Oral Solid Dosage CDMO Market Size & Share Analysis - Growth Trends and Forecast (2026 - 2031)

Global Oral Solid Dosage CDMO Market Trends and Insights

Outsourcing Acceleration for OSD Drug Product Development and Manufacturing

Capital allocation has shifted decisively toward molecule pipelines, with big-pharma sponsors redirecting more than USD 50 billion in 2024-2025 away from fixed assets. High-profile commitments—Eli Lilly (USD 27 billion) and Novartis (USD 23 billion)—signal that in-house oral solid capacity no longer delivers compelling returns. Large sponsors confronting patent cliffs are rerouting legacy brands to CDMOs, while virtual biotechs with zero manufacturing footprint accounted for 38% of FDA NDAs in 2025 ^{[1]U.S. Food and Drug Administration, “Novel Drug Approvals 2024,” FDA, fda.gov Drivers}. Contractors offering integrated formulation-through-commercial services are winning a disproportionate share because single-source models eliminate costly hand-offs.

Poorly Soluble Small Molecules Drive Enabling Technologies

More than 70% of pipeline candidates exhibit poor solubility, motivating rapid deployment of spray-drying and hot-melt extrusion. Commercial installations of spray-dried-dispersion towers tripled in 2024-2025 ^{[2]S. Kumar et al., “Amorphous Solid Dispersions: A Strategy for Enhancing Oral Bioavailability,” AAPS PharmSciTech, aaps.org}. Capital intensity remains a barrier; single dryers cost USD 3-5 million, creating structural advantages for incumbents. FDA draft guidance issued in 2024 clarified recrystallization-stability expectations, influencing CDMO selection by sponsors intent on derisking approval timelines.

Rising HPAPI and Cytotoxic Oral Therapies Require High-Containment OSD Capacity

High-potency molecules now represent 35% of oncology pipelines, yet only 18 CDMOs operate OEB 5 facilities, stretching project lead times to 24 months. Pfizer CentreOne’s USD 120 million containment suite in Freiburg, commissioned in 2024, was fully booked within six months. ISPE guidance released the same year raised engineering standards, adding 40% to build-out costs ^{[3]International Society for Pharmaceutical Engineering, “Containment Strategies for High-Potency APIs,” ISPE, ispe.org}.

Regulatory Support and Adoption of Continuous Manufacturing for OSD

FDA’s Emerging Technology Program approved 12 continuous lines between 2024 and 2025, slashing cycle times from weeks to days. Vertex gained cost savings of 30% on its cystic-fibrosis tablet after FDA’s 2024 approval. EMA granted its first continuous-manufacturing approval in 2025, signaling convergence that lowers adoption risk. 

Evolving Compliance Burden Increases Cost and Time

ICH Q3D elemental-impurity limits plus nitrosamine testing raised per-product compliance costs by an average of USD 1.2 million in 2025. CDMOs without in-house LC-MS now outsource assays at USD 5,000-15,000 per sample, eroding generic margins.

Pricing Pressure and Procurement Consolidation Compress Margins

Top-10 pharma companies cut CDMO rosters by a significant share during 2024-2025, extracting price concessions that lowered gross margins at leading contractors. For example, Catalent’s oral-technologies margin fell from 28% to 24%. Extended payment terms further stress working capital.

Segment Analysis

By Dosage Form: Capsules Gain on Swallowability and HP Suitability

Tablets held 33.6% market share in 2025, yet capsules are forecast for a 7.23% CAGR through 2031, outstripping tablets’ 5.8% advance. Hard-shell gelatin and HPMC capsules mitigate dust generation, making them preferred for OEB 4-5 compounds. Capsule formats were specified in 42% of 505(b)(2) approvals in 2024 because they better accommodate lipid-based or spray-dried dispersions. Patient studies show 68% favor capsules for ease of swallowing.

Lonza expanded capsule-filling in Portsmouth in 2024, adding 2 billion units of annual capacity focused on high-potency oncology products. While immediate-release tablets remain entrenched for commoditized generics, modified-release tablets capture incremental value through polymer-coated matrices that enable once-daily dosing.

Note: Segment shares of all individual segments available upon report purchase

By Release Mechanism: Modified Release Captures Lifecycle Extensions

Immediate-release formats commanded 55.23% revenue in 2025, yet controlled/modified-release variants are projected to grow 8.85% CAGR to 2031. Once-daily dosing boosts adherence to 78% versus 62% for twice-daily regimens. Delayed-release share reached a notable share in 2025, supported by enteric coatings for gastric protection. GLP-1 agonists reformulated into oral modified-release versions are expanding the scope of swallowable peptides; Novo Nordisk’s improved oral semaglutide, launched in 2024, demonstrated the feasibility of this approach. CDMOs with in-silico dissolution-modeling and IVIVC expertise accelerate submission readiness, reinforcing integrated service demand.

