This document summarizes a roundtable discussion between experts on current trends in pharmaceutical outsourcing. The experts discussed how consolidation in the pharmaceutical industry has led to CMOs focusing more on becoming full-service partners. They noted key drivers for outsourcing have shifted from cost to quality, speed, and gaining specialized expertise. CMOs need to invest in new technologies, maintain high quality, and form strategic partnerships to remain competitive in this evolving landscape. Effective communication and understanding between partners is important for developing win-win relationships. Globalization also presents challenges for outsourcing that require addressing regulatory and quality issues across different markets.
Strategies for becoming_a_preferred_providerTruong Pham
This document summarizes a roundtable discussion with representatives from several contract manufacturing organizations on the trend of pharmaceutical companies consolidating their supplier base to work with fewer preferred providers.
The representatives observed that pharmaceutical companies are pursuing this approach to gain efficiencies from managing fewer relationships and to foster more strategic partnerships. Larger pharmaceutical companies are primarily driving this trend. When a contract manufacturer becomes a preferred provider, the relationship changes to involve more transparency, commitment to long term planning, and integration between the companies. The key factors for a contract manufacturer to become a preferred provider include having a strong track record of delivery, a customer-centric approach, and transparency to build trust in the relationship.
Global Pharmaceutical Contract Manufacturing Resource Pack 2011Veronica Araujo
This document provides an overview of the global pharmaceutical contract manufacturing industry. It discusses key reasons why pharmaceutical companies outsource manufacturing, including lack of internal capacity, expertise, and the potential for cost savings. The most commonly outsourced areas of production are finished medicines. Emerging markets like India, China, and others offer lower costs and are attractive outsourcing destinations. However, outsourcing also presents challenges such as language/cultural barriers, meeting regulatory/quality requirements, and managing distant relationships. Overall, cost savings remain the top motivation for the 60% of pharmaceutical and biopharmaceutical manufacturing that is outsourced globally.
This document provides an overview of strategies that can help biotechnology companies unlock value in R&D. It discusses how value is often not recognized by stakeholders in a timely manner due to inefficiencies in traditional drug development. Three strategies are highlighted that can address this - precision medicine using biomarkers to identify patient subgroups, adaptive clinical trial designs that allow for real-time modifications, and precompetitive collaborations between companies. These approaches help reduce R&D risk, costs and time, while generating more evidence for payers. They allow resources to be used more efficiently to focus on assets most likely to succeed. The document also includes perspectives from industry experts on how these strategies impact different stages of development and help recognize the value created by biotech
Thinking Beyond Compliance Medical Device WhitepaperJenna Dudevoir
This white paper is based on a research study with leading medical device companies - from startups to multibillion dollar enterprises - to explore how they are balancing new product development with compliance requirements.
How does the licensing process differ for in-licensing and out-licensing comp...daisyrmuzzio
PHARMA & BIOTECH LICENSING & PARTNERING:
Filling the Pipeline & Growing Market Share Through Strategic Deal-Making-- March 2-3- San Diego California
The Baylor Licensing Group had a productive year in FY 2014, executing 59 new licensing transactions including 9 agreements with new startup companies commercializing Baylor technologies. BLG also received 118 invention disclosures and filed over 50 new patent applications. BLG's responsibilities have expanded to include negotiating material transfer agreements, sponsored research agreements, and other industry agreements in addition to license agreements. BLG aims to improve processes and provide better service to faculty and industry partners.
Strategies for Conducting New Product Scientific Assessment - Yavuz SILAY - D...Yavuz Silay
Strategies for Conducting New Product Scientific Assessment - Due Diligence - New Strategies for Successful Licensing Acquisitions , DIA , Session Panel, June 22 2008,
- Indian pharmaceutical companies have increased R&D spending and are targeting international companies for contract research and manufacturing deals.
- The global pharmaceutical outsourcing market was worth $57.2 billion in 2007 and is expected to grow to $76 billion by 2010, with contract research and manufacturing services making up $55.48 billion in 2007.
- The Indian pharmaceutical outsourcing market was valued at $1.27 billion in 2007 and is projected to reach $3.33 billion by 2010, growing at a CAGR of 37.6%.
Strategies for becoming_a_preferred_providerTruong Pham
This document summarizes a roundtable discussion with representatives from several contract manufacturing organizations on the trend of pharmaceutical companies consolidating their supplier base to work with fewer preferred providers.
The representatives observed that pharmaceutical companies are pursuing this approach to gain efficiencies from managing fewer relationships and to foster more strategic partnerships. Larger pharmaceutical companies are primarily driving this trend. When a contract manufacturer becomes a preferred provider, the relationship changes to involve more transparency, commitment to long term planning, and integration between the companies. The key factors for a contract manufacturer to become a preferred provider include having a strong track record of delivery, a customer-centric approach, and transparency to build trust in the relationship.
Global Pharmaceutical Contract Manufacturing Resource Pack 2011Veronica Araujo
This document provides an overview of the global pharmaceutical contract manufacturing industry. It discusses key reasons why pharmaceutical companies outsource manufacturing, including lack of internal capacity, expertise, and the potential for cost savings. The most commonly outsourced areas of production are finished medicines. Emerging markets like India, China, and others offer lower costs and are attractive outsourcing destinations. However, outsourcing also presents challenges such as language/cultural barriers, meeting regulatory/quality requirements, and managing distant relationships. Overall, cost savings remain the top motivation for the 60% of pharmaceutical and biopharmaceutical manufacturing that is outsourced globally.
This document provides an overview of strategies that can help biotechnology companies unlock value in R&D. It discusses how value is often not recognized by stakeholders in a timely manner due to inefficiencies in traditional drug development. Three strategies are highlighted that can address this - precision medicine using biomarkers to identify patient subgroups, adaptive clinical trial designs that allow for real-time modifications, and precompetitive collaborations between companies. These approaches help reduce R&D risk, costs and time, while generating more evidence for payers. They allow resources to be used more efficiently to focus on assets most likely to succeed. The document also includes perspectives from industry experts on how these strategies impact different stages of development and help recognize the value created by biotech
Thinking Beyond Compliance Medical Device WhitepaperJenna Dudevoir
This white paper is based on a research study with leading medical device companies - from startups to multibillion dollar enterprises - to explore how they are balancing new product development with compliance requirements.
How does the licensing process differ for in-licensing and out-licensing comp...daisyrmuzzio
PHARMA & BIOTECH LICENSING & PARTNERING:
Filling the Pipeline & Growing Market Share Through Strategic Deal-Making-- March 2-3- San Diego California
The Baylor Licensing Group had a productive year in FY 2014, executing 59 new licensing transactions including 9 agreements with new startup companies commercializing Baylor technologies. BLG also received 118 invention disclosures and filed over 50 new patent applications. BLG's responsibilities have expanded to include negotiating material transfer agreements, sponsored research agreements, and other industry agreements in addition to license agreements. BLG aims to improve processes and provide better service to faculty and industry partners.
