◆英語タイトル：Pharmaceutical Contract Development and Manufacturing Organization (CDMO) Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026)
The pharmaceutical CDMO market was valued at USD 160.1 billion in 2020, and it is expected to reach USD 242.64 billion by 2026, registering a CAGR of 7%, during the forecast period of 2021 – 2026.
- As a result of the growing demand for generic medicines and biologics, the capital-intensive 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 state-of-the-art 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 tenth-highest average after-tax 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 in-house 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 COVID-19 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 COVID-19 are limited, and they are expected to remain so for short-term, 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 anti-tuberculosis drug products, Huapont, is one of the fastest-growing 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.
Asia-Pacific Expected to Witness Highest Growth in CRO Market
- Over the forecast period, Asia-Pacific 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 five-year 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 US-based 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, 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 immuno-oncotherapeutics 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 50,000-square-foot facility may add more than 200 jobs and support the development, testing, and manufacture of viral vectors, which are critical to advancing new life-saving gene and cell therapies worldwide.
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1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2 RESEARCH METHODOLOGY
3 EXECUTIVE SUMMARY
4 MARKET DYNAMICS
4.1 Market Overview
4.2 Impact of the Recent Outbreak of COVID-19 on the Pharmaceutical Industry
4.3 Market Drivers
4.3.1 Increasing Outsourcing Volume by Big Pharmaceutical Companies
4.3.2 Advent of the CDMO Model in the Market
4.3.3 Increasing Investment in R&D
4.4 Market Restraints
4.4.1 Increasing Lead Time and Logistics Costs
4.4.2 Stringent Regulatory Requirements
4.4.3 Capacity Utilization Issues Affecting the Profitability of CMOs
4.5 Value Chain Analysis
4.6 Industry Policies
4.7 Porters Five Force Analysis
4.7.1 Threat of New Entrants
4.7.2 Bargaining Power of Buyers/Consumers
4.7.3 Bargaining Power of Suppliers
4.7.4 Threat of Substitute Products
4.7.5 Intensity of Competitive Rivalry
5 TECHNOLOGY SNAPSHOT
5.1 Dosage Formulation Technologies
5.2 Dosage Forms by Route of Administration
5.3 Key Considerations for the 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
184.108.40.206 Solid Dose Formulation
220.127.116.11 Liquid Dose Formulation
18.104.22.168 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 Geography-CMO Segment
6.3.1 North America
22.214.171.124 Segmentation by Service Type
126.96.36.199 Segmentation by Country
188.8.131.52.1 United States
184.108.40.206 Segmentation by Service Type
220.127.116.11 Segmentation by Country
18.104.22.168.1 United Kingdom
22.214.171.124.5 Rest of Europe
6.3.3 Asia Pacific
126.96.36.199 Segmentation by Service Type
188.8.131.52 Segmentation by Country
184.108.40.206.5 Rest of Asia Pacific
6.3.4 Latin America
220.127.116.11 Segmentation by Service Type
18.104.22.168 Segmentation by Country
22.214.171.124.4 Rest of Latin America
6.3.5 Middle East and Africa
126.96.36.199 Segmentation by Service Type
188.8.131.52 Segmentation by Country
184.108.40.206.1 United Arab Emirates
220.127.116.11.2 Saudi Arabia
18.104.22.168.3 South Africa
22.214.171.124.4 Rest of Middle East and Africa
6.4 Geography-CRO Segment
6.4.1 North America
6.4.4 Latin America
6.4.5 Middle East and Africa
7 COMPETITIVE LANDSCAPE
7.1 Company Profiles
7.1.1 Catalent Inc
7.1.2 Recipharm AB
7.1.3 Jubilant Life Sciences Ltd
7.1.4 Patheon Inc
7.1.5 Boehringer Ingelheim Group
7.1.6 Pfizer CentreSource
7.1.7 Aenova Holding GmbH
7.1.8 Famar SA
7.1.9 Baxter Biopharma Solutions
7.1.10 Lonza Group
7.1.11 CMIC Holdings Co. Ltd
7.1.12 Covance Inc.
7.1.13 Syneos Health Inc.
7.1.14 LSK Global Pharma Service Co. Ltd
7.1.15 Novotech Pty Ltd.
7.1.16 PAREXEL International Corporation
7.1.17 Pharmaceutical Product Development LLC
7.1.18 PRA Health Sciences Inc.
7.1.19 Quanticate Ltd
7.1.20 IQVIA Holdings Inc.
7.1.21 SGS Life Science Services SA
7.1.22 Hangzhou Tigermed Consulting Co. Ltd
7.1.23 Samsung Bioepis Co. Ltd
7.1.24 WuXi AppTec Inc.
7.1.25 Sagimet Biosciences (3V Biosciences Inc.)
7.1.26 Syngene International Limited
8 INVESTMENT ANALYSIS
9 FUTURE OF THE MARKET