Oral Solid Dosage CDMO Market By Product Type (Tablets, Capsules, Powders & Granules, Lozenges); By Phase (Preclinical & Clinical Manufacturing, Commercial Manufacturing); By End User (Pharmaceutical Companies, Biotechnology Firms, Nutraceutical Companies); By Region (North America, Europe, Asia Pacific, Latin America, Middle East & Africa); Segment Revenue Estimation, Forecast, 2024–2030.

Introduction And Strategic Context

The Global Oral Solid Dosage CDMO (Contract Development And Manufacturing Organization) Market will demonstrate CAGR of 6.7%, valued at $27.8 billion in 2024 and forecasted to hit $40.4 billion by 2030, propelled by Advanced Manufacturing Technologies, Pharmaceutical Outsourcing Growth, Tablet And Capsule Production, Regulatory Compliance Excellence, Clinical Manufacturing Services, and Global Pharma Expansion, as published by Strategic Market Research.

 

Oral solid dosage (OSD) forms—such as tablets, capsules, powders, and granules—remain the most prescribed and consumed pharmaceutical formats worldwide. As pharmaceutical companies increasingly seek to streamline operations and cut internal costs, outsourcing these manufacturing processes to CDMOs has become a strategic imperative. The CDMO industry not only handles large-scale manufacturing but also supports complex formulation development, clinical batch production, and regulatory compliance, offering end-to-end solutions across the drug development lifecycle.

 

This strategic shift is influenced by several macro-level forces. One key factor is the growing demand for generic drugs and specialty pharma products , which has elevated the complexity of solid oral formulations. Additionally, the regulatory tightening by global health authorities , such as the FDA and EMA, is compelling pharma innovators to partner with CDMOs that possess deep regulatory expertise and robust GMP-compliant facilities. This ensures accelerated approvals and de-risks the go-to-market timeline.

 

Further, technological evolution —particularly in areas like high-shear granulation, multi- particulate systems, taste masking, and controlled-release delivery—is transforming the capabilities of CDMOs. Many leading providers are incorporating continuous manufacturing, QbD (Quality by Design), and automation systems , thereby improving cost-efficiency and scalability for clients.

 

The growth of the oral solid dosage CDMO market is also underpinned by increased R&D activity by small and mid-sized biotech firms , which often lack in-house production capabilities. These firms heavily depend on external partners to support both clinical and commercial manufacturing. Additionally, global supply chain disruptions post-COVID-19 have prompted many pharmaceutical companies to diversify their manufacturing base through nearshoring and strategic partnerships, directly benefiting CDMO players with multi-regional capacity.

 

Key stakeholders driving the market include:

• Pharmaceutical and biotechnology companies (innovators and generic manufacturers)

• CDMOs and CMOs (full-service and specialized)

• Regulatory agencies and pharma consultants

• Private equity investors focused on healthcare manufacturing assets

• Healthcare providers requiring rapid access to outsourced solutions for new drug launches

In summary, the OSD CDMO market sits at the intersection of cost optimization, technical specialization, and operational flexibility. As the demand for patient-centric, high-quality oral therapies rises, the role of CDMOs will become more integral to the global pharmaceutical manufacturing ecosystem.

“The OSD outsourcing trend reflects the need for speed, scale, and scientific know-how, especially as molecules grow more complex and regulatory scrutiny intensifies,” notes a pharmaceutical supply chain expert.

 

Comprehensive Market Snapshot

The Global Oral Solid Dosage CDMO (Contract Development And Manufacturing Organization) Market is projected to expand at a 6.7% CAGR, rising from USD 27.8 billion in 2024 to USD 40.4 billion by 2030, driven by advanced manufacturing technologies, pharmaceutical outsourcing acceleration, tablet and capsule demand expansion, regulatory compliance specialization, clinical manufacturing services growth, and global pharma capacity diversification.

Regional Revenue Breakdown (Calculated from 2024 Global Base: USD 27.8 Billion)

• USA (30.5% Share): The USA accounted for the largest regional share of 30.5% in 2024, with a market size of USD 8.48 billion, and is projected to reach USD 11.74 billion by 2030, growing at a CAGR of 5.6% (2024–2030), supported by established CDMO infrastructure, regulatory expertise, and high branded generic outsourcing volume.