Strategies for Conducting New Product Scientific Assessment - Yavuz SILAY - D...Yavuz Silay
Strategies for Conducting New Product Scientific Assessment - Due Diligence - New Strategies for Successful Licensing Acquisitions , DIA , Session Panel, June 22 2008,
- Indian pharmaceutical companies have increased R&D spending and are targeting international companies for contract research and manufacturing deals.
- The global pharmaceutical outsourcing market was worth $57.2 billion in 2007 and is expected to grow to $76 billion by 2010, with contract research and manufacturing services making up $55.48 billion in 2007.
- The Indian pharmaceutical outsourcing market was valued at $1.27 billion in 2007 and is projected to reach $3.33 billion by 2010, growing at a CAGR of 37.6%.
Cros and other_outsourced_pharmaceutical_support_services_m_a_drivers_and_trendsAllu Sridhar Venkat
CROs (Contract Research Organizations) provide outsourced services to support pharmaceutical companies' research and development processes. This document discusses trends in the CRO industry, including drivers of mergers and acquisitions. It notes that the CRO market is expected to grow to over $30 billion by 2018 due to increasing biopharma R&D spending and the trend of outsourcing more services. Consolidation in the industry will likely continue, fueled by both strategic buyers seeking new capabilities and private equity firms. Specialized service providers in areas like patient recruitment and clinical technology remain a focus for larger CRO players.
The healthcare supply chain faces increasing pressures from growing complexity, global demand, and quality issues. The current supply chain model will not be able to meet these challenges. Developing new capabilities around segmentation, agility, measurement, alignment and collaboration can help transform supply chain performance. This would lower costs, improve access to healthcare, and enhance patient safety, while also providing strategic benefits to companies. Transforming healthcare supply chains requires an integrated, cross-functional effort.
Historically, the medical device industry has been highly attractive and relatively stable. As a consequence, established players have been able to compete successfully across the device spectrum, applying common business models and processes without much need for differentiation.
The future, however, is very different as disruptive change is underway. Companies will need to look at new segments and offer end-to-end solutions to secure additional revenue and maintain their profit margins.
The pharmaceutical industry is facing challenges developing new drugs due to limited knowledge of biology and chemistry. There are only about 500 validated drug targets and 9,500 known chemical compounds. The industry has relied on developing oral small-molecule drugs but is running out of viable targets and compounds. To succeed in the future, companies will need to accelerate target validation, invest more in new areas like genomics and proteomics, broaden their portfolios, and increase collaboration with external partners to gain expertise in areas like biologics development.
Future Pharma Trends - Long-term opportunities tempered by short-term challengesscottosur
An overview of the key trends shaping the pharmaceutical industry today, and those that are set to play a central role in the future, as companies transition towards a new business model: Pharma 2.0.
Provides key strategies and trends shaping the future of the pharmaceutical industry. Examines the impact of the Obama administration on US healthcare, and the implications for Pharma. Assesses the implications of the current economic and financial situation on healthcare. Analyzes key growth drivers and resistors set to shape Pharma\'s future.
Contact me at sosur@datamonitor.com to learn more!
This document discusses how pharmaceutical companies can improve clinical development and manufacturing processes through product lifecycle management (PLM). It identifies 7 key business processes for transforming R&D operations: 1) drug development program management, 2) regulatory archive management, 3) clinical trial management, 4) scale-up and commercial manufacturing, 5) quality management, 6) packaging and marketing asset management, and 7) global product registration. Implementing PLM using Oracle's solutions can deliver ROI by improving productivity, reducing time to market, and lowering development costs.
Clinical trial transparency requirements are becoming more complex, with evolving regulations and demands for greater disclosure. This creates compliance risks for sponsors. A technology solution is needed to manage clinical trial content, automate disclosure processes, and ensure accuracy and timeliness across global registries. An effective solution incorporates a platform approach, risk-based validation, SaaS deployment model, and content management foundation to address this challenge. Technology can help sponsors improve efficiency, mitigate risks, and respond to demands for increased transparency.
The CRO industry is valued at $25-30 billion globally and is growing at a rate of 7-9% annually. Preclinical services make up 25% of spending while phases I-IV clinical trials account for 75%. Growth has been driven by increasing trial volumes, complexity, and the ability of CROs to perform services more cost efficiently. Top CROs now account for 50% of the market. Emerging trends include personalized medicine approaches and use of big data, virtual trials, and digital biomarkers. To remain competitive, large CROs need to innovate in these areas and develop new models to better serve smaller biotechs and pharmaceutical companies.
This document analyzes and dispels five common myths about the drug delivery industry. It argues that drug delivery has delivered many new products, the market is growing not declining, the business model can be sustainable, product line extensions using drug delivery approaches are effective strategies, and drug delivery companies offer diverse technologies, not just similar controlled release solutions. The drug delivery industry plays a key role in addressing challenges in pharma by developing improved treatment options.
This document summarizes research examining factors that impact the valuation of biotechnology firms. It finds that advancement of drugs through clinical trials is associated with increased firm value, while drug failures are associated with decreased value. Surprisingly, partnerships and alliances do not seem to result in better performance than independent firms. The presence of medical doctors on boards of directors is associated with higher valuation metrics. Small cap biotech firms seem less likely to get drug approvals, possibly because promising small firms are acquired. Higher approval rates are seen for AIDS/cancer drugs and when financiers make up more of the board.
Disseminate Clinical Data Early to Support Payer Coverage DecisionsTodd Berner MD
This document summarizes Todd Berner's presentation on early dissemination of clinical data to support payer coverage decisions. The presentation discusses comparative effectiveness research standards and how cost, comparators, and ambiguous results should be handled. It also addresses tailoring drug development to patient heterogeneity and biomarkers. Developing an open dialogue with payers throughout drug development is emphasized to demonstrate clinical and economic value. Field teams can establish relationships, disseminate outcomes data, and conduct research to support products. The goal is for clinical programs to demonstrate value through meaningful endpoints and real-world evidence.
Technology is disrupting the process behind drug development. Growing realization that current clinical trial strategies are not sustainable or feasible means one thing - change. But, where do pharmaceutical companies go from here? An integrated clinical trial ecosystem will arise through leveraging emerging business technologies. But, are companies prepared to take advantage?
Biotech revolution changed the pharmaceutical industry, triggering a wave of risky collaborations between rivals. Based on the research findings, we answer the question why cooperation in the field of immuno-oncology is a better strategy for Pfizer and Merck KGaA, which aim to achieve competitive advantage quickly and with minimum effort. Combining their assets and core expertise companies realize benefits of greater size and variety in the conduct of research, development and commercializing of their new breakthrough therapy for cancer treatment.
