Global GMP Biologics Market Size By Product Type, By Application, By End-User, By Geographic Scope And Forecast
Report ID: 366502|No. of Pages: 202
Global GMP Biologics Market Size By Product Type, By Application, By End-User, By Geographic Scope And Forecast
GMP Biologics Market Size And Forecast
The global GMP Biologics Market size was valued at USD 15,592.0 Million in 2023 and is projected to reach USD 31,839.7 Million by 2030, growing at a CAGR of 10.9% during the forecast period 2024-2030.
Global GMP Biologics Market Drivers
Several major factors are responsible for the GMP Biologics Market’s expansion and development. These consist of:
- Growing Demand for Biopharmaceuticals: One major driver is the growing demand for biopharmaceuticals, which includes monoclonal antibodies, vaccines, and therapeutic proteins. Biologics provide specialised and efficient treatments for a range of ailments, which increases the demand for GMP-compliant biologics manufacturing.
- Biotechnology Advances: The manufacture of biologics is constantly being innovated due to biotechnology advances such as gene editing and cell culture technologies. In order to guarantee the quality and safety of biopharmaceutical goods, this encourages businesses to invest in GMP-compliant facilities.
- Growing Biologics Pipeline: The pharmaceutical sector is home to a large number of biologics that are currently under development. There is a rising need for GMP-compliant manufacturing facilities as production is scaled up when these drugs move through clinical trials and earn regulatory certification.
- Severe Regulatory Standards: To guarantee product safety and efficacy, regulatory agencies like the FDA and EMA have severe regulations for the production of biologics. To achieve these legal requirements, businesses are required to follow Good Manufacturing Practises (GMP), which is what is causing the GMP Biologics Market to expand.
- Increasing Investments in R&D: Pharmaceutical and biotechnology businesses are spending a lot of money on R&D projects, especially in the biologics industry. Modern GMP facilities are therefore required to move new biologics from the discovery stage to commercialization.
- Chronic Disease Incidence is on the Rise: The need for biologics is driven by the rising incidence of chronic diseases such cancer, autoimmune diseases, and infectious diseases. To produce high-quality and secure biopharmaceuticals to treat these health issues, GMP-compliant manufacturing is necessary.
- Global Expansion of Biopharmaceutical Companies: The global footprint of biopharmaceutical businesses is growing as they try to meet the needs of various markets. Companies can offer biologics to a larger patient base and meet regional regulatory requirements by establishing GMP-compliant facilities in other regions.
Global GMP Biologics Market Restraints
While there are numerous factors that can impede the growth of the GMP Biologics Market, there are also many potential drivers. Some significant market obstacles include:
- High Cost of GMP Compliance: Setting up and keeping processes and facilities that adhere to GMP standards can be costly. Costlier production is a result of the strict quality control procedures, specialised machinery, and people training. This can be a major obstacle, particularly for smaller biotech businesses with few financial resources.
- Complex Manufacturing Procedures: The production of biologics entails numerous, intricate, and complex procedures, such as cell culture, purification, and formulation. The total cost-effectiveness of GMP production may be impacted by problems with scalability, process optimisation, and efficiency caused by these processes’ complexity.
- Long Development Timelines: Long and complex development schedules are frequently required for the development and commercialization of biologics. The length of time needed for preclinical and clinical studies, regulatory approvals, and market access may prevent biologics from being commercialised and affect the return on investment for businesses that produce GMP biologics.
- Regulatory Challenges: Obtaining regulatory permits and adhering to GMP guidelines can be difficult processes. Manufacturers of biologics may experience delays and higher expenses as a result of changes in regulatory criteria or unforeseen roadblocks in the approval process.
- Contamination Risk: In the production of biologics, maintaining aseptic conditions is essential for avoiding contamination and guaranteeing the quality of the final product. Contamination risk presents an ongoing challenge that necessitates careful adherence to GMP standards and ongoing monitoring of manufacturing procedures.
