CMO in Pharmaceutical Industry Market 2024-2028

The CMO in pharmaceutical industry market size is forecast to increase by USD 40.6 million at a CAGR of 6.6% between 2023 and 2028. The pharmaceutical industry's CMO market is experiencing significant growth, driven by several key factors.

Firstly, the availability of cost-efficient resources in emerging markets is attracting CMOs to expand their operations. Secondly, the increasing number of FDA-regulated drug products under development necessitates the need for reliable CMOs to ensure drug formulation and clinical trial compliance. Supply chain issues continue to challenge CMOs, requiring quality management systems to mitigate risks and ensure timely delivery. Drug discovery and development processes are becoming increasingly complex, necessitating CMOs to stay updated with the latest technologies and regulatory requirements. In summary, the CMO market in the pharmaceutical industry is witnessing growth due to the increasing demand for FDA-approved manufacturing facilities, the need for cost-effective solutions, and the challenges posed by supply chain issues and complex drug discovery processes.

The Contract Manufacturing Organization (CMO) in the pharmaceutical industry plays a pivotal role in bringing drug products to market. This critical function involves managing various aspects of drug manufacturing, from production to quality management, ensuring regulatory compliance, and maintaining ethical standards. Biopharmaceutical startups often rely on CMOs for their manufacturing needs due to the complexities and high costs associated with in-house production. These organizations offer production capacity for drug products, drug formulation development, and clinical trial manufacturing. Manufacturing drug products involves several stages, including raw material sourcing, production, quality control, and packaging. CMOs must adhere to Current Good Manufacturing Practice (CGMP) regulations to ensure the highest standards of quality and safety. These regulations cover various aspects, such as facility design, equipment, record keeping, and personnel training.

Drug discovery is a lengthy and expensive process. Once a potential drug compound has been identified, it undergoes rigorous clinical trials to evaluate its safety and efficacy. CMOs support this process by manufacturing the drug substance and formulation for these trials. Quality management is a crucial responsibility for CMOs. FDA-regulated items require stringent quality control measures to ensure consistency, purity, and potency. CMOs must establish quality agreements with their clients and adhere to these agreements throughout the manufacturing process. Supply chain issues can significantly impact drug manufacturing. CMOs must maintain a reliable supply of raw materials and manage their inventory effectively to minimize disruptions.

Additionally, they must have contingency plans in place to address any unexpected delays or shortages. FDA regulations are essential in the pharmaceutical industry. CMOs must comply with these regulations to maintain their reputation and protect their clients' products. Non-compliance can result in reputational damage, regulatory fines, and even recalls. Maintenance is another critical aspect of CMO operations. Proper maintenance of equipment and facilities is necessary to ensure production capacity and minimize downtime. CMOs must invest in regular maintenance and upgrades to maintain their competitive edge. Labor is a significant cost for CMOs. They must hire and train skilled personnel to manage various aspects of drug manufacturing. CMOs must also ensure their workforce adheres to ethical standards and follows good manufacturing practices.

In conclusion, the role of a CMO in the pharmaceutical industry is multifaceted. They play a crucial role in drug manufacturing, from production to quality management, ensuring regulatory compliance, and maintaining ethical standards. Their expertise and capabilities are essential for biopharmaceutical startups and other organizations looking to bring drug products to market.

Market Segmentation

The market research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD million" for the period 2024-2028, as well as historical data from 2018-2022 for the following segments.

• Service
  • API manufacturing service
  • FDF manufacturing service
• Geography
  • Europe
    • Germany
    • UK
    • France
  • North America
    • US
  • APAC
    • China
  • Middle East and Africa
  • South America

By Service Insights

The API manufacturing service segment is estimated to witness significant growth during the forecast period. In the global Contract Manufacturing Organizations (CMO) market within the pharmaceutical industry, the API manufacturing service segment is projected to expand significantly during the forecast period. This growth is attributed to the increasing collaborations between multinational pharmaceutical companies and CMOs, particularly in countries like India and China.

The API manufacturing service segment was valued at USD 69.80 million in 2018. These partnerships provide API manufacturers with the opportunity to either compete on cost or offer unique custom synthesis capabilities. Additionally, large pharmaceutical firms are attracted to the cost-effective bulk production capabilities of Indian and Chinese manufacturers, which is a significant factor fueling the expansion of the API manufacturing segment in the CMO market for pharmaceuticals.

Regional Analysis

APAC is estimated to contribute 35% to the growth of the global market during the forecast period. The analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period.

The European region holds a significant position in the global Contract Research Organizations (CMO) in the pharmaceutical industry, leading the market due to the high prevalence of chronic diseases, such as cancer and metabolic disorders. The presence of a large number of CMOs in Europe contributes to market growth, as these entities provide vital services from drug development to manufacturing. This assistance is indispensable for pharmaceutical companies seeking to optimize their operations and reduce costs. Europe's advanced manufacturing capabilities and rigorous regulatory standards ensure top-notch production that adheres to international guidelines, making it an alluring destination for pharmaceutical outsourcing. Additionally, the development and production of generic drugs in Europe contribute to the market's expansion, as these cost-effective alternatives cater to a vast patient population. The focus on precision medicine and technology transfer further propels the market forward, as CMOs collaborate with pharmaceutical companies to bring innovative therapeutic solutions to the market.

The researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.

Key Market Driver

The availability of cost-efficient resources in emerging markets is notably driving market growth. Pharmaceutical companies from developed nations are increasingly outsourcing supply chain activities, such as drugs and therapies research and manufacturing, to countries like China, India, Brazil, and Mexico. This trend is driven by several factors, including the availability of skilled labor at lower costs and the increasing number of FDA-approved manufacturing facilities in these countries.

For instance, India, which is a popular destination for Contract Research Organizations (CMOs), boasts over 100 US FDA-approved manufacturing facilities. This not only reduces production costs but also ensures regulatory compliance. These reports focus on the cost advantages and regulatory compliance as the primary reasons for this trend. Thus, such factors are driving the growth of the market during the forecast period.

Significant Market Trends

The US FDA-approved manufacturing facilities is the key trend in the market. The pharmaceutical Contract Manufacturing Organizations (CMO) industry in the global market is witnessing a significant expansion, particularly in the sector of FDA-regulated drug products. Two prominent countries, China and India, have seen an increase in US Food and Drug Administration (FDA)-approved manufacturing facilities. India, with over 400 such facilities, is a preferred destination for pharmaceutical manufacturing services outsourcing. The country boasts approximately 230 approved Active Pharmaceutical Ingredient (API) facilities and 150 Facilities for Finished Dosage Forms (FDF), the highest numbers globally.

Additionally, India ranks second for pharmaceutical formulation facilities, with approximately 147 in the country. Clinical trials, supply chain issues, and quality management are crucial aspects of the pharmaceutical industry, and these FDA-approved facilities ensure adherence to stringent regulations, addressing these concerns effectively. Thus, such trends will shape the growth of the market during the forecast period.

Major Market Challenge

The stereotypical nature of CMOs is the major challenge that affects the growth of the market. The CMO market in the pharmaceutical industry is experiencing significant growth, particularly among startups and biopharmaceutical companies. However, this market encounters a substantial challenge due to the limited capabilities of CMOs, particularly in emerging countries with the largest market shares, such as China and India.

Although advancements in healthcare infrastructure have been made, CMOs in Asia lack access to advanced manufacturing technologies. Consequently, they rely on older methods to produce drugs, primarily focusing on small molecule-based medications due to their large-scale production capacity. However, these CMOs struggle to manufacture biological drugs and vaccines on a large scale due to the intricate processes involved, which necessitate advanced technologies. Hence, the above factors will impede the growth of the market during the forecast period.

Exclusive Customer Landscape

The market forecasting report includes the adoption lifecycle of the market, covering from the innovator's stage to the laggard's stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth analysis strategies.

Key Companies & Market Insights

Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market.

Almac Group Ltd. - The company offers CMO products such as 14C Radiolabelling and NeoPeptides.

The market research and growth report also includes detailed analyses of the competitive landscape of the market and information about key companies, including:

• Almac Group Ltd.
• Boehringer Ingelheim International GmbH
• Cadila Pharmaceuticals Ltd.
• Cambrex Corp.
• Catalent Inc.
• Chongqing Huapont Pharmaceutical Co. Ltd.
• Cipla Inc.
• Cmic Holdings Co. Ltd
• Curia Global Inc.
• Dr Reddys Laboratories Ltd.
• FAMAR Health Care Services
• Jubilant Pharma Ltd.
• Lonza Group Ltd.
• Lupin Ltd.
• PCI Pharma Services
• Pfizer Inc.
• Recipharm AB
• Samsung Biologics Co. Ltd.
• Thermo Fisher Scientific Inc.
• Vetter Pharma Fertigung GmbH and Co. KG

Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

In the pharmaceutical industry, CMOs (Contract Manufacturing Organizations) play a pivotal role in manufacturing drug products for biopharmaceutical startups and established pharma companies. CMOs offer production capacity for FDA-regulated items, ensuring adherence to CGMP regulations and ethical standards. Drug formulation and production processes are outsourced to CMOs, enabling companies to focus on drug discovery and clinical trials. Supply chain issues, such as raw material availability and quality agreement negotiations, are managed by CMOs. Quality management is a top priority, with CMOs implementing rigorous control measures to prevent risks and ensure compliance liabilities are met.

Experienced CMOs possess technological capabilities that drive process efficiencies, cost savings, and innovation. They offer infrastructure for various modalities, including monoclonal antibodies and personalized medicine, catering to the needs of chronic disease treatments. CMOs maintain a strong focus on quality and compliance, ensuring that healthcare providers receive high-quality drug products. Their expertise in technology transfer and drug development, from drug candidate identification to supply chain activities, makes them indispensable partners in the pharmaceutical industry.