Oral Solid Dosage Contract Manufacturing Market Focused on Innovation

Revenue, 2025

USD 41.08 Billion

Forecast, 2035

USD 75.26 Billion

CAGR, 2026-2035

6.24%

Report Coverage

Global

Oral Solid Dosage Contract Manufacturing Market Size, Key Players with Insights and Trends

The global oral solid dosage contract manufacturing market size was estimated at USD 41.08 billion in 2025 and is predicted to increase from USD 43.65 billion in 2026 to approximately USD 75.26 billion by 2035, expanding at a CAGR of 6.24% from 2026 to 2035.

Contract manufacturing offers substantial cost-effectiveness, advanced technologies, and specialized professionals to the diverse pharma firms, especially small and medium-sized companies. Moreover, the global researchers are promoting the broader adoption of 3D printing solutions for the immersive development of oral solid dosage forms. Additionally, firms are widely leveraging AI algorithms to expand advanced solutions from R&D to the operational effectiveness of OSDs.

Key Takeaways

• Oral solid dosage contract manufacturing sector pushed the market to USD 43.65 billion by 2026.
• Long-term projections show USD 75.26 billion valuation by 2035.
• Growth is expected at a steady CAGR of 6.24% in between 2026 to 2035.
• Asia Pacific registered dominance in the market in 2025.
• North America is expected to be the fastest-growing region during the forecast period.
• By product, the tablets segment captured a major revenue share of the market in 2025.
• By product, the capsules segment is expected to grow at a rapid CAGR during 2026-2035.
• By mechanism, the controlled release segment dominated the oral solid dosage contract manufacturing market in 2025.
• By mechanism, the immediate release segment is expected to witness the fastest growth in the coming years.
• By end use, the large-sized companies segment was dominant in the market in 2025.
• By end use, the medium & small size companies segment is expected to grow rapidly during 2026-2035.

Executive Summary Table

What is the Oral Solid Dosage Contract Manufacturing?

Those pharmaceutical companies are involved in outsourcing the development and manufacturing of solid medications, especially tablets, capsules, and powders, to a specialized third-party organization, i.e., a CDMO, which is known as the oral solid dosage contract manufacturing market. The global market is specifically driven by CDMOs' affordability & effectiveness, with increasing demand for generic drugs, and strengthening small & virtual pharma companies. However, these firms are emphasising bioavailability enhancement by leveraging amorphous solid dispersions, hot melt extrusion, nanomilling, and lipid-based formulations.

How is AI Governing the Oral Solid Dosage Contract Manufacturing Market?

In the respective market, AI algorithms are increasingly assisting through the unification of AI-driven monitoring and sophisticated data analytics, which bolster quality control, optimize operational efficiency, and allow rapid, data-driven decisions from formulation design to commercial production. Moreover, ML algorithms support the prediction of drug behaviour, stability, and drug-excipient interactions, primarily at the R&D stage. Recently, Thermo Fisher Scientific explored the Quadrant 2 platform, which utilizes AI/ML-based in-silico modeling to estimate optimal solubility enhancement techniques for poorly soluble compounds.

Trends & Future Outlook of the Oral Solid Dosage Contract Manufacturing Market

Surging Continuous Manufacturing & Automation

Day by day, the leaders are moving towards continuous production, which facilitates increased effectiveness, consistency, and scalability. Additionally, the adoption of automation and real-time process analytical technology (PAT) is used through their integration to enhance quality control and lower waste.

Elevating Green Manufacturing

The era is focusing on raising eco-friendly solutions, such as the adoption of biodegradable excipients, solvent-free manufacturing processes, and energy-efficient operations to minimize environmental impact and meet emerging regulatory and consumer expectations.

Transforming 3D Printing

Researchers are highly employing 3D printing technology as it allows tailored medicine through personalised dose, accurate control over drug release profiles, and the production of combination (polypill) products.

Segmentation Analysis

Product Insights

Which Product Led the Oral Solid Dosage Contract Manufacturing Market in 2025?

In 2025, the tablets segment registered dominance with a major share of the market. Specifically, these products offer cost-effectiveness, ease of use, and patient compliance, while their affordability in terms of manufacturing, packaging, and transportation as compared to other forms is fueling the overall adoption. However, CDMOs are promoting the production of orally disintegrating tablets (ODTs), mini tablets, and tablet-in-capsule solutions. Firms, like Akums, Sun Pharma, Cipla, Dr Reddy’s, etc., are widely developing chewable, coated, modified-release formulations for general, nutraceutical, or Ayurvedic products.