A presentation I did for my Leadership and Special Topics in Pharmaceutical Marketing and Management class on social media. I completed this project with Tae Lee.
BJC HealthCare and Medtronic won awards for innovative supply chain initiatives in healthcare. BJC partnered with Cardinal Health and Cook Medical to centralize medical device inventory, providing visibility and reducing costs. Medtronic developed a program to manage hospital cath labs end-to-end, creating cost savings and improved outcomes for providers. Both winners demonstrated collaboration across the healthcare value chain can improve efficiency, lower costs and enhance patient care.
McKinsey Sağlık Tedarik Zinciriyle, FMCG Tedarik Zinciri karşılaştırıyor. Sağlık Tedarik Zincirindeki iyileştirme fırsatına ve toplumsal boyutuna dikkat çekiyor.
This document discusses the "value challenge" facing the biopharmaceutical industry. It conducted a global survey of 399 life sciences executives and interviewed experts. The key findings are:
1) Demonstrating value is a significant and long-term challenge for most drug companies worldwide. While financial pressures have increased scrutiny, demands for proof of value have evolved for decades.
2) Many industry stakeholders, especially biopharmaceutical companies, lack confidence in their ability to respond effectively to the value challenge.
3) Companies are experimenting with various strategies to address value but have not converged on any single approach across business models, R&D, or commercial strategies.
The document provides biographies of three executives from Reimbursement Intelligence: Rhonda Greenapple, Julie Schachter, and Maxim Miller. It then summarizes an article about challenges faced by the pharmaceutical industry during product development and strategies to optimize commercial opportunities. The summary identifies four critical steps in product development covered in the article: proof of concept, opportunity identification, pre-launch planning, and post-launch/life cycle management. It emphasizes the importance of understanding reimbursement and health outcomes at each step to maximize access and commercial success of new products.
This document discusses strategies for maximizing the success of partnerships between pharmaceutical/biotech companies (sponsors) and contract research organizations (CROs). It notes that while outsourcing is growing, productivity remains a challenge as the number of new drugs reaching the market is flat. True partnerships between sponsors and CROs are needed to drive gains in productivity. Critical factors for successful partnerships include having senior-level strategic involvement rather than procurement-driven, encouraging information sharing between multiple partners, and sponsors providing long-term visibility of objectives.
Advances and investment in digital health is growing at an incredible rate and Contract Manufacturing Organizations and Contract Development and Manufacturing Organizations are becoming an essential part of the new pharma value chain. From wearables, to apps, to digital platforms, the data and efficiencies generated by these innovations are opening up important avenues across the pharma ecosystem. As pressure on improving drug development heats up, data, digital and technological innovations are critical to delivering the desired business and patient outcomes, promoting significantly more networking and outsourcing strategies. CMOs are evolving from service providers to strategic partners. CMOs now cover the entire value chain of pharma production, including specialized services such as R&D.
Cros and other_outsourced_pharmaceutical_support_services_m_a_drivers_and_trendsAllu Sridhar Venkat
CROs (Contract Research Organizations) provide outsourced services to support pharmaceutical companies' research and development processes. This document discusses trends in the CRO industry, including drivers of mergers and acquisitions. It notes that the CRO market is expected to grow to over $30 billion by 2018 due to increasing biopharma R&D spending and the trend of outsourcing more services. Consolidation in the industry will likely continue, fueled by both strategic buyers seeking new capabilities and private equity firms. Specialized service providers in areas like patient recruitment and clinical technology remain a focus for larger CRO players.
The healthcare supply chain faces increasing pressures from growing complexity, global demand, and quality issues. The current supply chain model will not be able to meet these challenges. Developing new capabilities around segmentation, agility, measurement, alignment and collaboration can help transform supply chain performance. This would lower costs, improve access to healthcare, and enhance patient safety, while also providing strategic benefits to companies. Transforming healthcare supply chains requires an integrated, cross-functional effort.
Historically, the medical device industry has been highly attractive and relatively stable. As a consequence, established players have been able to compete successfully across the device spectrum, applying common business models and processes without much need for differentiation.
The future, however, is very different as disruptive change is underway. Companies will need to look at new segments and offer end-to-end solutions to secure additional revenue and maintain their profit margins.
The pharmaceutical industry is facing challenges developing new drugs due to limited knowledge of biology and chemistry. There are only about 500 validated drug targets and 9,500 known chemical compounds. The industry has relied on developing oral small-molecule drugs but is running out of viable targets and compounds. To succeed in the future, companies will need to accelerate target validation, invest more in new areas like genomics and proteomics, broaden their portfolios, and increase collaboration with external partners to gain expertise in areas like biologics development.
Future Pharma Trends - Long-term opportunities tempered by short-term challengesscottosur
An overview of the key trends shaping the pharmaceutical industry today, and those that are set to play a central role in the future, as companies transition towards a new business model: Pharma 2.0.
Provides key strategies and trends shaping the future of the pharmaceutical industry. Examines the impact of the Obama administration on US healthcare, and the implications for Pharma. Assesses the implications of the current economic and financial situation on healthcare. Analyzes key growth drivers and resistors set to shape Pharma\'s future.
Contact me at sosur@datamonitor.com to learn more!
This document discusses how pharmaceutical companies can improve clinical development and manufacturing processes through product lifecycle management (PLM). It identifies 7 key business processes for transforming R&D operations: 1) drug development program management, 2) regulatory archive management, 3) clinical trial management, 4) scale-up and commercial manufacturing, 5) quality management, 6) packaging and marketing asset management, and 7) global product registration. Implementing PLM using Oracle's solutions can deliver ROI by improving productivity, reducing time to market, and lowering development costs.
Clinical trial transparency requirements are becoming more complex, with evolving regulations and demands for greater disclosure. This creates compliance risks for sponsors. A technology solution is needed to manage clinical trial content, automate disclosure processes, and ensure accuracy and timeliness across global registries. An effective solution incorporates a platform approach, risk-based validation, SaaS deployment model, and content management foundation to address this challenge. Technology can help sponsors improve efficiency, mitigate risks, and respond to demands for increased transparency.
The CRO industry is valued at $25-30 billion globally and is growing at a rate of 7-9% annually. Preclinical services make up 25% of spending while phases I-IV clinical trials account for 75%. Growth has been driven by increasing trial volumes, complexity, and the ability of CROs to perform services more cost efficiently. Top CROs now account for 50% of the market. Emerging trends include personalized medicine approaches and use of big data, virtual trials, and digital biomarkers. To remain competitive, large CROs need to innovate in these areas and develop new models to better serve smaller biotechs and pharmaceutical companies.