• Europe (27% Share): Europe held a market share of 27% in 2024, valued at USD 7.51 billion, and is expected to reach USD 9.79 billion by 2030 at a CAGR of 4.5% (2024–2030), driven by mature pharmaceutical outsourcing networks and strong compliance standards.

• APAC (22% Share): APAC represented 22% of the market in 2024 with a valuation of USD 6.12 billion, and is projected to expand to USD 10.38 billion by 2030, registering the fastest CAGR of 9.2% (2024–2030), fueled by cost-efficient manufacturing hubs, expanding Indian and Chinese formulation capacity, and growing biotech outsourcing.

 

Regional Insights

• USA accounted for the largest market share of 30.5% in 2024, supported by established CDMO infrastructure, regulatory expertise, and high branded generic outsourcing volume.

• APAC is expected to expand at the fastest CAGR of 9.2% during 2024–2030, driven by cost-efficient manufacturing hubs, expanding Indian and Chinese formulation capacity, and growing biotech outsourcing.

 

By Product Type

• Tablets (47.5% Share): Tablets dominated the product landscape with a 47.5% share in 2024, generating USD 13.21 billion out of the global USD 27.8 billion market, reflecting high prescription volume, manufacturing scalability, and stability advantages.

• Capsules (28% Share): Capsules accounted for 28% of the market in 2024, valued at USD 7.78 billion, and are projected to grow at a notable CAGR through 2030, supported by nutraceutical expansion and personalized dosage formats.

• Powders & Granules (16% Share): Powders & granules held a 16% share in 2024, equivalent to USD 4.45 billion, driven by flexibility in formulation and demand across pediatric and specialty applications.

• Lozenges (8.5% Share): Lozenges represented 8.5% of the market in 2024, amounting to USD 2.36 billion, supported by OTC demand and specialty therapeutic applications.

 

By Phase

• Commercial Manufacturing (68% Share): Commercial manufacturing accounted for the highest share of 68% in 2024, generating USD 18.90 billion, reflecting high-volume batch outsourcing by large pharmaceutical companies and established product portfolios.

• Preclinical & Clinical Manufacturing (32% Share): Preclinical & clinical manufacturing contributed 32% of the market in 2024, valued at USD 8.90 billion, and is expected to grow at a strong CAGR during 2024–2030 due to rising IND filings and biotech-led formulation development demand.

 

By End User

• Pharmaceutical Companies (62% Share): Pharmaceutical companies represented the largest end-user segment with 62% share in 2024, generating USD 17.24 billion, driven by lifecycle management strategies, generics production, and global portfolio expansion.

• Biotechnology Firms (26% Share): Biotechnology firms accounted for 26% of the market in 2024, valued at USD 7.23 billion, and are anticipated to expand at a robust CAGR through 2030, supported by oncology pipelines and orphan drug commercialization.

• Nutraceutical Companies (12% Share): Nutraceutical companies held a 12% share in 2024, contributing USD 3.34 billion, supported by rising consumer demand for preventive healthcare and contract-based supplement manufacturing.

 

Strategic Questions Driving the Next Phase of the Global Oral Solid Dosage CDMO (Contract Development And Manufacturing Organization) Market

1. What specific services are explicitly included within the Oral Solid Dosage (OSD) CDMO market (e.g., formulation development, scale-up, tech transfer, commercial manufacturing), and which adjacent services remain out of scope?

2. How does the OSD CDMO market structurally differ from biologics CDMOs, sterile injectables CDMOs, and integrated full-service outsourcing platforms?

3. What is the current and forecasted size of the Global OSD CDMO Market, and how is value distributed across tablets, capsules, powders, granules, and specialty formats?

4. How is revenue allocated between early-stage (preclinical/clinical) manufacturing and large-scale commercial manufacturing, and how will this mix evolve through 2030?

5. Which dosage formats (e.g., immediate release, controlled release, enteric-coated, high-potency OSD) account for the largest and fastest-growing revenue pools?

6. Which service segments contribute disproportionately to margin generation—high-potency APIs (HPAPIs), complex formulations, or high-volume generics manufacturing?

