Oral Solid Dosage Contract Manufacturing Market Size, Share & Trends Analysis Report By Product Type (Tablets, Capsules), By Mechanism (Controlled-, Immediate-release), By End-user, By Region, And Segment Forecasts, 2022 - 2030

Report Overview

The global oral solid dosage contract manufacturing market size was valued at USD 31.9 billion in 2021 and is anticipated to exhibit a compound annual growth rate (CAGR) of 6.0% over the forecast period. An increase in the advancement of drug delivery technology, such as targeted drug delivery and sustained release dosage forms, rising investments by CDMOs to expand the oral solid dosage (OSD) development and increasing demand for novel therapies drive the market growth. Oral dose pharmaceutical products are highly improbable to be replaced with new technologies anytime in the near future. The expansion of solid dose pharmaceutical manufacturing is driven by new solid dose formats and increased efficiency.

According to an article published in Pharma Manufacturing, tablets would be the preferred solid dosage form, with estimated sales of more than USD 500,000 by the end of 2027. There were 24 solid dose tablets and 7 capsule solid dose forms among the 59 new molecular entities approved in 2018. Catalent recently completed a USD 1.2 billion regenerative medicine partnership with Paragon Bioservices, and the company is already investing USD 40 million to increase tablet and capsule controlled-release capacity. Metrics Contract Services invested USD 80 million in a new OSD pharmaceutical manufacturing facility in North Carolina in 2018. However, the pandemic had a positive impact on the market.

In 2021, small molecules accounted for 72% of newly approved drugs, and nearly 50% of new drugs approved were OSD. As the world engrossed itself in the possibility of vaccine therapy in 2021, another treatment of OSD small molecule products, such as azithromycin and hydroxychloroquine, demonstrated promising results. These OSD products, designed to treat fewer common diseases, such as malaria, also find themselves in the spotlight as their efficacy against COVID-19 symptoms becomes known. Small molecules, capsules, tablets, gummies, effervescence, soft gels, and pills are all OSD forms, which refer to a final drug product therapy that is consumed through the mouth, dissolved in the digestive system, and delivered to the body via absorption into the bloodstream.

There are three major reasons for the dominance of OSD. It is relatively simple to administer, it is simple to differentiate one OSD product from another, and OSD manufacturing approaches are well developed.The overarching objective of OSD processing, regardless of product type, is to establish a formulation that helps ensure that each dose is consistent. Each has a repeatable distribution of ingredients, as well as uniformity in dissolution and bioavailability, to verify that the drug product is safe and effective.

Tier 1 players such as AbbVie Contract Manufacturing, Patheon (Thermo Fisher Scientific), Piramal Enterprises, Capsugel (Lonza), Catalent Inc., Siegfried AG, NextPharma, Recipharma AB, Piramal Pharma Solutions, Aurobindo Pharma Ltd., and CordenPharma, account for nearly 63% of the global market, while tier 2 and 3 represent approximately 12% & 25% of the total market share. Furthermore, contract manufacturing is the primary business of approximately 64% of OSD contract manufacturing firms. According to the Patheon director, oral delivery of new drug candidates, solid dose manufacturing, a new formulation of existing molecules, controlled release dosage forms, fixed-dose combinations, and other life cycle management strategies would then maintain their importance and market share.

Product Type Insights

The tablets segment dominated the OSD contract manufacturing market in 2021 and accounted for the largest share of 32.7% of the global revenue. Tablets are the most common OSD form. This form contains an Active Pharmaceutical Ingredient (API), which is also known as a dry powder ingredient and a drug substance. Compression is used to form tablets, which can be coated or uncoated. The pharmaceutical companies have a preference for tablets as they are simple to make, package, & transport, have good physical & chemical stability and allow for simple and accurate dosing. Various coating processes supposedly enable them for the adjustment of API release profiles, and also for the cosmetic modification of tablet color and shape. In addition, sugar-free gummies made from fruit and plants are gaining popularity in developed countries.

Europe remains a key market for soft gelatin capsules. The capsules segment is expected to register the fastest CAGR over the forecast period and is the second-most lucrative dosage form in the market.Capsules are a widely known oral dosage formulation that is common among both pharmaceutical companies and consumers. While buyers comprehend the tasteless and easy-to-take capsules, the pharmaceutical industry appreciates the streamlined development timelines and manufacturing simplicity. They are solid preparations that contain drug substance(s) and/or excipients within a soft or hard soluble shell. The shell is typically made of gelatin or another appropriate polymeric material, resulting in a simple, tasteless, odorless, elegant, and easy-to-swallow dosage form that does not require a second coating step.

