A lot of big pharmaceutical companies are outsourcing their production so they can focus on research and development, which is what they do best. Only 20% of the nine hundred CMOs that work in the US can package their products. This makes the prices of supplies for research trials go up.
The market, on the other hand, is mostly affected by the complicated process of making pharmaceuticals, which itself lacks quality control. These contract makers must follow Parts 210 and 211 of Title 21 CFR (Code of Federal Regulations). These rules are set by the FDA. There are many parts to packaging a finished product, such as design and sample services that need to be done before mass production can begin.
With this situation, drug companies will still need to rely on contract producers to meet their needs. Many drugs and other medical goods are made by CMOs for different pharmaceutical businesses around the world. This industry has grown very important. Because of this, these companies work directly with clients that include generics providers and new biotech companies. Because of this, there has been a growing movement toward using contract producers more and more.
The pharmaceutical contract manufacturing business is going through big changes because of globalization, the way markets work, and the need for more flexible and efficient pharmaceutical production. The growing trend of transferring production tasks to Contract production Organizations (CMOs) is a big change in the pharmaceutical industry. Drug companies can focus on their main skills, like research and development, by changing their business plans in this way. At the same time, they can use CMO's unique skills to make drug substances and finished dose forms. The trend is in line with how cost-effective, flexible, and quick it is for this sector to adopt new technologies that are useful.
More biopharmaceuticals and complicated treatments are being made, which has an effect on pharmaceutical contract production. Complex drug types like biologics and gene treatments are becoming more popular. Making them, however, is harder than ever and needs special equipment and knowledge.
The number of CMOs offering expertise in bioprocessing, cell culture, aseptic processing is increasing as owners look for partners who have the ability to manage complexities around advanced therapy manufacturing.
In the context of contract pharmaceutical production one notable shift concerns quality improvement and adherence to regulatory standards. This calls for continuous investment by CMOs into quality systems, cGMP compliance as well as robust manufacturing procedures due to stringent regulatory frameworks within the pharma sector that must be complied with. This means that companies will rely on CM contractors who strictly follow regulations thereby ensuring quality safety efficacy throughout.
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Pharmaceutical Contract Manufacturing Market was valued at USD 193.2 billion in 2023 and is projected to grow from USD 200.9 billion in 2024 to USD 321.47 billion by 2032, exhibiting a CAGR of 4% during the forecast period(2024 - 2032). Rising demand for biological therapies, patent expiry and increasing demand for generic drugs, and increasing demand for gene and cell therapies are the key market drivers enhancing the market growth.
Source: Secondary Research, Primary Research, MRFR Database and Analyst Review
The market is growing as a result of several factors, the most important of which are the rising need for biological treatments, the expiration of patents and the subsequent rise in generic medication demand, and the rising desire for gene and cell therapies. CMOs in the pharmaceutical business are expanding because to rising demand for cutting-edge production techniques and technology, which have shown great success in conforming to relevant regulations.
More money will be put into pharmaceutical R&D and state-of-the-art manufacturing technologies by the CDMO. Rising demand for biological treatments, focus on speciality drugs, expansion of nuclear medicine, and cell and gene therapy discoveries are all seen as potential growth drivers for the pharmaceutical contract manufacturing industry. Many pharmaceutical companies have realized the financial benefits of outsourcing their clinical and commercial stage manufacturing to a CMO (contract manufacturing organization) due to the increasing demand for generic medicines and biologics, the high capital costs, and the complexity of the manufacturing requirements.
The market was boosted by the COVID-19 epidemic because pharmaceutical firms were suddenly faced with the daunting task of manufacturing the tens of millions of vaccine doses that would likely be required. Contract manufacturing organizations (CMOs) entered contract manufacturing service agreements at an unprecedented rate with the start of the pandemic because of the shortened schedules and manufacturing scaling problems associated with the COVID-19 vaccines and medications. Because of the industry's continued expansion and the aftermath of the Covid-19 outbreak, pharmaceutical innovator firms are scrambling to fill their pipelines with new products. However, they lack the means to do research, design, and produce new goods. As a result, there is a serious need for CMOs.
Low labor costs, low capital and overhead costs (relative to the United States and Europe), tax incentives, and an undervalued currency provide a significant cost advantage for pharmaceutical companies outsourcing to countries like China, India, and Japan, which hold a significant share of the pharmaceutical CMO market.
