Pharmaceutical Contract Manufacturing Market

Pharmaceutical Contract Manufacturing Market: Industry Trends and Global Forecasts, Till 2035: Distribution 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)

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Pharmaceutical Contract Manufacturing Market Overview

The global pharmaceutical contract manufacturing market size is projected to grow from $99 billion in 2024 to $156 billion by 2035, representing a CAGR of 4.3%, during the forecast period 2024-2035.

Pharmaceutical Contract Manufacturing Market By Dosage Form, 2017-2035 (USD Billion)

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In the dynamic landscape of pharmaceutical industry, the dominance of small molecule drugs continues to shape the trajectory of innovation and development. Presently, 90% of the total pharmaceutical drugs are small molecules, despite the fact that biologics have garnered more attention in the recent years due to their capability to treat wide array of disorders. Further, the domain has witnessed a resurgence in the approval of novel small molecule drugs, with over 50 candidates gaining US FDA approval solely in 2020. This trend has driven the business for pharma contract research organization services.

It is worth mentioning that manufacturing of these novel drug candidates requires specialized facilities, advanced equipment and operational expertise. As a result, the pharmaceutical companies might encounter difficulties in conducting development and manufacturing operations independently. Additionally, time and cost-intensive nature of setting up or acquiring manufacturing capabilities has prompted both small and big pharmaceutical companies to increasingly outsource their manufacturing operations to contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs). In addition, the imperative need for safer and more effective drugs has further increased the demand for contract manufacturing services.

Driven by the need for enhanced efficiency, traceability and cost-effectiveness, pharmaceutical contract manufacturing is undergoing technological advancements. Outsourcing manufacturing operations to CMOs and CDMOs entails the implementation of specialized solutions to optimize production workflows, ensure regulatory compliance, and maintain product quality standards. Furthermore, there is a growing emphasis on personalized medicinal products, necessitating flexible manufacturing capabilities to meet diverse patient needs. As pharmaceutical companies navigate these evolving dynamics, the demand for advanced solutions tailored to the unique requirements of contract manufacturing services is expected to rise over the forecast period.

Pharmaceutical Contract Manufacturing Market Segmentation Insights

The pharmaceutical CMO market research report presents an in-depth analysis of various contract manufacturers that are involved in production of small molecules, across different segments, as defined in the table below:

Pharmaceutical Contract Manufacturing Market: Report Attributes / Market Segmentations

Key Report Attributes Details
Historical Trend 2017-2023
Base Year 2023
Forecast Period 2024-2035
Market Size 2024 $ 99 Billion
Market Size 2035 $ 156 Billion
Growth Rate CAGR of 4.3% from 2024 to 2035
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
  • Middle East and North Africa
Key Companies Profiled 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
(Full list of 420+ companies captured is available in the report)
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  • Market Landscape Analysis
  • Mergers and Acquisitions
  • Recent Expansions
  • Capacity Analysis
  • Demand Analysis
  • Market Sizing and Opportunity Analysis

One of the key objectives of this market report was to estimate the current market size, opportunity and the future growth potential of contract manufacturers in the pharmaceutical contract manufacturing market, over the forecast period. Based on multiple parameters, likely adoption trends and through primary validations, we have provided an informed estimate on the market evolution during the forecast period till 2035. 

The market report also features the likely distribution of the current and forecasted opportunity for contract manufacturers in the market across various segments, such as type of product manufactured (API & Intermediated 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, blisters, parenteral and others), scale of operation (clinical and commercial), type of end-user (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). In order to account for future uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three pharmaceutical contract manufacturing market forecast scenarios, namely conservative, base, and optimistic scenarios, representing different tracks of the industry’s evolution.

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

  • President and Chief Executive Officer, Corporate Strategy and Business Development, Mid-sized Company, US
  • Former Chief Executive Officer, Large Company, Switzerland
  • Former Vice President Business Development, Marketing, and IP, Mid-sized Company, Israel
  • Director, Operations, Mid-sized Company, India
  • Former Director of Business Development, Large Company, US
  • Former Director, Commercial Development, Cell Therapy, Mid-sized Company, Switzerland
  • Former Director, Pharmaceuticals Marketing, Large Company, France
  • Digitalization and Artificial Intelligence Manager, Large Company, Switzerland 

Further, all actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market report are in USD, unless otherwise specified.

