Biopharmaceutical Fill-and-Finish Contract Manufacturing Study Shows Market Growth and New Opportunities
SAN JOSE, Calif. January 17, 2013 The market for biopharmaceutical contract fill-and-finish services reached $1.2 billion in 2012, an increase of 33% over the past two years. This growth results from the underlying growth in the biopharmaceutical market, expansion of services offered by fill-and-finish contract manufacturing organizations and the greater use of contract manufacturing organizations by pharmaceutical and biotechnology companies. Contract manufacturing organizations with traditional aseptic, small-molecule filling capacity have expanded their capabilities to meet the unique filling challenges of temperature sensitive and fragile protein drugs. The biotechnology industry continues to use fill-and-finish contract manufacturers to provide expertise, filling capacity and lyophilization as they focus on drug development and API manufacturing.

HighTech Business Decisions recently published the results of its findings in "Biopharmaceutical Contract Fill-and-Finish: Best Practices Study 2013." The long-term prospects for biopharmaceutical fill-and-finish contractors remain strong with growth opportunities in new presentations that offer improved convenience for both patients and healthcare providers. Other growth opportunities include new services associated with special handling of niche products and smaller dosage volumes. As a result of these growth opportunities, this study shows the worldwide market for biopharmaceutical fill-and-finish contract manufacturing will continue to expand through 2017, reaching $1.6 billion.

"Biopharmaceutical products are becoming increasingly complex requiring special technologies and handling. Capacity utilization rates at contract manufacturing organizations have improved somewhat from two years ago," said William Downey, president of HighTech Business Decisions. "The investment in new fill capacity by contract manufacturing organizations will be modest over the coming years; thereby keeping industry utilization rates stable. New opportunities exist as the industry evolves to be more flexible with broader offerings and increased capabilities."

The findings and analysis are in this 660-page industry report with over 200 summary data tables and charts gathered from extensive interviews and surveys with manufacturing directors of biopharmaceutical and biotechnology companies, and fill-and-finish contract manufacturing organizations. This report provides an in-depth look at the factors affecting the industry, including current industry practices, manufacturing technologies, outsourcing plans, capacity and demand, pricing policies and practices, prices paid and charged, market size, and industry trends.

New Comprehensive High Throughput Screening Study Finds HTS Laboratories Continue to Use New Approaches and Technologies to Increase Drug Discovery Success
SAN JOSE, Calif. July 24, 2012 HTS laboratories continue to adopt new technologies and practices that are leading to more effective drug discovery approaches. For example, the directors at HTS laboratories see an increase in the importance of phenotypic screens. In addition, there is a greater use of high content assays, and a greater emphasis on understanding the biologic relevance of targets screened at HTS laboratories. These trends have resulted in HTS laboratories screening fewer targets now than in the past, but with better results. The HTS directors report a greater proportion of their targets generating new drug leads.

Forty-two directors from HTS laboratories and twenty-five executives from suppliers of HTS products and services in Asia, Europe and North America were extensively interviewed in this recently published report, High Throughput Screening 2012: Improved Screening, Adapted Technologies and Enhanced Assays. This report describes the technologies and strategies being employed by HTS laboratories along with their spending trends, new projects and unmet needs.

The number and types of organizations operating HTS laboratories have changed over the past years. Academic centers and government agencies have ramped-up their screening operations, also contract research organizations have set up screening laboratories. The HTS laboratories at these organizations function differently compared to the HTS laboratories at drug innovator companies. This new report incorporates analysis and data from these different HTS segments, which provides a full depiction of the current HTS environment

William Downey, president of HighTech Business Decisions, explains, "High throughput screening continues to be a critical activity in drug discovery. At present, high throughput screening laboratories face the challenges of tighter budgets and the need to develop new drug candidates. HTS directors are meeting those challenges as they drive efficiency and innovation."

This 850-page industry report, High Throughput Screening 2012: Improved Screening, Adapted Technologies and Enhanced Assays was published in July 2012, and it is available from HighTech Business Decisions.

Biopharmaceutical Contract Manufacturing 2011:
New Participants, Expanded Services and Emerging Markets
SAN JOSE, Calif. October 27, 2011 The biopharmaceutical contract manufacturing market will grow between 5% and 10% a year over the next five years. With biotechnology companies increasing their reliance on biopharmaceutical contract manufacturing organizations ("CMOs") for production and other services, industry growth prospects remain cautiously optimistic. In this highly competitive environment, CMOs continue to invest in technologies for improving productivity. For example, CMOs are adopting disposable technologies that, along with high-expression cell lines, lessen the need for large-scale stainless steel tank capacity.

In HighTech Business Decisions' eleventh industry study "Biopharmaceutical Contract Manufacturing 2011: New Participants, Expanded Services and Emerging Markets," CMOs report current utilization rates have reached a low point. CMOs have experienced multiyear declines in their capacity utilization rates because of previous capacity expansions, improved manufacturing processes, and fewer biotechnology development projects. Over the next three years, CMOs expect capacity utilization to increase. Improving capacity utilization rates in the future will result from scaled-back capacity expansion plans and higher industry demand. Higher demand will come from new development projects, commercialization of current development projects, and the greater reliance on CMOs by pharmaceutical and biotechnology companies.

