The high‑potent oral solid dosage (HP‑OSD) contract manufacturing market is set to expand from USD 6.59 billion in 2025 to approximately USD 15.32 billion by 2035, with a projected CAGR of 8.8% over the period. This growth is being fueled by rising demand for specialized oncology and chronic disease treatments. As more high‑potency APIs enter clinical pipelines, reliance on CDMOs with advanced containment and manufacturing capabilities continues to rise.
Recent industry activity underscores this trend. PCI Pharma Services unveiled its second Contained Manufacturing Facility (CMF) in the UK in 2023, doubling its capacity to handle highly potent products. A dedicated High‑Potent Packaging Facility was also launched, enabling full‑spectrum handling-from clinical production to commercial packaging. In an official statement, David O’Connell, PCI’s Director of Scientific Affairs, noted that the combined focus on “safety, quality and integration” had strengthened the firm’s competitiveness in the CDMO sector.
Technology-led innovation is also being embraced. In 2024, Douglas CDMO invested in a GEA multiprocessor to support small‑scale and clinical production of modified‑release OSD forms. This equipment enables efficient pellet and powder processing for varied dosing needs. Such solutions align with a broader industry shift toward flexible, multi-formulation manufacturing platforms.
Recipharm reported record growth in late 2024, driven by investments in continuous manufacturing and expanded high-potency production suites. The launch of the ReciPredict™ platform was also announced, offering integrated predictive modeling and risk reduction across tech transfer and scale-up. According to Greg Behar, CEO of Recipharm, these advances will “help our customers bring high‑quality drug products to market efficiently” while ensuring compliance with rigorous safety standards.
With continued investment in high-containment infrastructure, automated multi-product systems, and digital predictive platforms, the HP‑OSD contract manufacturing market is positioned for sustained expansion. Projects aimed at improving efficiency, safety, and regulatory compliance are expected to define the next wave of growth.
| Attributes | Description |
|---|---|
| Estimated High-Potent Oral Solid Dosage Contract Manufacturing Market Size (2025E) | USD 6.59 Billion |
| Projected High-Potent Oral Solid Dosage Contract Manufacturing Market Value (2035F) | USD 15.32 Billion |
| Value-based CAGR (2025 to 2035) | 8.8% |
The high-potent oral solid dosage (HPOSD) contract manufacturing market is witnessing strong growth, driven by the rise in oncology therapies and the increasing need for high containment manufacturing. In 2025, tablets are expected to dominate with a 46.5% market share by dosage form. Meanwhile, fluid bed granulation will lead the formulation technology segment with a 34.2% share, offering superior versatility and process control.
Tablets are forecast to capture a 46.5% market share in the HPOSD contract manufacturing market in 2025. Their high patient acceptance, dose flexibility, and manufacturing scalability make them the most preferred format for HPOSD products. CDMOs such as Lonza Group, Catalent Inc., Thermo Fisher Scientific, and Siegfried Holding AG are continuously expanding tablet production capacity to meet rising demand from oncology, immunology, and rare disease drug developers. Oncology, in particular, remains the key therapeutic area driving tablet demand, with over 50% of oral cancer drugs being developed in tablet form.
Innovations in multi-layer tablets, press-coated tablets, and controlled-release tablets further support their adoption for complex HPOSD profiles. CDMOs also invest in high-containment isolators, automated production lines, and zero cross-contamination protocols to ensure safe and compliant tablet manufacturing. With ongoing advancements and the continued expansion of the oncology pipeline, tablets will remain the dominant dosage form in the HPOSD market through 2025.
Fluid bed granulation is projected to lead the HPOSD formulation technology segment in 2025, with an estimated 34.2% market share. Its ability to produce uniform granules with excellent flowability and content uniformity is critical for high-potent drugs, particularly when handling low-dose oncology formulations.
