PUBLISHER: Roots Analysis | PRODUCT CODE: 1250133
PUBLISHER: Roots Analysis | PRODUCT CODE: 1250133
Over the years, rising complexity of active pharmaceutical ingredients (APIs) has led to the development of a myriad of novel formulations that enable efficient drug delivery to the intended site of action. Nonetheless, th e demand for oral solid dosage (OSD) forms, including tablets and capsules, remains unparalleled. In fact, over two-thirds of the total drugs prescribed worldwide are dispensed in the form of oral solids. , In addition to being cost effective and relatively more stable as compared to their large molecule counterparts, these orally administered small molecules are patient-centric, and therefore play a critical role in fixing the medication adherence problem. Since the demand for oral solid drugs is rising, the development of modified oral solid formulations (including disintegrating tablets (ODTs), combination products and prolonged-, controlled-, and sustained- release dosage forms) that can improve API solubility and enhance bioavailability can offer the drug developers a huge opportunity to stand out in this mature and competitive market. However, the manufacturing of specialized solid doses, especially those containing highly potent APIs, from early development formulations to scale-up is a complex process that requires multidisciplinary expertise. Consequently, drug developers are increasingly relying on contract service providers with specialized equipment and a trained workforce to navigate the technical and routine operations-related challenges, including those associated with complex formulations, stringent regulatory requirements and multiple suppliers. Considering the immense popularity of oral solid dosage forms, especially amongst the pediatric and geriatric populations, we believe that the demand for conventional as well as modified oral solid formulations is likely to drive commendable growth within the contract manufacturing market in the coming years.
The "Oral Solid Dosage Contract Manufacturing Market: Distribution by Type of Finished Dosage Form (Tablets, Capsules, Granules, Powders and Others), Type of Packaging (Blisters, Sachets, Inhalers, Bottles and Others), Scale of Operation (Preclinical, Clinical and Commercial), Company Size (Small, Mid-sized, Large and Very Large), Therapeutic Area (Oncological Disorder, Neurological Disorder, Cardiovascular Disorder, Infectious Disease, Metabolic Disorder, Respiratory Disorder, Immunological Disorder, Genetic Disorder, Gastrointestinal Disorder and Others, and Key Geographical Regions (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa): Industry Trends and Global Forecasts, 2023-2035" report features an extensive study of the current market landscape and future opportunity for the players involved in the oral solid dosage contract manufacturing, over a span of 12 years. The report answers the following key questions related to this domain.
Q1. What are the Current Opportunities within the Oral Solid Dosage Contract Manufacturing Market?
Although biologics have provided breakthroughs for the treatment of diseases with unmet medical needs, the approval of orally administered small molecule entities has been on the rise, recently. In fact, around 84% of the best-selling pharmaceuticals are administered orally. In addition, oral solids account for nearly 30% of the small molecules in the development pipeline. The oral solid dosage market is expected to continue to grow at a healthy rate, and as a result, we anticipate a surge in demand for the affiliated development and manufacturing support.
Q2. What is the Current Market Landscape and Recent Trends in the Oral Solid Drug Contract Manufacturing Domain?
Presently, close to 300 companies have the required capabilities to offer oral solid dosage contract manufacturing services across different scales of operation. More than 30% of these players serve as one-stop-shops, possessing an extensive range of capabilities (from formulation and analytical development to quality, regulatory support and commercialization) to meet client requirements. In order to cater to the increasing demand for OSD products, several CMOs and CDMOs have established strategic partnerships with other industry players and carried out expansion projects, thereby differentiating their offerings through niche enabling technologies, formulation expertise and manufacturing capacities, across different scales of operations.
Q3. What are the Key Benefits Offered by Oral Solid Dosage (OSD) Formulations?
Oral solid dosage formulations, including tablets, capsules, granules, sachets, powders, dry powder inhalers, and lozenges represent the most preferred dosage forms that are widely accepted by patients, worldwide. These time-tested means of treatment are relatively easy to manufacture, package and transport, offer good physical and chemical stability, and facilitate simple and accurate dosing. In addition, various coating methods make them easier to swallow, and allow modification of shape and color for aesthetic purposes. Moreover, the low production costs of oral solid formulations make them an economical option for manufacturers, healthcare institutions and patients.