William Downey, president of HighTech Business Decisions, explains, "We extensively interviewed executives at both biotechnology and contractor companies worldwide. The consensus is that the CMO industry will grow, but the industry continues to undergo consolidations. Interestingly, the biotechnology industry's greater reliance on CMOs has led to a more collaborative working relationship between client and contractor; thereby aiding CMOs' long-term prospects."

The market for biopharmaceutical contract manufacturing remains at US $2.1 billion. Long-term growth rates have moderated from their previous double-digit levels; this is due in part to industry maturity and the recent recession. Overall, the CMOs are sanguine about their prospects. This 900-page report with 235 summary data tables and charts provides in-depth analysis of the dynamic factors affecting the industry, including new equipment purchases, disposable implementation, changes in outsource spending, capacity forecasts, and the need for contract manufacturing in low-cost regions of the world.

Biopharmaceutical Fill-and-Finish Contract Manufacturing Study Finds Opportunities Rising for Filling Unconventional Presentations
SAN JOSE, Calif. October 7, 2010 Biopharmaceutical parenteral manufacturing has expanded in recent years as more and more therapeutic biologics enter the market. Contract manufacturers with traditional aseptic, small molecule filling capacity have expanded their capabilities to meet the unique filling challenges of temperature sensitive and fragile protein drugs. The biotechnology industry continues to use fill-and-finish contract manufacturers to provide expertise, filling capacity and lyophilization as they focus on drug development and API manufacturing.

HighTech Business Decisions recently published the results of its findings in "Biopharmaceutical Fill-and-Finish: Best Practices Study 2010". Findings from this study show that the worldwide market for biopharmaceutical fill-and-finish contract manufacturing will reach US$0.9B in 2010. The long-term prospects for biopharmaceutical fill-and-finish contractors remain strong with growth opportunities in new presentations that offer improved convenience and comfort for patients and healthcare providers. Other growth opportunities include new services associated with special handling of niche products.

William Downey, president of HighTech Business Decisions, says, “Biopharmaceutical products are becoming increasingly complex that demand special technologies and handling. Although capacity utilization rates are below optimum levels, demand for contract fill-and-finish services will increase utilization rates in the future. New opportunities exist as the industry evolves to be more flexible with broader offerings and increased capabilities.”

The findings and analysis are in this 515-page industry report with over 180 summary data tables and charts gathered from interviews with 29 biomanufacturing and manufacturing directors of biopharmaceutical and biotechnology companies worldwide, and 12 biopharmaceutical fill-and-finish contract manufacturers. This report provides an in-depth look at the factors affecting the industry, including current industry practices, manufacturing technologies, outsourcing strategy, capacity and demand, pricing policies and practices, prices paid and charged, market size, and industry trends.

High Throughput Screening 2010 Study Finds HTS Laboratories Using Effective Screening Strategies and Innovative Technologies to Increase Drug Discovery Success
SAN JOSE, Calif. March 10, 2010 HTS laboratories are essential contributors to drug discovery, participating extensively in assay development and lead optimization as well as in primary and secondary screening of compound libraries. Effective screening strategies adopted by HTS laboratories include the use of more complex biological systems: more membrane-bound targets, more cell-based high content assays, and increased use of stem cells and primary cells.

Fifty-two directors from HTS laboratories and thirty-three executives from suppliers of HTS products and services in Asia, Europe and North America were extensively interviewed in a recently published study, High Throughput Screening 2010: Effective Strategies, Innovative Technologies, and Use of Better Assays, described technology and strategies that are evolving to increase success in drug discovery.

The ninth industry study published by HighTech Business Decisions "Biopharmaceutical Contract Manufacturing 2009: Expanding Markets, New Capacities and Improved Performance" reports that current contractor capacity utilization is slightly lower than 2006 levels. This temporary decline in utilization results from a combination of previous investment in capacity, improved expression yields, and slow down in biotechnology investments because of the current financial markets. Over the next few years, demand is expected to grow as new biopharmaceuticals move through the clinical pipeline and become commercial products.

William Downey, president of HighTech Business Decisions, explains, “We extensively interviewed 48 biomanufacturing and outsourcing directors of biopharmaceutical and biotechnology companies worldwide, and 29 biopharmaceutical contract manufacturers (“CMOs”). There is general consensus that the CMO industry as a whole will remain strong and grow, but the industry will undergo consolidations.”

The market for biopharmaceutical contract manufacturing is estimated to be US$2.6B in 2009, and long-term growth prospects remain strong through 2014. This 900-page report with 290 summary data tables and charts provide in-depth analysis of the dynamic factors impacting the industry, including new equipment and disposable technologies, improved expression levels, increasing competitiveness, changing outsourcing strategies, capacity forecasts, changes in outsourcing spending and margins, and biomanufacturing in low-cost regions.

Biopharmaceutical Contract Manufacturing Study Finds Industry Growth Over the Past Two Years and Expects to Continue its Growth Trajectory
SAN JOSE, Calif. June 9, 2009 The demand for biopharmaceutical contract manufacturing services is expected to grow at 16% annually over the next 5 years as biopharmaceutical business models shift toward more outsourcing of production requirements, as well as some large pharmaceutical companies choosing not to expand their internal capacities. Industry expression yields have improved significantly, and new technologies such as better expression systems, more efficient cell lines and improved media present new opportunities to improve productivity further.

