Visiongain has launched a new report on Global Biopharmaceuticals Contract Manufacturing Market Forecast 2022-2032: - Market Segment by Source (Mammalian, Non-mammalian), Service {Process Development (Downstream, Upstream), Fill & Finish Operations, Analytical & QC Studies, Packaging}, Product {Biologics (Monoclonal antibodies (MABs), Recombinant Proteins, Vaccines, Antisense, RNAi, & Molecular Therapy, Others), Biosimilars}, Company Size (Small, Mid-sized, Large), Scale of Operations (Preclinical, Clinical, Commercial), By Region (North America, Europe, Asia Pacific, Latin America, Middle East & Africa), Plus analysis of leading regional/national markets and leading companies in the market. COVID-19 Impact Recovery Analysis (V-shaped recovery, W-shaped recovery, U-shaped recovery, L-shaped recovery)
Global Biopharmaceuticals Contract Manufacturing Market Outlook
According to Visiongain analysis, the Global biopharmaceuticals contract manufacturing market was estimated to be valued at US$12,944.3 million in 2021. The worldwide market is expected to witness a CAGR of 8.53% from 2022 to 2027 and is expected to reach US$21,009.4 million in 2027 from its previous value of US$13,955.6 million in 2022. Visiongain further anticipates that the global market will reach US$33,852.8 million in 2032 while growing at a CAGR of 9.27% from 2022 to 2032.
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What are the Market Drivers?
Rise in Investment by CMOs for Capacity Expansion
The emergence of early-stage bio/pharma firms is due to the maturity of biotechnology and the availability of external investment. These businesses are considered important consumers of CMOs because they lack the necessary expertise to create strong manufacturing operations. To meet the rising demand, key firms are expanding their capacity. For example, in the year 2020, Thermo Fisher Scientific announced an investment of US$180 million in the manufacturing of viral vectors at a new commercial manufacturing facility in Plainville, Massachusetts. Similarly, to enhance manufacturing capacity, Boehringer Ingelheim spent US$84 million in Mexico in 2019.
Advantages Offered by Contract Services in Term of Cost & Timelines
According to Visiongain analysis in 2032, the global biopharmaceuticals contract manufacturing market is expected to be worth US$33,852.8 million, with a compound yearly growth rate (CAGR) of 9.27% from 2022 to 2032. The biopharmaceutical market's success is primarily due to contract manufacturers. CMOs provide advantages such as reduced total investment necessary to bring a novel medicine product to market, access to advanced technology, speedier product entrance into markets, & more flexibility, prompting corporations to outsource their biopharmaceutical manufacture. Furthermore, as the biopharmaceutical business continues to grow, organizations are encountering production challenges, such as a lack of experience and advanced equipment, while performing in-house manufacturing.
What are the Market Opportunities?
Expansion of Fill-and-Finish CMOs
CMOs have offered biopharma companies a broad range of services, from cell culturing to final product packaging. CMOs offer manufacturing services such as process development, fill and finish operations, analytical and quality control research, and packaging.
The analytical & QC studies category is predicted to expand at a substantial rate throughout the forecast period, owing to rising quality concerns and regulatory changes for biopharmaceutical development. New constraints for CMOs generating biologics are being applied in compliance with regulatory standards to assure product purity and safety.
Emerging Economies to Offer Lucrative Growth Opportunities
In terms of API production, Asia-Pacific is a significant geographical area with several growing nations. Even though the APAC area has a lower share of healthcare expenditure than established markets in North America and Europe, the region's growth rate has surpassed that of mature markets in North America and Europe. Rising healthcare expenditure has resulted in more affordable healthcare as well as stronger demand for pharmaceutical products throughout APAC. The majority of the medications used in this country are made in onshore manufacturing facilities. Contract manufacturing businesses are also important outsourcing partners for pharmaceutical companies that sell their products in North America and Europe. Drugmakers are outsourcing raw material procurement and production operations as a result of rising competition, price constraints, and regulatory changes. Due to rising consumption, healthcare expenditures, and availability of pharmaceuticals, Asia-Pacific is the fastest-growing market for APIs.