This document analyzes and dispels five common myths about the drug delivery industry. It argues that drug delivery has delivered many new products, the market is growing not declining, the business model can be sustainable, product line extensions using drug delivery approaches are effective strategies, and drug delivery companies offer diverse technologies, not just similar controlled release solutions. The drug delivery industry plays a key role in addressing challenges in pharma by developing improved treatment options.
This document summarizes research examining factors that impact the valuation of biotechnology firms. It finds that advancement of drugs through clinical trials is associated with increased firm value, while drug failures are associated with decreased value. Surprisingly, partnerships and alliances do not seem to result in better performance than independent firms. The presence of medical doctors on boards of directors is associated with higher valuation metrics. Small cap biotech firms seem less likely to get drug approvals, possibly because promising small firms are acquired. Higher approval rates are seen for AIDS/cancer drugs and when financiers make up more of the board.
Disseminate Clinical Data Early to Support Payer Coverage DecisionsTodd Berner MD
This document summarizes Todd Berner's presentation on early dissemination of clinical data to support payer coverage decisions. The presentation discusses comparative effectiveness research standards and how cost, comparators, and ambiguous results should be handled. It also addresses tailoring drug development to patient heterogeneity and biomarkers. Developing an open dialogue with payers throughout drug development is emphasized to demonstrate clinical and economic value. Field teams can establish relationships, disseminate outcomes data, and conduct research to support products. The goal is for clinical programs to demonstrate value through meaningful endpoints and real-world evidence.
Technology is disrupting the process behind drug development. Growing realization that current clinical trial strategies are not sustainable or feasible means one thing - change. But, where do pharmaceutical companies go from here? An integrated clinical trial ecosystem will arise through leveraging emerging business technologies. But, are companies prepared to take advantage?
Biotech revolution changed the pharmaceutical industry, triggering a wave of risky collaborations between rivals. Based on the research findings, we answer the question why cooperation in the field of immuno-oncology is a better strategy for Pfizer and Merck KGaA, which aim to achieve competitive advantage quickly and with minimum effort. Combining their assets and core expertise companies realize benefits of greater size and variety in the conduct of research, development and commercializing of their new breakthrough therapy for cancer treatment.
A presentation I did for my Leadership and Special Topics in Pharmaceutical Marketing and Management class on social media. I completed this project with Tae Lee.
BJC HealthCare and Medtronic won awards for innovative supply chain initiatives in healthcare. BJC partnered with Cardinal Health and Cook Medical to centralize medical device inventory, providing visibility and reducing costs. Medtronic developed a program to manage hospital cath labs end-to-end, creating cost savings and improved outcomes for providers. Both winners demonstrated collaboration across the healthcare value chain can improve efficiency, lower costs and enhance patient care.
McKinsey Sağlık Tedarik Zinciriyle, FMCG Tedarik Zinciri karşılaştırıyor. Sağlık Tedarik Zincirindeki iyileştirme fırsatına ve toplumsal boyutuna dikkat çekiyor.
This document discusses the "value challenge" facing the biopharmaceutical industry. It conducted a global survey of 399 life sciences executives and interviewed experts. The key findings are:
1) Demonstrating value is a significant and long-term challenge for most drug companies worldwide. While financial pressures have increased scrutiny, demands for proof of value have evolved for decades.
2) Many industry stakeholders, especially biopharmaceutical companies, lack confidence in their ability to respond effectively to the value challenge.
3) Companies are experimenting with various strategies to address value but have not converged on any single approach across business models, R&D, or commercial strategies.
The document provides biographies of three executives from Reimbursement Intelligence: Rhonda Greenapple, Julie Schachter, and Maxim Miller. It then summarizes an article about challenges faced by the pharmaceutical industry during product development and strategies to optimize commercial opportunities. The summary identifies four critical steps in product development covered in the article: proof of concept, opportunity identification, pre-launch planning, and post-launch/life cycle management. It emphasizes the importance of understanding reimbursement and health outcomes at each step to maximize access and commercial success of new products.
This document discusses strategies for maximizing the success of partnerships between pharmaceutical/biotech companies (sponsors) and contract research organizations (CROs). It notes that while outsourcing is growing, productivity remains a challenge as the number of new drugs reaching the market is flat. True partnerships between sponsors and CROs are needed to drive gains in productivity. Critical factors for successful partnerships include having senior-level strategic involvement rather than procurement-driven, encouraging information sharing between multiple partners, and sponsors providing long-term visibility of objectives.
Advances and investment in digital health is growing at an incredible rate and Contract Manufacturing Organizations and Contract Development and Manufacturing Organizations are becoming an essential part of the new pharma value chain. From wearables, to apps, to digital platforms, the data and efficiencies generated by these innovations are opening up important avenues across the pharma ecosystem. As pressure on improving drug development heats up, data, digital and technological innovations are critical to delivering the desired business and patient outcomes, promoting significantly more networking and outsourcing strategies. CMOs are evolving from service providers to strategic partners. CMOs now cover the entire value chain of pharma production, including specialized services such as R&D.
1. Mergers and acquisitions are increasing in the pharmaceutical sector as companies seek to gain access to new drugs, save costs, and realize synergies. However, past M&A activity in the sector showed uneven success, with integration challenges hindering results.
2. Information technology can significantly impact whether an M&A deal succeeds by enabling efficient integration of operations, processes, and systems or causing delays and inefficiencies if not properly planned.
3. CIOs and life sciences companies should consider IT early in M&A planning to facilitate communication and collaboration from the start, standardize systems to reduce costs, and ensure flexible IT infrastructure can support both the initial transaction and long-term business strategy.
Best Practices, LLC conducted a benchmarking study of global strategic marketing organizations supporting oncology products and programs. The study found that large companies spend on average $805,000 per pipeline program and $6.2 million per in-market product. Marketing and market intelligence activities receive over half of strategic marketing budgets on average. Ensuring collaboration and understanding new technologies, markets, and stakeholders will be critical to strategic marketing success in the next 2-3 years.
The Healthtech Exits site tracks deals and trends in a vital sector. Our goal is to provide relevant records and tools to serve the health technology sector. We want to be a resource for executives and investors in health technologies companies who are considering their strategic growth and exit options in today’s environment.
1st Riyadh Marketing Club (Introduction to Business Development Management) ...Mahmoud Bahgat
#Mahmoud_Bahgat
#Marketing_Club
Join us by WhatsApp to me 00966568654916
*اشترك في صفحة ال Marketing Club* عالفيسبوك
https://www.facebook.com/MarketingTipsPAGE/
*اشترك في جروب ال Marketing Club* عالفيسبوك
https://www.facebook.com/groups/837318003074869/
*Marketing Club Middle East*
25 Meetings in 6 Cities in 1 year & 2 months
Since October 2015
*We have 6 groups whatsapp*
*for almost 600 marketers*
From all middle east
*since 5 years*
& now 10 more groups
For Marketing Club Lovers as future Marketers
أهم حاجة الشروط
*Only marketers*
From all Industries
No students
*No sales*
*No hotels Reps*
*No restaurants Reps*
*No Travel Agents*
*No Advertising Agencies*
*Many have asked to Attend the Club*
((We Wish All can Attend,But Cant..))
