Pharmaceutical Contract Manufacturing Market by Type of Product Manufactured (API & Intermediates and FDF), Type of API (Originator API and Generic API), API Potency (Low Potent API and High Potent API), Type of FDF (Originator FDF and Generic FDF), Dosag

Pharmaceutical Contract Manufacturing Market by Type of Product Manufactured (API & Intermediates and FDF), Type of API (Originator API and Generic API), API Potency (Low Potent API and High Potent API), Type of FDF (Originator FDF and Generic FDF), Dosage Form (Oral Solids, Liquids, Emulsions and Other Dosage Forms), Type of Packaging Offered (Bottles, Blister, Parenteral and Others), Scale of Operation (Clinical and Commercial), End Users (Small, Mid-sized, and Large and Very Large Companies) and Key Geographical Regions (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa): Industry Trends and Global Forecasts, Till 2035

PHARMACEUTICAL CONTRACT MANUFACTURING MARKET: OVERVIEW

As per Roots Analysis, the global pharmaceutical contract manufacturing market is estimated to grow from USD 99 billion in the current year to USD 156 billion by 2035, at a CAGR of 4.3% during the forecast period, till 2035.

The market sizing and opportunity analysis has been segmented across the following parameters:

Type of Product Manufactured

API & Intermediates

FDF

Type of API

Originator API

Generic API

API Potency

Low Potent API

High Potent API

Type of FDF

Originator FDF

Generic FDF

Dosage Form

Oral Solids

Liquids

Emulsions

Other Dosage Forms

Type of Packaging Offered

Bottles

Blisters

Parenteral

Others

Scale of Operation

Clinical

Commercial

Type of End-user

Small Companies

Mid-sized Companies

Large and Very Large Companies

Key Geographical Regions

North America

Europe

Asia-Pacific

Latin America

PHARMACEUTICAL CONTRACT MANUFACTURING MARKET: GROWTH AND TRENDS

The pharmaceutical contract manufacturing market is poised for significant growth, primarily driven by the demand for efficiency and flexibility in bringing products to the market. Factors such as operational expertise, advanced equipment and specialized facilities have led to an increase in outsourcing operations. It is worth highlighting that by outsourcing manufacturing operations to CMOs and CDMOs with a global footprint, companies can diversify their supply chains and reduce risks associated with political and economic uncertainties. Moreover, the integration of advanced technologies, such as automation, continuous manufacturing and data analytics, boosts production capabilities and ensures high-quality outcomes. With the rapidly evolving pharmaceutical landscape, contract manufacturers bring expertise in navigating complex regulatory frameworks, optimizing production workflows, and supporting a seamless transition from clinical studies to commercial scale manufacturing. The aforementioned factors are likely to present lucrative market growth opportunities for contract service providers during the forecast period.

PHARMACEUTICAL CONTRACT MANUFACTURING MARKET: KEY INSIGHTS

The report delves into the current state of the pharmaceutical contract manufacturing market and identifies potential growth opportunities within the industry. Some key findings from the report include:

1. Presently, close to 425 organizations offer pharmaceutical contract manufacturing services; of these, majority of the CMOs provide fill-finish / packaging and labelling services.

2. A relatively larger proportion of CMOs manufacture FDFs; close to 15% of the players have the required capabilities to manufacture all types of finished dosage forms.

3. In pursuit of building a competitive edge and to establish themselves as one-stop shops, stakeholders are actively consolidating their capabilities related to small molecule manufacturing through mergers and acquisitions.

4. In order to meet the rising demand for APIs and finished products, CMOs have made elaborate investments in expanding their existing capacities and capabilities; this trend is most pronounced in the US and India.

5. The global pharmaceutical contract manufacturing capacity is well distributed across different facilities worldwide; notably, large and very large players account for 80% of the total capacity.

6. Owing to the increase in outsourcing activity for small molecule manufacturing operations, the demand for pharmaceutical contract manufacturing is anticipated to rise significantly over the decade.

7. In the past decade, a shift in trend has been observed in the pharmaceutical contract manufacturing industry as more players have set up their manufacturing facilities in developing regions across Asia-Pacific.

