◆英語タイトル：Pharmaceutical Contract Development and Manufacturing Organization (CDMO) Market - Growth, Trends, Forecast (2020 - 2025)
The pharmaceutical CDMO market was valued at USD 148.5 billion in 2019, and it is expected to reach USD 224.9 billion by 2025, registering a CAGR of 7%, during the period of 20202025.
As a result of the growing demand for generic medicines and biologics, the capitalintensive nature of the business, and the complex manufacturing requirements, many pharmaceutical companies have identified the potential profitability in contracting with a CMO (contract manufacturing outsourcing) for both clinical and commercial stage manufacturing.
The biggest factor driving the growth of CMOs in the pharmaceutical industry is the growing need for stateoftheart processes and production technologies, which have proven highly effective in meeting regulatory requirements.
US is one of the largest R&D spenders in the pharmaceutical and biotechnology sector. According to Axios, a prominent online news company in the United States, as of 2018, pharmaceutical industries in the country had the tenthhighest average aftertax profit levels, when compared to more than 100 different industries. While drug companies are responsible for 23% of the US health revenue, they also make 63% of the total profits.
R&D sections of several pharmaceutical companies, especially operating at small scales, were condensed after the emergence of CRO players. As more CROs have started to offer research services with valuable cost, they won the competition with inhouse pharmaceutical R&D departments. CROs also follow several strategies to stay ahead of top pharmaceutical players.
The CMO/CDMO service sector is uniquely positioned to address some of the challenges that drug developers are facing amid the COVID19 pandemic. This pandemic has impacted multiple aspects of the pharma and biopharma industry, from drug development, clinical trials, supplies, manufacturing, to supply chain logistics. However, the drug shortages due to COVID19 are limited, and they are expected to remain so for shortterm, due to stockpiles of pharmaceuticals, APIs, globally.
[Key Market Trends]
Increasing Investment in R&D to Drive the Market Growth
The United States is the world’s largest market for drugs and accounts for almost half of the R&D spending in the pharmaceutical and biotechnology markets. Hence, CMOs play a critical role in this market and have invested in new facilities and technologies to cater to a wide range of outsourcing units.
The biggest Chinese professional manufacturer of dermatology and antituberculosis drug products, Huapont, is one of the fastestgrowing pharmaceutical manufacturers in China, mainly dependent on product R&D and market expansion.
CRO/CMOs can leverage their expertise, owing to their R&D and complex manufacturing capabilities, to fill the needs of the large generic, big pharmaceutical, and biotech companies.
A major stake of R&D investments and capacity expansions are likely in the injectable and sterile liquid dose formulations segment. Small biotech firms get access to specialized knowledge and resources, which help them expedite their R&D activities.
[AsiaPacific Expected to Witness Highest Growth in CRO Market]
Over the forecast period, AsiaPacific is expected to witness the highest growth in the CRO market, owing to the low cost offered by the region, as compared to the United States and other developed economies. Additionally, growing incidences of chronic and lifestyle diseases, such as diabetes and heart disease, coupled with ease of patient recruitment and availability of expertise for clinical trials, are few driving factors boosting growth in the region.
With the increasing privatization of clinical trials, there has been an increase in the outsourcing of research processes in developing regions like China and India. For instance, the market is witnessing increased outsourcing of research services, such as Clinical Data Management, Pharmacovigilance, Biostatistics, etc., by large pharmaceuticals.
Growing investments by several pharmaceutical and biopharmaceutical drug manufacturing companies are also supporting the growth of the CRO market in the region. As part of its fiveyear Research, Innovation, and Enterprise 2020 plan, the Singaporean government has committed to invest nearly USD 2.4 billion in advancing manufacturing and engineering in the pharmaceutical market.
In January 2019, Lambda, headquartered in India, announced the acquisition of USbased Novum Pharmaceutical Research Services, in a move to increase its presence in the United States.
The CDMO Market is consolidated in nature. The need for continued research and development related expenses push forward for the extension of business opportunities. In the pharmaceutical industry, medicine is continuously tested and are most profitable during the patent period; the emergence of competitive solution can hamper the rate of return. Such factors push for continued innovation and fast track the introduction time to market. Major players include Catalent Inc., Recipharm AB, Jubilant Life Sciences Ltd.
February 2020 Catalent, has signed an agreement with Zumutor Biologics Inc., to manufacture Zumutor’s, ZM008, for the treatment of solid tumors. Zumutor is a biologics company that develops novel immunooncotherapeutics to drive transformational improvements in cancer treatment.