Pharmaceutical Contract Manufacturing Market Share Insights

Market Share by Type of Product Manufactured

The global pharmaceutical contract manufacturing market is segmented into different types of products manufactured, such as API & Intermediates and FDF. The FDF segment captures the highest market share in 2024 and is expected to remain dominant during the forecast period. This can be attributed to the high value addition, complex regulatory requirements, and increased demand for ready-to-make products.

Market Share by Type of API

This segment highlights the distribution of the pharmaceutical contract manufacturing market across different type of APIs, such as generic API and originator API. Owing to the competitive pricing and quality standards maintained by generic manufacturers, alongside the continued demand for branded drugs from originator companies, both generic and originator APIs capture almost similar market share in the pharmaceutical contract manufacturing.

Market Share by API Potency

This segment highlights the distribution of the pharmaceutical contract manufacturing market across types of API by potency, such as low potent API and high potent API. Driven by the increasing demand for targeted therapies for the treatment of various chronic diseases, the highly potent API (HPAPI) market is expected to rise at a significant rate. The enhanced efficacy and lower dosage requirements of HPAPIs make them preferable over low potent APIs.

Market Share by Type of FDF 

This section segments the pharmaceutical contract manufacturing industry into type of FDFs, such as generic FDF and originator FDF. It is worth highlighting that the originator FDF captures comparatively larger market share owing to the brand loyalty, established market presence, and ongoing investments in research, development, and marketing by originator pharmaceutical companies.

Market Share by Dosage Forms

The global pharmaceutical contract manufacturing market features different dosage forms, such as oral solids, liquids, emulsions and others. It is worth highlighting that owing to the ease of administration, improved patient compliance and expanding applications in paediatric and geriatric populations, liquids are likely to grow at a higher annualized growth rate (CAGR) in the coming years.

Market Share by Type of Packaging Offered

The global pharmaceutical contract manufacturing market features various types of packaging for the finished products. Owing to the versatility, cost-effectiveness, and suitability for accommodating a wide range of formulations and dosages, enhancing convenience for both manufacturers and patients, bottles capture the highest share among other dosage forms.

Market Share by Scale of Operation

The global pharmaceutical contract manufacturing market features various contract manufacturers, having the ability to manage operations at clinical and commercial scales. It is worth highlighting that contract manufacturers employed for managing clinical operations are likely to grow at a higher CAGR in the coming years as compared to the contract manufacturers operating at commercial scale of operation.

Market Share by End Users

The global pharmaceutical contract manufacturing market highlights the distribution based on the type of end-users, including small, mid-sized, large, and very large companies. Currently, small companies capture the highest share, and this trend is unlikely to change during the forecast period, as well. This can be attributed to the limited availability of the resources and lack of in-house capabilities of small companies.

Market Share by Key Geographical Regions

This segment highlights the distribution of pharmaceutical contract manufacturing market across various geographies, such as North America, Europe, Asia-Pacific, Latin America and Middle East and North Africa. According to our projections, North America captures the majority share (37%) of the market opportunity, and this trend is unlikely to change during the forecast period. It is worth highlighting that the pharma manufacturing market in Asia-Pacific is expected to grow at a relatively higher CAGR, during the forecast period, till 2035.

Pharmaceutical Contract Manufacturing Market Key Insights

The “Pharmaceutical Contract Manufacturing Market: Industry Trends and Global Forecasts, Till 2035” report features an extensive study of the current market landscape, market value and future opportunities associated with contract manufacturers within the pharmaceutical contract manufacturing industry, during the given forecast period. The market report highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry. Key takeaways of the market report is briefly discussed below.

Advantages of Outsourcing Pharmaceutical Manufacturing Operations

Outsourcing pharmaceutical manufacturing operations to CMOs allows the drug developers / pharmaceutical companies to focus on their core competencies, including research and development, marketing, and distribution, while leaving the manufacturing processes to specialized firms, thus enhancing efficiency and cost-effectiveness. Further, it provides access to state-of-the-art facilities and expertise, enabling the production of high-quality drugs that meet the stringent regulatory standards. Additionally, outsourcing can facilitate flexibility in scaling production capacity according to fluctuating demands, mitigating risks associated with underutilized or overburdened manufacturing facilities. 

The factors to be considered while deciding whether to keep the manufacturing operations for small molecules in-house or to outsource them include scale and complexity of manufacturing processes, regulatory requirements and compliance considerations. In addition to these, cost-effectiveness, access to specialized technologies, capacity constraints and the need for flexibility and agility in response to market dynamics also assists while considering the outsourcing opportunities.