*Criteria of Marketing Club Members*
•••••••••••••••••••••••••••••••••••••
For Better Harmony & Mind set.
*Must be only Marketer*
*Also Previous Marketing experience*
●Business Managers
●Country Manager,GM
●Directors, CEO
Are most welcomed to add Value to us.
■■■■■■■■■■■■■■■■
《 *Unmatched Criteria*》
Not Med Rep,
Not Key Account,
Not Product Specialist,
Not Sales Supervisor,
Not Sales Manager,
●●●●●●●●●●●●●●●●●●
But till you become a marketer
you can join other What'sApp group
*Marketing Lover Future Club Group*
■■■■■■■■■■■■■■■■
《 *Unmatched Criteria*》
For Conflict of Intrest
*Also Can't attend*
If Working in
*Marketing Services Provider*
=not *Hotel* Marketers
=not *Restaurant* Marketers
=not *Advertising* Marketer
=not *Event Manager*
=not *Market Researcher*.
■■■■■■■■■■■■■■■■
■■■■■■■■■■■■■■■■
*this Club for Only Marketers*
Very Soon we will have
*Business Leaders Club*
For Sales Managers & Directors
Will be Not for Markters
●●●●●●●●●●●●●●●●●●●●
■ *Only Marketers* ■
*& EPS Marketing Diploma*
●●●●●●●●●●●●●●●●●●●●
Confirm coming by Pvt WhatsApp
*To know the new Location*
*#Mahmoud_Bahgat*
00966568654916
*#Marketing_Club*
http://goo.gl/forms/RfskGzDslP
*اشترك بصفحة جمعية الصيادلة المصريين* عالفيسبوك
https://lnkd.in/fucnv_5
■ *Bahgat Facbook Page*
https://lnkd.in/fVAdubA
■ *Bahgat Linkedin*
https://lnkd.in/fvDQXuG
■ *Bahgat Twitter*
https://lnkd.in/fmNC72T
■ *Bahgat YouTube Channel*
https://www.Youtube.com /mahmoud bahgat
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*#Mahmoud_Bahgat*
*#Legendary_ADLAND*
www.TheLegendary.info
The medical devices industry is experiencing fast growth rates of 5-15% annually due to factors like aging populations and emerging middle classes. However, growth is being constrained by rising costs pressures like tightening healthcare budgets and lack of consumer willingness to pay high prices. To address this, medical device companies need to differentiate their products, optimize their portfolios, and streamline their operations through measures like process improvements and organizational redesign. Innovation strategies also need to adapt to the new challenges around shorter product lifecycles and the need for higher per-innovation returns.
The opportunities for the Indian pharmaceutical industry are immense but increasing competition, increasing regulatory pressures and stringent price control means that companies need to constantly improve their costs and service levels. Supply chain efficiencies will play a crucial role going forward and will become the key differentiator for companies. Companies will therefore need to adopt an approach that encompasses strategic, tactical and operational interventions to remain competitive and create value for their customers
This document provides an abstract and table of contents for a research paper that examines the impact of communication on mergers and acquisitions in the life sciences industry, using the Pfizer-Wyeth acquisition as a case study. The abstract outlines that the paper aims to understand how strategic communication can impact M&A business outcomes and reputation, and how it can emphasize clinical value. It also provides an overview of the paper's theoretical framework and methodology. The table of contents provides further detail on the structure and content of each chapter.
The document discusses how specialty pharmaceutical manufacturers can benefit from data-driven decision making. It notes that approximately 50% of medications pending approval are specialty-oriented, and developing these medications requires high financial investments of $50 million or more. Specialty manufacturers manage product lifecycles that differ from broadline manufacturers due to serving smaller, distinct patient populations. The document cites a study showing companies that use data-driven decision making experience 5-6% higher productivity. It argues that clear, real-time data can help specialty manufacturers make profitable decisions across a product's lifecycle to create lasting success.
Square Pharmaceuticals is the largest pharmaceutical company in Bangladesh. It has over 16 departments that handle functions like product management, marketing, finance, HR, and supply chain. Square produces over 400 medicines across various dosage forms like tablets, capsules, injections, liquids and inhalers. External factors affecting the pharmaceutical industry include political pressure on pricing, economic pressures reducing disposable income, an aging population, and increasing regulations.
This document discusses how life sciences companies can address challenges in the industry by adopting new technologies. It identifies trends putting pressure on companies, such as new regulations and shifting customer expectations. It then presents solutions that technology can provide: a new multi-channel commercial model to better engage customers; business agility through cloud-based platforms to accelerate innovation; and a focus on outcomes through data analytics and patient services to improve care. Adopting modern cloud technologies, the document argues, is key for companies to transform their business models and adapt to changes in the industry environment.
Beyond-the-pill: how to move from selling pills to value-added solutionsexecutiveinsight
The document discusses strategies for pharmaceutical companies to move beyond just selling pills to developing value-added services. It recommends that companies first undertake mapping to determine the optimal breadth and customization level of services, which can be categorized into archetypes. A rigorous review is then needed to identify what services to provide internally versus using external partners. While services have traditionally been free, new commercial models may be needed to sustain comprehensive service strategies and maximize value for stakeholders.
The document discusses how pharmaceutical companies are changing how they evaluate contract manufacturing organizations (CMOs). It describes the new "value proposition" approach, which focuses on generating the best value for customers through practices like open book calculations, buying manufacturing capacity, supply chain visibility and management. This entails strategic partnering between pharma companies and CMOs and changes their relationship from simply focusing on cost cutting to making the CMO the customer's supplier of choice. The value proposition approach requires a shift in mindset and more collaborative strategic thinking to effectively meet the complex demands of the pharmaceutical sector. CMOs that adopt this new approach will be better able to satisfy customers and remain competitive in the market.
The healthcare ecosystem is rapidly changing as it transitions to Pharma 3.0. In the past year, pharmaceutical companies have expanded their Pharma 3.0 initiatives by 78%, with nearly half of all initiatives launched in 2010 alone. However, pharmaceutical companies are still investing much less in Pharma 3.0 business model innovation than non-traditional players, who have invested an estimated $20 billion. The ecosystem has also grown more complex, as initiatives have expanded across more disease areas, technologies, and stages of care. The rapid rise of mobile health apps, especially smartphone apps, has been a major driver of new Pharma 3.0 initiatives. However, pharmaceutical investment in Pharma 3.0 remains far below what is needed
The document discusses emerging business and operational models in the pharmaceutical industry. It notes that the traditional vertically integrated model is shifting to a more fragmented model. It also discusses factors driving changes like rising costs and competition. The document analyzes current blockbuster and niche models and potential future models involving more specialization. It proposes a "progressive drug development model" to reduce risks and costs through targeted development.
