Company profile

PolyPeptide is a focused contract development and manufacturing organization (CDMO) specializing in the development and manufacturing of synthetic peptides and oligonucleotides used as active pharmaceutical ingredients (API) or intermediates in therapeutic products. It serves a diversified customer base of over 250 pharmaceutical and biotech companies around the world. It also produces a range of generic peptides and peptides used in cosmetics, animal health, and medical devices.

With a history of over 70 years and a strong manufacturing track record with over 1,000 distinct therapeutic peptides manufactured for customers, the Group has developed into a full-service drug substance provider with differentiated technologies and capabilities to support complex and innovative drug development projects.

As a CDMO, PolyPeptide is subject to comprehensive regulations, including current Good Manufacturing Practices (cGMP), to assure quality and to ensure the safety of patients. The Group runs a global network of six manufacturing sites in Europe, the United States of America, and India, with each of the sites subject to regular inspections by regulatory agencies and audits by its customers. All sites are cGMP certified, demonstrating suitable processes, methods, facilities, and controls.

Beyond the rigorous regulatory environment, PolyPeptide’s market is characterized by distinct structural factors that create high barriers to entry and high switching costs for customers. These factors include the specialized technical expertise and knowledge required to meet customer specifications in relation to quality, reliability and security of supply, the high capital intensity of manufacturing, and the importance of an established track record.

Business model

PolyPeptide provides its offering through its manufacturing sites and with a “start here – stay here” philosophy, covering the entire life cycle of a drug, starting with the customer’s pre-clinical drug development projects, followed by clinical phases through to commercialization. As a result, its customer relationships are typically strategic and long-term by nature.

PolyPeptide’s business model

Activities include process and analytical method development and stability studies as well as the production of API and intermediates. In addition, the Group provides its customers with regulatory documentation and support.

Revenue related to drug development projects results from the Group’s active custom projects pipeline and includes the manufacturing of non-cGMP material for pre-clinical studies and cGMP material for clinical phases. Once a drug has received regulatory approval, PolyPeptide recognizes related sales as commercial revenue.

PolyPeptide maintains a holistic quality system to ensure compliance with cGMP and adherence to applicable guidelines, including those from the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Market

According to Evaluate Pharma, the global peptide therapeutics market has been valued at approximately USD 45 billion in 2023 and is projected to reach approximately USD 130 billion by 2030 with a compound annual growth rate (CAGR) of above 10% from 2023 to 2030.

PolyPeptide believes that the main growth driver is the increasing demand for peptide-based therapies for metabolic disorders, in particular for the treatment of diabetes, obesity, and other co-morbidities. The advancement of hundreds of pre-clinical and clinical development projects in other therapeutic areas, including oncology, infectious diseases, orphan diseases, cardiovascular, neurology, or gastro-enterology applications, is expected to further complement the growth beyond metabolic disorders.

PolyPeptide has observed that the global drug development landscape remains increasingly focused on synthetic peptides with complex molecular structures and novel formulation technologies, including oral peptides. In addition, PolyPeptide has identified a strong trend towards outsourcing, particularly favoring western-based CDMOs due to customers’ geopolitical considerations.

According to the GlobalData drug database, accessed in January 2025, approximately 800 peptide drug projects (synthetic and recombinant) were in development, of which approximately 300 were in clinical development, with 70 in phase III or pre-registration. Based on third-party market reports, over 100 peptide-based therapies were approved by the US Food and Drug Administration (FDA) as at the end of 2024.

The addressable market for PolyPeptide is the outsourced market for synthetically manufactured peptide-based APIs and intermediates. It was estimated by PolyPeptide, based on public company reports from the financial year 2023, to be valued around USD 1.8 billion in 2023. Out of the approximately 800 peptide drug projects in development, approximately 80% are estimated to be synthetically manufactured.

Compared to the market for peptide-based therapeutics, the market for oligonucleotide-based therapeutics is at an earlier development stage. According to the GlobalData drug database, accessed in January 2025, approximately 900 oligonucleotide drugs were in development, of which approximately 200 were in clinical development. Based on third-party market reports, over 20 oligonucleotide-based therapies were approved by the FDA as at the end of 2024.

According to the GlobalData drug database, accessed in January 2025, the estimated market size for marketed oligonucleotide-based therapeutics is USD 5.1 billion in 2023, with an expected CAGR of around 20% until 2030. Within oligonucleotides, PolyPeptide focuses on the phosphorodiamidate morpholino oligonucleotides (PMOs) and the peptide-conjugated phosphorodiamidate morpholino oligonucleotides (PPMO) segments due to synergies with peptide manufacturing equipment and chemical processes.

Strategy

Vision, mission, values

PolyPeptide’s vision is to be the most innovative peptide CDMO by shaping the future of peptide drug manufacturing and contributing to the health of millions of patients across the world.

The Group’s mission is to help customers develop products, secure regulatory approvals, and successfully launch and commercialize their products by combining cGMP-compliant manufacturing practices with efficient and sustainable technologies.

Building on its values of “Innovation”, “Excellence” and “Trust”, PolyPeptide aims to be the preferred long-term partner for its customers throughout the entire drug life cycle.

Customers expect their CDMO to have deep scientific knowledge, technical expertise, and operational experience, demonstrating a relentless focus on quality and high delivery performance. PolyPeptide strives to meet and exceed these expectations.

Strategy update

During the course of 2024, PolyPeptide sharpened its growth strategy based on expected rapid market growth, its strong market position, and the large commercial agreements communicated in December 2022 and March 2024.

