Press release
GMP Biologics Market Report on the Untapped Growth Opportunities in the Industry
The GMP Biologics Market is estimated to reach over USD 153.9 Bn by 2031, exhibiting a CAGR of 14.6% during the forecast period.
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Good Manufacturing Practices (GMP) represent a framework of rigorous guidelines and operational protocols applied during the production of pharmaceuticals, biologics, and medical products to ensure product safety, quality, and consistency. Biologic therapies-originating from living organisms-play a crucial role in modulating or enhancing physiological functions. These include treatments such as hormone replacements for endocrine conditions and vaccines that stimulate the immune system.
GMPs are instrumental in mitigating risks related to contamination, manufacturing errors, and instability of biologic products. Due to their biological origins, these therapies are more intricate than conventional small-molecule drugs, with their development influenced by various biological and environmental factors, including genetic variability, exposure to pathogens, and naturally occurring biochemical impurities. These complexities make the production of biologics particularly challenging, necessitating strict adherence to GMP protocols across all stages of development and manufacturing.
List of Prominent Players in the GMP Biologics Market:
• Amgen Inc.
• F. Hoffmann-La Roche Ltd
• AbbVie Inc.
• AstraZeneca plc
• Merck KGaA
• Creative Diagnostics
• Fisher Bioservices (Thermo Fisher Scientific)
• Polpharma Biologics
• Intertek
• HemaCare
• AGC
• AstraZeneca plc
• Merck KGaA
• Sanofi
• GlaxoSmithKline plc
• Johnson & Johnson
• Pfizer Inc.
• Novartis AG
• Eli Lilly and Company
• Samsung Biologics Co. Ltd.
• WuXi AppTec
• Lonza Group Ltd.
• Rentschler Biopharma SE
• Boehringer Ingelheim International GmbH
• Celltrion Inc
• Catalent Inc.
Market Dynamics
Drivers:
The surging global demand for biopharmaceuticals-including therapeutic proteins, monoclonal antibodies, and vaccines-is a key factor propelling the growth of the GMP-compliant biologics manufacturing sector. These biologics provide precise and highly effective treatment options across a spectrum of medical conditions, prompting greater emphasis on stringent production standards to ensure quality, safety, and efficacy. The increasing incidence of chronic illnesses such as cancer, autoimmune diseases, and infectious disorders has intensified the need for advanced biologic therapies, further amplifying the requirement for GMP-aligned production practices.
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Challenges:
One of the most pressing challenges in biologics production is maintaining aseptic conditions across all stages of the manufacturing lifecycle. The complex and sensitive nature of biologic products makes them particularly susceptible to contamination, thereby requiring rigorous adherence to GMP protocols. Continuous environmental monitoring and stringent quality assurance measures are critical to safeguarding product integrity and protecting patient health.
Regional Trends: North America is projected to maintain a leading position in the GMP biologics market over the forecast period. This dominance is attributed to the region's concentration of major biopharmaceutical players, cutting-edge manufacturing infrastructure, and supportive regulatory frameworks-particularly the guidance provided by the U.S. Food and Drug Administration (FDA). The U.S. remains at the forefront of innovation in biologic therapies, including next-generation treatments such as gene therapies and monoclonal antibodies.
Meanwhile, the Asia-Pacific region is experiencing a notable acceleration in market growth. This expansion is driven by rising healthcare demands, substantial investment in biotech R&D, and growing regional expertise in biologics manufacturing processes.
Recent Developments:
• In Feb 2024, Abbie established a strategic relationship with Tentarix Biotherapeutics to explore and create novel, multi-specific, conditionally active biologic candidates in immunology and oncology.
• In June 2023, Wuxi Biologics, which provides comprehensive solutions for biologics R&D and manufacturing, has declared that it can now produce more therapeutic components and pharmaceuticals at its plant in Wuppertal, Germany.
• In March 2023, Samsung Biologic, Incheon, South Korea's Samsung Biologics is undergoing planned expansion in response to increasing market demand. When the facility is completed, it is expected to have a manufacturing capacity of 180,000 L. The firm plans to invest KRW 1.9 trillion to boost the site's capacity to 784,000 L.
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Segmentation of GMP Biologics Market.
Global GMP Biologics Market- By Type
• Monoclonal Antibodies
• Polyclonal Antibody
Global GMP Biologics Market - By Application
• Hospitals
• Clinics
• Others
Global GMP Biologics Market - By Region
North America-
• The US
• Canada
• Mexico
Europe-
• Germany
• The UK
• France
• Italy
• Spain
• Rest of Europe
Asia-Pacific-
• China
• Japan
• India
• South Korea
• Southeast Asia
• Rest of Asia Pacific
Latin America-
• Brazil
• Argentina
• Rest of Latin America
Middle East & Africa-
• GCC Countries
• South Africa
• Rest of the Middle East and Africa
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