July 2023: This first high potency (HP) fully automated sterile injectable production line at WuXi STA's pharma product site was revealed in July 2023. WuXi STA is a contract research development and manufacturing organization (CRDMO) that operates as a subsidiary of WuXi AppTech. According to a press statement, the company's production capabilities and capacity for injectable dosage forms will be improved with the addition of a new HP injectable line with an annual capacity of 12 million units. The line employs completely enclosed isolation systems and automated filling equipment to provide quality control for sterile products with minimal risk of contamination.
As doctors have become more scientifically interested in medicine and have sought and developed remedies for life-threatening disorders, the market for pharmaceutical contract manufacturing has grown tremendously over the past ten years. Artificial intelligence is also included in the manufacturing process since it aids in analyzing the patient's symptoms and tracking other individuals who exhibit the same symptoms to prevent the early emergence of these fatal diseases. One of the primary factors driving the growth of the Healthcare contract manufacturing market is the participation of governments throughout the globe in the healthcare sector to promote the discovery and invention of new pharmaceuticals to treat the most serious illnesses. The government has maintained a balance between medicine production and delivery by investing in the development and manufacturing industries. Manufacturing companies can concentrate more on developing novel drug classes and evaluating how well they can combat deadly viruses and diseases thanks to contract manufacturing organisations (CMOs).
The CDMO will invest more in pharmaceutical R&D and cutting-edge manufacturing technology. Market opportunities for the pharmaceutical contract manufacturing to expand are anticipated by rising demand for biological therapies, attention to specialty medications, nuclear medicine expansion, and cell and gene therapy developments.
Based on type, the pharmaceutical contract manufacturing market segmentation includes active pharmaceutical ingredient (API) manufacturing and finished dosage formulation (FDF). The active Pharmaceutical Contract Manufacturing segment held the majority share in 2021, contributing to the pharmaceutical contract manufacturing market revenue. This is primarily owing to the rising government initiatives in the healthcare sector, increasing cancer and age-related diseases, and innovations in biologics across the globe. The finished dosage formulation is the fastest-growing segment in the coming years. For instance, as per the National Institutes of Health (US) statistics published in 2020-2021, the prevalence of degenerative disc disease is typically proportional to age, with 40% of people aged 40 years having degenerative disc disease, rising to 80% among those aged 80 years or over.
January 2021:5N Plus Inc, a global manufacturer of specialty chemicals and engineered materials, announced that it had entered into a strategic agreement with Bozeman, Montana-based Microbion Corporation to expand the company's Active Pharmaceutical Ingredient (API) Portfolio to include substances for a new class of Antibiofilm and Antibiotic drugs.
August 2021:Trillium Therapeutics Inc., a clinical-stage immuno-oncology business exploring novel treatments for cancer treatment, and Pfizer Inc. announced they had signed a definitive agreement. As a result of this arrangement, Pfizer will acquire Trillium. For an estimated equity value of USD 2.26 billion or USD 18.50 per share, in cash, Pfizer will purchase all of Trillium's outstanding shares that it does not already hold. This is 118% more expensive than Trillium's 60-day weighted average price.
In April 2023:Bridgewest will introduce a new CDMO under the name NovaCina, which will be based in Australia and produce only sterile injectable drugs. After acquiring Pfizer's sterile injectable manufacturing facilities in Perth, Australia, Bridgewest Group formed a contract development and manufacturing organization (CDMO). The CDMO's first capabilities will include manufacturing sterile injectable medicinal products throughout all stages, from preclinical to clinical to commercial.
By Region, the study provides market insights into North America, Europe, Asia-Pacific and the Rest of the World. The North America Pharmaceutical Contract Manufacturing market, accounted for USD 49.4 billion in 2021 and is expected to exhibit a significant CAGR growth during the study period. This is attributed to the growing incidence of age-related diseases, increasing cancer diseases, biological innovations, and increasing cell and gene therapies across the region.
Further, the major countries studied in the market report are The U.S., Canada, Germany, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.
Figure 3: Pharmaceutical Contract Manufacturing Market Share by Region 2021 (%)
Source: Secondary Research, Primary Research, MRFR Database and Analyst Review
Europe's Pharmaceutical Contract Manufacturing market accounts for the second-largest market share due to the availability of cutting-edge treatment facilities, government backing for the growth of the healthcare industry, an aging population, and an increase in the incidence of life-threatening disease, cancer incidence, and biologic innovations. Further, the Germany market of pharmaceutical contract manufacturing held the largest market share, and the UK mmarket of pharmaceutical contract manufacturing was the fastest-growing market in the European region.
