profile, potentially positioning AMG 133 as a first-in-class treatment when pivotal Phase 3 results become available in 2025. In oncology, Pfizer is progressing PF-06863135, a peptide-drug conjugate for solid tumors, which harnesses targeted delivery to improve efficacy while minimizing off-target toxicity.

In infectious diseases, Polyphor recently completed a Phase 3 trial of murepavadin, a first-in-class outer membrane protein-targeting peptide antibiotic for drug-resistant Pseudomonas aeruginosa infections. This achievement underscores the growing role of peptides as critical tools against antimicrobial resistance. Meanwhile, Novartis is leveraging its proprietary peptide platform to accelerate candidates for cardiovascular and metabolic diseases, with several compounds expected to enter late-stage clinical trials by 2026.

Manufacturing innovation remains a cornerstone of pipeline progression. Companies like Bachem and Lonza are scaling up solid-phase peptide synthesis (SPPS) and introducing continuous manufacturing technologies to meet the increasing demand for high-purity, large-scale peptide APIs. These efforts are expected to reduce production costs and improve supply chain reliability for late-stage and commercialized peptides over the next few years.

Looking forward, the peptide therapeutics sector is anticipated to see a significant uptick in regulatory submissions and potential launches through 2026. The integration of artificial intelligence and machine learning into peptide design and optimization, as evidenced by collaborations between industry players and digital technology firms, is expected to further expand the range of druggable targets and accelerate the entry of next-generation peptides into the clinic.

Key Players and Strategic Partnerships: Company Profiles and Official Insights

The peptide-based biotherapeutics sector continues to be shaped by established industry leaders and dynamic partnerships, with a focus on innovation, scalability, and global expansion. As of 2025, several key companies have demonstrated a sustained commitment to advancing peptide drug development, manufacturing, and commercialization, often through strategic alliances and investments in cutting-edge technologies.

Key Players: Bachem Holding AG remains a global leader in peptide synthesis and biotherapeutics production, leveraging decades of expertise and expanding its capacity with new facilities, such as its large-scale production site in Switzerland. Bachem’s collaborations with pharmaceutical partners have facilitated the commercial supply of peptides for both approved drugs and pipeline candidates. Lonza Group AG is another dominant force, offering integrated peptide manufacturing services from clinical to commercial scale, and investing heavily in process automation and capacity expansion to address growing market demand for complex peptide APIs.

PolyPeptide Group has further consolidated its position by expanding its global manufacturing footprint, including investments in GMP facilities in the US and Europe. The company’s partnerships with biopharma innovators have enabled the rapid development and scale-up of novel peptide therapeutics, particularly in oncology and metabolic diseases. CordenPharma and AmbioPharm Inc. also play prominent roles, focusing on custom peptide synthesis and the development of specialized manufacturing technologies to enhance yield and purity.

Strategic Partnerships and Collaborations: The peptide therapeutics landscape is increasingly collaborative, with CDMOs forming alliances with biotech startups and major pharma companies. In 2023-2025, Bachem Holding AG announced multiple joint development partnerships aimed at accelerating clinical translation of next-generation peptide drugs, including collaborations on peptide-drug conjugates and depot formulations. Lonza Group AG has also formed strategic alliances with emerging biotechs, supporting them from early-phase development through to commercial launch with a full suite of manufacturing and analytical services.

Outlook: Looking ahead to the next several years, industry players are poised to meet rising demand for peptides used in chronic disease management, rare diseases, and cancer immunotherapy. Continued investment in automation, continuous manufacturing, and green chemistry is expected to improve efficiency and sustainability. The sector is likely to see further consolidation and cross-border alliances as companies seek to expand their capabilities and geographic reach, ensuring robust supply chains and access to new markets.

Regulatory Landscape: 2025 Updates and Global Compliance Pathways

The regulatory landscape for peptide-based biotherapeutics production in 2025 is experiencing significant evolution as agencies worldwide adapt to the sector’s growing complexity and innovation. Peptide therapeutics, due to their unique structural and functional characteristics, require tailored regulatory approaches distinct from traditional small molecules and biologics. Regulatory authorities are updating guidance documents and frameworks to accommodate advances in synthesis, characterization, and manufacturing.

In the United States, the U.S. Food and Drug Administration (FDA) continues to refine its expectations for peptide drugs, emphasizing the need for robust analytical methods, impurity profiling, and solid documentation of peptide synthesis routes. The FDA’s Office of Pharmaceutical Quality has recently highlighted the importance of demonstrating process consistency for both synthetic and recombinant peptides, with increased scrutiny on critical quality attributes (CQAs) and the control of process-related impurities.

In the European Union, the European Medicines Agency (EMA) is updating its guidance on biological active substances, including synthetic and recombinant peptides. The EMA’s revised guidelines, anticipated for full adoption by mid-2025, place emphasis on comparability protocols for changes in manufacturing processes and greater transparency in the characterization of post-translational modifications. These changes reflect ongoing collaboration between regulatory bodies and industry to ensure product quality, safety, and efficacy.

