The Pharmaceutical Contract Manufacturing Market is valued at USD 99 billion in 2024 growing at a CAGR of 4.3% during the forecast period 2024-2035.
In the rapidly evolving pharmaceutical landscape, small molecule drugs continue to play a pivotal role in shaping innovation and development. Currently, small molecules account for 90% of all pharmaceutical drugs, even as biologics have gained more attention in recent years due to their ability to address a wide range of disorders. The sector has also seen a resurgence in the approval of novel small molecule drugs, with over 50 candidates receiving approval from the US FDA in 2020 alone. This trend has significantly boosted the demand for services provided by pharmaceutical contract research organizations (CROs).
It is important to note that the manufacturing of these novel drug candidates necessitates specialized facilities, advanced equipment, and operational expertise. Consequently, pharmaceutical companies may face challenges in conducting development and manufacturing operations independently. Additionally, the time and cost associated with establishing or acquiring manufacturing capabilities have driven both small and large pharmaceutical companies to increasingly outsource their manufacturing operations to contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs). The pressing need for safer and more effective drugs has further heightened the demand for contract manufacturing services.
Influenced by the desire for improved efficiency, traceability, and cost-effectiveness, pharmaceutical contract manufacturing is undergoing significant technological advancements. Outsourcing manufacturing operations to CMOs and CDMOs involves implementing specialized solutions to optimize production workflows, ensure regulatory compliance, and uphold product quality standards. Moreover, there is a growing focus on personalized medicine, which requires flexible manufacturing capabilities to cater to diverse patient needs. As pharmaceutical companies adapt to these evolving dynamics, the demand for advanced solutions tailored to the specific requirements of contract manufacturing services is anticipated to increase in the coming years.
Key Market Segments
Type of Product Manufactured
FDF
Type of API
- Originator API
- Generic API
API Potency
- Low Potent API
- High Potent API
Type of FDF
- Originator FDF
- Generic FDF
Dosage Form
- Oral Solids
- Liquids
- Emulsions
- Other Dosage Forms
Type of Packaging Offered
- Bottles
- Blisters
- Parenteral
- Others
Scale of Operation
- Small Companies
- Mid-sized Companies
- Large and Very Large Companies
Type of End-user
- Oral Solids
- Liquids
- Emulsions
- Other Dosage Forms
Key Geographical Regions
- North America
- Europe
- Asia-Pacific
- Latin America
- Middle East and North Africa
Research Coverage:
- This report provides a comprehensive look at pharmaceutical packaging, including various types and their features, as well as sustainable packaging options. It also explores the regulatory framework, benefits, and challenges of sustainable packaging, emphasizing the need for adoption and highlighting future perspectives and opportunities.
- A general overview of contract manufacturing services, highlighting details on different types of third-party manufacturers. It also features evolution of global pharmaceutical contract manufacturing market. Further, it provides information on the recent CDMO trends, along the opportunities and future perspectives.
- A detailed discussion on various guidelines laid down by major regulatory bodies, across different countries, featuring an elaborative assessment of over 420 CMOs in pharmaceutical contract manufacturing industry, 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.
- An overview of the current market landscape of companies engaged in offering contract manufacturing services for small molecules, including a detailed analysis based on several relevant parameters, such as year of establishment, company size (based on number of employees), location of headquarters, location of manufacturing facility, type of manufacturer (CDMO and CMO), product manufacturing capability (API & Intermediates and FDF), type of services offered (pre-formulation development, formulation development, method / analytical / process / assay development, scale-up, fill-finish / packaging and labelling and regulatory support), type of finished dosage form manufactured (oral solid, liquids, emulsions and lyophilized products), type of packaging offered (blister packaging, tubes, vials / cartridges, ampoules, sachets / pouches / bags, inhalers / nasal sprays, glass / plastic bottles / dropper bottles and prefilled syringes / autoinjectors / pen injectors) and scale of operation (preclinical, clinical and commercial).
- A detailed regional capability of pharmaceutical contract manufacturing facilities in different regions (North America, Europe, Asia-Pacific and Rest of the World) across the globe.
- Elaborate profiles of key contract manufacturers in the pharmaceutical contract manufacturing market. Each profile features a brief overview of the pharmaceutical contract manufacturing companies, along with information on location of headquarters, year of establishment, number of employees, leadership team, manufacturing portfolio, financial information, recent developments, and an informed future outlook.
- A brief description of companies in pharmaceutical contract manufacturing. Each profile features a brief description of the company overview, along with information on the manufacturing portfolio.
