According to Nova One Advisor, the global high potency API contract manufacturing market size was estimated at USD 8.15 billion in 2024 and is expected to hit around USD 23.00 billion by 2034, poised to grow at a CAGR of 10.93% from 2024 to 2034.
High Potency API Contract Manufacturing Market Key Takeaways:
• The innovative segment dominated the market with a share of 72.4% in 2024.
• The oncology segment dominated the market in 2024 and is projected to witness significant growth during the forecast period.
• The synthetic segment dominated the market in 2024.
• The injectables segment dominated the market share of 51.0% in 2024 owing to rapid delivery of HPAPI to the target location.
• North America high potency API contract manufacturing market dominated globally with a market share of 38.0% in 2024.
The market is majorly attributed to the rising prevalence of chronic conditions including cancer, which is rising demand for targeted therapies and drugs. Rising advancements in high potency API manufacturing technologies are further anticipated to drive the market. The high potency API contract manufacturing market deals with compounds that elicit a biological response at a very low dose. Highly potent drugs represent a growing proportion of medicines, such as therapies in development and those that are commercially available.
The increasing number of regulators globally is creating greater emphasis on the design to improve multi-product procedures including high-potency APIs to reduce the risk of cross-contamination. This trend has led to stringent cleaning and validation needs for contract developers, which many companies are meeting by adopting single-use technologies and systems.
Furthermore, contract manufacturers are rapidly estimated to adopt engineering controls rather than solely based on standard work practices and personal proactive equipment to minimize exposure to high potency APIs. These regulatory shifts have significantly driven the production of HPAPIs across contract manufacturers, thereby accelerating the market growth.
In addition, the expiration of subsequent patent launches of generic versions is a main drive for pharmaceutical companies to enter attractive markets and extend their product portfolios in this technology-fueled industry. Furthermore, the rising ongoing attempts to replicate branded biological medications and increased research and development activities are playing the major role in the market. Various major pharmaceuticals are expected to lose their patent protection and create new opportunities in the high potency API contract manufacturing market.
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Growth Factors
• The rising research and development activities, combined with rising investments by pharmaceutical companies, are driving the development of high-potency APIs.
• The increasing focus of major market players to expand and invest their service offerings in several locations is expected to drive market growth.
• The technological developments in high-potency API production, a greater emphasis on precision medicine, and increasing demand for pharmaceuticals are anticipated to drive the market growth.
• The rising robust pipeline of Targeted Therapeutic Medications and the increasing need for outsourcing HPAPI manufacturing is further expected to enhance the high potency API contract manufacturing market during the forecast period.
High Potency API Contract Manufacturing Market Report Scope
|
Report Attribute |
Details |
|
Market size value in 2025 |
USD 9.04 Billion |
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Revenue forecast in 2034 |
USD 23.00 Billion |
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Growth rate |
CAGR 10.93% from 2024 to 2034 |
|
Actual data |
2019 - 2022 |
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Forecast period |
2024 - 2034 |
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Quantitative units |
Revenue in USD million/billion, and CAGR from 2024 to 2034 |
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Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
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Segments covered |
Product, Application, Synthesis, Dosage Form, Region |
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Regional scope |
North America, Europe, Asia Pacific, Latin America, MEA |
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Country scope |
U.S.; Canada; Mexico; UK; Germany; France; Italy; Spain; Denmark; Sweden; Norway; Japan; China, India, South Korea, Thailand, Australia; Brazil; Argentina; South Africa; Saudi Arabia; UAE; Kuwait. |
|
Key companies profiled |
Piramal Pharma Solutions; Lonza, Catalent, Inc.; VxP Pharma, Inc.; Pfizer CentreOne, Gentec Pharmaceutical Group; AbbVie; Aurigene Pharmaceutical Services Ltd.; CordenPharma International; Curia Global, Inc. |
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Customization scope |
Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country, regional & segment scope. |
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The future of HPAPIs and ultra-high potency APIs
The ongoing demand for better, more targeted treatments and therapies for cancer and other diseases is pushing not only the growth for services, but also the nature of HPAPIs to become ultra-high potency APIs. Some therapeutics, including ADC toxins and certain medicinally used psychedelics, can have extremely high levels of potency based on clinical microdosing. This requires especially high levels of containment and, in the case of psychedelics, the additional security infrastructure, systems, and licensing necessary to handle controlled substances.
Containment for these ultra-high potency APIs can go down to the single-digit nanogram or picogram levels, much lower than those of typical mid-range HPAPIs. Outsourcing is even more prevalent for these materials, as even organizations that are equipped to handle typical HPAPIs may not have the high levels of containment required to support these compounds.
