Global Orphan Drugs CDMOs Market Size, Share, Growth Opportunities, Trends, Investments & SWOT Analysis by 2027 - Novartis AG, Roche, Celgene, Bristol-Myers, Sanofi, Bayer, Doppel, LLS Health

Orphan drugs are designed to address various medical conditions thus impacting a relatively small population, typically fewer than 200,000 individuals in the United States or a similarly low prevalence in other countries. Orphan Drugs CDMOs offer a broad range of services, including drug formulation, process development, clinical trial materials manufacturing, and commercial-scale production. They work closely with pharmaceutical companies and biotech firms to bring orphan drugs to the global market.

Growing Orphan Drugs CDMO Market: Addressing Unmet Medical Needs for Rare Diseases

The Orphan Drugs Contract Development and Manufacturing Organizations (CDMOs) market is poised for a significant growth due to growing investments in therapies for rare diseases. This growth is being fueled by the global orphan drug CDMOs market, which is motivated by unmet medical needs and regulatory incentives, thus making it an appealing sector for CDMOs.

For instance,

In February 2023, AskBio, which is a subsidiary of Bayer AG, announced today that the European Commission (EC) has granted orphan drug designation to AB-1003, also known as LION-101*. This designation is for the purpose of treating limb-girdle muscular dystrophy (LGMD). AB-1003 represents a groundbreaking investigational gene therapy based on recombinant adeno-associated virus (AAV) and is currently in development as a one-time intravenous (IV) infusion.

In US, more than 30 million people are affected by over 7,000 uncommon diseases, many of which are life-threatening and lack effective medical treatments. The development of drugs, biologics, and medical devices for these rare diseases is challenging due to their complex biology and limited understanding of their natural progression. Given the critical nature of orphan drugs and their often-complex manufacturing processes, maintaining high quality and compliance with regulatory standards is paramount. Outsourcing is frequently employed in the manufacturing of orphan drugs to CDMOs which provide quality control systems to meet these requirements. Orphan drugs typically cater to relatively small patient groups, necessitating the creation of smaller batches for clinical and commercial use. Consequently, producing orphan drugs demands flexibility in both batch size and process design, making outsourcing a favored choice.

Major Factors Driving the Rapid Growth of the Orphan Drugs CDMO Market

The rapid growth of the orphan drugs CDMO market is shaped by many factors that contribute to the growing patient population looking out for rare disease treatments. To begin with, there has been a significant rise in the accuracy of rare disease diagnoses due to fast advancements in medical diagnosis and heightened awareness, which has created a larger demand for orphan drugs. Also, governments across the world have implemented legislation which offers pharma companies' many incentives, including extended market exclusivity and tax benefits, thus encouraging them to develop treatments for rare diseases. Furthermore, the global population's growth means that even rare diseases can affect a substantial number of individuals, thus contributing to the expansion of the orphan drugs CDMOs market. Moreover, the emergence of precision medicine and genomics has allowed for more precise rare disease diagnosis and treatment, further intensifying the need for customized orphan drugs.

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Collaborations between patient advocacy groups, pharmaceutical companies, and research institutions has resulted in increased research funding and enhanced drug development efforts. The globalization of healthcare services has made rare disease treatments more accessible to patients, thus expanding the potential orphan drugs CDMOs market.

For instance,

In September 2022, Sanofi received FDA clearance for Xenpozyme, an enzyme replacement therapy for acid sphingomyelinase deficiency (ASMD) without central nervous system involvement. Xenpozyme is the FDA-approved drug sanctioned for addressing non-CNS ASMD symptoms in both children and adults in USA.

Key Market Challenges Impacting the Orphan Drugs CDMOs Market Growth

The global orphan drugs CDMOs market has a significant and a vast growth potential but it also faces challenges such as limited availability of essential ingredients (API), lengthy formulation development processes, and the necessity for dependable small-scale manufacturing.

North America Holds the Largest Market Share in the Orphan Drugs CDMOs Market

The global orphan drugs CDMOs market is growing rapidly, with a strong presence in North America where many pharmaceutical companies and biotech firms are headquartered. The region's dominance can be attributed to many key factors such as growing patient population, favourable regulatory policies and the presence of leading market players in the region.

The Asia-Pacific region is also anticipated to witness a rapid growth during the forecast period. The rising awareness of rare diseases, surge in the number of clinical trials, and growing adoption of orphan drugs are some of the major factors which may drive the orphan drugs CDMOs market growth in this region.

Competitive Landscape Analysis: Global Orphan Drugs CDMOs Market

Some of the key players operating in the global orphan drugs CDMOs market are Novartis AG, F. Hoffmann-La Roche Ltd, Celgene, Bristol-Myers Squibb Company, Sanofi, Bayer Healthcare, Doppel and LLS Health, among others.

Aggressive and Efficient Growth Strategies Adopted by the Leading Market Players to Establish Their Foothold in the Orphan Drugs CDMOs Market

All key players operating in the global orphan drugs CDMOs market are adopting both organic and inorganic growth strategies such as partnerships and collaborations, new product launches and acquisitions of other companies to garner a higher market share.

For instance,

In December 2020, AGC Biologics unveiled its collaboration with Laboratoire Pierre Fabre for the production of ER-004 which is an intra-amniotic drug that is expected to revolutionize the treatment of a rare and incapacitating genetic condition. The role of AGC Biologics is to manufacture GMP material to support the upcoming phase of clinical trials.

The global orphan drugs CDMO market is set to gain a consistent momentum in the upcoming years due to growing number of orphan diseases, positive government policies such as longer marketing for orphan drugs, and aggressive and efficient growth strategies adopted by the leading market players.

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Ruta Halde
Associate, Medi-Tech Insights
+32 498 86 80 79
info@meditechinsights.com
https://meditechinsights.com/

Medi-Tech Insights is a healthcare-focused business research & insights firm. Our clients include Fortune 500 companies, blue-chip investors & hyper-growth start-ups. We have completed 100+ projects in Digital Health, Healthcare IT, Medical Technology, Medical Devices & Pharma Services.

This release was published on openPR.