01 Buccal / Orodispersible
02 Buccal / Orodispersible
03 Buccal / Orodispersible
04 Buccal / Orodispersible
05 Buccal / Orodispersible
18 Chewable / Suckable
19 Clinical Supply
20 Clinical Supply
21 Clinical Supply
22 Clinical Supply
23 Clinical Supply
24 Clinical Supply
25 Clinical Supply
27 Controlled / Immediate / Modified Release
28 Controlled / Immediate / Modified Release
29 Controlled / Immediate / Modified Release
30 Controlled / Immediate / Modified Release
31 Controlled / Immediate / Modified Release
32 Controlled / Immediate / Modified Release
33 Controlled / Immediate / Modified Release
34 Controlled / Immediate / Modified Release
35 Controlled / Immediate / Modified Release
36 Controlled / Immediate / Modified Release
37 Controlled / Immediate / Modified Release
38 Controlled / Immediate / Modified Release
39 Controlled Substance
40 Controlled Substance
41 Controlled Substance
42 Controlled Substance
43 Controlled Substance
44 Controlled Substance
45 Controlled Substance
46 Cream / Gel / Lotion / Ointment
47 Cream / Gel / Lotion / Ointment
48 Cream / Gel / Lotion / Ointment
49 Cream / Gel / Lotion / Ointment
50 Cream / Gel / Lotion / Ointment
51 Cream / Gel / Lotion / Ointment
52 Cream / Gel / Lotion / Ointment
53 Cream / Gel / Lotion / Ointment
54 Cream / Gel / Lotion / Ointment
55 Cream / Gel / Lotion / Ointment
56 Cream / Gel / Lotion / Ointment
57 Cream / Gel / Lotion / Ointment
59 Granule / Pellets
60 Granule / Pellets
61 Granule / Pellets
62 Granule / Pellets
63 Granule / Pellets
64 Granule / Pellets
65 Inhalation / Nasal
66 Inhalation / Nasal
67 Inhalation / Nasal
68 Inhalation / Nasal
69 Inhalation / Nasal
70 Inhalation / Nasal
71 Injectable / Parenteral
72 Injectable / Parenteral
73 Injectable / Parenteral
74 Injectable / Parenteral
75 Injectable / Parenteral
76 Injectable / Parenteral
77 Injectable / Parenteral
78 Injectable / Parenteral
79 Injectable / Parenteral
80 Injectable / Parenteral
81 Injectable / Parenteral
82 Injectable / Parenteral
83 Injectable / Parenteral
84 Injectable / Parenteral
85 Injectable / Parenteral
86 Injectable / Parenteral
87 Lipid Formulation
88 Liposome / Microsphere / Nanoparticle
89 Liposome / Microsphere / Nanoparticle
90 Liposome / Microsphere / Nanoparticle
91 Liposome / Microsphere / Nanoparticle
92 Liquid Formulation
93 Liquid Formulation
94 Liquid Formulation
95 Liquid Formulation
96 Liquid Formulation
97 Liquid Formulation
98 Liquid Formulation
99 Liquid Formulation
123 Pediatric Formulation
124 Pediatric Formulation
125 Pediatric Formulation
126 Pediatric Formulation
127 Pediatric Formulation
128 Pediatric Formulation
129 Pediatric Formulation
130 Pediatric Formulation
133 Process Development & Optimization
134 Process Development & Optimization
135 Process Development & Optimization
136 Process Validation Studies
137 Scale-Up Capabilities
138 Scale-Up Capabilities
139 Scale-Up Capabilities
140 Scale-Up Capabilities
141 Scale-Up Capabilities
142 Scale-Up Capabilities
143 Scale-Up Capabilities
144 Scale-Up Capabilities
145 Scale-Up Capabilities
146 Scale-Up Capabilities
147 Scale-Up Capabilities
148 Small Scale Batch
149 Spray Drying
150 Sterile Liquid Formulation
151 Sterile Liquid Formulation
152 Sterile Liquid Formulation
153 Sterile Liquid Formulation
182 Tech Transfer
183 Tech Transfer
184 Tech Transfer
185 Tech Transfer
186 Tech Transfer
187 Tech Transfer
188 Tech Transfer
01 AbbVie Contract Manufacturing
02 Adare Pharma Solutions
03 Ascent Innovative Medicines
04 Astral SteriTech
05 Athena Pharmaceutiques
06 Aurigene Pharmaceutical Services
07 Biophore India Pharmaceuticals Pvt Ltd
08 Bora Pharmaceuticals
09 Catalent Pharma Solutions
11 Douglas Pharmaceuticals
13 Etico Lifesciences
17 GRAM Laboratory Inc
18 Gentec Pharmaceutical Group
19 Halo Pharmaceutical Inc
20 JSC Olainfarm
21 LGM Pharma
23 Mission | CDMO
24 Nippon Fine Chemical
25 Octavius Pharma Pvt. Ltd
26 Oncomed Manufacturing A.S
27 One Pharma
28 Pfizer CentreOne
29 Piramal Enterprises Limited
30 Piramal Pharma Solutions
31 Polfa Tarchomin
32 Prague Scientific
33 Pylote SA
34 Quotient Sciences
35 Recipharm AB
36 Ropack Inc
37 Senopsys LLC
40 Sushen Medicamentos Pvt. Ltd
41 TriRx Pharmaceutical Services
01 Czech Republic
02 Czech Republic
19 New Zealand
35 United Kingdom
Overview of custom synthesis & drug product manufacturing services offered by contract development & manufacturing organizations (CDMOs) for API & FDF
A pharmaceutical contract development and manufacturing organization or a CDMO, is a company which specializes in providing CDMO services ranging from drug product development & manufacturing to pharmaceutical packaging services including pharmaceutical serialization and aggregation, with complete trust and transparency. An increasing complexity in the development of new molecular entities (NMEs) has created a need for niche capabilities and competencies that pharmaceutical companies prefer to access externally via a CDMO facility rather than incorporate in-house.