The Asia-Pacific market of pharmaceutical contract manufacturing is expected to grow at the fastest CAGR from 2024 to 2032. This is due to open pharma companies for manufacturing and developing drugs. Moreover, the China market of pharmaceutical contract manufacturing held the largest market share, and the India market of pharmaceutical contract manufacturing was the fastest-growing market in the Asia-Pacific region.
For instance, the India Pharmaceutical Contract Manufacturing market is the favored destination for medical travelers due to the availability of surgeons, cutting-edge technology, & cost-effective treatments. On the other hand, Singapore is famous for the presence of well-trained doctors, state-of-the-art facilities, and quality care. As per the data cited in the Medical Tourism Index 2021-21 published by Medical Tourism Association in July 2021, Singapore is ranked in 2nd position, Japan at 3rd, India at 10th, South Korea at 14th, and China at 33rd out of the top 46 international healthcare destinations. Hence, Asia-Pacific is anticipated to register the highest growth rate over the forecast period from 2024–2032.
Pharmaceutical Contract Manufacturing Key Market Players
Major market players are spending a lot of money on R&D to increase their product lines, which will help in the market growth of pharmaceutical contract manufacturing. Market participants are also taking various strategic initiatives to grow their worldwide footprint, with key market developments such as new product launches, contractual agreements, mergers and acquisitions, increased investments, and collaboration with other organizations. Competitors in the Pharmaceutical Contract Manufacturing industry must offer cost-effective items to expand and survive in an increasingly competitive and rising market environment.
One of the primary business strategies manufacturers adopt in the global Pharmaceutical Contract Manufacturing industry to benefit clients and expand the market sector is manufacturing locally to reduce operating costs. The Pharmaceutical Contract Manufacturing industry has provided medicine with some of the most significant benefits in recent years. In the Pharmaceutical Contract Manufacturing market players such as Grifols International, S.A., Catalant, AbbvIE Inc., Boehringer Ingelheim, Lonza AG, Vetter, Patheon Inc., Pharmaceutical Product development and others are working on expanding the market demand by investing in research and development activities.
GlaxoSmithKline (GSK) is a multinational biopharmaceutical business whose mission is to bring talent, technology, and science together to fight disease. Over the next ten years, the company wants to benefit the health of 2.5 billion individuals. New commitments to growth and a step-change in performance reflect in their big goals for patients. We are an organization where exceptional people may succeed. For Instance: GSK launched a new production corporation, Bioventure Healthcare FZE, an approved manufacturing facility in the United Arab Emirates. Through this collaboration, GSK will deliver to the Arab Emirates the secondary packaging of 20 significant drugs used to treat various medical ailments, such as allergies, central nervous system conditions, dermatology, urology, and skin. With the implementation of this agreement, supply will be constant, and new supply shortfalls will be resolved faster by the company. Our approach also serves patients by ensuring that people have access to the premium GSK medications that their doctors have prescribed.
Also, AGC Biologics, a pioneer in biopharmaceutical contract development and manufacturing (CDMO), Provides pharmaceutical research and manufacturing services for biologics based on proteins and cell and gene therapies. The company has the tools and capacity to quicken your race to GMP, with seven facilities and teams of scientists spread across three continents. At any level of the medication research and manufacturing process, from development through clinical trials to full-scale commercialization, AGC Biologics can assist you in achieving your objectives. For Instance: AGC Biologics established a partnership with W.L. Gore & Associates (Gore) that combines Gore's technology for Protein A affinity purification with the company's contract development and manufacturing capabilities.
Biopharmaceutical companies can use GORE and AGC Biologics to increase the productivity of the Protein A step in downstream purification processes, enabling a full single-use downstream process that can reduce manufacturing footprint, eliminate column bioburden from storage, and lower costs for clinical manufacturing and select scale commercial manufacturing.
Key Companies in the Pharmaceutical Contract Manufacturing market include
Pharmaceutical Contract Manufacturing Industry Developments
August 2021: Lonza stated that it would invest in building its production capacity for pharmaceutical products in Guangzhou, China. The 17,000 m2 cutting-edge cGMP mammalian facility will get an aseptic medicinal product fill and finish production line thanks to the increased investment.
November 2021: Baxter International Inc. announced plans to expand its sterile fill/finish manufacturing facility in Halle/Westfalen, Germany, by about USD 100 million. The company in charge of running this facility is BioPharma Solutions (BPS). This Baxter division focuses on collaborating with top biotech and pharmaceutical firms to develop and contract-manufacture pharmaceutical products for parenteral (injectable) use.
North America
Europe
Asia-Pacific
Rest of the World
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