Building on its multi-site network, PolyPeptide’s strategy aims at strengthening both its foundations and competitive advantages:

1. The foundation consists of operational and quality excellence, industrial-scale capabilities, talent and working culture with a commitment to meeting the Group’s corporate responsibilities and sustainability objectives.
2. The competitive advantages center around innovation, with a focus on green chemistry and process intensification, superior pipeline development capabilities, and rapid and flexible capacity expansion that leverages the potential for modularity.

By executing its strategy, PolyPeptide seeks to offer its customers a distinctive value proposition that further differentiates it from competition. The Group’s strategy includes transformational elements to adapt to evolving customer needs and to enhance its industrial-scale capabilities. As a result, PolyPeptide strives to advance its peptide manufacturing practices through efficient and sustainable ways of working and new technologies.

PolyPeptide’s strategy

To execute its strategy, the Group remains committed to continually strengthening its core foundations:

Operational and quality excellence: PolyPeptide strives to meet customer requirements in terms of quality, quantity, and time. The design of operational and quality processes is key to reducing technical and business risks while meeting performance standards. PolyPeptide’s operational and quality excellence programs focus on optimizing production planning and execution, enhancing technical proficiency, and sharing best practices across the manufacturing network. Execution requires a continuous improvement mindset to achieve increased efficiency and capacity utilization.

Industrial scale capabilities: Given the strong demand and expected peptide therapeutics market growth, the industry needs to evolve its capabilities to satisfy large-scale manufacturing requirements. To accommodate the shift from laboratory- to industrial-scale production, PolyPeptide employs proprietary technology and integrated engineering (including improved process controls and enhanced automation) to drive productivity, safety, and sustainability.

Talent, culture, and ESG: As a CDMO focused on the development and manufacturing of synthetic peptides, PolyPeptide operates in a specialized field employing a highly educated workforce. By the end of 2024, 63% of its employees held academic degrees and 7% held PhDs in various relevant fields, including in chemistry and engineering. The talent agenda is further focused on enhancing the organization with industrial-scale manufacturing and commercial capabilities. Furthermore, the Group adheres to fundamental principles of business ethics, corporate responsibility, and compliance and integrates relevant criteria into its strategy and operations to cultivate sustainable value creation over the long term.

Building on these core foundations, PolyPeptide aims to achieve excellence through its competitive advantages:

Innovation: PolyPeptide is focused on innovative manufacturing technologies. Its green chemistry agenda aims to improve environmental sustainability by optimizing the use of hazardous solvents in production. The importance of PolyPeptide’s green chemistry agenda is further fueled by the growing volume of products and the increasing complexity of their structures. In addition, PolyPeptide is focused on process intensification programs to enhance production throughput and optimize yield, speed, and reaction capacity.

Development: PolyPeptide strives to offer customers superior manufacturing processes and analytical methods, focused on providing tailored support to achieve desired capacity requirements. With more than 70 years of manufacturing experience, PolyPeptide’s regarded development capabilities stem from its (i) agile mindset, attentive to evolving customer needs, (ii) strong customer proximity via its multi-site network, and (iii) ability to build long-term trusted relationships. These strengths are reflected in PolyPeptide’s rich pipeline of active custom projects and commercial products with large exposure to GLP-1 and the metabolic opportunity.

Modularity: Through a standardized modular approach, PolyPeptide seeks to optimize speed, flexibility, and output. A standardized modular approach is intended to accelerate time to market while enhancing flexibility to ensure high utilization. Compared to large-scale infrastructure projects, a modular expansion is expected to carry lower execution and operational risk. The potential of modularity is intended to provide customers with reliable capacity, timely scalability, and flexible manufacturing options to support their supply chain and growth strategies.

PolyPeptide is implementing its growth strategy across its global network of six cGMP- certified manufacturing sites. The presence in Europe, the United States of America, and India allows for customer proximity and flexibility. As part of its strategy, PolyPeptide is advancing its capacity expansion roadmap with targeted capex investments. In 2024, it started production of the large-scale SPPS capacity in Braine-l’Alleud, Belgium. In addition, the Group started the construction work to double SPPS capacity in Malmö, Sweden, combining the proprietary manufacturing technology and integrated engineering design already deployed in Braine-l’Alleud with the potential of modularity.

The Group maintains a Global Balanced Scorecard to support the implementation of its strategy and operational plans. In addition to the financial targets for a given period, the scorecard includes ESG performance objectives.

For more details, refer to the Corporate Responsibility Report and the Remuneration Report. For the review of the financial and operational performance, including the guidance for 2025, refer to the Business Review.

Mid-term outlook

With its strategy, PolyPeptide targets to double revenue reported for 2023 by 2028. Revenue growth projections are supported by commitments and supply forecasts of existing customers.

Profitability is expected to approach an EBITDA margin of 25% by 2028, driven by growth initiatives, improving profitability in the existing base business with higher asset utilization and efficiency as well as operating leverage.

Capital expenditures of 15% to 20% of revenue are required to ensure capacity also beyond 2028. PolyPeptide plans to expand manufacturing capacity in an efficient way, capitalizing on its existing multi-site network and proprietary technology to maximize manufacturing throughput.

PolyPeptide plans to build additional capacity in phases in line with specific customer projects and their growth trajectory. The phasing of the capacity being made available is expected to result in an uneven year-on-year growth in revenue and operational expenses, impacting profitability for a given period.

PolyPeptide’s guidance and mid-term outlook assumes, inter alia, no unexpected adverse events.