8. Driven by the increasing pace of expansions and mergers between the stakeholders in this domain, the market for pharmaceutical contract manufacturing is poised to witness steady growth in the foreseeable future.

9. The pharmaceutical contract manufacturing market is anticipated to grow at a steady rate, till 2035; North America is expected to capture the majority share (over 35%) of the market by 2035.

10. In the long term, small and mid-sized companies are likely to drive the growth of the pharmaceutical contract manufacturing market; oral solids is expected to capture the majority share (~50%) by 2035.

PHARMACEUTICAL CONTRACT MANUFACTURING MARKET: KEY SEGMENTS

FDF segment is Likely to Dominate the Pharmaceutical Contract Manufacturing Market During the Forecast Period

Based on the type of product manufactured, the market is segmented into API & Intermediates and FDF. It is worth highlighting that majority of the current pharmaceutical contract manufacturing market is captured by the FDF segment and this trend is likely to remain the same in the forthcoming years. This can be attributed to the growing demand for ready-to-make products, high value addition and stringent regulatory guidelines.

Currently, Generic and Originator APIs Hold Similar Market Share of the Pharmaceutical Contract Manufacturing Market

Based on the type of APIs, the market is segmented into generic API and originator API. It is worth highlighting that, at present, both generic and originator APIs capture almost similar market share in the pharmaceutical contract manufacturing market. This can be attributed to competitive pricing and quality standards maintained by generic manufacturers. It is worth noting that there is continued demand for branded drugs from originator companies.

High Potent API Segment is the Fastest Growing Segment of the Pharmaceutical Contract Manufacturing Market

Based on the types of API by potency, the market is segmented into low potent API and high potent API. Owing to their enhanced efficacy, lower dosage requirements and increasing demand for targeted therapies, the highly potent API (HPAPI) market is likely to grow at a relatively higher CAGR.

Currently, Originator FDF Occupies the Largest Share of the Pharmaceutical Contract Manufacturing Market

Based on the type of FDFs, the market is segmented into generic FDF and originator FDF. Owing to brand loyalty, ongoing investments in research and development, and established market presence, the originator FDF holds the maximum share within the pharmaceutical contract manufacturing market.

Liquid Dosage Form is the Fastest Growing Segment of the Pharmaceutical Contract Manufacturing Market

Based on the dosage forms, the market is segmented into oral solids, liquids, emulsions and others. It is worth highlighting that, due to the simplicity of administration, growing applications in pediatric and geriatric populations and enhanced patient adherence, liquids are likely to grow at a higher CAGR in the forthcoming years.

Currently, Bottles Occupy the Largest Share of the Pharmaceutical Contract Manufacturing Market

Based on the type of packaging offered, the market is segmented into bottles, blisters, parenterals and others. It is worth highlighting that, at present, bottles hold the maximum share within the pharmaceutical contract manufacturing market. Bottles offer various advantages, such as cost-effectiveness, versatility and capability to accommodate various types of formulations and dosages.

By Scale of Operation, Commercial Scale is Likely to Dominate the Pharmaceutical Contract Manufacturing Market

Based on the scale of operation, the market is segmented into clinical and commercial scale. Whilst commercial scale manufacturing will be the primary driver of the overall market, it is worth highlighting that the pharmaceutical contract manufacturing market at the clinical scale is likely to grow at a relatively higher CAGR.

Small Companies Account for the Largest Share of the Pharmaceutical Contract Manufacturing Market

Based on the type of end-user, the market is segmented into small, mid-sized, and large and very large companies. It is worth highlighting that, at present, small companies capture the highest share within the pharmaceutical manufacturing market. This trend is unlikely to change in the near future.

North America Accounts for the Largest Share of the Market

Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America. Majority share is expected to be captured by contract manufacturers based in North America. It is worth highlighting that over the years, the market for Asia-Pacific is expected to grow at a higher CAGR.

