Global Investigational New Drug CDMO Market by Service (Contract Manufacturing, Contract Development), by Product (Small Molecule, Large Molecule) and Region (North America, Latin America, Europe, Asia Pacific and Middle East & Africa), Forecast To 2028

Summary of the Report

Global investigational new drug CDMO markets were valued at USD4.2 billion in 2020. They are expected to grow at a compound annual rate (CAGR of 6.9%) between 2021 and 2028. Market growth can be attributed mainly to the increased outsourcing of pharmaceutical companies, increasing R&D investments and strict regulations for clinical studies. After screening the new drug for pharmacological activity, and its acute toxicity potential in animal models, the sponsor of the drug decides that the FDA will test the new drug's therapeutic or diagnostic potential in humans. The Federal Food, Drug, and Cosmetic Act changes the legal status of the molecule, making it a new drug that is subject to drug regulatory system's requirements.

The post-pandemic pharmaceutical landscape predicts that the industry will see an increase in innovation. Cancer and rare diseases are expected to be the biggest beneficiaries. Contract services are expected to increase significantly due to the recent rise in new drug investigation (IND) applications. There are 75 FDA approvals annually by 2025. The FDA received 3,806 new drug investigation (IND) applications between April 2020 and June 2020. This is more than the eight previous years combined (3.576 in 2012-2019).

In May 2020, FDA issued two new guidelines documents to industry and investigators working with COVID-19 drugs. These guidances "COVID-19 Public health emergency: General considerations for pre-IND meetings requests for COVID-19 related drugs and biological products" and "COVID-19 Developing drugs and biological products for treatment of prevention" outline the FDA's expectations.

This Pre-IND Guidance states that all COVID-19 drug interactions should be initiated via IND meeting requests. These were created to give broad considerations to help sponsors develop Pre-IND meetings requests for COVID-19-related medicines. In order to streamline potential sponsor bids and improve the quality of IND submissions, the FDA recommends that drug applications for development be submitted through Pre-IND programs and not a pre-Emergency Use Authorization.

Approval trends are affected by the constant evolution of review and approval processes for IND and NDA applications. Mid-2018 saw FDA Commissioner Scott Gottlieb announce plans to improve the agency's drug review office. The agency also issued draft guidance documents that outline how the FDA would incorporate patient input into regulatory decision-making. The FDA must take into consideration real-world evidence of off-label drug usage when approving regulatory applications. FDA and other regulatory agencies consider patient-reported outcomes when evaluating drug applications for approval.

Product Insights

In 2020, the small molecule segment accounted for 89.0% of the market and will likely continue to dominate the forecast period. This is due in large part to the growing number of small molecules currently under development. More than 90% of drugs on the market today are small molecules. The U.S. FDA approved 262 new molecular entities (NMEs) over a period of seven years, with small molecules accounting to 76%. In 2018, 71% of FDA-approved medicines were small molecules.

Large molecule segments are expected to experience the fastest CAGR at 8.8% over the forecast period. Because of their specificity, large-molecule therapeutic proteins allow for targeting previously unaddressed diseases such as neurology, oncology and metabolic disease. This is due in part to biotech and pharmaceutical companies investing more in this area. From 20%, 50% of the top 100 drug list will be dominated by biologics in 2020. There would be more interest from pharma and biotech companies to move innovative biotherapeutics through development as quickly as possible. Outsourcing provides sponsors with immediate access and expanded expertise, allowing them to compete in large molecule space.

Service Insights

With a market share of 85.5%, the contract development segment was dominant in 2020. This segment is expected to grow at the fastest CAGR over the forecast period. Contract development has many advantages over in-house drug development. These include access to industry experts, a shorter time to market, lower cost, and a greater focus on core competencies. Due to a lack of internal resources, most small-sized biopharmaceutical and pharmaceutical companies prefer to outsource their drug development activities. This will drive the market during the forecast period.

Over the forecast period, contract manufacturing is expected to experience lucrative growth. Sponsor firms that develop therapeutics are under extreme pressure to reduce costs and speed up market approval. Safety and efficacy are the most important factors in determining the success of a drug. However, there are other factors that can impact the cost and timeframe of the drug development process. It is crucial that a sponsor chooses a CMO who has a thorough understanding of the IND process.

End-user insights

In 2020, the pharmaceutical sector accounted for 69.4% of the market. This is due to increased investments in the pharmaceutical industry. There are approximately 7,000 rare diseases that affect 350 million people around the world. More research is underway than ever before. The FDA approved two cell-based gene therapies in 2017. This brings the number of active Investigational New Drug Applications for gene and cell therapies (INDAs) to over 700.

Over the forecast period, the biotech company segment is expected to experience a 7.0% growth rate. Basic research can be done both alone and in collaboration with other researchers from different parts of the biomedical ecosystem such as venture capital and disease foundations. The field is unique in the long development time it faces. The normal time frame for a new drug from its filing of the IND until market entry, after regulatory approval, is eight years. The eight-year process includes phases of testing, research, and FDA evaluation. All of these stages have the potential to cause the medicine's failure.

Regional Insights

North America accounted for 41.1% of the total in 2020. This is due to increased R&D investments made by pharmaceutical and life sciences companies. These investments are expected to increase the demand for contract manufacturing within the region. It takes on average 12 years for an investigational drug to go from the laboratory to the medicine cabinets in the United States. Five medications only out of 5,000 that have undergone preclinical research are made it to human clinical trials. One of the five medications approved by FDA has been tested on humans. The likelihood of a new drug being approved for market is 1 in 5,000.