7. How does sponsor demand differ between large pharmaceutical companies, biotechnology firms, and nutraceutical companies, and how does this influence contract structure and capacity allocation?

8. How are formulation complexity, solubility challenges, and modified-release technologies reshaping CDMO capability requirements?

9. What role do long-term strategic supply agreements versus project-based contracts play in stabilizing revenue growth and improving plant utilization?

10. How are global pharmaceutical outsourcing trends, cost-containment strategies, and capacity rationalization shaping demand for OSD CDMOs?

11. What regulatory compliance factors (FDA, EMA, PMDA, WHO GMP) most strongly influence site selection and sponsor trust?

12. How do pricing pressure, tender-based procurement, and generics competition affect margin realization in high-volume OSD manufacturing?

13. How robust is the development pipeline of small-molecule drugs, and how will pipeline concentration in oncology, CNS, and metabolic diseases impact OSD outsourcing demand?

14. To what extent will emerging drug modalities (e.g., targeted oral oncology therapies) expand addressable outsourcing volumes versus intensify competition among CDMOs?

15. How are continuous manufacturing technologies, automation, and digital quality systems transforming cost structures and scalability in OSD production?

16. How will patent expirations and loss of exclusivity across blockbuster oral drugs reshape generic manufacturing demand and CDMO capacity utilization?

17. What role will generics expansion and biosimilar spillover (oral adjunct therapies) play in driving volume-based outsourcing growth?

18. How are leading CDMOs aligning investments in high-potency suites, containment infrastructure, and geographic expansion to defend or grow market share?

19. Which geographic regions (USA, Europe, APAC) are expected to outperform global growth, and which dosage formats or service segments are driving this outperformance?

20. How should manufacturers and investors prioritize capacity expansion, technology upgrades, and regional footprint optimization to maximize long-term value creation in the OSD CDMO market?

 

Segment-Level Insights and Market Structure

Global Oral Solid Dosage CDMO (Contract Development And Manufacturing Organization) Market

The Oral Solid Dosage (OSD) CDMO market is organized around distinct service categories and client engagement models that reflect differences in development complexity, production scale, regulatory intensity, and sponsor strategy. Each segment contributes uniquely to total contract value, operating margins, and long-term growth potential. Market structure is influenced by drug lifecycle stage, formulation sophistication, sponsor type, and geographic manufacturing footprint.

 

By Product Type Insights

Tablets

Tablets represent the structural backbone of the OSD CDMO market. Their dominance is driven by manufacturing efficiency, scalability, and widespread therapeutic applicability across chronic and acute disease areas. CDMOs benefit from established compression technologies, coating capabilities, and high-throughput batch production lines that support large commercial volumes.

From a commercial standpoint, tablet manufacturing provides predictable demand, particularly for generics, lifecycle-managed products, and high-volume primary care therapies. Over time, value within this segment is increasingly shifting toward modified-release formats, bilayer tablets, fixed-dose combinations, and high-potency containment production, which offer stronger pricing power compared to conventional immediate-release products.

Capsules

Capsules represent a strategically important and innovation-oriented segment within the OSD outsourcing landscape. Hard gelatin, HPMC, enteric-coated, and specialty capsules are widely used for drugs requiring enhanced bioavailability, taste masking, or targeted release profiles.

Capsule manufacturing often supports differentiated products, nutraceutical expansion, and personalized medicine applications. As sponsors pursue patient-centric formulations and complex release mechanisms, CDMOs with encapsulation expertise and formulation optimization capabilities are gaining competitive advantage. This segment is particularly attractive in oncology and specialty small-molecule pipelines where dosage precision and tolerability are critical.

Powders & Granules

Powders and granules serve as intermediate and final dosage forms across pediatric, geriatric, and reconstitution-based therapies. These formats are commonly used where flexible dosing, rapid dissolution, or sachet-based packaging is required.

Operationally, this segment demands expertise in blending uniformity, moisture control, and packaging integrity. While not as large as tablets or capsules in absolute value, powders and granules are important for niche therapeutic areas and emerging markets where sachet-based dispensing is common. Growth in this segment is supported by demand for dispersible formulations and cost-sensitive high-volume treatments.