The typical compounds that fall into this level of potency can usually be classified as either cytotoxic or and genotoxic, and when handling such materials, it is important to recognize that there are specific guidelines regarding acceptable limits of exposure.
Manufacturing of ultra-high potency APIs takes place either in dedicated suites, or with the use of additional fully contained nanogram level primary containment within existing HPAPI suites. This adds the necessary level of extra control within room controls and migration controls such as interlocked unidirectional entries, pressure cascades and downflow booths.
Where possible, to avoid cross contamination, product contact equipment is either single-use or dedicated to a product. When this is unfeasible, carefully designed cleaning processes must be used to ensure the removal of the target compound, with verification using validated analytical techniques. All solid handling must be performed within isolation chambers to minimize the risk of migration of material within the suite. These solid handling operations and the associated engineering controls are also validated as a part of the suite/equipment qualification, to demonstrate that migration does not occur. Additionally, it is also common for destructive cleaning methods—such as oxidation—to be used, which decomposes the active compound. However, this can be more complicated and requires additional clearance studies/testing.
For operators, any need for additional personal protective equipment will be based on a risk assessment and will depend upon the design of the manufacturing suites, and the built-in engineering controls.
Because of their nature and small dosages needed for patients, manufacturing of ultra-high potency APIs is on a typical scale of 1-200 grams. This makes process development more challenging, as it must be carried out at the milligram scale due to the high cost and limited availability of key materials. Processing of final product would then typically involve purification by column chromatography, which requires specialized equipment across a range of scales to support the potential for medium and high-pressure chromatography requirements. Lyophilization is commonly leveraged for final isolation and drying of product, with methods such as crystallization/filtration and traditional drying more rarely used.
For analysts, the challenges are chiefly associated with cleaning validation, but for product testing, standard characterization is not always deployed because of the low volume of material. High volume destructive testing such as residue on ignition, and others require special instrumentation to perform on the micro scale.
Successful outsourced manufacturing
Because HPAPI development and manufacturing require substantial capital investment in multiple means of containment, specialized expertise and extensive training on proper handling and containment measures, the complexity, as well as cost and time commitment, means that these services are often outsourced to contract manufacturers. This has led to a rise in the number of companies offering HPAPI manufacturing and the sector becoming competitive, meaning innovators must look beyond purely the service offering to find a suitable partner.
There are several factors that need to be considered when drug developers are selecting outsourcing partners to ensure the greatest potential for a successful collaboration and minimize the risk to a program’s progression.
With the growth in opportunities for contract manufacturers in the HPAPI field, capacity to handle materials is vital, but it is also important to find a partner with purpose-built facilities at the necessary scale rather than facilities that have been retrofitted to be suitable for handling HPAPIs. Specifically designed facilities are more likely to employ a fit-for-purpose, multi-layered approach that ensures that HPAPI operations are as safe and controlled as possible.
As well as the layers of containment, having these specialized facilities offers asset flexibility to handle a range of process requirements, and a facility-wide awareness of safety measures. For example, if controls within glove box isolators fail unexpectedly, these isolators should be migration controls to prevent highly potent materials from entering the GMP suite that houses them. On top of that secondary measure, airlocks within the containment suites themselves should be in place to prevent the ingress of potent materials into the wider facility.
In addition, it is important that a manufacturing facility can support a range of potencies and levels of containment. As a project progresses, additional studies may be run on the potent material that may determine whether it is more or less potent than originally anticipated, requiring a change in the level of containment necessary. The ability to support the full range of potency and containment, if any new information alters the containment strategy, is crucial to avoid time and cost delays that may otherwise occur in having to transfer the project to a different partner.
Even with the appropriate controls in place within the facility, it is important to remember that there is no “one-size-fits-all” approach to containment. Failing to use sufficient levels of containment creates significant risk for operators working with highly potent materials, as well as the facility. Conversely, using high levels of containment when it is not necessary based on the material’s potency can create added costs and project delays.
As well as physical assets, specialized teams and processes are integral to the success of any HPAPI project. Equipment is only as effective as the people operating it, and anyone working with HPAPIs should have extensive training in containment, controls, and cleaning, as well as how to respond appropriately in the event of any issue or emergency.
Ongoing testing and monitoring are also critical throughout any HPAPI project to ensure that target containment levels can be achieved and maintained. Containment verification testing of the suite should be carried out as a part of the initial qualification of the suite before any work with highly potent material begins, using a surrogate material such as naproxen sodium. This will affirm that the suite can properly contain the HPAPI, and that the operators have received proper safety training.