Asia Pacific will experience 7.7% growth over the forecast period. Europe and North America have begun to expand their biotech businesses in the region. A significant number of prominent opinion leaders and principal investigators have also been attracted to the region. The governments have worked to improve their regulatory systems, and align them with American and European standards. As a result, countries such as Singapore, South Korea and Greater China have seen significant improvements.

China has seen a 16-month decrease in regulatory delays since 2016. China's National Medical Products Administration (NMPA), has recommended that fast-track reviews be conducted for breakthrough technologies and clinical priority indications. A series of reforms were announced recently with the goal of improving drug review processes, reducing time to revise (IND), and speeding up the development of new drugs.

Market Share Insights & Key Companies

Market players implement a variety of strategic activities such as collaborations, new partnerships, mergers and acquisitions with the goal of increasing their services and manufacturing services in order to gain a competitive edge.

In June 2021, Charles River Laboratories International, Inc. purchased Vigene Biosciences, Inc. This acquisition bolstered its cell and gene therapy contract manufacturing capabilities, and offered a complete solution for gene-modified cells in the U.S. The following are some of the most prominent players in global investigational new drug market (IND) CDMO:

• Covance Inc.

• Charles River Laboratories Inc.

• Cambrex Corporation

• IQVIA Holdings Inc.

• Syneos Health

• Lonza

• Catalent

• Recipharm AB

• Siegfried Holding AG

• Thermo Fisher Scientific Inc.

Up Market Research published a new report titled “Investigational New Drug CDMO Market research report which is segmented by Service (Contract Manufacturing, Contract Development), by Product (Small Molecule, Large Molecule), By Players/Companies Syneos Health, Catalent, Cambrex Corporation, Siegfried Holding AG, IQVIA Holdings Inc, Charles River Laboratories Inc, Thermo Fisher Scientific Inc, Lonza, Recipharm AB, Covance Inc”. As per the study the market is expected to grow at a CAGR of XX% in the forecast period.

Report Scope

The report covers comprehensive data on emerging trends, market drivers, growth opportunities, and restraints that can change the market dynamics of the industry. It provides an in-depth analysis of the market segments which include products, applications, and competitor analysis.

Global Investigational New Drug CDMO Market Report Segments:

The market is segmented by Service (Contract Manufacturing, Contract Development), by Product (Small Molecule, Large Molecule).

Investigational New Drug CDMO Market research report delivers a close watch on leading competitors with strategic analysis, micro and macro market trend and scenarios, pricing analysis and a holistic overview of the market situations in the forecast period. It is a professional and a detailed report focusing on primary and secondary drivers, market share, leading segments and geographical analysis. Further, key players, major collaborations, merger & acquisitions along with trending innovation and business policies are reviewed in the report.

Key Benefits for Industry Participants & Stakeholders:

• Industry drivers, restraints, and opportunities covered in the study
• Neutral perspective on the market performance
• Recent industry trends and developments
• Competitive landscape & strategies of key players
• Potential & niche segments and regions exhibiting promising growth covered
• Historical, current, and projected market size, in terms of value
• In-depth analysis of the Investigational New Drug CDMO Market

Overview of the regional outlook of the Investigational New Drug CDMO Market:

Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa (MEA). North America region is further bifurcated into countries such as U.S., and Canada. The Europe region is further categorized into U.K., France, Germany, Italy, Spain, Russia, and Rest of Europe. Asia Pacific is further segmented into China, Japan, South Korea, India, Australia, South East Asia, and Rest of Asia Pacific. Latin America region is further segmented into Brazil, Mexico, and Rest of Latin America, and the MEA region is further divided into GCC, Turkey, South Africa, and Rest of MEA.

Highlights of The Investigational New Drug CDMO Market Report:

1. The market structure and projections for the coming years.
2. Drivers, restraints, opportunities, and current trends of Investigational New Drug CDMO Market.
3. Historical data and forecast.
4. Estimations for the forecast period 2028.
5. Developments and trends in the market.

                1. Contract Manufacturing

                2. Contract Development

                1. Small Molecule

                2. Large Molecule

8. Market scenario by region, sub-region, and country.
9. Market share of the market players, company profiles, product specifications, SWOT analysis, and competitive landscape.
10. Analysis regarding upstream raw materials, downstream demand, and current market dynamics.
11. Government Policies, Macro & Micro economic factors are also included in the report.

We have studied the Investigational New Drug CDMO Market in 360 degrees via. both primary & secondary research methodologies. This helped us in building an understanding of the current market dynamics, supply-demand gap, pricing trends, product preferences, consumer patterns & so on. The findings were further validated through primary research with industry experts & opinion leaders across countries. The data is further compiled & validated through various market estimation & data validation methodologies. Further, we also have our in-house data forecasting model to predict market growth up to 2028.

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Reasons to Purchase the Investigational New Drug CDMO Market Report:

• The report includes a plethora of information such as market dynamics scenario and opportunities during the forecast period
• Segments and sub-segments include quantitative, qualitative, value (USD Million,) and volume (Units Million) data.
• Regional, sub-regional, and country level data includes the demand and supply forces along with their influence on the market.
• The competitive landscape comprises share of key players, new developments, and strategies in the last three years.
• Comprehensive companies offering products, relevant financial information, recent developments, SWOT analysis, and strategies by these players.