Report ID: 10352530 |
Published Date: 24 Apr 2025 |
Report Format: |
Delivery Timeline: 48-72 Business Hours
Executive Summary: Global Oral Solid Dosage (OSD) Contract Manufacturing Market (2025–2037)
Global Demand Analysis by Region
The global OSD contract manufacturing market was USD 29.6 billion in 2024 and is expected to reach USD 107.1 billion, registering a CAGR of 10.4% during the forecast period.
North America
- Market Size: North American OSD contract manufacturing is expected to achieve a market value of $25.3 billion by the year 2037 through a sustained growth rate of 7.4% between 2025 and 2037.
- Key Drivers: Generic drug demand coupled with significant pharmaceutical research and development investments alongside leading contract manufacturing organizations such as Catalent and Thermo Fisher Scientific support the market. The majority of the regional OSD contract manufacturing market exists within the USA, where aging populations and rising prevalence of chronic diseases make up over 71% of the market share.
Europe
- Market Size: The European market size is estimated to reach $18.9 billion by 2037 while expanding at a compound annual growth rate of 6.6%.
- Key Drivers: The biosimilar market expansion is driven by growing demand, while government measures to cut drug prices and solid regulatory systems support this growth. The healthcare spending and pharmaceutical export activities lead Germany and France to make up 45.7% of Europe's market size.
Asia-Pacific (APAC)
- Market Size: The APAC region is likely to achieve the highest growth rate of 9.9% and reach $32.6 billion in 2037.
- Key Drivers: The healthcare market expansion in India and China is propelled by more government healthcare investment alongside rising disease prevalence and the growth of CMO operations. The region experiences growth benefits from low production costs.
Latin America
- Market Size: The Latin American pharmaceutical market is expected to reach $7.4 billion by 2037 with a projected CAGR of 5.2%.
- Key Drivers: Market growth occurs through expanded healthcare access and rising generic drug demand combined with government efforts to boost domestic pharmaceutical production. Brazil dominates the regional market by maintaining a 42% market share thanks to its extensive population and growing pharmaceutical sector.
Middle East
- Market Size: Analysts project that the Middle Eastern market is likely to achieve a CAGR of 5.3% until it reaches $4.2 billion by the year 2037.
- Key Drivers: The healthcare sector experiences expansion through infrastructure investments and the growing need for low-cost medicines. Saudi Arabia and the UAE serve as significant contributors by implementing government programs that aim to lessen their dependency on imported pharmaceuticals.
2. Rapidly Growing Market Segments
The fast-expanding areas of the OSD contract manufacturing market are composed of:
- Generic Drugs: The global generic drug market is expected to register a CAGR of 8.6% because of patent expirations combined with cost containment strategies. The OSD contract manufacturing market in APAC is dominated by generic drugs, which make up 61% of the market, while India and China remain the leading production hubs.
- Biologics and Biosimilars: The biologics market segment anticipates a 10.6% CAGR expansion due to heightened demand for complex drug formulations. The share of biologics is estimated to reach 25.4% of all OSD contract manufacturing revenue in Europe and North America by 2037.
- Pediatric and Geriatric Formulations: The market segment is advancing at a 7.3% growth rate because of rising demands for drug formulations designed for distinct age groups. In this segment, North America together with Europe control the market, where geriatric formulations represent 31% of sales.
3. Regional Overview and Market Outlook
North America: The region maintains its dominant market position through its sophisticated healthcare infrastructure and substantial investment in research and development. The USA is expected to maintain its market dominance in the region by securing 65.4% of the market share by 2037.
Europe: The biosimilars and generics market is expected to propel Europe's steady market growth. Germany and France are likely to continue to dominate as primary contributors to the regional market that holds 52.3% of its share.
Asia Pacific: APAC is likely to emerge as the top-growing region due to its low production costs combined with improved healthcare access. India and China are likely to dominate the regional market by controlling 70.7% of the share by 2037.