Top CDMOs including Lonza, Recipharm AB, Catalent, and Almac Group extensively rely on fluid bed granulation for developing controlled-release and taste-masked HPOSD products. Its versatility in processing a wide range of API solubilities and particle sizes makes it the go-to technology in high-containment environments.
Fluid bed granulation also supports advanced closed-loop manufacturing, ensuring regulatory compliance and consistent product quality-essential in oncology, where precise dosing is paramount. Innovations such as continuous fluid bed granulation, automated cleaning-in-place (CIP) systems, and AI-enabled process controls are further enhancing efficiency and safety. As a result, fluid bed granulation will continue to be the leading HPOSD formulation technology through 2025, supporting the market’s transition toward personalized and targeted therapies.
Challenges
The stringent regulatory compliance hinders the market growth
The HP-OSD contract manufacturing market faces challenges related to regulatory compliance, especially since changes to regulations require high investment in facility upgrades and the complicated potential of handling compounds. The need for specialized containment technologies such as isolators and negative pressure environments raises the operational costs of manufacturing.
The prevention of cross-contamination in multi-product facilities requires a highly developed cleaning validation process. The growing demand for personalized medicine and niche drug formulations aggravates the issues of scalability and process standardization in production.
In addition, talent shortages related to handling high-potency APIs and strict OELs are limiting operational flexibility for manufacturers. In addition, limited awareness of high-containment handling protocols in emerging markets has further hindered the transition to best practices in HP-OSD manufacturing.
Opportunities
The increasing adoption of continuous manufacturing and automation is driving the market growth.
The contract manufacturers have a huge opportunity for growth with the ever-increasing adoption of continuous manufacturing, automation, and AI-oriented process optimization. Investments in modular containment technologies and flexible manufacturing capabilities aim to increase production efficiency and safety. The growing requirement for oncology drugs, immunosuppressants, and hormone therapies is further propelling the demand for specialized contract manufacturing services.
Besides, partnerships between pharma companies and CDMOs trying to shorten the timeline for drug development are also encouraging innovations in HP-OSD formulations. The higher adoption of high-barrier packaging solutions, such as blister packs with protective coating, shall enhance the drug stability and patient safety while providing further impetus for market growth.
Emerging markets in Asia and Latin America that appeal to CDMOs for expanding their footprint in cost-effective manufacturing locations remain largely untapped.
Progression within Containment Technologies: These continue to evolve high containment production spaces, isolator-based processing systems, and RABS to improve safety for the worker and reduce contamination risks in HP-OSD production facilities.
Expansion in Oncological and Specialty Drug Manufacturing: Growing incidences of cancer and other chronic diseases are driving demand for higher potency oral solid dosage. Consequently, CDMOs are expanding their scope to cover increased demand for oncology potent treatments and targeted therapies.
Regulatory and Policy Developments: Stringent guidelines issued by the respective regulatory agencies such as FDA and EMA as well as PMDA of Japan, are helping shape manufacturing practices as per occupational health and safety standards and environmental sustainability in high-potency drug production. Development of including increased GMP compliance and cleanroom technologies is also defining the investment decisions about high-containment facilities.
Digital transforming high-potent oral solid dosage (HP-OSD) manufacturing is revolutionizing the industry by adding speed and quality. Predictive analytics through AI, digital twin, and real-time process monitoring increases the efficiencies of production while minimizing waste and ensuring consistent quality. These technologies are creating a faster decision-making process and also improving the probabilities of meeting regulatory standards.
Finally, an increased application of blockchain technologies is expected to solidify supply chain traceability as well as data integrity. The digitalization of HP-OSD manufacturing continues to modernize operational processes while reinforcing compliance and contributing to the overall growth and development of pharmaceutical manufacturing.
The pharmaceutical industry is going towards sustainability in the production process to lessen its environmental footprint. HP-OSD contract manufacturers utilize green containment technologies and solvent recovery systems aiding energy as well as waste reduction so that energy-consuming and wasteful processing methods are minimized.
