Similar to what the CRO industry experienced in the ten years from 2005-2015, consolidation has turned its sights on the CMO and CDMO sector. Leading global providers as well as smaller, specialty service providers are the target of acquisition efforts to gain/dominate market share. In line with increased outsourcing within the pharma/biopharma industry, demand for greater capacity, advanced technologies, and global infrastructure, for increasingly complex drug products, namely biologics, has prompted a flurry of M&A within the past nine months.
Most recently, Catalent entered an agreement to acquire Cook Pharmica for $950 million, significantly expanding its position in biologics development and analytical services, manufacturing, and finished product supply.
Cook Pharmica operates an 875,000 sq.-ft. development and manufacturing facility in Bloomington, IN with capabilities across biologics development, clinical and commercial cell culture manufacturing, formulation, finished-dose manufacturing, and packaging. For the twelve months ended June 30, 2017, the company generated $179 million in revenue.
Additionally, 3SBio Inc., a Chinese biopharmaceutical company, through a joint venture formed with CPE Funds, acquired the CDMO business of Canada-based biologics manufacturer Therapure Biopharma for $290 million. With this acquisition, 3SBio enters the North American biopharmaceutical sector, and expands its CDMO business with manufacturing assets that enhance its technical biologics capabilities.
Therapure Biopharma provides therapeutic protein development and manufacturing services, including technology transfer and process development, analytical development and testing, scale-up and cGMP manufacturing and aseptic fill/finish and lyophilization.
In June, Albany Molecular Research was acquired by affiliates of The Carlyle Group and GTCR for $922 million. AMRI, a global contract research and manufacturing organization with locations in North America, Europe and Asia, has business segments including Discovery and Development Services (DDS), Active Pharmaceutical Ingredients (API), Drug Product (DP), and Fine Chemicals (FC).
In another major deal, Thermo Fisher Scientific, a leading maker of scientific instruments, acquired Patheon, a contract development and manufacturing organization for $7.2 billion, expanding its capabilities and efforts to become a one-stop shop for drug development and manufacturing services.
Patheon has a network of facilities primarily in North America and Europe, and employs approximately 9,000 professionals worldwide. Earlier this year, Patheon acquired a 300,000 sq.-ft. API manufacturing facility in Florence, SC, from Roche Holdings, expanding the company’s capacity for manufacturing highly potent compounds and adding capabilities to support solid-state chemistry, micronization, and eventually, commercial spray drying. This was the company’s sixth acquisition in the last five years to expand pharma development and manufacturing services.
The company generated 2016 revenue of approximately $1.9 billion and will become part of Thermo Fisher's Laboratory Products and Services Segment.
In December 2016, Lonza acquired Capsugel for $5.5 billion in cash, expanding its market reach and contract development and manufacturing products businesses. The acquisition aims to integrate services in drug development, formulation, delivery technologies and manufacturing for the global pharma and consumer healthcare industries. The combined business will offer active pharmaceutical ingredients (APIs) and excipients to dosage forms and delivery technologies.
Capsugel brings advanced oral dosage delivery technologies, including its hard capsule technologies, and the combined technologies and offerings will provide services in both large and small molecules. The company has approximately 3,600 employees and 13 facilities on three continents. The combined business would have had combined 2015 revenues of approximately CHF 4.8 billion.
APIs, Early Development and Beyond
In the early development arena, several CDMOs have expanded capabilities into later phases of the development and manufacturing process. For example, Evotec acquired Aptuit for $300 million, strengthening its outsourced drug discovery and development services. Aptuit offers services across drug discovery, preclinical testing and both drug substance and drug product manufacturing.
Aptuit provides early discovery to mid-phase drug development services to the pharma and biopharma industry. It has approximately 750 employees working across three discovery, development and manufacturing facilities in Europe (Verona, Italy; Basel, Switzerland; and Oxford, UK).
The acquisition substantially expands Evotec’s business and extends its offering through to investigational new drug (IND) submission and beyond to integrated drug substance and drug product and commercial manufacture.
In July, STA Pharmaceutical, a WuXi AppTec group company, merged with WuXi AppTec’s Pharmaceutical Development Services (PDS) division.
The PDS division offers pre-formulation development, formulation development, as well as clinical trial material (CTM) manufacturing, packaging and labeling of oral solid dosage forms including tablets, capsules, sachets and oral solutions/suspensions. PDS also established various enabling technology platforms for low soluble drugs including spray dried dispersion, hot melt extrusion, micro or nano suspension and liquid-filled hard gelatin capsules. Two commercial-scale drug product manufacturing facilities currently under construction are expected to become operational later this year and early next year, respectively.
STA Pharmaceutical, after this merger, will provide small molecule active pharmaceutical ingredient (API) and drug product services and enables STA to advance new chemical entities from preclinical stage to new drug application (NDA) and to market.
Growth in the Cell Therapy arena has also prompted capability expansions. In June, Lonza acquired PharmaCell B.V., a cell and gene contract manufacturer in Europe with employees in Maastricht and Geleen (NL). In 2016 PharmaCell had sales of €11 million.
PharmaCell was primarily selected due to its core expertise in autologous cell and gene therapy manufacturing, which includes experience with two commercial advanced therapy medicinal products (ATMPs)-licensed products. Autologous therapies use a patient’s own cells.
Established in 2005 when cell manufacturing was still in its infancy, PharmaCell has since been the manufacturer of the only two European-approved commercial cell therapy products. PharmaCell has more than 6,000 square meters of GMP clean rooms, QC and other support spaces.
In August, the FDA approved the first cell therapy, Novartis’ chimeric antigen receptor T cell (CAR-T) cell therapy, Kymriah for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL). It is the first FDA-approved CAR-T immunotherapy, which uses specifically developed Cell Therapy Systems (CTS) Dynabeads technology, part of Thermo Fisher's Cell Therapy Systems (CTS) portfolio. The magnetic beads isolate, activate and expand T cells that have been genetically engineered to recognize and fight cancer cells in each individual patient.
In cell therapy manufacturing, CTS Dynabeads CD3/CD28 beads deliver a scalable platform that help to streamline production with high reproducibility. Dynabeads products are for research use only or for the manufacturing of cell-, gene- or tissue-based products.
These highly sophisticated therapies will require equally advanced capabilities for service providers. We can expect to see more M&As drawing on the expertise of successful CMO/CDMOS.