Lozenges

Lozenges represent a smaller but specialized segment of the OSD CDMO market. Typically used for throat, oral cavity, and localized therapeutic applications, lozenges require expertise in molding, flavor integration, and stability control.

Although volume contribution is comparatively limited, this segment supports consumer-health crossover opportunities and branded specialty formulations. CDMOs offering lozenge capabilities often compete in differentiated therapeutic niches rather than high-volume pharmaceutical production.

 

By Phase Insights

Preclinical and Clinical Manufacturing

Preclinical and clinical manufacturing services focus on formulation development, pilot-scale production, analytical validation, and regulatory documentation support for IND and early-stage trials. This segment is characterized by smaller batch sizes, high customization, and close sponsor collaboration.

Revenue per batch is typically higher relative to volume due to the technical complexity and development intensity involved. CDMOs operating in this segment differentiate through formulation science expertise, rapid turnaround, and regulatory advisory capabilities. Growth is closely tied to biotech pipeline activity and early-stage small-molecule innovation.

Commercial Manufacturing

Commercial manufacturing represents the largest value pool within the OSD CDMO market. It involves high-volume, GMP-compliant production for approved products across global markets. Sponsors increasingly outsource commercial-scale production to optimize fixed costs and reduce capital investment in manufacturing infrastructure.

This segment benefits from long-term supply agreements, multi-year contracts, and predictable demand patterns. However, competitive pressure is stronger in commoditized generics manufacturing, whereas complex oral products and high-potency drugs command premium pricing. Capacity utilization rates and geographic cost positioning play central roles in profitability.

 

By End User Insights

Pharmaceutical Companies

Pharmaceutical companies constitute the core customer base for OSD CDMOs. Large and mid-sized pharma firms outsource both development and commercial manufacturing to increase operational flexibility, streamline supply chains, and focus on R&D and commercialization.

Outsourcing partnerships are often long-term and strategically structured. Demand is strongest for lifecycle management projects, reformulations, geographic expansion manufacturing, and generic portfolio support. This segment provides revenue stability and scale.

Biotechnology Firms

Biotechnology companies represent a fast-growing client segment, particularly in targeted oncology and rare disease pipelines. These sponsors typically lack in-house manufacturing infrastructure and rely heavily on CDMOs from early development through commercialization.

Projects tend to be smaller in volume but higher in technical complexity, often involving high-potency APIs or specialized release mechanisms. As biotech pipelines expand globally, this segment is expected to drive incremental growth in development-phase services and specialty commercial production.

Nutraceutical Companies

Nutraceutical and consumer health companies increasingly utilize OSD CDMOs for capsule and tablet production, particularly in vitamins, supplements, and functional health products. This segment emphasizes speed-to-market, branding differentiation, and flexible production runs.

While regulatory frameworks differ from prescription pharmaceuticals, quality compliance and scalability remain important. The segment contributes diversification benefits for CDMOs and provides exposure to high-growth wellness markets.

 

Segment Evolution Perspective

The OSD CDMO market is transitioning from volume-centric generic manufacturing toward a more balanced mix that includes complex formulations, high-potency compounds, and development-phase specialization. Simultaneously, sponsor diversification—from large pharmaceutical companies to biotech and nutraceutical firms—is reshaping revenue distribution.

Advances in formulation science, automation, digital quality systems, and continuous processing are gradually redefining competitive differentiation. Over the forecast period, value is expected to concentrate in technically sophisticated, regulatory-intensive, and long-term partnership-driven segments rather than commoditized high-volume production alone.

 

Market Segmentation And Forecast Scope

The global oral solid dosage CDMO market is segmented to provide granular insights into demand patterns, production complexity, and commercial potential. Strategic Market Research has categorized the market across four primary dimensions:

By Product Type

• Tablets

• Capsules

• Powders & Granules

• Lozenges

Among these, tablets dominate the market, accounting for approximately 47.5% of the global revenue in 2024 . This is due to their high patient compliance, ease of production, and extended shelf life. However, capsules are emerging as the fastest-growing sub-segment , especially in the nutraceutical and personalized medicine sectors, where soft gels and enteric-coated capsules are gaining traction.