- Limited Experience and Highly Skilled Workforce: Manufacturing GMP biologics demands a workforce that is both highly skilled and specialised. Because there aren’t many experienced specialists in the industry, hiring and maintaining suitable staff may be difficult for businesses.
- Intellectual Property Concerns: Complex technology and intellectual property are frequently involved with biologics. Patent-related legal issues may arise for businesses, causing disagreements and posing the risk of product launch delays.
- Market Competition: Several businesses are seeking for market share in the GMP biologics industry. Price pressure brought on by fierce competition may affect profit margins and the overall financial feasibility of the production of GMP biologics.
- Risks Associated with the Supply Chain: The availability of raw materials and components necessary for the production of biologics can be impacted by global supply chain disruptions, as witnessed in situations like the COVID-19 pandemic. Production delays and problems with the supply chain may result from this.
- Ethical and Social Considerations: Some biologics, such as those made from live organisms, may give rise to ethical and social issues. Market acceptability and regulatory decisions might be influenced by public perception and ethical issues.
Global GMP Biologics Market Segmentation Analysis
The Global GMP Biologics Market is segmented based on Product Type, Application, End-User, and Geography.
GMP Biologics Market, By Product Type
- Monoclonal Antibodies (mAbs): Monoclonal antibodies are widely used in the treatment of various diseases, including cancer and autoimmune disorders.
- Vaccines: GMP biologics include the manufacturing of vaccines for the prevention of infectious diseases.
- Recombinant Proteins: Production of therapeutic proteins using recombinant DNA technology falls under this segment.
- Gene and Cell Therapy Products: GMP-compliant manufacturing for gene therapies and cell-based therapies is a growing segment.
GMP Biologics Market, By Application
- Oncology: Biologics used in the treatment of cancer, such as monoclonal antibodies targeting specific cancer markers.
- Infectious Diseases: GMP biologics include vaccines and therapeutic antibodies for infectious diseases.
- Autoimmune Disorders: Biologics targeting the immune system for the treatment of autoimmune conditions.
- Hematology: Biologics used in the treatment of blood-related disorders.
GMP Biologics Market, By End-User
- Biopharmaceutical Companies: Companies engaged in the development and commercialization of biopharmaceutical products.
- Contract Development and Manufacturing Organizations (CDMOs): Organizations that provide contract manufacturing services for biologics production.
- Academic and Research Institutes: Institutions involved in biologics research and development.
GMP Biologics Market, By Geography
- North America: Market conditions and demand in the United States, Canada, and Mexico.
- Europe: Analysis of the GMP Biologics Market in European countries.
- Asia-Pacific: Focusing on countries like China, India, Japan, South Korea, and others.
- Middle East and Africa: Examining market dynamics in the Middle East and African regions.
- Latin America: Covering market trends and developments in countries across Latin America.
Key Players
The major players in the GMP Biologics Market are:
- Amgen Inc.
- F. Hoffmann-La Roche Ltd
- AbbVie Inc.
- 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.
- Thermo Fisher Scientific Inc.
- Charles River Laboratories International, Inc.
- Catalent Inc.
- Boehringer Ingelheim International GmbH
- Merck KGaA
- Rentschler Biopharma SE
- Celltrion Inc.
Report Scope
| REPORT ATTRIBUTES | DETAILS |
|---|---|
| STUDY PERIOD | 2020-2030 |
| BASE YEAR | 2023 |
| FORECAST PERIOD | 2024-2030 |
| HISTORICAL PERIOD | 2020-2022 |
| UNIT | Value (USD Million) |
| KEY COMPANIES PROFILED | Amgen Inc., F. Hoffmann-La Roche Ltd, AbbVie Inc., AstraZeneca plc, Merck KGaA, Sanofi, GlaxoSmithKline plc, Johnson & Johnson |
| SEGMENTS COVERED | By Product Type, By Application, By End-User, and By Geography. |
| CUSTOMIZATION SCOPE | Free report customization (equivalent up to 4 analyst’s working days) with purchase. Addition or alteration to country, regional & segment scope. |
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Industry Analysis Matrix
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