The global biologics contract manufacturing market is poised for significant growth, with worldwide revenue expected to grow from USD 16.01 billion in 2024 to a substantial USD 36.3 billion by 2031. Projected to expand at a CAGR of 12.4%, this market reflects an increased demand for novel biologic and biosimilar products, especially as companies embrace contract manufacturing to streamline R&D and commercialization processes.
The biologics contract manufacturing market is driven by the expansion of the biopharmaceutical contract manufacturing organization (CMO) sector. Consolidation efforts are underway, with market participants adopting inorganic growth strategies and developing end-to-end integrated solutions that offer clients comprehensive services. Biopharmaceutical CMOs with advanced technological capabilities are uniquely positioned to capitalize on this burgeoning market, bolstered by rapid scientific advancements in the field.
Drivers of Market Growth
1.Growing Demand for Biologics and Biosimilars: The need for innovative biologics and biosimilars is expanding, spurring demand for contract manufacturing services.
2.R&D Outsourcing: Companies increasingly rely on CMOs and CDMOs (contract development and manufacturing organizations) to optimize R&D expenditures, enhancing operational efficiency.
3.Scientific and Technological Advancements: Innovations in biopharmaceutical manufacturing, such as single-use bioreactors and cell & gene therapy capabilities, are propelling market growth. Notable examples include Lonza Group AG's acquisition of a Shire plc facility, enhancing their mammalian manufacturing operations, and AGC Biologics' acquisition of Molecular Medicine S.p.A. to strengthen its gene therapy capabilities.
Business Opportunities
The CDMO business model is evolving to support high potency drug development and biopharmaceuticals, offering a range of product options that drive competitive differentiation. By outsourcing stages of clinical development to strategic partners, companies can achieve greater efficiencies across the value chain. Furthermore, as CMOs and CDMOs optimize manufacturing technologies, they are also creating opportunities for long-term profitability through cost-effective and scalable solutions.
Region Analysis
- United States: In North America, the U.S. holds a leading position, capturing approximately 89.9% of the market in 2023. Strong pipelines for biologics, high venture capital investment in biotechnology R&D, and a growing presence of prominent manufacturers and research institutions contribute to the U.S. market's strength.
- Germany: Holding around 33.7% of the European market share in 2023, Germany is emerging as a lucrative market. Increasing biopharmaceutical research and clinical trials drive demand, with many companies outsourcing their research activities to reduce costs.
- China: China commands an 18.2% market share within East Asia, driven by collaborations between global and local firms. As pharmaceutical and biopharmaceutical companies increase their presence in China, they unlock opportunities for contract manufacturing growth over the forecast period.
Impact of Regulatory Dynamics
The biologics contract manufacturing market faces some challenges due to shifting regulatory policies, cGMP compliance requirements, and complex supply chain security issues in emerging countries. Entry barriers are high for small and medium enterprises (SMEs) due to substantial financial requirements. Additionally, many countries face a shortage of skilled professionals and adequate funding, slowing the development of a robust biotech industry similar to that in the U.S.
Competitive Analysis
Leading companies are focusing on expanding their service portfolios and establishing a presence in emerging markets to capitalize on growth potential. Major players in the biologics contract manufacturing market include:
- BioXcellence (Boehringer Ingelheim)
- Lonza Group AG
- Samsung Biologics
- Fujifilm Diosynth Biotechnologies
- AbbVie CM (AbbVie Inc.)
- WuXi Biologics (Cayman) Inc.
- AGC Biologics
- Patheon N.V. (Thermo Fisher Scientific Inc.)
- Emergent BioSolutions Inc.
- Ajinomoto Bio-Pharma
- Avid Bioservices, Inc.
- KBI Biopharma
- Rentschler Biotechnologie GmbH
- Merck KGaA
- Catalent Inc.
- Therapure Biopharma Inc.
- Novasep
- Abzena plc.
- ProBioGen AG
Biologics Contract Manufacturing Market Segmentation
The biologics contract manufacturing market is segmented as follows:
Product:
- Monoclonal Antibodies
- Recombinant Proteins
- Vaccines
- Insulin
- Interferons
- Growth Factors
- Others
Platform:
Therapeutic Area:
- Oncology
- Autoimmune Disease
- Metabolic Disease
- Ophthalmology
- Cardiovascular Disease
- Infectious Disease
- Neurology
- Respiratory Disorder
- Others
Application:
Region:
- North America
- Latin America
- Europe
- South Asia
- East Asia
- Oceania
- Middle East & Africa