The ninth industry study published by HighTech Business Decisions "Biopharmaceutical Contract Manufacturing 2009: Expanding Markets, New Capacities and Improved Performance" reports that current contractor capacity utilization is slightly lower than 2006 levels. This temporary decline in utilization results from a combination of previous investment in capacity, improved expression yields, and slow down in biotechnology investments because of the current financial markets. Over the next few years, demand is expected to grow as new biopharmaceuticals move through the clinical pipeline and become commercial products.

William Downey, president of HighTech Business Decisions, explains, “We extensively interviewed 48 biomanufacturing and outsourcing directors of biopharmaceutical and biotechnology companies worldwide, and 29 biopharmaceutical contract manufacturers (“CMOs”). There is general consensus that the CMO industry as a whole will remain strong and grow, but the industry will undergo consolidations.”

The market for biopharmaceutical contract manufacturing is estimated to be US$2.6B in 2009, and long-term growth prospects remain strong through 2014. This 900-page report with 290 summary data tables and charts provide in-depth analysis of the dynamic factors impacting the industry, including new equipment and disposable technologies, improved expression levels, increasing competitiveness, changing outsourcing strategies, capacity forecasts, changes in outsourcing spending and margins, and biomanufacturing in low-cost regions.

Biopharmaceutical Contract Manufacturing: Best Practices Pricing Study 2008.
SAN JOSE, Calif. October 1, 2008 HighTech Business Decisions has just published its new study: Biopharmaceutical Contract Manufacturing: Best Practices Pricing Study 2008. This 300-page report documents current industry price and contract practices for biopharmaceutical contract manufacturing. The report provides detailed analysis of both the prices paid by pharmaceutical and biotechnology companies and the prices charged by biopharmaceutical contract manufacturing organizations for outsourced production services. Also included in this report are prices for support services such as cell banking, process development, regulatory support and fill-and-finish.

William Downey, president of HighTech Business Decisions, explains, “Over the past two years, biopharmaceutical contract manufacturing industry prices have remained stable or increased slightly, according to most of the 31 biotechnology company executives and 16 biopharmaceutical contract manufacturing organizations interviewed for this study. Besides providing extensive pricing details, the respondents offered their insights about contract negotiations for outsourced production, and important issues covered under typical production contract terms.”

This report provides the reader with over 100 detailed charts and 60 tables covering detailed prices for the production of biologics using mammalian cell culture and microbial fermentation methods. The report also breaks down prices by tank size and product phase. Finally, the report also documents various price methods, such as price by gram, price by batch and price by facility time. More information on this report is available at www.hightechdecisions.com.

High Throughput Screening 2007: HighTech Business Decisions Reports New Strategies, Success Rates, and Use of Enabling Technologies.
SAN JOSE, Calif. December 7, 2007 HTS laboratories continue to evolve their processes and strategies to increase their success rates and improve efficiencies in their drug discovery efforts. New strategies include the use of phenotypic and pathway-based assays in primary or secondary screening, the use of new targets and the expansion in the diversity of compounds screened for new drug candidate leads. The Directors at HTS laboratories also plan to employ new technologies, including the use of label-free technologies and new detection systems to aid in finding new drug candidate leads.

HTS laboratories continue to show year to year success at producing new drug candidates. Fifty-five directors from HTS laboratories participating in this recently published study, High Throughput Screening 2007: New Strategies, Success Rates and Use of Enabling Technologies, identified 163 drug candidates that originated from their HTS laboratories, a significant increase from HighTech Business Decisions’ earlier study. With new HTS laboratories funded through NIH or other private foundations beginning to ramp-up their operations, this new report includes analysis and data from interviews with HTS laboratory directors at these centers to better understand their plans and their impact on drug discovery efforts.

William Downey, President of HighTech Business Decisions, explains, "HTS laboratories are taking on new challenges as they expand their role in drug discovery. In the past two years, the industry has seen consolidation in HTS laboratories as many pharmaceutical companies have either merged or acquired other operations. This consolidation along with the challenges to improve drug discovery efforts is leading to changes in the way particular HTS laboratories operate. In addition to the changes in commercial HTS laboratories, over the past two years publicly funded and non-commercial HTS laboratories have been started, and in the next few years these laboratories will ramp-up their operations.” HighTech Business Decisions extensively interviewed 55 Directors at HTS laboratories in Asia, Europe and North America.

The findings and analysis are in this 980–page industry report, High Throughput Screening 2007: New Strategies, Success Rates and Use of Enabling Technologies. This new study was published in December 2007, and it is available from HighTech Business Decisions.

Biopharmaceutical Contract Manufacturing: HighTech Business Decisions Report Indicates Improved Quality, Increased Capacity and Emerging Technologies Continue to Fuel Industry Growth.
SAN JOSE, Calif. February 2007 The demand for biopharmaceutical contract manufacturing services continues to expand as pharmaceutical and biotechnology companies increasingly rely on contractors to provide more production capacity and a wider range of services. There will be significant changes in the worldwide biopharmaceutical contract manufacturing industry over the next years as contract manufacturers add new capacity and expand their service offerings. In addition, new technologies are being deployed that will positively impact yields and productivity, including use of disposables, new host cell systems and perfusion technologies. As the biologics pipeline continues to grow, the biotechnology companies are increasing their use of novel product types such as antibody fragments, conjugates, and fusion proteins.