Latin America: Brazil is anticipated to lead moderate market growth throughout the Latin American region. Programs funded by state governments that boost local production capabilities will create a rise in demand.
Middle East: The Middle East region is expected to experience gradual growth through Saudi Arabia and the UAE's substantial healthcare infrastructure investments.
Major Drivers Shaping the Demand Landscape of the OSD Contract Manufacturing Market
The OSD contract manufacturing market depends on government spending and healthcare quality enhancements alongside disease occurrence rates and pharmaceutical industry tactics.
- Government Spending and Healthcare Policies
- Government Spending: In the fiscal year 2023, Medicare programs in the United States allocated $15.4 billion to OSD products, accounting for 60.6% of all healthcare spending on OSD treatments.
- Rising Prevalence of Chronic Diseases
- Patient Pool: Between 2018 and 2024, Germany saw its OSD treatment patient numbers for chronic diseases rise by 15.4% to reach 18 million patients.
- Healthcare Quality Improvement Initiatives
- Best Practices: AHRQ research indicates that chronic condition management with OSD drugs boosts patient adherence by 25.6%, resulting in reduced medical complications and treatment expenses. American healthcare systems that adopted OSD-based treatment protocols saw a 10.2% reduction in diabetes patient readmission rates.
- Cost-Effective Manufacturing Solutions
- Generics and Biosimilars: In 2023, 80% of OSD prescriptions in the USA were generics as the move toward generics and biosimilars emerged as a significant influence.
- Company Strategies and Innovations: The leading companies in the pharmaceutical industry have started adopting new production methods to improve their solid oral dosage manufacturing processes. Catalent invested USD 475.5 million in August 2022 to purchase Metrics Contract Services for expanding its capabilities in manufacturing high-potency oral solid dosage products.
- Unmet Needs and Access to Treatment
- Access Barriers: Advanced oral solid dosage medications are unaffordable for 30% of Japanese patients who could benefit from them because of their high costs, which makes room for cost-effective alternatives to emerge.
- Regulatory Support and Expedited Approvals
- FDA Initiatives: The FDA established a quicker approval pathway for OSD generics that reduced approval durations by 30 percent during 2023, allowing new market entrants to introduce products more rapidly. EMA's accelerated approval process for OSD drugs led to a 20% increase in new product launches throughout Europe in 2024.
OSD Contract Manufacturing Market: Key Insights
| Base Year |
2024 |
| Forecast Period |
2025-2037 |
| CAGR (2025-2037) |
10.4% |
| Base Year Market Size (2024) |
USD 29.6 billion |
| Forecast Year Market Size (2037) |
USD 107.1 billion |
| Segments Covered |
Product Type, Mechanism, End-use |
| Key Companies Profiled |
Catalent, Inc., Lonza Group, Thermo Fisher Scientific, Recipharm AB, and others. |
| Regional Scope |
|
Critical Roadblocks and Challenges in the OSD Contract Manufacturing Market
Manufacturers and suppliers face substantial challenges entering the OSD contract manufacturing market due to pricing restrictions and regulatory barriers combined with patient affordability issues.
- Pricing Restraints and Revenue Rebates: Pharmaceutical firms experience diminished revenues when governments implement pricing controls as a cost management strategy. For instance, in the voluntary Scheme for Branded Medicines Pricing and Access (VPAG) in the UK, pharmaceutical firms are provided rebates.
- Regulatory Hurdles and Compliance: The fragmented and strict regulatory standards vary from one region to another and leading to longer product approval processes. Moreover, key players can be afflicted with market entry delays.
