Category Forecast – R&D

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By: Beroe Inc -- Beroe Inc

04 November, 2020

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Category Forecast – R&D
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Solid Dose Formulation CMO Market

  1. Solid Dose Formulation CMO Market Growth & Share
  2. Key Solid Dose CMO Market Trends to Continue in 2021
  3. Solid Dose CMO Regulatory Trends

Solid Dose Formulation CMO Market Growth & Share

  • Global oral solid dosage market is highly fragmented. North America dominates the CMO market by revenue due to increasing investment in this sector that facilitates the capabilities of the CMO as a one-stop-shop
  • Tablets and capsules are the dosage forms leading the market in terms of production and number of CMOs with manufacturing capability
  • Demand for tablets is higher with varying forms like film-coated, sugar-coated, and effervescent tablets due to ease of consumption and well-established manufacturing technology
  • Europe is highly active in the soft gelatin capsule sector and has many suppliers in both pharmaceutical and nutraceutical industries
  • CMOs are creating sugar-free gummies with fruit-based and plant-based raw materials that are gaining traction in developed markets

Key Solid Dose CMO Market Trends to Continue in 2021

Mergers and Acquisitions are driving the consolidation of the highly fragmented CMO industry. The future will see increased M&A’s with a primary focus on expanding capabilities to manage API shortages and entering the new emerging markets of the Middle East and Africa

M&A’s and Partnerships

  • Top CMOs are aiming to extend their service offerings to areas adjacent to their core capabilities. E.g., Catalent, Capsugel (Lonza), etc.
  • The CDMOs based in North America and Europe are using the one-stop-shop model as a differentiator to low-cost alternatives in Asia

Increased Investments

  • CMO/CDMO’s are heavily investing (~75%) in a new capacity to meet the increasing demand, enter new markets, and be an integrated service provider for drug manufacturing, packaging and R&D, along with geographic scale
  • Over 30% of the overall expansion investment belonged to Catalent, followed by Capsugel (Lonza) and CordenPharma, at 11% each

Technology Trends

  • OSD manufacturing CMOs prefer technology that is efficient and works at high speed
  • Encapsulator and fluid bed containment for formulation manufacturing also come with fully automatic cleaning systems that make it flexible for CMOs to operate contamination-free

Regional Trends

  • The U.S. dominates the Oral Solid Dosage from CMO market with 37% market share by revenue. Driving factor for higher revenue includes developed healthcare sector, higher investment in new technology, and increasing govt. focus on generics
  • Europe has a greater number of CMOs by geographic distribution (65%) for oral solid dosage forms catering to both pharmaceutical and cosmetic industries
  • Asia Pacific market has CMOs in India and China who manufacture generic drugs and biosimilar products
  • Due to increasing patent expiry, generic drug manufacturing is generating the second largest revenue in the APAC region

Solid Dose CMO Regulatory Trends

Increasing regulatory approvals to NME and NDA has increased the trend for outsourcing. CMO facilities are adopting a sustainable growth model to attain ISO certification

Key Regulatory Trends

Serialization Software

  • To prevent theft and counterfeit of drugs, which accounts for 15% of annual cargo theft, governments around the globe are taking initiatives to ensure methods to track the supply chain
  • China (CFDA) and Turkey ensured smooth supply chains that used government databases to track the drug supply
  • U.S. model requires lot  traceability shared with each member of the value chain as of 2015, with individual saleable package serialization by 2017, and verification at the point of dispensing by 2023
  • By 2020, 65% of the market will adopt serialization
  • TOP CMOs that have installed serialization services include Recipharm, Delpharm, Corden Pharma, CoreRx, Patheon, Alchem, etc.

Drug Approvals

  • Outsourcing of solid dose NMEs accounts for 54% in 2020
  • Large companies have been partnering with Patheon, Vetter formulation manufacturing; however, Catalent, CoreRx, Delpharm have partnered with smaller companies 

Facility Approvals

  • To remain competitive, CMOs are keen to adopt ISO standards for energy consumption, environment and quality management

Warning Letters & Recalls

  • Warning letters have considerably lessened since 2014-2018 in developed markets. However, Asia Pacific remains on alert due to increasing warning letters
  • In 2018, the company initiated recalls in US accounts was 687. For example, Dr. Reddy's lab voluntarily recalled Ranitidine formulations in the U.S., and Orion recalled Burana caps
  • Top recalls have been due to violation of cGMP standards in manufacturing
  • Companies have initiated reduction of batch size to hundreds of thousands so that the recalls don’t affect a million drugs in each batch

Lab Chemicals

  1. Lab Chemicals: Market Growth & Share
  2. Lab Chemicals: Key Market Trends to Continue in 2021
  3. Lab Chemicals: Technology Trends

Lab Chemicals Market Growth & Share

  • The lab chemicals industry will see a steady growth grow of 5 – 6% CAGR from 2018 to 2023. The increased demand may result in higher prices in 2021
  • Adoption of green chemical alternatives will enable laboratories to consume fewer resources and reduce hazardous wastes
  • The laboratory chemicals market is largely driven by increasing R&D activities in biological and chemical sciences. The laboratory chemicals market is growing due to a substantial increase in basic research applications, along with large-scale commercial usage
  • Apart from the macro factors, internal factors include the supplier relationship and competitor research, which helps pharma to stay ahead in the market. Restructuring business strategy and reviewing quality on a regular basis provides an advantage to pharma

Key Lab Chemical Market Trends to Continue in 2021

  • Techniques like alternate environment friendly chemicals as well as energy and paper conservation can help maintain sustainability in the lab chemical space
  • Reselling surplus chemicals can help reduce hazardous and dangerous chemical waste, helping with efficient waste management