Contract development and manufacturing organizations (CDMO's) activities refer to the production of goods by a production plant, but under the label or brand of another firm. Contract manufacturers provide such support services to several firms based on their own or their consumers' designs, formulas, and specifications. In many cases they provide a combination of scientific expertise and integrated project management combined with cost-effective CDMO services, which in turn help their partner companies get drug products to market more safely and rapidly.
Drug product manufacturing is the process by which pharma companies produce drugs at an industrial scale. The full development program can often be broken down into a series of unit operations which run from pre-formulation development, to clinical trial manufacturing and commercial manufacturing. In today's day and age, pharma companies often need to access specialized manufacturing resources, facilities, and capabilities to advance a drug from the development phase through to commercial production. Therefore, there is an increasing trend of outsourcing drug formulation, development and delivery services to contract development and manufacturing organizations - CDMOs (or contract manufacturing organizations - CMOs).
Outsourcing manufacturing of drug products has evolved from being a transactional need to a strategic function. Working with a limited number of supplier partners helps sponsor companies to optimise costs, speed products to market, reduce internal complexity and increase agility, while ensuring that these partners focus on investing capital to meet their future needs. While CDMOs have been a feature of the pharmaceutical industry for some time now, they emerged as critical components for commercial manufacturing in the past 20 years.
During their formative years, CDMOs were involved in the production of small API needs, cGMP intermediates, and providing other specialized services. However, 1996-2007 saw multiple strategic acquisitions by companies looking to become a fully integrated CDMO or a one stop shop CDMO, such as the ones made by Lonza and Cardinal Health. The CDMO market is currently undergoing consolidation through M&As on the back of sustained customer demand for CDMO services and as market participants continue to acquire the necessary scale and capabilities to become more relevant to their most important biopharma customer partners.
The three factors that contributed to the industry’s launch from 1996-2007 are:
1. Pharmaceutical companies ridding themselves of aged-off patent assets for nominal prices, being acquired by emerging pharmaceutical CDMOs.
2. Certain companies such as Vertex, Gilead, and Shire, which surfaced during the early stage of the pharma CDMO companies’ explosion, remaining devoted to outsourcing some or all of their development & manufacturing requirements.
3. The success of clinical research organizations (CROs) in developing positive relationships between pharma companies and contract service providers, on the foundation of which CDMOs then built strong lasting relationships.
Contract Services offered by fully integrated CDMOs (contract development and manufacturing organizations) include, but are not limited to, pre-formulation, formulation development, stability studies, method development, pre-clinical and Phase I clinical study materials, late-stage clinical trial materials, formal stability, scale-up, registration batches and commercial manufacturing. CDMOs often offer operational excellence in CDMO services such as early formulation development services, analytical development services, pharmaceutical packaging services and have bulk manufacturing capabilities as well.
1. Cost Saving and Restructuring: Outsourcing manufacturing to an end-to-end CDMO or full services pharmaceutical CDMO, turns fixed production costs into variable costs, giving consumers the flexibility of choosing a low-cost CDMO service provider. Therefore, many pharmaceutical companies outsource their manufacturing processes to low cost economies like India and China.
2. Reduced Operational Cost & Minimized Ownership Cost: Outsourcing production reduces excess production capacity by divesting facilities and minimizes investments in capital intensive facilities. The outsourcing firm can make strategies to lower company expenses ready by reducing these fixed costs and modifying their capacities.
3. Focus on Core Strengths: The hiring firm doesn’t need to purchase manufacturing facilities, pharmaceutical manufacturing equipments, machinery, raw materials or hire labor to process the goods. Instead, they are able to solely focus on placing orders with contract development and manufacturing organizations (CDMO), advertising, and marketing the product.
4. Accelerated time to Market: Outsourcing reduces the total time allotted for a drug product’s project management. This in turn shortens the time to market the product, which translates to quicker income and a longer duration of its patented life enabling the company to introduce new products into the market and ultimately accelerating time to market.
