Large Molecule Drug Substance CDMO Market

Market Overview

The global large molecule drug substance CDMO market size was worth USD 10 billion in 2021 and is anticipated to reach USD 21 billion in 2031 at a CAGR of 8.6% during the forecast period (2022-2030).

 Contract development and manufacturing organization (CDMO) is a business that provides customers with adequate services from drug discovery through manufacturing while also assisting the pharmaceutical sector. The knowledge, research, and manufacturing capabilities of CDMOs are vital for integrating external third-party ventures. The main drivers of the market growth are an increase in extensive molecule drug approvals, particularly with the FDA, rising infectious disease incidence, growing preference for novel therapeutics, and increased capital financial assets by pharma and biotech companies in cutting-edge technologies for forming partnerships with CDMOs.

Market Dynamics

Market Dynamics

Global Large Molecule Drug Substance CDMO Market Drivers

• Growing Demand for Pharmaceutical Products

Because of the expanding population, increased acceptance of a westernized lifestyle, and accelerating economic development, the burden of chronic diseases is rising significantly worldwide. The World Health Organization (WHO) predicts that in 2020, the burden of non-communicable diseases (NCDs) will increase to 57 percent. Pharmaceutical businesses are encouraged to develop efficient pharmaceutical solutions to quicken the healing process by the rising incidence of chronic diseases and the aging population. Additionally, the ability of CDMOs to streamline the pharmaceutical supply chain and the adoption of the one-stop-shop model to introduce efficient drug goods to the market are projected to drive the growth of the CDMO market during the forecast period.

Global Large Molecule Drug Substance CDMO Market Restraint

• Stringent Government Regulations

The primary factors most likely to restrain the expansion of the CDMO market throughout the forecast period are the existence of stringent government restrictions and a decline in the licensing of biologics in advanced countries.

Companies must spend more money to adhere to rules imposed on producers. As a result, the challenging technology transfer and IP security issues in the highly regulated production processes are preventing the industry from expanding and being adopted as expected in various areas.

Global Large Molecule Drug Substance CDMO Market Opportunities

• Increased Investments and Strategic Partnerships

Many CDMOs are placing a significant emphasis on capital investments to create innovative chemicals and broaden their geographic reach. The strategic acquisition of €3.7 million in CordenPharma International's Swiss facility for producing small molecule APIs was announced in October 2017. Additionally, another significant driver projected to spur the CDMO market expansion during the forecast period is an increment in the number of new players entering the market through partnerships.

Regional Analysis

Region-wise, the global large molecule drug substance CDMO market analysis is segmented into North America, Europe, Asia-Pacific, and LAMEA. 

North America dominated the global market. The United States has made significant investments in R&D, and more are anticipated in the upcoming years. The Congressional Budget Office (CBO) reported that the United States spent USD 11 billion on big molecules in 2019. The FDA approved only 29 biosimilar medications in December 2020. The market is also growing due to the presence of numerous players, including Catalent, Cambrex Corp., LabCorp Drug Development, and Fujifilm Diosynth Biotechnologies. To increase its capacity to produce large molecular therapeutic products and drug substances, Catalent announced in April 2022 a multi-year investment of USD 350 million at its facility in Bloomington, India. Such developments fuel the market expansion in this area.

Asia-Pacific is projected to be the fastest-growing regional market during the forecast period. With the change in the regulatory environment, a low-cost, trained workforce is a significant driver of the market expansion. For instance, India is a fantastic destination for the CDMO sector because it has a highly skilled workforce and FDA approval for many medication goods. The business of regional CDMOs will then soar as access to healthcare in emerging economies improves, and the number of generic manufacturers in India rises because India can handle a vast diversity of products very affordable. In essence, developing the nation's healthcare infrastructure promotes market expansion.

Segmental Analysis

The global considerable molecule drug substance CDMO market is segmented by services, source, end-user, and region. 