Circular Economy

  • Regulatory requirements significantly will increase as the environmental impact of emissions and waste becomes more evident
  • Lab consumable companies are correspondingly in greater demand; a few companies are already expanding to establish end-to-end concepts

Green Chemicals

  • Green chemicals have not only reduced carbon footprint at the manufacturing level, but also have integrated into the entire lifecycle of lab testing and reduced overall chemical cost by 13%

Surplus Management

  • Market for surplus chemicals is growing rapidly in Asia due to the high potential of reuse
  • Reformulation  of  the surplus chemicals by the suppliers can help in turning the expiring chemicals into samples with a quicker turnaround

Digitization

  • Chemical companies plan to invest 5 % of their annual revenue on digitization over the next five years, and nearly a third of them have already reached an advanced level of digitization
  • These initiatives can produce near-term benefits across three primary business dimensions: operations, customer relations, and organization

Lab Chemical Technology Trends

When Supply Chain and Laboratory teams utilize data and analytics to assess utilization and purchasing patterns, inefficiencies within the supply chain are often uncovered. These inefficiencies can turn into savings opportunities.

E-Commerce

  • Shift towards e-commerce platforms is reducing turn around time for routine products, thereby allowing suppliers to reduce the tail length size and offer data-driven decision making in purchases is leading to a savings of 18 to 19%
  • This number is achievable since suppliers tend to pass on cost benefits gained from the e-Commerce shift to buyers

Cloud-based LIMS

  • Lab Suppliers are focusing more on data integrity  and cloud solutions where the data can be linked to various systems and the quality of the information is assured
  • LIMS is being adopted by all industry domains, but it is preferred by pharma companies to manage huge amounts of research data. This, in turn, makes the lab process leaner

Adoption of Artificial Intelligence (AI)

  • Artificial intelligence has been mostly applied to routine work with benefits being logarithmically high
  • As a result of automation, AI is expected to reduce the cost involved in FTE rates of some specific personnel such as document writers, junior lab technicians, etc.

Remote Monitoring

  • To manage lab data in real-time and optimize lab equipment utilization, companies are collaborating with technology providers and robotic companies to automate labs, which in turn will reduce costs by approximately 10-15 percent
  • Organizations like SmartSense, Moonit, and Lab Forward have partnered with various pharma companies, aiding them to monitor their lab operations and equipment by providing custom dashboards for data access

Medical Injection Molding

  1. Medical Injection Molding: Market Growth & Share
  2. Medical Injection Molding: Market Trends to Continue in 2021
  3. Medical Injection Molding: Technology Trends

Medical Injection Molding  Market Growth & Share

  • Molders are aware of the growth expected for the medical industry in coming years. Taking that into consideration, medical molders are enhancing their capacities by adding more cleanrooms, increasing manufacturing space, opening new facilities, and adding more technologically-advanced presses.
  • Advancements like micromolding, automated work cells, spot cooling technology will drive the market by enabling more efficient, cost-effective, and superior injection molded products
  • North America is expected to remain the leader in terms of the consumption of medical resins until 2021. Plastic consumption has grown mainly due to the growth and advancement from specialized pharmaceutical formulations and administration devices

Medical Injection Molding Market Trends to Continue in 2021

  • Standardizing materials, consolidating supply bases to full-service suppliers (R&D, Tooling, Production and Packaging), and outsourcing support and auxiliary services of tooling, material purchase, packaging will enable overall cost reductions.

Preferred Sourcing Destination

  • Europe and North America are the preferred destinations for medical molding, influenced by parameters like quality and regulation
  • China, though cost effective, is deemed unsatisfactory regarding western markets’ quality requirements

Customer Base

  • Lifescience (medical, pharma and biotech) contributes to 13 – 14% of the overall revenue among global injection molders
  • A majority of medical molders cater across industries, while around 20% focus only on medical applications

High Competition Among Companies

  • The medical injection molding supply market is highly competitive with the top suppliers continuously innovating and having a high supplier power
  • Around 14% of the injection molded plastic demand comes from low-volume healthcare device companies compared to other end users, hence the buyer’s negotiation power varies from low to medium

Material Trend

  • Innovative protective additives, coatings, bioresorbables, biocompatibles, highly purified and engineered plastics are the new material opportunities seen for medical applications
  • Arkema, Covestro, ConMed Linvatec, TOPAS, MMATech, RTP Company, and Solvay are the key companies for material innovations for medical applications

Medical Injection Molding Technology Trends

  • A large number of technology and material innovations were seen in 2018. Predictive systems, remote monitoring, advanced robots with industry 4.0, and all-electric presses were some of the top innovations within the injection molding space

All-Electric Presses

  • All electric molding and pressing are trending for manufacturing facilities with limited space. This technology is also quieter and cleaner, providing a better working environment

Automation

  • Robot and automation system manufacturers are innovating constantly to provide advanced robots with remote access and an overall reduction in manufacturing lead time
  • Collaboration among injection mold manufacturers and automation system providers is producing integrated units with improved speed and automation

Remote Access

  • Applications and software that can be integrated into the injection molding machines as process monitoring systems are being developed by manufacturers
  • These provide remote access to production data and can enable a reduction in parts replacement

3D Printing

  • Cost and speed are the major benefits of 3D injection molding, wherein the costs are 60–75 % less than for most molding products
  • They can hold up to 50 to 100 shots using resins such as ABS, nylon, polycarbonate, polypropylene, etc. The pitfalls are material finish, machine throughput, tolerance, and limited material options



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