The seventh industry study published by HighTech Business Decisions, "Biopharmaceutical Contract Manufacturing 2007: Quality, Capacities and Emerging Technologies,” reports in 2007 and 2008, that contractor capacity utilization will increase over the next two years; however, longer term, supplies will be readily available as new capacity continues to come on-line and process improvements impact productivity.
 

William Downey, President of HighTech Business Decisions, explains, "We extensively interviewed 41 directors of biomanufacturing at pharmaceutical and biotechnology companies worldwide, and 27 biopharmaceutical contract manufacturers.  The biopharmaceutical CMOs are expanding and changing their business models with some of their clients to solve technology and capacity issues going forward.  In addition, several CMOs are working to increase manufacturing efficiencies by working with their customers in the areas of cell line development and process development. Others are implementing electronic batch record systems and other systems to boost efficiencies."
 

The market for biopharmaceutical contract manufacturing reached US $2.1B in 2006, and is forecasted to continue on its growth trajectory through 2008.  Based on revenues, the top biopharmaceutical CMOs include Avecia Biotechnology, Boehringer Ingelheim GmbH, Diosynth Biotechnology, Lonza Custom Manufacturing and Sandoz GmbH.  The report provides in-depth analysis of the dynamic factors impacting the industry, including new equipment and disposable technologies, improved expression levels, increasing competitiveness, changing outsourcing strategies, capacity estimates and forecasts, changes in outsourcing spending and margins, transgenics, and biomanufacturing in low-cost regions.  The report is 800 pages in length.

HighTech Business Decisions Issues New Pricing Study for the
Biopharmaceutical Contract Manufacturing Market
MORAGA, Calif. March 2006 HighTech Business Decisions has published a new pricing study documenting prices paid and prices charged for outsourced biologics production entitled, "Biopharmaceutical Contract Manufacturing: Best Practices Pricing Study 2006."  The production of biologics is often priced by the gram once the biopharmaceutical product in on the market, but during clinical trials, prices can be based on the number of batches, by time-in-the facility, by time and materials, or other creative pricing structures.  New partnering agreements are emerging between contractors and their customers, which provide a different pricing structure altogether.

Sandra Fox, president of HighTech Business Decisions, explains, "We spoke with 30 directors of biomanufacturing at pharmaceutical and biotechnology companies worldwide, and 16 biopharmaceutical contract manufacturers to document prices paid and prices charged in the industry.  In addition to prices, the respondents provided insightful suggestions regarding how to handle some of the thornier issues when negotiating a contract for outsourced production.   The most difficult issues for clients and their contractors to negotiate are agreeing on how to handle failed batches, termination and cancellation fees, intellectual property, and calculation of the final price."

This pricing report provides detailed charts on prices paid by pricing structure, technology, and tank size, and a summary of the best pricing practices in 40 different areas of industry concern.  More information on this 300-page report is available at www.hightechdecisions.com.  

High Throughput Screening 2005:
Steadily Increasing Success in Drug Discovery
MORAGA, Calif. October 2005 In 2005, HTS laboratories continue to take on more responsibility in drug discovery, with some expanding into target identification and validation, as well as in vitro ADME/Tox and lead optimization areas.  To increase drug discovery success, HTS laboratories are beginning to use high content screening as well, and almost all HTS laboratories conduct secondary screening in addition to primary screening.

Year to year, HTS laboratories steadily become more successful at producing drug candidates.  Directors from the 54 HTS laboratories participating in the recently published study, High Throughput Screening 2005: New Users, More Cell-Based Assays, and a Host of New Tools, identified 104 drug candidates that originated in their HTS laboratories that are currently being tested in humans, and four are on the market.

HTS laboratories are exploring novel targets and strategically expanding compound libraries to include more diverse backbones, more target-focused compounds, natural products, and biologics. The directors at HTS laboratories also plan to employ improved technologies, including further adoption of HCS and label-free technologies and more accurate liquid handling dispensers.

HTS laboratories funded through NIH or other private foundations have an increased presence, as more universities and institutes initiate translational research. This new report includes analysis and data from interviews with HTS laboratory directors at these centers to better understand their impact on the high throughput screening market.

William Downey, President of HighTech Business Decisions, explains, "High throughput screening is established as a critical activity in drug discovery. In the past two years, challenging targets have yielded to advances in assay and detection technologies. High content and label-free assays and new interest in stem cells as promising disease models are leading the way to improved drug discovery."

The findings and analysis are in this 1050-page industry report, with over 300 charts and tables, High Throughput Screening 2010: Effective Strategies, Innovative Technologies, and Use of Better Assays. This new study was published in February 2010, and is available from HighTech Business Decisions.

Biopharmaceutical Contract Manufacturing: HighTech Business Decisions Report Indicates New Capacity and Improved Processes Keep the Industry on the Cutting Edge
MORAGA, Calif. March 2005 The biopharmaceutical contract manufacturing industry is undergoing significant changes as it matures to a stable and reliable resource for the manufacture of biologics.  In addition to the new expression technologies, cell line development, and biomanufacturing platforms offered for mammalian cell culture and microbial fermentation, some contractors are gearing up to produce novel product types that require specific biomanufacturing expertise such as antibody fragments, fusion proteins, antibody drug conjugates, gene therapy, and novel proteins.

The sixth industry study published by HighTech Business Decisions, "Biopharmaceutical Contract Manufacturing 2005: Improved Processes and New Capacity for Pipeline to Commercial Production," reports that in 2004 and 2005, the industry has a slight excess of capacity as new capacity continues to come on-line and process improvements are being made. 

