Investigational New Drug CDMO Market Size
| Study Period | 2019 - 2029 |
| Market Size (2024) | USD 4.45 Billion |
| Market Size (2029) | USD 7.49 Billion |
| CAGR (2024 - 2029) | 6.55 % |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Investigational New Drug CDMO Market Analysis
The Investigational New Drug CDMO Market size is estimated at USD 4.45 billion in 2024, and is expected to reach USD 7.49 billion by 2029, growing at a CAGR of 6.55% during the forecast period (2024-2029).
The market is majorly driven by factors such as increasing demand for outsourcing services in the pharmaceutical and biotechnology industry and rising research and development (R&D), as well as favorable government support.
For many businesses in the pharmaceutical sector, pharmaceutical outsourcing has emerged as a critical business strategy. Several developments, including cost reduction, globalization, regulatory compliance, faster drug development, virtual and hybrid business models, technical advancements, and risk management, have transformed the pharmaceutical outsourcing environment. For instance, in October 2023, Ampio Pharmaceuticals Inc. announced that it had selected Ascendia Pharmaceuticals Inc. to provide services to support the clinical development of OA-201, a new drug for the treatment of symptomatic osteoarthritis pain. Ascendia Pharmaceuticals, a CDMO, will be responsible for helping the company with the IND application process. Hence, with the activities that are being carried out by such contract development and manufacturing organizations, the market is expected to witness significant growth in the coming years.
Outsourcing offers various productivity benefits, including access to new technology, variability costs, and risk sharing. With contract manufacturing, significant costs can be saved. Besides, it also eliminates the need to juggle between vendors, which helps avoid unexpected costs and significantly reduces labor costs. According to the 20th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, published in April 2023, biomanufacturers incurred more expenses, demanded better technologies, and expressed greater optimism, with 86.9% of biopharmaceutical respondents reporting outsourcing of at least some activities in 2023, up from 82.6% in 2022. Therefore, with the rising outsourcing of biopharmaceuticals, the market is expected to benefit significantly.
However, compliance issues associated with outsourcing are expected to hinder market growth in the long run.
Investigational New Drug CDMO Market Trends
The Contract Manufacturing Segment is Expected to Witness Significant Growth During the Forecast Period
Pharmaceutical drugs have a complex structure, which makes it difficult for companies to meet the requirements of specific techniques and equipment during mass production. Therefore, companies usually opt for a contract manufacturing process.
Segmental growth is majorly driven by factors such as increasing strategic activities taken by the companies and the growing demand for contract manufacturing in the pharmaceutical and biotechnology sectors. For instance, in May 2022, ALSA Ventures collaborated with Lonza to help ALSA’s development of pre-clinical and early clinical biotechnology products and manufacture biologics and small molecule drug candidates. The collaboration aimed to significantly increase the chances for the future success of these therapies by providing early de-risking, development, and manufacturing services. Such company activities in contract manufacturing are expected to propel segmental growth over the forecast period.
In September 2022, Bora Pharmaceutical Laboratories Inc. (Zhunan), a division of Bora Pharmaceuticals, partnered with TaiRx Inc., a new drug development company based in Taiwan, to manufacture a novel anti-cancer drug, CVM-1118. In various human cancer cell lines, CVM-1118, a novel small molecule chemical entity, exhibits substantial anti-cancer efficacy, a large safety margin, and multiple modes of action in targeting cancer-specific components.
Therefore, owing to rapid movement by the CDMOs, the segment is expected to grow significantly during the forecast period.
North America is Expected to Hold a Significant Market Share Over the Forecast Period
The North American countries have well-established pharmaceutical and biotechnology sectors, which is beneficial for the market. Also, these countries have made significant investments in research and development activities, fueling market growth across the region.
The growing focus on expanding and launching manufacturing facilities in various countries to fuel the production of biopharmaceutical drugs is expected to propel the growth of the market. For instance, in September 2023, Bolt, a California-based clinical-stage biotechnology company, partnered with Samsung Biologics to accelerate the execution of its early-phase drug development for IND submission. With such partnerships, the market is expected to witness considerable growth in the United States.
Companies that are involved in investigational new drugs tend to wait for the FDA's Safe To Proceed letter before proceeding further. The process is time-consuming; hence, companies are taking advantage of a pre-IND labeling and packaging strategy for their clinical studies. Companies such as PCI Pharma Services are doing this by working with a CDMO operating in Canada. PCI Pharma Services is the only company in Canada that provides clinical trial services. Hence, with the emergence of such companies, the IND CDMO market in the country is expected to grow significantly in the coming years.
Therefore, with increasing company activities and high investments in R&D, the market is expected to grow in the region during the forecast period.
Investigational New Drug CDMO Industry Overview
The investigational new drug CDMO market is semi-consolidated, with several companies operating globally. Most companies are engaged in strategic activities like mergers and acquisitions, collaborations, and partnerships to sustain in the market. Some of the key players involved in the market are Lonza, Charles River Laboratories International Inc., Labcorp Corporation, Recipharm AB, and Syneous Health.
Investigational New Drug CDMO Market Leaders
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Lonza
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Charles River Laboratories International, Inc.
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Recipharm AB
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Syneous Health
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Labcorp Corporation
*Disclaimer: Major Players sorted in no particular order
Investigational New Drug CDMO Market News
- September 2023: Societal CDMO Inc. announced new project expansion agreements with several existing customers. The six new scopes of work across four different current customers highlight Societal’s ability to drive revenue growth through the ongoing strengthening and maturation of existing relationships.
