GMP Biologics Market Size was valued at USD 50.2 Billion in 2022. The GMP Biologics market industry is projected to grow from USD 58.3 Billion in 2023 to USD 193.9 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 16.20% during the forecast period (2023 - 2032). Increasing Biopharmaceutical Demand and Expanding Biologistics Pipeline are the key market drivers boosting the expansion of the market.
Source: Primary Research, Secondary Research, MRFR Database and Analyst Review
Market CAGR for GMP Biologics is being driven by the rising biopharmaceutical demand. GMP biologics are pharmaceuticals made under Good Manufacturing Practices (GMP). In order to guarantee that these goods are safe for patients to use, they must adhere to strict quality and safety criteria. Worldwide, GMP biologics are frequently utilized in clinics and hospitals.
Additionally, A primary motivator is the increasing need for biopharmaceuticals, encompassing medicinal proteins, vaccines, and monoclonal antibodies. The need for GMP-compliant biological products manufacturing is growing as a result of biologics' ability to treat a variety of illnesses with specificity and effectiveness. Thanks to developments in biotechnology like editing genes and cell culture techniques, the production of biologics is continuously being developed. Businesses are encouraged to make investments in GMP-compliant facilities in order to ensure the safety and quality of biopharmaceutical goods. Many biologics that are presently under development can be found in the pharmaceutical industry. As these medications pass clinical trials and receive regulatory clearance, there is an increasing demand for manufacturing facilities that adhere to GMP standards as production is ramped up.
Strict guidelines for the manufacturing of biologics are enforced by regulatory bodies such as the FDA and EMA in order to ensure product efficacy and safety. The GMP Biologics Market is growing as a result of companies having to adhere to Good Manufacturing Practices (GMP) in order to meet these legal obligations. Businesses in the biotechnology and pharmaceutical sectors, particularly those in the biologics sector, are heavily investing in research and development. Therefore, in order to advance novel biologics from the research phase to commercialization, state-of-the-art GMP facilities are needed. The increased prevalence of chronic illnesses like cancer, autoimmune diseases, and infectious diseases is what is driving the need for biologics. GMP-compliant manufacturing is required to create safe, effective biopharmaceuticals to address these health concerns.
For instance, The National Medical Products Administration (NMPA) declared in April 2020 that it will be enforcing random inspection schedules for the production, handling, and distribution of medical equipment sold in China. The NMPA and its regional sections would carry out arbitrary examinations in the initial quarter of the year in accordance with the new legislation. Thus, result in driving the GMP Biologics market revenue.
The GMP Biologics market segmentation, based on type includes Monoclonal Antibodies, and Polyclonal Antibody. The Monoclonal Antibodies segment dominated the market. GMP biologics use monoclonal antibodies as a means of illness treatment. Monoclonal antibodies are a particular class of antibody produced by a single type of immune cell known as a monoclonal antibody producer. One kind of antibody, called a monoclonal antibody, is produced from a single kind of immune cell, like B cells.
The GMP Biologics market segmentation, based on application, includes Hospitals, Clinics, and Others. The Hospitals category generated the most income. The dominance is ascribed to elements like growing manufacturer spending in R&D to create new products with improved performance features and strong product demand because of its many applications. Because GMP biologics can reestablish a normal immune system response to tumor cells, they are primarily employed in cancer treatment, prevention, and diagnosis. This leads to better patient survival rates.
Figure1: GMP Biologics Market, by Application, 2022&2032(USD Billion)
Source: Primary Research, Secondary Research, MRFR Database and Analyst Review
By region, the study provides the market insights into North America, Europe, Asia-Pacific and Rest of the World. The North American GMP Biologics market area will dominate this market. The FDA and other regulatory agencies have approved a growing number of products, which is the reason for the growth.
Further, the major countries studied in the market report are The US, German, France, the UK, Canada, Italy, Spain, India, Australia, South Korea, China, Japan, and Brazil.
Figure2: GMP BIOLOGICS MARKET SHARE BY REGION 2022 (USD Billion)
Source: Primary Research, Secondary Research, MRFR Database and Analyst Review
Europe GMP Biologics market has the second-largest portion of the market. Given the growth of the biopharmaceutical business, there is an increasing need for production facilities that adhere to GMP standards. Further, the German GMP Biologics market had the biggest market share, and the UK GMP Biologics market was the fastest growing market in the European region
The Asia-Pacific GMP Biologics Market is anticipated to expand between 2023 and 2032 at the quickest CAGR. This is due to elements including rising healthcare costs and patient and physician knowledge of biosimilars. Moreover, China’s GMP Biologics market had the biggest market share, and the Indian GMP Biologics market was the fastest growing market in the Asia-Pacific region.
GMP Biologics Key Market Players& Competitive Insights
Leading market players are putting a lot of money on R&D to expand their product lines, which will help the market for weight reduction products grow. Additionally, market players are engaging in a range of calculated initiatives to increase their worldwide presence, with important market developments involving the introduction of new products, contracts, M&A transactions, increased investment, and cooperation with other enterprises. to grow and endure in an increasingly cutthroat and dynamic market, GMP Biologics industry must provide reasonably priced goods.