Global harmonization efforts are also intensifying. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has been working on harmonized guidelines relevant to peptides, particularly regarding impurities (ICH Q3A/B) and analytical method validation (ICH Q2). These guidelines are expected to influence regulatory submissions and inspections across major markets in the coming years.

In Asia, regulatory agencies such as Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and the National Medical Products Administration (NMPA) in China are aligning more closely with ICH standards for peptide-based products. Both agencies have launched new initiatives for expedited review and approval of innovative peptide therapeutics, with pilot programs aimed at streamlining Good Manufacturing Practice (GMP) inspections and lot release procedures.

Increased digitalization of regulatory submissions is expected, with agencies adopting cloud-based dossier review systems and automated data checks to improve efficiency.
Manufacturers are responding by investing in advanced analytics, continuous manufacturing, and automated quality control to meet evolving compliance demands.
Global regulatory convergence is projected to reduce time-to-market for peptide biotherapeutics, particularly for multi-region launches.

Overall, 2025 marks a pivotal year for regulatory modernization, with agencies and industry stakeholders working together to ensure that peptide-based biotherapeutics reach patients safely and efficiently worldwide.

Market Forecasts Through 2029: Growth Sectors, Geographies, and Revenue Projections

The global peptide-based biotherapeutics production sector is experiencing significant momentum as of 2025, driven by increasing adoption in oncology, metabolic disorders, and rare diseases. According to leading biopharmaceutical manufacturers, the demand for synthetic and recombinant peptides is projected to rise steadily through 2029, underpinned by the expanding pipeline of clinical candidates and approvals for peptide-based drugs. For example, Lonza and Bachem, two of the foremost peptide contract development and manufacturing organizations (CDMOs), have each reported robust growth in peptide production capacity and investments in new manufacturing technologies.

Growth sectors within peptide-based biotherapeutics production are most pronounced in oncology, diabetes, and obesity therapies. The recent approvals of peptide drugs targeting GLP-1 receptors for diabetes and weight management have catalyzed a surge in manufacturing requirements, with companies such as Novo Nordisk and Eli Lilly and Company expanding their production capabilities to meet global demand. Moreover, the increasing prevalence of rare diseases and orphan indications is fueling the development of highly specialized peptide therapeutics, as evidenced by ongoing collaborations between biotechs and CDMOs.

Geographically, North America and Europe are expected to maintain leadership in both innovation and production capacity, owing to a concentration of advanced manufacturing facilities and regulatory expertise. However, Asia-Pacific is emerging as a rapidly growing region, with countries such as China, India, and South Korea investing heavily in peptide synthesis infrastructure and regulatory alignment. CordenPharma and Peptide Sciences have announced recent expansions in these markets to support local and global clients.

Revenue projections through 2029 remain strong, buoyed by the growing number of commercialized peptide drugs and late-stage clinical candidates. As per recent corporate statements, both Bachem and Lonza anticipate double-digit percentage growth in peptide production revenues over the next several years, with substantial investments in high-throughput solid-phase synthesis and continuous manufacturing platforms. The industry outlook also points to increasing adoption of green chemistry and automation to improve cost-efficiency and scalability.

In summary, the peptide-based biotherapeutics production market is poised for robust expansion through 2029, led by advances in production technologies, strong therapeutic demand, and global expansion of manufacturing capabilities. The sector’s outlook is further strengthened by ongoing partnerships between large pharma, specialized CDMOs, and regional biotech innovators.

Challenges in Scalability, Purity, and Cost: Solutions from Industry Leaders

The landscape of peptide-based biotherapeutics production in 2025 is marked by both persistent challenges and innovative industry responses, particularly in scalability, purity, and cost. As demand for therapeutic peptides grows in oncology, metabolic disorders, and infectious diseases, manufacturers are under pressure to deliver high-quality products at industrial scale without compromising economic feasibility.

Scalability has traditionally been limited by the complexity of solid-phase peptide synthesis (SPPS), which can be resource-intensive and less efficient for longer peptides. In response, leading companies are adopting hybrid synthesis approaches and continuous manufacturing platforms. For example, Bachem Holding AG has invested in large-scale SPPS reactors and automated process controls, enabling multi-kilogram batch production with improved yield and reproducibility. Similarly, PolyPeptide Group has expanded its global facilities, integrating high-throughput and modular production lines to support increasing market demand through 2025.

Purity is another critical challenge, as even trace impurities can impact the safety and efficacy of peptide therapeutics. Advanced purification technologies, such as preparative high-performance liquid chromatography (HPLC) and novel membrane filtration systems, are being widely implemented. Lonza Group Ltd reports the use of multi-dimensional HPLC and orthogonal analytical techniques to ensure compliance with stringent regulatory standards for clinical-grade peptides. Furthermore, the integration of process analytical technology (PAT) enables real-time monitoring and control of critical quality attributes, minimizing batch-to-batch variability.

Cost reduction remains a key focus area, as peptide drug production is often more expensive than small-molecule synthesis due to raw material costs and process complexity. To address this, manufacturers are embracing green chemistry and solvent recycling, as well as optimizing synthesis routes for higher atom economy. CordenPharma highlights the use of microwave-assisted synthesis and proprietary resin technologies to reduce solvent consumption, reaction times, and overall manufacturing costs. Additionally, strategic collaborations between peptide manufacturers and pharmaceutical companies are facilitating process innovations and supply chain efficiencies, further driving down costs.

