Pharmaceutical Contract Manufacturing Global Market estimated to be worth $120.1 billion by 2027
Small molecule drugs are organic compounds with defined chemical structures and molecular weights typically ranging from 500 to 900 Daltons. Unlike biologics, these compounds can easily diffuse across cell membranes to reach intracellular sites and are designed to modulate a specific target that controls the biological processes associated with a specific disease.
The manufacturing of Pharmaceutical products includes active pharmaceutical ingredients (APIs) and finished dosage form (FDF). Active pharmaceutical ingredient (API) is any substance or combination of substances used in a finished pharmaceutical product (FPP), with pharmacological activity and has direct effect in the cure, mitigation, treatment of the disease, or has direct effect in restoring, correcting, or modifying physiological functions in human beings. API manufacturing involves the conversion of key starting materials or raw materials like fine chemicals and intermediates into active ingredients, which will be used for the formulation of drug products. Whereas, finished dosage form is a combination of API and excipients. Some of the types of finished dosage forms are solids (tablets, capsules, powders, and granules), injectables (injectable solutions, suspensions, and emulsions), and semisolids, liquids (syrups and solutions for oral use), and gaseous dosage forms (inhalants and sprays).
Traditionally, pharmaceutical products were manufactured by pharmaceutical companies and were maintained as in-house activity. Over the period, as the industry becomes a matured, pharmaceutical company started to look out for additional manufacturing capacity to meet the ever rising demands of the market. This created an opportunity for CMOs to establish in the industry and play a crucial role in the pharmaceutical manufacturing process.
The pharmaceutical contract manufacturing global market is expected to grow at a single digit CAGR from 2020 to 2027 to reach $120,124.7 million by 2027. Increased trend of outsourcing, high uptake of small molecules drugs across diverse therapeutics, patent expiration of small molecules, advanced technologies in API and FDF manufacturing, increasing deals and investments, increased demand for generic injectables, increasing incidence and prevalence of chronic diseases, and increase in geriatric population are some of the factors driving the market growth. However, contamination of pharmaceutical products (API and FDF), pricing pressure for pharmaceutical contract manufacturing, requirement of highly skilled technicians, increasing biologics approvals and adoption in disease management, stringent regulatory policies, and environmental concerns are some of the factors that are hindering pharmaceutical contract manufacturing global market growth.
The global pharmaceutical contract manufacturing is segmented based on product, phase, therapeutic application, and geography. Based on the product, the market is segmented into API manufacturing (Generic and Branded) and FDF manufacturing (Solid Dosage form, Injectables, semisolid, liquid, and gaseous dosage form). Based on the phase, the pharmaceutical contract manufacturing global market is segmented into commercial manufacturing and clinical manufacturing. Based on therapeutic application, the pharmaceutical contract manufacturing global market is segmented into infectious diseases, oncology, cardiovascular disorders, central nervous system, pulmonary disorder, gastrointestinal disorder, endocrine disorders, metabolic disorders, genito-urinary disorders, musculoskeletal disorders, and others such as others such as ophthalmology, autoimmune diseases, ENT, dental, dermatology, and pain management. The pharmaceutical contract manufacturing global market by geography is segmented into North America, Europe, Asia-Pacific and the Rest of the world (RoW).
The promising future of pharmaceutical contract manufacturing is further substantiated in the report through several IQ4I analyses of the production volume, patent analysis, API average selling price (ASP), production of controlled substances, company capabilities, acquisitions, collaborations, expansions, ANDA approvals, patent expiry data of key drugs, impact of COVID-19 in the supply chain and the production of drugs, FDA approved manufacturing facilities, drug master filings, and company matrix tables.
During 2020 - 2021 majorities of the ANDA approvals received by generic API manufacturers were focused on therapeutic areas like infectious diseases, musculoskeletal disorder, cardiovascular disorders, CNS, metabolic disorder and oncology. Among these, drugs approved for treating infectious disease accounted for 14.3% of the total ANDA approved generics.
To increase their market reach and to perpetuate their leading position in the market, pharmaceutical contract manufacturing companies have adopted the strategies of launching of novel drugs and manufacturing services with modified formulation and manufacturing technology through collaborations or partnerships, up-scaling of their pharmaceutical products, agreements, and acquisitions. The pharmaceutical contract manufacturing market is fragmented with the top 7 players occupying minor share of the global market. Some of the top players are Lonza Group (Switzerland), AbbVie Inc. (AbbVie contract manufacturing, U.S.), Thermo Fisher Scientific (Patheon, N.V., U.S.), Pfizer Inc. (Pfizer CentreOne, U.S.), Permira Funds (Cambrex Corporation, U.K.), Carlyle Group (Albany Molecular Research Inc. U.S.), WuXi AppTec (WuXi STA pharmaceuticals, China), Recipharm AB (publ) (Sweden), Aenova Group GmbH (Germany), China Resources Pharmaceutical Group Limited (China), and others.