Biopharmaceuticals CMO and CRO Market Size, Share | 2032

Report Description

Biopharmaceuticals CMO and CRO Market

The global biopharmaceuticals CMO and CRO market size was USD 32.7 Billion in 2023 and is likely to reach USD 57.6 Billion by 2032, expanding at a CAGR of 6.5% during 2024–2032. The market growth is attributed to the ­­reduction of costs and capital expenditure.

Biopharmaceuticals refer to drugs or medications derived from living organisms or their biological processes. They include vaccines, antibodies, enzymes, and gene therapies. Biopharmaceutical CMOs and CROs are two types of companies that play a crucial role in the development and manufacturing of these drugs.

A biopharmaceutical contract manufacturing organization (CMO) contracts with pharmaceutical and biotechnology companies to manufacture biopharmaceutical products, acting as outsourced manufacturing facilities. They specialize in specific areas such as biologics manufacturing and sterile fill-finish. A biopharmaceutical CRO provides contract research services, supporting drug development in therapeutic areas such as oncology, infectious diseases, and neurology.

Biopharma CMOs and CROs are crucial partners for biopharmaceutical companies due to their reduced costs, expertise, efficiency, scalability, and focus on core competencies. They save capital expenditure, expertise, and personnel costs associated with in-house development teams. They also offer flexible manufacturing capabilities, allowing companies to concentrate on their core competencies.

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Impact of Artificial Intelligence (AI) in Biopharmaceuticals CMO and CRO Market

Artificial Intelligence (AI) is set to significantly impact the Biopharmaceuticals CMO and CRO market by transforming drug development and manufacturing. AI helps identify promising drug targets, generate potential drug candidates, and create virtual models for in-silico simulations. It optimizes clinical trial design by analyzing patient data and optimizing trial protocols. AI predicts potential failures and schedule preventative maintenance, optimizes manufacturing processes by analyzing real-time data, and streamline supply chain management by forecasting demand for raw materials and finished products.

The benefits of CMOs and CROs include increased efficiency and productivity, reduced costs and improved timelines, enhanced quality control, and data-driven decision-making. AI automate tasks, improve data analysis, and optimize processes, leading to fast drug discovery, optimized trials, and time-to-market for biopharmaceutical products.

Biopharmaceuticals CMO and CRO Market Dynamics

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Major Drivers

Reduction of costs and capital expenditure for infrastructure and equipment is expected to drive the global market. Biopharmaceutical companies significantly reduce upfront costs for infrastructure, equipment, and personnel by outsourcing manufacturing and development activities to CMOs and CROs. This frees up capital for core competencies such as drug discovery and research, thus driving the market. Focus on core competencies such as drug discovery and research are leading to the launch of novel products with high efficacy and less side effects, thus driving the market.

Existing Restraints

Regulatory complexity in the development and manufacturing of biopharmaceuticals is expected to hamper the market. The development and manufacturing of biopharmaceuticals are subject to stringent regulations by agencies such as the FDA (US Food and Drug Administration) and EMA (European Medicines Agency). These regulations ensure the safety, efficacy, and quality of biopharmaceuticals but are complex and time-consuming to navigate.

Emerging Opportunities

Gene therapy and cell therapy are creating opportunities in the market. Growing demand for novel therapies with a potential to cure diseases is creating an opportunity for CROs and CMOs. Moreover, rising demand for affordable biosimilars and expanding biologics is expected to present opportunities for CMOs to develop affordable and efficient drug manufacturing processes. 

Scope of the Biopharmaceuticals CMO and CRO Market Report

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

Biopharmaceuticals CMO and CRO Market Segment Insights

Source Segment Analysis

Based on source, the biopharmaceuticals CMO and CRO market is bifurcated into mammalian and non-mammalian. The mammalian segment dominated the global market in 2023 owing to introduction of novel and enhanced expression systems. Furthermore, the lack of internal expertise in the industries is expected to boost the segment substantially during the forecast period. Additionally, the improvements in the of process monitoring solutions and cell line engineering tools are propelling the segment.

The non-mammalian segment is anticipated to expand at a substantial CAGR during the forecast period due to its reduced immunogenicity. The non-mammalian systems often introduce simple glycan patterns, potentially reducing the risks of immunogenicity in humans. Moreover, increasing scalability and cost-effectiveness of non-mammalian system are expected to fuel the segment during the forecast period. Non-mammalian systems such as bacteria, yeast, or insect cells are cheap and quick to establish for protein production.

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Service Type Segment Analysis

On the basis of service type, the global market is bifurcated into contract manufacturing and contract research. The contract manufacturing (CMO) segment held a key share of the market in 2023 owing to large-scale drug manufacturing. CMOs offer a wide range of services, from formulation development and pilot production to large-scale commercial manufacturing and packaging. This caters to various stages of the biopharmaceutical product lifecycle, thus propelling the segment.

The contract research segment is projected to expand at a robust pace during the assessment years owing to the drug discovery and development. Contract Research Organizations offer expertise in pre-clinical testing, clinical trial design and execution, and regulatory affairs support. These services are essential for bringing new drugs to the market. Furthermore, focus on core competencies is expected to fuel the segment. By outsourcing research activities to CROs, biopharmaceutical companies focus their resources on core competencies such as drug discovery and early-stage development.

Product Segment Analysis

On the basis of product, the biopharmaceuticals CMO and CRO market is bifurcated into biologics and biosimilars. The biologics segment held a key share of the market in 2023 due to its wide range of applications. Biologics encompass a broad range of therapeutic applications, including treatments for cancer, autoimmune diseases, and chronic conditions. This diversity translates to a the high demand for CMO and CRO services catering to these diverse products. Additionally, the high maturity of biologics results in large market size and high volume of CMOs and CROs services needed for biologics development and manufacturing.

The biosimilars segment is expected to expand at a significant pace over the projection period due to the cost effectiveness. The biosimilars offer an affordable alternative to brand-name biologics, making them attractive to healthcare providers and patients. Additionally, the high adoption rates of biosimilars among patients and has the healthcare providers are expected to boost the segment during the forecast period. For instance,

In February 2023, Adalimumab biosimilars are being commercially supplied by Enzene Biosciences, a subsidiary of Alkem Laboratories, to treat autoimmune diseases such rheumatoid arthritis and ankylosis spondylitis. Enzene Biosciences anticipates that millions of patients in India would benefit from low treatment costs for rheumatoid arthritis as a result of the commercial launch employing continuous production technology.

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Regional Analysis

In terms of region, the global biopharmaceuticals CMO and CRO market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America dominated the market in 2023 owing to presence of major market player. Increasing number of product development and significant number of products in pipeline  is expected to propel the regional market during the forecast period. Furthermore, the increasing adoption of advanced research and growing investments in manufacturing technologies is boosting the regional market. For instance,

• In March 2022, Cambrex, a US-based CDMO added 11 cGMP laboratories to its US facilities as part of an expansion of its biopharmaceutical testing services business. The expansion involved the inclusion of instruments for imaging, mass spectrometry, immunoblotting, nanoparticle size analysis, qPCR, and other applications.

• In March 2022, Meadowhawk Biolabs, Inc., announced the launch of its operations in the Boston and San Francisco areas.

• The market in Asia pacific is projected to grow at a significant pace in the coming years owing to development of infrastructure. The increasing investments in R&D activities is expected to propel the regional market substantially during the forecast period. Moreover, regulatory changes are expected to propel the market in the region significantly during the forecast period.
  

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