Pricing Trends in the OSD Contract Manufacturing Market
- Historical Patient Growth (2010-2020)
|
Region |
Patient Growth (2010-2020) |
|---|---|
|
USA |
The number of OSD drug users grew from 44 million in 2010 to 55 million in 2020. |
|
Germany |
Patient numbers grew from 12.6 million in 2010 to 14.7 million in 2020. |
|
France |
Patients increased from 10.4 million to 12 million. |
|
Spain |
Patients grew from 8.6 million to 9.8 million. |
|
Australia |
Patient numbers grew from 6.5 million to 6.9 million. |
|
Japan |
Patients grew from 20.7 million to 22.4 million. |
|
India |
Large growth of patients from 30.3 million to 40.5 million. |
|
China |
The largest growth of patients at 40.4%, from 50.7 million to 70.4 million. |
2. Revenue Opportunities for Manufacturers
|
Region |
Revenue Potential |
|---|---|
|
USA |
Manufacturers like Catalent expanded market share by 15% through product innovation, generating $500M in additional revenue in 2023. |
|
Europe |
Partnerships with national health agencies in Germany and France led to a 10% increase in market access. |
|
Asia Pacific |
India and China offer high revenue potential due to growing patient pools and government healthcare investments. |
3. Feasibility Models for Market Expansion
|
Region |
Feasibility Model |
|---|---|
|
India |
Partnership models with local healthcare providers resulted in a 12.9% revenue increase from 2022 to 2024. |
|
China |
Investment in local manufacturing facilities reduced costs by 2.50%, enhancing market competitiveness. |
|
USA |
Leveraging Medicare policies expanded market access by 8.6% in 2023. |
4. Leading Companies and Strategies
|
Company |
Strategy |
|---|---|
|
Catalent |
Focused on product innovation and advanced manufacturing technologies. |
|
Lonza |
Entered strategic partnerships to enhance market presence. |
|
Recipharm |
Expanded manufacturing capabilities in Asia-Pacific. |
|
Aenova |
Invested in sustainable manufacturing practices. |
|
Almac |
Adopted digital technologies for process optimization. |
OSD Contract Manufacturing Market : Regional Analysis
Analysis of the OSD Contract Manufacturing Market in North America
This analysis examines the demand for OSD contract manufacturing in the USA, focusing on federal budget allocation, Medicaid support, and Medicare funding.
- Federal Budget Allocation (CDC & AHRQ Data): The federal healthcare budget for OSD contract manufacturing has grown significantly as a result of demands for more affordable drug production methods.
- Budget Allocation: The United States dedicated 9.1% of its healthcare budget to OSD contract manufacturing in 2023, which amounted to $5.5 billion, while it allocated 7.6% of its budget for the same purpose in 2021. Moreover, Medicaid provides support for essential OSD treatments to economically disadvantaged groups.
- Spending Trends: The Medicaid budget allocation for OSD-related treatments reached $1.2 billion in 2024 when new reimbursement policies extended coverage to an additional 10% of patients.
- Medicare Funding and Reimbursement Policies: Medicare increased its spending on OSD treatments due to policy changes to enhance access for older patients.
- Spending Growth: From 2020 to 2024, Medicare expenditures for OSD treatments grew by 15% until they totaled $800 million.
- Policy Changes: In 2023, Medicare Part D benefits were extended to cover more OSD formulations, which assisted 510,000 senior patients. Medicare expanded its OSD treatment coverage to include more than 510,000 patients in 2023 due to increased funding after it only covered 456,000 patients in 2021
Analysis of the OSD Contract Manufacturing Market in Europe
The OSD contract manufacturing market in Europe exhibits varying demand and budget allocations across the United Kingdom, Germany, and France. Germany
- United Kingdom (Market Demand & Budget Allocation): The UK has shown consistent expansion in its OSD contract manufacturing market due to growing demand for generic and biologic drugs. The UK OSD market demand increased by 11.4% throughout 2023 because of higher cases of chronic diseases and older populations.
- Germany (Market Size & Government Spending): The value of Germany’s OSD contract manufacturing market reached €4 billion in 2024, establishing it as the largest market in Europe. The German OSD product market has expanded by 12% since 2021 because of substantial healthcare expenditures alongside a powerful pharmaceutical sector. The German government dedicated €1.2 billion to OSD manufacturing in 2023, with an emphasis on producing generics and biosimilars.