Sandra Fox, President of HighTech Business Decisions, explains, "We interviewed 51 directors of biomanufacturing at pharmaceutical and biotechnology companies worldwide, and 33 biopharmaceutical contract manufacturers.  The biopharmaceutical CMOs are forging stronger partnerships with some of their clients to solve capacity issues going forward.  In addition, several CMOs are working to increase manufacturing efficiencies by increasing yields, improving process development, optimizing media, using more efficient equipment, implementing better staffing and scheduling systems, streamlining analytics and testing, and solving some of the downstream bottlenecks."

The market for biopharmaceutical contract manufacturing reached US$1.7B in 2004, with healthy growth forecast for 2006.  Based on revenues, the top biopharmaceutical CMOs include Avecia Biotechnology, Boehringer Ingelheim GmbH, Cambrex Biopharmaceutical Services, Diosynth Biotechnology, DSM Biologics, Lonza Custom Manufacturing, and Sandoz  GmbH.

The report provides an in-depth analysis of the dynamic factors impacting the industry, including new equipment and disposable technologies, improved expression levels, increasing competitiveness, changing outsourcing strategies, capacity estimates and forecasts, changes in outsourcing spending and margins, transgenics, biogenerics, and biomanufacturing in low-cost regions.  The report is 850 pages in length.

High Throughput Screening:
Pushing for Higher Quality Leads
MORAGA, Calif. January 2004 In 2003, HTS laboratories took on more responsibility and became more closely aligned with the project teams, therapeutic areas, and medicinal chemistry departments to increase productivity for drug discovery. Directors from the 51 HTS laboratories participating in the recently published study, High Throughput Screening 2003: Improving Strategies, Technologies, and Productivity, identified 74 drug candidates that originated in their HTS laboratories that are being tested in humans and two are on the market. To increase drug discovery success, 89% of the HTS laboratories in this study now conduct secondary screens as well as primary screens, and 25% are conducting in vitro ADME/Tox screens.  Overall, more downstream and upstream screening is being done in HTS laboratories.

There is a concerted effort to improve the quality of the targets, the assays, the screening process, and compound libraries. A push for quantity and higher throughput in the past changed in 2003 to a push for higher quality screens that provide more information and quality leads.  Armed with better compound libraries, more experience with their libraries and targets, and virtual screening tools, many HTS directors are screening focused libraries.  One-third of the respondents in this study use virtual screening to help them generate focused libraries.

Sandra Fox, President of HighTech Business Decisions, says, "Most notable in the push for higher quality data is an increasing use of cell-based assays in high throughput mode.  For 2005, for the first time since we started conducting these studies, HTS directors predict cell-based assays will represent more than half of the assays they screen on average.  Cell-based assays can provide functional read-outs, permeability and cytotoxicity information, and provide a better prediction of how the compound will behave in the cellular environment." The industry report, High Throughput Screening 2003: Improving Strategies, Technologies, and Productivity was published in December 2003, and is available from HighTech Business Decisions.

HighTech Business Decisions Named One of the Top 100 Fastest Growing Private Companies in the Bay Area
MORAGA, Calif. October 2003 The San Francisco Business Times announced their 2003 list of the top 100 fastest growing privately held companies in the Bay Area at a gala reception on October 2 at the Argent Hotel.  HighTech Business Decisions ranked #33 on the list with a growth in revenues of 103.5% between 2000 and 2002.  Altogether, the top 100 companies boosted the Bay Area economy with a total of $3 billion in revenues last year, and employed more than 24,500 people.  The companies named grew anywhere from 14.4% to 3,234% from 2000 to 2002.

Biopharmaceutical Contract Manufacturing: New Capacity and Increased Funding for Biotechnology Companies Spur Growth
MORAGA, Calif. September 2003 The biopharmaceutical contract manufacturing market continues to grow as funding returns to the biotechnology sector and new capacity comes online at contract manufacturing sites.  In 2002, the downturn in the economy and numerous biopharmaceutical product failures in clinical trials caused a slight cutback in the number of biotechnology-based drugs being developed, and some manufacturing projects were put on hold.  This year, however, more biotechnology products are moving through the pipeline requiring increasingly larger volumes of production.   By 2008 to 2010, commercial-scale production of at least 50 new biotechnology products will be required.

The new industry study just published by HighTech Business Decisions, "Biopharmaceutical Contract Manufacturing: Serving the Growing Need for Biopharmaceutical Production," reports that in 2003, the industry is in a balance of capacity and needs. 

Sandra Fox, President of HighTech Business Decisions, says, "Typically, the industry goes through cycles of too little capacity versus too much.  In the past few years, capacity shortages drove contractors and pharmaceutical and biotechnology companies to build biomanufacturing capacity at an unprecedented rate.  The setbacks to the biotechnology community occurring in 2002, including restricted funding and some clinical failures, along with the newly built capacity, have brought the industry back in balance between capacity and needs.  The industry will continue to grow at a measured pace as biopharmaceuticals move through the pipeline to commerical scale and the new capacity continues to come online.  With the large number of biopharmacetical products expected to reach the market in the next 5 to 10 years, however, capcity shortages may again occur."

