• 出版社/出版日：Mordor Intelligence / 2022年1月
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・競争状況（Cambrex Corporation、Patheon (Thermo Fisher Scientific, Inc.)、Recipharm AB、CordenPharma International、Samsung Biologics、Lonza、Siegfried、Piramal Pharma Solutions、AbbVie Inc.、Catalent, Inc.）
The active pharmaceutical ingredients (API) CDMO market is projected to register a CAGR of 6.8% during the forecast period.
The COVID-19 pandemic has had a huge impact on the API contract development and manufacturing organization (CDMO) Market. As the vaccines and therapeutics for Covid-19 rolled out globally, the demand for CDMO services is skyrocketing. CDMOs have gone to great extents to meet the needs of their pharmaceutical customers during the crisis. CDMOs provide a broad range of services to pharmaceutical companies such as drug development & supply chain, commercial API & drug manufacturing, and packaging. These services permit pharmaceutical firms to lessen their development & manufacturing costs, along with the capital investments, and timelines while benefitting from the most advanced technologies.
The first half of 2021 has marked the increased participation of CDMOs in COVID-19 vaccine manufacturing and robust mergers and acquisition activity. The first half of 2021 has highlighted the indispensability of CDMOs in the bio/pharmaceutical industry. They have been vital to the successful launch of vaccines and therapies to combat the COVID-19 virus.
As per the article published by Drug, Chemical & Associated Technologies Association, Inc. (DCAT) Value Chain Insights on “Mid-Year CDMO Review: COVID-19 Vaccine Manufacturing and M&A”, in the first months of the pandemic, less than 10 CDMOs were known publicly to be working with the bio/pharma companies and government agencies to develop and manufacture vaccines. Contracts were going to CDMOs that had the accessible capacity or could expand it rapidly, including Catalent, and Lonza. CDMOs are engaged in producing the vaccine’s active ingredients and key excipients. The demand for vaccine capacity has elevated the status and profiles of many CDMOs that were earlier dependent on the older products & generics. Some companies, for instance, Rovi Contract Manufacturing, have got both the drug substance & drug product contracts.
Besides, the first half of 2021 has also seen a high number of mergers & acquisitions activities as investors seek to buy their way into the industry and incumbents seek to broaden and deepen their capabilities. A total of 32 deals were announced or closed during the first five months of 2021. Out of these, five deals were for small molecule API businesses, and four for large molecule API assets.
Outsourcing to CDMOs can also offer companies access to a flexible workforce including highly-specialized experts. In recent times, increased outsourcing to CDMOs has been seen for drug owners from pharmaceutical to biopharmaceutical companies, from small to large firms, and for early to late-stage development projects.
The quality of APIs has a noteworthy effect on the efficacy as well as the safety of medications. Hence, selecting a CDMO that can provide the precise API at the required strength, purity, and quality is, therefore, a vital decision for drug development companies.
Key Market Trends
The Commercial Segment is Expected to Hold a Major Market Share in the Active Pharmaceutical Ingredients CDMO Market
The COVID-19 pandemic has led to an increase in the demand for pharmaceutical products and the hoarding of supplies by some nations in the wake of production disruptions has boosted the exports. With the increasing number of COVID-19 cases, there is a need for new COVID-19 vaccines and therapeutics. Some governments even started considering the localization regulations to ensure that sufficient quantities of therapeutics would be produced domestically.
As a result, many pharmaceutical companies started expanding their manufacturing footprints and some began to rethink their manufacturing footprint to plan for the years ahead. The largest source of additional capacity was CDMOs. Pharmaceutical firms reserved, and sometimes even double-booked a considerable space with the contract manufacturers. AstraZeneca, Moderna, and Pfizer have declared their partnership agreements with a number of CDMOs, including Lonza, Catalent, Emergent Biosolutions, among others. Making the most of the opportunity, Cambrex, Catalent, Samsung Biologics, and many other developing country CDMOs have declared a major expansion to their plants.
