The global cytotoxic drugs market has been witnessing steady growth over the past few years due to increasing cancer prevalence and rising demand for targeted therapies. While large pharmaceutical companies have their in-house manufacturing facilities to cater to this demand, contract manufacturing is emerging as a viable option to supplement their capabilities and stay ahead of the competition.
Market Landscape
As per recent studies, the global cytotoxic drugs market size was valued at over $35 billion in 2020 and is projected to grow at a CAGR of 6-8% through 2028. This rapid growth has opened up lucrative opportunities for contract manufacturing organizations (CMOs) that can offer development and commercial manufacturing services for cytotoxic drugs at scale.
Currently, the major categories in cytotoxic drug manufacturing include alkylating agents, antimetabolites, plant alkaloids and terpenoids, topoisomerase inhibitors, and others. Among these, alkylating agents accounted for the largest market share of over 30% in 2021 due to the dominance of generic drugs like cyclophosphamide and cisplatin. However, newer targeted therapies like monoclonal antibodies, antibody-drug conjugates and small molecule therapies are expected to gain traction in the coming years.
Regulatory Landscape
Being medicinal products used for the treatment of cancer, cytotoxic drugs undergo stringent regulations and demand high purity, quality and sterility. Manufacturing of these life-saving drugs requires specialized facilities, equipment and know-how that meet current Good Manufacturing Practices (cGMP) stipulated by regulatory agencies like the FDA, EMA, etc.
CMOs operating in this space need to obtain specialized approvals and certifications to provide contract services. There are additional requirements for sterile drug products and controls on hazardous waste disposal. Manufacturers also need to follow guidelines on occupational safety and handle dangerous raw materials and intermediates carefully. With regulatory oversight increasing globally, being compliant to quality standards is imperative.
Capabilities Required
Given the complexity involved, cytotoxic drug manufacturing requires sophisticated capabilities across the entire value chain under one roof. Some of the key areas that CMOs need to focus on include:
- Active Pharmaceutical Ingredient (API) Manufacturing: Capabilities for small molecule API synthesis include process R&D, scale-up, commercial manufacture and characterization for impurity profiling.
- Fill/Finish Operations: Highly sterilized facilities for filling vials/ampoules, lyophilization, inspection, packaging and labeling of oncology injectables.
- Analytical Development and Quality Control: Equipped labs for physicochemical analysis, impurity profiling, sterility testing, particle size analysis, etc.
- Stability Studies: Stability chambers and programs to monitor drug product stability over time as per protocols.
- Supply Chain Management: Effective management of raw materials, logistics, inventory and distribution to several markets globally.
- Tech Transfer: Ability to seamlessly adopt clients' manufacturing processes and ensure compliance.
Ready access to such complex capabilities allows CMOs to undertake client projects from early clinical to commercial stages.
Market Leaders
A few leading CMOs have established strong market positions by making long-term investments to build advanced cytotoxic capabilities.
- Lonza: A global leader with 9 manufacturing sites for oncology injection manufacture including aseptic fill/finish and lyophilization.
- Samsung Biologics: A fully-integrated player with multi-product facilities approved by global authorities like FDA and EMA.
- Catalent: Specialized in cytotoxic APIs, clinical supplies manufacture and offers specialized technology like oseltamivir phosphate synthesis.
- Siegfried: Provides integrated services including process optimization, analytical validation and commercial supplies for Europe and U.S. markets.
- Recipharm: One of the largest CDMOs with specialized sterile injectables facilities across Europe and Oral Solid Dosage facilities in India.
These CMOs have enabled several large pharma innovators to launch critical cancer drugs while supplementing their own internal capacities at key junctures.
Outsourcing Trends
The complex nature of cytotoxic drug development and manufacturing has led to a few notable outsourcing trends over the past decade:
- Increasing Outsourcing of Commercial Activities: Large pharma players now outsource up to 30-50% of their commercial cytotoxic drug supplies to a few strategic CMO partners.
- Rising Contract Sterile Injectables Manufacturing: Areas like fill/finish see higher outsourcing ratios of 70-80% as these require substantial long-term investments.
- Emerging Markets Focus: Localized supply agreements in high growth regions like Asia, Latin America to ensure affordability and access.
- Multi-Site Approval Models: CMOs focusing on an integrated ‘multi-site model’ for supply security, dual sourcing via different geographies.
- Technology Transfer Expertise: Established CMOs are increasingly selected to seamlessly take over new product transfers from innovators.
The outsourcing pie is expected to further expand to 60-70% of commercial volumes in the near future as patent cliffs loom and cost pressure increases in R&D. CMOs are well-positioned to leverage emerging opportunities in this critical space.
Future Prospects
Bolstered by a flourishing oncology pipeline and the increasing dominance of biologics, the cytotoxic drugs market shows no signs of slowing down. This represents a massive opportunity for large CMOs to cement long-term partnerships and aggressively invest in capacity expansion. Some of the key areas that can drive future growth include:
- Monoclonal Antibody - Drug Conjugates: With approvals of ADCETRIS and KADCYLA, this class is witnessing rapid uptake.
- Cell and Gene Therapies: While still experimental, CMOs are prepping expertise to handle the next wave of advanced therapies.
- Regional Capacity Increases:especially markets like India and China experiencing a rise in local production to serve their populations at affordable costs.
- Contract Development capabilities: Integrating clinical-stage services to offer ‘end-to-end’ solutions versus standalone manufacturing.
- Advanced Analytics capabilities: Data-driven quality oversight, predictive monitoring via real-time release and PAT.
The massive R&D pipeline and rise of precision oncology will sustain pharmaceutical outsourcing in the long-term. With specialized investments, established CMOs stand to significantly gain market share by emerging as true end-to-end partners.
