Market Introduction

A contract research organization (CRO) also known as a clinical research organization, is an organization that provides services to pharmaceutical, biotechnology, and medical device companies. The services provided by CRO include drug discovery, preclinical research, clinical research, clinical trials management, commercialization, pharmacovigilance, and post-approval services. Contract development and manufacturing organization (CDMO), is a company that serves healthcare companieson a contract basis to provide comprehensive services from drug development through drug manufacturing. By combining a CRO and CDMO business model, the result is a full-scale Contract Research, Development and Manufacturing (CRDMO)that provides a fully integrated suite of end-to-end solutions for discovery, development, and manufacturingto meet all future market demands.

Market -Headwinds & Tailwinds

The growing trend of big pharma companies outsourcing to CRDMOs, growth of small molecules, increasing API complexities, need to optimize costs, regulatory expertise, lack of internal manufacturing capabilities among small biotech companies, the prevalence of chronic diseases, intensifying competition among pharmaceuticals & biopharmaceuticals companies, strong product pipelines, rising demand of precision medicine, industry consolidation and rising collaborations among CRO/CDMOs & pharmaceuticals companies are some of the pivotal factors propelling the growth of the Contract Research, Development, and Manufacturing (CRDMO) market. However, the capacity constraint is likely to hinder the growth of the market to a certain extent.

Market Segmentation& Insights

The global CRDMO market has been analyzed fromtwo main perspectives:Service Typeand Region.

Contract Research, Development, and Manufacturing (CRDMO) Market, By Service Type

Based on Service Type,the global CRDMO market has been segmented intoCDMO services and CRO Services. The CDMO services are further categorized into API Manufacturing, Finished Product Development &Manufacturing, and Packaging. Whereas, CRO Services are further categorized into Discovery, Preclinical, Clinical, and Laboratory Services. The CDMO services hold the largest share in the market. The growth of the market can be attributed to patent expiry and rising demand for generic drugs. Companies are increasingly outsourcing API manufacturing as it requires special expertise and large capacities.

Contract Development and Manufacturing (CDMO)Market,By Region

Based on Region, the global CRDMO market has been segmented into North America, Europe, Asia Pacific, and the Rest of the World (ROW). North America dominated the CRDMO market, followed by the Asia Pacific. The large share of North America in the global market can be largely attributed to rising cancer incidence, developed healthcare infrastructure, presence of prominent pharmaceutical & biopharmaceutical companies, rising investment in R&D, robust product pipeline,favorable regulatory policies, and rising adoption of outsourcing as a cost-cutting measure.

Competitive Landscape

The CDRMO market is marked by the presence of prominent players such as Thermo Fisher Scientific, Catalent, Inc, Lonza, Recipharm AB, AbbVie Inc, Almac Group, Evonik, WuXi AppTec, Samsung Biologics, Corden Pharma International, Syneos Health, Parexel International Corporation, IQVIA, Labcorp Drug Development, Charles River, ICON plc, PPD Inc., Bioduro-Sundia, Eurofins Scientific, Curia Global, Inc., among others.

Snapshot: Industry Developments

• In Feb 2022, CordenPharma, announced the completion of the acquisition of three manufacturing facilities from Vifor Pharma, to be ultimately renamed Corden Pharma Fribourg S.A. (including its Ettingen branch) in Switzerland, and Corden Pharma Lisbon S.A. in Portugal

• In Feb 2022, Piramal Pharma, an Indian CDMO, is expected to invest 55 million pounds sterling ($74.4 million) to expand its antibody-drug conjugate (ADC) and active pharmaceutical ingredient (API) manufacturing facilities in the U.K.

• In Dec 2021, China-based WuXi STA, a subsidiary of WuXi AppTec, and Coherent Biopharma, signed a strategic partnership agreement.According to the agreement, WuXi STA will become the preferred contract development and manufacturing organization (CDMO) partner and provide Coherent Biopharma with integrated Chemistry, Manufacturing, and Controls (CMC) servicesto accelerate its present and future drug candidates from API to drug product

• In Dec 2021, Bora Pharmaceuticals announced a partnership with Taishin Healthcare Limited at the 2021 Biotech Investor Forum. Both the companies will jointly invest up to NT$3 billion (approx. US$108 million) to target forward-looking contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs), in response to the development trend that is taking place worldwide

• In Dec 2021, Adare Pharma Solutions ("Adare"), announced the acquisition of Frontida BioPharm ("Frontida"), a vertically integrated CDMO focused on the oral formulation to expand leading CDMO offerings

• In Dec 2021, SGS, the Swiss-based (TIC) Testing, Inspection, and Certification company acquired Quay Pharma, a contract development and manufacturing organization (CDMO). The acquisition provides Quay with the investment to further grow its range of services and capabilities

• • In Sept 2021, ten23 health, a globally operating contract development and manufacturing organization (CDMO), announced its launch. The company supports biotech start-ups and established pharmaceutical customers in developing safe injectable biopharmaceutical drugs for patients

• In Sept 2021, German active pharmaceutical ingredient (API) maker PharmaZell and France-based Novasep, a CDMO entered into exclusive negotiations to create a leading European platform in the attractive API manufacturing and CDMO space with a complementary set of differentiated technologies and a highly diversified base of blue-chip pharma and biotech customers

• In Aug 2021, Recro Pharma, Inc. signed a non-binding letter of intent ("the LOI") for its acquisition of the "Target"full-service CDMO with capabilities that range from formulation development to commercial manufacturing for various dosage forms including oral liquids, sterile injectables, tablets, topicals, liquid/powder-filled capsules, ophthalmic droppers, liposomes, and nano/microparticles

• In Aug 2021, Recro Pharma, Inc., a contract development and manufacturing organization (CDMO) specializing in oral solid dose drug products, acquired fellow CDMO IRISYS. The acquisition was aimed to expand Recro's technical focus beyond oral solid dose drug products and establish a bi-coastal presence in the U.S.

• In Mar 2021, ANI Pharmaceuticals, Inc. signed a definitive agreement to acquire Novitium Pharma, a privately held, New Jersey-based pharmaceutical company with development, manufacturing, and commercialization capabilities. The acquisition willstrengthen its R&D engine and expand generics and CDMO business

Key InsightsCaptured in the Report

•  Quantitative (market size and forecasts) and qualitative insights of the market across years - historical years, current year, and forecasted years

• Deep-rooted insights on headwinds, tailwinds, and opportunities prevailing in the market

• Quantitative (market size and forecasts) and qualitative insights at a segment and sub-segment level

• Comprehensive quantitative (market size and forecasts) and qualitative insights on geographic, regional, and country-level markets

• Granular insights on the competitive landscape prevailing in the market

• Competitive mapping of strategic developments