Contract pharmaceutical manufacturing organizations are involved in performing several kinds of research and drug production activities for various pharmaceutical companies. Presently, there is a large need for pharmaceutical contract manufacturing and research, as drug companies face increased costs for manufacturing and research due to various old drug patents expiration, drug industry competition, along with stringent regulations by government for novel drug development. Pharma manufacturers are able to decrease manufacturing and R&D costs through outsourcing of several processes which previously were carried out in-house, right from the studies of initial drug research to the complete manufacturing procedure.
The global contract pharmaceutical manufacturing market size is estimated to be accounted for US$ 127.9 billion in 2018, and is projected to exhibit a CAGR of 9.3% during the forecast period (2018–2026).
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Contract manufacturing organizations (CMOs) provides pre-formulation, stability studies, formulation development, method development, materials of clinical and pre-clinical phase trials, materials for late-stage clinical trials, registration, scale-up, along with commercial drug productions. For instance, as per the 2016 report from Outsourcing Resources Supplement to Pharmaceutical Technology, over 80% of the U.S. Food and Drug Administration (FDA) approved products representing small pharma or biotechnology firms are contract manufactured, while 50% of the mid-size companies sponsored products (US$ 500 Mn – US$ 5 Bn in revenues) uses CMO for manufacturing its products. The Contract research organizations (CROs) provide effective services for the biotechnology and pharmaceutical organizations by decreasing time and cost required to perform clinical trials.
Increasing requirements for outsourcing the manufacturing of small molecules in expected to drive the global contract pharmaceutical manufacturing market growth during the forecast period. Small molecule demand is notably high as compared with large molecules, due to its several advantages within clinical trials and manufacturing. For instance, as per the 2017 report from Cambrex Corporation, pharmaceutical industry is dominated by the small molecules, with 34 new small molecule entities receiving approval from the U.S. Food and Drug Administration (FDA) in 2017, which is the last decade’s highest number. Moreover, small molecules could be engineered for delivering strong therapeutic effects with little dose, less than 10 mgs and even in μg (micrograms).
Moreover, as per the October 2015, BioPharm International Journal published data, in 2014 the small-molecule pharmaceuticals valued for 82% of the entire approvals for new drug application (NDA) and 60% of the entire new molecular entities. Moreover, it represented around 66% of the pipeline of drug development. Contract manufacturing firms act as the site of additional manufacturer in company’s network of multiple site supply, offering backup capacity along with rising supply security.
Around 50% of the outsourced commercial manufacturing revenue is attributed for the manufacture of drug product, which includes majorly oral solid dosage (OSD). The oral medications compared with injections are more convenient to patients. Furthermore, key pharmaceutical players majorly outsource capabilities of production through firms of contract manufacturing through shifting the economic burden and risk to update machinery changes and raw material within a new product’s manufacturing faculty.
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Generic drug developments provides opportunities for companies, as there is increasing demand for inexpensive pharmaceuticals in consumers. Treatments of patients with chronic disease using generic drugs are expected to continue with their drug therapies and get refilled prescriptions than using the branded drugs. Furthermore, emerging markets, expiring patents, increasing elderly population, rising chronic diseases prevalence, and the healthcare service providers and governments efforts have contributed in the increased acceptance and use of the generic drugs. This rising generic drugs demand is expected to offer conducive growth opportunities for organizations of contract pharmaceutical manufacturing, over the forecast period.
Moreover, acceptance of novel technologies of manufacturing, growing competition, along with shrinking margins of profit has compelled pharmaceutical companies for outsourcing its manufacturing processes including R&D of drugs to the contract manufacturing organizations (CMO) and contract research organization (CRO), for staying competitive within the market.
Generic drugs outsourcing offers significant benefits when the production is done to supply multiple costumers (parent generic organization) having the similar active pharmaceutical ingredient (API). Furthermore, rising expiration of patents and firms of originator product manufacturing increasingly preferring for contract research companies to conduct clinical trials is expected to register growth in the segment of API small molecule for manufacturing generics.
However, regulatory concerns associated with processes of contract manufacturing are expected to hinder growth of the global contract pharmaceutical manufacturing market over the forecast period. Furthermore, increasing number of facilities of Food and Drug Administration (FDA) inspections of foreign manufacturing are uncovering increased volatile operations. Regulatory notices have been issued by the U.S. Food and Drug Administration (FDA) regarding practices of volatile production along with inappropriate quality control to CMOs and CROs. For instance, Dr. Reddy’s Laboratories, in November 2016, received the U.S. FDA warning letter, covering two facilities, that manufacture APIs at Miryalaguda (Telangana) and Srikakulam (Andhra Pradesh), and a at Duvvada (AP) facility in India manufacturing cancer products. For avoiding the Food and Drug Administration (FDA) warnings or further losses, manufacturers are needed to make sure that their drugs are manufactured in accordance to the regulations from Food and Drug Administration (FDA) ensuring product quality, safety, identity, purity and strength.
Among regions, Asia Pacific is expected to register robust growth within the global contract pharmaceutical manufacturing market, due to expanding infrastructure for healthcare, low operational costs for clinical trials, manufacturing and research, and skilled scientific staff availability.
Moreover, administrative process outsourcing of manufacturing and research, to players within emerging economies, specifically BRIC (Brazil, Russia, India, and China) could substantially decrease time required for conducting clinical researches and manufacturing, along with reducing economic expenses. Moreover, within this region outsourcing often provides access to larger patient populace with faster enrollment and a short trial timeline in general from starting till finish. This in turn will increase adoption for services of contract pharmaceutical manufacturing’ within the region over the forecast period.
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Key players functioning in the global contract pharmaceutical manufacturing market include Accenture plc, ATOS SE, Cognizant Technology Solutions, Catalent, Inc., Boehringer Ingelheim GmbH, Covance, Inc., Genpact Limited, PAREXEL International Corporation, Lonza Group, Quintiles Transnational Corporation, Baxter International Inc., Abbvie, Inc., Dr. Reddy’s Laboratories Ltd., Pfizer, Inc., Aurobindo Pharma, The Almac Group, Piramal Enterprises Ltd, and Teva Pharmaceutical Industries Ltd.
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Table of Content
Global Contract Pharmaceutical Manufacturing Market Research Report
Section 1: Global Contract Pharmaceutical Manufacturing Industry Overview
Section 2: Global Economic Impact on Contract Pharmaceutical Manufacturing Industry
Section 3: Global Market Competition by Industry Producers
Section 4: Global Productions, Revenue (Value), according to Regions
Section 5: Global Supplies (Production), Consumption, Export, Import, geographically
Section 6: Global Productions, Revenue (Value), Price Trend, Product Type
Section 7: Global Market Analysis, on the basis of Application
Section 8: Contract Pharmaceutical Manufacturing Market Pricing Analysis
Section 9: Market Chain, Sourcing Strategy and Downstream Buyers
Section 10: Strategies and key policies by Distributors/Suppliers/Traders
Section 11: Key Marketing Strategy Analysis, by Market Vendors
Section 12: Market Effect Factors Analysis
Section 13: Global Contract Pharmaceutical Manufacturing Market Forecast
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