COVID-19 Impact Analysis on Biopharmaceuticals Contract Manufacturing Market
Customers and CMOs are working together to standardize contract terms to make contract discussions easier. This is in response to concerns about the regulatory environment and the complexity of service delivery. IP rights, warranty, liability, pricing, and timeliness are all important concerns raised by CMOs and clients, making negotiations inherently complex. Breakthrough technical developments and innovations in bioprocessing have aided contract service providers' growth by overcoming manufacturing challenges such as high production costs and the necessity for the batch changeover. One of the most significant breakthroughs is single-use bioprocessing systems, which assist to reduce total production and scale-up costs.
Product Analysis
The global biopharmaceuticals contract manufacturing market is segmented based on product into biologics and biosimilars. Biologics is further sub-segmented into monoclonal antibodies, recombinant proteins, vaccines, and others. The biologics segment is projected to dominate the global biopharmaceuticals contract manufacturing market on the basis of product with 71.6% market share in 2022 which is projected to reach 68.3% in 2032. There are a large number of FDA-approved biologics in the market, which contributes to the segment's dominance in terms of commercial success.
Over the forecast period, mAbs will hold the largest market share, contract services for mAbs production have been accelerated by the high capital requirements for the construction of an mAbs facility, which has contributed to the segment's growth. However, over the forecast period; the biosimilars market is expected to grow with the highest CAGR of 10.46% from 2022 to 2032. Due to biosimilars production being a key strategy for business expansion, investments in biosimilars manufacturing help biopharmaceuticals reach the market quickly. The biopharmaceutical CMO industry has also benefitted from biosimilars in terms of cost-saving advantages.
Service Analysis
The global biopharmaceuticals contract manufacturing market is segmented on the basis of service into process development, fill & finish operations, analytical & QC studies, and packaging. The process development segment is projected to dominate the global biopharmaceuticals contract manufacturing market on the basis of Service with 38.4% market share in 2022 which is projected to reach 39.6% in 2032. High downstream processing capital expenditure is credited with the segment's dominance. To ensure product quality and minimize waste, downstream processes necessitate careful attention to final product recovery and purification steps.
Source Analysis
The global biopharmaceuticals contract manufacturing market is segmented on the basis of source into mammalian, & non-mammalian. The mammalian segment is projected to dominate the global biopharmaceuticals contract manufacturing market on the basis of Source with 64.4% market share in 2022 which is projected to reach 68.1% in 2032.
The biopharmaceutical market is expected to grow as a result of ongoing research into the use of various sources and species in the development of new drugs. The key objective of these studies is to enhance biopharmaceutical manufacturing productivity & efficiency. Given the high percentage of mammalian expressed biopharmaceuticals currently in development, this sector is expected to remain at the top over the forecast period.
The expansion of mammalian cell culture manufacturing facilities for the development of biologics and biosimilars is a major investment by key companies. Companies that provide contract services using mammalian cell culture include AGC Biologics, Boehringer Ingelheim GmbH, and WuXi Biologics among other prominent players.
Scale of Operation Analysis
The global biopharmaceuticals contract manufacturing market is segmented on the basis of the scale of operations into preclinical, clinical, and commercial. The commercial segment is projected to dominate the global biopharmaceuticals contract manufacturing market on the basis of scale of operations with 67.6% market share in 2022 which is projected to reach 69.1% in 2032. CDMOs provide complete, end-to-end solutions for preclinical and clinical outsourcing services of both Drug Substance / API and Drug Product. These firms provide comprehensive services to enable (bio) pharmaceutical companies to advance quickly from the research stage to the clinical stage of drug development, reducing time to market.
For instance, CDMO offers the following services:
- Pre-Clinical Services
- Small Molecules: API Development & Manufacturing; Solid State Research & Development, and DP Development & Manufacturing
- Biologics – DS/DP Development & Manufacturing
- Sterile & Non-sterile Manufacturing
- Regulatory Services
Regional Analysis
According to Visiongain analysis, North America is projected to hold a maximum share of 39.4% and 38.1% in 2022 and 2032, respectively. This is attributed to the presence of multiple service providers across the region. CMOs also produce a significant number of pharmaceutical products in the United States. Several small and mid-sized biopharmaceutical firms (SMEs) may lack the necessary resources or funds to establish well-equipped facilities. As a result, there is increasing reliance between CMOs & SMEs in the U.S., thus driving the regional market growth.