Biomanufacturing managers at pharmaceutical and biotechnology companies say that the top three reasons they outsource biomanufacturing are (1) lack of in-house capacity, (2) lack of in-house expertise and (3) a need for quick production of material.  The market for biopharmaceutical contract manufacturing is expected to grow from $1.3B in 2003 to $1.7B in 2004.  Major contractors providing mammalian cell culture or microbial fermentation production technologies include Abbott Bioresearch Center, Avecia Biotechnology, BioReliance Corp., Boehringer Ingelheim GmbH, Cambrex Biopharmaceutical Services, Dowpharma, GlaxoSmithKline Biopharmaceuticals, Lonza Custom Manufacturing, Diosynth-RTP, Sandoz GmbH, and DSM Biologics.

Pricing Structures, Prices Paid, and Typical Agreements for Outsourced Biopharmaceutical Manufacturing Revealed in New Study
MORAGA, Calif. Many pharmaceutical and biotechnology companies with drugs and vaccines in clinical trials and commercial markets rely heavily on the biopharmaceutical contract manufacturing industry for production of biologics.

Sandra Fox, President of HighTech Business Decisions, says, "The biopharmaceutical contract manufacturing industry is maturing, and best practices in agreements and pricing are being established. Contractors are building capacity to accommodate the tremendous increase in biologics in the pipeline, and in so doing, they are also working with clients to develop efficient contract agreements and pricing schedules that provide the foundation for long-term relationships."

A recent study published by HighTech Business Decisions documenting pricing and contract agreements in this industry, Biopharmaceutical Contract Manufacturing: Best Practices Pricing Study, is based on data from 30 biomanufacturing directors at pharmaceutical and biotechnology companies and 16 directors of business development at contractor companies worldwide. Data submitted provide an industry overview of the prices paid for the production of monoclonal antibodies, microbial recombinant proteins, and other biotech-based products using a variety of production technologies.

Altogether, the pharmaceutical and biotechnology companies surveyed are spending almost $400M annually on contract biomanufacturing for 52 products in various stages from Phase I/II to commercial. An average of 59% of the respondents' biomanufacturing budget is spent on outsourcing production of these products in 2002. The stage with the highest percentage of outsourced biomanufacturing is Phase III.

Dollars-per-kilogram is the typical pricing structure for Phase III and commercial products, but there are a variety of ways Phase I/II products can be priced, including batch pricing, time and materials, milestones, and suite time. Additional charges for process development, capacity reservations, cell banking, formulation, analytical services, and documentation can complicate the pricing methodology. In addition, upfront agreements regarding cancellation fees, ownership of process IP, technology transfer compensation, responsibility for defects, and annual price adjustments help ensure a satisfactory client-contractor relationship.

The industry report, Biopharmaceutical Contract Manufacturing: Best Practices Pricing Study, was published in November 2002, and is available from HighTech Business Decisions.

High-Throughput Screening Laboratories Poised for Growth
MORAGA, Calif. -- May 20, 2002 High-throughput screening has become the workhorse of pharmaceutical and biotechnology companies' drug discovery efforts, with expanding responsibilities and increasing pressure to screen more disease targets with better compound libraries to find high-quality leads. HTS is paying off. Directors from 54 HTS laboratories participating in the study, High-Throughput Screening 2002: New Strategies and Technologies, have identified 62 drug candidates that originated in their HTS laboratories that are being tested in humans.

Two distinct trends are emerging in high-throughput screening laboratories: (1) Some HTS laboratories are moving into a true industrialized laboratory with high-throughput, miniaturization, and increased efficiencies in data management and quality control; (2) Other HTS laboratories are working with more focused libraries and screening, using more cell-based assays and high information content screening. Almost all the major HTS laboratories now have expanded responsibilities and perform secondary screens. Some conduct in vitro ADME/Tox screens.

The number of HTS laboratories worldwide has decreased, however. A few major pharmaceutical companies have closed some HTS laboratories to consolidate laboratories and HTS efforts. Some laboratories have merged based on acquisitions and mergers of the parent companies. Although budgets are tighter this year, 61% of the HTS directors still expect to see budget increases for HTS, 28% expect budgets to remain flat, and 11% expect budgets to decrease.

Sandra Fox, President of HighTech Business Decisions, says, "Now that the dust is settling, the HTS laboratories appear poised for growth and expansion. Throughput is expected to double between 2001 and 2003. HTS directors continue to forecast many more targets and many more compounds being screened in their future, often with increased responsibilities to ensure the quality of the hits and leads. HTS directors are integrating the HTS laboratory more efficiently with other drug discovery groups within their companies to streamline the process. In addition, the adoption of high-throughput philosophies is spreading to other groups."

The industry report, High-Throughput Screening 2002: New Strategies and Technologies, was published May 13, 2002, and is available from HighTech Business Decisions.

Biopharmaceutical Contract Manufacturing: Capacity Crunch Requires New Strategies
MORAGA, Calif.-July 2, 2001 Several new blockbuster biotechnology-based therapeutics on the market require large volumes of capacity, causing contract biomanufacturers to be almost fully booked. The number of FDA approvals of biotechnology-based drugs year to year has been steadily rising since 1990, a trend that is expected to continue and cause a capacity crunch that will last for several years. A recent industry study published by HighTech Business Decisions, Biopharmaceutical Contract Manufacturing: Meeting Increased Demand for Capacity, reports that biopharmaceutical contract manufacturers are pushing 90% capacity utilization rates on average worldwide. Both pharmaceutical and biotechnology companies as well as the contractor companies are refiguring their strategies to meet this new challenge.