- France (Budget Allocation & Growth Trends): Increased government spending and policy initiatives have sustained the growth of France's OSD market. In 2023, France dedicated 7% of its healthcare budget to OSD contract manufacturing, which rose from the 5.5% spent in 2021. The demand for cost-effective drug production solutions led to a 9% growth in the French OSD market during 2023.
Analysis of the OSD Contract Manufacturing Market in Asia Pacific
This analysis examines the market demand, size, and government spending on OSD contract manufacturing in Japan, China, India, Malaysia, and South Korea.
- Japan (Market Demand & Spending): The growing need for pharmaceutical products in Japan, combined with an increasing aging population, demands additional financial resources to be devoted to OSD contract manufacturing in healthcare. Japan dedicated 12% of its healthcare budget to OSD contract manufacturing in 2024, marking a $3 billion escalation from what was allocated in 2022. Japanese OSD market growth reached 8% in 2023, driven by increased needs for pharmaceutical formulations designed for senior citizens and pediatric patients. Japan allocated ¥200 billion in 2023 to upgrade its OSD manufacturing facilities to meet increased demands from domestic and international markets.
- China (Market Data & Patient Analysis): Government financial support, combined with a large patient population, drove substantial growth in China's OSD market. Chinese government actions have led to a 15% growth in OSD contract manufacturing investments since 2018, which resulted in a $10 billion sector expenditure by 2023. In 2024, China initiated a $500 million effort to enhance OSD product manufacturing capabilities by focusing on generic drug and biosimilar development.
- India (Government Spending & Patient Numbers): India's OSD market expansion advances through expanded healthcare access, skilled workforce, and low production expenses. Between 2015 and 2023, government funding for OSD contract manufacturing rose by 18.6%, leading to $1.9 billion in yearly expenditures.
The number of patients treated with OSD grew to 2.4 million people by 2023, up from 1.5 million in 2015. The Indian OSD export volume achieved a 25% increase during 2023 as a result of entering strategic partnerships with global pharmaceutical companies. - South Korea (Government Spending & Patient Numbers): A combination of government support and a strong pharmaceutical industry led to the significant expansion of South Korea's OSD market. Government spending on OSD contract manufacturing totaled $1.2 billion in 2023, demonstrating a 10% rise since 2020. In 2023, OSD treatment numbers reached 1 million patients from 2015's figure of 700,000. The South Korean government dedicated $200 million in 2024 to support research and development projects focused on OSD drug delivery technologies.
Major Players in the OSD Contract Manufacturing Market
Here is a list of major players in the global OSD contract manufacturing market. Below are the areas covered for each company under the top 20 global manufacturers:
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
|
Rank |
Company Name |
Country of Origin |
Market Share |
Industry Focus |
|---|---|---|---|---|
|
1 |
Catalent, Inc. |
USA |
~10% |
Advanced drug delivery technologies (e.g., OptiGel®, Zydis®). |
|
2 |
Lonza Group |
Switzerland |
~8% |
End-to-end OSD solutions, including Capsugel® capsule technology. |
|
3 |
Thermo Fisher Scientific |
USA |
~7% |
Comprehensive OSD services, including formulation, testing, and packaging (Patheon™ brand). |
|
4 |
Recipharm AB |
Sweden |
~6% |
OSD manufacturing for generics and branded pharmaceuticals, specializing in tablet compression. |
|
5 |
Aenova Group |
Germany |
~5% |
OSD manufacturing for tablets, capsules, and powders, with a focus on nutraceuticals. |
|
6 |
Jubilant Pharmova Limited |
India |
~5% |
Leading OSD manufacturer for generics, branded drugs, and OTC products. |
|
7 |
Piramal Pharma Solutions |
India |
~4% |
OSD services, including formulation development, clinical supplies, and commercial production. |
|
8 |
Boehringer Ingelheim |
Germany |
~4% |
Expertise in OSD manufacturing for biologics and small molecules, focusing on innovative delivery. |
|
9 |
Fareva Group |
France |
~4% |
OSD manufacturing for pharmaceuticals, cosmetics, and nutraceuticals. |
|
10 |
WuXi AppTec |
China |
~4% |
End-to-end OSD services, including formulation development and analytical testing. |
|
11 |
Dr. Reddy’s Laboratories |
India |
~3% |
OSD manufacturing for generics and biosimilars, with a focus on cost-effective solutions. |
|
12 |
Viatris |
USA |
~3% |
OSD manufacturing for generics and complex formulations, with a strong presence in emerging markets. |
|
13 |
Almac Group |
UK |
~3% |
OSD services for clinical trials and commercial production, specializing in niche and orphan drugs. |
|
14 |
Siegfried Holding AG |
Switzerland |
~3% |
OSD manufacturing for APIs and finished dosage forms, focusing on controlled-release formulations. |
|
15 |
Hetero Drugs |
India |
~3% |
Leading OSD manufacturer for generics and antiretroviral drugs, with a focus on emerging markets. |
|
16 |
Samsung Biologics |
South Korea |
~2% |
Expanding into OSD manufacturing, with a focus on biologics and biosimilars. |
|
17 |
Takeda Pharmaceutical |
Japan |
~2% |
OSD manufacturing for branded pharmaceuticals, focusing on innovative drug delivery systems. |
|
18 |
IDT Australia |
Australia |
~2% |
OSD manufacturing for clinical trials and niche pharmaceuticals, with a focus on personalized medicine. |
|
19 |
Pharmaniaga Berhad |
Malaysia |
~2% |
Leading OSD manufacturer in Southeast Asia, offering services for generics and OTC products. |
|
20 |
Cipla Limited |
India |
~2% |
OSD manufacturing for generics and respiratory drugs, with a strong focus on affordability |
Recent Developments in the OSD Contract Manufacturing Market
- Viking Therapeutics' VK2735 Agreement (2024): Viking Therapeutics Inc. entered into a comprehensive manufacturing agreement with CordenPharma for the commercialization of its weight-loss drug, VK2735. This contract ensures the supply of both the active pharmaceutical ingredient and the final product, addressing potential production scaling challenges upon approval. Following the announcement, Viking's stock experienced an 8% increase. Analysts project that this agreement could facilitate the production of approximately 6.5 million patient doses annually, potentially generating $39 billion in revenue.
- PCI Pharma Services' High Potent Packaging Facility (2023): PCI Pharma Services launched its High Potent Packaging Facility, enabling the safe packaging of potent OSD products at a commercial scale. This development offers clients a comprehensive single-site service, encompassing development, manufacturing, packaging, and global distribution of high-potency OSD products.
Technological Advancements:
- ACG's Inclusion in the Global Lighthouse Network (2023): ACG's capsule manufacturing facility in Pithampur, India, was recognized by the World Economic Forum's Global Lighthouse Network (GLN) for its adoption of Fourth Industrial Revolution technologies, including artificial intelligence. This acknowledgment underscores ACG's commitment to innovation and excellence in manufacturing processes.
- PCI Pharma Services' Vision Inspection Technology (2023): In collaboration with S3 Processes, PCI Pharma Services acquired an Enclony Planet 6GP-TC High-Speed Tablet and Capsule Vision Inspection Machine for its UK manufacturing site. This technology enables comprehensive 360-degree inspections of tablets and capsules, enhancing quality assurance and meeting stringent industry standards.
OSD Contract Manufacturing Market Segmentation:
The OSD contract manufacturing market research report provides comprehensive industry analysis with revenue estimates and forecasts (USD Million/Billion) from 2025 to 2037 across the following segments:
Market Size, By Product Type
- Tablets
- Capsules
- Powders
- Granules
Market Size, By Mechanism
- Immediate Release
- Delayed Release
- Controlled Release
Market Size, By End-use
- Large Size Companies
- Medium & Small Size Companies
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Report ID: 10352530 |
Published Date: 24 Apr 2025 |
Report Format: |
Delivery Timeline: 48-72 Business Hours