High Potency API Contract Manufacturing Market Insights
By Product Types
The innovative segment dominated the market with a share of 72.4% in 2024. The segment growth is attributed to the increasing research and development activities for developing novel treatment options combined with rising government support. Innovative drugs are revolutionizing the pharmaceutical industry, especially in the treatment of chronic diseases such as rare diseases and cancer. In addition, the increasing investments in pharmaceutical research and development and the strong drug pipeline of leading pharmaceutical companies are anticipated to drive the segment growth.
The generic segment is expected to grow fastest during the forecast period. The segment growth is driven by the rising number of patent expirations for blockbuster drugs and the increasing demand for biopharmaceutical therapies. Furthermore, the growing trend of pharmaceutical companies adopting single-partner collaborations for HPAPI development and manufacturing services is fueling the growth in the generic segment. Companies can streamline their drug development processes, shorten time to market, and reduce costs, by partnering with contract manufacturing organizations that offer comprehensive services. This collaborative approach allows pharmaceutical companies to focus on their core competencies and improves operational efficiency.
By Application Insights
The oncology segment dominated the high potency API contract manufacturing market in 2024. The segment growth is majorly attributed to the increasing cases of cancer worldwide combined with increasing product pipelines by the major market participants. According to the FDA focused on oncology, 30% of new molecular entity (NME) approvals for small molecules, according to the data published in 2023 by Lonza. Furthermore, with about 90% of these being administered orally, small molecules account for over 60% of FDA NME approvals across the oncology market.
The glaucoma segment Is expected to grow fastest during the forecast period. The segment growth is attributed to the increasing prevalence of glaucoma in both developing and developed countries. In addition, the rapidly increasing disease has attracted various researchers to conduct clinical studies in this therapeutic area that are further driving the market growth.
By Synthesis Insights
The synthetic segment is dominated the market growth in 2024. The segment growth is attributed to the rising advancements in manufacturing technologies and synthetic chemistry that have improved the scalability and efficiency of production processes. Innovations such as improved analytical techniques, continuous manufacturing, and automated synthesis have streamlined the development of synthetic high-potency APIs and made it easier for manufacturers to address market demands and regulatory requirements.
The biotech segment is expected to grow fastest during the forecast period. The segment is driven by the high potency of these compounds and rising advancements in technology. The majority of HPAPIs are produced using molecular methods including recombinant DNA technology.
By Dosage Form Insights
The injectables segment dominated the market share of 51.0% in 2024 owing to rapid delivery of HPAPI to the target location. The segment growth is attributed to the rapid delivery of HPAPI to the targeted location. They can be delivered as either intramuscular, intradermal, or subcutaneous. Furthermore, various developments by the major players are further contributing to the segment's growth. Thus, rising continuous developments by the major players in the segment contributed to the growth of the high potency API contract manufacturing market during the forecast period.
The oral segment is expected to grow fastest during the forecast period. The segment growth is fueled by decreasing cross-contamination and reduced costs and time. Furthermore, by increasing fill speeds and reducing the potential exposure, manufacturing oral solids helps improve the safety of the operator. In addition, oral solids are a very convenient method and are more patient-centric, thus owing to increased demand for this dosage type. Thus, these factors are expected to enhance market growth.
By Regional Insights
Tech Innovation & Rising Cancer Cases: North America to Sustain as a Leader
North America high potency API contract manufacturing market dominated globally with a market share of 38.0% in 2024. The market growth in the region is attributed to the increasing prevalence of chronic diseases such as rare diseases and cancer. In addition, the increasingly strict regulatory requirements surrounding product quality and manufacturing are further anticipated to drive market growth in the region.
In the U.S., the market is driven by growing research and development activities and significant investments by pharmaceutical companies. In addition, the increasing demand for oncology therapies is also driving the market growth. Pharmaceutical companies are focusing on developing targeted therapies, as the prevalence of cancer continues to rise, that require high potency APIs. This trend is accelerating contract manufacturers to invest in specialized processes and improve their capabilities to produce these potent compounds efficiently and safely.
Europe High Potency API Contract Manufacturing Market Trends
The high potency API contract manufacturing market in Europe is anticipated to witness lucrative growth over the projected period. The growth is due to the expansion of outsourcing activities among pharmaceutical companies. Several companies are entering into a partnership and collaboration agreement with contract manufacturers that offer expertise in high potency API production. By outsourcing, companies can reduce operational costs, enhance production flexibility, and access advanced manufacturing technologies. This trend is contributing to the growth of the contract manufacturing market across the region.
The high potency API contract manufacturing market in the UK is anticipated to experience considerable growth over the forecast period. The UK operates under a rigorous regulatory framework that oversees the manufacturing and quality of high potency APIs. Thus, with the more stringent regulation, contract manufacturers are required to invest in robust quality assurance and compliance systems. This trend not only increases the operational costs for manufacturers but also emphasizes the importance of partnering with outsourcing organizations that follows proper regulatory compliance and ensures that products meet the highest standards of safety and efficacy.