There is a trend heading towards green chemistry, which doesn't employ the use of harmful and unsustainable chemicals that are definitely being produced for drug formulation. Biodegradable and recyclable packaging options are also being investigated for global sustainability goals in order to decrease plastic waste.
The industry has realized the value of environmental stewardship reflected by making HP-OSD manufacturing processes compliant with regulatory standards based on the fact that changing consumer preferences toward greener and more sustainable solutions are propelling the demand toward this direction.
The HP-OSD contract manufacturing market was valued at USD 6.59 billion in 2025 and will reach USD 15.32 billion by 2035 at an 8.8% CAGR. The factors for growth basically include the increasing prevalence of chronic diseases and the need for targeted high-potency treatments.
With materials and design advancements, including better containment systems and manufacturing technologies, operations are becoming safer and more efficient. In the coming years, trends aiming to minimize waste and consumption of energy will focus on customization of manufacturing solutions, compliance with regulatory specifications, and sustainability. Furthermore, Production capacity for HP-OSD manufacturing to meet the rising global healthcare demand shall be augmented through digitalization and AI solutions.
Market Outlook
the USA high-potent oral solid dosage (HP-OSD) contract manufacturing market is poised for significant growth. Due to increasing demand for niche drugs. Technological advancements in AI and digitalization offer promising acceleration for high-potency drug production. These advancements facilitate rapid and more efficient manufacturing.
On the other hand, regulatory hurdles and high production costs may hinder market growth. However, with continued funding for R&D amid an ageing populace in need of more advanced therapies, HP-OSD contract manufacturing shall grow. Also, the increased trend of pharmaceutical companies outsourcing will probably gain more acceptance, thus enabling greater innovation and efficiency in production.
Market Growth Factors
Market Forecast
| Country | CAGR (2025 to 2035) |
|---|---|
| United States | 7.2% |
Market Outlook
The HP-OSD contract manufacturing market in the UK is on a steady growth curve with a consistent rise in the need for specialized treatments, especially in oncology, neurology, or autoimmune diseases. The mature pharmaceutical industry in the UK together with advanced research capabilities has termed the country as an innovative manufacturing ground for drugs.
Digital technologies such as AI, automation, and real-time monitoring are enhancing the efficiency and safety of HP-OSD production. The UK facilities adhering to regulatory compliance and high standards of production are therefore sure to produce high-quality potent products. However, it could act against the growth owing to the implementation of complex regulatory requirements and costs of production.
Prompted by continuous investment in R&D and the increasing demand for therapies in the high-potency category considering the aging population, the market demands will persist. The UK maintains strong competence as the contract manufacture of HP-OSD on the global scale, substantiated by its technological competencies and strength in the pharmaceutical industry.
Market Growth Factors
Market Forecast
| Country | CAGR (2025 to 2035) |
|---|---|
| United Kingdom | 5.8% |
Market Outlook
The Chinese HP-OSD contract manufacturing segment is rapidly expanding due to large manufacturing capabilities. It is also supported by a growing healthcare demand in the country. The increasing demand for high-potency drugs is backed by a growing population. This population is suffering from chronic diseases. The sector has made large strides in integrating digital technologies and smart manufacturing in China.
These advancements aim to improve the efficiency of production processes. Also, government favoring policies and investment in overall healthcare infrastructure are significantly promoting the growth of HP-OSD contract manufacturing.
While some hurdles, such as regulatory challenges and control quality concerns, exist, the cost-effective nature of manufacturing in China and its strong export potential make it a favorable hub for the global HP-OSD market. China's demand for high-potency treatments will continue to maintain the traction of the HP-OSD market for the years to come due to its large and elderly population.
Market Growth Factors
Market Forecast
| Country | CAGR (2025 to 2035) |
|---|---|
| China | 12.7% |
Market Outlook
Japan's high-potent oral solid dosage (HP-OSD) contract-manufacturing market continues to witness growth. This is due to an aging population and demand for specialized high-potency drugs. The country has an established advanced healthcare system. There is also a high interest in pharmaceutical innovation. Hence it makes it an attractive environment for developing novel therapies for chronic diseases.
