New York, Jan. 17, 2024 (GLOBE NEWSWIRE) -- The dynamic and rapidly expanding field of biologics contract manufacturing, also referred to as the biopharmaceutical CMO market, is witnessing substantial investments in research and development by numerous players. These investments aim to advance new modalities, including antibody drug conjugates, biosimilar, and cell and gene therapies. Over the years, there has been a notable shift in investment from small molecule drugs to biologics, leading to the development of more than 250 biologic therapies and vaccines globally.
The global revenue generated by the biologics contract manufacturing market reached US$ 14.4 billion in 2022. Projections indicate a robust compound annual growth rate (CAGR) of 8.6%, foreseeing the market to expand significantly and attain a valuation of US$ 42.1 billion by the conclusion of 2033. This impressive growth trajectory underscores the increasing demand and strategic significance of biologics contract manufacturing within the pharmaceutical and biopharmaceutical industries.
Biologics have demonstrated higher success rates compared to conventional small-molecule drugs, primarily attributed to their lower off-target toxicity, a common cause of failures in small molecule drug development. The pharmaceutical industry is evidently entering the era of biologics, marked by ongoing scientific advancements and the increasing approval of biologics by regulatory authorities such as the FDA. Biopharmaceuticals are expected to play a pivotal role in shaping the pharmaceutical landscape, gradually becoming an integral part of traditional medicines.
The remarkable progress in biologics development has transformed the treatment of various therapeutic conditions, contributing significantly to the surging demand for biologic therapies. Notably, many biologics manufacturers, including biologics CMOs, have embraced digital technologies to augment the productivity and reliability of their existing biologics-related processes and facilities.
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Market Scope:
| Report Coverage | Details |
| Market Revenue 2023 | US$ 14.4 Billion |
| Estimated Revenue 2030 | US$ 42.1 Billion |
| Growth Rate - CAGR | 8.6% CAGR |
| Forecast Period | 2023-2033 |
| No. of Pages | 185 Pages |
| Market Segmentation |
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| Regions Covered |
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| Key Companies Profiled |
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Biotechnology Contract Manufacturing Market Dynamics:
DRIVER: Surge in Outsourcing Biologics Manufacturing
The growing prominence of biologics in medical applications has triggered a notable increase in the outsourcing of manufacturing processes. Biologics contract manufacturers possess the expertise and infrastructure necessary for ensuring the efficacy of these intricate therapies while adhering to stringent quality standards and regulations. These contract manufacturers exhibit in-depth knowledge in protein chemistry, cell culture, downstream processes, and the effects of various conditions on yield and protein structure during the transition from laboratory to Good Manufacturing Practice (GMP) scale.
Consequently, biopharmaceutical companies are inclined to adopt a highly efficient approach to expedite development and manufacturing by forming partnerships with Contract Development and Manufacturing Organizations (CDMOs). These CMOs demonstrate robust proficiency in biologics, chemistry manufacturing control, and commercial manufacturing.
Furthermore, the outsourcing of clinical and commercial bio manufacturing by biopharmaceutical companies serves as a strategic move to mitigate costs and risks associated with in-house development and manufacturing. This strategic outsourcing trend contributes significantly to the growth of the biopharmaceutical contract manufacturing market.
RESTRAINT: Challenges in Intellectual Property Rights
The safeguarding of intellectual property rights holds paramount importance in the realm of contract manufacturing. In the context of innovation, the innovating company must disclose comprehensive details of its patented drug to the contract manufacturer for the drug's production. This entails the inherent risk of unauthorized use of the information, potential replication of products, and the associated risks of infringements.
Notably, there is a growing trend in the industry towards outsourcing fundamental manufacturing activities. A prime example is the outsourcing of complex biologics manufacturing by pharmaceutical companies, driven by the need for specialized expertise and infrastructure to meet individual patient requirements. To sustain and nurture this trend in the biopharmaceutical contract manufacturing market, it is imperative to foster a transparent and trustworthy relationship between pharmaceutical companies and Contract Manufacturing Organizations (CMOs). This ensures the effective protection of intellectual property, thereby addressing the complexities associated with information sharing and potential unauthorized use.
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OPPORTUNITY: Surging Demand for Cell Therapies and Gene Therapies
Cell and gene therapies, characterized by their high specificity, hold significant promise in addressing medical needs that remain unmet by small molecule drugs and other biologics. The compelling therapeutic potential of these treatments has spurred the attention of pharmaceutical companies, prompting them to prioritize the development and commercialization of such therapies. Consequently, there is a growing demand for the development and manufacturing of cell and gene therapies.
As of April 2022, the US FDA has approved more than 20 cell and gene therapies, highlighting the increasing acceptance and recognition of these innovative treatments. The expanding pipeline of cell and gene therapy candidates, their progression through different clinical development phases, and the intricate nature of their manufacturing processes have resulted in a heightened demand for facilities providing manufacturing services tailored to these therapies. This trend is anticipated to create substantial growth opportunities in the realm of contract manufacturing for cell and gene therapies.