The high-potency API contract manufacturing market in Germany is expected to grow at a considerable rate over the forecast period. Technological advancements are significantly shaping the landscape of the market in the country. Innovations such as continuous manufacturing, single-use systems, and enhanced containment technologies are improving the efficiency and safety of high potency API production. These advancements have facilitated compliance with stringent regulatory standards and has enhanced the overall quality of the products.
Asia Pacific is expected to grow fastest during the forecast period
The increasing of a robust drug pipeline, increased risk management capabilities, high scope for cost savings, and improved regulatory framework are expected to drive market growth in the region. In addition, the market is also attributed to the increasing scope of opportunities, particularly in India, China, and Japan. Furthermore, the availability of a skilled workforce at lower costs than in developed countries is expected to drive market growth in the region.
The increasing demand for biopharmaceuticals is expected to drive the market growth in China. Pharmaceutical companies in China are increasing their focus on emerging innovative therapies, especially in chronic diseases and oncology. Thus, these factors are driving the market growth.
Which are the leading pharmaceutical CMOs offering Highly Potent APIs?
Various Contract Manufacturing Organizations (CMOs) which have HPAPI manufacturing capabilities can provide highly potent API services as well as manufacturing of active pharmaceutical ingredients (highly potent) and ultimately function as a highly potent API producer.
The different contract services may include HPAPI development, biologic–HPAPI conjugate manufacturing, large-scale highly potent API manufacturing or the commercial manufacture of highly potent compounds, etc.
Some Leading CMOs offering Highly Potent APIs:
Wavelength Pharmaceuticals - High Potency API Manufacturing
Wavelength Pharmaceuticals offers contract manufacturing services for the production of highly potent active pharmaceutical ingredients (HPAPIs) along with steroids and cytotoxic compounds. It has developed robust commercial scale processes including large scale highly potent API manufacturing or the commercial manufacture of highly potent compounds.
Eurofins CDMO - High-potency APIs (HPAPIs) Manufacturing
Eurofins CDMO offers integrated contract manufacturing services through the entire drug product life cycle. It has HPAPI manufacturing capabilities and thereby offers highly potent active pharmaceutical ingredients (HPAPIs). Furthermore, its cGMP manufacturing plant provides highly potent APIs handling and other contract services, thus establishing it as a highly potent API producer and service provider.
Pfizer CentreOne - High Potency API Manufacturing
Pfizer offers manufacturing expertise for potent drugs, liquid cytotoxics, biologics, controlled substances (II-IV), liposomal, inactivated vaccines, monobactam, etc. It also provides contract services for HPAPI development and manufacturing of active pharmaceutical ingredients such as small molecules, hormones, steroids and prostaglandins .
Minakem - High-potency API (HPAPI) Development & Manufacturing
Minakem offers a state-of-the-art high containment facility for highly potent API manufacturing equipped to handle highly potent API services from early-stage HPAPI (Highly Potent API) development to scale-up and commercial manufacture of highly potent compounds (large scale highly potent API manufacturing).
Medichem S.A - High Potency API Manufacturing
Medichem has HPAPI manufacturing capabilities at its API plant in Malta. It produces Class 4 HPAPIs within cGMP and FDA inspected environments. It has an R&D lab as well as a kilo-lab and can thus offer both development and manufacturing contract services. Medichem provides highly potent API services and thus functions as a highly potent API producer.
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High Potency API Contract Manufacturing Market Top Companies
• Piramal Pharma Solutios
• Lonza
• Pfizer CentreOne
• AbbVie
• Aurigene Pharmaceutical Services Ltd.
• CordenPharma International
High Potency API Contract Manufacturing Market Recent Developments
• In January 2023, one of India’s fastest growing Contract Research, Development & Manufacturing Organizations, Sai Life Sciences announced the opening of a new High Potency API manufacturing facility at its cGMP API Manufacturing campus in Bidar, India.
• In June 2024, a biologics facility in Hyderabad, India opened by Aurigene Pharmaceutical Services. This facility is designed to support customers with analytical development and process and recombinant proteins and small-scale manufacturing of antibodies for early-phase and preclinical clinical needs.
Segments Covered in the Report
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2034. For this study, Nova one advisor, Inc. has segmented the high potency API contract manufacturing market
By Product
• Innovative
• Generic
By Application
• Oncology
• Hormonal Disorders
• Glaucoma
• Others
By Synthesis
• Synthetic
• Biotech
By Dosage Form
• Injectable
• Oral Solids
• Creams
• Others
By Regional
• North America
• Europe
• Asia Pacific
• Latin America
• MEA
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