Mechanism Insights

Based on mechanisms, the market has been categorized into Immediate-release, delayed-release, and controlled-release. The controlled-release mechanism segment accounted for the maximum revenue share of the global market of more than 51.5% in 2021. The segment is also anticipated to register the fastest growth rate during the forecast period. Controlling the rate and/or location at which an API is released allows drug designers to develop medicines that are softer on patients while remaining effective. Controlling the release of the API excludes fluctuations in drug plasma levels, which usually results in fewer side effects, and it also allows for a decline in the number of doses required per day.

An Ideal controlled-release product allows administration once per day for oral treatments no less than once per week up to every six weeks for parenteral treatments. Controlled-release dosages are also simple to swallow or administrate, inexpensive, stable at room temperature for at least two years, and simple to pack and ship. A well-formulated controlled-release formulation is intended to release the drug consistently and reliably at a predetermined release rate and at the optimized site of absorption for its activity.

End-user Insights

The large size companies segment led the OSD contract manufacturing market in 2021 and accounted for the maximum share of more than 54.5% of the global revenue. Large pharmaceutical companies outsource OSD manufacturing.Quality and reliability are consistently taking the top two positions, but priorities diverge from there. Big pharma ranks productivity second, followed by regulatory, affordability, and innovation. With different reasons for outsourcing, the large pharma companies have differently preferred CMOs for OSD manufacturing. Next Pharma and Catalent, on the other hand, rank in the top three in two buyer categories.

Boehringer Ingelheim, Next Pharma, and AMRI are Big Pharma’s preferred CMOs in descending order. The medium- & small-size companies segment, on the other hand, is poised to witness significant growth over the forecast period. The high growth of the segment is majorly due to the increasing number of small- and medium-sized companies outsourcing their production work to contract manufacturers. The outsourcing of drug manufacturing is a popular option for many medium- to small-scale drug developers that may not incorporate the essential infrastructure to develop small molecule APIs and reference standards. Such organizations can fast-track development and reduce their R&D costs by outsourcing the production work to CMOs.

Regional Insights

Asia Pacific is projected to be the fastest-growing regional market with a CAGR of 6.4% over the forecast period. The region also accounted for the largest market share in 2021. India and China are OSD CMO market powerhouses in the APAC region, with significantly lower prices. Due to increasing patent expiration, generic drug manufacturing is the APAC region’s second-largest revenue source. CMOs are also continuing to pursue ISO certification in the areas of environmental management, quality management, and energy consumption. Moreover, though the number of warning letters has decreased in established markets, it has increased in Asia Pacific, and the majority of recalls have been caused by violations of cGMP manufacturing standards.

Asia has been providing low-cost alternatives to North American and European CDMOs, which rely on a one-stop-shop model to counter that threat. North America is the second-most lucrative region due to investments by regional companies and increased drug approval by FDA. For instance, in the U.S. alone, the FDA approved 50 novel drugs in 2021, 22 of which were tablets or capsules. The U.S. continues to dominate the OSD CMO market mainly due to developed healthcare industry, government focus on generics, and greater availability of funds.However, recent advances in drug delivery have enabled North American OSD manufacturers to achieve substantial bioavailability through the use of new drug delivery platforms. This is expected to increase the demand for oral controlled-release drug delivery technology in the region.

Key Companies And Market Share Insights

Mergers, acquisitions, and partnerships were the key strategies adopted by major players to maintain their market share. For instance, in June 2020, Piramal Enterprises Ltd. acquired G&W Laboratories Inc.’s oral solid dosage drug product manufacturing facility in Sellersville, Pennsylvania. This acquisition expands Piramal Pharma Solutions’ (PPS) offering in North America by adding oral solid dosage form capabilities (tablets and capsules). In February 2022, Corden Pharma announced the acquisition of three manufacturing facilities of Vifor Pharma. This acquisition would then broaden Corden Pharma’s capacities and capabilities in the production of Oral Solid Dosage (OSD) forms, such as capsules and tablets & non-sterile drug product dosage forms. Some prominent players in the global oral solid dosage contract manufacturing market include:

• Catalent, Inc.

• Lonza Group

• Piramal Pharma Solutions

• Aenova

• Jubilant

• Boehringer Ingelheim

• AbbVie Contract Manufacturing

• Patheon

• Recipharm

• Next Pharma AB

• Siegfried AG

• Corden Pharma

Oral Solid Dosage Contract Manufacturing Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For the purpose of this study, Grand View Research has segmented the global oral solid dosage contract manufacturing market report on the basis of product type, mechanism, end-user, and region:

• Product Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Tablets

  • Capsules

  • Powders

  • Granules

  • Others (Lozenges, Gummies, Pastilles, etc.)

• Mechanism Outlook (Revenue, USD Million, 2018 - 2030)

  • Immediate-release

  • Delayed-release

  • Controlled-release

• End-user Outlook (Revenue, USD Million, 2018 - 2030)

  • Large-size Companies

  • Medium- & Small-size Companies

  • Others (Startups & Generic Pharmaceutical Companies)

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia