Oral Solid Dosage Manufacturing Market by Type of Finished Dosage Form

ORAL SOLID DOSAGE CONTRACT MANUFACTURING MARKET: OVERVIEW

As per Roots Analysis, the global oral solid dosage contract manufacturing market is estimated to grow from USD 22.5 billion in the current year to USD 36.52 billion by 2035, at a CAGR of 4.49% during the forecast period, till 2035.

The market sizing and opportunity analysis has been segmented across the following parameters:

Type of Finished Dosage Form

Tablets

Capsules

Powders

Multi-particulates

Others

Type of Packaging

Bottles

Blisters

Sachets

Inhalers

Others

Scale of Operation

Pre-commercial

Commercial

Company Size

Small

Mid-sized

Large

Very Large

Therapeutic Area

Oncological Disorders

Infectious Diseases

Cardiovascular Disorders

Metabolic Disorders

Neurological Disorders

Genetic Disorders

Respiratory Disorders

Immunological Disorders

Other Disorders

Key Geographical Regions

North America

Europe

Asia-Pacific

Latin America

Middle East and North Africa

ORAL SOLID DOSAGE CONTRACT MANUFACTURING MARKET: GROWTH AND TRENDS

Despite several novel dosage forms being introduced into the pharmaceutical and nutraceutical sectors, oral solid drugs (OSD), particularly tablets and capsules, continue to be the most popular and widely used delivery forms. This is due to the fact that these formulations offer various advantages, including self-administration, stability, cost-effectiveness, convenience of handling, transportation and patient compliance. This mature yet high-value vertical of the overall pharmaceutical industry represents about 90% of the global market share of all formulations intended for human use.

However, OSD manufacturing operations is a complex process requiring specialized equipment and facilities, highly contained working environments and experts with multidisciplinary knowledge. Further, recent evolution to address the upstream bottlenecks associated with active pharmaceutical ingredients (API), such as poor bioavailability, low solubility, bitter taste and high potency, necessitate extensive technical expertise. As a result, drug developers are increasingly relying on contract service providers to leverage their capabilities and yield cost savings opportunities. Unlike drug developers, the capabilities of these third-party service providers are usually more focused on their respective service portfolios. They support pharmaceutical companies with specialized capabilities ranging from process and formulation development to drug substance characterization, analytical method development, and regulatory filings, as well as capacity for clinical and commercial manufacturing. Considering the growing trend of outsourcing and the ongoing efforts of service providers to improve / expand their offerings, it is anticipated that the oral solid dosage contract manufacturing market is likely to evolve at a steady pace, in the mid to long term.

ORAL SOLID DOSAGE CONTRACT MANUFACTURING MARKET: KEY INSIGHTS

The report delves into the current state of the oral solid dosage contract manufacturing market and identifies potential growth opportunities within the industry. Some key findings from the report include:

1. Presently, over 300 companies claim to have the required expertise to offer contract manufacturing services for a broad spectrum of oral solid dosage forms, including modified release formulations of tablets and capsules.

2. Nearly 30% of the players have established end-to-end capabilities, from early development to packaging of oral solids in a variety of containers; this simplifies supplier management activities for sponsor companies.

3. The current market landscape features the presence of both established and emerging players engaged in the manufacturing of oral solid dosages at various scales of operation, in compliance with the regulatory standards.

4. With more than 1,350 facilities, oral solid contract manufacturers have established global presence; majority of these players are based in the Asia-Pacific region, primarily in countries, such as China and India.

5. As part of their growth strategy, CMOs are investing in either expanding their existing facilities / capabilities or building facilities in other regions; majority of these initiatives were undertaken in North America.

6. The global installed oral solid dosage contract manufacturing capacity is spread across various geographies; over 30% of this capacity is dedicated to the manufacturing of tablets on a commercial scale.

7. The demand for oral solid dosage contract manufacturing is rising significantly owing to the growing complexity of APIs; by 2035, it is anticipated to reach over 35,000 metric tonnes, across clinical and commercial scales.

8. Driven by volume shifts from originators to generics and over-investments to create safety buffers, the contract manufacturing domain is currently witnessing an excess in capacity, thereby propelling consolidation efforts.

9. Over 65% of the market is expected to be captured by revenues from manufacturing anti-cancer drugs, including those based on HPAPIs; furthermore, North America based players are likely to contribute majorly to this domain.

ORAL SOLID DOSAGE CONTRACT MANUFACTURING MARKET: KEY SEGMENTS

Tablets Occupy the Largest Share of the Oral Solid Dosage Contract Manufacturing Market

Based on the type of finished dosage form, the market is segmented into tablets, capsules, powders, multi-particulates and others. At present, tablets hold the maximum share of the oral solid dosage contract manufacturing market. This trend is likely to remain the same in the forthcoming years.

Blisters Segment is the Fastest Growing Segment of the Oral Solid Dosage Contract Manufacturing Market During the Forecast Period

Based on the type of packaging, the market is segmented into blisters, sachets, inhalers, bottles and others. Currently, bottles capture the highest proportion of the oral solid dosage contract manufacturing market. It is worth highlighting that the oral solid dosage contract manufacturing market for blisters is likely to grow at a relatively higher CAGR.

By Scale of Operation, Commercial Scale is Likely to Dominate the Oral Solid Dosage Contract Manufacturing Market

Based on the scales of operation, the market is segmented into pre-commercial and commercial scale. Whilst commercial scale manufacturing is expected to be the primary driver of the overall market, it is worth highlighting that the oral solid dosage contract manufacturing market at pre-commercial scale is likely to grow at a relatively higher CAGR.

Very Large Companies Occupy the Largest Share of the Oral Solid Dosage Contract Manufacturing Market

Based on the company size, the market is segmented into small, mid-sized, large and very large companies. At present, very large companies hold the maximum share of the oral solid dosage contract manufacturing market. This trend is unlikely to change in the foreseeable future.

Oncological Disorders Account for the Largest Share of the Oral Solid Dosage Contract Manufacturing Market

Based on the therapeutic areas, the market is segmented into oncological disorders, neurological disorders, cardiovascular disorders, infectious diseases, metabolic disorders, respiratory disorders, immunological disorders, genetic disorders, gastrointestinal disorders, other disorders. Currently, oncological disorders hold the maximum share of the oral solid dosage contract manufacturing market. This trend is likely to remain the same in the coming decade.

North America Accounts for the Largest Share of the Market

Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa. The majority share is expected to be captured by players based in North America and Asia-Pacific.

Example Players in the Oral Solid Dosage Contract Manufacturing Market

Aenova

Alcami

Almac

Cambrex

Hetero Drugs

Ind-Swift

Laboratories

Lonza

Rubicon Research

ORAL SOLID DOSAGE CONTRACT MANUFACTURING MARKET: RESEARCH COVERAGE

Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the oral solid dosage contract manufacturing market, focusing on key market segments, including [A] type of finished dosage form, [B] type of packaging, [C] scale of operation, [D] company size, [E] therapeutic area and [F] key geographical regions.

Market Landscape: A comprehensive evaluation of companies offering contract services for oral solid dosage form, considering various parameters, such as [A] year of establishment, [B] company size (in terms of the number of employees), [C] location of headquarters, [D] company ownership, [E] type of service(s) offered, [F] type of finished dosage form(s) manufactured, [G] type of packaging offered, [H] scale(s) of operation and [I] additional manufacturing capabilities.

Company Competitiveness Analysis: A comprehensive competitive analysis of oral solid dosage contract manufacturing service providers, examining factors, such as [A] supplier strength and [B] service strength.

Regional Capability Analysis: A comprehensive regional capability assessment framework the oral solid dosage contract manufacturers that evaluates key geographies by various parameters, including [A] type of service(s) offered, [B] type of finished dosage form(s) manufactured, [C] type of packaging offered, [D] scale(s) of operation and [E] location of manufacturing facilities of the service providers.

Company Profiles: In-depth profiles of key oral solid dosage contract manufacturers, focusing on [A] company overviews, [B] financial information (if available), [C] oral solid dosage service portfolio, [D] manufacturing capabilities and facilities, [E] recent developments and [F] an informed future outlook.

Make Versus Buy Decision Framework: An insightful framework that emphasizes the key indicators and factors that need to be considered by oral solid dosage drug developers to determine whether to manufacture their respective products in-house or outsource the manufacturing operation to contract service providers.

Recent Expansions: An examination of the different expansion efforts made by service providers in this field to enhance their manufacturing capabilities. This analysis considers various factors, including the [A] year of expansion, [B] purpose of expansion, [C] type of an estimate of the global installed capacity (in terms of number of oral solid units and volume of API) for the manufacturing of oral solids, based on information provided by various industry stakeholders in the public domain. It also features the distribution of the available capacity on the basis of [D] company size, [E] scale of operation, [F] type of finished dosage form and [G] key geographical regions. Overall, the analysis represents a holistic view of the supply-side of the market, allowing us to present an informed opinion on whether the present capacity will be able to meet the likely future demand.

Demand Analysis: Informed estimates of the annual commercial and clinical demand for oral solid doses based on several relevant parameters, such as [A] key geographical regions and [B] therapeutic areas.

Total Cost of Ownership: A detailed analysis of the total cost of ownership for an oral solid dosage contract manufacturing service provider, highlighting the expenses associated with the establishment and maintenance of an oral solid dosage manufacturing facility, over a period of 20 years.

Regulatory Landscape: A discussion on general regulatory guidelines laid down by major regulatory bodies, across different countries, featuring an elaborative assessment of several CMOs engaged in this domain, along with information on their operational approvals, certifications received, and relative popularity of the key regulatory body. Additionally, the chapter features an insightful multi-dimensional bubble analysis, presenting a comparison of the current regulatory scenario in key geographies.

Case Study 1: A general discussion on taste masking service providers for oral solids, providing information on [A] scale of operation, [B] manufacturing scalability, other service(s) offered along with information on [C] type of formulation, [D] end users, [E] techniques used for taste masking, [F] branch of healthcare and [G] regional capability. Further, the chapter includes the current market landscape of taste masking technology providers, providing information on [H] technology name, [I] techniques used, [J] type of finished dosage form, [K] end users along with information on patent, availability of technology for partnerships and licensing. In addition, the chapter provides details on the [L] year of establishment, [M] company size and [N] location of headquarters.

Case Study 2: A general discussion on drug bioavailability enhancement service providers for oral solids, based on several relevant parameters, such as [A] year of establishment, [B] company size (in terms of number of employees), [C] location of headquarters, [D] bioavailability enhancement principle supported, [E] bioavailability enhancement approach employed, including [E1] solid dispersion, [E2] size reduction, [E3] lipid-based, and [E4] other bioavailability enhancement approaches, [F] type of dosage form supported (solids, fine particles and semi-solids).

KEY QUESTIONS ANSWERED IN THIS REPORT

How many companies are currently engaged in this market?

Which are the leading companies in this market?

What factors are likely to influence the evolution of this market?

What is the current and future market size?

What is the CAGR of this market?

How is the current and future market opportunity likely to be distributed across key market segments?

REASONS TO BUY THIS REPORT

The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.

Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.

The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.

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