Q4. What is the Need for Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) in the Oral Solid Dosage Domain?
Despite being the oldest and most-well understood formulation, oral solid dosage development and manufacturing is associated with several complications and challenges, including toxicity associated with potent APIs, complexity of formulations, deviations in quality, utility or transportation disruption and bottlenecks in process scale-up. Further, manufacturing of high-value dosage forms, including pediatric, geriatric, anti-abuse, controlled-release, and taste-masked drugs requires cutting-edge technologies which are expensive to acquire. As a result, around 60-70% of the companies engaged in this domain prefer to outsource their clinical and commercial manufacturing operations to contract manufacturing organizations (CMOs) or contract development and manufacturing organizations (CDMOs), enabling the former to focus on their core research and development competencies.
Q5. What are the Key Challenges Faced by Oral Solid Dosage Contract Manufacturers?
The oral solid dosage contract manufacturing market is highly competitive, as several in-house pharmaceutical operations are being converted to offer CMO services and existing service providers are expanding their service offerings. Moreover, owing to the increase in consolidation within the pharmaceutical industry, the customer base for contract manufacturers is declining. In order to navigate the growing competition, oral solid dosage contract manufacturers are making an active effort to enhance their offerings by manufacturing high and uniform quality products in a cost-effective manner, while accommodating the diverse expectations of sponsor companies.
Q6. What are the Key Trends Shaping the Oral Solid Dosage Contract Manufacturing Industry?
Considering the evolving customer demands and continuous updates in the regulatory requirements, innovator companies and manufacturers of oral solid dosage products must upgrade their capabilities in order to maintain dominance in the overall pharmaceutical sector. From a regulatory perspective, concepts from Industry 4.0, including quality by design (QbD) and process analytical technology (PAT) principles, are increasingly being implemented to optimize and accelerate pharmaceutical processes. In addition, the paradigm shift from batch to continuous manufacturing is instrumental in lowering the investment and operating costs, while concurrently improving the product quality and reducing the time to market. The efforts to develop more agile, responsive, and reproducible manufacturing processes are being combined with the applications of advanced technologies, including track-and trace systems, nano-milling, 3D printing technology, which enable the production of highly engineered drug products in a streamlined manner.
Q7. What is the Market Size of the Oral Solid Dosage Contract Manufacturing Market?
The oral solid dosage form continues to play a major role in the contract manufacturing industry, representing about 60% of the market. In the foreseen future, as several promising leads move into the clinic and / or get commercialized, the oral solid dosage contract manufacturing market is projected to grow at a noteworthy rate, in the period between 2023-2035. The opportunities for growth within this industry primarily exist in the high potency products as well as the niche products, including fixed dose combinations, orally disintegrating tablets, minitablets, flavored chewables, double-layered and multiple-layers tablets. In terms of geography, the oral solid dosage contract manufacturing market in the Asia-Pacific region is anticipated to grow at a relatively faster pace by 2035.
Q8. Who are the Key Players in the Oral Solid Dosage Manufacturing Market?
Examples of key players engaged in this domain (which have also been captured in this report) include Aenova, Alcami, Almac, Cambrex, Catalent, CMIC, Contract Pharmacal, Delpharm, Hetero Drugs, Madras Pharmaceuticals, Micro Labs and Recipharm.
The study presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain, across different geographies. Amongst other elements, the report includes:
One of the key objectives of the report was to estimate the current opportunity and the future growth potential of the oral solid dosage contract manufacturing market over the coming years. We have provided an informed estimate on the likely evolution of the market for the period, 2023-2035. Our year-wise projections of the current and forecasted opportunity have been further segmented based on relevant parameters, including type of finished dosage form (tablets, capsules, granules, powders and others), type of packaging (blisters, sachets, inhalers, bottles and others), scale of operation (preclinical, clinical and commercial), company size (small, mid-sized, large and very large), therapeutic areas (oncological disorder, neurological disorder, cardiovascular disorder, infectious disease, metabolic disorder, respiratory disorder, immunological disorder, genetic disorder, gastrointestinal disorder and others), and key geographical regions (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa). In order to account for future uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios, portraying the conservative, base and optimistic scenarios of the industry's evolution.