 

By Phase

• Preclinical and Clinical Manufacturing

• Commercial Manufacturing

The commercial manufacturing segment holds the largest share, as big pharma increasingly outsources high-volume batch production to reduce overhead. Yet, preclinical and clinical manufacturing is forecast to grow at a faster pace between 2024 and 2030 , driven by the proliferation of early-stage biotech startups and the need for formulation development expertise during IND/Phase I trials.

 

By End User

• Pharmaceutical Companies

• Biotechnology Firms

• Nutraceutical Companies

Pharmaceutical companies remain the core clients for OSD CDMOs, contributing over 62% of the market in 2024 , primarily for branded generics and lifecycle management projects. In contrast, biotechnology firms , especially those focusing on oncology and orphan drugs, are becoming significant outsourcing clients due to their limited in-house infrastructure.

 

By Region

• North America

• Europe

• Asia Pacific

• Latin America

• Middle East & Africa

North America leads in revenue, backed by a high concentration of pharmaceutical innovators, stringent regulatory oversight, and established CDMO infrastructure. However, Asia Pacific is projected to witness the highest CAGR during the forecast period, driven by low-cost manufacturing, talent availability, and rising domestic drug production in countries like India and China.

This multi-dimensional segmentation highlights the diverse client base and production complexity within the OSD CDMO landscape. Each sub-market offers unique growth levers, from innovation-intensive early-stage partnerships to high-volume commercial scale-up for legacy products.

“The segmentation across clinical phases and dosage forms reflects a CDMO’s dual role—supporting innovation at the front end and delivering scale at the back end,” observes a veteran pharma operations consultant.

 

Market Trends And Innovation Landscape

The oral solid dosage (OSD) CDMO market is undergoing a structural transformation, spurred by technological advancement, demand for formulation sophistication, and heightened expectations around compliance and speed-to-market. The innovation landscape is rich with change agents—from equipment modernization to the rise of 505(b)(2) reformulation strategies.

Formulation Innovation and Complexity Rise

As patient-centric therapies take center stage, CDMOs are investing heavily in complex oral delivery technologies , including:

• Modified-release systems (e.g., sustained, delayed, pulsatile release)

• Multilayer tablets

• Microencapsulation and nano -particle engineering

These technologies support the delivery of low-solubility APIs , improve bioavailability, and enable differentiated lifecycle management. CDMOs with proprietary capabilities in hot-melt extrusion, spray drying , and fluid-bed coating are winning long-term contracts, especially from mid-sized and specialty pharma.

“The ability to customize pharmacokinetics through advanced formulation is not just a technical skill—it’s a business moat,” states a formulation scientist from a leading CDMO.

 

Adoption of Continuous Manufacturing and QbD

One of the most notable innovations is the gradual adoption of continuous manufacturing (CM) over traditional batch processing. This shift allows for:

• Real-time quality monitoring

• Reduced batch failures

• Shorter production cycles

In tandem, Quality by Design ( QbD ) frameworks are becoming a regulatory expectation, not just a competitive advantage. CDMOs that integrate QbD principles—such as design space mapping and process analytical technology (PAT)—are increasingly trusted by regulatory authorities and clients alike.

 

Automation, Digitalization, and Industry 4.0

To improve throughput and consistency, leading CDMOs are leveraging:

• Automated capsule filling and tablet pressing lines

• MES (Manufacturing Execution Systems)

• Digital twins and predictive maintenance tools

These smart factory initiatives enhance both operational excellence and compliance traceability , which are vital in multi-client GMP environments.

 

Partnership Models and Strategic Deals

The CDMO landscape is seeing a surge in strategic collaborations between drug sponsors and contract partners. These include:

• Long-term capacity reservation agreements

• Joint IP development

• Exclusive formulation partnerships

Recent years have also seen a wave of private equity-backed consolidations , where smaller specialized players are being merged into global platforms with broader service offerings.

 

Pipeline Acceleration Through Outsourced R&D

Early-stage R&D outsourcing is growing, especially for 505(b )( 2) reformulations and fixed-dose combinations (FDCs) . CDMOs that offer integrated services—from analytical method development to IND filing support—are becoming strategic partners in early molecule development.