December 2019 Thermo Fisher Scientific Inc. opened its new USD 90 million viral vectors CDMO (contract development and manufacturing organization) site in Lexington, Mass. The 50,000squarefoot facility may add more than 200 jobs and support the development, testing, and manufacture of viral vectors, which are critical to advancing new lifesaving gene and cell therapies worldwide.
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1.1 Study Assumptions and Market Definition
1.2 Scope of the StudyA
2 RESEARCH METHODOLOGY
3 EXECUTIVE SUMMARY
4 MARKET DYNAMICS
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 Market Drivers
4.6 Market Restraints
4.7 Assessment of Impact of COVID-19 on the Industry
5 TECHNOLOGY SNAPSHOT
5.1 Dosage Formulation Technologies
5.2 Dosage Forms by Route of Administration
5.3 Key Considerations for Outsourcing of Pharmaceutical R&D
5.4 Major Segments in CRO – Bio Analytical Testing, Central Laboratory Testing, and cGMP Testing
6 MARKET SEGMENTATION
6.1 Service Type – CMO Segment
6.1.1 Active Pharmaceutical Ingredient (API) Manufacturing
6.1.2 Finished Dosage Formulation (FDF) Development and Manufacturing
126.96.36.199 Solid Dose Formulation
188.8.131.52 Liquid Dose Formulation
184.108.40.206 Injectable Dose Formulation
6.1.3 Secondary Packaging
6.2 Research Phase – CRO Segment
6.2.2 Phase I
6.2.3 Phase II
6.2.4 Phase III
6.2.5 Phase IV
6.3.1 For CMO Market Segment
220.127.116.11 North America
18.104.22.168.1 By Service Type
22.214.171.124.2 By Country
126.96.36.199.2.1 United States
188.8.131.52.1 By Service Type
184.108.40.206.2 By Country
220.127.116.11.2.1 United Kingdom
18.104.22.168.2.5 Rest of Europe
22.214.171.124.1 By Service Type
126.96.36.199.2 By Country
188.8.131.52.2.5 Rest of Asia-Pacific
184.108.40.206 Latin America
220.127.116.11.1 By Service Type
18.104.22.168.2 By Country
22.214.171.124.2.4 Rest of Latin America
126.96.36.199 Middle East and Africa
188.8.131.52.1 By Service Type
184.108.40.206.2 By Country
220.127.116.11.2.1 United Arab Emirates
18.104.22.168.2.2 Saudi Arabia
22.214.171.124.2.3 South Africa
126.96.36.199.2.4 Rest of Middle-East and Africa
6.3.2 For CRO Segment
188.8.131.52 North America
184.108.40.206 Latin America
220.127.116.11 Middle-East and Africa
7 COMPETITIVE LANDSCAPE
7.1 Vendor Market Share Analysis
7.2 Company Profiles
7.2.1 CMO Vendors
18.104.22.168 Catalent Inc.
22.214.171.124 Recipharm AB
126.96.36.199 Jubilant Life Sciences Ltd
188.8.131.52 Patheon Inc.
184.108.40.206 Boehringer Ingelheim Group
220.127.116.11 Pfizer CentreSource
18.104.22.168 Aenova Holding GmbH
22.214.171.124 Famar SA
126.96.36.199 Baxter Biopharma Solutions
188.8.131.52 Lonza Group
7.2.2 CRO Vendors
184.108.40.206 CMIC Holdings Co. Ltd
220.127.116.11 Covance Inc.
18.104.22.168 Syneos Health Inc.
22.214.171.124 LSK Global Pharma Service Co Ltd
126.96.36.199 Novotech Pty Ltd
188.8.131.52 PAREXEL International Corporation
184.108.40.206 Pharmaceutical Product Development LLC
220.127.116.11 PRA Health Sciences Inc.
18.104.22.168 Quanticate Ltd
22.214.171.124 IQVIA Holdings Inc.
126.96.36.199 SGS SA (SGS Life Sciences)
188.8.131.52 Hangzhou Tigermed Consulting Co Ltd
184.108.40.206 Samsung Bioepis Co. Ltd
220.127.116.11 WuXi AppTec Inc.
18.104.22.168 Sagimet Biosciences (3V Biosciences Inc.)
8 INVESTMENT ANALYSIS
9 MARKET OPPORTUNITIES AND FUTURE TRENDS