All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.
The data presented in this report has been gathered via primary and secondary research. For all our projects, we conduct interviews / surveys with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include:
While the focus has been on forecasting the market till 2035, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary sources of information.
Question 1: What is the global market size of oral solid dosage contract manufacturing market?
Answer: The current oral solid contract manufacturing market size is anticipated to be over USD 30 billion.
Question 2: Which are the top players in the oral solid dosage contract manufacturing market?
Answer: Presently, close to 300 companies are engaged in offering oral solid dosage contract manufacturing market, worldwide. The top players engaged in this domain (which have also been captured in this report) include Aenova, Alcami, Almac, Cambrex, Catalent, CMIC, Contract Pharmacal, Delpharm, Hetero Drugs, Madras Pharmaceuticals, Micro Labs and Recipharm.
Question 3: How many contract service providers possess capabilities to handle oral solid therapies based on highly potent APIs (HPAPIs)?
Answer: Over 40% of the contract service providers engaged in this domain claim to have the requisite capabilities for the safe handling and containment of highly potent oral solids.
Question 4: What are the factors driving the oral solid dosage contract manufacturing market?
Answer: The factors driving the oral solid dosage contract manufacturing market include the emergence of virtual pharmaceutical companies, and the surge in demand for novel oral solid formulations, such as such as pediatric / geriatric, taste-masked, abuse-deterrent and control release products that improve patient compliance.
Question 5: Which region has the highest market share in the oral solid dosage contract manufacturing market?
Answer: North America captures around 60% share in the current oral solid dosage contract manufacturing market, followed by Europe.
Question 6: What are the leading market segments in the oral solid dosage contract manufacturing market?
Answer: Currently, the oral solid dosage contract manufacturing market is dominated by tablet and capsule formulations. This can be attributed to several advantages offered by these dosage forms, including portability, ease in swallowing, excellent bioavailability and medical adherence. Further, in terms of company size, established players (with over 10,000 employees) are likely to capture over 50% of the current and future market, owing to their enhanced capabilities and huge production capacities.
Question 7: What is the growth rate (CAGR) in the oral solid dosage contract manufacturing market?
Answer: The oral solid dosage contract manufacturing market size is projected to grow at a CAGR of ~6% in the coming years.
Question 8: What are the upcoming trends in the oral solid dosage contract manufacturing market?
Answer: The market is presently witnessing the adoption of Industry 4.0 concepts, such as QbD and PAT. Further, several service providers are establishing / expanding their continuous manufacturing lines for the production of oral solids, thereby reducing manufacturing cost (by 15-30%), manpower (by 50-70%) and power consumption (by 40%).
Question 9: What are the current initiatives undertaken by big pharma players engaged in the oral solid dosage contract manufacturing market?
Answer: In order to tap the lucrative opportunity in this rapidly growing market, big pharma players have undertaken several initiatives, including strengthening product portfolio, establishing agreements, acquisitions and making investments. For instance, in August 2022, Catalent acquired Metrics Contract Services for USD 475 million to expand its high-potent and oral solid dosage manufacturing capabilities.
Tablet 4.1 Oral Solid Dosage Contract Manufacturing: List of Companies
Tablet 4.2 Oral Solid Dosage Contract Manufacturers: Information on Service(s) Offered
Tablet 4.3 Oral Solid Dosage Contract Manufacturers: Information on Type of Oral Solid Dosage Form Manufactured
Tablet 4.4 Oral Solid Dosage Contract Manufacturers: Information on Type of Packaging Offered
Tablet 4.5 Oral Solid Dosage Contract Manufacturers: Information on Scale of Operation and Additional Manufacturing Capabilities