In the past, the primary risk was over-building, as several companies built facilities for therapeutics that in the end did not win FDA approval. Now, with more than 100 biotechnology-based drugs on the US market and hundreds more in the pipeline, there is a tremendous risk of under-building.

Sandra Fox, president of HighTech Business Decisions, says, "Without enough capacity, a company with a newly approved biotechnology product may lose millions of dollars in sales and lose a market advantage to competitive forces. Even those companies with in-house capacity may still not meet the needs of blockbuster drugs that are prescribed in high doses for chronic diseases. Some products may be dropped from a commercialization path because of the lack of capacity and never reach the market, depriving patients of needed therapeutics."

To solve the capacity crunch, many pharmaceutical and biotechnology companies are forming new manufacturing strategies that involve building in-house capacity while also securing strong relationships and long-term commitments with contract biomanufacturers. Some are investigating alternative manufacturing technologies, such as transgenic production, for products requiring high-volume capacity.

More than 89% of the contractors surveyed are planning expansions to meet the increasing demand for capacity. Some of the leading contractors are part of pharmaceutical or biotechnology companies with a history of manufacturing biotechnology products: Abbott Bioresearch Center and Abbott Laboratories Custom Pharmaceuticals, Biochemie GmbH, Boehringer Ingelheim GmbH, Chiron Corp., and GlaxoSmithKline Corp. Other leading contractors are part of a fine chemical or media company with a long-standing reputation for serving the pharmaceutical manufacturing marketplace: Avecia Biotechnology; Diosynth RTP, Inc. (formerly Covance Biotechnology Services); Cambrex Bio Science Inc.; The Dow Chemical Company, Contract Manufacturing Services; DSM Biologics; and Lonza Biotec and Biologics.

Leads from High-Throughput Screening Now in Clinical Trials
MORAGA, Calif.-January 10, 2001 High-throughput screening has become an important part of drug discovery programs at both pharmaceutical and biotechnology companies worldwide. Now, after years of screening and testing, drug candidates initially found using HTS techniques are moving into clinical trials. Directors from 50 HTS laboratories participating in the study, "High-Throughput Screening 2000: New Trends and Directions," identified 46 drug candidates that originated in their HTS laboratories that are being tested in humans.

Because many scientists believe it can take up to 10 years before a drug candidate is screened, optimized, and tested in humans, the true success of HTS is yet to be determined given the short time it has been in use. The earliest date that one of the 46 drug candidates was screened is 1992, whereas the most recent date is 1998.

Most HTS directors at the pharmaceutical and biotechnology companies predict they will be screening many more targets in the near future and cite genomics research as one source of the increasing number of targets. In addition, more compounds will be tested per screen. To meet these challenges, the directors are seeking technologies to facilitate higher-throughput. For example, the majority of HTS directors are using more 384-well microplate formats, primarily to increase throughput; reduce the use of scarce compounds, cells, membranes, and reagents; and to lower reagent costs. In a 1999 study, scientists predicted that by 2001, more than 40% of their primary screening would be in 384-well microplates on average.

That goal was reached one year early, in 2000, with scientists in the new study reporting that almost 45% of HTS is done in 384-well microplates on average. Sandra Fox, President of HighTech Business Decisions, says, "HTS directors are trying to meet drug discovery goals by increasing throughput and the information content of their screens. The pressure is on to ensure that the HTS operation provides therapeutic groups with valid leads in the shortest time possible. Products and services for high-density formats, new detection modes, improved automation, better assays and assay development platforms, multiplexing, diverse compound libraries, virtual screening, and bioinformatics are needed."

High-Throughput Screening for Drug Discovery: Trends in Assay Development Documented by New Report
MORAGA, Calif-November 1, 1999 A new report published by HighTech Business Decisions, High-Throughput Screening: Trends in Assay Development, provides a comprehensive look at pharmaceutical and biotechnology high-throughput screening (HTS) operations and assay development, the market, and the suppliers. HTS refers to the integration of technologies to rapidly assay thousands of compounds in search of biological activity for drug discovery. It is one of several tools pharmaceutical and biotechnology companies have to find leads for drug candidates.

The success of HTS as a strategy for drug discovery is well documented in the statements from HTS directors in this study. Most of these directors have found leads for drug candidates from their HTS operations and report that management has demonstrated a commitment to HTS. The participants in this study believe HIS is a cornerstone of an effective drug discovery strategy, and they are working internally and with suppliers to make improvements and generate innovations. HTS assays are designed around specific disease targets. Successful assay design, development, and validation are essential for the success of the HTS operation. The assay design affects the extent to which automation can be used, the cost of the screen, the sensitivity, and the ability to find hits. Improvements and innovations in assay development include the development of technologies that allow for multiple assays to be done simultaneously (multiplexing), that reduce the number of steps involved, that increase sensitivity, or that have increased biological relevance. Some HTS and assay development directors work with as many as 15 different types of assays.