Manufacturing locally is one of the primary business techniques used by manufacturers to cut operational costs in the GMP Biologics industry to help customers and expand the market segment. In recent years, the GMP Biologics industry has provided some of the biggest benefits to medicine. Major players in the GMP Biologics market, including Creative Diagnostics, Fisher Bioservices(Thermo Fisher Scientific), Polpharma Biologics, Intertek, HemaCare, AGC., and others, are attempting to increase market demand by investing in research and development operations.
AstraZeneca plc is a multinational pharmaceuticals and biotechnology business of Anglo-Swedish descent. It offers a range of medications for treating serious illnesses in the fields of neurology, respiratory, inflammatory, gastrointestinal, cancer, and infection. AstraZeneca is a component of the FTSE 100 Index and is listed principally on the London Stock Exchange. It also has an additional listing on the Nasdaq Stockholm. Among pharmaceutical firms worldwide, AstraZeneca has one of the largest market capitalizations. In October 2019, AstraZeneca declared that it would pay up to US$276 million to German medicine maker Cheplapharm Arzneimittel GmbH for the worldwide marketing rights to its medication for acid reflux.
The Merck Group, which goes by the brand name Merck, is a multinational science and technology firm based in Darmstadt, Germany. It employs over 60,000 people and operates in 66 countries. About 250 businesses make up the group, with Merck KGaA in Germany serving as the leader. Healthcare, Life Sciences, and Electronics are the three business segments that make up the organization. Having been established in 1668, Merck is the oldest chemical and pharmaceutical firm in the world and among the biggest in the world. In February 2020, Merck declared that it would be selling its Allergopharma business to Dermapharm for an undisclosed sum. Merck's portfolio in Europe and certain regions of Asia, such as China and India, is included in the acquisition.
Key Companies in the GMP Biologics market include
GMP Biologics Industry Developments
June 2023: Cell and Gene Therapy Catapult and Albumedix have entered into a technology licensing arrangement whereby Albumedix's most recent innovations will be applied to enhance the production of viral vectors.
June 2023: Wuxi Biologics, which provides comprehensive solutions for the discovery, development, and production of biologics, has reported an increase in the amount of drug substances and drug products it can produce at its Wuppertal, Germany, site.
March 2023: Samsung Biologics at its Incheon, South Korea, location as part of a planned expansion meant to meet growing market demand. The facility is anticipated to have a 180,000 L manufacturing capacity when it is finished, and by investing KRW 1.9 trillion, the corporation will be able to increase the site's capacity to 784,000 L.
| Report Attribute/Metric | Details |
| Market Size2022 | USD 50.2 Billion |
| Market Size 2023 | USD 58.33 Billion |
| Market Size2032 | USD 193.9 Billion |
| Compound Annual Growth Rate (CAGR) | 16.20% (2023-2032) |
| Base Year | 2022 |
| Market Forecast Period | 2023-2032 |
| Historical Data | 2018- 2022 |
| Market Forecast Units | Value (USD Billion) |
| Report Coverage | Revenue Forecast, Market Competitive Landscape, Growth Factors, and Trends |
| Segments Covered | Type, Application, and Region |
| Geographies Covered | North America, Europe, AsiaPacific, and the Rest of the World |
| Countries Covered | The US, German, France, UK, Canada, Italy, Spain, India, Australia, South Korea, China, Japan, and Brazil |
| Key Companies Profiled | Â Creative Diagnostics, Fisher Bioservices(Thermo Fisher Scientific), Polpharma Biologics, Intertek, HemaCare, AGC |
| Key Market Opportunities | ·        The incidence of chronic diseases is rising, and biopharmaceutical companies are expanding ly. |
| Key Market Dynamics | ·        Expanding the pipeline for biologics and raising R&D expenditures |
Frequently Asked Questions (FAQ) :
In 2022, the size of the worldwide GMP biologics market was estimated to be USD 50.2 billion.
From 2023 to 2032, the market is expected to expand at a compound annual growth rate (CAGR) of 16.20%.
North America held the most market share worldwide.
The key players in the market are Creative Diagnostics, Fisher Bioservices(Thermo Fisher Scientific), Polpharma Biologics, Intertek, HemaCare, AGC.
In 2022, the market was dominated by the category of monoclonal antibodies.
The biggest market share worldwide belonged to hospitals.
Assistant Manager He holds an experience of about 7+ years in market research and business consulting, working under the spectrum of life sciences and healthcare domains. rahul conceptualizes and implements a scalable business strategy and provides strategic leadership to the clients. his expertise lies in market estimation, competitive intelligence, pipeline analysis, customer assessment, etc. in addition to the above, his other responsibility includes strategic tracking of high growth markets & advising clients on the potential areas of focus they could direct their business initiatives
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