Investigational New Drug CDMO Market Size, Share | 2032

Report Description

Investigational New Drug CDMO Market Outlook 2032

The global investigational new drug CDMO market size was USD 5.1 Billion in 2023 and is projected to reach USD 9.5 Billion by 2032, expanding at a CAGR of 7.2% during 2024–2032. The market growth is attributed to the increasing demand for innovative therapeutics.

Rising demand for efficient and specialized drug development and manufacturing solutions is boosting the investigational new drug contract development and manufacturing organization (CDMO) market. CDMOs offer expertise in formulation development and drug delivery technologies. Pharmaceutical companies seek these organizations to enhance the therapeutic performance of their investigational drugs. Furthermore, increasing focus on orphan drug development further boosts the demand for CDMOs specializing in rare disease therapies.

• As per the report publihsed by the National Library of Medicine on June 23, 2023, by December 31, 2022, the Office of Orphan Products Development (OOPD) awarded 6,340 orphan drug designations, encompassing treatments for 1,079 distinct diseases.
  

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Impact of Artificial Intelligence (AI) in Investigational New Drug CDMO Market

The use of artificial intelligence is likely to boost the investigational new drug CDMO market. AI algorithms analyze vast amounts of data to identify potential drug candidates with high efficacy and safety profiles. Moreover, AI-driven predictive modeling enhances formulation development by predicting drug stability and solubility to optimize formulations for improving bioavailability and patient outcomes.

Investigational New Drug CDMO Market Dynamics

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Major Drivers

Increasing demand for outsourcing services in pharmaceutical R&D is expected to drive the market. Pharmaceutical companies are increasingly relying on CDMOs to streamline their drug development processes, reduce costs, and access specialized expertise. Furthermore, rising investments in biopharmaceutical R&D are projected to propel the investigational new drug CDMO market.

• According to the report released by the Congressional Budget Office in April 2021, the pharmaceutical sector invested USD 83 billion in R&D activities in 2019. This figure represents a tenfold increase compared to the industry's annual spending during the 1980s.

Existing Restraints

Regulatory complexities and compliance challenges are expected to hinder the market during the forecast period. Regulatory agencies impose rigorous requirements for investigational new drug manufacturing, including good manufacturing practice (GMP) standards, quality control measures, and documentation protocols. Ensuring compliance with these regulations requires high investments in infrastructure, personnel training, and quality assurance systems. Moreover,  the complexity of investigational new drug manufacturing processes, particularly for biological drugs exacerbates scalability challenges and further hampers the market.

Emerging Opportunities

­High demand for specialized expertise and technological capabilities is expected to create immense opportunities for the players competing in the market. Pharmaceutical companies increasingly require CDMOs with specialized expertise in investigational new drug manufacturing processes, including formulation development, analytical testing, and regulatory compliance. Moreover, growing outsourcing trend among pharmaceutical companies, particularly among emerging biotech firms boost the market.

Scope of the Investigational New Drug CDMO Market Report

The market report includes an assessment of the market trends, segments, and regional markets. Overview and dynamics are included in the report.

Investigational New Drug CDMO Market Segment Insights

Product Segment Analysis

Based on product, the investigational new drug CDMO market is divided into large molecule and small molecule. The large molecule segment held the major share of the market in 2023, due to the increasing prominence in pharmaceutical pipelines.

The complexity and diversity of large molecule drugs present unique manufacturing requiring specialized expertise and infrastructure creating demand for CDMO services. Moreover, the growing prevalence of chronic and complex diseases and advancements in biotechnology have surged the development of large-molecule therapeutics which further boosts the segment.

• According to a report published by the American Hospital Association, by 2030, the number of the US population suffering from chronic disorders is expected to reach 170 million.

The small molecule segment is expected to expand at a significant pace in the coming years, owing to the rise of precision medicine and targeted therapies. This fuels the demand for customized small molecule formulations tailored to specific patient populations. Furthermore, advancements in synthetic chemistry and formulation technologies enable the development of increasingly complex small-molecule drugs, creating opportunities for CDMOs specializing in small-molecule investigational new drug manufacturing.

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Service Segment Analysis

On the basis of service, the global market is segregated into contract development and contract manufacturing. The contract manufacturing segment held largest market share in 2023, due to the growing demand for manufacturing services in the production of intestinal drugs on across the pharmaceutical industry.

Pharmaceutical companies increasingly rely on CDMOs to leverage their manufacturing expertise, infrastructure, and capacity to accelerate the development and commercialization of investigational drugs. Moreover, the flexibility offered by contract manufacturing services, including rapid scale-up and cost-effective production boosts the demand for contract manufacturing services.

The contract development segment is anticipated to expand at a substantial CAGR during the forecast period, as pharmaceutical companies increasingly seek CDMO partners to assist in the early stages of drug development. Additionally, the growing complexity of drug development processes in the biopharmaceutical sector fuels the demand for specialized expertise in formulation development and analytical testing.

End-user Segment Analysis

Based on end-user, the investigational new drug CDMO market is segmented into subsegments. The biotech companies segment is projected to register a robust growth during the assessment years, owing to the growing demand for healthcare contract development and manufacturing organizations in these companies. CDMOs provide specialized expertise and manufacturing capabilities to advance their investigational drugs through preclinical and clinical development stages. Moreover, the rise of emerging biotech firms in regions further propels the segment.

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Regional Outlook

In terms of region, the global investigational new drug CDMO market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America held a major market share in 2023, due to the region's established pharmaceutical industry.

The presence of numerous innovative biopharmaceutical companies, particularly in the US boost demand for CDMO services to support their investigational new drug manufacturing needs. Moreover, favorable government initiatives and regulatory policies aimed at fostering innovation and accelerating drug development fuels the market in this region.

The market in Asia Pacific is projected to grow at a significant pace in the years to come, owing to the expanding pharmaceutical industry in this region and increasing outsourcing trends among pharmaceutical companies.

Factors, such as a large patient population and a favorable regulatory environment are propelling the biopharmaceutical R&D activities in China, India, and South Korea. Moreover, lower labor and manufacturing costs as compared to the Western countries make it an attractive option for outsourcing investigational drug manufacturing thereby boosting the market.

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