“Today’s OSD CDMOs are not just manufacturers; they are solution architects that enable development acceleration and regulatory predictability,” notes a director of clinical operations at a mid-sized pharma.

The innovation trajectory of the OSD CDMO market indicates a future where technical depth, regulatory fluency, and smart manufacturing will define competitive advantage. Players that master these axes will secure premium partnerships and long-term growth.

 

Competitive Intelligence And Benchmarking

The global oral solid dosage CDMO market is moderately fragmented, characterized by a mix of large, vertically integrated providers and highly specialized niche players. The competitive landscape is evolving through capacity expansion, technical differentiation, and service model integration.

Below are seven influential players shaping the OSD CDMO sector:

Lonza

A powerhouse in the pharmaceutical services industry, Lonza offers comprehensive OSD capabilities ranging from early-phase development to commercial-scale production. Its strategic focus lies in high-potency oral solids and integrated development pathways. Lonza’s global footprint—with sites in Europe, the U.S., and Asia—gives it an edge in serving multinational pharma clients. It emphasizes innovation through complex dosage forms and high-containment facilities .

 

Catalent

Known for its broad-spectrum CDMO services, Catalent has cemented its position in OSD by investing in oral modified-release platforms , bioavailability enhancement , and softgel technologies . With dedicated facilities across the U.S. and Europe, it supports both branded and generic products. Its strategy includes collaborative R&D with biotech firms and end-to-end clinical-to-commercial transitions, especially for orphan and specialty therapies .

 

Thermo Fisher Scientific (Patheon)

Operating under the Patheon brand, Thermo Fisher Scientific delivers a robust mix of development and manufacturing solutions. Its strength lies in late-phase and commercial manufacturing , including multi-compartment tablets and coated capsules . It differentiates itself through integrated supply chain solutions and regulatory support, especially for global IND and NDA filings .

 

Recipharm

Sweden-based Recipharm focuses on tablets and capsules with a stronghold in Europe and growing presence in Asia. It serves both high-volume generics and complex Rx drugs. The company’s regulatory compliance record and supply reliability have made it a partner of choice for global brands seeking EU market entry.

 

Piramal Pharma Solutions

Headquartered in India, Piramal specializes in formulation development and clinical trial manufacturing of OSDs, with capabilities in controlled substances and multi-dose layering technologies . Piramal offers cost-efficient services combined with global regulatory alignment, making it particularly attractive to North American and European pharma clients.

 

Almac Group

Almac delivers niche and clinical-stage CDMO services for solid oral formulations. Its strength lies in early-phase formulation, dose escalation studies , and clinical packaging . The firm is known for its agile project timelines, quality consistency, and customer-centric approach, making it a go-to partner for emerging biotechs and university spinouts.

 

Aenova Group

With a pan-European footprint, Aenova is a major player in OSD manufacturing. It serves both human and veterinary health markets. Its service model emphasizes large-scale commercial production , regulatory documentation , and serialization support , enabling clients to streamline their EU and emerging markets operations.

 

Each of these companies competes on a combination of:

• Technical depth (e.g., high-containment, taste masking, controlled-release)

• Geographic reach

• Regulatory credibility

• Speed and flexibility in project execution

“Differentiation in this market is not about who can make tablets, but who can make them faster, cleaner, and smarter,” remarks a VP of pharma supply operations.

 

Regional Landscape And Adoption Outlook

The adoption of oral solid dosage CDMO services varies significantly across regions, influenced by regulatory complexity, pharma infrastructure, labor cost, and innovation maturity. The market displays a dynamic interplay between established pharmaceutical hubs and emerging manufacturing powerhouses.

North America

North America, particularly the United States, holds the dominant share of the global OSD CDMO market in 2024, thanks to its concentration of pharma innovators, clinical research organizations, and FDA-compliant facilities. U.S.-based CDMOs benefit from:

• High outsourcing penetration

• Strong preference for early-phase formulation services

• Increasing demand for 505(b)(2) repurposing and lifecycle extension strategies

In Canada, the OSD CDMO ecosystem is smaller but well-regulated, with niche providers focusing on clinical packaging and low-volume production .