- April 2023: Lonza signed an agreement with ABL Bio, a pioneering Korean biologics company with a focus on bispecific antibodies for immuno-oncology and neurodegenerative diseases. As part of the collaboration, Lonza provides ABL Bio with an end-to-end solution to support its Investigational New Drug (IND) application.
Investigational New Drug CDMO Market Report - Table of Contents
1. INTRODUCTION
- 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
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4.2 Market Drivers
- 4.2.1 Increasing Investigational New Drug Applications in Pharmaceutical Industry
- 4.2.2 Rising Investment in R&D
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4.3 Market Restraints
- 4.3.1 Compliance Issues Associated With Outsourcing
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4.4 Porter's Five Forces 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 (Market Size - Value in USD)
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5.1 By Product
- 5.1.1 Small Molecule
- 5.1.1.1 Drug Substance (API)
- 5.1.1.2 Drug Product
- 5.1.2 Large Molecule
- 5.1.2.1 Mammalian
- 5.1.2.2 Microbial
- 5.1.2.3 Others
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5.2 By Service
- 5.2.1 Contract Development
- 5.2.2 Contract Manufacturing
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5.3 By End User
- 5.3.1 Pharmaceutical Companies
- 5.3.2 Biotechnology Companies
- 5.3.3 Others
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5.4 Geography
- 5.4.1 North America
- 5.4.1.1 United States
- 5.4.1.2 Canada
- 5.4.1.3 Mexico
- 5.4.2 Europe
- 5.4.2.1 Germany
- 5.4.2.2 United Kingdom
- 5.4.2.3 France
- 5.4.2.4 Italy
- 5.4.2.5 Spain
- 5.4.2.6 Rest of Europe
- 5.4.3 Asia-Pacific
- 5.4.3.1 China
- 5.4.3.2 Japan
- 5.4.3.3 India
- 5.4.3.4 Australia
- 5.4.3.5 South Korea
- 5.4.3.6 Rest of Asia-Pacific
- 5.4.4 Middle East and Africa
- 5.4.4.1 GCC
- 5.4.4.2 South Africa
- 5.4.4.3 Rest of Middle East and Africa
- 5.4.5 South America
- 5.4.5.1 Brazil
- 5.4.5.2 Argentina
- 5.4.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
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6.1 Company Profiles
- 6.1.1 Labcorp Corporation
- 6.1.2 Charles River Laboratories Inc.
- 6.1.3 Cambrex Corporation
- 6.1.4 IQVIA Holdings Inc.
- 6.1.5 Syneos Health
- 6.1.6 Lonza
- 6.1.7 Catalent
- 6.1.8 Recipharm AB
- 6.1.9 Siegfried Holding AG
- 6.1.10 Thermo Fisher Scientific Inc.
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
** Subject To AvailablityInvestigational New Drug CDMO Industry Segmentation
As per the scope of the report, an Investigational New Drug (IND) is a drug that is in the early stages of development and has not yet been approved by regulatory authorities like the US Food and Drug Administration (FDA). IND status allows the drug's sponsor (often a pharmaceutical company) to conduct clinical trials to assess its safety and effectiveness in humans.
The investigational new drug CDMO market is segmented by product, services, end user, and geography. By product, the market is segmented into small molecules and large molecules. By services, the market is segmented into contract development and contract manufacturing. By end user, the market is segmented into pharmaceutical companies, biotechnology companies, and others. By geography, the market is segmented into North America, Europe, Asia-Pacific, the Middle East and Africa, and South America. The report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the value (in USD) for all the above segments.
| By Product | Small Molecule | Drug Substance (API) |
| Drug Product | ||
| By Product | Large Molecule | Mammalian |
| Microbial | ||
| Others | ||
| By Service | Contract Development | |
| Contract Manufacturing | ||
| By End User | Pharmaceutical Companies | |
| Biotechnology Companies | ||
| Others | ||
| Geography | North America | United States |
| Canada | ||
| Mexico | ||
| Geography | Europe | Germany |
| United Kingdom | ||
| France | ||
| Italy | ||
| Spain | ||
| Rest of Europe | ||
| Geography | Asia-Pacific | China |
| Japan | ||
| India | ||
| Australia | ||
| South Korea | ||
| Rest of Asia-Pacific | ||
| Geography | Middle East and Africa | GCC |
| South Africa | ||
| Rest of Middle East and Africa | ||
| Geography | South America | Brazil |
| Argentina | ||
| Rest of South America |
Investigational New Drug CDMO Market Research FAQs
How big is the Investigational New Drug CDMO Market?
The Investigational New Drug CDMO Market size is expected to reach USD 4.45 billion in 2024 and grow at a CAGR of 6.55% to reach USD 7.49 billion by 2029.
What is the current Investigational New Drug CDMO Market size?
In 2024, the Investigational New Drug CDMO Market size is expected to reach USD 4.45 billion.
Who are the key players in Investigational New Drug CDMO Market?
Lonza, Charles River Laboratories International, Inc., Recipharm AB, Syneous Health and Labcorp Corporation are the major companies operating in the Investigational New Drug CDMO Market.
Which is the fastest growing region in Investigational New Drug CDMO Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Investigational New Drug CDMO Market?
In 2024, the North America accounts for the largest market share in Investigational New Drug CDMO Market.
What years does this Investigational New Drug CDMO Market cover, and what was the market size in 2023?
In 2023, the Investigational New Drug CDMO Market size was estimated at USD 4.16 billion. The report covers the Investigational New Drug CDMO Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Investigational New Drug CDMO Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
Investigational New Drug CDMO Industry Report
Statistics for the 2024 Investigational New Drug CDMO market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Investigational New Drug CDMO analysis includes a market forecast outlook for 2024 to (2024to2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.