- A qualitative analysis highlighting various factors that need to be taken into consideration by pharmaceutical drug developers, while deciding whether to manufacture their respective products in-house or engage the services of a CMO.
- A detailed analysis of the various mergers and acquisitions in this domain since 2017, based on several relevant parameters, such as year of agreement, type of agreement, key value drivers of the deal, most active players (in terms of number of agreements signed) and geographical location of the companies. In addition, the chapter provides information on the financial terms of the deals (if available) in order to enumerate the deal multiples (in terms of annual revenues of the acquired firm (at the time of acquisition) and years of experience in this domain).
- A detailed analysis of acquisitions that have taken place in the pharmaceutical contract manufacturing domain, taking into consideration the historical trend of the activity of players that have acquired other firms since 2017, and offering a means for other industry stakeholders to identify potential acquisition targets. The primary purpose of this analysis was to develop a better understanding of the overall potential and capabilities of companies involved in this domain, that are likely to be acquired in the recent future.
- An estimate of the overall installed capacity for the manufacturing of pharmaceuticals, based on information reported by various industry stakeholders in the public domain, highlighting the distribution of the available capacity, based on size of manufacturer (small, mid-sized, and large and very large) and geography (North America, Europe, Asia-Pacific and Rest of the World).
- An informed estimate of the annual clinical and commercial demand for small molecule drugs, across key geographical regions.
- An in-depth analysis of the factors that can impact the growth of the global pharmaceutical contract manufacturing market. It also features identification and analysis of key drivers, potential restraints, emerging opportunities, and existing challenges.
- A detailed estimate of the current market size and the future growth potential of the pharmaceutical contract manufacturing market over the next decade. Based on multiple parameters, such as likely adoption trends and through reliable secondary and primary validations, we have provided an informed estimate on the market evolution during the forecast period 2024-2035. The report also features the likely distribution of the current and forecasted opportunity within the pharmaceutical contract manufacturing industry. Further, in order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base, and optimistic scenarios, representing different tracks of the pharmaceutical contract manufacturing market growth.
- Detailed projections of the current and future opportunity for contract manufacturers in the pharmaceutical CMO market across various types of products manufactured, such as API & Intermediates and FDF.
- Detailed projections of the current and future opportunity for contract manufacturers in the pharmaceutical contract manufacturing industry across various types of API, such as generic API and originator API.
- Detailed projections of the current and future opportunity for contract manufacturers in the pharmaceutical contract manufacturing industry across types of API by potency, such as low potent API and high potent API.
- Detailed projections of the current and future opportunity for contract manufacturers in the pharmaceutical contract manufacturing market across various types of FDF, such as generic FDF and originator FDF.
- Detailed projections of the current and future opportunity for contract manufacturers in the pharmaceutical CMO market across different types of dosage form offered, such as oral solids, liquids, emulsions, and other dosage forms.
- Detailed projections of the current and future opportunity for contract manufacturers in the pharmaceutical contract manufacturing market across different type of packaging, such as bottles, blisters, parenteral and others.
- Detailed projections of the current and future opportunity for contract manufacturers in the pharmaceutical contract manufacturing industry across different type of end-users, such as small, mid-sized and large and very large companies.
- Detailed projections of the current and future opportunity for contract manufacturers in the pharmaceutical contract manufacturing market across scales of operation, including clinical and commercial.
- Detailed projections of the current and future opportunity for contract manufacturers in the pharmaceutical contract manufacturing market across key geographical regions, such as North America, Europe, Asia-Pacific, Latin America and Middle East and North Africa.
- Detailed list of the current pharmaceutical contract manufacturing market across leading players.
- A case study highlighting a comparison of the key characteristics of large and small molecule drugs, along with information on the steps involved in their respective manufacturing processes.
Key Benefits of Buying this Report
- The report offers market leaders and newcomers valuable insights into revenue estimations for both the overall market and its sub-segments.
- Stakeholders can utilize the report to enhance their understanding of the competitive landscape, allowing for improved business positioning and more effective go-to-market strategies.
- The report provides stakeholders with a pulse on the Pharmaceutical Contract Manufacturing Market, furnishing them with essential information on significant market drivers, barriers, opportunities, and challenges.
Leading Market Companies
- AMRI Global
- Altasciences
- Cambrex
- Catalent
- DPT Laboratories
- Aenova
- Almac
- Corden Pharma
- Fresenius Kabi
- Glatt
- Hovione
- Recipharm
- Siegfried
- CMIC Group
- Nectar Lifesciences
- Syngene
- WuXi AppTec