These include cancer and autoimmune disorders. Initiatives in precision medicine and greater application of digital technologies are also present. AI and real-time process monitoring in manufacturing work toward the efficiencies and safety of HP-OSD production in Japan. Unfortunately, regulatory complexity and high-production costs can inhibit market growth.
Nevertheless, Japan's strong research and development (R&D) capacity together with increasing demand from an aging population will demand for growth stages in the HP-OSD market. Japan has the potential to be a major player in the global HP-OSD contract manufacturing space based on its technological advancement and healthcare leadership.
Market Growth Factors
Market Forecast
| Country | CAGR (2025 to 2035) |
|---|---|
| Japan | 3.7% |
Market Outlook
The high-potency oral solid dosage (HP-OSD) contract manufacturing market in South Korea has been expanded. Due to an increase in the number of chronic disease patients as well as fact that the country possesses an advanced pharmaceutical sector. South Korea has become one of the most attractive destinations for HP-OSD contract manufacturing as it represents a skilled workforce.
Government support for research in health and pharmaceuticals, in conjunction with increased digitalization in manufacturing processes, would also speed up production of especially high-potency drugs. The demand for HP-OSD formulations in oncology and other complicated treatment options is continuously escalating. However, regulatory barriers and the need to comply with international standards may be obstacles.
Precision and quality being the topmost consideration, South Korea's HP-OSD manufacturing market is poised to meet the high future global demand for high-potency drugs.
Market Growth Factors
Market Forecast
| Country | CAGR (2025 to 2035) |
|---|---|
| South Korea | 15.6% |
The high-potent oral solid dosage (HPOSD) contract manufacturing market thrives on tthe aging population and increasing chronic diseases.
All these factors further the demand for targeted therapies based on high-potency active pharmaceutical ingredients (HPAPIs). Improvements are happening with respect to innovation in drug formulation, employment of advanced containment technologies, and utilization of more digital manufacturing techniques to enhance production.
Regulatory approvals and partnerships between contract manufacturers and pharmaceutical companies also open up the market. The HPOSD market remains competitive and well-positioned for future growth as both pharmaceutical and technology firms invest in next-generation manufacturing solutions that will allow them to meet specialized drug needs.
Catalent Inc.
The company provide completely integrated services for high-potency oral solid dosage (HPOSD) manufacturing from formulation development, clinical and commercial production of high-potency tablets and capsules, and offering flexible solutions to complex therapies..
Lonza
Lonza excels in high-containment HPOSD manufacturing in the world. It carries out a complete range of activities, starting from early-phase development to commercial production of high-potency active pharmaceutical ingredients (HPAPIs) and finished dosage forms, without neglecting high safety standards and full regulatory compliance.
WuXi AppTec
The services on offer range from process development to commercial-scale production through to high-potency drug handling, placing emphasis on regulatory requirements and ensuring product quality across global markets.
Pfizer Inc.
This is a full-flow HPOSD manufacturing solution: from developing high-potency formulations, advanced containment systems, and large-scale production for oncology and other specialized therapeutic areas to leveraging its global network and regulatory expertise.
Recipharm
Provides comprehensive contract manufacturing services for HPOSD, specializing in the production of high-potency oral tablets and capsules, with a strong focus on containment, quality assurance, and regulatory compliance for global pharmaceutical clients.