Competitive Landscape of Contract Manufacturers in the Pharmaceutical Contract Manufacturing Market

The current landscape features the presence of close to 425 CMOs offering contract manufacturing services for small molecules. It is worth mentioning that there has been a steady rise in the number of small molecules manufacturing companies over the past decade, indicating a growing demand for capacities manufacturing both novel and conventional drugs. Further, a significant proportion of the companies (57%) offer services for both API manufacturing and FDF manufacturing to small molecules developers; notable examples include Acino, Glatt, Chemigran, AllChem Laboratories, Fujimoto Chemicals, Isochem, API Pharmatech, Afton Scientific and Nectar Lifesciences.  

Pharmaceutical Contract Manufacturing Market Trends: Increasing Mergers and Acquisitions Amongst the Contract Manufacturers to Foster Progress and Innovation

Stakeholders in the pharmaceutical contract manufacturing industry have forged several deals in order to acquire various manufacturing companies or production facilities. It is worth highlighting that more than 90% of deals were inked for acquiring manufacturing facilities. CDMOs acquire facilities to expand their geographical presence. In one such instance a German CDMO, Adragos Pharma, acquired a manufacturing facility for oral solid dosage manufacturing from Sanofi. This deal took place in October 2022 for Kawagoe, Japan facility. 

Additionally, this segment of the global contract manufacturing market has seen rapid growth after the COVID-19 pandemic. Notably, the majority of these deals are focused on acquisition of companies, followed by facility acquisition. This can be attributed to the incessant efforts of small molecules CMO to further advance the development of their product offerings, across different phases.

Key Drivers of the Pharmaceutical Contract Manufacturing Industry

The pharmaceutical contract manufacturing market growth is primarily driven by factors such as cost-effectiveness, as companies seek to optimize their operational expenses by outsourcing manufacturing to specialized firms. Additionally, the increasing complexity of drug development processes and regulatory requirements encourages pharmaceutical companies to leverage the expertise and capabilities of CMOs. Furthermore, the operational flexibility provided by CMOs enables pharmaceutical companies to cater to the increased demand for pharmaceutical products by optimizing manufacturing processes at various scales and handling unforeseen challenges more effectively.

Pharmaceutical Contract Manufacturing Market Size Analysis: North America Holds the Largest Share 

Presently, close to 40% of the market opportunity is created by the demand for personalized medicines in North America. This can be attributed to the increasing R&D investments, partnership activity and funding received by various therapy developers for the development of novel small molecule therapies. Further, the market for contract manufacturing operations in Asia-Pacific is expected to grow at a relatively higher CAGR of 4.9%, during the forecast period.

Leading CMOs Engaged in Small Molecules Contract Manufacturing Market

Examples of key players offering contract manufacturing services for small molecules (which have also been profiled in this market report) include (in alphabetical order) AMRI Global, Altasciences, Cambrex, Catalent, DPT Laboratories, Aenova, Almac, Corden Pharma, Fresenius Kabi, Glatt, Hovione, Recipharm, Siegfried, CMIC Group, Nectar Lifesciences, Syngene and WuXi AppTec. This market report includes an easily searchable excel database of all the pharmaceutical CMO and details on their manufacturing facilities worldwide.

Some of the pharmaceutical contract manufacturing companies have also entered biologics contract manufacturing market, details on which have been analyzed in a separate report.

Pharmaceutical Contract Manufacturing Market Report Coverage

The market report presents an in-depth analysis, highlighting the capabilities of various contract manufacturers in this market, across different segments. Amongst other elements, the market report includes:

  • A preface providing an introduction to the full report, Pharmaceutical Contract Manufacturing Market (4th edition), 2017-2023 (Historical Trends) and 2024-2035 (Forecasted Estimates).
Pharmaceutical Contract Manufacturing Market List Pharmaceutical Contract Manufacturing Market Distribution By Focus Area Pharmaceutical Contract Manufacturing Market Expansions
  • An outline of the systematic research methodology adopted to conduct the study on pharmaceutical contract manufacturing industry, providing insights on the various assumptions, methodologies, and quality control measures employed to ensure accuracy and reliability of our findings.
  • An overview of economic factors that impact the overall global pharmaceutical contract manufacturing market, including historical trends, currency fluctuation, foreign exchange impact, recession, and inflation measurement.
  • An executive summary of the insights captured during our research. It offers a high-level view on the current state of contract manufacturers for drug development and its likely evolution in the mid-long term.
  • A general overview of contract manufacturing services, highlighting details on different types of third-party manufacturers. It also features evolution of global pharmaceutical contract manufacturing market. Further, it provides information on the recent CDMO trends, along the opportunities and future perspectives.
  • A detailed discussion on various guidelines laid down by major regulatory bodies, across different countries, featuring an elaborative assessment of over 420 CMOs in pharmaceutical contract manufacturing industry, along with information on their operational approvals, certifications received, and relative popularity of the key regulatory body. Additionally, the chapter features an insightful multi-dimensional bubble analysis, presenting a comparison of the current regulatory scenario in key geographies.
  • An overview of the current market landscape of companies engaged in offering contract manufacturing services for small molecules, including a detailed analysis based on several relevant parameters, such as year of establishment, company size (based on number of employees), location of headquarters, location of manufacturing facility, type of manufacturer (CDMO and CMO), product manufacturing capability (API & Intermediates and FDF), type of services offered (pre-formulation development, formulation development, method / analytical / process / assay development, scale-up, fill-finish / packaging and labelling and regulatory support), type of finished dosage form manufactured (oral solid, liquids, emulsions and lyophilized products), type of packaging offered (blister packaging, tubes, vials / cartridges, ampoules, sachets / pouches / bags, inhalers / nasal sprays, glass / plastic bottles / dropper bottles and prefilled syringes / autoinjectors / pen injectors) and scale of operation (preclinical, clinical and commercial).
  • A detailed regional capability of pharmaceutical contract manufacturing facilities in different regions (North America, Europe, Asia-Pacific and Rest of the World) across the globe.
Pharmaceutical Contract Manufacturing Market Production Capacity Pharmaceutical Contract Manufacturing Market Geography Pharmaceutical Contract Manufacturing Market Regional Capability
  • Elaborate profiles of key contract manufacturers in the pharmaceutical contract manufacturing market. Each profile features a brief overview of the pharmaceutical contract manufacturing companies, along with information on location of headquarters, year of establishment, number of employees, leadership team, manufacturing portfolio, financial information, recent developments, and an informed future outlook.
  • A brief description of companies in pharmaceutical contract manufacturing. Each profile features a brief description of the company overview, along with information on the manufacturing portfolio.
  • A qualitative analysis highlighting various factors that need to be taken into consideration by pharmaceutical drug developers, while deciding whether to manufacture their respective products in-house or engage the services of a CMO.
  • A detailed analysis of the various mergers and acquisitions in this domain since 2017, based on several relevant parameters, such as year of agreement, type of agreement, key value drivers of the deal, most active players (in terms of number of agreements signed) and 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).
  • A detailed analysis of acquisitions that have taken place in the pharmaceutical contract manufacturing domain, taking into consideration the historical trend of the activity of players that have acquired other firms since 2017, and offering a means for other industry stakeholders to identify potential acquisition targets. The primary purpose of this analysis was to develop a better understanding of the overall potential and capabilities of companies involved in this domain, that are likely to be acquired in the recent future.
  • An estimate of the overall installed capacity for the manufacturing of pharmaceuticals, based on information reported by various industry stakeholders in the public domain, highlighting the distribution of the available capacity, based on size of manufacturer (small, mid-sized, and large and very large) and geography (North America, Europe, Asia-Pacific and Rest of the World).
  • An informed estimate of the annual clinical and commercial demand for small molecule drugs, across key geographical regions.
  • An in-depth analysis of the factors that can impact the growth of the global pharmaceutical contract manufacturing market. It also features identification and analysis of key drivers, potential restraints, emerging opportunities, and existing challenges.
  • A detailed estimate of the current market size and the future growth potential of the pharmaceutical contract manufacturing market over the next decade. Based on multiple parameters, such as likely adoption trends and through reliable secondary and primary validations, we have provided an informed estimate on the market evolution during the forecast period 2024-2035. The report also features the likely distribution of the current and forecasted opportunity within the pharmaceutical contract manufacturing industry. Further, in order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base, and optimistic scenarios, representing different tracks of the pharmaceutical contract manufacturing market growth.
  • Detailed projections of the current and future opportunity for contract manufacturers in the pharmaceutical CMO market across various types of products manufactured, such as API & Intermediates and FDF.
  • Detailed projections of the current and future opportunity for contract manufacturers in the pharmaceutical contract manufacturing industry across various types of API, such as generic API and originator API.
  • Detailed projections of the current and future opportunity for contract manufacturers in the pharmaceutical contract manufacturing industry across types of API by potency, such as low potent API and high potent API.
  • Detailed projections of the current and future opportunity for contract manufacturers in the pharmaceutical contract manufacturing market across various types of FDF, such as generic FDF and originator FDF.
  • Detailed projections of the current and future opportunity for contract manufacturers in the pharmaceutical CMO market across different types of dosage form offered, such as oral solids, liquids, emulsions, and other dosage forms.
  • Detailed projections of the current and future opportunity for contract manufacturers in the pharmaceutical contract manufacturing market across different type of packaging, such as bottles, blisters, parenteral and others.
  • Detailed projections of the current and future opportunity for contract manufacturers in the pharmaceutical contract manufacturing industry across different type of end-users, such as small, mid-sized and large and very large companies.
  • Detailed projections of the current and future opportunity for contract manufacturers in the pharmaceutical contract manufacturing market across scales of operation, including clinical and commercial.
  • Detailed projections of the current and future opportunity for contract manufacturers in the pharmaceutical contract manufacturing market across key geographical regions, such as North America, Europe, Asia-Pacific, Latin America and Middle East and North Africa.
  • Detailed list of the current pharmaceutical contract manufacturing market across leading players.
  • A case study highlighting a comparison of the key characteristics of large and small molecule drugs, along with information on the steps involved in their respective manufacturing processes.
Pharmaceutical Contract Manufacturing Market Type of Product Pharmaceutical Contract Manufacturing Market Dosage Forms Pharmaceutical Contract Manufacturing Market Penetration Growth