CHALLENGE: Navigating Reformed Regulations
Compliance with FDA regulations mandates that manufacturers strictly adhere to the guidelines set by the respective regulatory authorities. Contract Manufacturing Organizations (CMOs) grapple with the responsibility of obtaining regulatory approvals from various regions for the same molecule, tailoring submissions to meet specific client requirements. The complexity of this process is heightened by variations in regulations and submission criteria across different countries. Errors in this intricate endeavor can present significant hurdles for innovators seeking entry into regulated markets. Adding to the complexity is the imperative to align manufacturing practices with the latest regulatory reforms, posing a formidable challenge for CMOs to consistently meet evolving standards across diverse regions and countries.
Biologics Contract Development & Manufacturing Organization (CDMO) Market Trends:
Market Growth Fuelled by CDMOs' Access to New Technologies and Accelerated Execution Speed
The imperative to shorten supply chains and enhance lead-time efficiency has prompted companies to implement diverse measures, making contract manufacturing a pivotal element in the supply chain for expedited execution. Contract manufacturing is frequently followed by contract packaging for certain pharmaceutical drugs. Consequently, pharmaceutical firms seek vendors offering not only contract manufacturing but also contract packaging and comprehensive quality testing. Third-party logistics providers, exemplified by entities like DHL, are extending their service offerings to encompass contract-packaging services.
CDMOs are gaining substantial traction by leveraging advanced technology and specialized expertise. Remaining abreast of the latest technological advancements is particularly crucial for niche CDMOs focusing on specific compounds or dosage forms. In a fiercely competitive industry, biopharmaceutical CDMOs poised for success are those willing to embrace cutting-edge technology, dedicating time and capital to develop distinctive capabilities. The most adept CDMOs are swiftly expanding their capacity while maintaining flexibility and agility.
As the prevalence of infectious diseases rises and the demand for innovative therapies grows, pharmaceutical and biotech companies, necessitating substantial capital investments for advanced technologies, are establishing collaborations with CDMOs. This collaborative approach is a significant driver of the market's continued expansion.
Biologics Contract Manufacturing Market: Competitive Landscape
This report provides profiles of key players in the worldwide biologics contract manufacturing market, evaluating them based on various attributes such as company overview, financial summary, product portfolio, business strategies, and recent developments.
The biologics contract manufacturing market exhibits fragmentation, featuring a substantial number of global players alongside numerous smaller entities in regional markets.
Prominent participants in the global biologics contract manufacturing market include:
- Lonza Group
- Samsung Biologics Co., Ltd.
- Patheon by Thermo Fisher Scientific, Inc.
- Cambrex Corporation
- Siegfried Holding AG
- Fujifilm Holding Corporation
- AbbVie, Inc.
- Boehringer Ingelheim
- Recipharm Pharmaceuticals
- WuXi Biologics
- Catalent, Inc.
Biopharmaceutical Contract Manufacturing Market – Segmentation:
Categorization of the biopharmaceutical contract manufacturing market is conducted through the following segments:
Product Segmentation: The market is classified based on products, with a distinction between biologics and biosimilar. The biologics segment is further subdivided into monoclonal antibodies, recombinant proteins, vaccines, and other categories.
Service Segmentation: The market's services are categorized into process development, fill and finish operations, analytical and quality control studies, and packaging.
Source Segmentation: The source of biopharmaceutical contract manufacturing is segmented into mammalian and microbial-based biologics/non-mammalian.
Geographical Segmentation: The market is geographically segmented into North America, Europe, Asia Pacific, the Middle East and Africa, and South and Central America. The North American market is further divided into the US, Canada, and Mexico. European segmentation includes Germany, France, the UK, Spain, Italy, and the Rest of Europe. The Asia Pacific market is sub-segmented into China, India, Japan, Australia, South Korea, and the Rest of Asia Pacific. The Middle East and Africa market is further segmented into Saudi Arabia, the UAE, South Africa, and the Rest of the Middle East and Africa. The South and Central America market are sub-segmented into Brazil, Argentina, and the Rest of South and Central America.
Regional Analysis
In terms of geographical distribution, the global market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. Leading the market in 2022, North America commanded the largest share, constituting over 8.6% of the global revenue. Projected to maintain its dominance, the regional market is anticipated to expand steadily at a consistent CAGR throughout the forecast period. This growth is primarily driven by the escalating outsourcing activities in North America, where several key players are vigorously competing to secure larger market shares by introducing cost-effective and high-quality solutions.
The advancement and manufacturing of advanced therapies within the region are poised to further contribute to market growth in the years to come. Conversely, Asia Pacific is forecasted to emerge as the fastest-growing regional market during the forecast period. This surge in regional growth can be ascribed to modifications in the clinical trial evaluation standards by regulatory bodies overseeing biologics, aligning them with global requirements. Additionally, the cost of conducting clinical trials is comparatively lower in Asia Pacific than in other regions. Consequently, these factors are expected to propel substantial growth in the regional market over the forecast years.
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