Example Players in the Pharmaceutical Contract Manufacturing Market

AMRI Global

Altasciences

Cambrex

Catalent

DPT Laboratories

Aenova

Almac

Corden Pharma

Fresenius Kabi

Glatt

Hovione

Recipharm

Siegfried

CMIC Group

Nectar Lifesciences

Syngene

WuXi AppTec

Primary Research Overview

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders. The research report features detailed transcripts of interviews held with the following industry stakeholders:

Former Director of Business Development, Ajinomoto Althea

Former Chief Executive Officer, Bachem

President and Chief Executive Officer, CiVentiChem

Digitalization and Artificial Intelligence Manager, CordenPharma

Former Director, Commercial Development, Helsinn Group

Former Director, Pharmaceuticals Marketing, Novasep

Director, Operations, Sovereign Pharma

Former Vice President Business Development, Marketing, and IP, Wavelength Pharmaceuticals

PHARMACEUTICAL CONTRACT MANUFACTURING MARKET: RESEARCH COVERAGE

Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the pharmaceutical contract manufacturing market, focusing on key market segments, including [A] type of product manufactured, [B] type of API, [C] API potency, [D] type of FDF, [E] dosage form, [F] type of packaging offered, [G] scale of operation, [H] end users and [I] key geographical regions.

Regulatory Landscape: A discussion on general regulatory guidelines across different countries, featuring an elaborative assessment of various CMOs in the pharmaceutical contract manufacturing industry, along with information on their operational approvals, certifications received, and relative popularity of the key regulatory body. In addition, the chapter features an insightful multi-dimensional bubble analysis, presenting a comparison of the current regulatory scenario in key geographies.

Market Landscape: A comprehensive evaluation of companies involved in contract manufacturing of small molecules, considering various parameters, such as [A] year of establishment, [B] company size, [C] location of headquarters, [D] location of manufacturing facility, [E] type of manufacturer, [F] type of services offered, [G] type of finished dosage form manufactured, [H] type of packaging offered and [I] scale of operation.

Regional Capability Analysis: A detailed analysis of the capabilities of pharmaceutical contract manufacturing facilities in different regions (North America, Europe, Asia-Pacific and the Rest of the World) across the globe.

Company Profiles: In-depth profiles of key industry players in pharmaceutical contract manufacturing market, focusing on [A] company overviews, [B] manufacturing portfolio, [C] financial information, [D] recent developments and [E] an informed future outlook.

Additional Insights: An insightful framework that emphasizes the key indicators and factors that need to be considered by pharmaceutical drug developers to determine whether to manufacture their respective products in-house or outsource the manufacturing operation to contract service providers.

Merger and Acquisitions: A comprehensive examination of the various mergers and acquisitions, focusing on multiple relevant parameters, including [A] year of agreement, [B] type of agreement, [C] key value drivers of the deal, [D] most active players (in terms of number of agreements signed) and [E] geographical location of the companies. In addition, the chapter provides information on the financial terms of the deals (if available) in order to enumerate the deal multiples (in terms of annual revenues of the acquired firm (at the time of acquisition) and years of experience in this domain).

Acquisitions: An analysis of acquisitions has taken place in the pharmaceutical contract manufacturing domain, since 2017.

Capacity Analysis: Estimation of global pharmaceutical manufacturing capacity, derived from data provided by various stakeholders in the public domain. This analysis emphasizes the distribution of the available capacity on the basis of [A] company size and [B] key geographical regions.

Demand Analysis: Informed estimates of the annual commercial and clinical demand for small molecule drugs across key geographical regions.

Market Impact Analysis: The report analyzes various factors such as drivers, restraints, opportunities, and challenges affecting market growth.

KEY QUESTIONS ANSWERED IN THIS REPORT

How many companies are currently engaged in this market?

Which are the leading companies in this market?

What is the current global demand for small molecules?

What percentage of the pharmaceutical manufacturing operations are presently outsourced?

What factors are likely to influence the evolution of this market?

What is the current and future market size?

What is the CAGR of this market?

How is the current and future market opportunity likely to be distributed across key market segments?

REASONS TO BUY THIS REPORT

The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.

Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.

The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.

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