Pharmaceutical CDMO Industry Overview
|Study Period:||2018 - 2028|
|Fastest Growing Market:||Asia Pacific|
|Largest Market:||North America|
*Disclaimer: Major Players sorted in no particular order
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Pharmaceutical CDMO Market Analysis
The pharmaceutical CDMO market is expected to register a CAGR of 7.29% during the forecast period. The contract development and manufacturing organization outsourcing market may expand due to the expanding pharmaceutical sector. The key trend affecting the market's growth is the growing usage of analytics by CDMOs.
- A growing number of pharmaceutical companies recognized the potential profitability of working with a CMO for clinical and commercial-stage manufacturing due to the increasing demand for generic drugs and biologics, the capital-intensive nature of the industry, and the complex manufacturing requirements.
- The development of new therapeutic modalities focused on personalized medicine, emerging biopharma companies, consumer demand for more affordable medications and higher levels of productivity, and technological advancements, like artificial intelligence and digitization, are some of the main factors driving the growth of the CRO industry.
- Pharmaceutical outsourcing evolved from basic processes, namely bottling, to more value-added techniques, such as medical device engineering and R&D. The active process-outsourcing experience, the increasing number of patients subject to medical procedures, and the improvements in illness detection and diagnosis in developing countries are the factors driving the growth of the market.
- There has been a gradual change in the working principles of the companies in the market. The pattern shift from cost-control to re-emphasis on value-added services has led to the redefining of CMOs to CDMOs (contract development and manufacturing organizations) and allowed their integration into the value chain of companies.
- The costs invested in R&D are continuously increasing, yet the valuable results from these processes are becoming rarer. Many companies have realized that moving this part of the business overseas and taking advantage of the still-emerging pharmaceutical markets effectively reduce costs.
- The production of the COVID-19 vaccine and the expanding biologic pipeline fuelled the CMO market, particularly the parenteral market, with unprecedented growth. The COVID-19 outbreak positively impacted the market as pharma companies suddenly faced the challenge of producing millions of vaccine doses for the global population. Many companies, such as Pfizer and AstraZeneca, transferred non-COVID-19 biologics out of their proprietary manufacturing networks to make room for the new vaccines. Due to compressed timelines and manufacturing scaling challenges for the COVID-19 vaccines and medicines, CMOs signed contract manufacturing service agreements at an unprecedented rate in the previous years.
Pharmaceutical CDMO Industry Segments
Contract manufacturing can be defined as a manufacturer entering a formal agreement with another manufacturer for its parts, goods, or components as a kind of outsourcing. The manufacturer employs these components and goods in producing its goods.
Contract development and manufacturing organization (CDMO) caters to the pharmaceutical sector and offers clients complete services, ranging from manufacturing to drug research.
The pharmaceutical CDMO market study provides a detailed breakdown of the CRO (Contract Research Organization) and CMO (Contract Manufacturing Organization) market, as the term CDMO represents organizations that provide both development and manufacturing of drugs, encompassing the overall market trends and growth projections. The study provides a granular view of the current CMO and CRO industry, with a further breakdown of each segment by region. The impact of COVID-19 on the market ecosystem and the overall ecosystem is also covered in the study. The market sizes and forecasts are provided in terms of value (USD billion) for all the above segments.
|By Service Type CMO Segment|
|By Research Phase CRO Segment|
|By Geography - Global Pharmaceutical CMO***|
|By Geography - Global Pharmaceutical CRO|
|Middle-East and Africa|
Pharmaceutical CDMO Market Trends
This section covers the major market trends shaping the Pharmaceutical CDMO Market according to our research experts:
Increasing Investment in R&D Expected to Drive the Market
- The United States is one of the largest pharmaceutical markets, accounting for about half of the R&D spending in the pharmaceutical and biotech markets. CMOs play a vital role in this market, investing in new facilities and technology to serve a wide range of outsourcing entities. Companies are benefitting from their Asian footprint through in-house investments and aiming for research-based partnerships to acquire high-end sourcing expertise, build drug discovery, and invest in Asia.