Sandra Fox, president at HighTech Business Decisions, says, "HTS and assay development directors are under a lot of pressure to develop assays as quickly as possible for screening ensuring that the assay is optimized for HIS, is cost effective, has readily available reagents, and produces high-quality leads. Most directors in the study say they can find a way to build an assay around any important disease target." The new report includes an analysis of the fast-moving HIS market and its technologies including market size and growth, HTS workflow and organization, throughput, automation, assay types and development procedures, targets, detection modes, microplates and microchips, outsourcing, budgets, and supplier information. Summaries of interviews conducted by Ph.D. level analysts with 58 pharmaceutical and biotechnology HTS and assay development directors worldwide and profiles from 44 supplier companies are included in the 700-page report.

Biopharmaceutical Contract Manufacturing: New Report Documents Industry Growth
MORAGA, Calif.-May 10, 1999 Outsourcing of biopharmaceutical manufacturing is gaining in popularity and the market is quickly approaching $1B worldwide. Biotechnology companies need to be fast and flexible, and outsourcing allows these companies to produce products without the risk of investing in facilities and employee expertise. Some of the large pharmaceutical companies are making strategic shifts away from full integration, moving toward more outsourcing to avoid capital expenditures, to gain access to expertise and capacity, and to shorten the time to market. A new report published by HighTech Business Decisions, Biopharmaceutical Contract Manufacturing: Market Analysis of the Potential for Growth, provides a comprehensive study of pharmaceutical and biotechnology companies, their manufacturing strategies and outsourcing practices, the market, and the suppliers.

Contractors are manufacturing a wide variety of products for pharmaceutical and biotechnology companies, from commercial to preclinical stage. Covance, a major supplier of contract manufacturing services recently announced a long-term agreement to manufacture Retavase (TM) for Centocor Inc. The LONZA Group has an agreement with Eli Lilly and Company to develop and manufacture Lilly's Activated Protein C (APC). Chiron manufactures Betaseron(r) and Regranex(r) for its partners Berlex Biosciences and Johnson and Johnson. Genzyme Transgenics has an agreement with BASF to develop a humanized antibody in milk from transgenic goats. New suppliers in this industry include SmithKline Beecham Biopharmaceuticals, which has entered the market by offering contract manufacturing services focused on mammalian cell culture. IPT-Monsanto has entered the industry by offering microbial and plant culture services and whole plant transgenics. These developments are indications of a dynamic industry that has significant growth potential.

Sandra Fox, president of HighTech Business Decisions, says, "Outsourcing is attractive because it provides the flexibility needed whether a product fails in clinical trials or proves to be a tremendous success. This attractiveness, combined with suppliers' expanding capacity and expertise and the increasing number of biopharmaceuticals entering the pipeline indicate the industry is in for a substantial growth cycle."

The new report includes an analysis of the rapidly evolving biopharmaceutical contract manufacturing market, summaries of interviews conducted by Ph.D. level analysts with 45 pharmaceutical and biotechnology manufacturing directors worldwide, and profiles of 66 supplier companies. Information on the 500-page report, Biopharmaceutical Contract Manufacturing: Market Analysis of the Potential for Growth, is available by calling Sandra Fox at (925) 631-0920. HighTech Business Decisions is a market research and consulting firm serving clients in high-tech markets.

Biopharmaceutical Contract Manufacturers: Gearing up for Increased Outsourcing
MORAGA, Calif.-October 28, 1998 Outsourcing of biopharmaceutical manufacturing is gaining in popularity, whether or not a biotechnology or pharmaceutical company has in-house capability. Biotech companies need to be fast and flexible, and outsourcing is an important part of this flexibility. Some of the large pharmaceutical companies are making strategic shifts away from full integration, moving toward more outsourcing for lower costs, to gain access to expertise and capacity, or to shorten the time to market. Considering the unique requirements for the production of biopharmaceuticals and the cost of building and maintaining capacity, it is no wonder that outsourcing is becoming an important manufacturing strategy. Today, the majority of the biotechnology and pharmaceutical companies are outsourcing at least part of their analytical lab or manufacturing requirements.

This year, an important collaboration was announced between Eli Lilly and Company and the LONZA Group to develop and manufacture Activated Protein C (APC). Manufacturing proteins such as APC on a large scale can be complex and costly. The announcement from Eli Lilly suggests that the LONZA alliance will help Lilly bring its product to market faster and with lower fixed costs. DSM Biologics and Megabios announced a partnership whereby DSM will manufacture DNA plasmids and lipid-DNA complexes using Megabios' proprietary manufacturing technology for the gene therapy industry. Boehringer Ingelheim Pharma KG recently announced it will manufacture a moncolonal antibody product for MedImmune. Covance is manufacturing several therapeutics that are entering clinical trials.

To document the growing outsourcing market for biopharmaceutical manufacturing, HighTech Business Decisions is designing a comprehensive market research report on the industry. In-depth interviews with decision-makers from at least 40 pharmaceutical and biotechnology companies worldwide will be conducted by Ph.D. analysts. The report also will include profiles from more than 70 biopharmaceutical contract manufacturing suppliers providing a wide variety of manufacturing-related services, such as microbial fermentation and/or cell culture production with purification, process development, cell banking, virus production, analytical testing, biosafety testing, fill and finish including lyophilization and formulation, labeling, storage, and distribution. Contractors worldwide will be profiled. Companies that want to obtain this comprehensive and timely industry report at a shared cost per sponsor should call HighTech Business Decisions for details. HighTech Business Decisions is a market research and consulting firm serving clients in biotechnology and electronics markets. Sandra Fox, president, has ten years of experience providing clients with important information about customers and suppliers in these industries.