This document discusses go-to-market strategies for medical device companies entering the China market. It outlines several options for finding distribution partners in China, including partnering with a manufacturer, investor, or technology park/incubator. Partnering with a manufacturer who has an existing distribution network provides access to call points. Partnering with an investor can provide funding and support to achieve success in China. Partnering with a technology park/incubator allows companies to attract foreign medical technologies. The document recommends building trust with prospective partners through in-person meetings before selecting a distribution strategy tailored to a company's product and needs.
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Outsourcing continues to be part of pharma’s business strategy.
To gain insights on current trends in outsourcing and the
implications for CMOs and CDMOs, Pharmaceutical Technology Europe
conducted a roundtable discussion with industry experts. Participants
included Elliott Berger, vice-president, Global Marketing and
Strategy, Catalent; Antonio Magnelli, senior vice-president, European
Commercial Operations, Patheon; Cynthia Wooge, Global Strategic
Marketing, SAFC; Frédéric Gaussens, vice-president, Global Strategy
and Business Development, SGS; and Peter Soelkner, managing
director of Vetter.
PTE: As we see more consolidation in the pharmaceutical
industry, what is the impact on contract manufacturing
and outsourcing trends? Are there any particular activities
that tend to be outsourced more than others?
Magnelli (Patheon): Every market always
moves naturally toward optimization, with the
aim of increasing competitiveness between
the main players. Every merger consequently
leads to natural consolidation of the business,
driven by supply-chain optimization. The CMO
market is following the same trend, moving more
toward consolidation, with the best performers
becoming full-service partners to the pharma industry, not serving
as only occasional suppliers. These partnerships not only focus on
the general capabilities of a CMO, but also on the possibility to offer
extended services to support clients from early stage to market.
Gaussens (SGS): The impact of consolidation in the pharma
industry can go both ways. For instance, on the one hand, you
could have a scenario where a larger pharmaceutical company
acquires another and the result can be that work that was previously
outsourced is immediately internalized on the directive of the
acquiring company. Typically, this action can be justified by the
acquiring company initially needing to evaluate any particular
capacities it may have as a result of the consolidation. This being
Moderated by
Adeline Siew, PhD,
editor of
Pharmaceutical
Technology Europe
Moving with the
Changing Tides of
Outsourcing
said, we can point to examples
where a consolidation represented
an opportunity. In the second type
of scenario, there are instances
where SGS has been able to leverage
its existing relationship with the
acquiring company to gain immediate
credibility with the acquired company.
Over the past decade, there has
been an evolution in the kinds of
activities that are outsourced. In the
past, contract analytical outsourcing
typically consisted of more routine or
‘commodity’ kinds of services. Large
pharmaceutical companies were
reluctant to outsource high-value
services and projects that required
more method development. However,
what you find now is that more
companies are open to contracting
out high-value activities such as
cell-based assays, formulation, and
biologics characterization.
Soelkner
(Vetter):
As we have
seen with the
consolidation
in the
pharmaceutical
and biotech
industry, there has also been similar
activity in the service partner
network that supports this industry.
Typically, large pharmaceutical
and biotech companies prefer to
have a small number of carefully
chosen long-term strategic partners
rather than a large number of single
contractors. This approach helps
reduce administrative oversight,
including handling and managing
efforts, while also helping to
negotiate price.
Outsourcing is often done when
either the drug or its corresponding
manufacturing process is highly
complex, or when in-house
production is not able to be
performed economically due to
the volume or special nature of the
drug. A further reason to outsource
manufacturing is the flexibility it
affords in being able to react quickly;
for example, having a partner to help
with fill and finish operations at times
of peak demand. Thus, the partners
are considered an extension of their
fill and finish network.
Berger (Catalent): There has been
a shift that has seen the pharma
Industry experts share their perspectives on the evolving
outsourcing landscape and how current trends are shaping the
increasingly competitive contract manufacturing sector.
2 Pharmaceutical Technology Europe March 2015 PharmTech.com
2. Outsourcing Trends
majors increasingly outsource to
a smaller number of suppliers that
possess a wide range of services,
technologies, and expertise.
These partnerships are starting
earlier in the drug development
process, sometimes in the late
discovery phase, because with more
challenging molecules, there is
increased need to help optimize the
API and formulations of new drugs,
encompass deeper engagement
including analytical and clinical
support, and last longer, through
late-stage clinical manufacturing,
scale up, and global commercial
manufacturing. Consolidation has also
resulted in increased interest from
Big Pharma in partnering on more
complex and specialized capabilities,
including drug development, instead
of just outsourcing space capacity.
Wooge (SAFC): A sizable increase
in outsourcing has been seen in
recent years, even among Big
Pharma. This trend is especially true
for APIs using specialized services
or technologies. An example in this
class are antibody drug conjugates
(ADCs), which require specialized
handling for highly active containment
and biologics processing, as well as
sophisticated analytical methodology
for their development and
manufacturing.
PTE: Outsourcing was
primarily driven by cost
reduction in the past, but
a lot has changed over the
years. What are the key drivers for
outsourcing today compared to the
past decade?
Wooge (SAFC):
The primary
drivers today
are quality and
speed to clinic for
new therapeutic
molecules. When
an innovator
company can partner with a CMO that
is highly experienced in the target
technology, efficiency in product
delivery can be gained along with
lower capital and resource usage
internally. In the case of ADC and
highly active compounds, specialized
handling and containment is required,
so these types of products are
outsourced to minimize capital outlay.
Berger (Catalent): Sponsors are
more focused on seeing solution
providers as long-term collaborators,
with whom they can have the
confidence and assurance of long-
term supplies where appropriate.
The complexity of products and
development projects is rapidly
increasing and the industry is looking
for specialized expertise to help bring
these products to market rather than
cost-based outsourcing of routine
activities.
Large pharmaceutical companies
continue to focus on its core
capabilities in developing new
drugs and taking them to market,
and outsourcing enables them to
conserve capital and energy in this
space as opposed to driving lower
costs. In the current market, the
need to outsource to gain specialized
expertise and technology, supplied
reliably and at high quality, far
outweighs the cost factor.
Soelkner (Vetter): Today,
large pharmaceutical and biotech
companies tend to focus their efforts
on the late stage development and
marketing activities for drugs in
special indications, such as cancer or
haemophilia drugs. They are primarily
concerned with their business
activities and will often cooperate
or merge with other companies
operating in the same area to bring
about synergies in these activities.