Besides, the approval of many small and large molecules is driving segmental growth. As per the article published by DCAT on “The Pharma Pulse: Small Molecules and Biologics”, in 2020, the United States of Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has approved a total of 53 new molecular entities (NMEs), which surpassed the 48 NMEs in 2019, and was the second-highest level of NMEs approved in the last decade, except for 2018 where 59 NMEs were approved. Continuing a trend, small molecule drugs dominated NME approvals in 2020. In 2020, 75% or 40 of the 53 NMEs approved 2020 were small molecules. In 2019, 79% of NME approvals were small molecules; in 2018, it was 71% and 74% in 2017. Hence, the fast appoval of such molecules is likely to create demand for manufactruing services, thereby boosting the segmental growth.
The Asia Pacific is Expected to Hold a Significant Share in the Market and Expected to do Same in the Forecast Period.
Countries such as China and India have a significantly low cost of manufacturing as compared to the United States and Europe. As per Invest India, the cost of manufacturing in India is approximately 33% lower than that of the United States. While China and India have established themselves as a significant provider of API manufacturing services, the United States continues to be the main outsourcing hub for pharmaceutical development. This is owing to the combination of enormous amounts of financing and an exclusive concentration of university-affiliated pharmaceutical research hubs.
The expanding importance of traditional pharmaceuticals, as well as the rapidly rising incidence of persistent infections, are critical drivers in the Indian API CDMO’s market favorable growth. As per the article published in PHRMABIZ.com in 2020, generic APIs are exported to developed countries from India, accounting for 41.6% of total sales in India versus 24.7% in China. As per the Chemical Pharmaceutical Generic Association Research, India is the second-largest provider of generic API to the United States market, with a 24.4% share. The country is also increasing its supply to Western Europe, which accounts for 19.2% of the region’s total supply. Also, China accounts for 30% of the global nonexclusive API vendor market. Following China, the United States and India are the leading producers of nonexclusive APIs. Thus, India has become a major outsourcing center for manufacturing active pharmaceutical ingredients.
The active pharmaceutical ingredients CDMO market is fragmented competitive and consists of several major players. In terms of market share, a few of the major players are currently dominating the market. Some of the companies which are currently dominating the market are Cambrex Corporation, Patheon (Themo Fisher Scientific, Inc.), Recipharm AB, CordenPharma International, Samsung Biologics, Lonza, Siegfried, Piramal Pharma Solutions, Abbvie, Inc., Catalent, Inc.
The role of API manufacturers in the pharmaceutical supply chain is evolving in response to the newfound demands from customers and increasing pressures from global competitors. Traditional generic firms are looking to China and India for bulk activities, while specialty pharma companies have generated new demands for more specialized capabilities than those required by traditional generics.
- The market estimate (ME) sheet in Excel format
- 3 months of analyst support
1.1 Study Assumptions
1.2 Scope of the Study
2 RESEARCH METHODOLOGY
3 EXECUTIVE SUMMARY
4 MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Increasing pharmaceutical R&D investment
4.2.2 Rising demand for generic drugs
4.2.3 Complex manufacturing
4.2.4 Patent Expiration
4.3 Market Restraints
4.3.1 Compliance issues while outsourcing
4.3.2 Concerns about data quality & security
4.4 Porter’s Five Force Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5 MARKET SEGMENTATION
5.1 By Molecule Type
5.1.1 Small molecule
5.1.2 Large molecule
5.2 By Synthesis
5.3 By Drug Type
5.4 By Workflow
5.5 By Application
5.6.1 North America
184.108.40.206 United States
220.127.116.11 United Kingdom
18.104.22.168 Rest of Europe
22.214.171.124 South Korea
126.96.36.199 Rest of Asia-Pacific
5.6.4 Middle-East and Africa
188.8.131.52 South Africa
184.108.40.206 Rest of Middle-East and Africa
5.6.5 South America
220.127.116.11 Rest of South America
6 COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Cambrex Corporation
6.1.2 Patheon (Thermo Fisher Scientific, Inc.)
6.1.3 Recipharm AB
6.1.4 CordenPharma International
6.1.5 Samsung Biologics
6.1.8 Piramal Pharma Solutions
6.1.9 AbbVie Inc.
6.1.10 Catalent, Inc.
7 MARKET OPPORTUNITIES AND FUTURE TRENDS