“North America continues to set the regulatory benchmark and is driving premiumization of CDMO services,” notes a compliance analyst at a New Jersey-based pharma company.

 

Europe

Europe is the second-largest region, with strong demand across both generic drug manufacturers and originator pharma companies . Countries like Germany, Switzerland, the UK, and Sweden serve as strategic production and development hubs. Key regional traits include:

• Emphasis on EU-GMP compliance and serialization capabilities

• Mature CDMOs with experience in high-volume tablet production

• Government-backed initiatives in drug repurposing and rare diseases

Additionally, Eastern Europe (e.g., Poland, Czech Republic) is emerging as a cost-competitive region with skilled labor and regulatory harmonization under EMA.

 

Asia Pacific

Asia Pacific is forecasted to grow at the fastest CAGR through 2030 , driven by robust pharmaceutical manufacturing in India and China . Regional highlights include:

• India’s dominance in generic drug production and cost-efficient CDMO services

• China’s growing investment in high-containment oral solids and regulatory reform

• Japan’s focus on specialty and elderly-targeted formulations

Local CDMOs are evolving rapidly, upgrading capabilities in QbD , continuous manufacturing , and ICH compliance , making the region attractive not just for cost, but also for scientific depth.

 

Latin America

Countries like Brazil and Mexico are showing increased adoption of OSD CDMO partnerships, primarily for domestic generics and branded pharmaceuticals. While regulatory infrastructure is improving, limitations remain in:

• Advanced formulation expertise

• Access to scale-up technologies However, CDMOs in this region often act as regional supply nodes for multinationals looking to tap LATAM markets.

 

Middle East & Africa (MEA)

The MEA region represents a white space in the OSD CDMO map.

• Although demand is increasing—particularly in Saudi Arabia, UAE, and South Africa —the region lacks manufacturing scale and skilled formulation talent.

• Most pharmaceutical firms here rely on imports from Europe or Asia, opening opportunities for nearshore partnerships and technology transfer models.

“As regulatory frameworks in the GCC tighten and localization pressures mount, demand for regional CDMO capacity in oral solids could spike,” predicts a regional healthcare investment advisor.

This regional mosaic reflects a global rebalancing: while North America and Europe remain premium service centers, Asia Pacific is redefining the value proposition through technical maturity and cost advantage. Regions like LATAM and MEA offer future growth if local infrastructure and regulatory clarity catch up.

 

End-User Dynamics And Use Case

End users of oral solid dosage CDMO services span a diverse spectrum of healthcare stakeholders, from multinational pharmaceutical giants to emerging biotechs and nutraceutical startups. Each group seeks specific value propositions, shaping how CDMOs position their offerings across formulation, scalability, regulatory support, and cost-efficiency.

1. Pharmaceutical Companies

Large and mid-sized pharmaceutical companies form the backbone of the OSD CDMO client base. These players typically outsource for:

• Lifecycle management (e.g., reformulations, line extensions)

• Surge capacity to complement internal manufacturing

• Cost-reduction for non-core or legacy product lines

In many cases, they rely on CDMOs for modified-release tablets, fixed-dose combinations , and global supply chain logistics , especially during launch or patent expiry windows.

“For Big Pharma, CDMO relationships are strategic risk mitigators —offering quality, flexibility, and responsiveness without compromising IP,” notes a supply chain director at a top-10 pharma company.

 

2. Biotechnology Firms

Smaller biotech companies often lack in-house formulation or GMP capabilities, making CDMOs critical partners across:

• IND-enabling studies

• Phase I–III clinical supply

• Small-batch high-potency manufacturing

These clients are particularly reliant on CDMOs for complex formulations that involve low-dose APIs, pediatric delivery forms, or fast-dissolving platforms.

 

3. Nutraceutical Companies

The nutraceutical sector —encompassing vitamins, herbal supplements, and functional foods—is emerging as a growing consumer of OSD CDMO services. With a focus on capsules, chewables , and multi-layer tablets , these companies favor:

• Rapid scale-up and branding flexibility

• Taste-masking and color customization

• Global compliance for cross-border retail

They typically prioritize speed-to-shelf and cost-effective production, making Asia-based CDMOs especially attractive.