- According to a survey conducted by EY in July 2022, the number of CDMOs increased over the past decade, with mergers and acquisitions (M&A) and consolidations being the main growth drivers. The EY team analyzed these deals and reviewed 92 publicly disclosed internal investments from 15 selected global CDMO companies to provide a consolidated view of the CDMO's M&A landscape. The well-positioned CDMO flexibly changed its production line to meet the increasing demand for smaller and more diverse projects. New partnerships emerged, enabling CDMO players to further drive rapid growth in capacity, helping the industry to thrive in areas such as vaccine production.
- In June 2021, Bengaluru-based Kemwell Biopharma acquired two new clients from the United States for end-to-end novel biologics projects, including development and clinical manufacturing. It continued supporting commercial drug product manufacturing for two clients despite the lockdowns to ensure uninterrupted patient supplies. It successfully manufactured over 20 batches of a commercially approved drug substance at a 2,000 l scale.
- The company also took a few expansion initiatives. It added AMBR250, a high throughput process development equipment, to its existing facility. It also expanded its bioreactor capacity by ordering 200 l and 1000 l single-use bioreactors (SUBs). The company also built India's first cGMP cell therapy manufacturing site as a CDMO during the same period.
- In January 2022, Aragen Life Sciences (formerly GVK Biosciences) stated the demand for outsourced research, development, and manufacturing services may continue to gain momentum. With the increasing demand for end-to-end integrated services, the CRO and CDMO industry is likely to consolidate in India and globally. The company added that it expects CROs and CDMOs to invest in new capabilities, build additional infrastructure, and increase their geographic footprint organically or inorganically.
- The need for proper infrastructure for the safe handling and containment of high-potency drugs, especially appropriate analytical skills for high-potency drugs and adequate project management (including proper launch, execution, and completion), may help the market for R&D stand out in the future.
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Asia-Pacific is Expected to be the Fastest-growing Region for the CRO Segment
- Asia Pacific is anticipated to witness the highest growth in the CRO market over the forecast period due to the region's low cost compared to the United States and other developed economies. Growing incidences of chronic and lifestyle diseases, such as diabetes and heart disease, along with ease of patient recruitment and availability of expertise for clinical trials, are major drivers of growth in the region.
- For instance, China has over 180 million elderly citizens suffering from chronic diseases, with 75% having more than one disease, according to the National Health Commission (NHC). By 2030, the treatment of cardiovascular diseases may cost USD 1,044 billion to the Chinese government. There is also a high prevalence of diabetes across Asia-Pacific, including China, South Korea, and Australia.
- In April 2021, dMedGlobal, a full-service clinical CRO based in Shanghai, China, and ClinipaceIncorporated, also a full-service clinical CRO, announced a merger, which is expected to meet the needs of fast-moving biotech, pharma, and medical device companies and accelerate the delivery of innovative solutions to patients in the region and worldwide.
- With the increasing privatization of clinical trials, there has been an increase in research process outsourcing in developing countries such as China and India. For example, large pharmaceutical companies are increasingly outsourcing research services such as clinical data management, pharmacovigilance, biostatistics, etc.
- There are several reasons for certain regions attracting organizations conducting clinical trials, such as cost, patient recruitment, required testing, and shorter timelines. The overall number of clinical trials is increasing in China, India, and Japan, making Asia-Pacific one of the potential regions.
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Pharmaceutical CDMO Market Competitor Analysis
The pharmaceutical CDMO market is fragmented, where several vendors contribute to the market share. The existence of numerous competitors in the market has an impact on service pricing, making it a direct source of competition, particularly for small-scale providers. The vendors in the market are anticipated to concentrate on offering one-stop-shop services to gain a competitive edge. The CMO, with access to significant capital, would be able to engage in these activities, thus making entry difficult for new players and enhancing competition.
- SEP 2022 - Lonza reported the completion of the extension of its Highly Potent API (HPAPI) multifunctional suite in Visp. The expansion increases ADC payload development and manufacturing capacity, supporting the fundamental research and manufacturing pipeline, ranging from feasibility studies to commercial delivery.
- JUN 2022 - Pfizer CentreOne unveiled its new facility in Freiburg, Germany, established in collaboration with Bristol-Myers Squibb, to provide more assistance to European partners with medication manufacturing. With a floor area of 13,500m2, the new facility could make up to 7 billion more solid dosage forms. Overall, the new facility raised its total capacity by up to 12 billion pills and capsules annually, which is a 140% increase.
- APR 2022 - Aenova established a new structure for highly potent active chemicals at its Regensburg location. The new production facilities create extremely effective medications, particularly those fighting cancer. Aenova could significantly boost manufacturing capacity with an investment of roughly EUR 10 million (USD 10.28 million) to satisfy rising market demand.
Pharmaceutical CDMO Market Top Players
Jubilant Pharmova Ltd
Patheon Inc. (Thermo Fisher Scientific Inc.)
Boehringer Ingelheim Group
*Disclaimer: Major Players sorted in no particular order
Pharmaceutical CDMO Market Recent Developments
- OCT 2022 - BiohavenPharmaceutical Holding Company Ltd was acquired by Pfizer Inc. for a transaction of USD 11.6 billion. BiohavenPharmaceutical is the manufacturer of NURTEC ODT (rimegepant), a new migraine medicine licensed for both acute treatment and prevention of episodic migraine in adults.
- SEP 2022 - Lonza collaborated with Touchlight, a biotechnology start-up that developed enzymatic DNA manufacturing to fuel the genetic medicine revolution. Through this collaboration, Lonza can add another distinctive source of DNA to its end-to-end offering to clients creating messenger RNA (mRNA) therapeutics and vaccines. Touchlight will expand the channels, allowing clients to access its cutting-edge doggy bone DNA (dbDNA) technology.
- AUG 2022 - Aenova announced its plans to diversify its product development and production capabilities, especially in active medicinal components' bioavailability. To fill micro-dosed capsules, which contain minimal doses of the active ingredient down to the microgram, Aenova utilized a dry powder inhaler (DPI) platform. The solution makes it more effective in treating bronchial asthma and chronic obstructive lung disease.
Pharmaceutical CDMO Market Report - Table of Contents
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET INSIGHTS
4.1 Market Overview
4.2 Industry Attractiveness - Porter's Five Forces Analysis
4.2.1 Porter's Five Forces Analysis for CMO
4.2.2 Porter's Five Forces Analysis for CRO
4.3 Industry Value Chain Analysis
4.4 Industry Policies
4.5 Assessment of the Impact of COVID-19 on the Pharmaceutical Industry
5. MARKET DYNAMICS
5.1 Market Drivers
5.1.1 Increasing Outsourcing Volume by Big Pharmaceutical Companies
5.1.2 Advent of CDMO Model into the Market
5.1.3 Increasing Investment in R&D
5.2 Market Restraints
5.2.1 Increasing Lead Time and Logistics Costs
5.2.2 Stringent Regulatory Requirements
5.2.3 Capacity Utilization Issues Affecting the Profitability of CMOs
5.3 Emphasis on Solid-based Oral Dosage Formulations
5.4 Qualitative Coverage on the 3D Printing Developments in the OSD Segment
5.4.1 Evolution of 3D Printing in Fabrication Processes and the Key Advantages Over Conventional Processes
5.4.2 Analysis of Major Drugs Manufactured Using 3D Printing-based Process
5.4.3 Analysis of Key Techniques Deployed (SLS & FDM), Along with their Relative Advantages
5.4.4 Key Developments on Stakeholders
5.4.5 Market Outlook
6. TECHNOLOGY SNAPSHOT
6.1 Dosage Formulation Technologies
6.2 Dosage Forms by Route of Administration
6.3 Key Considerations for Outsourcing of Pharmaceutical R&D
6.4 Major Segments in CRO Bio Analytical Testing, Central Laboratory Testing, and cGMP Testing
7. MARKET SEGMENTATION
7.1 By Service Type CMO Segment
7.1.1 Active Pharmaceutical Ingredient (API) Manufacturing
184.108.40.206 Small Molecule
220.127.116.11 Large Molecule
18.104.22.168 High Potency (HPAPI)
7.1.2 Finished Dosage Formulation (FDF) Development and Manufacturing
22.214.171.124 Solid Dose Formulation
126.96.36.199.2 Others(Capsules, Powders, Etc.)
188.8.131.52 Liquid Dose Formulation
184.108.40.206 Injectable Dose Formulation
7.1.3 Secondary Packaging
7.2 By Research Phase CRO Segment
7.2.2 Phase I
7.2.3 Phase II
7.2.4 Phase III
7.2.5 Phase IV
7.3 By Geography - Global Pharmaceutical CMO***
7.3.1 North America
220.127.116.11 United States
18.104.22.168 United Kingdom
22.214.171.124 Rest of Europe
126.96.36.199 Rest of Asia-Pacific
7.3.4 Latin America
188.8.131.52 Rest of Latin America
7.3.5 Middle-East and Africa
184.108.40.206 United Arab Emirates
220.127.116.11 Saudi Arabia
18.104.22.168 South Africa
22.214.171.124 Rest of Middle-East and Africa
7.4 By Geography - Global Pharmaceutical CRO
7.4.1 North America
7.4.4 Latin America
7.4.5 Middle-East and Africa
8. VENDOR MARKET SHARE
9. COMPETITIVE LANDSCAPE
*List Not Exhaustive
9.1 Company Profiles
9.1.1 Catalent Inc.
9.1.2 Recipharm AB
9.1.3 Jubilant Pharmova Ltd
9.1.4 Patheon Inc. (Thermo Fisher Scientific Inc.)
9.1.5 Boehringer Ingelheim Group
9.1.6 Pfizer CentreSource
9.1.7 Aenova Holding GmbH
9.1.8 Famar SA
9.1.9 Baxter Biopharma Solutions (Baxter International Inc.)
9.1.10 Lonza Group
9.1.11 Tesa Labtec GmbH (TESA SE)
9.1.13 ARX LLC
9.1.14 CMIC Holdings Co. Ltd
9.1.15 Labcorp Drug Development
9.1.16 Syneos Health Inc.
9.1.17 LSK Global Pharma Service Co. Ltd
9.1.18 Novotech Pty Ltd
9.1.19 PAREXEL International Corporation
9.1.20 Pharmaceutical Product Development LLC (Thermo Fisher Scientific Inc.)
9.1.21 PRA Health Sciences Inc. (Icon PLC)
9.1.22 Quanticate Ltd
9.1.23 IQVIA Holdings Inc.
9.1.24 SGS Life Science Services SA
9.1.25 Hangzhou Tigermed Consulting Co. Ltd
9.1.26 Samsung Bioepis Co. Ltd
9.1.27 WuXi AppTec Inc.
9.1.28 Sagimet Biosciences (3V Biosciences Inc.)
10. INVESTMENT SCENARIO
11. FUTURE OF THE GLOBAL PHARMACEUTICAL CDMO MARKET
Pharmaceutical CDMO Market Research FAQs
What is the study period of this market?
The Pharmaceutical Contract Development and Manufacturing Organization (CDMO) Market is studied from 2018 - 2028.
What is the growth rate of Pharmaceutical Contract Development and Manufacturing Organization (CDMO) Market?
The Pharmaceutical Contract Development and Manufacturing Organization (CDMO) Market is growing at a CAGR of 7.29% over the next 5 years.
Which region has highest growth rate in Pharmaceutical Contract Development and Manufacturing Organization (CDMO) Market?
Asia Pacific is growing at the highest CAGR over 2018 - 2028.
Which region has largest share in Pharmaceutical Contract Development and Manufacturing Organization (CDMO) Market?
North America holds highest share in 2021.
Who are the key players in Pharmaceutical Contract Development and Manufacturing Organization (CDMO) Market?
Catalent Inc., Recipharm AB, Jubilant Pharmova Ltd, Patheon Inc. (Thermo Fisher Scientific Inc.), Boehringer Ingelheim Group are the major companies operating in Pharmaceutical Contract Development and Manufacturing Organization (CDMO) Market.
Pharmaceutical Contract Development and Manufacturing Organization (CDMO) Industry Reports
In-depth industry statistics and market share insights of the Pharmaceutical Contract Development and Manufacturing Organization (CDMO) sector for 2020, 2021, and 2022. The Pharmaceutical Contract Development and Manufacturing Organization (CDMO) research report provides a comprehensive outlook of the market size and an industry growth forecast for 2023 to 2028. Available to download is a free sample file of the Pharmaceutical Contract Development and Manufacturing Organization (CDMO) report PDF.