Capsules

In the future, the capsules segment is anticipated to register rapid expansion. Its prominent catalyst is easier to swallow than tablets and efficiently masks the unpleasant taste and odour of the active pharmaceutical ingredients (APIs). Also, it possesses flexibility for various formulations, particularly powders, granules, and even liquids by using liquid-filled capsules, which further supports personalized and combination therapies. Currently, CDMOs are experiencing a huge demand for plant-based capsules, like those made from Hydroxy Propyl Methyl Cellulose (HPMC), to continue to dietary, ethical, and "clean-label" consumer preferences.

Mechanism Insights

How did the Controlled Release Segment Dominate the Market in 2025?

The controlled release segment held the biggest share of the oral solid dosage contract manufacturing market in 2025. This primarily lowers the needed frequency of dosing, often to once daily, which raises patient adherence to medication schedules. Also, results in more consistent and sustained therapeutic effects with minimal adverse side effects, especially for patients with diabetes, hypertension, and pain. CDMOs are using advanced coating approaches, like Wurster coating, and matrix systems for accurate control of the rate and location of drug release.

Immediate Release

The immediate release segment is predicted to expand rapidly. These dosage forms require minimal complex manufacturing process, which fosters quicker development and rapid time-to-market, and is a substantial driver. While 3D printing techniques, such as Binder Jetting (BJT), are evolving highly porous structures, including Spritam (levetiracetam), it is the first FDA-approved 3D-printed drug, which is for patients with swallowing concerns (dysphagia).

End Use Insights

Why did the Large Size Companies Segment Lead the Market in 2025?

In 2025, the large-sized companies segment captured a dominant share of the oral solid dosage contract manufacturing market. This prominently includes Lonza, Catalent, Thermo Fisher Scientific, and Recipharm, which are immensely facilitating diverse services from drug formulation to commercial production and packaging. Whereas Aenova Group is Europe’s giant OSD firm, which explores different formats of OSD, especially bi-layer and chewable tablets, lozenges, and granules.

Medium & Small Size Companies

The medium & small size companies segment is anticipated to register the fastest growth. The emerging outsourcing of manufacturing services enables these companies to eliminate substantial overhead and capital investment in facilities and equipment, which ultimately improves their operational expenditures. Ongoing and upcoming patent expiration are creating significant opportunities for these companies to explore large-scale and affordable generics. Specifically, Ardena, Alcami, UPM Pharmaceuticals, and Rubicon Research are examples of medium & small size companies for OSDs development.

Regional Insights

How did the Asia Pacific Dominate the Market in 2025?

Asia Pacific captured the biggest revenue share of the oral solid dosage contract manufacturing market in 2025, due to the minimal manufacturing and operation spending, mainly in China & India. Alongside, regional governments are spurring domestic pharmaceutical manufacturing through favourable policies, tax benefits, and infrastructure development, which finally lowers dependency on imports and promotes a competitive environment.

China Market Trends

However, China has been putting efforts into technological breakthroughs, like AI-driven machine learning, automation, and real-time-monitoring. Additionally, they are focusing on developments in sustained-release, targeted-release, and high-potency APIs (HPAPIs), specifically for oncology treatments.

For instance,

• In November 2025, Zydus Lifesciences Limited received marketing approval from the National Medical Products Administration (NMPA), China, for its Venlafaxine Extended-Release (ER) Capsules.

Demand for Generic Drugs & a Strict Regulatory Landscape are Driving North America

In the coming era, North America will expand fastest in the oral solid dosage contract manufacturing market. The region is experiencing wider patent expirations of branded drugs, which impacts the rising demand for affordable generic drugs. For this, contract manufacturers are efficiently supporting large-scale production. Moreover, recently, the FDA unveiled the Commissioner’s National Priority Voucher (CNPV) program, which facilitates a 1–2 month expedited review for CMC submissions to manufacturers with local production, crucially raising the market entry of OSD products produced in North America.

U.S. Market Trends

Whereas the U.S. market will witness rapid expansion, as it is focusing on bolstering domestic production, with rigorous government initiatives and potential tariffs on imports.

For instance,

• In December 2025, Bora Pharmaceuticals Co., Ltd. and Corealis Pharma Inc. collaborated to explore perfect end-to-end services for oral solid dose (OSD) development and manufacturing. 

Emphasis on the Complexity of New Chemical Entities (NCEs) is Propelling Europe

In the oral solid dosage contract manufacturing market, Europe will experience a notable expansion. Eventually, the regional companies are reinforcing capacity growth and outsourcing to specialized CDMOs with sophisticated technologies, such as nano-milling and particle engineering.

For instance,

• In April 2025, Meribel Pharma Solutions was introduced as a mid-sized European CDMO with a multi-country network.

Germany Market Trends

Germany is stepping towards high-volume production automation, with a vitalinvestment in high-potency active pharmaceutical ingredients (HPAPI). Recently, Recipharm operationalized its new Pilot Scale Development Centre, which possesses three GMP set for blending, tableting, and hard capsule filling.

Key Players' Offerings in the Oral Solid Dosage Contract Manufacturing Market

SWOT Analysis

Strengths

• CMOs mainly facilitate immersive expertise and experience in OSD formulation development, processing, including granulation, compression, coating, and handling complex Active Pharmaceutical Ingredients (APIs), like highly potent compounds or those with poor solubility. 
• Also, they can conduct early-phase development and commercial production within the same united organization, which omits the time, spending, and risk associated with technology transfers between various sites.

Weaknesses

• A major limitation is that the global supply chain for raw materials, components, and Active Pharmaceutical Ingredients (APIs) can be complex and prone to disruptions, which results in delayed time and potential drug shortages.
• All CMOs are not entirely equipped with specialized containment and greater precision, which are required in ensuring uniform and accurate dosing, primarily when dealing with tiny amounts of HPAPIs.

Opportunities

• The market will shift towards the progression of personalized medicine by using 3D printing technology, which provides versatility for on-demand production of tailored tablets with precise dosage strengths, shapes, and controlled-release profiles.
• Researchers will implement advances in formulation science to allow the oral delivery of complex large molecules, especially peptides and proteins, which traditionally need injections.

Threats

• Robustly adhering to stricter Good Manufacturing Practices (GMP) and other regulations set by agencies, especially the FDA or EMA, is a significant threat to firms.
• Certainly, sharing proprietary drug formulations and manufacturing processes with a third party may lead to a risk of intellectual property theft or misuse.

What are the Key Developments in the Oral Solid Dosage Contract Manufacturing Market?

• In December 2025, Senores Pharmaceuticals received regulatory approval and unveiled Deferiprone Tablets USP in 500mg and 1000mg strengths for the US market, & marketed by Dr. Reddy's Laboratories Inc. 
• In October 2025, Natco Pharma launched a generic of Novartis’ immunosuppressant, partnering to launch the product in the U.S.
• In October 2025, Cycle Pharmaceuticals introduced PHYRAGO (dasatinib) tablets, its first oncology product in the US.

Segments Covered in the Report

By Product

• Tablets
• Capsules
• Powders
• Granules
• Others

By Mechanism

• Immediate Release
• Delayed Release
• Controlled Release

By End Use

• Large Size Companies
• Medium & Small Size Companies
• Others

By Region

• North America
  • U.S.
  • Canada 
  • Mexico 
  • Rest of North America
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Europe 
  • Western Europe 
    • Germany 
    • Italy
    • France
    • Netherlands
    • Spain
    • Portugal 
    • Belgium
    • Ireland
    • UK 
    • Iceland 
    • Switzerland
    • Poland
    • Rest of Western Europe
  • Eastern Europe 
    • Austria
    • Russia & Belarus 
    • Türkiye
    • Albania 
    • Rest of Eastern Europe 
• Asia Pacific
  • China 
  • Taiwan
  • India 
  • Japan 
  • Australia and New Zealand
  • ASEAN Countries (Singapore, Malaysia)
  • South Korea 
  • Rest of APAC 
• MEA 
  • GCC Countries
    • Saudi Arabia 
    • United Arab Emirates (UAE)
    • Qatar 
    • Kuwait 
    • Oman 
    • Bahrain 
  • South Africa
  • Egypt 
  • Rest of MEA