By Service Type: Integrated CDMO Models Capture Share

Contract development and manufacturing generated 65.38% of 2025 revenue and will rise at 6.90% CAGR through 2031. A 2024 survey showed 42% of tech transfers between separate organizations suffered six-month delays, prompting sponsors to favor single-source partners. Serialization regulations such as DSCSA are propelling packaging and labeling outsourcing, which held a notable share in 2025. Thermo Fisher’s Patheon unit, spanning 40 sites, captured a smaller share of the global Oral Solid Dosage CDMO market share in 2025.

Note: Segment shares of all individual segments available upon report purchase

By End User: Mid-Tier Pharma Drives Outsourcing Growth

Large pharma/biotech delivered 58.38% of 2025 revenue, but mid-size and emerging sponsors show faster expansion, at 6.58% CAGR. Venture-backed companies that outsourced manufacturing reached clinical milestones 30% sooner than peers that built internal capacity. Alcami’s biotech-focused model, launched in 2024, captured 15 new clients within a year. Roster consolidation among big sponsors squeezes unit prices yet opens opportunities for niche CDMOs specialized in flexible batch sizes.

Geography Analysis

North America accounted for 44.25% of the Oral Solid Dosage CDMO market share in 2025, underpinned by proximity to FDA headquarters and the Emerging Technology Program’s endorsement of 12 continuous-manufacturing platforms between 2024 and 2025. Regional revenue is projected to expand through 2031 as sponsors prioritize supply chains that reduce audit complexity and enable rapid regulatory engagement; a 2024 poll showed 72% of U.S. companies favor domestic contractors despite 15-25% cost premiums over Asian options. Thermo Fisher’s USD 180 million Greenville upgrade added three continuous lines in January 2025, targeting biotech clients that require flexible batches and fast turnarounds. Canada and Mexico jointly held notable share of regional sales in 2025; PCI Pharma Services’ USD 75 million Monterrey plant illustrates Mexico’s appeal for nearshoring under USMCA trade rules. High domestic labor costs 40-60% above Asia-Pacific continue to push commodity tablet work offshore while preserving high-value continuous-manufacturing and high-potency projects locally.

Asia-Pacific is forecast to grow at an 8.48% CAGR, the fastest among all regions of the Oral Solid Dosage CDMO market, driven by large-scale investments in China and India. India’s Production-Linked Incentive scheme spurred USD 4.2 billion of spending during 2024-2025; Granules India’s USD 220 million Gagillapur expansion, approved by FDA in December 2024, added continuous-manufacturing capability aimed at U.S. biotech clients. China’s sector grew 22% in 2024 as players such as WuXi AppTec acquired an oral-solids plant in Wuxi with 5 billion-tablet output for both domestic and export supply. Japan's regional revenue in 2025 faces headwinds from aging assets, whereas South Korea benefited from Samsung Biologics’ USD 310 million tablet-facility purchase in 2024. Australia kept a modest share, yet recent TGA alignment with ICH rules is drawing clinical-trial production from Northern Hemisphere sponsors. Although labor costs run 50-70% below those in North America and Europe, longer inspection lead times limit penetration in controlled-substance and cytotoxic segments.

Europe contributed significantly to the Oral Solid Dosage CDMO market size in 2025, anchored by Germany and Switzerland, which together house majority of the world’s OEB 5 facilities. Energy prices in Europe surged above pre-2022 levels during 2024, encouraging relocation of low-margin work to cheaper locales . Germany held notable share of of European revenue in 2025 following Siegfried’s USD 85 million Minden extrusion expansion for poorly soluble molecules. The United Kingdom has shortened MHRA approval timelines for CDMO output from 15 to 11 months, boosting its attractiveness for fast launches. France, Italy, and Spain collectively held notable share, highlighted by Recipharm’s USD 300 million Novo Nordisk contract for oral semaglutide tablets signed in September 2024. Middle East and Africa revenue share in 2025 is supported by Saudi Arabia’s USD 1.3 billion localization incentives, while South America’s stake reflects Brazil’s move to cut CDMO approval cycles from 18 to 12 months in 2024, enticing U.S. sponsors to nearshore Latin American supply.