Recent Developments in the Pharmaceutical Contract Manufacturing Market

Several recent developments have taken place in the market, some of which have been outlined below. These developments, even though they took place post the release of our market report, substantiate the overall market trends that we have outlined in our analyses.

  • In February 2024, Thermo Fisher Scientific announced the opening of a new sterile drug facility in Singapore, which includes a fully automated aseptic fill finish manufacturing line for small and large molecules.
  • In February 2024, CoreRx acquired the small molecule contract manufacturer, Societal CDMO, worth USD 130 million.
  • In November 2023, Procaps entered into a partnership with Genomma Labs to develop, manufacture and market Softgel products in Latin America.
  • In September 2023, Actylis launched a new cGMP WFI (Water for Injection) manufacturing, storage and distribution facility in Montreal, Canada.
  • In December 2023, Aenova expands its oral solids manufacturing capacity at Tittmoning.

Author(s): Pomila Kaushal, Nancy Kapila, Yash Tyagi

Frequently Asked Questions

Question 1: What is pharmaceutical contract manufacturing?

Answer: Pharmaceutical contract manufacturing refers to the outsourcing of drug production to specialized third-party manufacturers.

Question 2: How big is the market for pharmaceutical contract manufacturing?

Answer: The global pharmaceutical contract manufacturing market size is estimated to be $99 billion in 2024.

Question 3: What is the anticipated CAGR of the global pharmaceutical contract manufacturing industry?

Answer: The global pharmaceutical contract manufacturing market is anticipated to grow at a CAGR of 4.3% during the forecast period 2024-2035.

Question 4: Which regions represent the current key contract manufacturing hubs for small molecules?

Answer: Currently, North America holds the maximum share (37%) in pharmaceutical contract manufacturing market.

Question 5: What percentage of the pharmaceutical manufacturing operations are presently outsourced?

Answer: Presently, 25% of the API manufacturing and 75% of the FDF manufacturing is being outsourced to contract manufacturers.

Question 6: Who are the key players engaged in offering contract manufacturing services for small molecules?

Answer: AMRI Global, Altasciences, Cambrex, Catalent, DPT Laboratories, Aenova and Almac.

Question 7: What is the current global demand for small molecules?

Answer: Current global demand for small molecules is 31,869 metric tons.

Question 8: What are the key value drivers within the pharmaceutical contract manufacturing industry?

Answer: The key value drivers in the pharmaceutical contract manufacturing industry encompass cost-efficiency, specialized expertise and scalability.

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