Because they focus on those
elements of the business, they often
outsource their fill and finish work to
specialty firms as much as possible.
In our discussions with larger
companies, it has been our
experience that price is not
necessarily the decisive factor in
choosing an outsource partner.
Rather, they are looking for a partner
that can support drug development
and manufacturing effectively and
efficiently.
Gaussens (SGS): In the past,
the relationship between the
pharmaceutical company and
the contract analytical service
provider was more transactional
and largely driven by cost. Today,
however, price alone is no longer
the main consideration. Drivers
now include strong project
management and more open, pro-
active communication. Additionally,
companies expect service providers
to have transparency with regards
to project issues that may arise, and
they expect to have a dialogue with
the service provider on resolution.
Successful service providers can then
set proper expectations with regards
to on-time delivery.
Magnelli (Patheon): Clients are
looking for a lean supply chain,
favouring service relationships
and partnerships over purely price
negotiations. The focus is now on
integrated support and partnerships
with shared mutual goals. Clients
share future pipeline opportunities,
allowing their CMO partner to grow
with them in a common direction.
Key drivers for success as a CMO
include the ability to foresee and
anticipate client needs as well as the
flexibility to adapt to expectations.
Every CMO has to evolve and create
an organization that is capable of
contributing to the client’s strategy,
not only guaranteeing them “units,”
but providing solutions that are
integrated and seamless.
PTE: As the outsourcing
landscape evolves,
how have clients’ priorities
and expectations
changed?
Soelkner (Vetter): As outsourcing
projects to qualified specialists
continue to increase, so too does the
expectation for high-quality results.
Customers today expect state-of-
the-art equipment, laboratories,
and filling lines at their partners’
sites to enhance the quality of their
manufactured drug. They also expect
the highest possible flexibility in
equipment and processes. To meet
the specific needs of a product, the
service provider must be able to
offer both small and large-scale filling
lines as well as stainless steel and
disposable equipment. The service
provider must also have the capability
to process various systems such as
bulk and presterilized glass, as well as
polymer drug-delivery systems.
Gaussens (SGS): Today, especially
with more biologics in development,
companies are looking for providers
that can serve as medium- to long-
term partners. The level of technical
competence is now more important,
as the types of services being
Pharmaceutical Technology Europe March 2015 3
3. Outsourcing Trends
outsourced has changed. This being
said, companies typically engage the
service provider with an initial project
to demonstrate their capabilities.
Here is where project management
and an open dialogue are key in
dealing with issues and setting
client expectations. Because failures
at this stage can impact product
development, companies are more
demanding with their expectations.
Consequently, they are more apt to
abandon a service provider lacking
in competence, whether it be project
management or technology-related.
With stakes so high, companies are
not inclined to babysit a service
provide nor a project.
Magnelli (Patheon): In addition
to a lean supply chain and strategic
partnership, clients expect robust
quality and continuity. It is important
to meet increased customer demand
for integrated global solutions and
improved quality and regulatory
experiences, through building a
culture committed to reliability
and scientific excellence. On-time
delivery, simplicity, speed and quality,
are essential in demonstrating
commitment and success to a client.
Our clients seek CMOs with clear
investment strategies for future
growth that will deliver on the
promise of speed to market as well as
simplified and reliable supply chains.
Wooge (SAFC): Expectations for
outsourcing have changed from
CMOs being a low-cost provider of
large-volume APIs to that of a partner
providing a high-value, collaborative
service to expedite delivery of highly
complex new products into the clinic
and through commercialization.
There is an emphasis on technical
excellence and regulatory compliance
and knowledge, in which the CMO
can reliably provide both the product
and the necessary support for
regulatory filings.
Berger (Catalent): Long-term
relationships with a smaller number
of suppliers require a joint governance
structure that fosters deeper, multi-
site global relationship building.
Better communication is at the heart
of a successful long-term relationship
and tools such as gate-review
techniques and transparent balanced
scorecards help toward continuous
improvement in cooperation. These
partnerships also need quality
agreements that unite the two parties
in a single supply and quality chain.
Big Pharma increasingly expects a
high level of expertise, quality and
innovation from the CDMOs that they
partner with, as their own R&D and
operational budgets are focused on
fewer priorities.
PTE: How can CMOs and
CDMOs remain
competitive? And what are
the attributes of a
strategic partnership that benefits
both parties?
Berger
(Catalent): CMOs
and CDMOs will
need to continue
to invest in new,
differentiating
technologies
that Big Pharma
does not possess in-house. By
collaborating early and enabling
pharmaceutical companies to bring
truly differentiated products to
market, both the payers and the
patients will ultimately benefit.
Additionally, suppliers will need
to provide customized solutions
to smaller innovators who are
increasingly pursuing more
molecules further into development
independently.
Maintaining investment in both
quality and reliability is paramount
to maintain exemplary regulatory
compliance. A key policy at Catalent,
for example, is to harmonize
and strengthen its global quality
management system and to go above
and beyond what is necessary by one
single regulatory body.
Wooge (SAFC): CMOs and CDMOs
will need to stay abreast of the rapidly
changing technical landscape to
ensure they can meet the demands
of novel products being developed. In
many cases, these new therapeutics
are complex and require multiple
components. Having a strong
supply-chain network or strategic
partnerships that enable the end-
to-end seamless delivery of APIs and
drug product will offer a competitive
advantage to allow innovators to
focus on product development
instead of logistics. These strategic
partnerships are most valuable when
the independent companies work
together as a single entity with the
client and share similar cultures and
harmonized operational practices.
Magnelli (Patheon): CMO
and CDMOs must be efficient to
compete, but the best way to remain
competitive is to focus on being a
highly reliable partner that provides
excellent quality and on-time delivery.
Becoming a preferred partner will,
in any case, be dependent on the
ability to create relationships aimed
at sharing company strategies.
Client pipelines are one of the main
drivers for a CMO/CDMO strategy
because they offer the possibility to
preview and foresee market needs.
CMOs must develop solutions that
lead to robust product formulations,
simplified supply chains, and take
customer needs from start to finish,
from API all the way to commercial
supply. Through these partnerships,
customers find cost-effective support
for the launch of new products,
reducing the cost and time needed to
get to market, which is a ‘win-win’ for
clients seeking fair pricing and CMOs
seeking profitability.
Soelkner (Vetter): A key success
factor for a CDMO to remain
competitive today is to focus on key
competencies. That means ‘more is
not always better.’ Rather, a contract
services company must decide which
attributes it wants to excel at and
how it wants to be perceived in the
market. For example, a CDMO might
offer a wide service portfolio, or offer
highly competitive prices. Or, it may
be perceived as one that focuses
on high quality, offering a great deal
of experience in handling complex
compounds and manufacturing
processes.