Beyond the leading companies, several other contract manufacturers contribute significantly to the market, enhancing service diversity and technological advancements. These include:
| Report Attributes | Details |
|---|---|
| Market Size (2025) | USD 6.59 Billion |
| Projected Market Size (2035) | USD 15.32 Billion |
| CAGR (2025 to 2035) | 8.8% |
| Base Year for Estimation | 2024 |
| Historical Period | 2020 to 2024 |
| Projections Period | 2025 to 2035 |
| Quantitative Units | USD billion for value and million units for volume |
| Dosage Forms Analyzed (Segment 1) | Tablets, Orally Disintegrating Tablets, Hard Gelatine Capsules, Sublingual Tablets, Special Solid Dosage Forms, Press Coated Tablets, Bi-layer Tablets, Controlled Release Solids (Matrix) |
| Formulation Technologies Analyzed (Segment 2) | Fluid Bed Granulation, Roller Compaction, Direct Compression, Hot Melt Extrusion, Spray Drying, Microencapsulation |
| Therapy Areas Analyzed (Segment 3) | Cancer, Hormonal Disorders, Autoimmune Diseases, Neurological Disorders, Pain Management, Other Therapy Areas |
| Services Analyzed (Segment 4) | API Manufacturing, Drug Product Development, Clinical Trial Manufacturing, Commercial Manufacturing, Packaging & Serialization, Containment & Safety Systems, Regulatory Support & Compliance, Quality Control & Assurance, Supply Chain Management, Technology Transfer |
| End Users Analyzed (Segment 5) | Big Pharmaceutical / Biotech Companies, Small & Medium Size, Nutraceutical Companies, Emerging / Virtual Pharma Companies |
| Regions Covered | North America; Latin America; Western Europe; Eastern Europe; East Asia; South Asia & Pacific; Middle East & Africa |
| Countries Covered | United States, Canada, Brazil, Mexico, Germany, France, United Kingdom, Italy, Spain, China, India, Japan, South Korea, Australia, GCC Countries, South Africa |
| Key Players influencing the HP-OSD Contract Manufacturing Market | Catalent Inc., Lonza Group, Pfizer CentreOne, WuXi AppTec, Recipharm AB, PCI Pharma Services, Aenova Group, Piramal Pharma Solutions, CordenPharma International, AbbVie Contract Manufacturing (incl. Pfizer CentreOne) |
| Additional Attributes | Market size in dollar sales and CAGR, share by drug type (oncology, hormonal, others), formulation trends, regional dollar sales, capacity and tech capabilities of CMOs, regulatory compliance needs, competitive dollar sales, demand from small-mid pharma. |
Tablets, orally disintegrating tablets, hard gelatine capsules, sublingual tablets, special solid dosage forms, press coated tablets, bi-layer tablets, and controlled release solids (matrix).
Fluid bed granulation, roller compaction, direct compression, hot melt extrusion, spray drying, and microencapsulation.
Cancer, hormonal disorders, autoimmune diseases, neurological disorders, pain management, and other therapy area.
API manufacturing, drug product development, clinical trial manufacturing, commercial manufacturing, packaging & serialization, containment & safety systems, regulatory support & compliance, quality control & assurance, supply chain management, and technology transfer.
Big pharmaceutical /biotech companies, small & medium size, nutraceutical companies, and emerging / virtual pharma companies.
North America, Latin America, Western Europe, Eastern Europe, East Asia, South Asia & Pacific, Middle East & Africa
The overall market size for High-Potent Oral Solid Dosage Contract Manufacturing Market was USD 6.59 billion in 2025.
The High-Potent Oral Solid Dosage Contract Manufacturing Market is expected to reach USD 15.32 billion in 2035.
The increasing prevalence of chronic diseases and the rising demand for targeted therapies are driving growth in the high-potent oral solid dosage contract manufacturing market. Advancements in manufacturing technologies, such as AI-driven processes and enhanced containment systems, further boost market expansion.
The top key players that drives the development of High-Potent Oral Solid Dosage Contract Manufacturing Market are Catalent Inc, Lonza, Pfizer Inc., WuXi AppTec, and Recipharma.
Tablets by dosage form in High-Potent Oral Solid Dosage Contract Manufacturing Market is expected to command significant share over the assessment period.
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High-Potent Oral Solid Dosage Contract Manufacturing Market
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