 

Use Case: Clinical-Stage Biotech in South Korea

A mid-sized biotech firm based in South Korea developed a novel kinase inhibitor targeting rare pediatric tumors. The compound, characterized by low aqueous solubility and high first-pass metabolism , required a customized formulation approach. The company partnered with a European CDMO specializing in oral amorphous solid dispersions via hot-melt extrusion.

The CDMO:

• Designed a Phase I clinical batch with improved dissolution profile

• Supported bioavailability studies in two geographies

• Delivered cGMP-compliant pilot lots within 4 months

As a result, the biotech achieved faster IND approval, enabling it to initiate U.S.-based trials six months ahead of schedule.

“Without the CDMO’s formulation design and regulatory foresight, we would have missed our clinical milestone,” commented the biotech’s Chief Scientific Officer.

Each end-user segment drives demand in unique ways—from cost containment in mature portfolios to technical sophistication in early-stage molecules. CDMOs that adapt to these nuances—offering tailored service bundles, digital interface flexibility, and global quality alignment—stand to earn long-term, multi-project partnerships.

 

Recent Developments + Opportunities & Restraints

Recent Developments (Last 2 Years)

• Lonza expanded its oral dosage capabilities by opening a new high-potency API and solid oral manufacturing suite in Visp , Switzerland, aimed at meeting rising demand for oncology and immunology compounds.

• Catalent launched its SMARTag OSD platform, designed to streamline the development of bioavailability-enhanced solid oral dosage forms, targeting poorly soluble compounds in oncology and neurology.

• Recipharm acquired Arranta Bio's development site in Florida, signaling its push toward end-to-end OSD and biologics integration for emerging biotech clients.

• Aenova invested €15 million in digital manufacturing upgrades, incorporating MES and PAT systems across its tablet production lines in Germany, to enhance compliance and output quality.

• Thermo Fisher signed a 5-year CDMO contract with a top-20 pharma firm for global OSD manufacturing support, emphasizing continuous manufacturing and serialization capabilities.

 

Opportunities

• Growing complexity of oral formulations: The rising number of low-solubility APIs and highly potent compounds presents a major opportunity for CDMOs offering advanced oral formulation technologies like spray drying, hot-melt extrusion , and nano -milling.

• Demand from emerging and mid-sized biotech firms: With limited internal manufacturing infrastructure, these firms are outsourcing earlier and deeper , especially in rare diseases, oncology, and pediatric care—areas that demand novel delivery forms and flexible production.

• Digitization and Industry 4.0 adoption: CDMOs that integrate real-time analytics, MES systems, and automation can achieve compliance, speed, and cost advantages—becoming preferred partners for sponsors with complex global pipelines.

 

Restraints

• Regulatory delays and multi-jurisdictional complexities: Navigating different compliance standards (FDA, EMA, PMDA, CFDA) can delay launch timelines, especially for CDMOs that lack strong regulatory affairs infrastructure.

• Shortage of skilled formulation scientists and GMP-trained staff: As technical sophistication increases, the global talent gap in pharmaceutical engineering and quality control is becoming a growth bottleneck, particularly in emerging markets.

 

7.1. Report Coverage Table

Report Attribute	Details
Forecast Period	2024 – 2030
Market Size Value in 2024	USD 27.8 billion
Revenue Forecast in 2030	USD 40.4 billion
Overall Growth Rate	CAGR of 6.7% (2024 – 2030)
Base Year for Estimation	2024
Historical Data	2019 – 2023
Unit	USD Million, CAGR (2024 – 2030)
Segmentation	By Product Type, By Phase, By End User, By Region
By Product Type	Tablets, Capsules, Powders & Granules, Lozenges
By Phase	Preclinical & Clinical Manufacturing, Commercial Manufacturing
By End User	Pharmaceutical Companies, Biotechnology Firms, Nutraceutical Companies
By Region	North America, Europe, Asia Pacific, Latin America, Middle East & Africa
Country Scope	U.S., Germany, UK, India, China, Japan, Brazil, South Korea
Market Drivers	Growing demand for generic and specialty drugs; Regulatory stringency; Rising R&D outsourcing
Customization Option	Available upon request