Looking ahead, ongoing investments in digitalization, automation, and sustainable manufacturing promise to further alleviate these production bottlenecks. Industry leaders are expected to set new benchmarks in scalable, cost-effective, and high-purity peptide biotherapeutics by harnessing next-generation technologies through 2025 and beyond.

Investment Trends and Funding: Where Capital Is Flowing in Peptide Production

The peptide-based biotherapeutics sector has seen a surge of investment activity in 2024 and into 2025, reflecting heightened interest in the therapeutic potential of peptides for addressing diverse conditions, including metabolic disorders, oncology, and infectious diseases. Capital inflows are being directed toward both established manufacturing players and emerging biotech firms, with a notable emphasis on scaling up production capacity, advancing novel synthesis technologies, and expanding clinical pipelines.

Several key manufacturers have announced significant capital expenditures aimed at increasing peptide production capabilities. In January 2025, Bachem Holding AG, a leading global supplier, disclosed an investment of over CHF 500 million through 2027 to expand its facilities in Switzerland and the United States, targeting both solid-phase and liquid-phase peptide synthesis. The company cited robust demand from pharmaceutical partners and a growing pipeline of peptide-based drugs in clinical development as key drivers.

Similarly, Lonza Group announced in April 2024 the expansion of its peptide manufacturing site in Visp, Switzerland, aiming to double its peptide API output capacity by 2026. This investment is designed to address increasing market demand for complex and long-chain peptides, including those used in GLP-1 analogs and other metabolic therapies. Lonza’s strategy includes integrating advanced purification and analytical technologies to streamline production and ensure regulatory compliance.

Private and venture capital funding is also flowing to innovative startups employing new synthesis and optimization technologies. Peptone secured $40 million in Series B funding in late 2024 to accelerate its AI-driven peptide discovery platforms, underscoring investor confidence in computational approaches to peptide design and manufacturability.

Strategic partnerships and joint ventures are further shaping the investment landscape. In 2025, Evotec SE entered a multi-year collaboration with Alkermes to co-develop next-generation peptide therapeutics, pooling resources for both R&D and large-scale manufacturing infrastructure.

Looking ahead, the outlook for peptide-based biotherapeutics production is marked by continued capital inflows, driven by the expanding clinical success of peptide drugs and rising demand for scalable, high-purity manufacturing. Investors are expected to focus on companies with robust technological capabilities, regulatory track records, and the agility to respond to evolving therapeutic needs over the next several years.

Future Outlook: Transformative Technologies and Disruptive Opportunities Ahead

The landscape of peptide-based biotherapeutics production is poised for significant transformation in 2025 and the coming years, driven by advancements in synthesis technologies, automation, and manufacturing scalability. Peptides have emerged as a critical class of therapeutics due to their specificity, potency, and generally favorable safety profiles. The increase in FDA approvals for peptide drugs in recent years underscores their growing clinical importance, with more than 80 peptide drugs currently on the market and hundreds in clinical development.

Key players in the sector are investing in next-generation synthesis platforms to address challenges of cost, purity, and large-scale production. Companies such as Bachem and CordenPharma have announced expansions of their manufacturing capacities, including new facilities and automation technologies designed to support the expected surge in demand for peptide APIs and finished products. These expansions will enable gram-to-multikilogram scale production, a necessity for both clinical and commercial supply.

Technological innovation is driving the sector forward. Solid-phase peptide synthesis (SPPS) remains central, but new techniques such as continuous flow synthesis and hybrid chemical-enzymatic methods are being piloted for enhanced efficiency and sustainability. Bachem has reported success with automated continuous peptide manufacturing, reducing lead times and minimizing waste compared to batch processes. Additionally, companies like PolyPeptide Group are integrating real-time analytics and digital process control, aiming for higher consistency and regulatory compliance.

Another transformative trend is the increased focus on green chemistry and environmentally sustainable production methods. With regulatory pressures mounting, manufacturers are adopting solvent recycling and process intensification strategies to minimize environmental impact. Lonza has publicly committed to improving the sustainability of its peptide production, investing in process innovations that reduce both resource consumption and waste generation.

Looking ahead, the convergence of automation, AI-driven process optimization, and advanced analytical technologies is expected to further disrupt traditional peptide manufacturing paradigms. The advent of personalized peptide therapeutics, particularly in oncology and immunology, will require highly flexible and rapid manufacturing platforms. Collaborative initiatives between biopharma companies and technology providers are accelerating the adoption of these transformative capabilities. With robust pipelines and investment in production infrastructure, the sector is well-positioned to meet both the growing volume and complexity of peptide-based therapies over the next several years.

Sources & References

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2025’s Peptide-Based Biotherapeutics Revolution: What’s Powering the Next Wave of Breakthroughs and Market Expansion? Get Ahead of the Curve With Key Trends, Forecasts, and Innovations.

ByQuinn Parker