5. Regulatory Support: Contract manufacturers have a good understanding of their industry and FDA – health authorities’ activity, which they develop through years of experience. They can handle a project from start to finish, identify flaws and spot potential risks to quality agreements via regulatory intelligence monitoring throughout the supply chain and they thereby offer regulatory services.
6. Flexibility: Technologies: Outsourcing gives companies access to cutting edge technologies on a need basis, thereby giving hiring companies organization flexibility. This is important as owning novel technology can be very costly.
1. Quality Management System: In outsourcing, customers give up all decision making to the contracted company. If the wrong innovative CDMO solution provider is chosen who doesn’t match their partners’ needs, it could lead to a bad customer experience. Furthermore, differences in standards of customer services could lead to quality problems.
2. Less Control over Production: In-house productions provide the company ultimate control over the quality and the quantity of the products. Also, the company can easily change scope, adjust timelines and increase or decrease volume based on the market demand. Outsourcing production hands this power over to the CDMO quality charter and CDMO quality assurance facilities.
3. Loss of Intellectual Property: If a drug company has a proprietary right to a product which is responsible for most of their annual income, then it is recommended to keep the manufacturing process in-house as any margin for error could severely affect the brand name. On the contrary, for an established drug it makes more sense to outsource them. This is also in order to safeguard oneself against the risk of losing intellectual property to those working in production facilities.
Over the past decade, the pharmaceutical industry has witnessed rapid growth in outsourcing services, driven by various factors including the growth of small molecules, increasing API complexities and the need to optimize costs. 2019 proved to be a stellar year for the biopharma industry in general and for contract manufacturing organizations (CMOs) in particular. Many pharmaceutical CDMOs experienced double-digit growth, and the key indicators of opportunity for CDMOs, although down from the blowout levels of 2018, performed well.
The global pharmaceutical contract development and manufacturing market is projected to reach $126.6 billion by 2024 from $90.0 billion in 2019, at a compound annual growth rate over 6%. A main driver behind this growth is investment in advanced manufacturing technologies by contract development and manufacturing organizations (CDMOs). Additionally, mergers and acquisitions continue to be a big part of the CDMO story. There were three blockbuster deals completed in 2019, and more big deals are likely in 2020.
Thermo Fisher Scientific acquired Brammer Bio for $1.7 billion, Catalent acquired Paragon Bioservices for $1.2 billion, and Permira acquired Cambrex for $2.4 billion. These current trends exemplify that big pharmaceutical companies are embracing outsourcing to a CDMO facility as a strategic move to accelerate their drug development timelines. Furthermore, analysts report that pharma CDMOs with capabilities in gene and cell therapy, mammalian cell culture, HPAPIs (more potent APIs), and injectables, along with the vital analytical development services and regulatory support, should do very well.
However, not all CDMOs will have the same fate because they lack the portfolio of capabilities the contract development and manufacturing organization offers the market. This includes many pharma CDMOs in Europe that are stuck with undifferentiated low-value capabilities for which there is an over-abundant supply in the market.
While the end-to-end CDMO model as a whole is thriving, many CDMOs are facing challenges due to fierce competition, cost pressure, constant technological innovations and consolidation. These challenges are outlined in more detail:
• Protectionism: One of the biggest limitations to pharmaceutical CDMOs in the foreseeable future is the global push towards bringing manufacturingback into native countries. A shift towards in-house and local manufacturing is expected as a response to this outcome.
• Resources: A range of specialized technologies, processing and infrastructure is needed to support drug programs from concept to full commercialmanufacturing.
• Continuous Improvement Process: CDMOs increasingly need to demonstrate a strong track record of implementing quality by design (QbD), PAT, and continuous improvement. Meeting the continuous processing challenge is becoming ever more critical due to the need to significantly shorten drug development time, optimize cost efficiency, reduce wastage during production, and to find ways to execute drug development with smaller quantities of available high-value API’s.
• Adaptability & Time Constraints: A challenge that CDMOs are facing is the flexibility to adapt to each project dealing with different customers and the timelines for pharma CDMOs to deliver end results are often aggressive or unrealistic.
• Consolidation: One of the perennial issues facing the CMO/CDMO sector is consolidation, under the principle that there’s too much capacity overall and that a winnowing out through mergers and shutdowns will lead to more efficient and effective outsourcing.
• Data Integrity: A CDMO partner often faces the suspicion of the hiring firm when it comes to full traceability and deviation management.
A logical first step in selecting a CMO (contract manufacturing organization) or a CDMO (contract development and manufacturing organization) involves making an assessment of internal capabilities, strengths, and needs that can then be overlaid on anticipated external requirements. Following which, the criterions for selecting a compatible pharmaceutical CDMO partner are divided into two broad categories, namely culture and quality. Fully integrated CDMOs that are likely to make agile CDMO partners are flexible, good at problem solving, and have widespread experience of different dosage forms and production scale-up.
The following three factor checklist can used to select the right CDMO partner for you:
1. Capabilities, capacities, and technologies - match your current and future needs.
2. Regulatory - compliance. Track records of contract services and quality agreements can be used when assessing a company's regulatory standings.
3. Partnership: Look for a partner, not just a provider.