Biopharmaceutical Contract Manufacturing Market To Reach USD 25.1 Billion By 2034 At A 8.8% Of CAGR

(MENAFN- EIN Presswire)

Biopharmaceutical Contract manufacturing Market

Biopharmaceutical Contract Manufacturing

Learn how outsourcing trends in biopharma manufacturing are driving cost efficiency, scalability, and accelerated drug production.

NEWARK, DE, UNITED STATES, February 10, 2025 /EINPresswire / -- The biopharmaceutical contract manufacturing market is set for substantial growth, with its valuation projected to rise from USD 10.7 billion in 2024 to USD 25.1 billion by 2034, expanding at a robust CAGR of 8.8%. The increasing complexity of biologic drugs and the growing demand for efficient production processes are driving biopharmaceutical companies to outsource manufacturing to contract manufacturing organizations (CMOs). This shift allows firms to focus on core competencies while reducing costs and optimizing production efficiency.

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A key driver of market expansion is the rise of cell and gene therapies, which require specialized expertise and advanced manufacturing capabilities. Many small and mid-sized biopharmaceutical companies lack the infrastructure to produce these complex therapies in-house, creating a surge in demand for CMOs equipped with the necessary facilities and knowledge. The increasing regulatory requirements and technological advancements in biologics manufacturing are further reinforcing the need for outsourcing partnerships.

CMOs are playing a crucial role in accelerating drug development timelines by offering specialized production capabilities, process optimization, and compliance support. The industry is witnessing a trend toward strategic collaborations, mergers, and capacity expansions as CMOs aim to meet the rising demand for biologics, including monoclonal antibodies, vaccines, and recombinant proteins. With biopharmaceutical innovation on the rise, contract manufacturing is becoming an essential pillar in scaling production while maintaining quality and regulatory compliance.

Key Takeaways

The biopharmaceutical contract manufacturing market is expected to grow at a CAGR of 8.8%, reaching USD 25.1 billion by 2034.

Increasing complexity of biologics and cost reduction strategies are driving demand for CMOs.

Cell and gene therapies are fueling market growth, requiring specialized manufacturing expertise.

Strategic partnerships, technological advancements, and regulatory compliance are shaping the industry's future.

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Key factors driving market growth:

Rising number of biologics: There is an increase in the number of biologics requiring manufacturing.
Demand for advanced therapeutics: A growing need for advanced treatments for chronic diseases exists.
Advancements in manufacturing technologies: The biopharmaceutical contract manufacturing market is growing because of continuous innovation in manufacturing.
Increasing outsourcing: The increasing trend of outsourcing biologics manufacturing among biopharmaceutical companies is driving market growth.
Rising demand for cell and gene therapies: Increased need for specialized manufacturing of cell and gene therapies supports market expansion.

What are the main challenges faced by biopharmaceutical companies when outsourcing manufacturing?

Biopharmaceutical companies face several challenges when outsourcing manufacturing:

Complexity of Biopharmaceutical Medicines: The complexity of biopharmaceutical medicines means that each asset has unique features that need to be considered fully to enable progression through development; one size does not fit all.

Quality Issues: Quality issues are crucial, and a number of high-profile failures have put quality under scrutiny. For example, in 2013, GlaxoSmithKline filed a lawsuit against Hospira for not complying with quality standards. A wider trend has seen several manufacturing sites fail to meet the MHRA and FDA strict criteria on quality.

Supply Chain Disruptions: COVID-19-related supply chain disruptions have caused biopharma manufacturing companies to navigate supply delays due to workers isolating and consumables shortages. Many materials required for biopharma manufacturing have seen delays of six to 12 months, as well as having a higher cost due to increased demand.

Lack of Resources: Biotechnology companies are usually restrained by a lack of people, money, and time, which can cause challenges in outsourcing biopharmaceutical manufacture.

Selecting the Right CMO: It is important that biotech companies and their investors rise to the challenges of outsourcing: budget appropriately, have realistic timeframes, and choose contract manufacturing organizations (CMOs) wisely.

Transferring Manufacturing Processes: Because of the complexity of the manufacturing processes for biologics, transferring these processes to a contract manufacturer presents challenges.

Alignment of Quality Systems: One of the key challenges continues to be aligning quality systems at the CMO and sponsor companies.

Keeping Pace with New Technologies: The rate of technological innovation means designing a biopharmaceutical product and testing it completely and compliantly have become too differentiated and demanding for many biopharma manufacturers to be able to conduct 100% in-house any longer.

GMP Standards: Several important aspects are considered when outsourcing biopharmaceutical manufacturing to a CDMO. The important attributes are meeting international GMP standards, protecting intellectual property, compliance with the company's quality standards, pricing/cost of services, and demonstrated ability to do the work.

Maintaining Control: Challenges arise in supplier qualification, process validation, data management, and ensuring the consistent quality of raw materials.

Clear Communication: Difficulties can arise due to language barriers, cultural differences, or time zone differences that may impact ongoing project oversight and communication.

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Key Market Players

Catalent Inc.
Lonza Group Ag
Patheon N.V. (Thermo Fisher Scientific Inc.)
Abzena Plc.
Sandoz International GmbH (Novartis AG)
Fujifilm Diosynth Biotechnologies (FUJIFILM Holdings)
Baxter Pharmaceutical Solutions LLC (Baxter Inc.)
AbbVie Contract Manufacturing (AbbVie Inc.)
Samsung Biologics Co. Ltd.
ProBioGen AG
Pfizer Centre Source Ltd (Pfizer Inc.)
Novasep
Biomeva GmbH
Kbi Biopharma Inc
Rentschler Biotechnologie GmbH
Ajinomoto Althea Inc. (Ajinomoto Co., Inc.)

Key Market Segments

By Platform Type:

Mammalian Based

Microbial Based

By Product Type:

Monoclonal Antibodies

Recombinant Protein

Vaccine

Insulin

Growth factor

Interferons

Others

By Application Type:

Clinical

Commercial

By Therapeutic Area Type:

Autoimmune Diseases

Oncology

Metabolic Diseases

Ophthalmology

Cardiovascular Diseases

Infectious Diseases

Neurology

Respiratory Disorders

Others

By Region:

North America

Latin America

East Asia

South Asia

Europe

Oceania

MEA

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