‘Win-win’ partnerships are born
when a solid working relationship
between both parties is established.
Of critical importance in the
creation of this partnership is the
understanding between both parties
of the strategy and the business
roadmap. To achieve this, good
communication among team
members and peers is necessary,
though not always easy to achieve.
Differences in corporate cultures and
business models as well as varying
levels of knowledge and experience at
all levels are just a few of the issues
4 Pharmaceutical Technology Europe March 2015 PharmTech.com
4. Outsourcing Trends
that can make communication among
parties more difficult.
Nonetheless, once a good level of
communication is reached, the basis
for both parties to benefit is created.
The sponsor company gets valuable
time and resources to concentrate
on its core competencies, and the
strategic partner is well aware of the
sponsor’s expectations.
PTE: Has the increasing
globalization of the
pharmaceutical industry
added new challenges to
outsourcing? How can these
challenges be addressed?
Gaussens
(SGS): There
are plenty of
challenges in
outsourcing in
an increasingly
global pharma
industry. For
instance, the trend over the past
decades was establishing operations
in Asia. For pharmaceutical
companies, the move made sense
given the fast growth in China and
India, with the promise of lower
costs. The reality, however, is that
issues such as regulation on the local
level as well as the expectation of
equivalent quality of service have
proven to be initial hurdles. Over the
past decade, there has been more
focus on these quality and regulatory
issues given the scrutiny of the US
FDA. These issues do not need to be
dealt with in more mature markets
such as North America or Europe.
Soelkner (Vetter): A major
factor affecting the outsourcing
business is indeed globalization.
Drugs continue to be sold on a global
scale, and therefore, any company
doing business globally must provide
solutions that meet the different
market needs efficiently and reliably.
Consider, for example, the Asia Pacific
(APAC) region; approximately 10 years
ago, the medicines produced within
this region were primarily intended
to be used only there. Today, there is
a growing increase in activities that
are designed to enlarge the customer
base for drugs manufactured within
APAC to be distributed to countries
outside of APAC. We expect this
activity to increase in the future.
With this change in distribution
comes increased challenge for
pharmaceutical companies and their
contract manufacturers who now
face competition from outside the
region. Manufacturing companies
must adapt to differing criteria of the
recipient countries if they are going to
be successful. For example, they have
to make certain that distinct quality
requirements are met for countries
located inside, as well as outside,
the APAC region. As they enter this
market, contract service providers
will be faced with these challenges
and must react accordingly.
Wooge (SAFC): Globalization
in the pharmaceutical industry
is a reality—and certainly offers
challenges, such as operating in
multiple time zones, different cultures
and languages, as well as dealing with
import/export issues and transport.
These challenges can be overcome
with strong project management
and standardized processes to
ensure all aspects flow together.
However, to be efficient, clear and
transparent communication is a must
to understand and mitigate the risks
at each step, and proactively provide
solutions as a team.
Magnelli (Patheon): The CDMO
market is becoming increasingly
global and companies must be able
to operate in international markets.
Pharmaceutical companies are
looking for the ability to work with
more than one manufacturing site
in a CDMO’s network, maintaining
regulatory compliance and
capabilities for clients. Offering
strategic services on a global scale
not only allows CMOs to serve
local geographic markets, but also
serves clients seeking long-lasting
relationships into the future.
Berger (Catalent): We believe
that local market access as well as
access to local talent are key. Service
providers constantly have to adapt
to frequent regulatory changes
and be on top of proposed shifts in
legislations to be able to advise their
clients through the process.
PTE: In your opinion, what
is the future outlook of
outsourcing?
Gaussens (SGS): The
future of outsourcing looks quite
good. Specifically, the addressable
market (i.e., the portion of the R&D
market that can be outsourced
because there are certain activities
that can never be contracted out) will
be broader than previously. According
to a recent Frost and Sullivan report,
the penetration rate of outsourced
services is presently between 25–30%
of the addressable market. Within
the next decade, it is conceivable
that this number can reach 40–50%
[QA: please provide reference for this
figure].
Berger (Catalent): The rate of
outsourcing will only increase.
Customers’ demands are becoming
more diverse and specialized, and the
need for partnering and collaborative
innovation with experts in such
fields can only be matched with
outsourcing.
Partnering enables pharma
to focus on capabilities and
minimize investment in specialized
technologies and capacity while
getting better products to patients
faster. For smaller companies, time
is the pressure to allow for a return
on investment to be made as soon as
possible, and they recognize they are
unable to be experts in every stage of
the development or even to manage
multiple suppliers well. Allied to
this, they need integrated expertise
in development, formulation,
technology, manufacturing, clinical,
and regulatory expertise for any
given dose form (e.g., extractables
and leachables testing in inhalation
products or intravenous bags) and in
given geographies (e.g., how ANVISA
audits compare to FDA audits).
Magnelli (Patheon): The near
future will bring further consolidation,
and success will depend on building
a strong global presence with
end-to-end, integrated offerings.
Outsourcing, specifically by small and
mid-size pharmaceutical companies,
will continue to increase. The
decision to outsource will be different
for big, medium, and small-sized
companies, depending on their core
strategies. Outsourcing isn’t done
just for financial reasons anymore.
Outsourcing allows customers to
find smart business solutions for
simplified and reliable supply chains.
This approach allows customers to
focus on market growth and new
Pharmaceutical Technology Europe March 2015 5
5. Outsourcing Trends
product launches with strategic
partners.
Soelkner (Vetter): In the injectable
area where our company is operating,
we see that further growth is
forecast, with biologics being the
major reason behind it. This growth
represents significant opportunities
for companies operating in the
contract services sector that
support pharmaceutical and biotech
companies.
Also, the continuing erosion of the
blockbuster model combined with the
fact that many promising new drugs
come from small biotech companies,
means further opportunity for
CDMOs to help guide these small
companies and provide support early
in the drug-development process.
CDMOs subsequently can also
continue their partnerships with large
pharmaceutical companies after an
out-licensing process is realized.
There are, however, challenges to
recognize, and a good deal of hard
work is required to overcome these
challenges. For example, there is an
ever-increasing regulatory oversight
of the contract services industry
that is necessary to enable the safe
manufacturing of drugs. This is a
factor that every company operating
in this sector must pay special
attention to if they want to succeed.
They must work hard in ensuring their
quality systems stay ahead of the
market.
Wooge (SAFC): The market for
outsourcing continues to look strong,
especially for complex technologies.
With the recent rise in quality
citations in API manufacturing sites,
especially in Asia, there will be an
even stronger emphasis on quality
and transparency in outsourced
programs. Organizations that have
earned excellent reputations as CMOs
will continue to be sought after as
valued partners. PTE
6 Pharmaceutical Technology Europe March 2015 PharmTech.com