The Global Pharmaceutical Contract Development Market is estimated to reach USD 258.3 billion by 2028 from USD 176.5 billion in 2023, at a CAGR of 7.9% during the forecast period. The growth of this market is mainly driven by the increased adoption of outsourcing drug development & manufacturing by pharma companies. Furthermore, the escalating cost of in-house drug development and increased demand for generics coupled with the looming patent expiry of blockbuster drugs is likely to uplift market growth in coming years.
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Pharmaceutical manufacturing services accounted for the largest share of the service segment in the pharmaceutical contract development and manufacturing market in 2022.
Based on service, the pharmaceutical contract development and manufacturing market is broadly segmented into pharmaceutical manufacturing services, drug development services, and biologic manufacturing services. In 2022, pharmaceutical manufacturing services accounted for the largest share of the pharmaceutical contract development and manufacturing market for service. This segment’s large share can be attributed to factors such as growing investments in developing novel therapies & pharma research. Further, growth in the pharma outsourcing trend is supported by the increased demand for lower-cost alternatives, which is likely to support the market growth.
The pharmaceutical API manufacturing services accounted for the largest share of the type segment in the pharmaceutical contract development and manufacturing market in 2022.
Based on type, the pharmaceutical manufacturing services is categorized into two sub-segments—pharmaceutical API manufacturing services and pharmaceutical FDF manufacturing services. In 2022, pharmaceutical API manufacturing services accounted for the largest share of the pharmaceutical manufacturing services segment. Factors such as the demand for API manufacturing are growing due to the looming patent expiries in several countries. Furthermore, pharma companies have shown a growing focus on conducting core activities that have pushed them to outsource API manufacturing.
Pharmaceutical Contract Manufacturing Market Dynamics
DRIVER: High cost of In-House drug development is likely to propel the market growth
Drug discovery and development is higly expensive and time-consuming process for small and medium-sized pharmaceutical companies. However, pharmaceutical companies opt for a cheaper and efficient solution, i.e., to outsource their drug development processes to contract development and research organizations.
Also, drug development requires following stringent US FDA guidelines and maintaining quality and standards while developing formulations. This increases the in-house drug development and manufacturing cost of the formulation. Thus, the continuously increasing drug development costs, influenced by the costs of discovery & pre-clinical development, clinical development, capital, shortage of funds, and high failure rates for drugs tested on human subjects, pushed pharmaceutical companies to outsource their drug development processes to contract development and manufacturing organizations.
RESTRAINT: Varying regulatory requirements across regions
Noncompliance of guidelines and regulations by the respective authority and inferior quality of manufactured drugs brings serious consequences to the business and the brand name. Hence, compliance with regulatory guidelines is paramount in the pharmaceutical industry. For CDMOs, the drug substance/formulation manufactured on a contract basis is sold under the contractor’s brand. That requires large amounts of data to be submitted to the regulatory authority as the drug moves through phases of development and clinical trials. Hence, the handling of the data and submissions of different formulations across various countries becomes difficult for CDMOs and increases the risk of errors in regulatory filings. This factor will likely hamper the market growth of pharmaceutical CDMOs in the coming years.
OPPORTUNITY: Emerging markets
Emerging countries are bioprocess outsourcing hubs due to their cost advantages and workforce. Moreover, the increasing interest of pharmaceutical companies in drug discovery outsourcing due to the ever-increasing demand for vaccines, drying antibiotics pipelines, and rising R&D costs further fuel the growth of pharmaceutical contract development and manufacturing services in emerging markets. Likewise, advanced manufacturing technologies and the low manufacturing cost, low labour cost offered by emerging countries are supporting market players to invest in developing markets like Asia Pacific during the forecast period. Due to these factors, emerging markets such as India and China are expected to provide significant opportunities for the growth of the pharmaceutical contract manufacturing and development market in the coming years.
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Opportunities: Growing demand for cell and gene therapies
Given the personalised nature of cell and gene therapies, they are highly specific and hold the potential to address unmet medical needs associated with treating several disorders. Their promising therapeutic potential has led many pharmaceutical companies and investors to put a significant amount of capital towards developing and commercialising these therapies. As of February 2020, nine cell and gene therapies have been approved by the US FDA. In 2020, around 362 cell and gene therapies were under clinical development. The growing number of cell therapy candidates, coupled with their rapid progression through the various phases of clinical development and their complex manufacturing process, increases the demand for facilities that offer manufacturing services for these therapies.
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Key Market Players
The global pharmaceutical contract development and manufacturing market is highly consolidated. Key players in the pharmaceutical contract development and manufacturing market include Thermo Fisher Scientific Inc. (US), Catalent, Inc. (US), Lonza Group Ltd. (Switzerland), Recipharm AB (Sweden), AbbVie Inc. (US), Aenova Group (Germany), Almac Group (UK), Siegfried Holding AG (Switzerland). Acquisitions and product launches are the key growth strategies undertaken by these companies to maintain their positions in the market.
Asia Pacific is likely to grow at the highest growth rate during the forecast period.
Based on the region The global pharmaceutical contract development and manufacturing market is segmented into North America, Europe, the Asia Pacific, Latin America, and the Middle East & Africa. North America is the largest regional segment. The Asia Pacific region is estimated to grow at the highest CAGR in the pharmaceutical contract development and manufacturing market during the forecast period. The growth of the pharmaceuticals and biopharmaceuticals market in the region is primarily driven by the rising prevalence of chronic disease conditions, the presence of a large number of CDMOs in the region, and significant investments in pharmaceutical R&D.
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