Based on services, the global large molecule drug substance CDMO market growth has been further segmented into contract manufacturing and contract development. The contract manufacturing services segment dominated the global market. Many Indian pharmaceutical companies have extensive experience in contract manufacturing, and recent quality-control scrutiny is driving significant improvements in the manufacturing standards.

The contract development segment is the fastest growing. This is primarily because pharmaceutical and biotech corporations outsourced the service to CDMOs.

Based on end-users, the global large molecule drug substance CDMO market forecast has been further divided into Contract Research Organizations (CROs), biotech companies, and others. The biotech companies end-user segment dominated the global market. The significant share of this market may be ascribed to rising disease frequencies for which many biotech businesses are doing intensive research, as well as increased spending in research and development in the biopharmaceutical industry. In addition, mergers and acquisitions, geographical growth, service portfolio expansions, and affordable pricing are essential methods biotech companies use to stay strong and increase their market share.

The clinical research organization (CRO) segment is fragmented into discovery, preclinical, clinical, and laboratory services. Clinical trial services in the CRO segment also witnessed significant CAGR during the forecast period. The increased demand for efficient treatments and the growing number of goods under development are related to this. The need for clinical trial services is also projected to increase due to rising R&D spending and expanding cooperation among top pharmaceutical companies to outsource clinical trials, which will further boost the growth of the CDMO market.

The other end-user segment is the fastest growing. This segment includes government & research institutes, pharma companies, and academic institutes. Big pharma businesses are increasingly more concerned with large molecules than small ones, driving the category growth. Previously, pharmaceutical companies focused on tiny molecules while biotechnology companies focused on large molecules.

Based on sources, the global large molecule drug substance CDMO market trends has been further categorized into mammalian, microbial, and others. The mammalian source segment dominates the global market and is the fastest-growing. As more complicated biologics, like bi- and tri-specific antibodies and antibody-drug conjugates, develop, this category will grow. Due to their efficiency in treating various illnesses, including cancer, mAbs, and their synthetic analogs have attracted a lot of investment.

The microbial source segment is the second-largest segment. The health and well-being of humans have greatly benefited from microbes. They can produce secondary metabolites, which account for 50% of the medications available on the market. Some of the most significant pharmaceutical compounds have been created by microorganisms, which are a rich source of bioactive chemical metabolites. In addition to treating bacterial, viral, and fungal illnesses, secondary metabolites from microorganisms are already employed for various purposes. For instance, immunosuppressants have revolutionized medicine by making organ transplantation possible. One of the most effective cancer chemotherapy drugs is a microbial metabolite. Such variables aid in segment expansion.

Recent Developments

• April 2022 - ChimeronBio announced that it had signed a manufacturing agreement with FUJIFILM DiosynthBiotechnologies (FDB) to advance its Oncology portfolio to include clinics. ChimeronBio opted for FUJIFILM DiosynthBiotechnologies as its partner for transferring and scaling its drug substance manufacturing process.
• January 2022 - Samsung Biologics signed an agreement with Biogen to acquire Biogen's 50% stake in Samsung Bioepis, a joint venture formed by the two companies, for up to USD 2.3 billion. The complete buyout of Biogen's stake by Samsung Biologics is anticipated to strengthen Samsung Bioepis' biosimilar development capabilities and future performance in new drug development.
• April 2022 - Samsung Biologics announced that it had completed the purchase of Biogen's stake in the Samsung Bioepis joint venture for USD 2.3 billion. With the completion of the first payment of USD 1.0 billion under the terms of the acquisition agreement, Samsung Biologics has now fully acquired Samsung Bioepis as a wholly-owned subsidiary. The remaining USD 1.3 billion will be made in instalments over two years.
• December 2021 - Moderna, a biotechnology company, is pioneering messenger RNA (mRNA) therapeutics and vaccines, announced that the Ministry of Food and Drug Safety of Korea (MFDS) had issued a marketing authorization for Spikevax®, Moderna's COVID-19 vaccine (mRNA-1273) manufactured by Samsung Biologics, a leading global CDMO providing fully integrated end-to-end contract development and manufacturing services.