Asia Pacific is expected to grow with the highest CAGR over the forecast period. Cost-related advantages, such as reduced labour costs and operational expenses throughout the area, are a major cause for the development in outsourcing in Asian nations. Due to its vast volume of big molecule synthesis, India is expected to make great advances. The Indian market has been fuelled by a lack of worldwide regulatory uniformity for biosimilar clearance.
Even before COVID-19, outsourcing of biopharmaceutical research and manufacture was on the rise, especially as a rising number of tiny and virtual biotechnology businesses adopted business models that were entirely based on outsourcing all development and manufacturing operations.
A large amount of the production of COVID-19 vaccines and treatments was outsourced to fulfill worldwide demand for vaccine and therapeutic doses, with more than 230 manufacturing agreements publicly reported to date between COVID-19 vaccine and therapy researchers and contract manufacturers.
The COVID-19 pandemic has been one of the most difficult problems for biologics production in the world to date, and it has not let up since it began. As a consequence of the epidemic, CDMOs have experienced a surge in demand for pharmaceuticals to be delivered at breakneck speed. The need for manufacturing assistance will certainly persist in the foreseeable future due to the demand for frequent booster vaccines.
COVID-19-related supply chain interruption is one of the other supply challenges: "With resources like glass vials being prioritized for vaccine manufacture, biopharma manufacturing businesses have had to deal with not just supply delays but also consumables shortages." Due to growing demand, several materials essential for biopharma manufacture have experienced six to twelve-month delays as well as higher costs. As a result of these interruptions, it has become more vital for businesses to accurately estimate supply, increase inventory levels, and qualify alternative suppliers to avoid shortages.
Competitive Landscape
To gain a competitive edge, Biopharmaceuticals Contract Manufacturing, companies adopt a variety of strategies. These include product launch, investment in R&D, partnerships, regional business expansion, mergers & acquisitions, and facility expansion. Some of the major companies operating in the global biopharmaceuticals contract manufacturing market are AbbVie, Inc., AGC Biologics, Avantor, Binex Co., Ltd., Boehringer Ingelheim GmbH, Cambrex Corporation, Curia Global, Inc., FUJIFILM Diosynth Biotechnologies U.S.A., Inc., JRS PHARMA, Jubilant Pharma Limited, Lonza, Pfizer CentreOne, ProBioGen, Rentschler Biopharma SE, Samsung Biologics, Sandoz, TOYOBO CO., LTD., Thermo Fisher Scientific, and WuXi Biologics among other prominent players.
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Key Questions Answered by this Report:
- What is the current size of the overall global biopharmaceuticals contract manufacturing market? How much will this market be worth from 2022 to 2032?
- What are the main drivers and restraints that will shape the overall biopharmaceuticals contract manufacturing market over the next ten years?
- What are the main segments within the overall biopharmaceuticals contract manufacturing market?
- How much will each of these segments be worth for the period 2022 to 2032?
- How will the composition of the market change during that time, and why?
- What factors will affect that industry and market over the next ten years?
- What are the largest national markets for the world’s Biopharmaceuticals Contract Manufacturing?
- What is their current status and how will they develop over the next ten years?
- What are their revenue potentials to 2032?
- How will market shares of the leading national markets change by 2032, and which geographical region will lead the market in 2032?
- Who are the leading companies and what are their activities, results, developments, and prospects?
- What are some of the most prominent Biopharmaceuticals Contract Manufacturing currently in development?
- What are the main trends that will affect the world’s biopharmaceuticals contract manufacturing market between 2022 and 2032?
- What are the market's main strengths, weaknesses, opportunities, and threats?
- What are the social, technological, economic, and political influences that will shape that industry over the next ten years?
- How will the global biopharmaceuticals contract manufacturing market evolve over the forecasted period, 2022 to 2032?
- What will be the main commercial drivers for the market from 2022 to 2032?
- How will market shares of prominent national markets change from 2022, and which countries will lead the market in 2032, achieving the highest revenues and fastest growth?
- How will that industry evolve between 2022 and 2032, especially in R&D?
Discover sales predictions for the global biopharmaceuticals contract manufacturing market and submarkets.
Along with revenue prediction for the overall world market, there are 5 segmentations of the biopharmaceuticals contract manufacturing market, with forecasts for 2 Sources, 4 Services, 2 Products, 2 Company Size, and 3 Scale of Operations sub-segments each forecasted at a global, regional, and country-level, along with COVID-19 impact recovery pattern analysis for all segments.
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